Modern Pharmaceuticals - April 2012 by Infomedia18

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Editorial

The do’s of Budget dose ow much does it mater if one calls the Union Budget 2012-13 another missed opportunity or a cautious step? What’s worrying is the apparent hiatus between the industry’s overall expectation in terms of reversing the economy’s sluggish pace of growth by undertaking big-ticket reform measures and the status-quo of budgetary proposals. Seemingly ill-timed, the government’s message lacks a coherent and comprehensive stance towards shoring up weak investment sentiments and has unveiled only a few anti-deficit measures that include a raise in service and excise taxes.

If that is not all, the budgetary proposal to amend the Income Tax Act with retrospective effect has perhaps made the biggest dent on the long-term fiscal credibility of India story, not only outside but inside the country as well. It has come as a bolt from the blue when the national economy is pitted against tapering growth on one side and growing maturity of Indian manufacturing on the other, and hence, the domain seems set to see a higher flow of foreign investment. From a sectoral perspective, there is a bonanza to the pharmaceutical industry by extending weighted deduction of 200 per cent for R&D expenditure in an in-house facility for an additional period of five years beyond March 31, 2012. On the other, the rise in Service Tax from 10 to 12 per cent can potentially pull down the prospects of Indian pharma. So, while this Budget may have missed the booster dose for the industry, the need of the hour is to exercise ample jurisprudence and ensure that the India growth story stays on course.

Editorial Advisory Board Ajit Singh Chairman, ACG Worldwide & Head, ISPE

Dr Abraham Patani Past President, IDMA & CMD, Inga Laboratories

Dr Gopakumar G Nair

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Manas R Bastia manas@infomedia18.in

April 2012 I Modern Pharmaceuticals

Contents

REGULAR SECTIONS 7

Editorial

12 News, Views & Analysis

69 Event List 71 Book Review

In Conversation With

22 Technology & Innovation 72 Products

E Venu Madhav COO, Veeda Clinical Research

26 Technology Transfer

84 List of Products

67 Projects

85 List of Advertisers

Special Focus

IT in pharma ................................... 31

Post-Budget Analysis A ‘taxing’ Budget! ......................................................20

Automation Trends Pharma labelling and packaging On a fast track ............................................................54 Specialised IT service providers ...................................... 32 Cloud computing in pharma .......................................... 34

Energy Management

Interface - Sayantan Roy ................................................ 36

Plantwide energy optimisation Providing a holistic approach......................................56

Roundtable .................................................................... 38

Ajay Narula, Manager - Sustainable Solutions, Rockwell Automation India Pvt Ltd

Policies & Regulations Policies governing drug counterfeiting New solutions in store ................................................58

Facility Visit

Ashiﬁ Gogo, CEO, Sproxil Inc

Protection of agro-biotech inventions How patent laws can help? .........................................60

Indoco Remedies Ltd Streamlined processes = Stable growth

Anuradha Salhotra, Managing Partner, Lall Lahiri & Salhotra

Insight & Outlook

Cleanrooms .......................... 43

Strategy Internal staﬀ communication The key to smooth functioning ...................................64 Rajendra Pratap Gupta, International Healthcare Policy & Retail Expert

Tips & Tricks Indian cleanrooms market ............................................. 44 New design concepts in cleanrooms ................................ 46

Social media marketing Guidelines for pharma companies ..............................66 Susan Josi,Managing Partner, Sorento Healthcare Communications Pvt Ltd

Interface - Jignasu Mehta .............................................. 48

Highlights of Next Edition

Endometrial cancer therapeutics market ......................... 49

Special Focus: Nutraceuticals Insight & Outlook : Active Pharmaceutical Ingredients

Destination Ireland ........................................................ 50 Pharmaceutical branding ................................................ 52

Details on page no.: 39 April 2012 I Modern Pharmaceuticals

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April 2012 I Modern Pharmaceuticals

News,Views & Analysis Biocon Research Centre inaugurated by Nobel Laureate Prof Kurt Wüthrich Biocon,recently announced the inauguration of its state-of-the-art Integrated Research & Development Centre, by Noble Laureate Prof Kurt Wüthrich. Biocon Research Center (BRC), is aimed at pursuing world class research on biologics that will address unmet medical needs. BRC is a ﬁrst-of-its-kind facility in South-East Asia. Prof Kurt Wüthrich said, “I am quite enthralled with the BRC’s capability which is at par with international standards. I will keenly watch the outcome of innovation from this centre

(L-R): Wuthrich inaugurating BRC with Shaw

as I see a lot of promise in the scientiﬁc talent at Biocon.” Kiran MazumdarShaw, CMD, Biocon Group, said, “We

Sanofi launches immunisation awareness campaign In a run-up to the World Immunization Week in April, Sanofi Pasteur India, announced the launch of ‘I for Immunisation’ its nation-wide campaign to spread awareness on the importance of immunisation in India. Today, immunisation saves more than 3 million lives every year. With appropriate efforts, immunisation could prevent four to five million child deaths a year by 2015. Through the ‘I for Immunisation’ campaign, Sanofi Pasteur aims to sensitise citizens not only on the importance

of immunisation but also involve them as agents for change. Dr Joselito Sta Ana, Executive Director, Sanofi Pasteur India, stated, “After Louis Pasteur invented the world’s first vaccine, Sanofi Pasteur remains committed to its vision of a world in which no one suffers or dies from a vaccine-preventable disease.” Launched in association with Pantaloons Femina Miss India 2012, this campaign will also address the issues related to suboptimal coverage through education activities using on-ground and digital mediums.

Piramal to raise R&D spend for cancer drugs’ trials Piramal Healthcare is set to increase investment in this ﬁscal year on R&D as they plan to initiate the second phase of clinical trials for two oncology molecules. Previously, Piramal was spending approximately ` 121 crore on R&D, now they plan to increase the investment to ` 200 crore in 2012-13. It has successfully completed the phase I trial for tumour suppressor molecule P1446A-05, while its blood cancer treatment molecule P2745 is in the last stages of ﬁrst phase trials. The phase II trials for the same are expected to begin in 3-6 months, whereas the phase I trial for P2745 will end later this year or early next year.

Waters introduces new product line of traceable, certified analytical standards and reagents Waters Corporation has launched a new product line of analytical standards and reagents consisting of an initial portfolio of more than 200 pre-formulated reference materials and reagents for the scientiﬁc laboratory. Reagents Waters will manufacture its standards and reagents at a newly-built facility in Golden, Colorado. From small-molecule, single-component standards to protein digest and glycan standards, Waters Analytical Standards and Reagents will be available on a worldwide basis. The company will

will pursue an innovation-led effort to develop advanced yet affordable solutions for several debilitating diseases. It will epitomise Biocon’s efforts to galvanise the best talent available globally, and offer them an intellectually stimulating environment combined with an enabling ecosystem to conduct path breaking research for biopharmaceuticals.” A team of over 300 scientists based at BRC housed in Biocon Park, will be engaged in cutting-edge biologics research.

continue to add new products to its portfolio in response to customer demands. “For validated LC and LC/MS analyses, standards and reagents play a vital role in achieving optimal performance and compliance. They must be formulated from pure starting materials, mixed appropriately, analysed for stability, and documented correctly,” said Mike Yelle, Senior Director Chemistry Commercial Operations, Waters Division. A hallmark of Waters Standards and Reagents is absolute traceability.

Aurobindo receives US FDA approval for quetiapine fumarate tablets Aurobindo Pharma Ltd has received approvals from the US Food & Drug Administration (USFDA) to market quetiapine fumarate tablets 25 mg, 50 mg, 100 mg, 150 mg, 200 mg, 300 mg and 400 mg (ANDA 091388). These are the generic equivalent of AstraZeneca LP’s Seroquel® tablets 25 mg, 50 mg, 100 mg, 150 mg, 200 mg, 300 mg and 400 mg. Quetiapine fumarate tablets are indicated for the treatment of serious psychotic disorders such as schizophrenia and bipolar disorder and falls under the neurological (CNS) therapeutic category. The product has been approved out of Unit III facility in Hyderabad, India. Aurobindo now has a total of 147 ANDA approvals (118 ﬁnal approvals and 29 tentative approvals) from US FDA.

Modern Pharmaceuticals I April 2012

News,Views & Analysis Piramal presented data on its investigational drug candidates at the AACR well as mechanistic studies for all three compounds Piramal Healthcare Ltd presented data on three of will be discussed. Currently, both P1446A-05 its investigational new drug candidates at the annual and P2745 are undergoing Phase I clinical trials meeting of the American Association for Cancer and an IND application for conducting Phase I Research (AACR) that concluded recently in Chicago. clinical studies has been filed for P7170. The Annual Meeting of the AACR is one of the Dr Swati Piramal, Director, Piramal largest annual scientific meetings covering all major Healthcare, stated, “We are pleased to present key areas of cancer research. Each year more than 17,000 results of the preclinical evaluation of our lead participants from over 60 countries gather to present anti-cancer candidate molecules at this important and discuss basic, translational and clinical research in international scientific meeting. Our work in this every sub-discipline. Dr Piramal area reaffirms our commitment to changing the Cancer is a complex group of diseases fuelled by various underlying mechanisms. R&D at Piramal is built paradigm of drug discovery by using Indian drug discovery on recent discoveries in molecular genomics, rational drug capabilities to build a diversified and strong pipeline of products design and state-of-the-art drug discovery technologies. The to address unmet medical needs.” Dr Somesh Sharma, Chief Executive Officer, Drug four poster presentations from Piramal Healthcare reported results from preclinical studies of the following lead clinical Discovery and Development, Piramal Healthcare, stated, candidates: P1446A-05, an orally active cyclin-dependent “We are excited to present to the international scientific kinase inhibitor; P2745, an orally bioavailable molecule community our data on three promising anticancer compounds, effective in imatinib-resistant chronic myeloid leukemia cell two of which are undergoing Phase I clinical trials. These are lines including those with the T315I mutation; and P7170, very encouraging results, which extend our understanding an orally active PI3K/mTOR and ALK-1 inhibitor with anti- of the mechanism of action and anti-tumour activity of our tumour and anti-angiogenic activity. In vitro and in vivo data as clinical candidates.”

MediSeal in agency representation pact with Salesworth MediSeal Pharma Technology Solutions, Germany, for many decades has been supplying worldrenowned packaging machines to its customers in the pharmaceutical and cosmetics industry. MediSeal recently signed an agency representation agreement with Salesworth Synergies Pvt Ltd, one of India’s leading agencies houses representing world reputed machine manufacturing companies primarily in the ﬁeld of pharmaceutical

industry for exclusive representation throughout India. This development adds an important sales and customer support channel for MediSeal and is expected to have a signiﬁcant eﬀect on the company’s market growth in the region. The company has a wide customer network and extensive service capabilities that are ideally suited to help MediSeal expand its activity in this rapidly growing market.

Ranbaxy receives approval to market RAN™- rosuvastatin in Canada Ranbaxy Pharmaceuticals Canada Inc (RPCI), a wholly owned subsidiary of Ranbaxy Laboratories Ltd (RLL), announced that RPCI has received approval from Health Canada to manufacture and market RAN™Rosuvastatin tablets to the Canadian healthcare system. Rosuvastatin is a HMG-COA Reductase Inhibitor (cholesterol-lowering medication). “We anticipate making rosuvastatin tablets available to all classes of trade after April 2 when suﬃcient supplies are available to meet market demand,” said Paul Drake, President and General Manager, RPCI, Canada.

Sigma-Aldrich enhances Asia-Pacific customer support with new distribution and packaging capabilities in India Sigma-Aldrich Corporation recently completed a 57,000-square-foot expansion of its Bengaluru, India, campus. The expansion, which includes an expanded distribution centre and new packaging facility, enhances the company’s distribution capabilities in the Asia-Paciﬁc region, increasing operational excellence in one of the industry’s key markets. The new additions complement existing R&D, custom synthesis and manufacturing infrastructure and expand a localised

approach to better support customers in India as well as the Asia-Pacific region. “Sigma-Aldrich has built a strong foundation, achieving consistent doubledigit sales growth driven by our first mover advantage, our approach in providing excellent service, our investments and our high standards for operation. A key focus in the Asia-Pacific and Latin America regions has been to accelerate localisation to continue to drive further growth,” said Eric Green, Vice President and Managing

Director International, SigmaAldrich. This latest expansion enables Sigma-Aldrich to provide turnkey services at the Bengaluru site - improving service levels for customers in the region. The new addition features approximately 49,000 square feet of distribution space and 8,000 square feet of packaging space. The existing 10-acre campus will continue to house the administrative oﬃces, sales, marketing and distribution functions and manufacturing.

Modern Pharmaceuticals I April 2012

News,Views & Analysis AstraZeneca and Nobel Media bring Nobel Laureate Peter Doherty to India AstraZeneca and Nobel Media AB, the company responsible for managing and developing media rights in connection with the Nobel prize, recently brought 1996 Nobel Laureate in Physiology or Medicine Professor Peter Charles Doherty to the Indian Institute of Science (IISc) in Bengaluru. Professor Doherty spoke on Science Protects Humanity: Adventures in Infection and Immunity. The AstraZeneca Nobel Medicine Initiative was a global co-operation to bring the inspiring achievements of nobel laureates in physiology or medicine to the attention of a worldwide audience and to inspire the scientiﬁc community

he would also play a major role and demonstrating how in all the future products of such discoveries are AstraZeneca. critical to advancing Dr Manos Perros, Vice our understanding of President and Head - Infection how the human body Innovative Medicines Unit, works. Peter Doherty AstraZeneca, said, “In particular, and fellow recipient an important part of our Rolf Zinkernagel R&D eﬀorts in Bengaluru are were awarded the focussed on Tuberculosis (TB) 1996 Nobel Prize in Nobel laureate Doherty where we collaborate with Physiology or Medicine for their discovery of how the immune local and global partners in the system recognises virus-infected cells. development of medicines to treat this AstraZeneca would also be using the disease in both its drug sensitive and guidelines provided by Professor Doherty drug-resistant forms.” to manufacture TB vaccines in India and - Jasleen Kaur Batra

MSD and Safe Water Network in pact to reduce impact of water-borne disease in India MSD and Safe Water Network, announced the launch of a three-year, $ 1.5 million partnership to increase access to safe water and reduce the impact of water-borne diseases among impoverished communities in Andhra Pradesh, India. “Clean water is fundamental to the world’s health and to MSD’s mission of ﬁghting disease and helping the world be well,” said K G Ananthakrishnan, Managing Director, MSD India. Building on Safe Water Network’s ﬁeld activities in the area, this collaboration will provide clean water to additional villages in Andhra Pradesh and develop demand generation programmes that seek to increase household usage.

Dr Swati Piramal honoured with a Padma Shri award Dr Swati Piramal, Director, Piramal Healthcare Ltd, has been honoured with the prestigious Padma Shri award by the President of India, Prathiba Patil, for her exceptional and distinguished contribution to the field of trade and industry. On receiving the award, Dr Piramal said, “I would like to express my gratitude to the Government of India for recognising my contribution in the field of science, medicine, research and development. I dedicate this award to all my women colleagues. I hope the award motivates every woman in the country to fulfill her dreams.”

Phosphagenics enters manufacturing deal with Intas Australian drug delivery technology company Phosphagenics has signed a licensing agreement with India’s Intas Pharmaceuticals. The agreement is intended for the manufacture and sale of three anti-ageing products speciﬁcally formulated by Phosphagenics for the Indian market. Under the deal, Intas will pay an undisclosed royalty and will market the new products, incorporating Phosphagenics’ patented Targeted Penetration Matrix (TPM) technology across India. Esra Ogru, CEO, Phosphagenics, said, “The company is expected to launch a full dermatological line of personal care products in India if the ﬁrst three products are a success. TPM is a patented topical and transdermal delivery technology, which enables superior delivery of various active ingredients into or through the skin.”

Stempeutics announces development of Stempeutron™ stem cell isolation device Stempeutics Research, a group company of Manipal Education & Medical Group announced the development of an innovative point-of-care, fully automated stem cell isolation device named ‘Stempeutron™’ - to obtain a population of cells, collectively known as the Stromal Vascular Fraction (SVF) from adipose or fat tissue. SVF cells have signiﬁcant potential in plastic and reconstructive surgery applications such as soft tissue augmentation for post mastectomy breast reconstruction/ cosmetic breast augmentation, facial restructuring, deformity correction, scar and wrinkle reduction, etc. “When we talk about the biotech market it is mainly based on medicine, which addresses the symptoms but not the root

of the disease, but with this device we will be able to address the root cause of the disease. This will be an innovative device launched in India that has been developed indigenously by us in technical collaboration with Vignani, Bengaluru – a pioneering engineering services company. This device is going to push the growth of the overall biotechnology market and the cosmetic surgery market in India,” said BN Manohar, CEO, Stempeutics Research. The innovation in Stempeutron™ lies in the isolation, puriﬁcation and concentration of clinical grade SVF cells without centrifugation, which is the conventional process for recovering these cells. The device will be ready for marketing by early 2014. - Titash Roy Choudhury

Modern Pharmaceuticals I April 2012

News,Views & Analysis Onco receives USFDA nod for methotrexate injection Onco Therapies Ltd, a wholly owned subsidiary of Strides Arcolab Ltd (Strides), recently announced that it has received US FDA approvals for methotrexate injection USP 25 mg/ml packaged in 1 gram/40 m, 50 mg/2 ml, 100 mg/4 ml, 200 mg/8 ml and 250 mg/10 ml single dose vials (preservative-free).

Methotrexate is among the products in the drug shortage list of US FDA. According to IMS data, the US market for generic methotrexate is approximately $ 13 million. Methotrexate is part of the oncology portfolio licensed to Pﬁzer in January 2010 for the US market and expected to be launched shortly.

Schott Glass India holds FIOLAX in Chandigarh Leading pharma companies from India were recently given the chance to learn more about the benefits that high-quality primary pharma packaging made of glass has to offer for packaging manufacturers and drug companies alike. Protecting medications from harmful environmental influences and preserving their efficacy during shelf-life were two of the important topics discussed. Around 50 representatives from 17 pharma companies based in North India participated in a SCHOTT FIOLAX® academy event held in Chandigarh. SCHOTT is a recognised leader in the field of glass

and glass tubing with over 100 years of experience. “When it comes to supplying safe and dependable pharma packaging, quality really starts with producing the best quality raw material locally, if possible. This is where we come into the picture,” explains Sundeep Prabhu, Vice President - Sales and Marketing, SCHOTT Glass India Pvt Ltd. SCHOTT Glass India is currently the only local glass tubing manufacturer that has successfully implemented a quality management system certiﬁed by Germany’s TÜV Rheinland in accordance with the international standard ISO 9001:2000.

Yale Nobel laureate creates compound that halts growth of malaria parasite A drug candidate that has shown promise for neutralising dangerous bacteria also prevents the parasite that causes malaria from growing, new research by a Yale University team headed by Nobel laureate Sidney Altman shows. The compound created in the labs of Altman and co-senior author Choukri Ben Mamoun at the Yale School of Medicine, penetrates red blood cells and targets molecular machinery that enables the parasite to grow within the cells. “While we primarily looked at one species of parasite, it is clear the compound also knocks out drug-resistant strains of malaria as well,” Altman said. This compound can wipe out strains that are currently resistant to drugs such as chloroquine and pyrimethamine.

Piramal announces approval of BST-CarGel® Piramal Healthcare Ltd has testimony of Piramal Healthcare’s received the European CE commitment to become an innovation-led healthcare mark approval for its innovative company,” said Dr Swati Piramal, bio-orthopaedic product for Director, Piramal Healthcare. cartilage repair, BST-CarGel®.This Ajay Piramal, Chairman, approval enables the company to Piramal Group, commercialise BSTsaid, “The current CarGel® in all countries European approval of EU. Furthermore, provides access to the this approval will $ 200 million market serve as the basis to in Europe.” Piramal obtain commercial Healthcare plans to authorisation in other BST-CarGel® launch BST-CarGel® geographic areas of the world such as the Middle East, for sale in the fourth quarter of the Asia Paciﬁc region, South 2012 after completing user studies America and other countries with key opinion leaders. Piramal invested into the technology in including India. “We are looking forward to 2006 and subsequently in 2010, launch BST-CarGel® to treat acquired the assets relating to patients with cartilage injuries BST-CarGel® from BioSyntech of the knee around the world. Technologies Inc, a company The approval of this product is a located in Montreal, Canada.

Enaltec Labs® awarded ‘Fastest Growing SME Company’ consistent growth reinstates Enaltec Labs® has won the a big conﬁdence for people coveted position of CNBC associated with the company. It ICICI Bank’s Fastest Growing is certainly a proud moment for SME Company. Set up in 2006 us and the team, and this award Enaltec has so far developed and recognition belongs to the and commercialised more team,” said Anand Shah, MD than 50 products, in various & CEO, Enaltec. therapeutic segments and Part of the duo, Emerging has presence in more than Anand Shah India Awards 2012 recognising 30-35 countries. “After this kind of recognition and budding entrepreneurs, the awards was being in business for last 5 years with handed over to Anand Shah, MD &

April 2012 I Modern Pharmaceuticals

CEO, Enaltec, Susheel Koul, Director Operations, Enaltec and Dr B V Sivakumar, Chief Scientific Officer, Enaltec. “Future plans are getting into creating IP of new products, which are still in Phase III or Phase IV trials, in making innovative and cost-effective process. Getting in bigger way for P2P business (ie, formulation out licensing business in India) and also focus on countries such as South America, East Europe and Asia Pacific,” informed Shah.

News,Views & Analysis Biocon and Pfizer conclude commercialisation agreement Biocon and Pﬁzer recently announced the conclusion of their alliance to commercialise Biocon’s biosimilar versions of insulin and insulin analog products. As of March 12, 2012, all rights licensed to Pﬁzer will revert to Biocon, and all insulin distributed under the brand name UniviaTM and GlarviaTM will be commercially available from Biocon Ltd only. “Biocon remains committed to delivering its Biosimilar Insulins portfolio to

global markets in its endeavour to make a diﬀerence to diabetic patients across emerging and developed economies. Biocon will continue to work with its existing partners in several markets and will pursue a commercial strategy on its own and through new alliances in other markets,” said Kiran Mazumdar- Shaw, CMD, Biocon Ltd. “Pﬁzer continues to be dedicated to developing a broad portfolio of biosimilars medicines, including

Waters and Protea in co-marketing pact Waters Corporation and Protea Biosciences Group, Inc announced a co-marketing agreement enabling customers of Waters® SYNAPT® G2 & G2-S HDMS systems to take advantage of Protea’s LAESI DP-1000. Protea’s LAESI DP-1000 system uses Laser Ablation Electrospray Ionization (LAESI) technology to help identify biomolecules such as metabolites, lipids, peptides, and proteins in native biological samples including tissue, blood, urine, live cells, and colonies. With little or no sample preparation, biomolecules can be quickly ionised and accurately mapped to speciﬁc cellular structures or tissue locations under ambient conditions. According to Alessandro

Baldi, Vice President and General Manager, Protea, “This collaboration will provide Waters’ customers an excellent tool for 2D and 3D proﬁling of tissues.” “The combination of LAESI with SYNAPT’s ability to separate isomeric species based on cross sectional area, using ion mobility, is particularly exciting and will undoubtedly facilitate discovery in this kind of complex analysis,” said Dr Steve Smith, Senior Director - MS Product Management, Waters Division. Under the agreement, Protea will make the LAESI DP-1000 available to new and existing users of Waters SYNAPT G2 and SYNAPT G2-S mass spectrometers running under MassLynx® control.

monoclonal antibodies and recombinant proteins products, both internally and through collaborations,”said Diem Nguyen, General Manager-Biosimilars, Pﬁzer. He added, “In addition, we will continue to be active in our own research and business development eﬀorts for diabetes, which represents a huge unmet medical need, and we remain committed to seeking new solutions to help physicians and patients.”

Pearson in pact with Vrudhi for clinical assessment workshops Pearson Academy India (PAI), the training arm of Bangalore-based Pearson Clinical and Talent Assessment (PCTA), has signed on Mumbai-based Vrudhi as its authorised training centre for the western region. Vrudhi’s appointment will help PAI deliver its clinical workshops to mental health professionals, school teachers, special educators and post-graduate psychology students in Maharashtra and the surrounding western region. PAI plans for a nation-wide presence. Pranjal Barma, Head, Training & Certiﬁcation, PAI, said, “Mumbai is a hub for psychological services and caters to the mental-health needs of a rapidly growing population that requires trained professionals to meet these needs.” Dhaval Mody, Managing Director, Vrudhi, stated, “We have been working closely with schools in identifying, assessing and supporting children with special needs and promoting awareness about mental health. Our society not only lacks awareness and acceptance of mental-health issues but is also grappling with a severe service provider shortfall in the mental health sector. With this agreement, we wish to train professionals from various ﬁelds who address psychological, educational and developmental issues.”

Dr P V Appaji is the new Director General of Pharmexcil The new DG will now focus his concentration on the The Pharmaceutical Export Promotion Council policy matters of the council. Apart from devising policies of India (Pharmexcil) has created a new post of for pharmaceutical export promotion, the DG will also Director General (DG) and appointed Dr P V supervise the over all functioning of the council. “Now, Appaji as the new DG of the Council. Prior to this my job will be to focus more on policy matters. In the next appointment, Dr Appaji had served as Executive one to two months we will organize a meeting and come Director (ED) of the Council for the past 8 years out with a new frame work for our export activities,” said since 2004. Dr P V Appaji Dr Appaji. Raghuveer Kini has been appointed as the On the upcoming activities of the council, Dr Appaji said, next Executive Director of the council. Earlier, Kini had served the council in the capacity of additional executive director since “As of now we are concentrating on organizing India Pavilion at its inception. He is regarded as a well experienced and dynamic 15th South East Asia Healthcare & Pharma Show in Malaysia. The event will be held from April 17-19, 2012. personality who is fully aware of all the activities of the Council.

Modern Pharmaceuticals I April 2012

News,Views & Analysis Indoco Remedies launches Indoco CND, a new division for cardiology and diabetology Indoco Remedies Ltd, a pharmaceutical company with sales turnover of ` 600 crore recently launched a new division, viz Indoco CND (Care in Cardiology and Diabetology). “We have been present in this segment through successful product launches in diabetology and cardiology over a period of time. However, due to high prevalence of chronic ailments, we are focussing more on this segment through Indoco CND,” said Aditi Kare Panandikar, Managing Director, Indoco Remedies Ltd. She further added, “We intend launching products for hypertension, dyslipidemia, nutraceuticals and oral hyperglycemic

agents (OHAs) such as sartans, statins and combinations.” Rigorous training programmes are being conducted for a specialised and highly skilled ﬁeld force, ensuring Indoco CND’s success. Under the leadership of Panandikar and B Rajendra Kumar, Vice President - Sales & Marketing, this division will be spearheaded by Atul

Joshi, General Manager – Marketing & Sales. He will be backed by 245 trained field force. “The competition in this segment is high.We will focus on scientific promotion through sharing of information with doctors on the diseases and the products. As this segment is dominated by the Key Opinion Leaders (KOL), we will work with them through patient-related services. The product selection will also be from the niche areas, which will ward off competition to a certain extent,” informed Panandikar. - Titash Roy Choudhury

Sundeep V Bambolkar honoured at the ‘CFO 100 Awards’ 2012

Herbalife conferred with ‘Industry Recognition Award’ at Nutra India Summit 2012

Sundeep V Bambolkar, Joint Managing Director, Indoco Remedies Ltd, was awarded the ‘Winning Edge’ in cost management - (revenues below `1000 crore) at the 2ⁿd annual ‘CFO 100 Awards’ 2012. He has been felicitated by CFO100 for the second year, which is a matter of prestige and pride for every Indocoite. Bambolkar, a management professional with proven administrative capabilities has put in 30 years of service at Indoco. He has vast experience across various functions such as ﬁnance, operations, purchase, projects and international business at Indoco. Recently, the board of Indoco has elevated Bambolkar to the position of Joint Managing Director. The CFO100 is an annual initiative that recognises India’s ﬁnance leaders’ extraordinary contribution to the corporate world. The awards ceremony brought together about 200 CFOs from all across India to recognise and celebrate the excellence in the Finance Community.

