Modern Pharmaceuticals - May 2011 by Infomedia18

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Editorial

Innova ve regula ons for innova on

s it really a catch-22 situation when one tries to excel in innovation amid regulations? While one cannot overemphasize the criticality of innovation to sustain growth and expand application avenues, a robust regulatory framework ensures compliance as per prescribed norms. Some of the ground realities related to this came to the fore during the recently concluded Bangalore INDIA BIO 2011. Although it is obvious to have such operational challenges during the drug approval process, the worrying factor is the extent and impact it has on the efficacy as well as competitiveness of India’s biopharmaceutical pipeline in the global market. The intent is clear. India can and has the potential to play a major role in the global biotechnology space, especially when it is in this new emerging phase. However, as most in the industry feel, the existing regulatory environment has not been a great facilitator in this transition. Rather it seems to have slowed down the pace of drug development. Case in point is the incidence of destroying and remaking time-consuming products already manufactured. Apart from the extra money spent on remaking the product (which is already quite expensive), valuable

time is lost in re-manufacturing the product to have the mandatory clearance(s). Also, there are questions raised about the level-playing field for Indian companies vis-à-vis multinationals as far as a standard regulatory protocol is concerned. The bigger question that one needs to address, and sooner the better, is the way forward for this sector from the present predicament. To begin with, it calls for an incisive introspection and effective collaboration on the part of policy makers and the industry to put in place specific time-bound ways and means by which the operational excellence of the regulatory mechanism can be augmented significantly. If it needs an overhaul of the existing system, so be it! The urgency is very much apparent and India cannot afford to miss the emerging global opportunities in the biotech domain. Finally, the laws of the land should not only be supreme but also be subject to review from time to time.

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Editor: Manas R Bastia

May 2011 I Modern Pharmaceuticals

Contents REGUL A R SEC TIONS

FE AT URES 32

Editorial .........................................................11 National News...............................................14 World News...................................................22 Tech Updates.................................................28 Events Calendar.............................................71 Technology Transfer ......................................77 Book Shelf .....................................................81 Product Update ............................................82 Product Index ................................................86 Advertisers’ List.............................................87

LEADERS SPEAK 'In future, we would also focus on nutraceuticals that have an important role in treating diseases' ...says Dr Lukas Utiger, Executive Vice President and Head - Bioscience, Lonza, Maryland, US

IN DIALOGUE ‘The KPO boom is expected to overtake the BPO business, and as the KPO sector grows,over 300,000 new jobs will be created’ ...says Atulya Nath, CEO, Global Institute of Intellectual Property (GIIP)

ROUNDTABLE

Continuing medical education in pharma industry: A well-masked gift?

CAMPUS VOICE 'There is a strong need to develop industry-academia linkage' ...says Dr Saranjit Singh, Professor and Head, Department of Pharmaceutical Analysis and Dean, NIPER, SAS Nagar (Mohali)

FACILITY VISIT Elektrocraft (India) Pvt Ltd: Aiming for inorganic growth

INDUSTRY UPDATE Pharma machinery industry: Importing values, exporting volumes

INTERFACE 'We see a lot of opportunities in the biopharma space, among others’ ...says Rakesh Aggarwal, Director - Operations, Cole - Parmer, India

MARKET TRENDS Nutraceuticals market in India: Taking baby steps

VIEWPOINT Pharmaceutical risk assessments: Weighing the odds Adithya Bhat, MD,Protiviti Consulting Pvt Ltd

MARKETING The chemist’s counter: Dispensing the right dose? Dr Rajan T D, Pharma Consultant & Practising Dermatologist

CLINICAL RESEARCH Electronic data capture: Moving into a paperless world Dr Zubeen Dastur, Senior Manager - Clinical Data Management, SIRO Clinpharm

66 68

INDUSTRY INSIGHTS Global asthma market: Making waves on combination therapies

Highlights of Next Edition:

CASE STUDY

Industry Update R&D in pharma

Real-time analysis: Improving quality, reducing time in process development

REPORT

73 75

Bangalore INDIA BIO 2011 PharmaTech Expo 2011

Details on page no.

Market Trends Pharma SEZ

Note: ` stands for Indian rupee, $ stands for US dollar and £ stands for UK pound, unless mentioned otherwise Cover Photo: Mexy Xavier

Modern Pharmaceuticals I May 2011

National News Update Is India ready for so ware like Oracle’s Argus 7.0? The recent launch of version 7.0 of Argus Safety database application, by Oracle Software shows how Information Technology (IT) has become a crucial part of the healthcare system worldwide. This new updated version is a cloud-based product that allows healthcare firms to report and manage data from adverse drug events. This updated version will help healthcare companies keep a track of the adverse effects of drugs and will also help in efficiently running clinical trials. Oracle also has other software like Clinical, Remote Data Capture and Thesaurus Management System, but how many of them are being used in India? “In India use of specialised software like Argus is very rare. Unlike the US Food and Drug Association (FDA), in India too much emphasis or stress is not given to oragnised documentation of database. There are hardly any drug safety audits done in India and since no one asks for documentation of progress achieved at every level of a drug’s development, companies do not invest in specific software like Argus,” said Dr Arun Bhatt, President, ClinInvent Research Pvt Ltd. He continues, “We do use Oracle Clinical, but except that right now in India there are hardly any specialised softwares that are being widely used. And on top of that, the high cost of such software is another hindrance to its widespread use. All work done by Argus can easily be done in Microsoft Excel sheet and with very little stress given on organised documentation in India, Ms Excel can easily perform the task.” There are various data management software used by various companies and hospitals, but in specialised software progress is yet to be done. Few multinational companies such as Pfizer can use such specialised software but India is yet to fully utilise the power of such specialised software. And this will only be possible once the regulatory bodies set forward some hard and fast rules regarding drug safety and clinical trials, giving more emphaisis on documentation and organised database. -Titash Roy Chowdhury

Dr Reddy’s expands its R&D centre in Cambridge, UK Dr Reddy’s Laboratories has announced the opening of its newly expanded Chirotech Technology Centre at Cambridge Science Park, UK where Chirotech has been based for the last 20 years. Dr Anji Reddy, Chairman, and GV Prasad, Vice Chairman and CEO, Dr Reddy’s Laboratories, inaugurated the new site in the presence of Chief Guest Dr Hamied, Chairman of Cipla and Honorary Fellow of Christ’s College, Cambridge. Dr Reddy marked the occasion by planting a tree outside the facility. The new 33,000 sq ft facility built specifically for laboratories and offices and has been fitted to Dr Reddy’s specific requirements for chemistry, biology and analytics. The new facility is part of the Custom Pharmaceutical Services (CPS) business and will offer these expanded services worldwide. Prasad commented, “Being located in this historic city and in one of the leading European centres for Science and Innovation makes it the ideal location to expand and develop our research, development and technology capabilities. The facility will be a centre of excellence for chemistry and reinforces our commitment to building a leading edge research organisation to meet the innovation needs of our customers.”

India’s ﬁrst mixed stemcell transplant from CordLife CordLife India, Asia’s largest stemcell bank, saved the life of five-year old Moinam from Siliguri who was Moinam suffering from ebeta thalassemia since he was five months old. The bank had preserved the cord blood of Moinam’s sister and provided it to Moinam at the time of the transplant therapy. The stemcell transplant from cordblood and bone marrow gave him a new life and the transplant also became India’s first successful mixed stemcell transplant. Dr Ashish Mukherjee at the Netaji Subhash Cancer Research Institute carried out the stem cell transplantation and this is the first time that a mixed stem cell transplant has been performed in India. Dr Prosanto Chowdhury, Medical Director, CordLife India, said, “When stem cells are needed to treat a life-threatening disease, doctors can effectively predict transplant success by evaluating two factors - HLA compatibility and stem cell count. Transplants like these confirm CordLife’s technology and our assurance to parents who bank with us their baby’s cord blood.”

Gracure receives EU-GMP cer ﬁca on Following an audit conducted in February 2011, Gracure has received European Union-Good Manufacturing Practice (EU-GMP) certification for its manufacturing site in Bhiwadi, India, by Belgium’s Federal Agency for Medicines & Health Products (FAMHP). The site has been approved for manufacturing of non-sterile dosage forms, which includes capsules (hard shells), liquids, tablets, semi solid and other (dry syrup for reconstitution with water). The Belgium’s FAMHP certificate is accepted by all EU Health Authorities and by authorities of several other countries that recognise EU Certification. A S Bhargava, 14

CMD, Gracure Pharmaceuticals Ltd stated, “This achievement would help Gracure enter European countries with its products and gain confidence and recognition from existing and new clients. “EU GMP is an important milestone in scaling up for new ventures and it was a tremendous team effort of the entire Gracure team which resulted into this success,” he added. The long and rigorous preparation for EU-GMP, which had started in April 2009, finally paid off with receiving the certificate, which further confirmed Gracure and its team’s commitment for quality. Modern Pharmaceuticals I May 2011

National News PLSL demerges the NCE Research Unit into Piramal Healthcare Ltd Piramal Life Sciences Ltd (PLSL) and Piramal Healthcare Ltd (PHL) have announced that Boards of both the companies considered and approved the demerger scheme of arrangement between PLSL and PHL. Under the proposed demerger scheme, the New Chemical Entity (NCE) Research Unit of PLSL would be demerged into PHL with effect from April 1, 2011, which shall be the appointed date under the demerger scheme. The development projects from pipeline would need strong financial support going forward. The herbal products division that markets nutraceutical products to less regulated

markets globally will continue to be with PLSL. Through this demerger, PHL will have an access to an innovation platform of PLSL through which it can build its innovative discovery and commercialisation business. Subsequent to the progress that PLSL has made, the risk profile of NCE R&D activity has reduced considerably and hence presents a good investment opportunity to utilise some of the proceeds from the sale of domestic formulations business. PHL can also better utilise its manufacturing infrastructure and leverage its marketing experience with products from PLSL.

Lupin receives tenta ve FDA approval for me ormin hydrochloride extended-release tablets

Dabur acquires 30-Plus brand from Ajanta Pharma

Pharma major, Lupin Ltd has said that its US subsidiary, Lupin Pharmaceuticals, Inc (LPI) has received tentative approval for its metformin hydrochloride extended-release tablets, 500 mg and 1000 mg strengths from the US Food and Drug Administration (FDA). Lupin’s metformin Hydrochloride extended-release tablets are the AB-rated generic equivalent of Andrx Labs LLC’s Fortamet® 500 mg and 1000 mg tablets. Fortamet® is indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus. Annual sales for Fortamet® in the US was $83 million for the 12 months ending December 2010, as per IMS Health data. Lupin believes that it is the first applicant to file an Abbreviated New Drug Application (ANDA) for Fortamet® 500 mg and 1000 mg containing a Paragraph IV certification, under the provisions of the Hatch-Waxman Act. The product will be entitled to 180 days of marketing exclusivity. Speaking on the approval, Vinita Gupta, CEO, Lupin Pharmaceuticals, Inc. stated, “This product approval demonstrates our commitment to enhance our generic pipeline, leveraging our development and manufacturing strengths in extendedrelease dosage forms.”

Dabur India Ltd, India’s leading natural health care company, has entered into an agreement with Mumbai-based Ajanta Pharma Ltd to acquire their Over-The-Counter (OTC) energizer brand ‘30-Plus’, stated a press release. “We are very happy to announce the acquisition of ‘30-Plus’ brand. For every acquisition that we make, we look at synergies, which can complement Dabur’s existing portfolio. The acquisition of ‘30Plus’ is part of an aggressive strategy to build capability on the OTC healthcare business and I am confident that this transaction will help us in our endeavour to further strengthen our portfolio in this category,” said PD Narang, Group Director, Dabur India Ltd. 30-Plus, launched in 1990 as an herbal energizer capsule, is one of the oldest and strongest health care energiser brands in the country. It was a key brand for Ajanta Phramaceuticals and was endorsed by Bollywood veterans like Jeetendra. The capsule was positioned as an energizing capsule for thirty-plus males and was an instant hit among consumers in India. Dabur has identified healthcare as a key growth area for the future and is lining up a host of initiatives for this segment going ahead. Dabur is now focussed on quickly seizing attractive opportunities this transaction has created towards increasing its presence in the OTC healthcare market.