The ‘Industry Recognition Award’ was conferred to Herbalife for its outstanding contribution to industry growth in the sector of nutraceuticals and nutritionals at the Nutra India Summit 2012. The Nutra India Summit in its 7t edition is organised by Council of Scientiﬁc and Industrial Research (CSIR), International Union of Food Science and Technology (IUFoST) along with MM Activ Sci-Tech Communications and supported by leading industry associations. Herbalife India was selected by distinguished members of the jury comprised of Dr V Prakash, Chairman, Nutra India Summit

2012, distinguished scientist, CSIRIndia; President, Nutrition Society of India; Dr Mashelkar, National Research Professor and President, Global Research Alliance; S V Ranganath, Chief Secretary for the State and Jagdish Patankar, Managing Director, MM Activ, the organisers of the 7t Nutra India Summit. Herbalife India also received the exhibitor award for the category ‘Interactive and Best Managed Stall.’ Khanna said, “At Herbalife we are committed to setting a high standard and advancing the science of nutrition and infuse those insights into our inner and outer nutrition range of products.”

Sami Labs receives its 70th patent for TetraPure® Sami Labs Ltd has been granted its 70t patent for the treatment of superficial mycoses - fungal infections that affect the skin, hair and nails. The patent, which covers the company’s TetraPure® ingredient for hair, skin and nails, can be used effectively in healthcare and cosmetic products for better skin, hair and nails. Most fungal infections are caused by ‘dermatophytes’ – a parasitic fungi that leads to skin infections and while fungal

April 2012 I Modern Pharmaceuticals

infection of the nails is most common, skin and hair is also as susceptible often leading to itchy, burning skin and dandruﬀ, which in severe cases causes hair fall. TetraPure® combats these fungal infections and provides quick relief for several skin discomforts. Dr Muhammed Majeed, Chairman & Founder – Sami & Sabinsa Group of Companies, said that the company is extremely pleased at receiving

approval for the TetraPure® patent. “Our 70t patent for TetraPure® is a step towards elimination fungal infections that cause skin, hair and nail damage. With the approval for TetraPure®, we are all set to introduce a plethora of healthcare and cosmeceutical products that will keep at bay fungal skin infections and pave the way for healthier skin, hair and nails,” he added. - Chandreyee Bhaumik

Post-Budget Analysis Apurva Shah Chairman, Association of Clinical Research Organization (ACRO)

We had expected the government to recognise that Clinical Research Organisations (CROs) account for an important component of R&D, and therefore, the R&D set oﬀ should be spread to cover the R&D done outside pharma companies in CROs. By doing so it would speed up the R&D process and position India as a leader in pharmaceutical R&D. Further, we also appreciate the fund set aside for training and hope that we can avail these funds to train the professionals to conduct ethical clinical research as per Good Clinical Practice (GCP). Impact: It would speed up the R&D process and position India as a leader in pharmaceutical R&D.

Daara Patel Secretary-General, Indian Drug Manufacturers’ Association

A ‘taxing’

Budget The overall reaction for the Union Budget 2012 as far as the pharma industry is concerned is from neutral to negative. Few things that were expected like excise duty on the APIs, GST on life saving drugs, etc were not provided. Further, excise duty on bulk drugs has gone up from 10 to 12 per cent and for formulations, from 5 to 6 per cent, which will indirectly increase the price of drugs. Experts try to guage the impact.

Union Budget has not been very exciting for the pharma industry. We are afraid that it is going to be difficult for companies to maintain the price line as excise duty on bulk drugs has gone up from 10 to 12 per cent and for formulations from 5 to 6 per cent. Also, increase in Service Tax from 10 to 12 per cent is further going to affect the cost of medicines. What is encouraging is the fact that 200 per cent weighted deduction for R&D expenditure has been extended for a period of another 5 years. The new weighted deduction of 150 per cent on expenditure incurred on skill development is also very welcome. Further, minor benefits have been provided for the SME sector but that is across the board and not only for pharma industry. Impact: Challenging for companies to maintain the price line of drugs.

Quick Take The Union Budget has many pros and cons related to tax but increase in Service Tax will aﬀect the day-to-day routine of a common man. There are factors that would support inﬂation rather than recession as the Finance Minister has increased the burden of indirect taxes on the industrial sector. Modern Pharmaceuticals I April 2012

Post-Budget Analysis Kewal Handa Managing Director, Pﬁzer Ltd

Krishna Prasad Managing Director, Granules India

The Budget is in-line with expectations given the current political atmosphere. The government missed an opportunity to improve the country’s fiscal health by not reducing subsidies. Instead of directing new revenue into programmes that offer short-term benefits and hurt the country over the long-term, it would have been prudent to hold on to the revenue to demonstrate that the government is serious about reducing the fiscal deficit or at the very least, invest in capital expenditures, which will benefit the country and ultimately improve the growth rate. We hope the political environment will improve so the government can implement the structural reforms that are necessary to bring back market confidence and restore a robust growth rate. Impact: Since the Budget did not offer a plausible solution of bringing the fiscal deficit to 5.1 per cent, it does not seem likely the Reserve Bank will reduce interest rates that will continue to hurt the growth rate.

The pharmaceutical industry does not have much to cheer about in this Budget. In their efforts to address the fiscal deficit, the government has raised Service Tax rate from 10 per cent to 12 per cent. The standard excise duty hiked from 10 to 12 per cent thus adversely affecting the common man who is already burdened due to rising costs and inflation. In his speech, the Finance Minister spoke about improving supply side management of the economy – faster implementation of GST will definitely benefit the industry. Impact: The 1 per cent increase in excise duty will result in a 1.5 per cent increase in drug price.

Dr Krishna Ella Chairman & Managing Director, Bharat Biotech

Rajesh Varrier CEO, Activecubes

For entrepreneurs like myself, the one clause in the Union Budget 2012 which really shocks is that of taxation of angel investments. I think the industry as a whole should appeal for the withdrawal of this clause. This really is a blow to entrepreneurial community. Today, most start-ups start with angel funding, very rarely do they start with Venture Capital (VC) funds. Imagine considering an investment as an income and giving up 30 per cent as tax. That is ensuring that angel investments will die, and there by impacting the echo system of entrepreneurship itself. Impact: Can result in less new start-ups this year.

I am glad that India has ﬁnally become polio free. Weighed deduction (150 per cent) for skill development under SME might be useful for biotech industry but increased excise duty and Service Tax certainly takes away some of our growth path. Consumers may have to pay more. All the contribution of pharma and biotech to India’s growth is not recognised at all. We expect the government to provide good infrastructure and power, which is vital for manufacturing sectors such as vaccines and biotech to grow. No clear strategy for manufacturing policy is envisaged in the Budget. Impact: Increase in excise duty can result in reducing the growth of the biotech industry in India.

Tapan J Ray Director General, Organisation of Pharmaceutical Producers of India (OPPI)

A year extension has been provided for 200 per cent weighted deduction for in-house R&D that was set to expire on March 31, 2012. Basic customs duty on six speciﬁed life-saving drugs/vaccines (raltegravir potassium, Rotavirus Vaccine, Pneumococcal Polysaccharide Vaccine, Posaconazole oral suspension, Temsirolimus Concentrate for infusion for injection, Natalizumab) and their bulk drugs is being reduced from 10 to 5 per cent with nil CVD and excise duty exemption. Considering the same, I reckon, though there is no major reform initiatives for the pharma sector in the Budget, the Finance Minister has taken some laudable measures, as mentioned above, for the industry along with signalling a directional change towards the new Goods and Services Tax (GST) regime through his proposals on indirect taxes. Impact: There is no major reform initiative in the Budget.

April 2012 I Modern Pharmaceuticals

Technology & Innovation One Eleven, ROI² to develop e-sampling products for pharma marketing One Eleven Software has formed a strategic alliance with ROI² to develop e-sampling products for pharmaceutical marketing that identify and target physicians. Janet Carlson, CEO, One Eleven Software, said, “The combination of One Eleven’s e-sampling solutions with ROI²’s Sphere of Influence will improve pharmaceutical company targeting of physicians. “Network Sampling will instead sample based on the influence a physician has within their community and their network.” “This type of targeting is much more accurate and measures the impact of messaging and sampling in real-time,” Carlson added. Bonnie Rishell, CEO, ROI², said, “Pharma companies using the company’s Influence Vector score understand that the context of relationships is important and can have a greater impact than just decile. One Eleven Software develops software solutions that helps pharma companies improve their sampling efforts.

NuGenesis 8 for reduced laboratory transcription errors Waters Corporation has introduced Waters NuGenesis 8 featuring Laboratory Execution (LE) Technologies, a comprehensive workflow and documentation solution that links organisations’ analytical laboratory data systems to their business information technology systems. “Perhaps the biggest informatics challenge our customers face NuGenesis 8 is seamlessly linking analytical data to enterpriselevel information to facilitate business decisions. We want to leverage the data from all those applications and integrate them with an enterprise level business system,” said Mary Ellen Goff redo, Senior Director - Systems Marketing, Waters Division. In addition to featuring LE Technology, NuGenesis 8 automatically captures and catalogs information from disparate sources and provides access to a suite of information management tools including sharing, reuse and sample management. Using NuGenesis Electronic Laboratory Notebook (ELN), laboratories can track, assign, and manage samples, tests, and results. The user-centric design revolves around both laboratory managers who seek metrics about the laboratory workload, as well as analysts who need a convenient overview of pending tasks and the status of in-process tests. The result is a more efficiently run laboratory.

HyCell CHO cell-culture medium to increase bioprocess product yields up to five times

HyCell CHO

Thermo Fisher Scientific Inc has introduced the Thermo Scientific HyCell CHO cell-culture medium, a versatile animal-derived- componentfree (ADCF™) and chemically defined (CD) medium for culturing a broad variety of CHO cells. In testing, it increased bioprocess yields more than five times that of other comparable CHO products in the market. This can produce significant productivity gains for customers. “We continuously innovate to provide better solutions for our customers, and we are excited about the exceptional yield gains seen in the manufacture of recombinant proteins from CHO cells grown in the HyCell CHO medium,” said Tariq Haq, Senior Global Product Manager - Media and Buffers, Thermo Scientific Cell Culture and Bioprocessing Products. “This formulation is optimised for bioprocess applications involving CHO cells. Its versatility allows quick adaptation and supports exceptional growth, high cell density and high productivity.”

Ingenuity launches iReport solution for gene expression analysis Ingenuity Systems and Life Technologies have introduced Ingenuity iReport solution for Real-Time PCR optimised for TaqMan gene expression assays. Ingenuity iReport for Real-Time PCR provides a rapid and comprehensive understanding of pathways, processes, and diseases relevant to gene expression results.

The new solution is an interactive report that extends analysis beyond Ct or fold-changes to an accurate and dynamic view of the biological information relevant to a gene expression experiment. Chris Linthwaite, Genetic Analysis Head, Life Technologies said, “By integrating iReport into the company’s portfolio will

enable the customers to accelerate the pace of scientiﬁc discovery quickly connecting data to biological meaning.” Jake Leschly, CEO, Ingenuity Systems said, “With iReport for Real-Time PCR they have designed a product that will help researchers identify relevant biology from gene expression experiments.”

Modern Pharmaceuticals I April 2012

Technology & Innovation Discovery research imaging agent to enable personalised medicine approach for breast cancer research PerkinElmer, Inc has announced the availability of the HER2Sense™ preclinical imaging agent, to support breast cancer discovery research into personalised medicine. The HER2Sense agent is the first fluorescent, discovery research imaging agent to be based on a commercialised therapeutic antibody. The HER2Sense agent is an antibody-based optical probe for research applications that offers high therapeutic relevance because it is based on trastuzumab, a well-characterised

and validated commercially-available therapeutic antibody used to detect the HER2/Neu receptor for treating forms of cancer. The agent incorporates PerkinElmer’s proprietary VivoTag™ fluorescent dye, which is specifically optimised for use in living systems and trastuzumab is being supplied by Roche Custom Biotech. The therapeutic relevance of the agent offers significant value in helping researchers understand the mechanisms of disease.

Zensar technologies and BDI pharma engage for business growth Zensar Technologies recently announced the successful go live of the SAP ERP and CRM. The project was delivered through collaboration between BDI Pharma, Inc and Zensar Technologies. This deployment has been achieved with the use Zenlife - a proprietary accelerator tool and consulting capabilities in life sciences, which has resulted in significant cost saving and increased capabilities and efficiency for sales and distribution. ZenLife is a ready-to-use industry-specific templatised SAP solution for pharmaceutical companies covering about 80-85 per cent of the major business processes and manufacturing operations such as OTC, private label, generics, manufacturing / distribution and sale of products ranging from API to formulations (all kinds of dosage forms). The solution is comprehensive and validated for the pharmaceutical industry. On the successful completion of the project, Nitin Parab, Chief Executive Office and Global Head, Zensar Technologies, said, “Zensar’s SAP Methodology is refined overtime over multiple projects for multi-site global execution. Our seamless transition and installation capabilities have already shown results in the form of cost savings for BDI pharma and we hope to grow this engagement further in the years to come.”

Radiant Sage brings lab-in-a-box to bio and pharma businesses Radiant Sage LLC launched a product to provide on-demand Clinical Trial Image Management Solutions for organisations involved in drug discovery and research. The technology is specifically designed for imaging-based clinical trials, which will enable rapid trial start and would also increase the overall efficiency of the collection, distribution and processing of images within a few weeks and requiring no capital infrastructure investments. The software has been designed in a way that it would enable sponsors to retain control of their clinical trials by leveraging cost-effective, efficient and accurate image management solutions. These web-based real-time solutions also offer increased image/data integrity and meet necessary compliance requirements. Besides these the company also offers an Enterprise Edition of the Core-Lab-in-a-Box solution which is suited for clinical trial sponsors. With data hosted either internally or on an external private cloud and delivered for an annual fee, Enterprise Core-Lab-in-a-Box provides key functionality of an imaging core lab.

According to Peter Schramm, Vice President, Custom Biotech, Roche Applied Science (US ), “There is a clear need for the data generated in animal research to be more relevant to clinical diagnosis, treatment, and even prognosis. The speciﬁcity of the trastuzumab antibody, combined with the detection characteristics of PerkinElmer’s VivoTag dye, labeled with a high degree of consistency by Roche, will provide an important tool for discovery research.

AB SCIEX launches mass spectrometer for routine quantitation and screening

AB SCIEX QTRAP 4500

AB SCIEX has launched AB SCIEX 4500 series, a nextgeneration, mass spectrometry instrumentation that sets a new benchmark for routine quantitation and screening. The AB SCIEX Triple Quad 4500 system is a new triple quadrupole system that delivers 10x better sensitivity over competitive triple quadrupole systems in the same mid-level class. The new AB SCIEX 4500 system is designed to be the new workhorse mass spectrometer with industryleading ruggedness. AB SCIEX is also delivering the 4500 system with the option of QTRAP technology which is recognised as delivering the worlds’ leading solution for simultaneous quantitation and library searching.

Modern Pharmaceuticals I April 2012

Technology Transfer As part of our endeavour to spread the technology culture, this section provides a means to promote and facilitate exchange of select technologies. We strive to bring together suppliers of such technologies with suitable users for negotiations and industrial collaboration.

Technology Offered A novel process Foramides Synthesisamides synthesis The present technology provides with an amidation reaction of unprotected a-amino acids in water under neutral conditions with various aliphatic, aromatic and heteroaromatic amines in the presence of coupling reagent l,lâ&#x20AC;&#x2122;-carbonyldiimidazole (CDI) at ambient temperature to obtain the corresponding a-amino acid amides. Areas of application Medical and pharmaceutical industry Forms of transfer Technology licensing Anti-ulceritic APIs An Indian company offers anti-ulcer drugs like omeprazole, pantaprazole, omeprazole sodium, omeprazole magnesium and esomeprazole magnesium for operations in manufacturing processes. Areas of application Formulation industries Forms of transfer Consultancy Clorsulon and its intermediates An Indian company offers clorsulon, a highly potent anthelmintic drug, which is administered to de-worm the intestines of sheep and cattle. Areas of application Pharmaceutical industry Forms of transfer Consultancy Detection and analysis of heavy metals in the industrial effluents The present technology relates to a device and method for detecting and also measuring the concentration of copper in an industrial effluent. This device comprises of an ion selective electrode (ISE) coupled to immobilise Bacillus sphaericus strain characterized in producing Urease on its one end and to a voltage measuring

device which is calibrated to indicate the concentration of the heavy metal in the solvent at its other end. Areas of application Industrial effluents, accumulates Forms of transfer Technology licensing Filter cleaning system An Indian company offers an automatic filter media cleaning equipment with drying system. It consists of air wash, water wash and drying facilities. Areas of application Filter media cleaning Forms of transfer Joint venture, equipment supply Formulation for leucoderma It is well known that these diseases have property of recurrence and most of the medicines used for cure have various side effects and also the disease is not fully cured. The company offers the formulation that is quite effective in curing all the above three diseases in short period of time. In case of leucoderma after application of the formulation there starts formation of patches (natural colour of skin) within a week. Areas of application Pharma and medical industry Transfer terms Joint Venture, technology licensing, research partnerships

Herbal formulation for psoriasis and eczema An Indian company offers an innovative herbal formulation that has the ability to control & cure psoriasis and eczema within one month of application of the formulation. Areas of application Herbal medicine

Forms of transfer Joint venture, technical services, technology licensing Natural preparation for anxiety relief A company offers food supplement in the form of tablets that effectively relieves mild to moderate anxiety problems. The ingredient is an herbal extract, which has been scientifically proved for its efficacy. Efficient decrease of anxiety symptoms, quick onset of action and no side-effects are reported to be the advantages of this product. Areas of application Pharmaceutical industry Forms of transfer Equipment supply Process of preparation of nanoparticles for drug delivery system The present invention is related to a process for the preparation of the novel nanoparticles of apotransferrin or transferrin which are useful for the preparation of a pharmaceutical composition facilitating easy delivery of the drug. Areas of application Medical and pharma industry Forms of transfer Technology licensing Pharmaceutical composition for the treatment of ophthalmic disease A company can offer technology for manufacturing a drug useful in the treatment of opthalmic disorders. A composition comprising Lithium chloride is the product which causes retinal cell regeneration. Lithium chloride alone helped in proliferation of retinal cells but is associated with other effects. Areas of application Pharma and medical industry Transfer terms Consultancy, technical services, technology licensing

Modern Pharmaceuticals I April 2012

Technology Transfer

Technology Requested Biotechnology for wastewater treatment system A Thailand-based company, a wastewater service provider, is involved in the R&D of new technology for water, wastewater and waste treatment. It requires new ideas related to technology for developing its strength in the field of wastewater. Areas of application Biotechnology, engineering Forms of transfer Consultancy Calcium Gluconate A company needs technology for manufacturing of Calcium Gluconate Areas of application Pharmaceutical industry Forms of transfer Technical services, project report, others

Kite grading engineering A company is looking for kite grading, which is a subservient of genetic therapy research particularly for the cardiovascular novice. Areas of application Medical research Transfer terms Others Manufacture of intravenous fluids A company requires know how and technological requirements for the manufacture of intravenous fluids. Know how should include where to obtain appropriate grade raw materials. Areas of application

Pharma/medical Forms of transfer Others

Extract of medicinal and aromatic plants A company is interested in putting up a multi-purpose herbal extraction plant for the extraction of medicinal and aromatic plants and herbs like artemisinin/quinine sulphate and other alkaloids. Areas of application Pharmaceutical industry Forms of transfer Others

Manufacturing technology of hepatits B, tetanus, diphtheria and pertussis vaccines An Indian company is interested in a complete technology for start up of manufacturing of combination vaccines from bulk to formulations including supply of protocols for manufacturing and production strains. Areas of application Human vaccines Transfer terms Others

IV fluid manufacturing as SME An Indian company needs new and good technology to start manufacturing of IV fluids. Areas of application Medical technology Forms of transfer Technical services, others

Manufacturing of liquid bio fertilisers An agro biotech company is looking for a proven technology for manufacturing of liquid bio fertilisers. They would like to know the kind of technology that could be offered (ie the product, efficacy, length of field trial) and a procedure of buying the technology along with the cost incurred.

Areas of application Biotechnology Transfer terms Others Manufacturing technologies for montelucast, rosuvastatin, ursodeoxy cholic acid, D-biotin A company needs API/bulk drug manufacturing technologies for montelucast, rosuvastatin, ursodeoxy cholic acid and D-biotin Areas of application API/bulk drug Forms of transfer Others Pharma grade mannitol know-how A company is on the look out for a commercially proven latest technology & know how (turnkey) for manufacturing pharma grade mannitol in India. The estimated production capacity is 600 tonnes per annum. Areas of application Pharmaceuticals Forms of transfer Others Pharmaceutical Lyophilisation plant A Peru based company is looking for a Lyophilisation plant for pharmaceutical use. Capacity shall be around 175 to 200 square feet, for the lyophilisation of 20,000 vials of 10 mL per day. Areas of application Pharma and food processing industry Forms of transfer Others

Information courtesy: Dr Krishnan S Raghavan, In-Charge, Technology Transfer Services Group, United Nations - Asian and Pacific Centre for Transfer of Technology (APCTT), APCTT Building , C-2, Qutab Institutional Area, New Delhi 110 016, Tel: 011 - 2696 6509, Fax: 011 - 2685 6274, Email: krishnan@apctt.org, Website: www.apctt.org, For more information on technology offers and requests, please log on to www.technology4sme.net and register with your contact details. This is a free of cost platform provided by APCTT for facilitating interaction between buyers and seekers of technologies across the globe. After submitting technology offer or request to this website, you are requested to wait for at least two weeks for receiving a response from a prospective buyer / seeker through this website, before contacting APCTT for further assistance.

Share and Solicit Technology The mission of Modern Pharmaceuticals is to spread the technology culture. Here is an opportunity to be a part of this endeavour by sending your technology on offer or technology requirements. If you belong to any of these two categories, you are invited to furnish the techno-commercial details for publication. The write-up needs to be as per the format of this section with information about the particular technology offered or requested, its areas of application and forms of transfer. Contact us: Modern Pharmaceuticals, Infomedia 18 Ltd, â&#x20AC;&#x2DC;Aâ&#x20AC;&#x2122; Wing, Ruby House, J K Sawant Marg, Dadar (W), Mumbai 400 028. Tel: 022-3024 5000, 3003 4695 Fax: 022-3003 4499 Email: spedit@infomedia18.in

April 2012 I Modern Pharmaceuticals

In Conversation With: E Venu Madhav

“There are no clear guidelines to compensate the clinical trial victims and compensation is decided on a case-to-case basis” …informs E Venu Madhav, Chief Operating Officer, Veeda Clinical Research. After completing his Masters in Pharmacy, and starting a career in the Quality Control Department he moved on to clinical research after 9 years. Here, he talks about the current research market in India. Parita Dholakia Will India someday do away with the ‘generic market’ tag? I am not too concerned about the ‘generic market’ tag for India as it is one of the leading players globally because of its reverse engineering skills. If we look at the current scenario, even the research-based organisations such as Pfizer, Novartis, etc, actively involved in the generics business and some of them are working with Indian generic players. Hence, I prefer to further strengthen our position in the generics business. However, at the same time, I do agree that we have to go a long way to be recognised as ‘true innovator’ of new drugs. I believe that we are in the process of learning curve. Recent DCGI nod for Ranbaxy’s new anti-malarial drug can be considered as a new stimulus to our efforts and I am optimistic about getting more and more truly Indian new drug molecules in the near future. Is the pharma research scenario in India at par with developed countries? I would like to answer this question in two parts, ie, generic drug research and new drug research. Coming to generic drug discovery, the R&D expenditure of 30 leading Indian pharma companies increased by 18.7 per cent with significant higher product filings in highly regulated markets such as the US, Europe and Japan. In the current year, Indian companies captured US FDA approval for 99 ANDAs and tentative approval for 30 ANDAs during first 8 months of 2011. These are more than 30 per cent of total US ANDA approvals during the same period of time. All these numbers clearly demonstrate leading position

Modern Pharmaceuticals I April 2012

E Venu Madhav of Indian pharma companies in generic drug research. The recessionary economic conditions in the US and other western countries may offer further opportunities to Indian pharma companies to launch cost-effective generic products. Coming to new drug discovery, we are still at a nascent stage and not in a position to compare ourselves with other developed countries. This could be due to lack of adequate resources coupled with inadequate trained manpower in this area. The new initiative of Government of India to set up a ` 10,000 venture capital fund to finance new drug discovery projects would be of a great support to new drug research projects. Further Government of India’s proposed new initiatives of building infrastructure for talent and research, encouraging publicprivate partnerships in infrastructure development, providing financial incentives to encourage innovation, and shaping a favourable regulatory environment go a long way to boost new drug discovery. Ongoing collaborative research of MNCs with Indian companies in the long run will be helpful in creating well trained manpower to take up this research to the next level in India. By the next two decades we might be on par with developed countries in new drug research. How has the company grown since you have joined? By the time I joined Veeda, it had been established as one of the leading Indian CROs with a global presence in India, Europe and North America accompanied with knowledge base in bioavailability and bioequivalence studies, early phase studies, biometrics and complete range of clinical trials in oncology therapeutic segment. After I joined the Ahmedabad unit, the focus is more on optimum utilisation of resources, which has resulted in increased productivity levels by around 30 per cent in key departments. We expanded our clinical unit capacity by around 35 per cent and started a new state-of-theart bioanalytical facility having capacity to accommodate 26 LCMS machines. Our Malaysian unit is ready to initiate operations and waiting for regulatory approvals to initiate our first study. We still have to deal with pricing pressures and increasing costs and uncertainty in the current regulatory

April 2012 I Modern Pharmaceuticals

environment to be competitive in the market and grow further. Designing a clinical trial. Evaluating the statistical data. Putting the results on paper. Which one of these excites you the most? Study design, protocol preparation, study execution,evaluation of results and preparation of reports are all important aspects of a clinical trial and I do have practical hands on experience in all these aspects. In my opinion, one should be reasonably good in all these areas to become a good clinical research scientist. I can say that study designs and data evaluation are my passion. How difficult it is to gather patients/obtain consent from the population pool with specific inclusion criteria? Each and every clinical trial has a specific inclusion and exclusion criteria to recruit a unified patient population as far as possible to ensure reliable study outcome. Identifying patients who meet study specific inclusion and exclusion criteria and taking an informed consent from them to participate in the study are critical and difficult steps in the successful completion of the trial. Usually patientrelated issues such as disease status, level of education, economic, social and cultural aspects act as a barrier for patient recruitment in the study. Also, lack of enough time and resources with investigators also hinder a patient’s recruitment in the trial. At times, protocol design issues and negative influence of media also create hurdles for patient recruitment. However, good number of trials are carried out through appropriate protocol design, continuous education of patients and by providing enough resources to investigators to motivate them to take part in the trial. How often results from a pilot study does not lead to a pivotal study? It depends upon many factors such as nature of the drug substance, formulation characteristics, technical expertise of formulation scientist, risk-taking abilities of the organisations, country-specific regulatory requirements and so on. Based on my experience, in general around 50 to 60 per cent of pilot studies lead to pivotal studies.

Quick bytes Aim in life: Exploring myself continuously and to reinvent myself till the end Role model: N T Rama Rao Message to the younger generation: Be honest to yourself, have a big picture in mind and try to achieve it Pharma companies have been blamed too often for not paying compensation to hapless clinical trial victims. How helpful will be the upcoming Central Drugs Standard Control Organization (CDSCO)’s compensation chart? At present, there are no clear guidelines to compensate the clinical trial victims and compensation is decided on a case-to-case basis. This situation is leading to diﬀerences of opinions between both victims and pharma companies and at times biased approach from pharma companies. If the proposed compensation chart of CDSCO takes care of regional and economic disparities across India, it will certainly be a positive step towards ethical execution of clinical trials in India, as compensation payment is always a contentious issue in clinical trials. With requirements of a native English speaker, how has the medical writing scenario bloomed so much in India? Veeda’s contribution? Medical writers have become an integral part of drug development process. Medical writing contributes around 3 per cent of total clinical trial business outsourced to India and is expected to grow at around 16 per cent annually. Veeda provides medical writing services through its Biometrics division in Europe and India. What is your vision for the company? I have the habit of working with a big picture in mind as it drives and motivates me to achieve desired goals. My vision for Veeda is being recognised as a global clinical research CRO known for its scientiﬁc expertise, quality of services and project management skills. Veeda should be recognised globally as a true clinical research partner and as a one-stop solution provider in the areas of our expertise in clinical research. (parita.dholakia@infomedia18.in)

An invite that rewards as well...

Dear Reader, ‘Modern Pharmaceuticals’ solicits original, well-written, application-oriented, unpublished articles that reflect your valuable experience and expertise in the pharmaceutical industry. You can send us Technical Articles, Case Studies and Product Write-ups. The length of the article should not exceed 1,500 words, while that of a product write-up should not exceed 100 words. The articles should preferably reach us in soft copy (either E-mail or a CD). The text should be in MS Word format and images in 300 DPI resolution & JPG format. The final decision regarding the selection and publication of the articles shall rest solely with ‘Modern Pharmaceuticals’. Authors whose articles are published will be sent a complimentary copy of that particular edition. Published by Infomedia 18 Ltd, ‘Modern Pharmaceuticals’ is one of the leading monthly magazines exclusively meant for producers and user fraternities of the pharmaceutical industry. Well supported by a national readership of over 80,000 and our strong network of 26 branch offices across India, this magazine reaches out to key decision makers among the Indian manufacturers of pharma products, machinery and allied sectors. Brought out in association with Hong Kong-based Ringier Trade Media Ltd (one of the world’s largest trade publishing houses with more than 200 special interest titles and offices in every major country), it ensures that advertisers are able to promote their products and services across the globe at no extra cost. So get going and rush your articles, write-ups, etc… Thanking you, Yours sincerely,

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Special Focus

IT in pharma Specialised IT service providers Catalysts for growth of pharma .............................................32 Cloud computing in pharma A slow and steady growth ......................................................34 Interface Sayantan Roy Software Business Leader - GE Intelligent Platforms ................36 Roundtable Is IT in pharma in good health? ............................................38

April 2012 I Modern Pharmaceuticals

Special Focus: Specialised IT service providers

Catalysts for growth of pharma The progress of IT is crucial for the smooth functioning of any industry and the pharmaceutical industry is one among them. We look at the myriad of solutions provided by a few providers to help with the efficient functioning of pharma companies. Titash Roy Choudhury

esearch and studies have shown that India will emerge as a leading global player in the pharma industry by 2020, securing a place among the top ﬁve major global markets. With rising per capita income, evolving demographics, and government’s long term vision of making quality healthcare aﬀordable, growth of this industry is not only expected to be fuelled by domestic demand from metro and tier-I cities, but also aided by penetration into the rural areas and growth in consumption in such areas. To propel this growth further IT is going to play a major role, “An integrated clinical enterprise with proper IT infrastructure is always better prepared to respond to emerging market challenges. As India is

getting more and more integrated with global pharma regulatory market and standards, IT investments are expected to spread into regulatory compliance, pharmacovigilance and ensuring patient safety – thereby driving in future the need for integrating diverse enterprise systems to enable eﬃcient operations,” says Ram Yeleswarapu, President & CEO, TAKE Solutions. Pharma and life sciences sectors are highly regulated. Indian pharma companies therefore have to review their compliance strategies, methodologies and associated costs constantly. IT service providers for pharma companies can be categorised into global players such as IBM, Accenture, Capgemini, Hewlett Packard, etc who support many customers globally. Meanwhile, there are Indian players such Wipro, Infosys, etc who

have large outsourcing deals with pharma majors, and lastly niche players who provide speciﬁc solutions to the industry.

Pharma solutions The life sciences industry, including the pharma industry has been a strong focus area for Cognizant ever since its inception in 1994. Its clinical development team helps bring life-saving drugs to the market quicker and in a cost-eﬀective way while the pharmacovigilance teams help increase drug safety. Cognizant is recognised as a strong industry leader in the life sciences segment, partnering with 28 out of top 30 global pharmaceutical companies. “Cognizant provides ITO and BPO services supporting the entire life sciences value chain, covering R&D, manufacturing and supply chain, sales and marketing, pharmacovigilance, and regulatory compliance,” says J Sairamkumar, Vice President - Life Sciences Practice, Cognizant. Similarly, TAKE solutions too entered the pharma business looking at the industry need for credible business technology solutions

Modern Pharmaceuticals I April 2012

Specialised IT service providers IT investments are expected to spread into regulatory compliance, pharmacovigilance and ensuring patient safety – thereby driving in future the need for integrating diverse enterprise systems to enable efficient operations. Ram Yeleswarapu President & CEO, TAKE Solutions

that address 360° requirements across clinical, regulatory, pharmacovigilance and commercialisation areas. It is the variety of services provided by these companies that is aiding the growth of the pharma industry both domestically and worldwide. “Mostly the solutions oﬀered are around infrastructure support, data centre services, support, application implementation and support and business services such as consulting,” informs Vikram Venkateswaran, Healthcare and Lifesciences Professional. Besides providing core services such as application development, application maintenance, and testing for nonvalidated, validated, and 21 CFR Part 11-compliant systems, consulting, BPO, and ITIS Cognizant also provides ITIL process compliant infrastructure support and hosting services. It also provides set of services including mobile, cloud, social computing and enterprise analytics. “Social listening, social CRM, and virtualisation of infrastructure through private and public cloud setup are some of the other services that Cognizant delivers to life sciences customers,” informs Sairamkumar. Similarly, TAKE Solutions provides clinical data management, bio-statistics

Life sciences customers are clearly looking for partners to support them transform their businesses by optimising costs while helping them scale globally and drive innovation. J Sairamkumar Vice President - Life Sciences Practice, Cognizant

and SAS programming, clinical IT systems implementation, regulatory submissions, electronic trial master ﬁle management, pharmaceutical, supply chain execution, etc. “While we have over 100 customers worldwide using PharmaReady™, our web-based regulatory compliance suite for addressing regulatory submission and document management needs, Cadila Pharmaceuticals, Reliance Life Sciences, Indoco Remedies Ltd, NATCO are some of the prominent Indian customers. All submissions made using our solutions/ services have been accepted by the regulatory agencies,” informs Yeleswarapu.

Solutions sought after by the pharma The life sciences industry has more often been a pioneer in seeking IT solutions and outsourcing services in new and unique ways. Business climate for pharma companies has changed dramatically in the last few years with declining R&D productivity, rising commercialisation costs, expansion into emerging markets/newer portfolios and increasing regulatory/payer inﬂuence. The Indian pharma sector is also gearing up to meet the challenges of increased regulation – and this will drive demand for greater automation of regulatory and safety processes.

Many global as well as domestic IT firms have developed capabilities to support the Indian pharma industry. But there are many new entrants especially in emerging areas such as cloud, social media, mobility and analytics, which enhance the offerings provided by traditional IT firms. Vikram Venkateswaran Healthcare and Lifesciences Professional April 2012 I Modern Pharmaceuticals

“These have driven up the average cost per successful product launch and reduced average expected returns on new investment. Given these macro trends, life sciences organisations are constantly re-defining its core and noncore activities. More and more non-core activities and services are getting outsourced over the years. Life sciences customers are clearly looking for partners to support them transform their businesses by optimising costs while helping them scale globally and drive innovation,” says Sairamkumar. In addition, many Indian pharma companies have successfully implemented ERP systems and they are now looking to mobile enable their shop floor, warehouse and field operations. When asked about some of the frequently asked IT solutions, Yeleswarapu says, “How to ensure complete regulatory compliance? – This continues to be a burning question. Document management, structure product labelling, training records management, electronic trial master file management, clinical and safety systems implementation, and electronic/paper submissions are therefore likely to remain the key focus areas for the Indian pharma sector.” Some of the frequently sought IT solutions by pharma companies span multiple areas, including discovery, clinical trials, manufacturing, packaging and sales force. “Many global as well as domestic IT firms have developed capabilities to support the Indian pharma industry. But there are many new entrants especially in emerging areas such as cloud, social media, mobility and analytics, which enhance the offerings provided by traditional IT firms,” says Venkateswaran. (titash.choudhury@infomedia18.in)

Special Focus: Cloud computing in pharma

A slow and steady growth Although the concept is at a nascent stage, cloud computing is proving to be beneficial and advantageous for pharma companies worldwide, and Indian pharma giants are not lagging behind. The development of the looming ‘cloud’ over the Indian skies will be worth watching. Titash Roy Choudhury

n recent years we have seen many technological innovations that have driven the growth of various industries all over the world. Currently, the global pharma market is developing and growing in large proportion supported by integration of IT that is boosting the growth further. With time, niche IT solutions such as cloud computing has gained prominence within the industry. “Cloud computing services (Infrastructure as a service – IaaS) is deﬁned as computing, network and storage resources (servers, ﬁrewall, load balancers and storage devices) made available to users over the Internet on-demand, as and when needed. Users only pay for as much as they use and can upgrade their computing resources in near real-time as their requirements increase,” informs Karan

Kirpalani, GM - Product Management & Managed Hosting & Cloud Services, Netmagic Solutions. Traditionally, when IT users needed computing resources they had to ask the IT department for a server, which took almost 2-3 months to be installed and usually only a portion of the server was utilised. Cloud computing takes away the trouble of getting such IT resources. “Cloud computing is essentially computing done over the Internet rather than on one’s own internal servers. It also enables software vendors to provide Platform-as-a-Service (PaaS) and Software-as-a-Service (SaaS) products that they host on their own servers,” says Dr Ruchi Dass, Founder & CEO, HealthCursor Consulting Group.

Advantages of cloud computing The beneﬁts of cloud computing are recently experienced in the areas of

research, development and healthcare information exchange. “The main impact to pharmaceutical companies of increased usage of cloud computing is reduced dependence on their own IT infrastructure. This will provide the ability to move away from Capital Expenditure (CAPEX)-intensive deployments to an Operational Expenditure (OPEX) payas-you-go business model. The main business advantage of cloud computing is the standardisation and streamlining of operations, higher re-usability, better integration and stronger collaboration with external entities and the healthcare ecosystem,” informs Dr Dass. Several pharma companies are seeing ‘cloud’ as a key solution for a host of challenges that they face today. For example, “Cloud services are highly scalable and as such can be used to reduce processing time significantly and expedite the R&D processes. The time taken to conduct a typical modeling experiment could be reduced by several hours in comparison to the time taken by in-house applications,” informs Kirpalani. He further adds, “The cloud can also provide a flexible and cost-effective platform for collaborating between multiple parties. Drug manufacturers are experimenting with the sharing of algorithms for analytics and securely exchanging data with collaborators across geographies.”

At a nascent stage However, on the whole, the pharmaceutical industry is yet to harness the full potential that cloud computing has to offer. Perhaps the single biggest opportunity for the pharma sector is cloud computing’s capacity to store vast amount of data. “One of the best examples of how cloud computing could benefit researchers can be found in Next-Generation Sequencing (NGS). A single NGS experiment can generate hundreds of petabytes or even zettabytes of data, which makes this research method expensive. NGS promises to make DNA research far cheaper than possible with the current standard dye-terminator method, but the right platform is needed to host this information. Cloud computing offers a solution by providing a vast yet

Modern Pharmaceuticals I April 2012

Cloud computing in pharma

The main advantage of cloud computing is the standardisation and streamlining of operations, higher reusability, better integration and collaboration with the healthcare ecosystem.

The current roadblock is that there are no security solutions that can guarantee 100 per cent protection against cyber threats. Karan Kirpalani GM - Product Management & Managed Hosting & Cloud Services, Netmagic Solutions

scalable global processing environment,” says Kirpalani. Pﬁzer, for example, has tried the use of cloud computing to conduct online clinical research with customers and is now using it to deliver real-time information to its global sales team. In addition, The Pistoia Alliance, an industry body formed by informatics experts from leading pharmaceutical companies including AstraZeneca, GlaxoSmithKline and Novartis, has successfully piloted cloud-based sequence services that allow members to easily access and share their latest research.

The ‘cloud’ over Indian pharma According to a report by KPMG, the pharma industry has several characteristics that make it suitable for the cloud. “Drug manufacturers require enormous, varying and scalable computing resources throughout diﬀerent phases of the product lifecycle, for the complex informatics that go into scientiﬁc and drug development research. The industry has been using high-performance grid computing to

Increases collaboration and data sharing

Reduces time to discovery & development

Dr Ruchi Dass Founder & CEO, HealthCursor Consulting Group

support their R&D work,” says Kirpalani. However, the provisioning of computing resources internally is always faced with delays. “Cloud computing has its best application in next-generation DNA sequencing, pattern recognition, data mining, molecular modeling, simulation, protein docking, etc as it improves the application lifecycle, collaboration and can handle peaks with scale on demand,” informs Dr Dass, which is required for the Indian pharma companies to survive the cut-throat competition they are facing today. Dr Reddy’s Laboratories is using Salesforce’s CRM across 200 users. It moved its Active Pharmaceutical Ingredients (API) marketing business to the cloud in order to improve visibility into its deals pipeline, track its end-to-end sales cycle and better analyse its sales funnel.

Constraints faced Though this concept is catching up and proving beneﬁcial for pharma companies worldwide there are certain disadvantages involved. “The current roadblock is that

Reduce operational costs and capital expenditure

Cloud computing in pharma sector

Computes complex data sets & processing requirments

there are no security solutions that can guarantee 100 per cent protection against cyber threats. Nevertheless, there are steps that the service providers can take to tackle pharma’s hesitancy around the security risks of cloud computing. First, private cloud environments are more secure than public cloud services, since they are only accessible to the businesses they have been created for. Second, although no product is entirely secure, there is a wide range of encryption and access management tools available that cloud providers can employ to help pharmaceutical companies feel more confident in data safety,” informs Kirpalani. Another disadvantage is that standards are immature and things change rapidly in the cloud. All IaaS providers use different technologies and different standards. “One of the key concerns among pharma companies is whether cloud computing will offer sufficient Return On Investment (ROI). And at the moment, there is a lack of effective financial modeling to reassure companies of the business benefits,” says Kirpalani. This is accompanied by the issue of employee skills, staff may need retraining and they may resent a change to the cloud and fear job losses. Some alterations are required at the organisation and process level for which a big reluctance is exhibited from the pharma companies. Thus, with the plethora of uses and benefits for pharma companies, cloud computing will overcome constraints in its way and gain greater prominence in the coming years. How Indian pharma companies adapt and evolve with it, will be interesting to observe. (titash.choudhury@infomedia18.in)

Source: Dr Dass

April 2012 I Modern Pharmaceuticals

Special Focus: Interface - Sayantan Roy

“Achieving sustainable operational excellence would be the key imperative for this industry” …says Sayantan Roy, Software Business Leader, GE Intelligent Platforms. He discusses his views on IT adoption in the pharma industry and GE’s role in the same. Arshia Khan

Tell us about GE Intelligent Platforms’ interest in the pharmaceutical industry. GE has always been interested in advancing the state of the healthcare industry. GE Healthcare provides affordable, high quality healthcare to millions of patients worldwide. In the same vein, GE Intelligent Platforms (IP) endeavours to help pharma companies provide quality drugs at the right price to alleviate patients’ pain. However, pharma companies cannot produce high quality drugs at such high cost levels that no one can afford them. They need to maintain their costs low, and that is where we step in. We help them optimise their costs, while assuring them the same high quality. The industry is fast globalising, quality and regulatory compliance is attracting boardroom attention, and there is an urgent need to manage costs. We are well positioned to help the industry on all three counts. What are the biggest challenges the pharma industry faces today? Globalisation and compliance have brought more focus on regulations such as FDA, GMP, etc and have also increased competition. This has resulted in margin pressure. No longer can one afford to leave Work-In-Progress (WIP) production and material as a black box disconnected from business systems. Quality rejection costs, operator inefficiency and energy costs are three important parameters, which every pharma company needs to control. Most

plants have a basic level of automation by way of Programmable Logic Controllers (PLCs) and Distributed Control Systems (DCS). But none of these automations focus on the above factors. Globalisation of industry now demands that not only the best quality drug reaches the patient but also the same is produced at the minimum cost. How does GE help address these challenges? We recommend a step-by-step approach to protecting one’s investment. As first step, we integrate all the plant data into a central repository and build a visibility of the plant operations with respect to the manufacturing Key Performance Indicators (KPIs). As a part of visibility, we also provide real-time dashboards capturing Overall Equipment Effectiveness (OEE), energy costs and other KPIs, which play a role in achieving operational excellence. The next step is benchmarking current performance against the past one captured in the repository and identifying the gaps. The third step is to identify the root causes of the gaps and optimising the process parameters. The last step is digitising the Standard Operating Procedures (SOPs) based on the gaps and findings. These steps ensure that a pharma company produces a golden batch on a repeated basis and achieves sustainable operational excellence.

Explain in detail about golden batch and digitising SOP. The answer to the differences between a good and a bad batch lies in the plant data itself. One needs to capture this and put in the right context. The challenge here is integrating the process parameters data with quality data. Currently, quality data is analysed post the batch execution and the same is used for exception handling or quality assurance. But it does not help reducing waste, which decreases the yield. To avoid this, we offer process analytic and control tools that integrate the quality database with process data and identify the process parameters, which were responsible for a good batch and also compare them with process parameters in a bad batch. Thus, one can do the correction prior to the batch being rejected. SOPs exist in every plant but seldom all of them are followed in totality. This what an ERP has achieved at a business layer where it has ensured digitisation of a workflow between all business functions. A similar digitisation is required at a plant level as well. We offer this layer at the plant level on a real-time basis, which ensures every operator becomes a smart operator and all the operations are carried out on a role centric basis. The general perception of such solutions is that it is way too expensive for the Indian market. Your take. Not really, if you consider the total cost of ownership. Like I said earlier, we employ a

Modern Pharmaceuticals I April 2012

Sayantan Roy ‘stepped’ approach to operational excellence; never a rip-and-replace one. And we use client’s existing infrastructure to the maximum extent possible. More importantly, our solutions are completely modular, so our clients pick and choose the ones that they really need. They usually start with one production line or area and then scale to the entire plant, at times even multiple, geographically dispersed plants. Because our solutions operate on open technologies, they can connect to almost any brand of PLC or DCS. What heartens pharma COOs and CIOs most is their capability to connect to a variety or ERP systems (SAP, Oracle, Microsoft Dynamix), so they can connect their shop ﬂoor data to the top ﬂoor and derive decisions based on intelligent, real-time information, directly from their machines. Have any pharma organisations realised the benefits of these solutions? Yes. We have implemented these solutions at a few Active Pharmaceutical Ingredients (APIs) and formulations plants in India.

April 2012 I Modern Pharmaceuticals

Moreover, given the global nature of the pharma industry today, I believe Indian pharma organisations would be as much interested in our references world-wide. We have implemented these at a number of sites for reputed global pharma organisations. How much would it cost a pharma company to implement these solutions? Investments in such solutions depend upon a number of factors – number of parameters to be monitored, number of processes to be controlled, number of machines or lines to be tracked, integration with other systems, etc. Hence, it is diﬃcult to put a number on the investment. Each solution is customised to the plant requirements. A better way for a pharma company to look at such investment is to initiate a small pilot on a shared-cost basis, realise the beneﬁts and then scale the pilot to a larger area. What do you view as the next big thing in the industry? Achieving sustainable operational excellence would be the key imperative

for this industry. Although the industry has grown well during the slowdown, the global competition is intense. The current macro-economic scenario of high interest rates, increasing cost of raw materials is adding further pressure on margins. Hence, pharma COOs and CIOs cannot aﬀord large, disconnected WIP inventory as a black box any longer and need to integrate plant operations on a real-time basis with their business systems. How will IT adoption in pharma look like five years down the line? As Indian pharma companies scale and compete with global majors, their operations are bound to become more complex. Hence, they will increasingly adopt technology to simplify operations, manage risk and improve productivity. My recommendation to them is to start now than later. Start small, realise some quick beneﬁts that help you build a business case and scale your technology investments faster. Of course, we would be glad to help. (arshia.khan@infomedia18.in)

Special Focus: Roundtable

Is IT in pharma in good health? Pharmaceutical industry worldwide is progressing at a phenomenal rate and inclusion of IT is propelling that growth further. But is IT complacent enough for further escalation of the industry? Titash Roy Choudhury

Anand Shah MD, Enaltec Labs Pvt Ltd

Mukesh Bhaduria AGM - IT, Plethico Pharmaceuticals Ltd

S Ramesh President - Finance & Planning, CFO, Lupin Ltd

It is an unbiased fact that Indians are known for their technical competency in the arena of medicine, but what has made the consummate progress in the pharmaceutical industry is the application of IT. IT solutions keep the Indian industries abreast with frequent technological advances. Indian pharma industry ranks third in terms of volume in the global market and IT in pharma is in the pink of health in India. There is a huge volume of data easily handled on the ﬂick of ﬁngers using Enterprise Resource Planning (ERP), Laboratory Information Management System (LIMS), Sales Force Automation (SFA), Customer Relation Management (CRM) and myriad of other software applications. Enaltec Labs uses advanced IT solutions such as 21 CFR Part 11 compliance system, computerised instrumental and ERP that cover from development to business management, and ensure the supply of quality medicines across the globe.

The world is experiencing economic slowdown from the last few years, and India very recently experienced the same when the industrial output actually shrunk. In spite of this slowdown, one industry that showed signs of being more stable and continued to show impressive performance is the pharmaceutical industry. Considerable investment into ERP, LIMS, inter-connectivity with testing equipment through hardware/software has once and for all led to data integrity and reliance on data churned out by companies. The list is not exhaustive and is in fact ever expanding. This also means more investment is happening. All this is done with just one objective in mind - best quality products means happy consumer/ healthier patient. We at Plethico believe that achieving ‘uncompromised quality’ can only be possible through IT playing a signiﬁcant role in the healthcare space.

IT and telecom and the convergence therein has become more than missioncritical to our global operations; it is at the very core of business processes governing the existence of the Indian pharmaceutical industry that is increasingly assuming a global flavour. IT processes have allowed companies to streamline processes and work better, faster and smarter. Moreover, in a developing economy such as India, IT can play an important role – that of bridging the chasm between quality healthcare and rural areas. IT integration has helped Lupin in consolidating its position in advanced markets service new therapy areas and business segments, establish on-shore presence in all major markets, and improve operational efficiencies in core business processes while bringing down interim costs by over 15-20 per cent. Lupin became the first to adopt advanced anti-counterfeiting mobile solutions to ensure that customers and patients in India are getting authentic Lupin drugs.

Editorial take

Looking at the level of IT integration in these three companies, one can see the upward progression IT is making in the pharmaceutical industry in India. And, this space is likely to witness more investment in the coming years.

Modern Pharmaceuticals I April 2012

Facility Visit: Indoco Remedies Ltd

Streamlined processes = Stable growth Today, with eight marketing divisions, Indoco Remedies Ltd has reached the pinnacle of success. In the domestic market, Indoco’s strength lies with large brands and in the international market the image of the company is developed as an excellent service provider. Chandreyee Bhaumik

eadquartered in Mumbai, Indoco Remedies Ltd, is a fast growing, fully integrated, researchoriented pharma company with a global presence. Indoco manufactures a wide range of pharma products in various therapeutic segments for the Indian and international markets. It generates more than 50 million prescriptions annually from over 1,25,000 doctors in India. It has around 4,000 employees with a sales turnover of ` 580 crore and international business contributes to 35 per cent of the total sales.

Journey so far Reiterating on the journey of Indoco, Suresh G Kare, Chairman, Indoco Remedies Ltd, says, “My father, Govind Ramnath Kare, started a small set up in Goa to import pharma formulations from Europe, including France. Gradually, the business grew and the French company oﬀered my father the contract for the agency for the entire Western India, the condition being, to set up an

establishment in Mumbai. Thus, in 1945, ‘Indo Continental Trading Company’ was established, where the oﬃce space was smaller than my cabin today.” He continues that in 1947, after India’s independence, the new government in its bid to encourage manufacturing of medicines, banned import of several formulations. He recollects, “Instead of being discouraged, my father ventured into the manufacturing of medicines and that is how Indoco Remedies Ltd was formed on August 23, 1947. We started manufacturing syrups and other dosage forms.” He adds, “One day, my father came up to me and said, “Why do not you do something about the company that I started in Mumbai?” The whole capital was wiped out and I had to start from almost scratch. I made a list of successful doctors from Goa, practicing in Mumbai, and briefed them on the dialogue between me and my father to revive this company. This appeal really worked and the doctors started prescribing Indoco’s products.” He informs that the very ﬁrst year, the sales growth was 40 per cent. That gave him a lot of encouragement.

R&D plant, Rabale Indoco has set up a state-of-the-art stand-alone R&D centre at Rabale, near New Mumbai. Occupying an area of 70,000 sq ft, the R&D centre has three divisions ie formulations, APIs and intermediates and regulatory & IPR cell. The centre is equipped with a spectrum of library and information management services. The company has so far invested $ 12 million in this R&D centre. The centre has synthetic chemistry labs, formulation and development lab, AMD, regulatory and IPR cell. The facility is at the forefront of Indoco’s eﬀorts for a successful entry into the advanced regulated markets of US and Europe. The R&D centre and the kilolab facility are expected to boost the API synthesis and development eﬀorts that are primarily directed to meet several requirements of regulated markets. The R&D centre has strengthened and enabled the company to successfully complete Common Technical Document (CTD) dossiers for the regulated markets. The API section has capabilities to synthesise APIs, work on process improvement as well as development of non-infringing processes for APIs and intermediates. The formulation section is engaged in development of dosage forms – solid and liquid orals, creams & ointments, ophthalmic preparations, small volume parenterals

Modern Pharmaceuticals I April 2012

Indoco Remedies Ltd I had set an objective of growing 10 times every 10 years and we could achieve the same till the end of 2000. By that measure, we should have been ` 1,000 crore in 2009, but this did not happen, due to sturdy market conditions. Suresh G Kare Chairman and dental products. It is also engaged in research in the area of modiﬁed release products such as sustained release and controlled release tablets. The regulatory and IPR cell is equipped with online patent search tools and syndicated databases with access to various libraries and would be engaged in preparing regulated market ANDAs and dossiers in CTD format.