Cole-Parmer in an exclusive e-up with picoSpin™, LLC Cole-Parmer, a leading global source of laboratory and industrial fluid handling products, instrumentation, equipment and supplies has received the exclusive rights to sell the picoSpin™ Benchtop NMR Spectrometer, internationally. This product of picoSpin, LLC is an innovative and disruptive technology that combines low price and a compact footprint, with true spectroscopic capability. With this combination of sought-after features, research labs and educators now have affordable access to a dedicated NMR spectrometer. John Price, PhD, President and Chief Scientist of picoSpin, LLC, said, “You can now have an NMR system right at your lab bench. You can deploy multiple units within a factory to continuously monitor process fluids and control them all from a web browser anywhere in the world.” The new device is a complete liquid-phase proton NMR system, including permanent magnet, transmitter, receiver, data acquisition, programmable pulse sequencer, ethernet interface and intuitive web-based control software. As a breakthrough technology, it has already garnered the attention of the scientific community. 16

Modern Pharmaceuticals I May 2011

National News Himalaya’s ﬁrst herbal drug Liv.52 HB for Hepa s B The Himalaya Drug Company, one of India’s leading companies on herbal health has launched Liv.52 HB, the first herbal drug for the effective management of Hepatitis B Virus (HBV) infection. The drug is an US patent-pending phytopharmaceutical formulation that is recommended for the treatment of HBV infection. Liv.52 HB exerts antiviral activity and enhances the antioxidant defense system. L-R: Dr Pralhad Patki, Head Medical Sevices & “Available treatments, while Clinical Trials; Philipe Haydon; Ravi Prasad, Executive effective, come with serious Chairman, Himalaya Drug Company side-effects and are very costly. Clinical studies on Liv.52 HB have revealed that the efficacy rate is comparable to that of currentavailabletreatmentswithoutanyside-effects,evenafterlong-termadministration. Moreover, the entire cost of six-month treatment with Liv.52 HB comes to just ` 4,680,” said Philipe Haydon, CEO, Pharmaceutical Division, The Himalaya Drug Company.

Ranbaxy launches generic olanzapine tablets Ranbaxy recently announced the launch of olanzapine tablets, the generic version of Zyprexa following its patent expiry. It will be introducing olanzapine tablets 2.5 mg, 5 mg, 7.5 mg and 10 mg and also orodispersables in 5 mg and 10 mg. Zyprexa is the innovator product of Eli Lilly and has a market size of $210 million. Ranbaxy has received necessary regulatory approvals from the Spanish Health Authorities to manufacture and market olanzapine in Spain. Pere-Lluís Sala, Manager, Ranbaxy, Spain, said, “The generic alternative will bring about significant savings for patients and the Spanish Health System, which has been encouraging generic prescription.”

Cadila Healthcare records impressive ﬁnancial growth Cadila Healthcare, a `4450 crore plus pharma major from Ahmedabad, has recorded impressive financial performance during the year ended March 2011, on account of higher formulation export and domestic business, new products launch and strategic pact with Abbott Laboratories. The consolidated net

profit has taken a quantum jump of 40.8 per cent and touched to ` 711 crore from ` 505 crore in the previous year. Its consolidated net sales moved up by 24.9 per cent to ` 4,465 crore from ` 3,574 crore. Further, the board of directors has recommended higher equity dividend of 125 per cent (` 6.25 per share

of ` 5 each) for the year 2010-11 as compared to 100 per cent in the previous year. The earning per share worked out to ` 34.73 as against ` 24.67 in the last year. The company’s formulation exports was buoyed by 44 per cent growth in sales in the US market and 24 per cent growth in the emerging markets.

Biocon delivers strong mul -sector growth, to increase employee strength by 1000 Biocon has delivered strong multisector growth for the financial year 2011. Commenting on the results, Kiran Mazumdar-Shaw, Chairman and Managing Director, Biocon, stated, “Emerging markets have realised significant and sustained growth for our Active Pharmaceutical Ingredients (APIs), whilst our branded formulations have scripted business success in the Indian market place. Licensing income from Pfizer and others has contributed materially to profit generation this fiscal. Our research services businesses supported by Syngene and Clinigene have signaled a turn around. We are confident this will drive robust profitability next fiscal. 18

To support our expanding business operations, we expect to increase our employee strength by around 1000 in FY12. I am pleased to announce the payment of an interim dividend of ` 1.50 per share and recommend a final dividend of ` 3.00 per equity share as our on-going commitment to building incremental shareholder value.” The total annual income of Biocon group has increased by 17 per cent year-on-year (y-o-y), while the total income for the last quarter has gone up by 8 per cent, y-o-y. The biopharma business posted a 26 per cent y-o-y increase in revenues in the fourth quarter of this

fiscal on the back of strong growth in the sales of immunosuppressants, statins and the branded formulations segment. The branded formulations business posted a combined y-o-y growth of 36 per cent for FY11. “Biocon’s pipeline of innovative and biosimilar molecules as well as marketing partnerships will be the driving force to expand in India and other markets in 2011 and beyond,” said Rakesh Bamzai, President, Marketing, Biocon Ltd. Biocon also announced that it would divest its stake in its German subsidiary, AxiCorp GmbH, to the existing group of promoter shareholders. Modern Pharmaceuticals I May 2011

Advertorial

he Ministry of Health and Family Welfare (MoHFW) of India had set a deadline of 1st July 2010 for all pharma supplies procured by the MoHFW to comply with GS1 Standards for bar codes – this deadline was later extended to 1st July 2011. The MoHFW is responsible for the procurement of drugs, medical devices and other medical supplies for government run Healthcare providers and for various national health programmes, including universal immunisation, tuberculosis control, malaria control and AIDS control. Barcodes are required on primary, secondary and tertiary packaging as part of the anti-counterfeiting effort Primary packaging (eg: blister strips, vials and bottles) – 2D barcodes Secondary packaging – 2D or 1D barcodes Tertiary packaging (eg: shipper or carton) – 1D barcodes The barcodes need to encode a unique product identification code, batch number, expiry date and serial number. While the domestic drug industry has expressed that such a short time frame could wreak havoc with India’s 40,000 crore ($8.5bn) pharmaceutical export business, it is simultaneously working towards complying with these new serialization requirements, or looking for a standalone label inspection and data validation solution that is ready for future traceability initiatives with support for SG1 standards.

COGNEX MAKES IT POSSIBLE Cognex is the world leader of image-based ID readers and is the only company that can support all of your 1D barcode and 2D code reading requirements. The company’s DataMan® ID readers can read 1D code symbologies such as UPC, PDF and postal codes, 2D code symbologies such as Data Matrix and QR, or a mix of barcode and 2D codes simultaneously. The company is also the world’s leader in the machine vision industry, having shipped more than 500,000 machine vision systems, representing over $2.5 billion in cumulative revenue, since the company’s founding in 1981. Cognex’s In-Sight® Track & Trace™ provides the latest approach to traceability that is less expensive to install, less complex to validate, and less costly to maintain. And as it can be combined with a wide variety of third party products, manufacturers have the flexibility to customize and scale the serialization solutions to best suit needs – and budget. Cognex’s In-Sight® Track & Trace™ offering to the Pharma Industry enables manufacturers to: Read 1D and 2D barcodes, Validate encoded data is accurate and correctly formatted, Verify the accuracy of printed text and ensure it matches the contents of the code Check print quality and detect label misalignment.

to inspect the levels of liquid in vials of serum as well as inspecting for impurities at a speed of 10,000 bottles an hour.

10,000 bo les an hour Each blister pack contained 5 vials of serum. Two machines were equipped with 2 In-Sight cameras. The vials passed along a conveyor where they were inspected by the cameras. In-Sight uses PatMax™, the powerful Cognex vision tool for part finding and localization to locate the units of serum so each individual vial can be inspected for impurities. Any impurities detected result in the rejection of the pack. All inspected vials were sent for packaging. The vision solution was fully integrated into the company’s quality management system. The user friendly development environment in In-Sight Explorer proved beneficial, allowing a convenient user interface for programming vision tasks in addition to benefits such as Speed – 10,000 bottles inspected per hour Elimination of defects reliably at high speed No false rejects Ease of use After having worked with different vision suppliers, IPF chose Cognex vision systems for their robustness under industrial duress since the application demanded very high resolution vision in order to guarantee no impurities in the serum. When an impurity is as small as one square millimetre you need to know that the vision system you rely on can pick up traces this size. The speed of the 5603 and its ability to memorize inspections at the fastest line rates is remarkable and difficult to match. MPh

HOW COGNEX’S INSIGHT HELPED A DRUG MANUFACTURER TRACK IMPURITIES IPF Ingenieria a Barcelona based major manufacturer of special machines destined for high profile industrial customers needed a special machine capable of tackling the challenge of inspecting small vials of serum for its customer, Fresenius Kabi, a global leader in infusion therapy and clinical nutrition. IPF provided them with a machine equipped with In-Sight vision systems from Cognex as recommended and integrated by Cognex partner, Edge Vision. In this application, In-Sight cameras were installed May 2011 I Modern Pharmaceuticals

National News Piramal Healthcare’s cri care business grows by 31 per cent , OTC and opthalmology grow by 27 per cent Piramal Healthcare Ltd (PHL), hs recently announced the Quarter 4 (Q4) and year ending results for the Financial Year (FY) 2011. For the continuing businesses, total operating income for the quarter was up by 62 per cent to ` 689.1 crore. The total operating income includes ` 130 crore towards income from investments. Including this income, the operating profit for the quarter was at ` 263.1 crore against ` 58.5 crore for Q4 FY 2010. Net profit for the quarter was ` 201.8 crore and Earnings Per Share (EPS) was ` 9.0 per share. During the quarter the Piramal facilities at Ahemadabad, Ennore and Canada were audited by 14 out of the top 20 global innovator companies. Revenues from Piramal Critical Care business have grown by 31 per cent to ` 116.0 crore against ` 88.4 crore in Q4FY2010. Sevoflurane market share for PHL in US has increased from 14 per cent as on March 2010 to 20 per cent in March 2011. PHL will expand Sevoflurane sales to Europe with registration applied for in 26 European Union (EU) countries. Over-The-Counter (OTC) & Ophthalmology business recorded impressive growth of 27 per cent over Q4FY2010 to ` 67.6 crore. For the continuing businesses, total operating income for the year was up by 27 per cent to ` 2,009.2 crore. The total operating income includes ` 335.8 crore towards income from investments. Including this income, the operating profit for the year was at ` 379.0 crore against ` 139.2 crore for FY2010. Net profit for the year was `12,735.0 crore and EPS was ` 567.1 per share.

Aurobindo receives ﬁnal approval for venlafaxine extended-release capsules Aurobindo Pharma Ltd has received a tentative Abbreviated New Drug Application (ANDA) approval for Venlafaxine hydrochloride extended-release capsules 37.5 mg, 75 mg and 150 mg (ANDA No 200834) has received the final approval from the US Food & Drug Administration (USFDA). Venlafaxine hydrochloride extended-release capsules 37.5 mg, 75 mg and150 mg are the generic equivalent of Wyeth Pharmaceuticals Inc’s Effexor® XR capsules 37.5 mg, 75 mg and 150 mg. Venlafaxine hydrochloride extended-release capsules are indicated for the treatment of major depressive disorder (MDD) and falls under the neurological therapeutic category. The product has a market size of approximately $ 2.4 billion for the twelve months ending September 2010 according to IMS and will be launched after June 1, 2011. Aurobindo now has a total of 134 ANDA approvals (103 final approvals and 31 tentative approvals) from USFDA. 20

Modern Pharmaceuticals I May 2011

National News Suven Life Sciences bags Bio-Excellence Award Suven Life Sciences Ltd, a Hyderabad-based biopharmaceutical company, has been awarded the Bio-Excellence Award under Bioservices category at Bangalore India Bio 2011, a biotech event held from May 4-6, 2011 at Bengaluru. Instituted by the department of IT-BT & ST, government of Karnataka, the BioExcellence award recognises and honours biotech leaders for their outstanding achievements in the field of science and technology. The bio-pharmaceutical company that was initiated from 1989 is committed to discovery of New Chemical Entities (NCE) for central nervous system (CNS) disorders, provide niche scientific services through drug discovery research services and conduct research collaborative projects with major pharmaceutical companies. The company has been declared as a winner of Bio-Excellence Award under Bioservices category by the jury of Industry experts constituted by Association of Biotechnology Led Enterprises. The company is engaged in drug discovery and developmental activities for CNS disorders in India, the US, Europe, and rest of Asia.