Feathers of success Besides the plant at Rabale the company has various manufacturing sites in Goa and Patalganga. Growing slowly and steadily it has expanded geographically, introduced more products in the market and made a name for itself. Kare highlights, “Indoco’s employee strength grew gradually and today, we boast of around 4,000 employees, including skilled scientists. In the year 1979, we became ` 1-crore company, in 1989 we became ` 10-crore strong, and in 1999, our turnover was ` 100 crore. I had set an objective of growing 10 times every 10 years and we could achieve the same till the end of 2000. By that measure, we should have been ` 1,000 crore in 2009, but this did not happen, due to sturdy market conditions. However, we are set to touch ` 1,000 crore by 2014.” In 2005, the company shares were listed on BSE and NSE.

Establishing a brand name Indeed Indoco has its own special aspects that make it diﬀerent from the others. Talking about the success that the company has seen, Aditi Kare Panandikar, Managing Director, Indoco Remedies Ltd, avers, “We developed the

April 2012 I Modern Pharmaceuticals

We developed the company’s image by building excellent brands. Even today, some of our legacy brands are enjoying brand loyalty and some are among the top five. Aditi Kare Panandikar Managing Director

company’s image by building excellent brands. Even today, some of our legacy brands are enjoying brand loyalty and some of our brands are among the top five in their respective therapeutic categories. For a company of our size, it was really an achievement. We realised in time, that in a highly fragmented pharma market, it is essential to create USPs.” She continues, “With the global economy opening up, we had to upgrade our manufacturing and R&D skills to meet the international standards. Also, the CRAMS business was going to open up to the Indian market and we had to take the advantage of it. Indoco’s first formulations manufacturing plant for regulated markets was commissioned in Goa, in 1997, and we received our first international approval by UK-MHRA in 2003. Thus, Indoco’s international business kicked off in 2003. It has been eight years and there is no looking back.” Some of the top brands of the company are Febrex Plus, Cyclopam, Sensodent-K, ATM, Vepan, Cital, Oxipod, Sensoform, Cloben-G, Karvol Plus, Tuspel Plus.

Setting apart Elaborating on the milestones Kare comments, “I took advantage of the government policies towards the beneﬁt of the backward areas. All over, we have nine manufacturing plants - ﬁve for formulations and four for APIs and one R&D centre at Rabale in Navi Mumbai.” Further, Panandikar adds, “We had couple of inorganic acquisition opportunities. In 1999, we acquired Warren Pharmaceuticals that was into the ophthal and dental segments. Today,

we have two divisions operating out of that acquisition: one is Warren, which caters to dental products, and the other is Excel with ophthal products. In 2005, we acquired a big brand called Karvol Plus from Solvay Pharmaceuticals.” She adds that the company has achieved several milestones in the global business. These deals have further strengthened Indoco’s image in the international markets.” Indoco has two USPs. Panandikar avers, “One is the Indian market with large brands and the other is international, where we developed the image of our company as an excellent service provider.”

CSR activities Indoco has been actively contributing towards betterment of the society. Panandikar says, “When we completed 50 years in 1998, our chairman announced formation of ` 1 crore corpus and formed The Suresh Kare Indoco Foundation for the cause of education. The Foundation also works with several NGOs working for the cause of underprivileged and mentally challenged children.” Further, Indoco makes funds available to allow schools to set up infrastructure to inculcate better hygiene habits among young children. Indoco also distributes medicines and conducts free medical camps for the needy. Signing oﬀ, Panandikar reiterates, “Indoco is a complete solution provider for generic companies across the globe. With one foot ﬁrmly entrenched in the fast growing Indian pharma market and other in the vast international market, Indoco is beautifully poised to achieve new heights.” (chandreyee.bhaumik@infomedia18.in)

Insight & Outlook

Cleanrooms Indian cleanrooms market Picking up pace ..................................................................44 New design concepts in cleanrooms Indeginisation, the way forward ..........................................46 Interface Jignasu Mehta COO, Clestra Modular Systems Pvt Ltd ..................................48 Endometrial cancer therapeutics market Lacking treatment options ..................................................49 Destination Ireland Gateway to the global life sciences industry .........................50 Pharmaceutical branding Need for a little auto focus ..................................................52

April 2012 I Modern Pharmaceuticals

Insight & Outlook: Indian cleanrooms market

Picking up

pace

advanced technological areas such as bio and genetic engineering, space and nuclear applications, advanced material sciences, etc is extremely signiﬁcant. Thus, with time cleanrooms and air cleaning have become important considerations for food and agro, pharma, micro electronics, semi conductors, healthcare segments and many other verticals.

Classification

The need for controlled environmental conditions pertaining to temperature, air changes per hour, air borne particles count, illumination levels and many other factors have stimulated the development of clean rooms. Thus, they have gained its prominence in not only pharma industry but also in healthcare, bio-safety and research. Chandreyee Bhaumik

bout a century ago, the concept of clean environment and its management was first proposed in medical facilities. The then doctors perceived the need for controlling infections of wounds. Efforts were made by surgeons and microbiologists to formulate the concept of a clean zone. However, it was only in the early 60s that a first organised attempt was made in order to develop a cleanroom. Willis Whitfield, American

engineer and his team at Sandia Laboratories realised the concept of uni-dimensional or laminar air flow for effective removal of micro contaminants from clean space. Further, the HighEfficiency Particulate Air (HEPA) filters technology at the same time highlighted the concept and these filters quickly made their way into the air cleaning and clean room technology. Since then cleanrooms have come a long way. Today, we have diverse requirements of modern cleanrooms in various spheres of activities. The role of cleanrooms in

From the time when the first cleanroom was established in the early 60s, the perception of cleanrooms has undergone a sea change. At that time, Class 1000 or Class 100 were considered to be stringent, and today class 10 or even Class 1 can be considered as practical proposition. The increasing burden of the air pollution and the pressure of strict quality requirements have urged the engineers to maintain high class modern cleanrooms. Additionally, parameters such as the levels of noise and vibration, ionising and electromagnetic radiation, etc, have also been included for controlled environment in cleanrooms for certain special applications in the areas of material science, nuclear and space applications, etc. The latest International Standards Organisation (ISO) standard on cleanrooms is definitely a step in this direction that will provide strict guidelines for classification of cleanrooms. ISO has introduced ISO classification numbers for cleanrooms from ISO-1 to ISO-9 and has released two standards ISO14644-1 and ISO-14644- 2, wherein the objectives has been to combine the best features of the different base documents available from Europe, Japan and the US. This is a welcome measure from the point of view of standardisation. These standards have also clearly spelt out the mandatory tests along with the optional tests that are necessary to demonstrate the continuing compliance of cleanroom standards.

Indian scenario The Indian cleanrooms market has seen considerable growth in India during

Modern Pharmaceuticals I April 2012

Indian cleanrooms market

The Indian market for cleanrooms is huge. Cleanrooms are important not only for the pharma industry but also relevant for many other sectors.

In the temptation to offer cheaper prices if the quality and safety aspects are compromised it can affect the acceptance of this concept. Dr H G Koshia Commissioner, Food & Drugs Control Administration, Government of Gujarat

the past 10-15 years. This demand will always be on a rise since more and more industries and R&D centres will require this technology. Dr H G Koshia, Commissioner, Food & Drugs Control Administration, Government of Gujarat, says, “The pharma market is a strongly emerging market and rapidly growing because every new and upgraded/ renovated facility for sterile products is opting for modular panel cleanrooms. The cleanroom concept is preferred even in Oral Liquid Dosages (OLD) and is catching up with even Oral Solid Dosages (OSD).” Today, cleanrooms in India are not just concerned about microbial and particulate contamination control. They are also concerned about the complete environmental regime conducive to the process requirements, in which various parameters are systematically regulated and controlled. Over the years, industry experts have also realised the importance of education while dealing with the operation and maintenance of cleanrooms. Talking about the development of cleanrooms, Dr Koshia avers, “The focus on facility establishment for creating manufacturing facilities is comparatively high, ie, large number of new the manufacturing capacities is being created in India and in Asian countries in comparison to the US or Europe. Obviously, India should emerge as one of the strongest contender for market potential for cleanrooms. The fact that during the last 5 years manufacturing facilities for cleanrooms were established in India is a testimony to this.”

April 2012 I Modern Pharmaceuticals

T S Jaishankar Chairman, Confederation of Indian Pharmaceutical Industry (CIPI)

Discussing the Indian market for cleanrooms, T S Jaishankar, Chairman, Confederation of Indian Pharmaceutical Industry (CIPI), says, “The Indian market for cleanrooms is huge. Cleanrooms are important not only for the pharma industry but also relevant for other sectors such as electronic, software and many others.” He adds that every manufacturing process should be free from pollution. He highlights, “It must be remembered that quality is a continuous process and it just does not depend on the end product We should pay attention to quality through the entire ongoing process.” He further adds that it is unfortunate but in India there is no concept of cleanliness. He reaﬃrms, “In India, we have a long way to go. Our individual and overall sense of hygiene needs to improve. Thankfully, Indian companies are comprehending the worth of cleanliness. However, the quality of materials that are used in cleanrooms sometimes acts as a deterrent. While the imported materials are ﬁne it is the locally made ones that do not match the standards of Germany, Europe and the US.

Future of the market The global acceptance of India as the manufacturing base for pharmaceuticals is the primary growth driver for ancillary industries such as cleanrooms. Dr Koshia remarks, “The enhanced awareness about cGMP and the cost beneﬁt analysis of cleanrooms visa-vis conventional pharma grade civil construction has contributed

significantly. Cleanrooms have been considered as an integral part of an effective and performing HVAC system.” He further adds, “The indirect benefits of cleanrooms such as speed and ease of installation, flexibility, durability and lower maintenance costs, etc are recognised by designers and pharma professionals.” Discussing whether the Indian market has any hindrance for the development of cleanrooms, Dr Koshia comments, “As such I do not see a major hurdle or hindrance for cleanrooms. Only possible hurdle could be compromise on quality of cleanrooms. The high demand potential might attract several operators to this segment and in the temptation to offer cleanrooms at cheaper prices if the quality and safety aspects are compromised it can affect the acceptance of this concept.” He adds that the focus on quality and continued R&D efforts to keep adopting with the cGMP trends of pharma into design of cleanrooms is the assured approach to overcome the challenges. Jaishankar highlights that high cost at times becomes a challenge for cleanrooms Indian market to develop. He avers, “Constant efforts should be made that the cost is conducive. Additionally, research should be done so that the cost of the materials is also reduced. At present, we are blindly following the pattern that is practiced abroad. Overall, I can say that we have come a long way and we are capable of achieving more.” (chandreyee.bhaumik@infomedia18.in)

Insight & Outlook: New design concepts in cleanrooms

Indeginisation, the way forward Indigenisation is one of the practical ways to make cleanroom technology both acceptable and approachable. With specialisation assuming importance in every sector, indigenisation may be the path to be treaded. Chandreyee Bhaumik

Courtesy: Fabtech Technologies International Pvt Ltd

rom the late 90s, India has seen a substantial increase in use of cleanrooms and now it is almost a basic requirement for all life sciences facilities. Elaborating on the development that cleanroom segment has witnessed, P K Kulkarni, Managing Director, Technolutions Projects Pvt Ltd, avers, “Not much has changed since those days as far as the basic elements of cleanrooms, namely the structural elements such as the wall panels, view panels, windows, doors, ﬂooring, ceiling and support systems such as the air handling units and associated elements like the ducting, ﬁlters, etc are concerned.” He adds, “What has changed over a period of time is the availability of choice in selecting the systems and components. Thus, today a range of materials like powder-coated aluminium, stainless steel, high pressure laminates, Glass Reinforced Polyester (GRP)

are available for cleanroom panels. Similarly, a range of materials can be used for floor construction viz various grades of epoxy, terrazzo, vinyl, polyurethane, etc. Again, multiple choices are available for ducts, insulation, ceiling panels, etc.” According to Kulkarni we are moving towards pre-engineered and prefabricated components that are just assembled at a site that provides a super structure. He highlights, “In the process, the accuracy of design, the detailing of processing requirements and overall engineering efforts have increased significantly since any mistake can have serious consequences at site.”

Going for indigenisation Over a period of time, India is moving from process patents to product patents and miniscule process developments to a desired source for R&D outsourcing by regulated market players, the speciﬁcations for cleanrooms have started becoming

much more generic but definitely more stringent. Kulkarni remarks, “A pure contract manufacturing operations outfit will now need to have its facility designed for multiple presentations like the vials, cartridges, ampoules, etc as well as various packaging equipment. Here too, the emphasis on flexibility to include high potency molecules such as oncology, biotech, hormones and sensitising agents is seen to be growing fastest.” He further adds that one would now need to include multiple measures for containment, environmental controls, data acquisition systems, flexibility to change rooms’ sizes or equipment installed, etc, for a modern laboratory.” Kulkarni highlights, “The containment industry in pharma and biotech facilities is the fastest growing segment of the cleanroom business today. This includes the newer designs of the ‘bag-in-bag- out filters’, disposables used for cleaning and disinfection etc.” He comments, “While the basic cleanroom components may not have made too many upgrades, the design and fabrication issues have taken precedence.” D Rambabu, Director Marketing, Ahlada Engineers Pvt Ltd, says, “At present, in cleanrooms civil walls are making way for cleanroom partition made of galvanised iron. The latter helps in better maintenance of temperature, pressure. Additionally, cleanliness and hygiene are better maintained in cleanroom partitions.” As far as cleanroom design variables are concerned pressure differentials have become quite significant. The electronics industry, medical devices as well as conventional sterile pharma manufacturing demands positive pressure cleanrooms, whereas high potency operations, biotech, etc demand negative pressure rooms. These further need careful designing of the entire facilities inclusive of the HVAC systems, circulation corridor designs, different types of air locks (bubble, sunken and cascade), and local inactivation systems for effluents including exhausted air, etc.

Modern Pharmaceuticals I April 2012

New design concepts in cleanrooms

The containment industry in pharma and biotech facilities is the fastest growing segment of the cleanroom business today. P K Kulkarni Managing Director, Technolutions Projects Pvt Ltd Talking about further advancements, Kulkarni says, “Small scale cleanroom applications have given a further boost to specific applications like the mobile soft wall cleanrooms, flexible isolators, pre-engineered clean utility installations respirators, etc. However, they have limited applications when it comes to fully flexible applications.” Discussing the cost factor, Kulkarni says, “Typically the cost of installing a standard cleanroom excluding the cost of the Reinforced Cement Concrete (RCC) super structure varies between ` 9,000-45,000 per square meter of built up cleanroom of a standard height of upto 3.5 metres depending upon the various structural elements required as well as materials of construction and source of components.” He adds that typically the operational cost depends on the usage of the equipment, the types of consumables used, operational procedures employed, the degree of supervision, etc. He comments, “In our experience, a facility of approximately 1,000 square metres of cleanroom will have an operating cost of at least ` 10-15 lakh per month.”

While the basic cleanroom components may not have made too many upgrades, the design and fabrication issues have taken precedence. D Rambabu Director - Marketing, Ahlada Engineers Pvt Ltd

India is adequate to support this need and has even become a net exporter itself. This includes the cleanroom panels, containment solutions (mainly for negative pressure non-sterile applications). This indigenisation eﬀort has reduced the costs of installations in India signiﬁcantly. There is intense competition among the suppliers of cleanrooms components, auxiliary systems, consumables as well as designers and consultants.”

Maintaining the standards The regulatory standards as speciﬁed in Centre for Drug Evaluation and Research (CDER) Guidance, European Directorate for the Quality

Indigenisation effort has reduced the costs of installations in India significantly.

Benefits of indigenisation Cleanroom is the need of the biologics and electronics industry. Today, it is increasingly looking towards the regulated markets for business. The revised Schedule M requirements match those of the EU and WHO. Thus, it has become the need of the hour to indigenise in order to remain cost competitive. Kulkarni says, “The entrepreneurial zeal in

April 2012 I Modern Pharmaceuticals

of Medicines (EDQM), WHO Speciﬁcations as well as those of Indian Schedule M are sacrosanct. Elaborating on the standards, Kulkarni avers, “Clear standards are prescribed for diﬀerent operations to be carried out in manufacturing of sterile products. These provide acceptable limits for total particulates as well as viable counts.” He adds that it is the

customer-specific specification that is more difficult to design and validate. In fact, no regulatory requirement specifies a given cleanroom classification for processing non-sterile dosage forms such as tablets, capsules, liquid orals, etc.

Future path The special demands of containment have made the design of the cleanrooms a specialised discipline that needs to have controls over particulate count, viable count, pressurisation, temperature and humidity on an ongoing basis. Kulkarni says, “This demands a great design effort inclusive of 3D modelling to avoid clashes among utilities, advanced measuring and controlling instrumentation, better data acquisition systems, specific and easily understood qualification and validation protocols, etc. While it was alright to have a spray of disinfectant solution on the sterile gloves of the operating personnel earlier, it is discouraged by many regulatory auditors now since the disinfectant may contaminate the product.” Indigenisation will go a long way. Rambabu adds that cleanroom partitions provide flexibility to cleanrooms and they can be shifted to another base when need arises. Thus, indigenisation is a vital consideration for the cleanroom segment to develop. With time now cleanrooms have become modular and thus they have gained their prominence in not only pharma industry but also in electronics. So, today cleanrooms are established considering that there is a lot of ventilation, filtration and many such related factors. (chandreyee.bhaumik@infomedia18.in)

Insight & Outlook: Interface - Jignasu Mehta

“Over a period of time, with changing trends, almost all pharma companies are opting for modular cleanrooms” …says Jignasu Mehta, COO, Clestra Modular Systems Pvt Ltd. He discusses the growth trajectory of cleanrooms in India. Chandreyee Bhaumik

What are the new design concepts for cleanrooms? For cleanroom designing, we follow international standards used for Good Manufacturing Practices (GMP) and regulatory standards. Our R&D team is working for the technological advancement of our product range and that has resulted in better cleanrooms. Recently, Clestra has developed a new concept for cleanroom ceiling and partitions, which is really unique on a global platform. We have developed new walk-on type ceiling that has a single line joint from the cleanroom side and double line joint system from technical side. This new concept is designed and developed for more flexibility, true modularity and better cleanroom construction, and it also has more flexibility with arrangement of sliding suspension. New partition series has a single line junction but it is differentiated with its unique non-progressive nature, and moreover, it has in-built provision for running cables and possibility to have different size double line junctions as and where required. Today, all our products are manufactured at our Indian facility but are designed and developed by our central research team based at France. Thus, we have all the global products that are indigenised. Quality standards that need to be maintained for cleanroom technology? In pharma industry, everything has to be precise and standards have to be followed. Particularly for cleanroom, one has to follow

ISO 14644-1.This defines the basic cleanroom with different classification based on the application. At Clestra, we follow our internal standards that are beyond the ISO standards. We have stringent norms and set procedures for each and every step of designing, testing, manufacturing, commercialising and even for project management. How is India placed against the global scenario in this context? Here, we are required to have two different perspectives. The first one is the market condition for cleanroom in India and upward market demand for cleanrooms with growing awareness for international standards. So, India has a huge potential for cleanroom market. From another perspective of the Indian buyer, today the Indian pharma industry is looking for cost-effective products. Here, they should also consider important factors such as green values of the product and safety aspect of the system. Today, with increasing cost of energy, the overall design has to be energy conservational that will increase the operation cost benefits. This will help the market to have better overall product lifecycle cost and not just provide short-term benefits. Required cost (establishment and operational)? One needs to understand the balance between the establishment cost and the operational cost and that is where the ‘Clestra expertise’ counts. With the use of combination of

different infill, based on application and area requirement, at the end Clestra is more economical compared with the cheap capital cost products. Challenges and future of this market. There are no challenges as such. Today in India, majority of clients are using Poly Urethane Foam (PUF) as an infill material, whereas by using alternate infill ‘rockwool’ will have better environmental effects and minimal risk. Unlike European continent we do not have strict norms of insurance for using such products that needs to be inculcated in the near future. The future trend in the Indian cleanroom industry is surely going to be upwards as for pharma industry it is not merely restricted to high-end products, but now all segments are going for cleanroom technology. Other than pharma, there will be huge market in other industries such as automobile, glass, food, hospitals, semiconductor and the major user will be PV cells manufacturers. Companies such as Intel, Nokia, and Motorola are setting up their facilities in India and they will have huge cleanroom requirement. The inclination towards nonconventional sources of energy is resulting into increasing demand for solar power plants. These plants require PV cells, which need cleanroom for assembly. Looking at the growing trend of pharma and other industries, overall, I foresee a great future for the Indian cleanroom industry. (chandreyee.bhaumik@infomedia18.in)

Modern Pharmaceuticals I April 2012

Insight & Outlook: Endometrial cancer therapeutics market

Lacking treatment options

by the expected launch of the Ixempra (ixabepilone) in 2015.

The following data is an essential source of information and analysis on the global endometrial cancer therapeutics market. It identifies the key trends shaping and driving the global endometrial cancer market.

Current treatment options

Endometrial cancer therapeutics market, global, revenue and forecasts ($ million), 2005–2017 200 CAGR (2010-2017): 3.9%

180 Revenues ($ million)

160 140

CAGR (2005-2010): 3.9%

120 100 80 60 40 20 0 2005

2010

2017

Source: GlobalData, GLOBOCAN 2008, GlobalData Epidemiology-based Market Forecasting Model, Primary Research Interviews, KOL Interviews

ndometrial cancer is one of the most common cancers to be detected in women. It develops in the body of the uterus, or womb, which is a hollow organ located in the lower abdomen. It generally occurs post the reproductive years in women, ie, between ages 60 and 70. Some valuable insights are provided on the pipeline products within the global endometrial cancer sector. Most endometrial cancers are adenocarcinomas (cancers that begin in cells that make and release mucus and other ﬂuids). Some reports claim that taking tamoxifen for breast cancer or taking estrogen alone (without progesterone) can aﬀect the risk of developing endometrial cancer. Cancer rates in India are lower than those seen in Western countries, but are rising with increasing migration of rural population

April 2012 I Modern Pharmaceuticals

to the cities, increase in life expectancy and changes in lifestyles. The report provides insights on the prevalent competitive landscape and the emerging players expected to signiﬁcantly alter the market positioning of the current market leaders globally.

Forecast of slow growth GlobalData has estimated the global endometrial cancer market to be valued at $ 137 million in 2010. It is expected to grow to $ 179 million with Compounded Annual Growth Rate (CAGR) of 3.9 per cent by 2017. This growth is primarily attributed to the increasing prevalence of the disease due to the aging population, diabetes and obesity. The diagnosis and treatment seeking rate is also high in endometrial cancer. Currently, there are no approved drugs for endometrial cancer and the market will be driven

GlobalData’s analysis found that the unmet need in the endometrial cancer market is high, which implies that the market is not well served with the current treatment options and there is scope available for new technology products that would capture value from under-served segments. Standard treatment for endometrial cancer includes surgery to remove and stage the cancer. In some cases, however, the doctor may treat based on the clinical stage. Endometrial cancer is basically a surgically managed disease and there are no drugs approved for it. All the drugs that are currently used are generics and have high toxicity profiles. The response rates of these off-label drugs are high but the safety profile is low. Hence, drugs with high efficacy and safety profiles will be able to fulfill the unmet need in the market as advanced and recurrent stages of the disease are treated with drug therapy only. Women who cannot have surgery because of other medical problems are often treated with radiation alone.

Strong pipeline expects a race for blockbuster GlobalData’s analysis showed that there are 22 molecules in various stages of the pipeline. All the molecules in the pipeline have novel mechanisms, because of which the pipeline is strong. Research is prominent in the late phase (Phase III & II) of development, but the majority of the molecules are in Phase II, because of which their launch is not expected within the forecast period. Some of the promising molecules in late stage (Phase III & II) development are Ixempra which is a microtubule inhibitor; ridaforolimus, which is a mammalian target of rapamycin (mTOR) kinase inhibitors; and XL147, which is a phosphoinositide 3-kinase (PI3K) inhibitor. (Courtesy: GlobalData)

Insight & Outlook: Destination Ireland

Gateway to the

life sciences industry Ireland has an excellent track record in manufacturing pharmaceutical products and no Ireland-based companies have received notices from either FDA or other regulatory agencies in the past 10-12 years. Thus, companies are encouraged to carry out activities such as Intellectual Property (IP) management, supply chain management and global sourcing. Chandreyee Bhaumik

n recent years, the Irish economy has transformed from an agricultural focussed to a modern knowledge economy. Post the global ﬁnancial crisis of 2008, the economic situation in Ireland has changed drastically and is now stabilised with analysts expecting resumption of positive growth this year and beyond. Today, Ireland holds the following position in world competitiveness rankings: 1st for corporate taxes 4th for the availability of skilled labour 6th for labour productivity 7th for the availability of ﬁnancial skills

Growth rate While the European Union (EU) pharmaceuticals market is worth $ 48 billion, $ 16 billion is for generics. This presents huge opportunities for Indian players to use Ireland as a gateway to the global life sciences industry (Europe included). For pharmaceuticals, the EU market is going through an inﬂection

point. Elaborating on the growth rate, Brian O’Neill, Global Sectoral Manager - Life Sciences, Enterprise Ireland, remarks, “An Indian company looking at marketing its branded generic drugs directly to its consumers in the EU region could typically take 12-14 weeks for the go-to-market strategy. Reason being it involves the process of the drug leaving its manufacturing facility in India, shopping, getting the QA-QP approvals, etc and then reaching the consumer marketplace.” Furthermore, complexities in demand forecasting, managing inventory to fulﬁl the demand in the EU region are deepening. He adds that unlike the US market, the EU market is heterogeneous comprising 27 diﬀerent pricing and regulatory structures. Each country in the EU region has typical characteristics of operating the pharma industry. For instance, Germany is a tenderdriven market, whereas France is an innovator drug-driven market. With such a background, it becomes absolutely essential for Indian pharma companies to have an on-ground EU presence in order to expand into

the EU territories. Speaking in this regard, O’Neill clariﬁes, “An on-ground presence either in terms of sales and marketing or a small manufacturing base could help in achieving radical beneﬁts in terms of expediting go-to-market strategy by 40 per cent, reducing costs of inventory stuck in pipeline of logistics and regulatory procedures.” The Irish Life Sciences sector is about 45 billion (mainly export oriented).

Diverse array According to O’Neill, Ireland has a rich landscape of the world’s leading MNCs and the list includes the likes of the ‘who’s who’ of the global industry. He highlights, “Indeed, 18 of the world’s top 20 multinationals have operations (some multiple) in Ireland ranging from Pﬁzer through to Lilly, GSK, MSD, Abbott, Novartis and Genzyme etc. While export values are dominated by such MNCs, Ireland has built a dynamic and burgeoning indigenous industry.” Further, he adds, “There are now over 100 such companies competing in markets throughout the world. The single and most important shared characteristic of these entities is their innovative nature and value-added propositions – the most successful of which are now partnered with global multinationals that in turn are looking for new technologies, products and processes to support their development and manufacturing programmes.” Ireland now has nurtured the development of a diverse array of exciting companies ranging from New Chemical Entity (NCE)/biologic developers, drug delivery experts, leading global clinical research organisations to process and project management specialists, regulatory experts, cleanroom engineering specialists, construction services and specialist manufacturers – on the whole all areas of the biopharma supply chain. Examples include smaller companies such as Opsona, Merrion Pharma, Sigmoid, and Genable to global players such as ICON, PM Group and Elan.