Dr Reddy’s in talks to buy Doktor Mom Dr Reddy’s Labs (DRL), India’s second-largest pharmaceutical company has entered the race to acquire Doktor Mom, one of the largest selling Over-The-Counter (OTC) ranges of drugs in Russia & the Commonwealth of Independent States (CIS), along with Johnson & Johnson (J&J) who is also in talks to buy Doktor Mom, according to various sources. Doktor Mom, a range of cough and cold products, is owned by Mumbai-based JB Chemicals & Pharmaceuticals. With annual sales of ` 200 crore, it is the company’s largest OTC brand. The range is marketed in Russia and the CIS countries by Unique Pharmaceutical Laboratories, a JB Chemicals subsidiary. J& J and JB Chemicals were in talks for a while now, and DRL joined the race only recently. According to industry sources, the deal could be in the range of $250-300 million. Last year, DRL had entered into an agreement with Cipla for exclusive rights to market a portfolio of OTC and prescription products in Russia and Ukraine. It also signed a similar agreement with UK-based Vitabiotics Ltd for a range of nutraceutical products for Russia and some CIS countries. In 2009-10, DRL recorded sales of ` 910 crore in Russia & the CIS markets as against ` 762 crore in 2008-09. According to analysts, DRL’s sales in Russia will grow 21 per cent to ` 1,100 crore in 2010-11. The contribution from Russia & the CIS markets is expected to grow to 15 per cent. May 2011 I Modern Pharmaceuticals

World News New genera on of drugs for cancer treatment In a recent study conducted by investigators at Queen’s University and Almac Discovery Ltd reported that a recombinant protein and its peptide derivative that have been found to be potent inhibitors of blood vessel formation and form the potential for a new family of anticancer drugs. The investigators began by studying a recombinant form of the protein FKBPL (FK506 binding protein like). They found that this protein was a potent blocker of angiogenesis in multiple in vitro and in vivo model systems. Also, they were able to isolate and then synthesise a 24-amino acid peptide (AD-01) that was responsible for the anti-angiogenic activity.

Dr Tracy Robson, Professor – Pharmacy, Queen’s University, said, “By understanding the anti-angiogenic potential of the natural protein, FKBPL, we have been able to develop small peptide-based drugs that could be delivered to prevent tumour growth by cutting off their blood supply. This is highly effective in models of prostate and breast cancer. However, this also has the potential for the treatment of any solid tumour and we are excited about continuing to work with Almac Discovery as this drug enters clinical trials.” AD-101 is currently in the final stages of preclinical development.

New tools for studying epigene c processes will aid drug developers Development of tools to study epigenetic processes is a major project undertaken by PerkinElmer, Inc. Now, PerkinElmer’s epigenetic and post-translational screening tools cover nine different histone markers as well as the p53 tumour suppressor, with more than 15 validated enzyme assays to aid researchers developing novel drug compounds directed against several epigenetic enzymes, such as histone methyltransferases, demethylases, acetyltransferases and deacetylases. Dr Martina Bielefeld-Sévigny, Vice President and General Manager, Drug Discovery and Research Reagent Solutions Group, PerkinElmer, explained, “The development of novel therapies aimed at epigenetic drug targets has intensified over the last several years. PerkinElmer is excited to be in the forefront of this research by introducing a wide range of screening reagents that focus on assay selectivity, sensitivity and speed, factors which researchers indicate are critical requirements.”

Novozymes Biopharma collaborates with the University of Oslo Novozymes Biopharma, part of Novozymes A/S, has recently unveiled its enhanced nextgeneration albumin technology, which was developed in collaboration with the University of Oslo, Norway. Built on Novozymes’ original Albufuse platform, the proprietary Artist impression showing Albufuse Flex technology has been designed indicative albumin recycling to enable users to adapt and control the process pharmacokinetics of their target protein or peptide with retained efficacy, ensuring flexibility and optimal use. “Novozymes Biopharma is thrilled to introduce Albufuse Flex to the industry. Albumin is a natural and benign carrier molecule, and by having the unique ability to decrease or increase its half-life it will help our customers to develop novel drugs with improved pharmacokinetic properties for a wide range of applications,” said Dave Mead, Business Development Director, Novozymes Biopharma. Further, Prof Inger Sandlie, Group Leader, Norwegian Centre of Excellence for Immune Regulation, added, “The unique Albufuse Flex technology will result in enhanced treatment efficacy, more favourable dosing regimes and improved patient compliance.” 22

ERT announces appointment of New President and CEO ERT, a global technology-driven provider of clinical services and customisable medial devices to biopharmaceutical and healthcare organisations, recently announced that its Board of Directors has appointed Dr Jeffrey S Litwin as its new President & Chief Dr Jeffrey S Litwin Executive Officer (CEO) and a member of the board. Dr Joel Morganroth, who had served as interim President and CEO, commented, “After a thorough national search by Heidrick and Struggles, our Board selected Dr Litwin, an internal candidate, as the most qualified person to lead ERT. Dr Litwin brings to ERT knowledge of the clinical research domain, that is our core business, and also experience in the adjacent markets of phase IV safety surveillance and healthcare in which ERT’s assets will be employed. All of our employees look forward to continuing to work with Jeff to enhance ERT’s operational successes and strategy.” Dr Litwin joined ERT in 2000 as Senior Vice President and Chief Medical Officer and was subsequently promoted in December 2005 to Executive Vice President and Chief Medical Officer. Dr Litwin oversaw ERT’s global cardiac safety operations for seven years and was instrumental in implementing EXPERT, ERT’s digital operating system. During this time period, ERT experienced tremendous growth with revenues increasing more than three-fold. For the last four years, he has been responsible for leading ERT’s consulting business, assisting over 150 companies with the design and evaluation of cardiac safety testing programmes.

Modern Pharmaceuticals I May 2011

World News Thermo Fisher Scien ﬁc announces upgrade programme for NanoDrop instruments

New biosensor microchip for faster drug development

Thermo Fisher Scientific, Inc, has recently announced a new upgrade programme that includes the donation of reconditioned Thermo Scientific NanoDrop 1000 spectrophotometers to academic institutions in developing countries. Owners of a NanoDrop 1000 UV-Vis spectrophotometer can trade in their current instrument and receive a $1,500 credit with the NanoDrop 2000 and NanoDrop 2000c purchase of a NanoDrop 2000 or NanoDrop 2000c UV-Vis spectrophotometer. Thermo Fisher will refurbish all traded-in instruments and donate them to Seeding Labs, an organisation that places scientific instrumentation in the academic institutions of developing nations. Providing refurbished NanoDrop 1000 instruments through Seeding Labs supports scientific research in these countries and NanoDrop instruments are ideal candidates for this programme because they are easy to use and require no consumables. Hrissi Samartzidou, Senior Global Director, marketing UV-Vis, Thermo Fisher Scientific NanoDrop, said, “When a new instrument arrives at a laboratory, another may be put out of service. Together with Seeding Labs we can ensure that these instruments continue to serve science, supporting and expanding scientific research in institutions that otherwise could not afford this technology.”

Researchers have developed microchips stuffed with highly sensitive ‘nanosensors’ that analyse how proteins bind to one another. This is a vital step for assessing the effectiveness and possible side-effects of a potential medication. Moreover, these biosensor microchips could significantly speed up the process of drug development. “You can fit thousands, even tens of thousands, of different proteins of interest on the same chip and run the protein-binding experiments in one shot,” said Dr Shan Wang, Professor - Materials Science & Engineering, and Electrical Engineering, Stanford University, who led the research effort. This one centimetre sized array of the nanosensors can monitor simultaneously and continuously thousands of times more protein-binding events than any of the existing sensor. Furthermore, the new sensor is able to detect interactions with greater sensitivity and deliver the results significantly faster than the present gold standard method. The use of magnetic nanotags attached to the protein being studied greatly increases the sensitivity of the monitoring. Further, the analytic model that the researchers have developed enables them to predict accurately the final outcome of an interaction based on only a few minutes of monitoring data.

MRI-guided microcarriers for localised an -cancer therapy A remarkable new breakthrough in the field of nanomedicine was reported by Prof Sylvain Martel, Director - Nanorobotics Laboratory, Polytechnique Montréal (Canada). By utilising a Magnetic Resonance Imaging (MRI) system, his team effectively guided microcarriers loaded with a dose of anti-cancer drug through the bloodstream of a living rabbit, right up to a targeted area in the liver, where the drug was successfully administered. Further, Therapeutic Magnetic Microcarriers (TMMCs) were developed by Pierre Pouponneau, a PhD candidate under the joint direction of Prof Jean-Christophe Leroux and Prof Martel. These drug delivery agents that are made from biodegradable polymer and measure 50 µm in diameter, encapsulate a dose of a therapeutic agent as well as magnetic nanoparticles.

New inspec on process for leak tes ng of vials from Seidenader The particular attention paid to leak tightness of pharmaceutical containers has been increasing within the past months. Seidenader stays abreast of these changes with the development of a module for Head Space Analysis (HSA). Besides the penetration of oxygen and its possible reaction with the product, the loss of sterility of parenteral products is the most serious threat to the health of patients. Up to 600 vials per minute and 100 measurements per container are analysed using the Tunable Diode Laser Absorption Spectroscopy (TDLAS) technology. The vials pass the laser head in a precise handling system. The laser beam, tuned over a certain May 2011 I Modern Pharmaceuticals

Seidenader HSA

wavelength range, is sent through the headspace of the vial. A photo sensor receives the transmitted light and determines the absorption profile of the headspace gas. The analysis of this profile results in precise information. The obtained data are compared to threshold values to generate pass/fail decisions. The Seidenader HSA module can be integrated into Seidenader automatic inspection machines as a complementary check to camera inspection, as well as it may be integrated onto Seidenader’s IC platform as a stand-alone HSA inspection machine. 23

World News Payne Security launches newly designed website to showcase innova ve product range

Jevtana® (cabazitaxel) approved for second-line prostate cancer

Payne Security has launched its newly designed website to showcase their updated innovative product range and market information, improving ease of navigation for customers. This newly designed website reflects Payne Security’s continued commitment to investing Snapshot of new Payne Security website in facilities that ensure that the company remains at the forefront of technology and quality. The website now provides a new online customer experience and gives visitors a better understanding of Payne Security and its extended range of products designed to beat counterfeiters and prove personal identification. Comprehensive information is provided showcasing the three main business areas - brand protection, document security and card solutions. Richard Burhouse, Business Development Manager, Payne Security, commented, “The design of the contemporary, highly graphical website reflects Payne Security’s mission to not only develop innovative, high value-added products, but to deliver world class quality and service. The new website allows customers to access a comprehensive resource of products and relevant information. Payne Security is committed to keepings its customers ahead of industry challenges and developing tailored solutions to achieve continued commercial success.”

sanofi-aventis has announced that it has received marketing authorisation from the European Commission for Jevtana® (cabazitaxel) in combination with prednisone/ prednisolone for the treatment of patients with metastatic hormone-refractory prostate cancer (mHRPC) previously treated with a docetaxel-containing regimen. sanofi-aventis has also signed a new agreement with the World Health Organization (WHO) to donate $25 million to fight neglected tropical diseases, extending its decade-long partnership with the WHO for another five years. The agreement was signed by Christopher A Viehbacher, Chief Executive Officer, sanofiaventis, and Dr Margaret Chan, WHO Director-General, WHO headquarters, Geneva, Switzerland. Since the partnership in 2001, over 150,000 patients have been treated for sleeping sickness, a fatal disease if left untreated. The number of patients treated for sleeping sickness has dropped by over 60 per cent.

Sage-N Research releases new developer toolkit Sage-N Research, Inc, the world leader in computational proteomics has recently announced a new Application Programming Interface (API) toolkit for developers of proteomics data analysis software. The toolkit will enable software developers to add the power and sensitivity of SORCERER analyses to their existing software packages, expanding the utility of the SORCERER

platform for high-throughput proteomics laboratories. The new toolkit comprises a web service API based on XML data formats and accessible across a network. It also has a cross-platform client library to access the API on Windows, Linux and other operating systems. It also includes a Developer’s Toolkit with test beds, documentation and other resources

The toolkit has been designed and built in collaboration with Sage-N Research’s partners and is available immediately for application integration. Following the initial rollout to partners, it will be made available to other third party application developers by arrangement, and it will also be included in the SORCERER platform itself for customers to use in their own workflows.

Experimental drug inhibits ovarian cancer Investigators at the University of California, Los Angeles worked with the experimental drug NVP-BEZ235. This drug is an imidazoquinoline derivative and Phosphoinositide 3-Kinase (PI3K) inhibitor that inhibits PI3K and mammalian Target of Rapamycin (mTOR) kinase activity by binding to the ATP-binding cleft of these enzymes. PI3K and mTOR are members of a molecular signaling pathway, which once activated promotes ovarian cancer growth. Tumours 24

with this pathway are more aggressive and more likely to metastasize. The investigators described the drug’s effect on cell proliferation in 18 ovarian cancer cell lines, including four pairs of syngeneic cisplatin-sensitive and cisplatin-resistant cell lines. They also evaluated the in vivo effects of

NVP-BEZ235 on established tumour growth using an immunocompetent, transgenic murine ovarian cancer model. Results revealed that NVP-BEZ235 decreased cell proliferation in all ovarian cancer cell lines assayed and sensitised cisplatin-resistant cells to the cytotoxic effects of cisplatin. Oral administration of NVP-BEZ235 resulted in significantly longer survival of the mice with ovarian tumours compared to control animals that were not treated. Modern Pharmaceuticals I May 2011

World News Triad an sep c products under FDA scru ny US Marshals, at the request of the US Food and Drug Administration (FDA), recently seized more than $6 million in products distributed by Triad Group, Inc, at the company’s facility in Hartland, Wis. Triad Group and H & P Industries are owned and managed by the same parties. Several drug products were seized, which included povidone-iodine and benzalkonium chloride antiseptic products, cough and cold products, nasal sprays, suppositories, medicated wipes, antifungal creams, haemorrhoidal wipes, in-process drug products and raw materials.

The action was taken due to the continued failure of H & P Industries to comply with the FDA’s current Good Manufacturing Practice (cGMP) regulations, which are intended to assure the safety, quality and purity of manufactured drugs. Through this seizure, FDA seeks to prevent the company from distributing products that were manufactured in violation of federally mandated manufacturing requirements. Dara Corrigan, Associate Commissioner for Regulatory Affairs, FDA, said, “We took this action to stop Triad from continuing to distribute products, which may pose a risk to public health.”

Phase I enrolment begins for SelG1 in sickle cell disease Selexys Pharmaceuticals has initiated enrollment in a phase I clinical study of its lead compound, SelG1, a humanised anti-P-selectin antibody for sickle cell disease. This placebo-controlled, double-blind, first-in-human, ascending single dose and multiple dose study of SelG1 will enroll approximately 30 healthy subjects. This study will evaluate the safety and pharmacology of SelG1 prior to advancement into a phase II trial in patients with sickle cell disease.

Dr Scott Rollins, Selexys President and CEO, said, “This phase I study represents the first step in understanding the potential of SelG1 to address the unmet medical need in sickle cell disease and we are excited to initiate the clinical development of this novel compound. This phase I trial represents a key milestone for Selexys as we transition from a preclinical to a clinical development stage biopharmaceutical company.”

Collabora on on heterologous prime-boost therapeu c vaccina on against HPV Inovio Pharmaceuticals, Inc, has signed a collaboration agreement with Transgene S A and ChronTech Pharma AB to evaluate a novel therapeutic vaccination strategy against genotype 1 Hepatitis C Virus (HCV) in a phase I clinical study. In this collaboration, the strategy is to use different prime and boost vaccines with the goal of obtaining a clinical effect by inducing different immune responses. A phase I study, to be started later this year, will use ChronTech’s ChronVac-C® plasmid DNA vaccine delivered by in vivo electroporation using Inovio’s Medpulser® DDS as the prime and Transgene’s therapeutic vaccine TG4040, a Modified Vaccinia Ankara (MVA), as the boost. In the planned phase I clinical study, each company will contribute their respective products and equally share study-related costs. The study will enroll 12 treatment-naive patients with chronic hepatitis C at a site in Germany. Dr J Joseph Kim, President and CEO, Inovio, said, “We look forward to entering the clinic with this prime-boost approach that has demonstrated much promise in preclinical studies.” “The extensive preclinical studies that have been performed by the companies together with their unique clinical experience has paved the way for this very exciting clinical trial,” added Anders Vahlne, CEO, ChronTech.

In 2008, Selexys received orphandrug designation for SelG1 from the FDA Office of Orphan Products Development (OOPD) for the treatment of vasoocclusive crisis, a severe and painful complication of sickle cell disease. Orphan drug designation is awarded to therapeutics with the potential for safe and effective treatment diagnosis or prevention of rare diseases and disorders that affect fewer than 200,000 people.

New so ware for FT4 Powder Rheometer Freeman Technology has launched the FT4 Powder Rheometer, which is a new version of software for the company’s established universal powder tester. The new Powder Rheometer software introduces a completely redesigned graphical user interface providing a clearer look and improving the display of real-time test information. It has the flexibility to deliver systematic guidance to new users, while giving experienced operators the ability to develop and run bespoke methodologies. The new interface gives complete access to the full shear, dynamic and axial powder testing capabilities of the FT4, allowing users to build a comprehensive behavioural profile of a powder by drawing in results from each test methodologies. The FT4 Powder Rheometer is a universal powder tester that uses patented dynamic methodology, fully automated shear cells and several bulk property tests, including density, compressibility and permeability to quantify powder properties in terms of flow and process ability. Modern Pharmaceuticals I May 2011

Tech Updates

Nanowires for research studies New so ware for Exac ve benchtop LC-MS Nanoscale materials and technologies that are conventionally used for electronic devices have been combined with individual living cells by a team of Danish investigators. The researchers have shown that cells can grow and function on a carpet of small upright needles made of semiconductors, the so-called nanowires. Dr Karen Martinez, Group Leader, BioNano Group, Department - Neuroscience and Pharmacology, University of Copenhagen (Denmark), explained, “We have developed a new method that makes it possible for us to see how the cells function when they are impaled on carpets of nanowires. We think that the technique has great potential and that it could be used in laboratories within a couple of years to develop. For example, it could be used by the pharmaceutical industry to test new drugs for a variety of diseases including neurological problems, cancer and heart diseases.” Nanophysicists Jesper Nygård and Claus Sørensen are in charge of the development of nanowires with a diameter of approximately 100 nm, and Dr Martinez is responsible for the knowledge of the function and handling of cells. The project benefits considerably from the interdisciplinary background of Trine Berthing, a PhD student - Nanoscience, who has been working on this project since the beginning of her graduate studies in nanoscience in 2007.

Thermo Fisher Scientific, Inc, has recently announced new Thermo Scientific ExactFinder software for its Thermo Scientific Exactive benchtop Liquid Chromatography–Mass Spectrometry (LCMS) system powered by OrbitrapTM technology. This new software offers food and environmental Thermo Scientific safety, clinical research and forensic toxicology ExactFinder software laboratories a single streamlined data processing, review and reporting workflow for screening results with confidence and easy quantitation. When combined with the Thermo Scientific Exactive LC-MS, the ExactFinder software provides a single simplified workflow solution for routine screening and quantitation. Laboratories can process data for both targeted and unknown screening experiments without the need for multiple software packages. ExactFinder software also offers ease of integration into laboratory workflows, with minimal user training. Data processing and reporting are automated.

KKE 3800 S checkweigher: The most reliable weighing technology The integrated current The capsule checkweigher Good Manufacturing by Bosch, KKE 3800, sets the Practices (cGMP) standard in the field of 100 and ASB technology per cent capsule weighing. Its guarantees extremely precise gravimetric weighing high productivity and technology and ergonomic KKE 3800 S Checkdesign make them the ideal weigher the permanent positive choice for capsule check guidance of the capsules weighing needs. The ultra high-speed guarantees maximum pharmaceutical capacity of the KKE 3800 is ideally security. Other highlights include easy suited for application with more than accessibility, comprehensive production one capsule filler or for batch work. documentation and ease of cleaning. The checkweigher has an output of up It has comprehensive production documentation and is controlled to 230,000 capsules/hour. The Bosch KKE 3800 sets the standard by industrial PC and 21 Code of in the capsule weighing field with 100 Federal Regulations (CFR) Part per cent accuracy and high output. 11-compliant software.

Roche and NuGEN technologies develop whole transcriptome proﬁling solu on for 454 Sequencing Systems 454 Life Sciences, a Roche company, and NuGEN Technologies, have recently announced the development of a unique sample preparation method and highthroughput sequencing solution for small and degraded RNA samples. The collaboration leverages 454 Life Sciences’ capabilities to construct sequencing-ready cDNA libraries from RNA samples and NuGEN’s experience and innovation with genomic sample preparation solutions. This collaborative effort provides researchers an end-toend solution for transcriptome profiling using their most precious sample types. 28

“NuGEN’s innovative sample preparation solutions provide a unique and powerful tool that will enable researchers to obtain high-quality data from their less abundant samples. Together with 454 Sequencing Systems, the research community can perform whole transcriptome profiling on samples with as little as 500 pg of total RNA. Being able to collaborate with a leading NGS platform provider such as Roche, enables customers to leverage NuGEN’s linear amplification technology while obtaining long and highly accurate sequence reads,” said Elizabeth Hutt, CEO, NuGEN Technologies. Modern Pharmaceuticals I May 2011

Tech Updates

Chroma n analysis kit by Bio-Rad Bio-Rad Laboratories, Inc’s new EpiQ™ chromatin analysis kit is a real-time PCR assay for the rapid quantitative assessment of chromatin structure. Complementing existing epigenetic assays such as DNA methylation and chromatin immunoprecipitation, the EpiQ™ kit is the first commercial research tool that helps scientists quantify the impact of epigenetic events on gene expression regulation through chromatin state changes. The EpiQ™ kit can provide quantitative information about

EpiQ™ kit

chromatin accessibility, which correlates strongly with gene expression. The key benefits of the EpiQ™ chromatin analysis kit include assessment of chromatin structure in cultured cells within six hours, requirement of relatively few cells

Jet nebulisers versus controlled-dose nebulisers New study trials have shown that controlleddose nebulisers might reduce formulation costs and facilitate early-stage efficacy trials. Melbourn Scientific, a contract analysis and formulation company, has developed a rapid formulation screening service for poorly soluble drugs. It has been working with its clients to develop formulations that can be used in first-in-human trials. Controlled-dose nebulisers are more expensive than jet nebulisers and may require supervision of a clinician. However, they have the added advantage that the quantity of drug received by the patient can be accurately controlled and measured. Therefore, for small-scale trials they offer significant advantages. Nebulisers allow formulation in solution and so overcome some of the challenges of stabilising the drug. However, fragile Active Pharmaceutical Ingredients (APIs) can be denatured by conventional jet nebulisers. The drug is delivered as an aerosol created by a compressor blowing air through the solution or suspension at high speed. In contrast, a controlled-dose nebuliser uses vibrating mesh technology that is much gentler, and therefore less likely to damage the drug.