Modern Pharmaceuticals I April 2012

Destination Ireland Regulatory scenario The European Medicines Agency (EMA) is responsible for the scientific evaluation of applications via a centralised procedure. Clarifying the regulatory scenario O’Neill says, “Under the centralised procedure, companies submit one single marketing authorisation application to the EMA. All medicinal products for human use derived from biotechnology and other high technology processes must be approved via the centralised procedure. The same applies to all human medicines containing a new active substance intended for the treatment of AIDS, cancer, diabetes or new degenerate diseases and for all designated orphan medicines intended for the treatment of rare diseases.” He further adds that for medicinal products that do not fall under any of the above-mentioned categories, companies can submit an application for a centralised marketing authorisation to the EMA for consideration if it is a new active substance or the medicinal product constitutes a significant therapeutic, scientific or technical innovation or the product in any other respect is in the interest of patients in the community. A marketing authorisation granted under the centralised procedure is valid for the entire community market, which means the medicinal product may be put on the market in all member states. He highlights, “Another way to access the European pharma market is via the mutual-recognition and decentralised procedures. Both the procedures aim at facilitating access to a single

market by relying on the principle of mutual recognition.”

An ideal destination The Irish government has constantly observed and monitored global business trends and has moved ahead by creating strengths and capacities to foster and cater to global changes. This is clearly evident in Ireland’s ever-transforming economy - from being a low tech, assembly type manufacturing economy in the 80s to emerging as leaders in cutting edge R&D and high tech manufacturing. Further, Ireland has some of the best highly skilled talent in its young work force. Talking about the opportunities that Ireland holds for India and other countries, O’Neill says, “Ireland has a standard, EU-approved corporation tax rate of 12.5 per cent on all trading proﬁts. Additionally, Ireland has an excellent network of double taxation avoidance treaty with 55 countries in the world including India.” Continuous innovation plays a central role in Ireland’s future as a knowledge-based economy. Recognising this, the Irish Government put in place a National Strategy for Science, Technology and Innovation (SSTI) in the 1990s. O’Neill avers, “There is a 25 per cent tax credit provided to organisations for R&D & innovation. This is in addition to a tax deduction at 12.5 per cent for R&D expenditure in Ireland. Its purpose is to encourage both foreign and indigenous companies to undertake new and/or additional R&D activity in Ireland.”

There is a 25 per cent tax credit provided to organisations for R&D & innovation. This is in addition to a tax deduction at 12.5 per cent for R&D expenditure in Ireland. Its purpose is to encourage both foreign and indigenous companies to undertake new and/or additional R&D activity. Brian O’Neill Global Sectoral Manager - Life Sciences, Enterprise Ireland

April 2012 I Modern Pharmaceuticals

Some of the Indian companies that have a presence in Ireland Wockhardt: Entered Ireland by acquiring Pinewood Laboratory in 2006 Reliance Life Sciences: The manufacturing facility for Reliance GeneMedix Plc is situated in Ireland Ranbaxy: Ranbaxy has been in Ireland for 11 years and is now acquired by Daichi Sankyo

Partnerships O’Neill believes that partnerships are essential in this industry and ‘loners have no future’. He remarks, “Industry needs to continue investing in innovation and value-creating/ differentiating propositions. Enterprise Ireland, using its 31 overseas offices, continues to support our clients to build corporate linkages across all stages of our client’s supply chains with leading global entities (in addition to supporting R&D as above).” He continues that leadership and specialist functional management expertise are essential. He says, “We run hosts of programmes focussed on the ‘CEO’/leader through to international sales and partnering to senior management group training. These are run in conjunction with the leading global thought leaders in the space such as Leadership4Growth with Stanford University. We also support companies to directly hire key senior management. Additionally, global regulation and reimbursement practices and procedures are changing all the time. We run country-specific workshops in this area given by domain experts.” Signing off, he says, “Raising finance is always essential. In addition to directly investing in seed and Venture Capital (VC) funds, Enterprise Ireland hosts and runs international investor forums to attract leading global funds to facilitate later stage syndicated investment rounds for our clients.” (chandreyee.bhaumik@infomedia18.in)

Insight & Outlook: Pharmaceutical branding

Need for a little auto focus Pharmaceutical branding has gained immense popularity, now more than ever, to the public as well as the prescribing physician. Pharma companies spend considerable time to define the name, approach and feel the product should have in the market. A look at how this branding business can be made easy.

was recently given a pair of binoculars that automatically adjusted its focus, no need to ﬁddle or squint - Cast your gaze and clarity is instantaneous! No matter who is doing the looking or what they are looking at, the focus is always right. I was just amazed at how it works. And it got me thinking that something like this could be pretty helpful when it comes to the branding and marketing of pharmaceuticals — which seem to require a lot of ﬁddling and squinting to ensure accurate focus for all involved.

At its highest level, branding is actually an incredibly simple thing. It is about linking speciﬁc, concise associations to a given product or service by consistently communicating these associations over time to the general marketplace. Doing this allows the brand to burrow into and occupy a nice little niche in the universal market psyche, creating a sense of shared experience.

Defining the strategy A consistent premise repeated over time - Simple.

But, as I implied, in the pharmaceutical category we all know there is nothing simple about the industry. From insurance issues, to regulatory issues, to prescription formularies and patent issues, it is about as un-simple a category as you can get. In the case of life-enhancing drugs where consumer marketing enters the picture, things get even fuzzier. Especially when it comes to communication. What you can say, what you cannot say, who you need to say it to in order to tell and sell your story. This is the ﬁrst of the two major challenges inherent in the branding and marketing of drugs. There are myriad audiences involved in the pharma-marketing mix, each requiring a diﬀerent ‘set’ of information based on their role in the process. Physicians, pharmacists, medical reps, payers, and of course, patients, to name just a few, which makes delivering a simple, consistent message a bit like teaching in Marathi to a

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Pharmaceutical branding room full of diversely geographic students globally. The key to success in pharma-marketing is to ensure that anyone communicating to any audience is communicating the same simple, consistent associations about the product, regardless of group or channel. And that no matter who is looking and listening, everyone sees and hears the same thing. The trick is to bring fractured points of view together, but in a manner commensurate with individual ‘educational’ needs and perspectives. Lack of credibility in this category is not an option. What makes this ﬁrst challenge even stickier is the fact that each of the audience groups I mentioned typically has its own communications partner. Multiple ad agencies, promotional ﬁrms, PR folks, and in-house marketing departments make for a condition rife with ‘not invented here’ symptoms. For critical brand associations to be conveyed consistently agency by agency, creative director by creative director, channel to channel, everyone’s got to be working from the same brand vision. If the communicators are not singing from the same prescription pad, there are not going to be a whole lot of prescriptions written. As for the second major challenge in this category, consider the over time issue. Unlike other products or services, with pharmaceuticals there is no ‘over time’. Drugs that are here today may not be here tomorrow, whether due to evolving science and technology, the competition or patent situations. Time frames are truncated, which means any brand idea has to be enduring -- have a half-life far more sustainable and resonating than just clinical performance claims can provide. And it needs to be fast acting — to register instantly.

Successful pharma branding My premise is that to succeed in pharma branding you need a brand idea that will auto focus on contact anywhere, by anyone, at any brand touch point. An idea so clear and precise in intent it prompts a spontaneous ‘aaaah’ without any ﬁddling, squinting or adjustment.

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Absent the requisite optical equipment, how do you do this, especially given all the side eﬀ ects of the category? Quite simply, you have got to be focussed on exactly what you want your brand to stand for. The associations with which you want to be identiﬁed. No ambiguity. No potential for double vision or double meaning. No question at all about what condition it is for, who it is for, or why it is best-in-class. Your goal is a brand vision so cohesive, so right-between-the-eyes, it becomes indelible and motivating to whoever is on the other end of the lens. Has the

What you can say, what you cannot say, who you need to say it to in order to tell and sell your story. This is the first of the two major challenges inherent in the branding and marketing of drugs.

power and punch to be ‘gotten’ with a ﬂash of clarity by anyone who has to get it -- whether to prescribe it, to use it, to recommend it -- or to market it.

Creating an auto-focussed brand idea As I said, rather than working from functional attributes alone, auto focus in this category depends on finding the appropriate balance between the emotional attributes of the product and the rational reasons-to-believe. For impact with credibility, you need to grab an audience at both a visceral or higherorder benefits level, and at a ‘makes sense’ level. Call it a right brain/leftbrain approach. Getting into the system — the head and the heart of the matter — at the same time. ‘Make me feel like myself again — without the side effects, please!’

For this, you have got to give people something right-brain/left-brain to relate to. But more critical, a way to relate to each other. In other words, your brand associations should have the capacity to serve as a catalyst for common dialogue. To be the verbal cues that promote a comfortable, easy way to talk about the condition with no fine print in terms or conditions. Talk, in this category, especially talk between doctor and patient, is the best medicine for building brand preference. By presenting your disparate audiences with brand associations that facilitate dialogue and bridge communication gaps, you obviously promote shared understanding of your product promise and benefits. Your objective should not be just to show empathy for an audience, but to deepen empathy between audiences. To establish your brand as the definition for the relief of the condition. At the end of the day, to occupy that nice little niche in the universal pharma-psyche with regard to whatever it is that ails you. While the pharmaceutical industry will never be simple, there is a relatively simple cure for the process of branding and marketing. Look through those binoculars and focus on a brand idea that is, in itself, simple. That can be communicated consistently, without risk of mistaken identity, to anyone. And that gets to the point quickly, optimising both resources and positive outcomes. When a brand idea comes into focus automatically and instantaneously without any fiddling or squinting, you have definitely got something worth looking at. (barkha@barkhasbrandclinic.com)

Barkha Dattani Managing Director, Barkha’s Brand Clinic

Automation Trends: Pharma labelling and packaging regulations as well as the need for speed & eﬃciency due to increasing volumes,” informs Ashish Moghe, Market Manager - Pharmaceuticals, Avery Dennison (India) Pvt Ltd. The landscape is changing rapidly to adopt modern technologies like pressure sensitive technique, which is slowly taking over wet glue applications. As one of the biggest manufacturers of pharmaceutical products, Indian companies is also getting focussed on alternative solutions for their products.

Role of automation and latest trends

Pharma labelling and packaging industry forms a crucial part of the booming pharmaceutical sector. This section of the industry is gradually understanding the importance of automation and accepting newer technologies. We are witnessing a paradigm shift in automation trends in India but it will take some more efforts to get the industry acknowledge the power of automation. Titash Roy Choudhury

e Indian pharmaceutical industry is looking towards a positive growth trend and within this industry there is a sub-sector that focusses on the labelling and packaging of the pharma products. Labelling and packaging holds utmost importance as a slight mistake in the same may lead to health/dosing hazards and we have seen such examples over the year where pharma products were drawn oﬀ the market due to labelling or packaging errors. “Labelling has become a necessity not only to track the products, but also to identify and assess the need upfront to ensure eﬃciency in cost and time. The Government of India

has asked all companies to implement the Unique Identiﬁcation (UID) number to be printed on all pharma products. Hence, the labelling and packaging of pharma products has been evolving to a great extent,” says Ajit Singh, Chairman, ACG Worldwide. Automation is a step forward for ensuring proper packaging and labelling, and we need to look at how well automated are the current practices. Current scenario is where bulk of the industry is still with the conventional form of labelling - wet glue. “Wet glue application process is mainly a manual process and at best a semi-automatic one. Even the most updated machine have much lower speeds of labelling. But the needs of industry are rapidly changing to match the international standards of packaging &

The entire process from labelling to verification needs to be automated to avoid human errors. “Labelling has multiple parameters to look into, such as product strength, batch code details, advised dosage, expiry date, etc, and it is almost impossible for humans to be engaged for so long in the various processes. Here in, automation avoids errors and confusion and can process a complete accurate multi-parameter check across the product,” says Singh. Automatic application is a part of Quality Assurance (QA) too, which ensures the correct application of the label and provides verification systems to ensure the presence of a label. “ Positioning sensors, verifiers are increasing in the pharmaceutical sector and the wet glue labels are reducing day by day. Many pharmaceutical companies have seen and experienced the advantages of self-adhesive labels in comparison with wet glue labels. Automation has also increased the use of special concept labels,” informs Karl Vandenbussche, Director, Reynders Label Printing India Pvt Ltd. All new investments in the industry are adopting automation. A large number of existing companies have already moved to pressure sensitive technology or are in the process of shifting from wet glue to pressure sensitive. “ To match the needs of higher productivity, lower wastages, increased efficiency, right positioning of labels, aesthetics, track & trace solutions, pressure sensitive technology is one of the best solutions. Automation is seen as a big enabler and driver to adopt pressure sensitive technology,” says Moghe.

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Pharma labelling and packaging

Labelling has become a necessity not only to track the products, but also to identify and assess the need upfront to ensure efficiency in cost and time. Ajit Singh Chairman, ACG Worldwide

Print & apply (on-line) in the applicators is seen as a trend catching up in India. Print and apply solutions mean applicators, which have the capability of not only applying labels but also printing variable info on the label, online. One of the drivers of this trend is the notification by the Indian government on tertiary, secondary and primary labelling. “Equipment manufacturers are also trying to integrate their equipment with print and apply technology to address this need,” Moghe informs. Automation is an important part of a plant strategy network, improving the plant progresses and eliminating excess capacity by effective use of resources and technologies giving pharmaceutical companies the benefit of aligned production with market demand at lower costs. “QA during label application has changed. The constant improvement in applicators has given every pharmaceutical company multiple options according to the requirement of the customer,” says Vandenbussche. Automation is also fundamental to tackle the problem of counterfeit drugs.

Pros and cons of automation Automation in pharma packaging and

The needs of industry are rapidly changing to match the international standards of packaging & regulations as well as the need for speed & efficiency due to increasing volumes. Ashish Moghe Market Manager - Pharmaceuticals, Avery Dennison (India) Pvt Ltd

labelling has several advantages, such as it increases productivity and efficiency. “As an average, 30-35 per cent increase in efficiency is observed in India,” says Moghe, who also points out that automated plant helps in reduction in wastages; for example, lower line stoppages, lower wastage of labels, lesser change over time, reduced manpower. Automated plants provide cleaner and more hygienic process environment while serialisation is much easier with automation. “Automated labelling gives a company the chance to label the produced products faster to meet the market demand, ensure quality of application by reducing/ eliminating discrepancies in comparison with manual applied labels, reduces employees and people management costs giving pharmaceutical companies the option to implement extra online verification systems as sensors, cameras and online batch and 2D barcoding,” says Vandenbussche. Some of the other advantages include the ability to introduce filmic labels, higher graphics and use of functional labels such as, hanger labels, low migration labels, luminescent labels, booklet labels, blood bag labels (primary & secondary), security labels made possible

QA during label application has changed. The constant improvement in applicators has given every pharmaceutical company multiple options according to the requirement of the customer. Karl Vandenbussche Director, Reynders Label Printing India Pvt Ltd

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with automation with pressure sensitive. “While we see a positive movement in the industry of moving towards automation, speed of adoption is slow because of cheap labour (though becoming more expensive by the day), initial investment in applicators and Drug Pricing Control Order. These are some of the hurdles as seen by the industry,” says Moghe. “Self-adhesive products have been well engineered over the years for multiple applications; to ensure a correct application suppliers need to understand the requirement of the customers. There are various choices of materials available depending on the bottle or container,storage temperatures, application temperatures, etc. A wrong choice of material can create a discrepancy in the process. Awareness and guidance to select the correct product is the responsibility of the label converter with the support of substrate suppliers. And proper training will ensure the same,” avers Vandenbussche. High initial investment and regular maintenance are some of the other deterring factors. But still around 60 per cent of pharma companies in India are fully automated while the rest are gearing towards complete automation, as Singh puts it. The need for automation in labelling and packaging is indisputable but a company in India needs to consider various factors before investing in the same. Though a highest exporter in pharmaceutical products more initiatives have to come from the companies in imbibing newer automation techniques to ensure higher productivity and cost eﬃciency. (titash.choudhury@infomedia18.in)

Energy Management: Plantwide energy optimisation

Providing a holistic approach Competition from both brand and generic manufactures are increasing time-to-market and patent pressure. With all these challenges, one definitely has other things to worry about than energy problems - but energy is critical for success. Efficient energy management solutions that offer core competencies in design, validation and integration into building automation are a basic requirement for success in any industry.

energy costs, reduced downtime and total costs of ownership. Furthermore, these solutions can provide access to energy data, enabling intelligent decisions regarding energy capacity planning and designing energyefficient processes to help customers work towards making zero-discharge plants a reality.Through a four-stage methodology (awareness, efficiency, optimisation and aggregation) manufacturers can transform their practices and production to enable supply chain optimisation and boost profitability. Most of these solutions also give an ‘inside-out’ approach that enables manufacturers to use automation and power control investments to begin saving wages resources more effectively, and investing them more intelligently. This blueprint – or what Rockwell Automation refers to as an ‘Industrial GreenPrint’ helps manufacturers gain better control over how they use those resources, helping reduce the burden of utilities cost on profitability and lessen the risks associated with external factors affecting energy price and supply.

Energy efficiency and cost reduction

ife sciences companies have traditionally lacked the insight necessary to develop truly strategic energy management initiatives. This is because they have not had proper visibility into where, when and how much energy is being consumed within the four walls of the plant. This information is at the core of a successful and eﬀective energy management campaign. While many companies have ways of collecting and proﬁling energy data, some of these methods may involve unreliable, time-consuming manual

processes. Instead, these companies can start with an energy audit to monitor a facility’s utility spend. These are some of the challenges that need to be overcome, and here certain software solutions have enabled the companies to overcome the same roadblocks.

Solutions galore! There are certain power and energy solutions that can help meet the growing challenges in the life sciences industry to meet plant objectives in terms of product quality, regulatory compliance, reduced

Before applying any software solutions one needs to have proper knowledge of the various areas and sub-areas of energy management that needs to be controlled and monitored. Industrial environmental automation systems ensure the security, integrity and conﬁdentiality of records. Works as an interface between facility systems and industrial processes to control environmental quality and ensure, the quality of the product, FDA validation, batch-related control and recording, safe product storage, providing people comfort and lastly optimised energy management. Pre-engineered Programmable Logic Controller (PLC)-based industrial controllers for Heating, Ventilation and AirConditioning (HVAC), boilers, chillers, and compressors, lowers life cycle and maintenance costs in comparison with

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Plantwide energy optimisation commercial controllers. It also provides clean room environmental control. Supervisory Control and Data Acquisition (SCADA) system controls and supervises all the equipment in the plant to perform in a way the user wants, thus achieving the operational philosophy of the plant. This is a customised technology that provides the real time status of every equipment running in the plant and can be used for power and energy control. Scada technology-based plant power management system looks into the control and monitoring of electrical power for limiting energy consumption with demand management solutions, identifying and correcting power quality problems with power quality and monitoring systems, monitoring energy consumption with cost allocation/load proﬁling systems and avoiding power outages with emergency load shedding/ distribution system monitoring solutions. It also helps plant power distribution network while managing the power generation. Control and optimise: Refrigeration Compressed air Vaccuum pumps Steam and hot water generation Diesel generator Chilled water distribution Central plant efficiency improvement: Where a company should integrate multiple third party systems with open PLC architecture and optimise and co-ordinate HVAC scheduling. Apply drives on HVAC and process pumps and evaluate options to reduce process heating and cooling demand. Energy monitoring and analysis: Where we need to collect and store energy for all WAGES (Water, Air, Gas, Electric, and Steam) through power monitors including third party metres, water, air, gas steam metres from third party metres, PLCs and including third

April 2012 I Modern Pharmaceuticals

party controllers. Provide web-based energy management analysis tools for charting, reporting and billing, power quality, targeting and conducting ‘what if ’ analysis. Having consulting services to identify energy saving opportunities and deﬁne scope of projects. Focus on projects with measurable results and internal rate of return/net present value that meets or exceeds customer’s ﬁnancial targets

Maintenance optimised

efficiency

Eﬃcient energy management solutions that oﬀer core competencies in design, validation and integration into building automation are critical for continued success. In the end, manufacturing optimisation is all about making decisions; the right decisions to create a sustainable competitive advantage in the life sciences industry.

Efficient energy management solutions that offer core competencies in design, validation and integration into building automation are critical for continued success.

Automation solutions necessary to conquer the energy challenge exist today and can be applied immediately to achieve measurable results. Using the same Rockwell Automation control, information, and power systems that automate their facilities today, manufacturers can visualise, control and optimise their resource usage. The Industrial GreenPrint allows manufacturers to use automation devices and systems that they

already have installed today to obtain much of the necessary WAGES data needed to improve their understanding of resource consumption. RSEnergyMetrix® and FactoryTalk VantagePoint® software provides measurement and veriﬁcation solutions for tracking WAGES consumption data to help identify causes of ineﬃciencies and set improvement targets through increased data analysis. Power monitors improve manufactures’ ability to track energy usage. Open networks, such as EtherNet/IP, deliver real-time WAGES use data to all levels of the business Direct-drive motor technology eliminates lost power in the form of heat, friction and noise, and often allows machine builders to specify a smaller motor and drive that require less current. Direct-drive solutions also can eliminate the need for pneumatic or hydraulic systems. In the end, manufacturing optimisation is all about making decisions; the right decisions to create a sustainable competitive advantage in the life sciences industry. Manufacturers in this industry who are most adept at meeting the challenges before them have a golden opportunity to improve energy consumption processes and optimise their performance. This trend of having automated and customised solutions is the need of the market, which can give greatest value to the user to manage their energy cost for improving the sustainability of the plant. (anarula@ra.rockwell.com)

Ajay Narula Manager - Sustainable Solutions, Rockwell Automation India Pvt Ltd

Policies & Regulations: Policies governing drug counterfeiting

New solutions in store When brand India is under attack, it responds in a big way. Last year, a batch of questionable pharmaceutical products made outside India were labelled ‘Made in India’ and shipped to Africa, sparking off a diplomatic incident. Authorities in Nigeria came to India for answers, only for both parties to discover the products were made by another country and tagged ‘Made in India’. What solutions are in store for such menace?

he Government of India has stepped in to intervene, and now there is a potential solution on the horizon to tackle counterfeiting. After reviewing multiple solutions recommended by stakeholders, including Pharmexcil, the Directorate General Foreign Trade (DGFT) announced new barcoding measures for all Indian pharmaceutical exports that could put brand India in a protective kevlar vest. The DGFT barcoding directive leverages GS1 global standards and with the Indian primary pack labelling requirements, provides even higher data resolution than some of the barcoding measures put in place in Europe. Sounds good, right? Well – protecting India’s colossal brand is not that easy. A large section of India’s small and medium

scale enterprises are unable to keep up with the technological complexities packaged with the DGFT norms, despite commendable actions by GS1 India to put freely available compliance guidelines on the Internet. There is a notable gap between a guideline document and a functioning technology stack – a gap that can be closed with proper expertise and access to funds. Even some of the Indian pharmaceutical giants have reservations on the impact compliance will have on their high-speed manufacturing lines. Pilots will have to be conducted, experiments set up and many rolls of packaging will mostly be wasted as line speeds are tweaked, vision systems realigned and print-heads cleaned and reﬁlled with ink. Who will bear this cost when one can ‘follow the leader’ and get results without the painful guinea pig experience?

India’s Directorate General Foreign Trade (DGFT) barcoding mandate (export pharma only) Increase trust in ‘Made in India’ products by using barcoding technologies Tertiary pack by October 1, 2011

Secondary Pack July 1, 2012*

Primary Pack Jan 1, 2013*

Implementing 50-year old technology today: How hard can it be? Ever since the US pioneered the use of barcodes for wide-reaching business applications, the world has become more efficient at identifying people and physical objects. You benefit from barcodes every time you check in your luggage at the airport, check out at your favourite supermarket chain or even mail a package overseas. Recently, to cope with increasing data storage demands, a new cadre of barcodes has been developed that encodes data in multiple dimensions. The so-called 2D barcodes come in various forms – from Quick Response (QR) Codes to GS1’s DataMatrix symbology. Even 3D barcodes exist today, using vivid colours to represent the third dimension, but these are yet to catch on globally. Barcoding technology is inherently simple. You can even print your own barcodes at home when you print a boarding pass! Barcodes are typically created by encoding data into a series of high-contrast lines, dots or polygons in a way that is easy for computers to image and analyse. Engineers invent ways to arrange the high-contrast shapes to pack as much data as possible into a set amount of physical space. Once these algorithms are written, programs are created to automatically turn data into barcode images, and barcode scanners are developed that can accept barcode images and produce the data originally encoded. Good barcode generation algorithms make provision for data redundancy, so if part of the barcode is hidden or damaged, the original data can still be retrieved. It all seems pretty straightforward until you consider the complex calculations supply chain executives have to perform in preparation for DGFT norms compliance. Take a high-speed pharmaceutical manufacturing line for instance. It can make 600 blisters per minute. That is an amazing 10 units of finished pharmaceutical product every second! Now to match that speed and avoid costly production slowdowns that leaves only 0.1 seconds to successfully complete the following five steps for each unit produced:

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Policies governing drug counterfeiting Labelling solutions Solution

Pros

Cons

Inline direct printing

Great option for fast production lines Proven technology already used to print batch and expiry date information

Initial setup cost can be high Does not work well on knurled surfaces, like on many blisters Extremely fast production lines still a challenge

Label solution

Cheapest route to compliance for small and medium batch sizes Easily integrates value add features like SMSbased product validation with scratch-oﬀ Colour printing available

Care needed to ensure labels are not peeled oﬀ easily Additional investments needed for label applicator Labels should not cover critical pre-printed regulatory information

Print and apply solution

Provides a wide range of customisation options for manufacturers Combines some of the beneﬁts of both inline direct print and label solutions

Maintenance of multiple consumables is a potential point of failure that can delay production Labels should not cover critical pre-printed regulatory information

Identify a product on a manufacturing line Ensure the product is properly aligned Print a 2D barcode on the product with human readable information per GS1 standards Visually inspect the product with printing, and Reject any product with printing errors In cases where barcodes include a unique ID and have to be generated on the ﬂy, one needs even more time because there are more steps involved as each barcode is unique. The truth is that the 50-yearold technology has evolved and new aﬀordable printing technologies have to be developed to keep up with the pace of barcoding innovation.

Solutions Solutions include the three main technologies that facilitate DGFT norms compliance. DGFT norms compliance is not an impossible task. Challenging? Yes. Infeasible? Certainly not. Depending on a company’s manufacturing setup, there are three main routes to compliance: Inline direct printing Label solution Print and apply solution Inline direct printing uses print heads integrated in the manufacturing line to directly print human readable codes and barcodes onto products. A label solution entails using pre-printed adhesive labels to aﬃx barcoding information onto products

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without obstructing critical product information required by regulators. The print and apply option provides on-demand labels that can be applied to products on the manufacturing line. It is essentially a hybrid of the inline direct printing and label solutions. While each solution has merits, there is currently no single one-size-ﬁts-all solution. In all cases, additional kit such as code database management software, vision and rejection systems could enhance performance. Pharma companies are advised to seek input from technology service providers prior to making investments in such equipment.