Comprehensive gene map for human brain The Allen Institute for Brain Science has recently released the world’s first anatomically and genomically comprehensive human brain map. The mappings are the foundation for the Allen Human Brain Atlas, which is an online public resource, developed to advance the Institute’s goal to accelerate understanding of how the human brain works and fuel new discovery among the global research community. While developing the Allen Human Brain Atlas, the Allen Institute characterised and mapped the biochemistry of two normal adult human brains. This has provided opportunities for scientists to study the brain with new detail and accuracy. The data reveals a remarkable 94 per cent similarity between human brains, establishing strong foundation for translational and clinical research. The data analysis from the two human brains also indicates that at least 82 per cent of all human genes are expressed in the brain. This highlights the great complexity of the human brain while also providing an essential genetic blueprint to understand brain functionality better and fuel research in neurologic disease and other brain disorders. May 2011 I Modern Pharmaceuticals

(as few as 50,000) to perform analysis and generation of quantitative chromatin structure information for multiple genomic elements. The chromatin state of a gene can be identified in situ based on its sensitivity to the action of the nuclease in the EpiQ™ kit. In heterochromatin, genomic DNA is inaccessible to nuclease digestion and remains available for subsequent qPCR. Analysis of heterochromatin using the EpiQ™ kit reveals a minimal quantification cycle (Cq) shift between digested and undigested samples.

New Biopharm system by Waters Waters Corporation has introduced its Waters® Biopharmaceutical System solution. The new biopharmaceutical system brings together UPLC®/MS characterisation technology with UNIFI™ Scientific Information System, an industry first comprehensive software solution that uniquely unites all aspects of biotherapeutic analyses and workflows for high-resolution analytics across the Waters® Biopharmdevelopment process aceutical System continuum. The combination of Ultra Performance Liquid Chromatography (UPLC®), mass spectrometry and bioinformatics technologies results in efficient flow of data and information. It also conforms to biopharmaceutical quality guidelines and regulations. Focussed on task-specific workflow design, the Biopharmaceutical System features automated data processing and simplified results validation. Leveraging UNIFI’s architecture, the intuitive user interface can be configured for the roles and capabilities of the scientists throughout an organisation. Critical to biopharmaceutical organisations is reliance on an analytical system that supports Good Manufacturing Practice (GMP) and compliance tools all with underlying secure database technology. 29

Tech Updates

Digoxin for prostate cancer

CRMS for eﬀec ve study reports

A paired laboratory and epidemiological study has identified the cardiac drug digoxin as the basis for a new chemotherapeutic approach for the treatment of prostate cancer. Investigators at Johns Hopkins University have screened 3,187 compounds that yielded digoxin as the most potent inhibitory agent. The investigators then evaluated epidemiological data from studies where incidence of prostate cancer was linked to digoxin use. This evaluation produced a cohort of about 47,000 men aged 40-75 who had participated in Harvard’s Health Professionals Follow-up Study (HPFS) from 1986 through 2006 and did not have a cancer diagnosis before 1986. Results revealed that regular digoxin users, especially users for at least 10 years, had a lower prostate cancer risk. Thus, digoxin was both highly potent in inhibiting prostate cancer cell growth in vitro, and its use was associated with a 25 per cent lower prostate cancer risk. Dr Elizabeth Platz, the first author and Professor - Epidemiology, Oncology and Urology, Johns Hopkins University, said, “We realised that combining our laboratory and epidemiologic approaches could reduce the possibility that results on the candidate drugs might be due to chance. Adding the epidemiology study to the drug screen step provided an assessment of the drug’s potential activity in people.” However, despite the promising findings presented in this study, digoxin was not shown to prevent prostate cancer, and the authors do not suggest the drug be used to prevent the disease.

A new Clinical Research Management System (CRMS) helps in improving the efficiency and efficacy of clinical research studies, enterprise-wide, by driving better management of treatment plans, processes and protocols while also supporting researchbilling compliance. Centricity Research, developed by GE Healthcare, is the industry’s first enterpriseclass CRMS. Centricity Research helps institutions conducting clinical or translational research manage the growing complexity of research processes and compliance requirements. Centricity Research has robust functionality, built on the foundation of the currently available Centricity Patient Protocol Management (CPPM) solution, to support both the institutions’ and researchers’ efforts in achieving compliance, enhancing safety, increasing subject recruitment and facilitating agency audits. Moreover, GE Healthcare has developed a strategic partnership with mdlogix (Medical Decision Logic, Inc), which developed its CRMS in collaboration with the Johns Hopkins University School of Medicine and other leading clinical research institutions.

Asep c set ups for CDMO

Therapure’s aseptic fill/finish & lyophilisation facility

A key aspect of pharmaceutical product manufacturing is the delivery of a sterile and potent product to the patient. A key aspect of pharmaceutical product manufacturing is the delivery of a sterile and potent product to the patient. Therapure, an integrated global Contract Development and Manufacturing Organization (CDMO)

offering a complete range of therapeutic protein development and manufacturing services, has validated aseptic fill/finish suites for cost-effective formulation, filling and finishing of both therapeutic proteins and small molecules into vials, preformed IV bags and prefilled syringes. Therapure also provides lyophilisation cycle development and optimisation services at both clinical and commercial scale. Following the fill/finish, Therapure provides final labelling and packaging capabilities. However, once the product is filled and finished, 100 per cent inspection is performed on the drug product containers prior to labelling, and then finish with packaging and cartooning.

Smart design eﬃcient biological safety cabinets by Thermo Scien ﬁc Thermo Scientific biological safety cabinets combine smart design and extraordinary value with best-inclass energy efficiency, reliability and usability. The advanced design of the MSC-Advantage biological safety cabinet improves overall operation and maintenance, maximises safety and optimises service and clean-up. Units feature 60 per cent less energy consumption and heat output. The MSC-Advantage fully complies with the EN 12469 safety standard as independently tested and certified by TUV Nord. It is available in 130 and 190 cm widths with microprocessor control. It has large front-panel display that provides constant readout of downflow 30

MSC-Advantage class II biological safety cabinets

and inflow velocities and filter usage status. The exclusive performance factor monitoring system advises when cabinet service is needed. The patented window opens to 20 cm working height, 53.5 cm maximum height and easily lowers for interior cleaning. It has an ergonomically angled window that is sloped at 10° for better comfort and reduced operator fatigue. Besides, it has unique airflow technology and intelligent motor design that improve energy efficiency, operation and serviceability, thus providing excellent sample protection. The divided stainless-steel work tray removes easily for cleaning or autoclaving. Modern Pharmaceuticals I May 2011

Leaders Speak

‘In future, we would also focus on nutraceu cals that have an important role in trea ng diseases’ …says Dr Lukas U ger, Execu ve Vice President and Head - Bioscience, Lonza, Maryland, US. Lonza is headquartered in Basel, Switzerland and is listed on the SIX Swiss Exchange. In 2010, the company had sales of CHF 2.680 billion. Speaking during the sidelines of recently concluded BIoAsia 2011, Hyderabad, Dr U ger shares his vision for Lonza in India. Arshia Khan & Dr Asma Mohd Yousuf Lonza is a global leader in the production and support of Active Pharmaceutical Ingredients (APIs) both chemically and biotechnologically. Biopharmaceuticals are one of the key growth drivers of the pharmaceutical and biotechnology industries. From 1897 to the present day, combining Swiss tradition with global experience, the company has had an enterprising character, adapting its offerings and services to the needs of customers and to changing technologies. We have maintained a strong culture of performance, results and dependability that is valued by all of our customers. And it is through reliability, quality and dependability that a brand stands out.

Growth drivers and business model Today it has become essential to find new form of cures for the existing chronic diseases. There is a need for biosimilars in the market. Also, there should be a strong focus on the development of small molecules, which includes chemical, pharmaceutical, protein, cells, antibodies, etc. Lonza has strong capabilities in large and small molecules, peptides, amino acids and niche bioproducts, which play an important role in the development of novel medicines and healthcare products. In addition, Lonza is a leader in cell-based research, endotoxin detection and cell therapy manufacturing. Furthermore, the company is a leading provider of value chemical and biotech ingredients to the nutrition, hygiene, preservation, agro and personal care markets. Moreover, Lonza is one of the world’s leading suppliers to the pharmaceutical, healthcare and life science industries. Products and services span its customers’ needs from research to final product manufacture. Our focus is to develop as well manufacture molecules. R&D is a very crucial element of our business model. 32

Modern Pharmaceuticals I May 2011

Leaders Speak India strategy India’s share in the global biotech market is about two per cent. However, India is not strong when it comes to patented drugs. There is hardly any discovery R&D being conducted on proteins, biosimilars and biotech products in India. Our investments are 300 million Swiss Francs per year in biopharma, and major part of the investment will be in Asia; last year investments were made in Singapore and China, and this year, we plan to focus our investments in India. We are setting up Lonza R&D and manufacturing facilities in the Genome Valley, Hyderabad. This knowledge centre set-up will have both the R&D and sales unit, which will help in larger operation. “In the phase I, Lonza is setting up state-of-the-art R&D centre to conduct research in cell biology, scaleup and process optimisation research in the area of regenerative medicines, new biocides formulations in hygiene and preservation, and advance protein sciences (APS) to come up with predictive models for immunogenicity in bio-pharmaceuticals including biosimilars,” says Dr Harry Rathore, Managing Director & Head, Lonza India Operations.

USP of Indian life sciences segment The Indian government has been very active. This was evident from the proactive administration of the Andhra Pradesh State Government that has enabled the establishment of Genome Valley, which is a knowledge gateway for biopharmaceutical companies. Also, the approval system in India is fast as compared to other countries. Besides, the infrastructural development in India is a plus point. With the large English speaking population and adequate availability of trained and efficient manpower and scientists, it is increasingly gaining importance for R&D. Hence, progress is expected at a faster pace in India. However, high tariffs on import of materials and taxes are some of the challenges that have to be smoothened. May 2011 I Modern Pharmaceuticals

Career graph at Lonza Dr Lukas Utiger holds a PhD in Chemical Engineering from Imperial College, London. He has also worked at ICI Chemicals & Polymers Division in Runcorn (1988-1992). He joined Lonza as Development Engineer in R&D engineer, Switzerland in 1992. In 1998, he worked as Group Leader - Process R&D, Fine Chemical Div, Switzerland From 2000 to 2001, he was the R&D Head Exclusive Synthesis (Chemical Custom Manufacturing), Switzerland From 2001 to 2006, he was Business Head – Exclusive Synthesis (Chemical Custom Manufacturing), Switzerland From 2006 to 2010, he was COO – Life Science Ingredients Business Sector, Switzerland From 2010 he is the Executive Vice President and Head - Lonza Biosciences, Maryland, USA Also, since 2001 he is a member of the Lonza Group Management Committee

Your success mantra Environment consciousness is very important. We know our responsibility in the area of safety, health and environmental protection towards our employees, human society, and we will continue to improve and optimise our performance. The safety and health of our employees, the well being of our stakeholders and minimisation of our impact on the natural environment remains a group priority. We focus on green building. At Lonza, we use incinerators that are highly efficient in waste management. Besides, we also take steps to reduce or reutilise energy consumption by utilising solar energy panels in our R&D site.

Ten years hence At Lonza, we make optimal use of and further develop high-tech biology and chemical technology platforms. In bioscience, currently our focus is on specific areas like developing therapies for cardiovascular diseases, central nervous system disorders, diabetes and obesity, as well as protein cancer treatment. However, in future, we would also focus on nutraceuticals that have an important role in treating diseases. Further, development and manufacture of nucleotides, drug conjugates and cell therapy will also be our areas of concentration. Our focus

at Lonza is serving customer’s R&D and manufacturing needs in clearly defined life science markets, and optimal utilisation and further development of our high-tech biology and chemical technology platforms. Our endevours are in creating a platform for longterm, sustainable, above average, profitable growth. Over the last two decades life sciences segment in India has witnessed an exciting growth in small molecule API and formulations for global markets. Many companies in India are expanding their expertise from vaccines to biosimilars (or interchangeable biologics), from insulin to insulin analogues. Large scale producton of these biologic drugs including regenerative medicines will bring unique challenges for Indian companies. Building talent pool and enacting regulatory pathways for these drugs may slow down availabilities of these therapies to Indian consumers. Global pharma majors will be keen to acquire Indian companies or form strategic alliance. All in all, future of the life science segment in India looks bright. MPh With inputs from Dr Harry Rathore, MD & Head - Lonza India Operations, Lonza India Pvt Ltd (arshia.khan@infomedia18.in, asma.yousuf@infomedia18.in)

In Dialogue

‘The KPO boom is expected to overtake the BPO business, and as the KPO sector grows, over 300,000 new jobs will be created’ …says Atulya Nath, CEO, Global Ins tute of Intellectual Property (GIIP). He discusses importance of patents and policy framework in the life sciences ver cal, which is favoured towards domes c companies. Arshia Khan What is the importance of Intellectual Property (IP) in pharma and healthcare?

industry, innovator companies are also gaining a solid footing and recent market analysis indicates that many such companies are investing more and more into their R&D divisions.