Problem solved? The question of unbearable costs still remains for very small manufacturers. The Government of India is oﬀering 75 per cent reimbursement of GS1 registration and annual fees for up to 3 years for micro and small industries. Helpful, but equipment and technology costs still remain. Some may also wonder – why only for exports? Why can’t Indians within their own country beneﬁt from this barcoding technology if the goal is to increase patient safety? Should the DGFT norms be expanded to include drugs made for local consumption? Not all legal concerns have been resolved so far. Recently, a High Court in Chennai ruled to postpone implementation deadlines for secondary and primary packaging levels. The

Confederation of Indian Pharmaceutical Industries (CIPI) and Indian Drugs Manufacturers Association (IDMA) had asked the court to temporarily halt the DGFT norms. The new deadlines are July 1, 2012 for secondary packaging and January 1, 2013 for primary packaging, buying manufacturers 6 more months in each case. Industry as a whole may not agree that this is suﬃcient extra time. So far, DGFT norms compliance at the tertiary packaging (shipper) level has not been much of a problem to date, mainly because of the much slower packaging speeds and fewer units to be labelled at the tertiary level. However, with so many issues still in the air some stakeholders are now adopting a ‘wait and see’ approach. Hopefully, decision makers will not wait till there is another diplomatic incident. India has a great opportunity to implement one of the largest and most complex pharma product barcoding exercises the world has ever seen. (ashiﬁ@sproxil.com)

Ashiﬁ Gogo CEO, Sproxil Inc

Policies & Regulations: Protection of agro-biotech inventions

How patent laws can help? Agro-biotech is an emerging sector witnessing fast growth and it is imperative that for prevention of any misuse and promotion of further growth, India requires development of strong legal and regulatory intellectual property regime for protection in this sector.

Plants Fruits and Seeds (Regulation of Import into India) Order, 2003, now has been replaced by the Plant Quarantine (Regulation of Import Into India) Order, 2003. In addition, there also exist Biological Diversity Act 2002 and Rules for manufacture, use, import, export and storage of hazardous microorganisms and genetically engineered organisms or cells, 1989. India has adopted a sui-generis system for the protection of plant varieties integrating the rights of breeders, farmers and rural communities. Sui-generis is an addition or alternative system for protection of plants over patent system. The main reason behind adopting a sui-generis system is that India is predominantly an agricultural nation, has a vast diversity of landraces of agricultural resources and indigenous, traditional knowledge and conventional plant breeding methods are largely practiced. However, the Plant Varieties and Farmer’s Rights Act, 2001 and patent laws are not converging when it comes to protection of plant material.

Plant varieties and Farmer’s Rights Act

griculture is the backbone of Indian economy and in the last few decades, biotechnology has played a major role in advancing agriculture research in India. Biotechnological research and techniques are breaking through natural barriers and genetically modiﬁed crops are being developed. For prevention of any misuse and promoting further growth of the agro-biotech sector, legal and regulatory processes need to be in place.

Indian legislations In India, various legislations and statutes exist for protecting plants materials. The Protection of Plant Varieties (PVP) and Farmer’s Rights Act (FRA), 2001, is one of the principal legislations drafted in consonance with the provisions of the Agreement on Trade-Related Intellectual Property Rights (TRIPS), dealing with a sui-generis system of protection of plant and crop varieties in India. Seeds Act, 1996, which was enacted so as to regulate and control the quality of seeds and for any matters connected therewith.

As per PVP and FRA, varieties of all species are eligible for protection, whereas patent laws confer protection to inventions only. The criteria to obtain protection under PVP and FRA include being new, distinct, uniform and stable, whereas patentability criteria include novelty, inventiveness and industrial applicability. The duration of protection under PVP/ FRA is 15-18 years, depending on type of plant material, whereas patent protection is for 20 years. The scope of breeder’s rights under PVP/FRA extends to production, marketing, import, export and stocking of all material, whereas patent protection allows commercial use of protected matter. PVP/FRA confers privilege to farmers, whereas patent protection is allowed irrespective of any such distinction. There is also a breeders’ exemption option under PVP/FRA that allows breeders to use protected varieties as sources of initial variation to create new varieties of plants, whereas no such provision exist under patent law.

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Protection of agro-biotech inventions In India, awareness regarding protection of plant material is on rise. Recent analysis of application filed in plant variety registry shows filing of more than 2,500 applications including 1423 extant variety, 969 new variety and 226 under farmer category. Similarly, patent applications filed in agriculture sector from 2007-2010 alone are 188. There has been a sharp division of opinion regarding whether plant material created through biotechnological efforts should be allowed to be protected. As per PVP/FRA provision related to biotechnology, the farmer shall be deemed to be entitled to save, use, sow, resow, exchange, share or sell his farm produce including seed of a variety protected under this Act, provided that the farmer shall not be entitled to sell branded seed of a variety protected under this Act. PVP/FRA also forbids breeders to use gene using restricting technology (GURT) or terminator technology and requires breeders to submit an affidavit confirming that variety does not contain GURT.

Patent law Currently, the Indian Patent Law is in the process of evolution with regard to biotechnological agricultural innovation. Although, the Act does not allow patenting of plant material per se, however, amendments of Act 38 of 2002 in Section 3(i) and 3(j) were mainly aimed to address the protection of agro-biotech invention. This article presents an overview of the kind of agro-biotech inventions being granted in India and provides primary knowledge of avoiding few potential pitfalls. Prior to amendment of 2002, Section 3(i) precludes patentability of any process for medicinal, surgical, curative, prophylactic (diagnostic, therapeutic) or other treatment of human beings or any process for a similar treatment of animals or plants to render them free of disease or to increase their economic value or that of their products The term plant was deleted in the amendment paving way for patentability of process with regard to plant material. As of now Section 3(h) and 3(j) jointly restricts the scope of patenting the agriculture related inventions. Section 3(h) precludes patentability of method of agriculture or horticulture.

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Hence, cultivation of plant material, production of new form of a known plant, preparation of an improved soil, etc are unpatentable, however, agricultural equipments and compositions related to agricultural inventions are patentable. Section 3(j) restricts patentability of plants and animals in whole or any part thereof other than microorganisms but including seeds, varieties and species and essentially biological processes for production or propagation of plants and animals. In view of this, clones and new varieties of plants, processes for production of plants if it consists entirely of natural phenomena such as crossing, plant breeding methods like grafting, artiﬁcial pollination, tissue culture or selection and essentially biological process are unpatentable. In spite of limitations set forth by the sections discussed above, the past few years have witnessed substantial rise in biotechnology patent ﬁling and grant of applications in agro-biotech area. By taking few considerations into mind, one can successfully secure allowance of agrobiotech patent; for example, processes based on recombinant DNA technology, molecular genetics, genetic transformation methods, expression vectors, gene cassettes, could escape the clause of ‘essentially biological’ , hence considered patentable subject matter.

Agro-biotech patents Cropdesign has been granted patent for increasing seed yield of plant, improving plant growth characteristics, increasing biomass, increasing yield of plant under non stress conditions for producing transgenic plant cells producing interacting protein or immunologically active fragment thereof. Bayer Crop science/Bio science have been granted patents for producing transgenic cotton plant, producing transgenic rice plant, production of plant tolerant to stress condition, and production of transgenic plants having increased starch content and amylase content. Tamil Nadu Agriculture University has been granted patent for construction of chimeric CRY2AX1 gene of Bacillus thuringiensis-encoding protein with enhanced insecticidal activity. Indian

Agricultural Research Institute has been granted patent for cloning synthetic gene encoding CRYFA1 deltaendotoxin, chimeric, delta-endotoxin of Bacillus thuringiensis. The above provides an overview of the agro-biotech subject matter being considered patentable in India. However, in practice, each case is decided on its merit and no clear guideline in this regard has been drawn so far.

More to go... Granting of patent protection and related intellectual property rights may have merits as well as demerits. In present scenario, where cultivation of new plant varieties using new biotechnological techniques may be decisive in improving rural income and economic development, protection of innovations and resultant new varieties of plants and crops will be helpful in ensuring development and supply of innovative genetic resources of improved varieties speciﬁc to Indian needs. Hence, there is a need to develop policies and laws, which could ensure promotion of R&D, easier availability of new improved varieties and safeguarding intellectual eﬀorts of innovators. Intellectual Property practice pertaining to agriculture biotechnology in India is still at infancy. Keeping in view the social, ethical and prevailing economic conditions in the farming sector, Indian policy makers should progressively develop and implement systems that cater to Indian farmers’ needs, at the same time enable protection of rights of domestic as well as multinational innovator companies, while ensuring harmonisation with international treaties. (salhotra@lls.in)

Anuradha Salhotra Managing Partner, Lall Lahiri & Salhotra

Strategy: Internal staff communication

Internal staff communication Communication with staff is the key to keeping the morale of the employees high and for the retailer to achieve the key objectives of his business – customer service, growth and profits. A step-by-step guide on how to create a healthy communicative environment.

few weeks ago, a major pharmacy retail chain’s CEO was speaking with me about the crisis within his organisation. The problem was that the chain had grown very fast and was now facing the ‘growth crisis’. The growth had stopped, payments to suppliers were defaulting and staff was having a low morale! A complex problem, and the entire senior management was worried about the fallout; staff speaking negative and leaving the chain to join other chains! If that happened, the retail chain could fail in its efforts to raise funds and could even shut down as it was burning cash every month at a frantic pace.

In such a situation communication plays an important role; but how, when and what to communicate and to whom is the key in turning around the situation. It is the store staﬀ that speaks with the customer and interacts with the suppliers on a day-to-day basis for the business dealings, so it might as well be the best idea to keep the staﬀ informed on what needs to be conveyed.

Why and what matters? Imagine a situation where the supplier payments are delayed and the store staﬀ speaks negative and tells the supplier that things are not going well within the chain and the future is a big question mark!

Result is that the suppliers would also hold on to future supplies and demand an instant payment. This could lead to a decline in sales, start up a vicious cycle of prescription bouncing leading to customer dissatisfaction and eventually lead to closure! Imagine another scenario: Supplier payments are delayed but the store staﬀ that interacts with the supplier tells that it is a temporary phenomenon and the issue will soon get resolved out as they are about to open another X number of stores in the coming year, and the entire focus is on getting the same in order! Also, the supplies are directed towards new store openings lined up in the next two months – so there is nothing to worry about. This is just a temporary cycle and would get addressed soon. No supplier wants to part ways with a business that is growing, and so not only the supplies would continue from a majority of the suppliers but support would increase as the

Modern Pharmaceuticals I April 2012

Internal staff communication supplier would like to be a part of the growing chain. The key diﬀerence in both the scenarios is that the communication to the staﬀ has kept them motivated. So clearly, the internal communication holds the key to managing a tough situation in any retail chain, and it is a fact that every business passes through a tough phase in the ‘growth cycle’.

Communication till the last letter Ideally, the communication must start from the top - the CEO or the top most man in the organisation How often: Certainly not more than once every month to the staff, and the contents should be based on reality. Also that, the essential pre-condition is that the CEO should have a track record of keeping his/her commitment. Medium of communication: Through newsletters - A monthly newsletter to highlight the achievements of individuals, stores and management and sharing the views of the customers Family get-togethers of the staff is critical to create a bonding while communicating to the staff. But the most important tool for communication with motivation lies in involving the staff bottoms up in planning and strategy. This is the best motivation tool. The frequency of such meetings can be quarterly to be effective. Ideal date and time for the meeting: The ideal date for the meeting is a Tuesday or Wednesday, as Mondays have the weekend load and the Saturdays are also a little tight as the banks and distributors are closed on Sundays. The ideal day is Tuesday, and the best time is to start around 11 am and finish it by 4.30 pm. So the staff can open the store in the morning, come to the meeting during the ‘lean period’ and return back to the store during the ‘peak hours’ for sales. Ideal setting is to have the staff (around 40 in each session) meets up with the CEO or the top management and discuss the success stories, pain points and plan the right strategy. It is

April 2012 I Modern Pharmaceuticals

always better if the CEO sets the stage for the meeting by a short presentation about how he sees the company going forward for the quarter, next year and so on, and then also share some of the key messages that he wishes to share during the course of the meeting. The presentation should be based on a ‘Sandwich’ approach, a good news to start with and then the pain points and end with good news and the grand plans. Once the CEO has set the stage with his introductory presentation or talk, it is best to pick up a point – say ‘plan for the new stores growth’ and let the managers and then the store staff comment on the same. Also, it is wiser to let the floor staff speak more and make them feel that they have become the part of the planning team, as this is the biggest motivation for them - to be a part of the growth plan for

The presentation should be based on a ‘Sandwich’ approach, a good news to start with and then the pain points and end with good news and the grand plans.

an organisation. Also, when the plan gets rolled out, these employees become the patrons for execution and there is a sense of ownership. Best way is to let everyone speak on the topic, and start with a hand picked person to speak who is best in customer service! With this, the positive points come out ﬁrst.

are rarely brought to the notice of the senior management or their peers. These forums present a great platform for such outstanding employees to speak up, and sets an internal competition for others to achieve similar feats and inspires other staff. Such meetings will take an hour or so for the attendees to get adjusted to the environment and then become more open to share their thoughts. When this stage is reached, it is always good to even discuss some ‘problematic issues’ and seek answers and ideas from the staff. The experience is that the best solutions to the management problems can come from such meetings and the discussions that take place here. This is also the best place for getting the best ideas from the team. One should take care in these sessions that, no employee should be ‘scolded’. Also that ‘negative comments’ should be avoided in such meetings so that employees should be free from the fear of being ‘insulted’ before their colleagues. How to end such meetings: Such meetings come out with some good points that needs to be followed up with the senior management and also with the ‘team’. It is good to make a note of such meetings, appreciate the inputs and set the ownership of the best ideas with the individuals of the team and put timelines for each ‘action items’. This way the team is motivated, you get the best ideas and the biggest threat at times becomes the best opportunity for the organisation. As it goes without saying, ‘TEAM’ stands for ‘Together Everyone Accomplishes More!’ (office@rajendragupta.in)

Getting innovative These internal ‘brain storming’ sessions about strategy and growth as also the best forums for ‘experience sharing’ and help create ‘role models’ within the organisation for setting bench marks in diﬀerent spheres of the retail operations. I have seen that some self-motivated staﬀ always accomplish good feats but

Rajendra Pratap Gupta International Healthcare Policy & Retail Expert

Tips & Tricks: Tips for making the best of social media

Guidelines for pharma companies

espite the fact that more than 90 per cent of Indian Internet users search for online health information and 60 per cent search for specific medicine information, marketers are yet to make use of this media opportunity to its advantage. While reasons often

quoted are Return on Investment (ROI), legal restrictions and actual outcome, time has come to closely evaluate this opportunity and the ones who make the first moves in the right direction should earn long-term benefits for their brands.

1 T

4 T

Understand your brand ips scrupulously: First, decide ricks whether your brand is consumer facing and they are the ones who will make decisions to buy (OTC brands) or they need the inﬂuence of other stakeholders such as doctors, paramedic, etc. In case of OTC brands, one can directly talk about the brand but one needs to be aware of the advertising regulations and treat it like any consumer media channel.

2 T

Defining your digital ips marketing strategy: ricks With the Internet feeding consumers’ hunger for health information, digital channels offer life science companies significant untapped potential to reach and interact with physicians and patients. It is important to define the end objective, which may vary from plain brand awareness to market shaping for a new molecule/category.

Be honest and transparent in sharing information: People log on to Facebook to socialise, not to ‘friend’ any brands. If pharma companies are to earn the attention of any modern consumer, they should provide useful information and value to the consumers instead of asking them to do things or give personal information.

Tips& Tricks

(sjosi@sorentohealth.com)

Cultivate the art of ips listening: Once consumers ricks voluntarily give their attention and visit the companies’ Facebook/Twitter or some other social media websites pages, then it is important to ask intelligent questions and listen to the feedback. Instead of telling, asking and listening is a way to earn the dialogue with consumers and fans.

Build credibility with expert advisors: When consumers interact with advertisers, they expect complete transparency and candor. So instead of having marketing or PR representatives ﬁeld questions from users, it is important for companies to have real experts (scientists, MDs, etc.) answer questions and concerns from consumers. This will help making the brand more credible and lively on social media.

Tips& Tricks

Make your process a commitment and not a campaign: Social media is media created by the conversations of people. Brand advertisers have to earn the right to participate in these conversations by creating a community with valuable content. The eﬀorts in social media should not stop as if it is a marketing campaign.

Tips& Tricks

Susan Josi Managing Partner, Sorento Healthcare Communications Pvt Ltd

Need to invest in a social media jockey: It important to have something new to talk about periodically, which calls for the role of a knowledgeable jockey. The key is to do this consistently and regularly, thus creating a publishing schedule of both content and questions.

Tips& Tricks

Understand and share human stories: If you want people to share what you have to say make it human. People are touched by human stories and more likely to feel engaged and share them.

Tips& Tricks

Establish the right success metrics: Just having high number of fans or ‘likes’ are not the best success metrics. Metrics that involve actual actions of the users which has been planned for, the number of conversations, the number of repeat visits, the pages viewed per visit — are better than one-oﬀ actions like clicking the ‘like’ button.

Tips& Tricks

Stay in close contact with your legal team: Marketers and attorneys approach risk-reward scenarios with diﬀering perspectives; therefore, working with your legal counsel is essential in social media marketing. Think creatively on how to advance your brand goals and provide your legal team with multiple campaigns.

Tips& Tricks

Modern Pharmaceuticals I April 2012

Projects New projects and expansion activities are the barometers of industrial growth. These also present business opportunities to service providers like consultants, contractors, plant & equipment suppliers and others down the value chain. This feature will keep you updated with vital information regarding new projects and capacity expansions being planned by companies in the pharma/lifesceinces industry.

Hyacinths Pharma Pvt Ltd

Natco Pharma Ltd

Ranbaxy Laboratories Ltd

Project type New facility Project news Hyacinths Pharma Pvt Ltd is planning to set up a new pharmaceutical project. The project involves manufacturing of Ethambutal.

Project type New facility Project news Natco Pharma Ltd is planning on setting up a new manufacturing unit. The project will involve manufacturing of Clozapine.

Project type New facility Project news Ranbaxy Laboratories Ltd hopes that the new lab would open doors for a direct business presence in North Africa with Morocco’s pharma market.

Project location Srikakulam, Andhra Pradesh Project cost Unknown Implementation stage Construction

Project location Mahaboobnagar, Andhra Pradesh Project cost Unknown Implementation stage Construction

Project location Morocco Project cost Unknown Implementation stage Planning

Contact details: Hyacinths Pharma Pvt Ltd Pragathi Nagar Yousufguda, Hyderabad- 500045 Tel: 040 - 5861042334 Fax: 040- 3008727787 ---------------------------------------------

Contact details: NATCO HOUSE Road No.2, Banjara Hills Hyderabad-500 033 Tel: 040-2354 7532 Fax: 040-2354 5298/23548243 Email: natinfo@natcopharma.co.in ---------------------------------------------

Contact details: Ranbaxy Laboratories Ltd Gurgaon - 122001 Haryana India Tel: 0124-4135000 Fax: 0124-4106490 Email: secretarial@ranbaxy.com ---------------------------------------------

Malvern Instruments Ltd Project type New facility Project news The new facility is designed to serve customers in the north and north east of India. They will provide demonstrations and deliver training, applications and technical support as well as undertake sample analysis. Project location Delhi Project cost Unknown Implementation stage Established Contact details: Malvern Instruments Ltd Enigma Business Park Grovewood Road, Malvern, Worcestershire WR14 1XZ, UK Tel: 044 1684 892456 Fax: 044 1684 892789 Email: alison.vines@malvern.com --------------------------------------------April 2012 I Modern Pharmaceuticals

Praxair Project type New Facility Project news US-based industrial gas company Praxair plans to set up a new R&D lab in Bengaluru, as India has a lot of potential. Project location Bengaluru, India Project cost ` 1, 200 crore Implementation stage Planning Contact details: Praxair India Pvt Ltd “Praxair House” PO Box No – 4251 No 8, Ulsoor Road Bengaluru Tel.: +91-80-3057-6821 Fax: +91-80-2559-3499 Email: rakesh_srivastava@praxair.com Website: www.praxair.co.in ---------------------------------------------

RPG Life Sciences Ltd Project type New facility Project news The project involves manufacturing of Haloperidol Decanote. The company has received industrial license from the Department of Industrial Policy and Promotion for the same. Project location Mumbai Project cost Unknown Implementation stage Construction Contact details: RPG Life Sciences Ltd RPG HOUSE, Dr. Annie Besant Road Worli, Mumbai – 400 030 Tel: 022 2498 1650 / 51 Fax: 022 2497 0127 Email: sachinraole@rpgls.com ---------------------------------------------

Projects

Sharp Menthol India Ltd

Vasudha Pharma Chem Ltd

Watson Pharma Pvt Ltd

Project type New Project Project news Sharp Menthol India Ltd is planning to set up a new pharmaceutical project. The project would involve manufactur ing of Menthol Crystal BP/USP Menthol USP, Levo-Menthol Rectified Peppermint Oil Mint Blend.

Project type New facility Project news Vasudha Pharma Chem Ltd is planning to set up a new manufacturing plant. The project will involve manufacturing of Amitripyline Hci.

Project type New facility Project news Watson Pharma Pvt Ltd is planning to set up a new Pharmaceuticals project at. The project involves manufacturing of Tetrabenazine

Project location Srikakulam, Andhra Pradesh Project cost Unknown Implementation stage Construction

Project location Thane, Maharashtra Project cost Unknown Implementation stage Construction

Contact details: Vasudha Phamrma Chem Ltd 78/A, Vengalrao Nagar Hyderabad - 500 038 Andhra Pradesh Tel: 040-4476 3666 / 2371 1717 Fax: 040-2370 6696 / 2381 1576 Email: vasudha@vasudhapharma.com ---------------------------------------------

Contact details: Watson Pharma Pvt Ltd 301, Corporate Enclave B D Sawant Marg Chakala, Andheri (East) Mumbai – 400099, Maharashtra Tel: 022 – 66886713/9920788411 Fax: 022 - 66886799 Email: babu.suri@watsonpharma.co.in ---------------------------------------------

Project location Alwar, Rajasthan Project cost Unknown Implementation stage Planning Contact details: Plot No.9, Lsc Sharp House, Gujran Wala Towen-1, Delhi Tel: +91-11 - 27131325 Fax: +91-11-27226406 Email: menthol@del3.vsnl.net.in Website: www.sharpmenthol.com ---------------------------------------------

Teckbond Laboratories Pvt Ltd Project type New facility Project news The project involves manufacturing of Sparfloxacin. Project location Medak, Andhra Pradesh Project cost Unknown Implementation stage Construction Contact details: Teckbond Laboratories Pvt Ltd Vengala Rao Nagar Hyderabad – 500 038 Andhra Pradesh Tel: 040-23801871 Fax: 040-23811864 Email: teckbondlabs@yahoo.com ---------------------------------------------

VKT Pharma Pvt Ltd Project type New facility Project news VKT Pharma is planning on setting up a new pharmaceutical plant. This facility will involve manufacturing of Ranitidine Tablets 150 mg. Project location Srikakulam, Andhra Pradesh Project cost Unknown Implementation stage Construction Contact details: VKT Pharma Pvt Ltd Plot no 186 Road No 15 Jubilee Hills Hyderabad-500033 Andhra Pradesh Tel: 9870121847 Fax: 022- 28123143 ---------------------------------------------

Zim Laboratories Ltd Project type New facility Project news Zim Laboratories Ltd is planning to set up a new pharmaceuticals project. The project will involve manufacturing of capsules. Project location Nagpur, Maharashtra Project cost Unknown Implementation stage Construction Contact details: Zim Laboratories Ltd MIDC Industrial Area, Kalmeshwar, Nagpur – 441501 Maharashtra Tel: 07118-271990-271370 Fax: 07118-271470 Email: bdd01@zimlab.in ---------------------------------------------

Modern Pharmaceuticals I April 2012

Event List

NATIONAL AHMEDABAD

PUNE

CHENNAI

LUDHIANA

Gujarat, Oct 5-8, 2012

Maharashtra, Nov 2-5, 2012

Tamil Nadu, Nov 22-25, 2012

Punjab, Dec 21-24, 2012

INDORE

AURANGABAD

RUDRAPUR

Madhya Pradesh, Jan 11-14, 2013

Maharashtra, Feb 1-4, 2013

Uttarakhand, Feb 23-26, 2013

India’s premier industrial trade fair on products and technologies related to Machine Tools, Hydraulics & Pneumatics, Process Machinery & Equipment, Automation Instrumentation, Packaging & Auxiliaries, IT Products, Electrical & Electronics, Material Handling and Safety Equipment.