IP protection boosts innovation. It goes without saying that a strong enforceable IP regime fosters research and encourages inventors to produce technology, which is both beneficial to

What kinds of training services do you provide? Which are the other ins tutes that provide such trainings?

The number of patent ﬁlings in India is increasing every year and so is the number of patents being granted by the Indian Patent Oﬃce. This inevitably has led to a demand for skilled patent professionals having sound technical knowledge.

the society at large and has commercial value for the innovator. With the coming-in of the TRIPS compliant product patent regime in India, effective 2005, India has come a long way in the field of establishing a patent system, which can boast to be at par with the rest of the world. IP protection for the pharma and healthcare sector in India assumes a great significance, since apart from the considerable size of our generic 34

GIIP provides basic and advanced training services in the field of IP generation, protection, commercialisation and management. GIIP, a pioneer in IP education, has been involved in capacity building for IP & patent professionals since the past four years and has trained more than 200 professionals in the PG Diploma and certificate courses and over 2000 corporate employees.

GIIP offers diploma (full-time), certificate (full-time & part-time), executive and corporate (customised) programmes to hone skills of pharma, biotech, science, engineering, law graduates, post-graduates, PhDs in the field of Intellectual Property Rights (IPR) with focus on patents and patent process of US, European and Indian jurisdictions. Some of the other institutes that provide training in field of IPR are National Law School University Bengaluru, National Academy of Legal Studies and Research (NALSAR) University of Law, Hyderabad, Indira Gandhi National Open University (IGNOU) Delhi, Institute of Intellectual Property Research & Development (IIPRD) NCR, The Academy of Intellectual Property Studies (AIPS) Mumbai, Institute Of Intellectual Property Studies (IIPS) Mumbai, etc.

What is the need of the hour in the Indian IP scenario with regard to the life sciences ver cal? The life sciences vertical is predominantly revolving around the pharma and the biotech sectors, which are seeing a flurry of IP activity, especially with patent oppositions and litigations on the rise. An increase in patentrelated issues has thus created a great demand for skilled professionals having sound technical knowledge clubbed with patent skills. Trained personnel having key patent skills such as searching, drafting of patent specifications, filing, prosecution and Modern Pharmaceuticals I May 2011

In Dialogue other pre and post grant issues, are the need of the hour. The Indian Patent law being very complex, especially with respect to pharma and biotech, the industry is always on the lookout for professionally qualified and skilled people in this sector.

How are we placed in terms of IP services over other highly regulated Western countries? India became WTO/TRIPS compliant with the passing of the 2005 amendments in the Indian Patents Act. We are a global player in terms of providing IP services as is evident from more and more inbound offshore work to KPOs and LPOs. Broadly speaking, the Indian IP service segment is now fine-tuned with the requirements of the overseas clients and at least the key players do pay a lot of attention to the quality of work being generated for in-bound work thereby ensuring customer satisfaction.

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What are the issues faced by the Indian pharma industry with regard to patent protec on? According to Dr Deepa K Tiku, Program Director, GIIP, the Indian pharma

The Indian IP service segment is now ďŹ ne-tuned with the requirements of the overseas clients and at least the key players do pay a lot of a en on to the quality of work being generated for in-bound work thereby ensuring customer sa sfac on.

industry is presently embroiled in a lot of patent litigation issues that have arisen due to patents being granted (post 2005) on the innovator drugs for which they have traditionally been producing generic versions. The prohibition on

drug patents in the country till 2005 enabled India, a country with a relatively large domestic market, to develop a strong generic drug industry. From 2003 to 2008, in programs supported by donor organisations like the Global Fund, Indian generic drugs accounted for more than 80 per cent of the drugs used to treat AIDS, including 91 per cent of paediatric antiretroviral products, and 89 per cent of the adult nucleoside and non-nucleoside reverse transcriptase inhibitor markets [(J Int AIDS Soc., 2010; 13:35)] India is also the most important source of generic drugs for cancer, heart disease and other diseases. While India introduced drug patents in 2005, provisions such as Section 3(d) in the Law have meant that Novartis could not obtain patent protection of a new formulation of the cancer drug, Imatinib, and Abbott could not stop the manufacture of generic heat stabilised versions of the AIDS drugs, Ritonavir and Lopinavir. Taken together, the policies in place in India even today are favoured

In Dialogue towards the domestic pharma companies. However, since even Indian companies are turning innovative, it would be interesting to see the repercussions of these new provisions on such Indian companies.

Kindly provide us with an analysis on the demand for trained patent professionals, agents and IP li ga on a orneys in India. How has the same increased over the last decade and the reasons for the same? Today, we have approximately 5000 practicing patent professionals (patent agents, patent attorneys, patent engineers, patent analyst) in the country, which is expected to grow nearly four times to reach 20,000 by 2015. About 60 per cent of these professionals are working in the Knowledge Process Outsourcing (KPO) & Legal Process Outsourcing (LPO) segments and the rest are employed with MNCs, domestic companies and law firms. This number was less than 1200 patent professionals in 2005 out of which only 800-900 were in actual practice. India being a WTO/TRIPS signatory was under International obligation to comply with the standards set by the Treaty and in this direction, made substantive amendments to its Patent Law. Effective January 1, 2005, a transition from a process patent regime to a full-fledged product patent regime took place, which has significantly boosted innovation. With the opening up of trade in goods and services, IPR has become more susceptible to infringement without adequate return to the creator of knowledge. A quantum jump in R&D costs with an associated jump in investment is required for putting a new technology in the market place. Hence, the need to protect the knowledge from unlawful use has become expedient. Increase in patent-related off-shoring services to India. At present, India generates $ 100 million in revenue from patent services off-shoring industry, which is expected to reach $ 495 million by the end of 2015. 36

What is the demand for LPO and KPO services in India?

Tell us about the campus placements at GIIP.

The number of patent filings in India is increasing every year and so is the number of patents being granted by the Indian Patent Office. This inevitably has led to a demand for skilled patent professionals having sound technical knowledge. It is envisaged that KPO holds strong potential as it is not restricted only to Information Technology (IT) or Information Technology Enabled Services (ITES) sectors but also includes other sectors like LLPO, Legal research, IP-related services, business research and analytics, engineering R&D, finance and accountants management and consultancy, education, clinical research, market research (market research KPO), etc. The KPO boom is expected to overtake the BPO business, and as the KPO sector grows, over 300,000 new jobs will be created. Further, a report by Forrester Inc. estimates that an additional 35,000 new jobs will move to offshore locations by 2010, while a massive 79,000 more will shift to offshore locations by 2015. Again, nearly 70 per cent of those jobs will be shifted to India.

GIIP provides campus placements to all participants of its full-time programs. We have placed more than 200 program participants at organisations, such as, Honeywell, Infosys, GE, Symantec, HCL, TCS, Siemens, Evalueserve, Altacit Global, Lexadigm, CPA Global, Ripple IP Services, Inventurus, Ius-Juris, IPpro Inc., Panacea Biotech, Sanofi Aventis, Biocon, Ranbaxy Laboratories, Dabur, Jubilant, Amarchand & Mangaldas, Anand & Anand, K&S Partners, Remfry & Sagar.

Tell us about the accredita ons at GIIP. GIIP is a professional education institution established with the objective of developing employable global skills in the area of patents and IPR. GIIP trains both technical and legal professionals looking for a full-fledged career in this emerging area. GIIP programs have strong credibility in the industry and ex-GIIPians are working with MNCs, large organisations, KPOs and law firms across India. GIIP is an academic partner with IIT Delhi, National Law University Delhi, Ministry of Micro Small and Medium Enterprises (MSME), Council of Scientific and Industrial Research (CSIR), Centre for Development of Advance Computing (C-DAC), University of Washington USA, Dutch User Group (WON), The Netherlands, and has earned the reputation of being the leaders in field of IP education & training.

Till date, GIIP has trained more than 2500 professionals working in the ICT, automobile, pharmaceu cal, biotechnology, heavy engineering, KPO sectors. Can you give us a break up of professionals working in pharma, biotech and KPO segment? GIIP has trained graduate, post graduate, PhD students with pharma, biotech, engineering background and placed them in different industries in India and has also conducted corporate programs for professionals working in the ICT, automobile, pharmaceutical, biotechnology, heavy engineering, KPO sectors. Out of the total of 2500 trained so far, GIIP has trained more than 1200 people who at present are working in the phrama (175+), biotech (300+) and KPO (725+) sectors.

What are your plans with regard to expansions? Going forward, GIIPâ&#x20AC;&#x2122;s training division has the following expansion plans (12 â&#x20AC;&#x201C; 15 months) a) Set up new learning centres at Pune, Hyderabad, Baroda, etc. b) Launch distance learning and e-learning courses in area of patents & IPR c) Seek affiliations, tie-ups with US, UK universities and international training organisations d) Launch new IP programs for experienced & management level professionals MPh (arshia.khan@infomedia18.in)

Modern Pharmaceuticals I May 2011

Roundtable

Con nuing medical educa on in pharma industry

A well-masked gi ? In the world of mixed iden es and subsequent ambigui es, the essence of a noble concept like Con nuing Medical Educa on (CME) by pharma companies seems diluted. In doubt is the inten on ‘is it crystal clear’, ie, impar ng up-to-date medical educa on such that the professionals can keep themselves abreast with the growth in market, or ‘is it one of the innova ve and strategic tools for marke ng’? Experts share their views and opinions. Chandreyee Bhaumik

nowledge without justice ought to be called cunning rather than wisdom. -Pato When pharma companies are organising CME programmes, several in the industry are observing this action as a cunning move rather than one meant for mere knowledge-imparting purpose. By definition, CME refers to a specific form of Continuing Education (CE) that helps those in the medical field to maintain competence and learn about new & developing areas of their field. These activities may take place as live events, written publications, online programmes, audio, video or other electronic media. However, under the guise of CME, hefty gifts like laptops, overseas trips and many others are provided. Thus, the question that quite commonly surfaces is: Has CME become a charade? Is it another strategic tool of marketing? Thus, the once symbiotic relationship between the medical professionals and pharma companies appears to be dwindling. Photo by: Mexy Xavier

With growing demand for a more meaningful involvement of physicians to provide clinical support to patients, an imminent need is felt by the medical education providers for insights on drug information and current status of therapeutics available. Physicians usually incorporate a drug in their practice through the knowledge gained during conferences, seminars and the literature supplied by pharma companies. They seldom have time and inclination to assess the current published drug literature covering aspects like adverse drug reactions and interactions. Participation of pharma companies in medical education would focus on merits and limitations of multitude of products available in the market and thereby help in the evaluation, selection and utilisation of drug products. However, the recipient must decide on his own to promote rational drug use. Rapid advances in medical science increase pressures on 38

physicians to stay up-to-date in their field. Again, it must be remembered that cost of medical education is rising and funding sources are scarce and therefore in such a situation medical education providers are turning to pharma industry for assistance. A well-informed physician would ultimately benefit the patient through latest therapeutic advances. Patients with their life at stake, depose their trust and full faith in the practising physician. However, one can say that this ethical controversy comprising medical practice and pharma industry has been exaggerated. Hence, the information supported by the pharma industry has to be objective and rational. Dr Amrita Bajaj Professor of Pharmaceutics & Director-Centre for CURIE-DST, SNDT Women’s University Modern Pharmaceuticals I May 2011

Roundtable

The pharma industry and the medical professionals share a very healthy symbiotic relationship. Hence, it is not incorrect to say that the effort of the pharma industry to support educational conferences is indeed fruitful. Everything has its own pros and cons. The medical professionals need to have regular updates about the current state-of-the-art treatment protocols, which are discussed in annual monthly national or regional meets. Further, these meets are arranged with educational grants from pharma industry. Again, the industry in turn gets updated with the latest trends in practice along with the prescribing protocols so that in this way they are able to fine tune their marketing and sales techniques. Further, the trend of having ‘best of ’ the international conferences summarised can be of great input to doctors

who did not attend the meets and also the industry to look at the trends and possibility of utilising such protocols in the Indian scenario. Again, the practice of getting international speakers to share their respective experiences is beneficial to everyone. It can be said that all these are all possible with educational grants. However, misuse of this aspect with multiple meetings by different companies intending on promoting their products render no educational benefit at all.

When anyone is discussing this, one tends to blast pharma companies for their ‘unethical’ ways of coercion towards prescribing their products. One is usually found to term them as the plague that has turned the ‘noble’ medical profession into ‘business’. In India, there is no direct way of patient marketing except for Over-The-Counter (OTC) brands. Pharma companies have to reach out to their customers through the doctors. Thus, the companies would like to do all promotional activities. But why do they have to do that? There are several pharma companies with infinite products. Therefore, there is too much choice for the customer. Thus, in this scenario, strong promotional activity is required to maintain the sales of the company. Again, India never had a CME credit culture in the past, but this scenario has changed a lot. Medical Council of India (MCI) now requires mandatory CME credit points

for renewal of the medical licence. Further, MCI has also laid down guidelines as to which CME activity will be eligible for CME credits. Thus, more doctors now want to attend and conduct CMEs. Again, it can be said that CME is sometimes used as a marketing tool rather than an educational tool these days. Newcomers in practice prefer to be the speakers at CMEs so that they can get introduced to the doctors in the healthcare arena. Thus, there is definitely a need for self-discipline, self-regulations and governance. If the fraternity puts a united resolve to attend such activities in the absence of lavish venues/food/drinks, the actual pharma pressure on them would be released automatically.

Exposure to CME is almost mandatory for physicians. Further, research-based pharma companies in turn are involved both in sponsoring research as well as in providing a channel for spreading the available information. Thus, the relationship between the pharma industry and the practising physician though viewed with great scrutiny in recent times is in fact symbiotic. At sanofi-aventis, it is our constant endeavour to structure CMEs in conjunction with the needs of the physicians and offer unbiased information. Topics of interest are sought from physicians themselves. Again, post-CME, feedback is also collected from them. For instance, in the area of oncology through our ‘Pink Poll’ initiative, consensus on the best treatment of breast cancer patients among key opinion leaders is derived. Another example is ‘Prayas’, a programme that focusses on empowering doctors in rural India with the latest developments and updates in medicine. These workshops involve doctors sharing updated medical

information along with practical insights. Further, these two programmes do not have any product branding, be it in terms of their content (presentations) or at the locations (venues). However, when incorrect or skewed data is used, CME programmes’ credibility is affected. Companies and doctors must be mindful of local [Organisation of Pharmaceutical Producers of India (OPPI), Medical Council of India (MCI)] and international regulations [The International Federation of Pharmaceutical Manufacturers and Associations (IFPMA)] as well the company’s ethical guidelines while conducting such programmes.

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Dr Dhairyasheel N Savant Consultant Cancer, Reconstructive Surgeon, S L Raheja (a Fortis associate) Hospital

Dr Mandar Kubal Consultant Infectious Diseases and HIV Aids, Infectious Diseases and Pulmonary Care (IDPC)

Dr Muruga Vadivale Senior Director, Medical and Regulatory Affairs, sanofi- aventis Group- India 39

Roundtable

It is a matter of great concern that has attracted great attention recently from all walks of life. The pharma industry’s image is tarnished by supporting medical education due to its so called ‘inherent bias for physicians’ education. As a social cause, we would support the fact that as in case of other segments, healthcare segment is also to be updated as if the ‘health of the nation’. It is worthwhile to note that our physicians after getting through the prescribed course of their study, start their practice/profession and later ‘translating knowledge into practice’ & ‘keeping-upto-date on new requirements, treatments, and procedures’ in their field is very difficult to acquire. In such a situation, high quality medical education such as pharmacy, imparted by pharmaceutical industry bridges the gap by way of providing value support to the healthcare providers especially the physicians with current updates in their field. Again, one should appreciate the fact that it is obviously not harmful or unethical to provide funding support for CME, the pharma industry gets public recognition and advertising and in-turn benefits the healthcare providers and patients. Further, the pharmacists’ role in healthcare, especially in the emergence of new diseases, cannot be ruled out, where the physicians can diagnose the anatomy of the patient. However, the therapeutic areas and disease prevention is most important. In such a situation, the industry can shift its focus from brands to therapeutic areas and disease prevention; they could help healthcare providers better diagnose and treat patients from a holistic perspective. Here the notable advantage is that by providing medical education/CME, the industry can address issues such as

clinical practice guidelines and patient adherence and in-turn better health outcome from greater and more consistent product usage. The so called ‘benefit or undue influence’ is merely a matter of integrity of the persons involved in the process. In every field we can see corruption, which does not mean that all involved are corrupt. In public sector, we get quality services provided without any bias or getting undue influences. Ultimately, our motto should be to get the patients benefited when physicians are well-informed about latest therapeutic advances, by staying up-to-date on the advancements in their field. Wherever the new drugs are part of the general advance in therapeutics, patients will be best served when their physicians know as much as possible about these drugs as soon as possible. The ethical concern is that professionals ought to aspire to trustworthiness – to conduct themselves in such a manner that the public would feel that the high level of trust that they bestow on the professional is fully justified. Exactly how far physicians must go in putting all other interests in order to serve the patient might be debated. Thus, it is not wrong to have an expectation that the physicians of scientific attainment and good character should rise above the conflicts of ethical issues - and therefore serve the patients well. Thus, in a rapidly advancing field like medicine, ongoing continuing education is a professional necessity however definitely, with consistent professional integrity.

This is a raging topic for debate whether pharma industry financially supporting the medical education is beneficial or it is actually undue influence. In fact, this is also a topic of discussion in the US. Medical education in India is primarily trust based. However, unfortunately, even in this situation people are trying to take advantage and therefore sometimes manipulating several factors. Thus, the structure of the trust, how the fund in the trust is coming is a significant consideration. The Indian pharma market is primarily generics driven. And, it is only very recently that the market is going towards innovation. In this situation, sponsoring medical education is more of help. Thus, in this scenario, sponsoring medical education cannot have direct influence on prescription writing. In the US context, the scenario is different. In the US market, where there is a high presence of

innovation-oriented drugs, influence is possible to some extent. However, in India, where the medical education requires a lot of financial support, pharma companies extending help is beneficial rather than an influence. In this situation, one may say that in order to maintain transparency, the corporate positioning structure must be clearly defined like who are on the board, what is the source of the fund and many other such aspects. Therefore, from the fundamental level only, the MCI guidelines and many such regulations should have enough clarity. Thus, broadly speaking, pharma companies offering medical education do not have direct influence.

N R Munjal President, Indian Drug Manufacturers’ Association (IDMA), Vice Chairman & MD, Ind Swift Group, and Vice Chairman, Pharmaceuticals Export Promotion Council (Pharmexcil)

Vikram Gupta Founder and Managing Director, IvyCap Ventures Advisors Pvt Ltd Modern Pharmaceuticals I May 2011

Campus Voice

‘There is a strong need to develop industry-academia linkage’ …says Dr Saranjit Singh, Professor and Head, Department of Pharmaceu cal Analysis and Dean, NIPER, SAS Nagar (Mohali). He reviews the present pharma educa on system and stresses on the need for infrastructure and aid in government ins tutes. Chandreyee Bhaumik Your views on the Indian pharma industry. The world is gradually recognising the quality status of the Indian pharma industry. There is a strong future that lies ahead. The coming times will be tough for those who do not grow at the required pace and are unable to prove the quality of their manufacturing. It is important

gradually. However, in order to strengthen their foothold further, SMEs need to update themselves and be prepared for the challenges ahead. Certainly, it is going to be tough for them to do so. Internationally, the slogan being raised is: ‘one drug - one quality’. International agencies, including World Health Organization (WHO), are working on this principle and therefore the stringent requirements. This leaves no

Historically, pharma educa on in India has been driven by government ins tutes and departments, and there were very few private players.

for Indian companies to match the international standards. Also, the country needs to improve its regulatory system and raise the standard of academic training to support the industry.

option but to upgrade and meet the quality standards. For this, the SMEs need support from the government, which is reasonable.

How is the current scenario of pharma SME culture in India?

Historically, pharma education in India has been driven by government institutes and departments, and there were very few private players. The

The Small and the Medium Enterprises (SMEs) are gaining momentum May 2011 I Modern Pharmaceuticals

How well placed are we in terms of pharma education?

trend has reversed in the last decade with the mushrooming of private institutions. There are only few private institutions that have state-ofthe-art infrastructure and faculty in optimum number and quality. This is harming graduate pharmacy students, who are forced to accept low-paid jobs and are treated as cheap labour. Thus, there is urgent need to bring in semblance in the pharma education sector. NIPER, SAS Nagar is trying its best to live up to its commitment towards quality deliverance and training of post-graduate students.

How important is industryacademia interaction? There is a strong need to develop industry-academia linkage for the training and placement of students. This can be done through different modes. One is institution and faculty level interaction. For this, institution needs to create facilities and faculty has to acquire exclusive practical skills so that industry is attracted to get their specific problems solved. The other mode is setting up of public-private partnership institutions, a model that has been suggested for new NIPERs in the country. The third is setting up of institutions by industry itself, where the student has access to quality infrastructure and has good scope of job-oriented practical training. Already, a few successful examples exist of this and hence should be encouraged. MPh (chandreyee.bhaumik@infomedia18.in)

Facility Visit

Elektrocra (India) Pvt Ltd

Aiming for inorganic growth With an aim to carve a niche in the manufacturing segment, Elektrocra (India) Pvt Ltd is a dedicated performer in the line of products ranging from centrifuges to s rrers. It currently caters to biotechnology, pharma and several other sectors and is looking to further widen the exis ng expanse.

Chandreyee Bhaumik

stablished in 1977, Elektrocraft (India) Pvt Ltd is committed to manufacturing various types of centrifuges, laboratory stirrers as well as highspeed emulsifiers, magnetic stirrers and vortex mixers for research laboratories, hospitals, chemical & pharma industries, educational institutions, etc. Over the years, the facility has come to be identified with credible quality and reliability among industries. With time, the company has affirmed its position as the driving force behind some of India’s most significant scientific and industrial projects. Further, the primary activities of the company encompass 42

export and import of electric motors, speed reducers & laboratory equipment for biotechnology, pharma and food processing industry. Meeting the Bureau of Indian Standards (BIS) criteria, the motors manufactured here ensure that the customers get a wide range of state-of-the-art products.

A reﬂec on of the journey A centrifuge is a kind of equipment, generally driven by an electric motor that puts an object in rotation around a fixed axis applying a force perpendicular to the axis. The centrifuge functions using the sedimentation principle, where the centripetal acceleration causes more dense substances to separate out along

the radial direction (the bottom of the tube). Further, by the same method, lighter objects will tend to move to the top of the tube. Simple centrifuges are used in chemistry, biology and biochemistry for separating suspensions. These vary rapidly in capacity and speed. In 1977, Elektrocraft established itself as a small scale industrial unit at Goregaon for manufacturing of electric motors. In 1981, the company started manufacturing laboratory centrifuges. Later, in 1990, it expanded its products wing by introducing laboratory centrifuges with digital controls and manufacturing high-speed refrigerated centrifuges. In 1993, the company introduced high-volume refrigerated blood bank centrifuge. Elektrocraft gradually began expanding and, in 1997, started exporting its products to African and South Asian countries. In 2003, the company established itself as ‘Eltek International’, which is now known as ‘Eltek Overseas Pvt Ltd’. The company is involved in the export and import of laboratory instruments. This year, the company bagged another feather in its success cap. It implemented ISO 9001:2000 and was audited by AQSR, USA. In 2004, the company received CE marking for its laboratory products range. P Ramachandran, Chairman and Managing Director, airs, “We manufacture various types of electric motors, including AC and DC high-speed motors. We produce Modern Pharmaceuticals I May 2011

Facility Visit gear motors as well.” Commenting on the products line of the facility, Ramachandran adds, “We also manufacture laboratory equipment, namely, centrifuges meant for scientific and medical research, especially laboratory mixers.”