For details Infomedia 18 Ltd

Ruby House, 1st Floor, J K Sawant Marg, Dadar (W), Mumbai 400 028. • Tel: 022 3003 4651 • Fax: 022 3003 4499 • Email: engexpo@infomedia18.in

Lab Expo & Conferences Pune For many years the Indian government has been conducting this expo in different cities of India. Exhibitors of various lab commodities from all over the world will come to display their newly launched products. Exhibitors will exhibit their products, instruments and equipment. It will play an immense role for broadening their investment market and technology. The participants will also be able to exchange their experiences with the viewers; April 20-22, 2012, Auto Cluster Development & Research Institute Ltd, Pune For details contact: Paramount Exhibitors Tel: +91 172-2274801 Fax: +91172 2274803 Email: contact@paramountexhibitors.com Website: www.paramountexhibitors.com

Lab Expo & Conferences Coimbatore This is an event that focusses on various aspects related to lab equipment manufacturing as well as promoting good lab practices among the fellow professionals. The trade show will be a two-day affair and will witness attendance from a considerable number of professionals who have been involved with this profession for a long time. This expo will also be supplemented with informative sessions and workshops, which will benefit the participants in a great way. This is an excellent platform for the lab equipment April 2012 I Modern Pharmaceuticals

manufacturers and distributors to display their latest technological innovations and creations in front of an international audience. Moreover, this event also takes care of a number of important issues related to lab automation and labware equipment; June 15-17, 2012, Codissia Intec Technology Centre, Coimbatore For details contact: Paramount Exhibitors Tel: +91 172 2274801 Fax: +91 172 2274803 Email: contact@paramountexhibitors.com Website: www.paramountexhibitors.com

Automation 2012 All leading companies in industry will showcase their latest products and help one find the solutions at the show. The show brings latest technologies from an interesting array of fields such as: factory automation, process automation and control systems, robotics & drives, field instrumentation & smart sensors bus technologies, software solutions, wireless technology, building automation, and hydraulic & pneumatic automation in renewable energy. From technocrats to solution providers, vendors and tech-buffs, the fair is all set to draw every one alike; September 7-10, 2012, NSE Complex, Mumbai For details contact: IED Communications Pvt Ltd Tel: + 91 22 22079567 Fax: + 91 22 22074516 Email: arokiaswamy@iedcommunications.com Website: www.iedcommunications.com

Pharmac India

This is one of the dedicated platforms that will bring together senior level decision makers from across the marketing and strategic planning functions within the Indian pharmaceutical industry. During these action packed three days, with high value networking and business content, Indian and multinational pharma companies, marketing consultants, communication agencies, supply chain and logistics management companies will identify the key challenges within the industry and discover business critical solutions to overcome them; June 21-22, 2012, Holiday Inn, Mumbai

It is a-three-day event that aims towards highlighting several issues of the industry. This will be large hub of reputed professionals from pharma formulation, herbal products, veterinary drug, medical & disposal, pharma machinery and many other sectors. There will be visitors from pharma company marketing/purchase/ export executive, marketing company & consultant, merchant exporters, contract manufacturers, pharma distributors, generic & OTC manufacturer & wholesalers, Government supplier, liaison agents, sourcing companies, production & purchase professionals, and international business representatives; September 8-10, 2012, Gujarat University Exhibition Hall, Ahmedabad

For details contact: UBM India Pvt Ltd Tel: +91 22 6612 2600 Fax: +91 22 6612 2626-27 Email: info.india@ubm.com Website: www.ubmindia.in

For details contact Orbitz Exhibitions Pvt Ltd Tel: +91-22-24102801 Fax:+91-22- 24102805 Email: ramesh.v@orbitexhibitions.com Wewww.orbitzexhibitions.com

Pharma Rural Marketing 2012

Event List

INTERNATIONAL Bio IT World 2012 The 2012 Expo plans to unite 2,000 life sciences, pharmaceutical, clinical, and IT professionals from 30+ countries. The expo provides the perfect venue to share information and discuss enabling technology that are driving biomedical research and the drug development process. Spanning three days, the meeting includes 12 parallel conference tracks and 16 pre-conference workshops; April 24-26, 2012, World Trade Center, Boston, Massachusetts, US For details contact: Cambridge Healthtech Institute Tel: +781 972 5400 Fax: 781 972 5425 Email: chi@healthtech.com Website: www.bio-itworldexpo.com

Anti-Counterfeiting for Pharmaceuticals 2012 There will be discussions on the global threat of counterfeit medicines and brainstorming on how to best confront the problem and provide insights into establishing and implementing an anti- counterfeiting programme in the global pharma market to ensure that one is in a better position to secure the products against counterfeiters and most of all ensure consumer safety. This will be a unique opportunity to exchanges ideas and address anti-counterfeiting and brand protection matters in an open forum; April 30-May 01, 2012, Philadelphia, USA For details contact: IQPC Tel: +91 80 4322 4100 Fax: +91 80 4322 4103 Email: jai.das@iqpc.com Website: www.anticounterfeitingpharma.com

US-India BioPharma & Healthcare Summit 2012 The event will witness a congregation of biopharma, medical devices, healthcare companies, venture capitalists, policy makers from Europe, the US and India. Panel discussions will cover areas like drug discovery and collaborative research, restructuring R&D in order o maximise productivity and innovation, therapeutic areas like oncology (research areas, investor perspective, market opportunities, challenges and so on). Further, there will be discussion on emerging market opportunities, strtageies, funding innovation, cross border investments, M&A trends in the biopharma & healthcare and so on; May 11, 2012, Hyatt Regency Cambridge Massachusetts, USA

Biomarkers World Europe This event aims to discuss how to support target identification and eliminate dead-end candidates, how to understand the range of biomarker candidates, how to create sophisticated animal models of human disease to develop biomarkers for proof-of pharmacology, how to facilitate clinical trial stratification and employ early surrogate end points of efficacy, how to define the correlation between biomarker and disease/therapeutic inter vention; May 22-24, 2012, Business Design Centre, London, UK

For details contact: USAIC Tel: +781 586-1212 Email: info@usaindiachamber.org Website: www.usaindiachamber.org

For details contact: Health Network Communications Ltd Tel: +44 0 207 608 7055 Fax: +44 0 207 608 7050 Email: skhamissa@ healthnetworkcommunications.com Website: www.healthnetworkcommunications.com

RDD 2012

CPhI Worldwide

There will be discussions of the developing issues surrounding aerosol drug delivery including new therapeutic opportunities and drug design technologies, progress in drug development alongside novel in vitro and in vivo testing methods, regulatory science and much more. Further, there will be scientific poster session and technology exhibition in which device and equipment designers and component suppliers will present their latest developments alongside scientific posters from the aerosol community; May 13-17, 2012, JW Marriott Desert Ridge Resort & Spa Phoenix, Arizona

The event hosts over 1900 exhibitors and is the market leader for the global pharmaceutical ingredients industry. CPhI Worldwide has three co-located events: ICSE, P-MEC Europe and InnoPack. These events focus on specific sub-sectors of the pharma ingredients industry and provide visitors and exhibitors with additional capability to network and do business in dedicated areas; October 9-11, 2012, Feria de Madrid, Spain

For details contact The Indian Pharmaceutical Association Tel: +91-22-2667 1072 Fax: +91-22-2667 0744 Email: ipacentre@ipapharma.org Website: www.rddonline.com

For details contact: UBM India Pvt Ltd Tel: +91 22 6612 2600 Fax: +91 22 6612 2626-27 Email: info.india@ubm.com Website: www.ubmindia.in

The information published in this section is as per the details furnished by the respective organiser. In any case, it does not represent the views of Modern Pharmaceuticals

Modern Pharmaceuticals I April 2012

Book Review Pharmaceutical Process Development – Current Chemical and Engineering Challenges Author: A John Blacker and Michael T Williams Price: ` 10,000 The book is an excellent manual for chemistry, pharmacy and engineering students, professionals and industry personnel. The area of new drug discovery and its initial phases of planning have been broken down into individual components and explained in simple lucid language. The book comprises 15 chapters dealing from the early history of pharmaceutical drug discovery and R&D processes and ends with future trends and challenges from the pharmaceutical R&D. Each chapter takes anecdotal account of existing molecules to explain its point and this makes it relevant to the reader. The initial chapters outline in brief the chemistry behind initial drug discovery and the various reactions a chemist must be aware of. The next part then proceeds into making a selection of raw material, green processes, safe and eﬀective designs and route, safety regulations, and data extraction methods. The book also highlights the various technologies such as liquid – liquid extraction, HPLC, etc. The concluding section deals with solid form design and crystallisation processes as they are now an integral part of the drug regulatory landscape. The chapter on technology and process transfer is of real value and relevance to Indian chemist and/or engineers as it is happening more often when Indian generic pharma companies are associating with international innovators. The last chapter outlays the diﬃculties and newer avenues for an R&D scientist in the area of process development. It describes key challenges for the future and also possible solutions to the same.

Quality Control Training Manual Author: Syed Imtiaz Haider and Erfan Syed Asif Price: ` 7300.00 Every pharmaceutical company aims to enter the US and European markets for selling its finished products. Here, it has to meet with the stringent requirements posed by the FDA, EMA, WHO-GMP and others. The book deals with quality control issues applicable to a pharmaceutical laboratory in securing the approvals of various regulators. The book is a ready to use manual on various processes and procedures in the laboratory and training of staff in these respective areas. It is divided into 12 major parts. Every section defines the process under consideration in brief and outlines the quality control areas. It then goes on to provide simple check lists and training protocols for the process under consideration. The accompanying CD also provides modifiable ready to use training and monitoring programmes for individual processes in the lab. The quality control protocols are designed to comply with the ISO 9000 industry standards. The concluding section on various regulatory bodies and compliance provides an excellent comprehensive view on the regulatory scenario worldwide. Overall, a fairly straightforward, technical book designed specifically for quality control and regulatory needs and training of a pharmaceutical laboratory.

Reviewer: Dr Mandar Kubal Consultant - Infectious Diseases and HIV AIDS, Infectious Diseases and Pulmonary Care (IDPC)

April 2012 I Modern Pharmaceuticals

Products Gas detector Gasman pocket-type gas detector (monitor) is small, lightweight and easyto-use in tough environments. It weighs between 105-130 gm, depending on the sensor type. It is durable with high impact resistance and ingress protection to IP65/67. When a hazardous gas is detected, the device alerts the user with a loud 95 dBA alarm, a bright red blue visual warning and also by vibrating. It is small enough to ﬁt easily into to a top pocket or clip on to a belt or lapel. It features single button control and full interchangeable I-module intelligent sensors for oxygen, toxic and ﬂammable gas monitoring. Detection Instruments (I) Pvt Ltd Navi Mumbai - Maharashtra Tel: 022-27617663 Email: sales@detection-india.com Website: www.detection-india.com

Moisture separator The moisture separator comes in lightweight aluminium die cast body and manual transparent drain bowl. It prevents the damage that is caused by moisture. The moisture separator is maintenancefree and available for all ﬂows, line size, pressure, temperature screwed and ﬂanged ends with advance moisture relief systems like auto drain valves.

Variation of the ambient temperature is compensated by means of a bimetal strip inside. Micro Process Controls Gandhinagar - Gujarat Tel: 02764-232425, Mob: 09825060787 Email: mpcchl@sancharnet.in Website: www.microprocesscontrols.com

Lyophiliser The lyophiliser is used for pharmaceuticals, biotechnology and allied industries. Lyophilisation is the preferred drying process, for heat labile substances or where any physical, chemical or enzymic changes are detrimental to the products and its applications. Sublimation of frozen ice directly in the form of vapour under high vacuum is the basis of lyophilisation process. The system oﬀers optimal ﬂexibility in programming the recipe to suit a wide variety of products. The drying chamber is designed for full vacuum and overpressure of 2.5 bar. Its door has provision of view port and manual/automatic holding clamps. Machinfabrik Mumbai - Maharashtra Tel: 022-25555596 Email: machinfabrik@vsnl.com Website: www.machinfabrik.com

Gas monitor The range of this gas monitor is 0-5 ppm (V/V), resolution is 0.1 ppm, and the response time is typically less than 60 seconds. Detection principle is based on the sealed electromechanical sensor. The operating life of the sensor is expected to be of 1-year. The operating temperature ranges from 0 to 50°C. It has a LCD with battery indication. The alarm is both viewable and audible.

Airmax Pneumatics Ltd Ahmedabad - Gujarat Tel: 079-25324833 Email: airmaxvalves@hotmail.com Website: www.airaindia.com

Temperature gauge The mercury-filled temperature gauge is an economical, rugged, reliable and accurate measuring instrument. It is made of a bulb, transmitting capillary and flat bourdon tube, which is pressure-filled with mercury.

Uniphos Envirotronic Pvt Ltd Dist Valsad - Gujarat Tel: 0260-2730156 Email: cel@uniphos.com Website: www.uniphos-she.com

Looking For A Specific Product? Searching and sourcing products were never so easy. Just type MPH (space) Product Name and send it to 51818

eg, MPH Laboratory software and send it to 51818

72 72

Modern Pharmaceuticals I April 2012

Products Powder characteristics tester The Hosokawa PT-X powder characteristics tester employs methods to determine the flowability and floodability of dry powders. This model is the latest design of the powder characteristics tester, which utilises state-of-theart features to identify the specific characteristics of powdered samples for a wide range of application fields. Features are automated vibration with electronically controlled vib-sensor for repeatable results, optional integrated HEPA filter dust protection, test sieve identification measure by recording test sieve serial number, complete powder characterisation in one instrument, reduced operator intervention insuring analysis accuracy and repeatability, user-friendly software, reduce analysis time, complies with FDA tapped bulk density (USP) ASTM, Kawakita’s equation for Compressibility, etc. Hosokawa Micron India Pvt Ltd Chennai - Tamil Nadu Tel: 044-26211257 Email: mail@hmindia.hosokawa.com Website: www.hosokawamicron.co.jp

Safety light curtain The safety light curtain is an opto-electronic device in the form of invisible wall, which detects any unintentional movement across it and gives signal to be used for activation of protective circuits. This curtain is mainly used for safety of persons in machinery, which has potential to cause harm. The safety light curtain is used as an alternative or addition to mechanical safety system and other form of traditional machine guards. It is placed between an operator and the machine so that if the operator puts any part of his body into the machine unintentionally, then some of the optical beams get interrupted and the receiver generates trigger signal for the controller section to stop the machine. Katlax Enterprises Pvt Ltd Gandhinagar - Gujarat Tel: 02764-286784 Email: info@katlax.com Website: www.katlax.com

Liquid paraffin The liquid paraffin comes in two grades, light-liquid and heavy liquid. These paraffins are manufactured using sophisticated technology, and are highly refined grades. Light liquid paraffin has

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a viscosity of 25-80 mPa and heavy liquid paraffin has a viscosity of 110-230 mPa. Both comply with IP, BP and USP specifications. These are water-white in colour, odourless and tasteless and also comply with UV absorbance test. These are of pharmaceutical grade and are used as liquid carriers for solid and semisolid substances in medicinal preparations. The liquid paraffin finds application as parting agents for capsules, tablets and as a base for ointments. Unicorn Petroleum Industries Pvt Ltd Mumbai - Maharashtra Tel: 022-25299990 Email: unipetro@vsnl.com Website: www.unicornpetro.co.in

Symmetrical gravimetric analyser The model SGA-100 symmetrical gravimetric analyser is a continuous gas flow adsorption instrument specially designed for the study of water or organic vapour isotherms at temperatures ranging from 0°C to 80°C (standard version) and 250°C (high temperature version), at an ambient pressure. This gravimetric analyser is available in a size of 18”width x 30” height x 20”diameter with a weight of 125 lbs. The symmetrical gravimetric analyser finds applications in pharmaceuticals, chemicals, drugs, food products, paper, fibres, powders, carbon, catalyst, etc. Smart Instruments Company Thane - Maharashtra Tel: 0251-2801123,Mob: 09323509969 Email: smartins@vsnl.net Website: www.smartinsrument.com

Linear bearings DryLin R linear plain bearings are based on highly wear-resistant polymers developed especially for linear technology. The standard gliding films are made of iglidur-J material for gliding friction coefficients, the high-temperature gliding films made of iglidur-X ensure use with a long-term application temperature of up to 250°C. igus (India) Pvt Ltd Bengaluru - Karnataka Tel: 080-39127800, Mob: 09845039812 Email: info@igus.in Website: www.igus.in

Products Multi-processing system The unique multi-processing system for pharma R&D and pilot batches comes with 5-in1 options. This system consists of basic 100 AFG fluidised bed opposed jet mill with integrated dynamic classifier. It is used for milling heat sensitive, sticky materials with mohs hardness up to 10. The 50 ATP is the turboplex classifier already fitted in the 100 AFG. By a simple adapter kit, the mill is converted to a 50 ATP classifier alone, enabling separation of different fractions from the given powder. The 50 ZPS is a special kit of the 50 ZPS impact mill which is attached to the basic machine after removing the milling section of the 100 AFG. Hosokawa Micron India Pvt Ltd Chennai - Tamil Nadu Tel: 044-26211257 Email: mail@hmindia.hosokawa.com Website: www.hosokawamicron.co.jp

Spiral jet mill Model 50-AS is an extremely compact spiral jet mill which enables micronising even batches as low as 3 gm, with minimum loss. This is designed for the ultraﬁne size reduction of dry materials with a crystalline structure up to a Moh’s hardness of 3. Micronised particle size in the range of 0.5 to 30 microns is achieved. The 50 AS is utilised for a wide range of pharmaceutical materials, including paranterals, DPI (dry powder inhalants), and other active ingredients. Hosokawa Micron India Pvt Ltd Chennai - Tamil Nadu Tel: 044-26211257 Email: mail@hmindia.hosokawa.com Website: www.hosokawamicron.co.jp

Crate washing machine Type CrateWash crate washing machine is especially made for cleaning of standard plastic crates. It cleans up to 100 pallets per hour and contains a separate pre-wash-zone and a ﬁnal rinse-zone. Soiled crates to be washed are manually placed on the machine and conveyed by a chain conveyor into the wash chamber. The crates pass through

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high-pressure waterjet spray generated by nozzles having accurate spray angles for washing the pallets both externally and internally. This ensures optimum cleaning in the shortest possible timing. If desired the crates can be washed by detergent solution or hot water. Flow Control Industries Mumbai - Maharashtra Tel: 022-32227296, Mob: 09833889965 Email: ludwig_vaz@rediﬀmail.com Website: www.ﬂowcontrol-industries.com

Monoblock rinser/filler and capper The monoblock three-inone rinser, filler and capper incorporates rotary rinsing, rotary gravi filling and rotary screw-on capping operations on a single base. The neck gripper inverts the bottles for rinsing and automatically unloads into the inlet turret of the gravi-filling section in the upright position after rinsing internally. Bottles once located at the rinsing station are released only after the rinsing, filling and capping operations are over. Adequate neck holders are provided at filling and capping station to eliminate buckling of PET bottles. Universal hopper is provided for automatic capping, provided diameter of the caps is larger than its height. The Master Mechanical Works Mumbai - Maharashtra Tel: 022-26493459 Email: mastermmw@gmail.com

Hydraulic orbit motor The hydraulic orbit motor comes with maximum peak power rating of 20 kW. This motor provides high-torque low-speed performance with limited overall dimensions. The orbit motor is made with a system of lobe shaped geroter/geroller. Some of the features of include well designed compact structure, good weight to power ratio, reversible rotation direction, excellent eﬃciency, uniform torque, standard mounting ﬂanges, etc. The hydraulic orbit motor is used in applications like road sweepers, agricultural and forestry machines, plastic injection moulding machines, wood-working machinery, printing machines, conveyor, mining equipments, food & textiles processing. Pioneer Transmission Solutions Bangalore - Karnataka Tel: 080-51273369 Email: pioneer123@touchtelindia.net

Modern Pharmaceuticals I April 2012

Products Rotary vacuum pump This is a sliding vane, oil-lubricated type rotary vacuum pump. The design of the lubricating system positively feeds minimum quantity of oil to important points. The oil from the exhaust is baffled, collected and returned back to the oil chamber. Heat treated fibre vanes are used in the pumps in place of stator, end covers and rotor slots. The pump is driven by V-belt and is fan-cooled. The complete unit with motor and base plate is suitable for mounting inside the equipment. The pump can be modified to suit specific requirements. Acmevac Sales Pvt Ltd Mumbai - Maharashtra Tel: 022-28375837 Email: acmevac@vsnl.com Website: www.acmevac.com

Single-source diffractometer The Xcalibur-E is a most popular single wavelength system for routine crystal structure determination, although it is also suitable for more challenging high resolution electron density studies for small molecules. It comes mounted with ﬁne focus molybdenum or copper Enhance X-ray source and Eos CCD detector, the fastest and most sensitive CCD detector available today. This is user-friendly software that can fully automate the crystallography experiments and produce accurate molecular structures in just three clicks. Single wavelength molybdenum or copper ﬁne focus enhances X-ray source. Agilent Technologies India Pvt Ltd New Delhi Tel: 011-46237100 Email: agilent@agilent.com Website: www.agilent.co.in

Tube filler This tube filler is used for auto filling and sealing of plastic/laminated and aluminium tubes. It performs auto feeding and positioning of tubes with auto filling, sealing, crimping, fold stations, coding & ejection. All contact parts are in SS 316 and Teflon as per cGMP. It is sturdy and compact and is simple in operation. It is provided with Ferguson Indexer and no-tube-no-fill device and cassette feed device for auto feeding arrangement of empty tubes into the feed device along with tube orientation. For aluminium tubes, reverse or saddle fold

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is provided and for plastic/laminated tubes hot-air sealing with leister (Swiss make heater) is provided. Arsee Engineering Works Navi Mumbai - Maharashtra Tel: 022-56053602 Email: sales@arsee.com Website: www.arsee.com

X-ray inspection system The X-ray inspection system incorporates simultaneous inspection of individual products on multiple lane conveyors. It has quick release conveyor belt for easy cleaning and re-assembly. Masking function is provided to eliminate constant dense area. Other features include on-screen simultaneous imaging and operating adjustment, variety of models for packed, unpacked, bulk and liquid products, rejecters to every application, and IP69K protection model available. Jay Instruments & Systems Pvt Ltd Mumbai - Maharashtra Tel: 022-23526207 Email: ctpsales@jayinst.com Website: www.jayinst.com

Products Centrifuge The full lid opening centrifuge conforms to GMP standards for active pharmaceutical ingredients, herbal extracts, ﬂavours, colours, chemicals and allied process industries. This centrifuge is of four-point suspension-type in stainless steel construction. The entire body is lifted and opened hydraulically. Thus the basket and drain platform are exposed facilitating easy and quick cleaning. The body is hydraulically lowered into the closed position and clamped to the lower portion of the casing by means of quick clamps. The centrifuge is most suitable for manufacturing facilities that require frequent product change over. United Engineering Enterprises Mumbai - Maharashtra Tel: 022-23083990 Email: uenggent@gmail.com Website: www.united-centrifuges.com

Orbital welding machine The orbital welding machine is used for joining of stainless steel tubing for system in which the products ﬂowing through them must be maintained in a clean and/or sterile condition. Orbital welding is fully penetrated with a uniform crevice-free inner weld bead with good alignment. Crevice-free welds are essential for controlling the growth of microorganisms in hygienic piping systems. This machine ﬁnds applications in pharmaceutical/biotechnology, sanitary (hygienic) process pipe, food processing/dairy, instrumentation lines, semiconductor/high purity, etc. IUS Equipments Pvt Ltd Navi Mumbai - Maharashtra Tel: 022-56116626 Email: iusequip@vsnl.net Website: iusequip.com

Digital panel meter Fuji Electric’s FD5000 digital panel meter is highly modular 1/8 DIN panel meter with up to 19 diﬀerent ﬁeld-replaceable input boards. It comes with optional alarms and analogue outputs, in addition to RS232 or RS485 communications functions. This panel meter can be connected to a PC to process and control various data. It accepts inputs from

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temperature probes, pressure transducers, load cells, strain gauges, potentiometers, pulse inputs, large voltage and current signals. It is used in pharmaceutical, food, textiles and automotive industries. Procon Technologies Pvt Ltd Ahmedabad - Gujarat Tel: 079-27492566 Email: info@procon.co.in Website: www.procon.co.in

Tablet coating system The tablet coating system is available in various models from laboratory scale up to tonnage capacity. All models are in compliance with GMP requirements. Features include pan construction with air-tight cover to provide good condition for mixing and drying. For sugarcoating, the hot air supply and the exhaust can be automatically controlled by the auto damper and the sequence spray-pause-1, pause-2, dry is automatically operated by the preset timer. The reverse rotation discharge system, discharges with simple operation without any damage of tablets. Umang Pharmatech Pvt Ltd Dist Thane - Maharashtra Tel: 0250-6450835 Email: info@umangpharmatech.com Website: www.umangpharmatech.com

Pharma inspection machine The paper folding, shrink pack and pharma inspection machine is tested for CE marking, and thus fulfills one of the major statutory requirements of European Union. A range of customised solutions as per pharma industry requirements is also offered. Pharma inspection solutions include: pharmacode readers, leaflets and cartons. The pharma inspection machine is specially designed for online checking of pharma codes printed on tubes, cartons, leaflets, labels, etc. Pratham Technologies Pvt Ltd Pune - Maharashtra Tel: 020-24352624, Mob: 09822047399 Email: enquiry@prathamtech.com Website: www.prathamtech.com

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Products Steam boiler The fully automatic package steam boiler (IBR) has capacity ranging from 100 kg/hr to 2000 kg/hr with operating pressure of 10 kg/ cm² g. Smoke tube & water tube version is also available. Coil is made from seamless tube of asthma 106 GR-B pipes. The unit is equipped with high eﬃciency oil/gas burner with air pre-heater arrangement which gives high thermal eﬃciency. Aero Therm Systems Pvt Ltd Ahmedabad - Gujarat Tel: 079-25890158, Mob: 09825008720 Email: contact@aerothermsystem.com Website: www.aerothermsystem.com

Aerosol generator The aerosol generator (fogger machine) is used for sterilising air in the production shops of pharma, food, biotech and healthcare industry. This fogger machine takes care of 5,000 cu ft volume in single ﬁll giving 100 per cent eﬃcacy. The portable fogger machine is tested for droplet size of aqueous formulations in sub-microns. It generates droplet size in sub-microns and is approved by nuclear division of BARC, nuclear power stations and is patronised by leading hospitals and pharmaceutical industries. The machine comes with a 5 ltr capacity tank made out of best grade disinfectant tank & wetted parts. Gouri Engineering Pvt Ltd Navi Mumbai - Maharashtra Tel: 022-27701285 Email: gouriengg@vsnl.com

Vibratory finishing system The vibratory finishing system incorporates a rubber or polyurethane lined bowl of U-cross section mounted on precisely calculated springs. This system is driven by a highly efficient vibratory motor. The open top of the bowl can be loaded with suitable ceramic/ plastic or steel media and parts to be processed. Vibratory finishers shake parts and media at high speeds, causing the media to scrub the surface of the parts in an action similar to lapping. Since the

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parts and the media are moving at small increments on each stroke, the parts are not subject to severe stress or damage. Niraj Optical Machinery Ahmedabad - Gujarat Tel: 079-29295747, Mob: 09909904148 Email: badrakia@rediﬀmail.com Website: www.nirajopticalmachinery.com

Cleanroom moulds Adapplicator, Alu cap, Snap cap, PE bottle pack cap, PE twin port cap are only some of many cleanroom moulds from Braunform. Highly sensitive packaging and measuring components, caps for use in dental and insulin ﬁelds, dialysis components, hygiene products and the Adapplicator system developed by Braun, the spray alternative to needle injection, are few examples. Neejtech India Ahmedabad - Gujarat Tel: 079-26561312, Mob: 09825040231 Email: info@neejtech.com Website: www.neejtech.com

Products Fluid bed dryer

Pull action clamp

The fluid bed dryer has batch capacity of 15 kg to 500 kg. The digital temperature indicator controller gives accurate temperature control. Control action can be switched ON/OFF or PID as per control accuracy required. Construction of the dryer is made of MS, aluminium, SS316/304, or as per requirements. Flameproof and sparkproof versions are also available. Heating is electrical/thermic fluid or steam radiator/oil fired hot air generator.

The pull action clamp comes in latch type, and horizontal-cum-vertical toggle type in stainless steel. This latch-type toggle clamp is used for sealing chambers, lids, doors of moulds, drums, containers or other vessels, etc. The clamp is most suitable for chemical, pharmaceuticals and food industries. The pull-action clamp’s unique design enables the use of the same clamp as a horizontal pull-action clamp as well as a vertical pull action clamp just by changing the position of the pulling pin. It is manufactured as per international standards in many diﬀerent designs and sizes for use on various kinds of jigs & ﬁxtures.

Aero Therm Systems Pvt Ltd Ahmedabad - Gujarat Tel: 079-25890158, Mob: 09825008720 Email: contact@aerothermsystem.com Website: www.aerothermsystem.com

Chemical and corrosion-resistant grating FRP grating is a long term solution to needs of industrial and recreational applications, like walkways, platforms, trench covers, staircase, floorings, footbridges, fencing, elevated car parking, earth pit covers, etc. The FRP grating is manufactured by combining a matrix of resin and fiberglass. The FRP grating does not corrode like steel gratings and is used in corrosive environments and has lower maintenance costs. Also offered are pultruded grating and moulded grating. Aeron Composite Pvt Ltd Ahmedabad - Gujarat Tel: 079-26565731, Mob: 09909988266 Email: info@aeroncomposite.com Website: www.aeroncomposite.com

Rotary bottle washing machines The rotary bottle washing machines (model NRWM–96) are multifunctional machines that meet the GMP requirements of washing glass and plastic bottles. These operate on the rotary principle GENEVA mechanism and require manual loading and unloading of bottles. The output consists of 4300 to 9000 numbers and direction of the machine is clockwise. National Pharma Machinery Ahmedabad - Gujarat Tel: 079-30903433 Email: sales@nationalinda.co.in Website: www.nationalpharmamachinery.com

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Summit Engineering Technology Pvt Ltd Navi Mumbai - Maharashtra Tel: 022-27642776 Email: summit2@vsnl.com Website: www.summitengg.com

DC drive The thyristor-controlled DC drive is a variable speed regulator suitable for controlling speed of shunt or compound motor up to 200 hp. It is used as OEM equipment in various industries, like chemical industry, packaging industry, paper industry, pharmaceutical industry, plastic industry, rolling mill industry, rubber industry and textile industry, etc. Gayatri Control & Automation Pvt Ltd Ahmedabad - Gujarat Tel: 079-25840686, Mob: 09825387551 Email: info@gayatricontrol.com Website: www.gayatricontrol.com

Vacuum pool system This energy saver vacuum pool system keeps vacuum virtually constant. Since the system is designed for best possible capacity control, it is a big-time energy saver. The system also features recirculation of sealing liquid with inter-cooling. This feature signiﬁcantly cuts down on the cost of sealing liquid and reduces the load on eﬄuent treatment. Joyam Engineers & Consultants Pvt Ltd Ahmedabad - Gujarat Tel: 079-26569533, Mob: 09879099100 Email: joyam@joyamvactech.com Website: www.joyamvactech.com

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Products AODD pump The Lutz Pumpen air-operated doublediaphragm (AODD) pump comes in sizes ranging from ¼” size to 3” size. The pump housing is available in polypropylene, PVDF, nylon, aluminium and stainless steel and the internal is available in Teflon, EPDM, nitrite rubber or viton. This pump runs on dry, non-lubricated clean air. It is designed for a variety of industrial applications. The AODD pump is self-primping and carries solid particles/slurries without damage. It is available in bolted and damped versions. The pump finds applications in pharmaceuticals, glass and fibreglass, marine/ shipbuilding, metal and steel, effluent treatment, paint, aircraft, electroplating/surface treatment, food and beverage; automotive; chemical and petroleum; clay and ceramics, etc. Shanbhag & Associates Mumbai - Maharashtra Tel: 022-28346604 Email: shanbhags@vsnl.com Website: www.shanbhags.com

Digital controller This is an upgraded digital controller that comes with various functions. Some of the features include easy-to-use & multiple inputs, self-tuning PID, blind function, simpliﬁed timer, priority display, multiple inputs, standardisation of conformity, compact size, manual control, balance less & bump less , communication function (RS-485), digital PV ﬁlter, PID over-shoot protection, digital input function, heating/cooling control, CT input, etc. Mifa Systems Ahmedabad - Gujarat Tel: 079-26871367, Mob: 09327220008 Email: sales@mifasystems.com Website: www.mifasystems.com

Nitrogen generator The nitrogen gas generator operates on pressure swing adsorption (PSA) technology. For continuous generation of nitrogen, two adsorption towers are provided which are interconnected with auto-change over valves controlled by PLC in the control panel. After saturation of one tower with oxygen the process automatically changes over to another tower and thus the nitrogen production is continuous. The onsite nitrogen generator is custom-made and is adjusted to give the desired nitrogen quality for process and application. The nitrogen gas generator is fully automatic and requires virtually no attention of the operator. Once

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started it is left unattended. All operations take place automatically and nitrogen purity remains very consistent. Airox Nigen Pvt Ltd Ahmedabad - Gujarat Tel: 079-26841322, Mob: 09825109744 Email: ceo@airoxnigen.com Website: www.airoxnigen.com

Stainless steel wire mesh The stainless steel wire mesh comes in a wide variety of range, size and quality. It is available in coarse-to-fine aperture with wire diameter up to 16 mm thick. It is also manufactured in galvanised iron, spring steel, mild steel, brass copper, nickel monel, silver, etc. The wire mesh netting finds applications in screening sieving straning, grading, filtering, fencing, aggregating, pertition, reinforce, insulations, conveying, etc. Jeetmull Jaichandlall (P) Ltd Kolkata - West Bengal Tel: 033-22389811, Mob: 09831124843 Email: jjmesh@vsnl.com Website: www.wiremeshes.com

Products Extrusion melt-pressure transducer The melt-pressure transducer and transmitter come in liquid ﬁlled capillary design. It provides an electronic signal which is proportional to the measured pressure and allows the transducers to operate at process wheatstone bridge-bonded strain gauge design, ensuring high accuracy, reliability and repeatability. The melt pressure transducer and transmitter is available in two distinct accuracy grades, general-purpose grade with accuracy (non-linearity) of better than 0.5 per cent FSO, laboratory grade feature accuracy (non-linearity) of better than 0.25 per cent FSO. It is fully compatible with the industry standard wiring pattern and colour-coding, as well as oﬀering the 6-pin bayonet connector. Adinath Controls Pvt Ltd Ahmedabad - Gujarat Tel: 02764-286573 Email: info@adinathcontrols.com Website: www.adinathcontrols.com

Pneumatic cylinder valve The Y-type angled pneumatic cylinder valve is used for process control application. This valve is used for ON/OFF application to control steam, water, coolants, air, gas and light oil at line pressure up to 10 bar. The actuator is pneumatic cylinder-type with pressed stainless steel. It is available in sizes ranging from ½” to 2” bsp with 2-way and 3-way investment casted body. The valve ﬁnds application in pharmaceutical machinery, textile dyeing machinery, air-drying equipment, autoclaves, automobile industry and automatic process control applications. Madho Controls Pvt Ltd Thane - Maharashtra Tel: 022-25883252, Mob: 09820066046 Email: madho@vsnl.com Website: www.madhocontrols.com

Flow control equipment The flow control equipment is used in food, dairy, beverage, pharmaceutical, biotech, personal care and fine chemical components. All surface finish products are processed by auto polished machine. The process criteria for interior surface finishes includes no more than 4 pits per each ½” x ½” inspection window, the cumulative total of all relevant pits shall not exceed 0.040”, dents are

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not accepted, when nicks id depth is <0.01, pits have diameter of <0.020” and the bottom is shiny. Weld slag and surface residuals are not accepted. The total area is <5 per cent when visually inspected. King Lai International Co Ltd Taichung - Taiwan Tel: +886-4-26815368 Email: sales@kinglai.com.tw Website: www.kinglai.com.tw

Torque actuator Torque of the actuator is 4,500 Nm at 5 bar air pressure. Tube is made from stainless steel. It easily operates 8”, 10”, 12” & 14” ball valves with double acting actuator, 8”, 10” & 12” ball valves with single acting actuator, 20”, 24”, 26” & 36” eco tech butterﬂy valves, up to 40” spherical disc valves and up to 10” plug valve. It comes with accessories solenoid valve and limit switch box with position indicator as per NAMUR standard, ﬁlter and regulator with gauge, manual override, pneumatic valve positioner, I/P converter, etc. Aira Euro Automation Pvt Ltd Ahmedabad - Gujarat Tel: 079-40247003 Email: info@airaindia.com Website: www.airaindia.com

Radial drilling machine The heavy-duty high precision all-geared drill head radial machine comes with forged steel gears and toughened spindle. This drilling machine has automatic vertical movement of arms. It also provides horizontal automatic movement of man spindle head for face milling as well as keyway milling operations. The machine has arm titling at 360-degrees to get inclined drilling. Accuracy is as per ISI chart. The main spindle runout is within 0.005 mm, ie, within 5 microns. Drilling capacity of the machines is 38 mm in steel. The radial drilling machine is supplied with electric control panel push-button pendant and overload relay. Poly Kraft Machines Ahmedabad - Gujarat Tel: 079-22743639, Mob: 09898003625 Email: pkmdrill@gmail.com Website: www.polykraftmachines.com

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Products Pressure data logger This high-accuracy and easy-tooperate pressure data logger is suitable for pharmaceutical industry. It stores 94,000 data in memory and has a measuring capacity that ranges from 0 to 5 bar, accuracy ±0.5 per cent of the measuring and resolution of 1 mbar with measuring sensor of ceramic pressure. The pressure data logger has housing pressure resistance of 0 bar to 10 bar. It has a measuring rate from 1 sec to 8 hr and battery life of approximately three years. The dimension of the logger diameter is 48 mm x 28 mm & weight 140 gm. This logger has IP68 protection class/housing for pharmaceutical industries. Ambetronics Mumbai - Maharashtra Tel: 022-28371086 Email: ambetronics@vsnl.com Website: www.ambetronics.com

Ball valve This ball valve comes with pneumatic rotary actuator. The valve is of ON/OFF type with screwed, flanged, socket weld, tri-clover end in three-piece design. It is available in SS-304 and SS-316 investment castings and is fitted with double-acting pneumatic rotary actuator that operators through 90-degrees angular movements of ball valve or butterfly valves. Pneumatic actuator is mounted directly on the shaft of the valve. The actuator is supplied with solenoid valve mounted on it. It is available in different sizes up to 4” to control fluids such as steam, chemicals, oil, air, and water. Madho Controls Pvt Ltd Thane - Maharashtra Tel: 022-25883252, Mob: 09820066046 Email: madho@vsnl.com Website: www.madhocontrols.com

Leak test apparatus These apparatus are fully programmed equipment, ﬁtted with oil free vacuum pump, a countdown electronic timer and a LCD module for display. The vacuum displayed in the LCD module is factory calibrated. These leak test apparatus have all parameters of 101 but with provision to connect a printer to download all data. In the pharmaceutical industry, these are used to check leakages in packed strips, blisters and small sachets containing tablets, capsules, liquids, cough syrup, shampoo packets, etc, and also sutures. The

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leak test apparatus are complaint with USP/EP/JP standards in product packaging and integrity evaluation. Servewell Instruments Pvt Ltd Bengaluru - Karnataka Tel: 080-23573309 Email: serwell@vsnl.net Website: www.servewel.com

Analytical balance Citizen basic line analytical balance is used for precise and reliable weighing with speed, stability and excellent performance. It is provided with high contrast LCD display for easy viewing. The balance comes with standard RS232C interface and automatic external calibration. It conforms to GLP/GMP and ISO 9001 standard. The analytical balance is made of die-cast aluminium design for long-term stability and accurate result and has a spacious draft shield interior. It is used for piece counting, percentage weighing and density measurement for solid and liquid in various units like gm, mg, ct, oz, dwt, mon, GN. Sakova Scientiﬁc Co Mumbai - Maharashtra Tel: 022-56084622 Email: sakova@vsnl.net Website: www.sakova.com

Disposable bioreactor This disposable bioreactor as opposed to conventional bioreactor is a single use system made of medical grade plastics, which are pre-sterilised and ready-for-use, therefore not needing cumbersome SIP and CIP. Agitated by means of an external gyrational motion, which uses gravity naturally to make the contents flow in a uniform circumferential direction in a specially shaped round bag, the disposable bioreactor system has definite advantages over conventional and existing disposable bioreactor manufactured in other countries. Produced in Class-10000 cleanrooms with imported medical grade PVC film, the disposable bioreactor system is very versatile and is used to manufacture high end vaccines to low end bio-fertiliers. Lablinks Biotech Pvt Ltd Bengaluru - Karnataka Tel: 080-32440830, Mob: 09343748099 Email: ravindranath@lablinksbiotech.com Website: www.lablinksbiotech.com

Products Rapid mixer granulator The rapid mixer granulator is designed to meet requirements of GMP. Contact parts are made of SS-304/316. This granulator comes with specially designed control panel with display system and microprocessor. The bowl, lid mixing agitator and discharge housing are made of stainless steel. All MS parts of the machine are cladded and covered with stainless steel. Limit switch is provided on main lid and discharge valve for safe operation. Components of the machine are easily accessible for cleaning. All electrical and pneumatic parts are pre-wired to simplify installation. It is provided with impeller, which consists of two full and two half solid mixing blades. Avon Pharma Machines Pvt Ltd Dist Thane - Maharashtra Tel: 0250-2450638 Email: contact@avonpharmamachines.com

Stoppering machine The servo rotary stoppering machine is crafted for cleanroom productions. Its compact size allows for a side-by-side configuration, doubling the speed and matching the speed of the liquid filling machines for over 200 vials per minute side. The system performs full and partial insertion and is easily changed over to different stopper and bottle sizes. The multi-axis servo system synchronises stoppers with bottles eliminating the need for difficult mechanical adjustments over years of operations. Vibratory feeder bowl orients and supplies stoppers, and is servo driven for programmable changeover to a different bottle height. Automated Machine Technologies Inc North Carolina - USA Tel: +1-919-3610121 Email: office@amtliquidfilling.com

Bottle capper The rotary chuck-style bottle capper is designed to apply and rotate a pre-sorted cap on a container, based on a pre-determined applied torque. The containers are fed onto the rotary chuck style capper and are separated and positioned on individual capping stations. Caps are pre-sorted and fed on the sliding table of the machine. The continuously rotating chucks pick up and secure the caps, then apply the caps to the containers. When the preset applied torque value is achieved, the magnetic clutch

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disengages, the chuck releases the cap and the closed container is discharged from the machine. US Bottlers Machinery Company North Carolina - USA Tel: +1-704-5884750 Email: info@usbottlers.com

Microfluidiser processor The portable M-110P microfluidiser processor is a bench-top lab machine that requires no compressed air or cooling water. Designed to operate at up to 30,000 psi process pressure, this portable microfluidiser processor requires a standard 20 A, single-phase household electrical outlet and is easily incorporated into any laboratory setting. Utilising Microfluidics’ fixed geometry diamond interaction chamber technology and ceramic plunger, the processor easily enables the production of nano-suspensions and nano-emulsions, as well as liposomal encapsulation and cell disruption with the fewest number of passes. TTL Technologies Pvt Ltd Bengaluru - Karnataka Tel: 080-25251859 Email: tmidirect@ttlindia.com Website: www.ttlindia.com

Temperature and humidity sensor The SureCross temperature and humidity sensor is a robust instrumentation optimised for use with the company’s SureCross wireless network. This sensor is factory-calibrated to determine relative humidity to ±2 per cent or ±3.5 per cent (depending on model) and delivers temperature accuracy to ±0.3°C for simple critical data monitoring. Manufactured with a rugged metal housing and IP67 electronics, it provides maintenance-free operation in a wide variety of environmental monitoring applications. It delivers dependable monitoring in a broad range of environments, including large-scale refrigeration and cold chain storage systems, greenhouses, warehouse areas, pharmaceuticals, HVAC, textiles, energy management, IT resources and data centers, etc. Banner Engineering India Pvt Ltd Pune - Maharashtra Tel: 020-66405624, Mob: 09322339208 Email: salesindia@bannerengineering.com Website: www.bannerengineering.com

Modern Pharmaceuticals I April 2012

Products Strip seal The pilfer-proof strip seal prevents imitation of branded and quality products and helps control adulteration and pilferage. It has a tamper-evident locking action in a one-piece construction and is precision moulded from durable, tough, high strength, weather resistant engineering Nylon 66 material. The strip seal is lightweight, corrosion-effective, economical and cost-effective. The company’s name/logo can be permanently hotstamped on it. This seal is used in pharmaceuticals industry, bulk drugs, airlines baggage, postal department, chemical industry, bank lockers, courier bags, containers, drums, etc. Novoflex Marketing Pvt Ltd Kolkata - West Bengal Tel: 033-22260513, Mob: 09903163634 Email: novoflex@vsnl.net Website: www.novoflexgroup.com

Zero hold-up filter press The zero hold-up filter press (model BPZH8) offers direction of flow of liquid in opposite to that in standard filter. Plate diameter is 8”. Number of plates is 6. Filtering area is 0.217 m². Cake holding capacity is 4.9 litres. Flow rate is 600 hours. Pump size is ½”. Motor size is 1 hp. Bombay Pharma Equipments Pvt Ltd Mumbai - Maharashtra Tel: 022-28594877, Mob: 09820124804 Email: bombaypharma@vsnl.net Website: www.bombaypharma.com

Pharma print cartridge The pharma print cartridge and felt pad/roller are made for blister packaging machine, FFS machine and coding machine. Absorbing material used is poly porous in various microns varying from 1 micron to 25 micron, depending upon the requirement of customer. The absorbing capacity of these cartridges is quite high and the cartridges are hard so the impression is good as there is cotton cloth knitted

April 2012 I Modern Pharmaceuticals

sleeves (covering) which is used to avoid direct contact of stereo with roller. The cartridges are made in various ID, OD and length depending on customer’s requirement. The maximum OD can be 85 mm, length up to 300 mm. Process Instrumentation & Controls Vadodara - Gujarat Tel: 0265-2357228 Email: batchprinting@yahoo.com Website: www.piccode.com

Vibro finishing machine This machine is a bowl-type centrifugal ﬁnishing machine. The machine bowl is loaded with suitable ceramic/plastic or steel media and the components be processed. Mutual rubbing action takes place inside the chamber due to the gyratory vibrations. This method completes the deburring process faster. The machine is driven by powerful vibratory motor causing intense rubbing and trouble free output. Other features include heavy-duty vibratory motor, PBR rubber lining, PU lining also available, bowl is stress relieved, heavy-duty springs, machine with auto discharge is also oﬀered. Premium Vijimech Pvt Ltd Ahmedabad - Gujarat Tel: 079-40083450, Mob: 09712987467 Email: sales@vijimech.com Website: www.vijimech.com

Tablet and capsule packing line The tablet and capsule packing line arranges bottles, counts and ﬁlls medicine, ﬁlls paper (absorbent cotton and desiccant) in bottle, screws cap, aluminium foil seal cap, paste label, test and eliminates functions. The tablet and capsule packing line is used to pack capsules, tablets, pills, grain and powder. Shanghai Hengyi Medicine Making Equipment Co Ltd Shanghai - China Tel: +86-21-64789720 Email: scb@hengyi-sh.com

The information published in this section is as per the details furnished by the respective manufacturer/ distributor. In any case, it does not represent the views of

Modern Pharmaceuticals 83

List of Products

Looking For A Specific Product? Searching and sourcing products were never so easy. Just type MPH (space) Product Name and send it to 51818

eg, MPH Laboratory software and send it to 51818 Sl No

1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 25 26 27 28 29 30 31 32 33 34 35 36 37 38 39 40 41 42 43 44 45 46 47 48 49 50 51 52 53 54 55 56

Product

Pg No

Sl No

Acoustic enclosure ........................................ 25 Aerosol generator ................................................77 Agitator..................................................................5 Air filter .........................................................13, 15 Alpha press ............................................................8 Analytical balance ...............................................81 Analytical instrumentation ..............................BIC Analytical instruments ........................................86 AODD pump ....................................................79 Ball valve ...................................................... 81 Batch disperser ......................................................5 Bearings ...............................................................10 Biological safety cabinet ...............................13, 15 Booklet and leaflet label ................................ FGF Bottle capper .......................................................82 Cable carrier ................................................. 10 Calorimeters ..........................................................5 Caster wheel ......................................................BC Centrifugal monoblock pump ............................75 Centrifuge............................................................76 Chain ...................................................................10 Chemical and corrosion-resistant grating ..........78 Chlorine gas cylinder and tonner.......................37 Chromatography .................................................86 Cleanroom door ............................................13, 15 Cleanroom moulds..............................................77 Coating machine ...................................................8 Colloid mill ...........................................................8 Coloumns and chemistries ................................bic Columns ..............................................................86 Communiting mill ................................................8 Connector ............................................................10 Crate washing machine ......................................74 DC drive ...................................................... 78 Dedusting and deburring machine ......................8 Digital controller .................................................79 Digital panel meter .............................................76 Dispensing booth ..........................................13, 15 Disperser................................................................5 Disposable bioreactor ..........................................81 Double rotary tableting machine .........................8 Drives.................................................................BC Dry vane pump ...................................................25 Drying oven ..........................................................8 Duo label ........................................................ FGF Dust extractor........................................................8 Electronic chlorine dosing system and chloroscope ................................................. 37 Elemental analysis ...............................................86 Empower ..........................................................BIC Extrusion melt-pressure transducer....................80 Fan filter unit........................................... 13,15 Flag label ........................................................ FGF Flow control equipment .....................................80 Fluid bed dryer....................................................78 Fluid bed processor ...............................................8 Fluid bed system ...................................................8

57 58 59 60 61 62 63 64 65 66 67 68 69 70 71 72 73 74 75 76 77 78 79 80 81 82 83 84 85 86 87 88 89 90 91 92 93 94 95 96 97 98 99 100 101 102 103 104 105 106 107 108 109 110 111 112

Product

Pg No

Gas chlorinator............................................. 37 Gas detector ........................................................72 Gas monitor ........................................................72 Giga press ..............................................................8 Gravity and vacuum feed....................................37 Heating bath...................................................5 Hepa filter terminal housing ........................13, 15 High pressure homogeniser ..................................5 Hot plate ...............................................................5 HPLC ....................................................... BIC, 86 Hydraulic orbit motor.........................................74 Industrial fitting ......................................... BC Informatics .......................................................BIC Injectable manufacturing line .......................13, 15 Inline disperser ......................................................5 Kneading machine ..........................................5 Laboratory reactor ..........................................5 Laboratory software ..............................................5 Laminar air flow workstation .......................13, 15 Large diameter welded pipes..............................77 Leak test apparatus .............................................81 Linear bearings....................................................73 Liquid paraffin ....................................................73 Lyophiliser ...........................................................72 Magnetic stirrer ..............................................5 Mass mixer granulator ..........................................8 Mass spectroscopy ...............................................86 Mega press.............................................................8 Microfluidiser processor......................................82 Mill ........................................................................5 Mini cm mill .........................................................8 Mini roll compactor ..............................................8 Moisture separator ..............................................72 Molecular spectroscopy .......................................86 Monoblock rinser/filler and capper....................74 Motor vibrators .................................................BC Multi-processing system .....................................74 Nitrogen generator ....................................... 79 Orbital welding machine............................... 76 Overhead stirrer ....................................................5 Packaging solution..................................... FIC Pass box .........................................................13, 15 Pharma inspection machine ...............................76 Pharma print cartridge .......................................83 Pilot plant ..............................................................5 Pilot press ..............................................................8 Pneumatic cylinder valve ....................................80 Powder characteristics tester ...............................73 Pre-engineered & pre-fabricated modular panel ............................................................13, 15 Pressure data logger ............................................81 Pressure sensitive paper & film label ..............FIC Pull action clamp ................................................78 Pump ...................................................................25 Punches and dies...................................................8 Quick change terminal house .................. 13,15 Radial drilling machine................................. 80

Sl No

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Product

Pg No

Rapid endotoxin detection system .....................79 Rapid mixer granulator .......................................82 Return air risers.............................................13, 15 Roll compactor ......................................................8 Roots blower .......................................................25 Rotary bottle washing machines ........................78 Rotary evaporator..................................................5 Rotary gear ..........................................................75 Rotary lobe pump ...............................................75 Rotary vacuum pump .........................................75 Rupid mixer...........................................................8 Safe change housing ................................13, 15 Safety light curtain..............................................73 Sampling booth.............................................13, 15 Sanitary centrifugal .............................................75 Screw pump.........................................................75 Seamless pipes .....................................................77 Self-priming monoblock.....................................75 Sensors .................................................................23 Shaker ....................................................................5 Single rotary tableting machine ...........................8 Single-source diff ractometer...............................75 Solid-liquid mixer .................................................5 Spiral jet mill .......................................................74 Stainless steel pipes .............................................77 Stainless steel wire mesh.....................................79 Steam boiler ........................................................77 Sterilising/depyrogenating tunnel.................13, 15 Stoppering machine ............................................82 Strip seal ..............................................................83 Submersible .........................................................75 Symmetrical gravimetric analyser.......................73 Tablet and capsule packing line..................... 83 Tablet coating system..........................................76 Tefzel HHS isotactic PP material .......................6 Temperature and humidity sensor .....................82 Temperature gauge..............................................72 Thermoplastic valves and piping system 6............. Thermostat & vacuum dryer and mixer ..............5 Torque actuator ...................................................80 Triplex plunger ....................................................75 Trolley wheels....................................................BC Tube filler ............................................................75 Tubes....................................................................77 UHPLC........................................................ 86 UPLC ...............................................................BIC U-tubes ................................................................77 Vacuum booster pump .................................. 25 Vacuum pool system ...........................................78 Vacuum system....................................................25 Vertical inline ......................................................75 Vibrators ............................................................BC Vibratory finishing system..................................77 Vibro finishing machine .....................................83 Welded pipes ................................................ 77 X-ray inspection system ................................ 75 Zero hold-up filter press ............................... 83

BC-Back cover, BIC-Back inside cover, COC-Cover on cover, FGF-Front gate fold, FIC-Front inside cover

Modern Pharmaceuticals I April 2012

List of Advertisers Advertiser’s Name & Contact Details

Pg No

Aqua Services

Advertiser’s Name & Contact Details

Cognex Sensor

Pg No

Advertiser’s Name & Contact Details

Ika India Private Limited

T: +91-265-2331748

T: +91-20-40147840

T: +91-80-26253900

E: aquaas@satyam.net.in

E: sales.in@cognex.com

E: process@ika.in

W: www.aquaservicesindia.com

W: www.cognex.com

W: www.ika.in

Ask Me

T: +91-22-3555 5555 W: www.askme.infomedia18 Avery Dennison India Pvt Ltd

Dev Engineers

Pg No

Reynders Label Printing India Pvt Ltd FGF

T: +91-79-26403839

T: +91 149 3305400

E: info@devpumps.com

E: india@reynders.com

W: www.devpumps.com

W: www.reynders.com

FIC Eng Expo

T: +91-124-2215581

Suraj Limited

T: +91-09819552270

T: +91-79-27540720

E: engexpo@infomedia18.in

E: suraj@surajgroup.com

W: www.engg-expo.com

W: www.surajgroup.com

E: lpm.in@ap.averydennison.com W: www.enhanceyourbrand.com Bonfiglioli Transmissions (Pvt) Ltd

BC Everest Blower Systems

Thermo Fisher Scientific Sid Division

T: +91-44-67103800

T: +91-11-45457777

T: +91-22-67429494

E: info@everestblowers.com

E: pradeep.kumar@thermofisher.com

W: www.everestblowers.com

W: www.thermofisher.com

E: sales.buins@bonfiglioli.com W: www.bonfiglioli.com Chamunda Pharma Machinery Pvt Ltd

8 Fabtech Technologies Intl Pvt Ltd

13,15

UNP Polyvalves India Pvt Ltd

T: +91-79-25842712 E: shahil@cm1981.com W: www.cm1981.com Charles River T: +91-80 -25588175

T: +91-22-61592900

T: +91-265-2649248

E: mails@fabtecheng.com

E: mktg@polyvalve.com

W: www.fabtecheng.ae

W: www.polyvalve.com

Igus India Pvt Ltd

Waters (India) Private Limited

T: +91-80-39127800

T: +91-80-28371900

E: india.customercare@crl.com

E: info@igus.in

E: waters_india@waters.com

W: www.criver.com

W: www.igus.in

W: www.waters.com

BC-Back cover, BIC-Back inside cover, FGF-Front gate fold, FIC-Front inside cover April 2012 I Modern Pharmaceuticals

BIC

Our consistent advertisers

Modern Pharmaceuticals

RNI No: MAHENG / 2008 / 27125 Postal Regd No: G / NMD / 122 / 2011 - 13 Posted at P.C Stg. OfďŹ ce, GPO, Mumbai 400 001 On 19th & 20th Of Every Month Date Of Publication: 16th Of Every Month

April 2012