Spreading wings... Two manufacturing units of Elektrocraft are located in Vasai near Mumbai. One unit undertakes motor and equipment manufacturing, while the other manufactures motors only. Ramachandran avers, “Initially, all the work was carried at the Goregaon facility, but it has now been shifted to Vasai. We are planning for further expansion to increase productivity and also include more research equipment for start developmental activities in the next financial year.” For any venture to assume an important dimension, a definite and significant investment is an essential requirement. Elaborating on the investment pattern, Ramachandran explains, “Currently, the turnover is about ` 7 crore, which includes both facilities at Vasai. And in the next two years we plan to reach ` 15 crore.”

Success mantra: Innovate to grow For any entity to flourish and spread its wings with vibrancy, continuous innovations are not only needed but are also essential. Thus, Ramachandran believes that reaching the success peak requires adding more products to the existing range. Explaining the required and ongoing innovations, Ramachandran comments, “We hope that soon microprocessors would be controlling all research equipment. Thus, the company will also utilise computerised operations in most of its equipment.” In few words, as far as the technological advancement and changes are concerned, the company believes in involving improved version of technology for the latest product. Adding to May 2011 I Modern Pharmaceuticals

e next ﬁve years, we plan to achieve a turnover of pproximately ` 50 crore. All these years the graph has reﬂected rela vely slower growth, but we are now aiming and hoping to reach even higher. P Ramachandran Chairman and Managing Director

this, Ramachandran avers, “With superior and better quality products, we can increase our exporting services and improve the Return on Investment (ROI), leading to inflated revenue. Tie-ups are a common but strong way for expansion. Commenting on the tie-up strategy, Ramachandran clarifies, “Although there is no formal talk on mergers with partners, we plan to tie up with laboratory equipment manufacturers as well.”

signs off saying, “In the next five years, we plan to achieve a turnover of approximately ` 50 crore.” In this concern, he adds, “Candidly speaking, ` 50 crore is inflated, but we have to focus and be determined to reach there. All these years, the graph has reflected relatively slower growth, but we are now aiming and hoping to reach even higher.” MPh (chandreyee.bhaumik@infomedia18.in)

Dawn over dusk Every company faces challenges, but countering the hurdle and metamorphosing it into strength is what sets one company apart from others. In short, this is the USP. In this regard, Ramachandran reiterates, “Inevitably, competition arises, but we can create more innovative products by taking advantage of this. We are currently contemplating on this line only.” Thus, with a vision of improving the existing product array, the company aims to achieve a wider market horizon. Commenting on the strategy of extensive growth potential, Ramachandran explains, “We not only need innovative products but also aggressive marketing. Thus, our focus is on both areas.” Explaining this, Ramachandran A showcase off products at Elek 4 43

Industry Update

Pharma machinery industry

Impor ng values, expor ng volumes When one tries to put the success story of the Indian pharma machinery industry in words, it can be observed that the establishment was a blessing in disguise, and the sector has cleared the troubles that were laid in the way. Today, the small and large manufacturers are successfully running this industry. The tables have turned with regard to import and the industry stands at the verge of huge achievements. Yet, there are bi er pills to digest when it comes to further growth.

Parita Dholakia

t is rightly said that necessity is the mother of invention, and thinking on these lines it is no surprise that the Indian pharma machinery industry is performing well. Currently valued at $8 billion, it has trudged a tough road of success, and is standing at the verge of a plethora of opportunities. At present, there are 20,000 pharma companies in India with more than 700 small and large pharmaceutical machinery manufacturing companies. With 44

this significant number of industries manufacturing machines locally, they can cater to almost 95 per cent of the pharma industryâ&#x20AC;&#x2122;s equipment needs. This industry provides the pharma companies a basic advantage of using machinery made in the domestic market in lieu of foreign machines, which are five times more expensive. Because Indian pharmaceutical machinery are inexpensive and provide quality products, they are in demand locally as well as globally. There is no denying that the industry has seen good growth, but is this only

The xxxx and balance sheets? Are there on paper some sweet bitter pills manufactured by the industry internally that are eventually making further growth difficult? Industry is high on the growth radar, and they need to clear hurdles that may come in the form of people, government or funds.

Then and now In the 1970s, dearth of foreign funds prompted the government to introduce some high import duties and various import licensing policies, which in turn led the Indian pharma Modern Pharmaceuticals I May 2011

Industry Update companies to search for local meets. This was the beginning of the surge of the plethora of industries present today. The pharma industry that was heavily dependent on exports in the 60s, became an independent player and how. As Ajay Mehra, Director, ACE Technologies & Packaging Systems Pvt Ltd, mentions, “The Indian pharma machinery industry has come of age and is moving at a very rapid pace to cover in a short span what others have done in the past decades by all kinds of inputs, especially organic and inorganic. There was a time when no one ever considered the Indian manufacturers to be world class, but now Indian companies are giving international companies a run for their money as technological advances are being embraced by Indian manufacturers at a faster pace to keep up with the maxim survival of the fittest.” The industry today is definitely on the correct path; however, there may be some invisible factors that are acting as a hindrance for further growth to permeate through. The industry is able to fulfill a huge range of demand for equipment, and with a positive attitude more favourable results are expected. Avers Mehra, “With more and more pharma companies now realising the benefits of sophisticated technology available worldwide, many are embracing the global technology, while many are still using the traditional equipment that are available in India.”

Turning tables There may be a number of reasons why we started manufacturing these machines locally, and how the imposing rules from the government at one stage has acted as a blessing in disguise. It is indeed a marvelous achievement to state that the industry, which a few decades ago was dependent on imports, is making almost 30 to 40 per cent revenue through exports. Today, the industry has kept itself almost free of imports. Says May 2011 I Modern Pharmaceuticals

The Indian manufacturers need to understand that pharma machine manufacturing is not just fabrica on of steel but is knowledge-based manufacturing, which provides solu ons rather than just equipment. Ajay Mehra Director, ACE Technologies & Packaging Systems Pvt Ltd

Pramod Panchal, Director - Sales and Marketing, JK Industries, “We may need to import technology. European Union (EU)-based technology is in demand, but as far as machinery are concerned, we are self-sufficient.” It is good to note that the Indian industry has become similar to the solutions provided by countries like Germany or Italy wherein the entire range of plant, machinery, HVAC and clean room installations, are manufactured. However, as Mehra notes, “Equipment that have to be imported till date includes the scientific and analytical equipment. We can overcome this shortcoming

The industry, which a few decades ago was dependent on imports, is making almost 30 to 40 per cent revenue through exports.

by being open to ideas and being creative and to take calculated risks in inventing equipment that can do the same. There is nothing that cannot be done locally and is seen from the recent advances that our machine industry has taken.”

Going global Price factor: This definitely acts as a major marketing tool for Indian products. In the commonest of the sense, if one is getting the same product with the same

output, one would definitely wish to reduce their cost and opt for such machines. Indian machines are hence being exported globally, and several companies’ revenue is thriving on their exports. Informs Mehra, “Recently, all the stalwarts of the industry are relooking at their infrastructures and gearing up to meet the international standards. This has also been possible due to the acceptance of the Indian machinery worldwide as cheaper alternatives to their international counterparts.” At the same time, the cost-conscious customer may get allured by machinery not focussing entirely on quality. Customer needs to be alert while making choice, and cannot totally depend on less input. Updated technology: If one manufacturer can buy a machine having all the latest trends and tricks, locally, why would he turn to imports? It is good to see that the industry has in the past few years tried to match with the latest technical developments globally. As Yogesh Babbar, General Manager, SS Packaging Industries, says, “Our company is self-sufficient when it comes to procuring or learning new technology. We observe a lot of European technology that is new in the market, and that can be and is brought to the country.” Informs Panchal, “The industry can manage technology improvisation on its own. We are coming up with new technology regularly. We are parallel to the new technology and all new machines or technology can be manufactured and learnt by us on our own and we might not 45

Industry Update

It is sad to see that in an important sector like pharma, people are compromising on quality of machines for cost. It will be good if people realise the importance of quality over cost and opt for the right choice. Pramod Panchal Director - Sales and Marke ng, JK Industries

need external support to do this.” The industry is indeed trying hard to renew or refresh their thought process, and is accepting and embracing change. Compliance to standards: The surge in demand for ‘Made in India’ machinery overseas is undeniable. As Mehra informs, “Indian manufacturers are open to changes and are fast learning the trends of CFR 21, GAMP V, Process Analytical Technology (PAT), etc and are incorporating the changes needed to comply with the latest guidelines also.” This definitely leads to an increase in demand for machines. The lead customers for these machines have been from US, Bangladesh and China. Says Panchal, “The Middle East, especially Iran, holds tremendous potential. However, there are some strict RBI norms. If RBI would be ready to sanction these duties, it will be a huge step forward for us.”

G for growth. G for government It is good to see that most of the industries are finding a helping hand from the government, which is essential for growth. The Government is viewed on the positive side by

most industrial experts. With exports forming a major part of their profits, import and export duties seem satisfactory to them. Panchal says, “The government has been helpful to the industry. They do give a helping hand whenever required.” However, a few experts still believe that governments support is not to the fullest. Quips Aasif Khan, Managing Director, Fabtech Technologies International Pvt Ltd, “Government can definitely help by increasing the allocation of funds to the industry. Most of the developments seen in the industry are due to the companies doing well on their own and due to the products that they manufacture. They still have to face hindrances in the form of laws and norms. The government can consider easing norms, reducing export taxes, allocating more funds for R&D specific to this sector.” Experts also believe that the support exists, however, trying to achieve the same gets difficult due to the complexity of the process. Adds Mehra, “The government should encourage new ideas and support the industry with infrastructure and incentives to get brilliant ideas. There are policies for the small and medium scale companies to help them move ahead in the growth path, but then the

How is the government helping? Helping in development of Special Economic Zones (SEZs) Growth of certain region-specific pharma industries Fostering growth by not raising the export/import duties substantially Good support ensures that the industry does not have to turn to private institutions or banks for finance help With the status that the government has provided the industry, it will be easy to go into tie ups and mergers and acquisitions 46

procedures are so tedious that a normal man almost gives up midway to utilise those resources. The government framework is very complex and the rules are such that it offers an umbrella to people who do not need one.” Getting funds has become easy for certain players due to their strong balance sheets. As Panchal says, “With the growth that the industry has achieved over the years, it is easy for us to get support from local banks or institutions.” Companies not requiring financial support also exist, as Babbar informs, “Our company is self-sufficient when it comes to procuring or learning new technology, and we do not need much financial help.” But then, several of these companies are in the process of manufacturing the same type of equipment year over year and are happy with their growth. Do they lack the innovation quotient? Talking about the need to be innovative and the flow of bright ideas, it is important to note the down side involved for new firms or start-ups. Mehra gives an interesting view about this. He adds, “The ability of receiving funds is like the chicken and hen story. A good idea needs to be recognised but to play safe institutions look for established players to fund, hence many a times good ideas are lost in infancy stage itself. The process of receiving funds a long drawn process which sometimes outlives the need itself.” Small companies might have some brilliant ideas of innovation, but lack of funds might be a huge hindrance for them even today. Avers Khan, “New R&D ideas, novel plans to manufacture new machines should be encouraged to increase the innovation quotient of this industry. Only with support from a higher body like the government can ideas turn into reality. With the recent growth in this industry it is easier than before to obtain funds, but for setting up a new industry financial institutions and banks are still skeptical and one Modern Pharmaceuticals I May 2011

Industry Update needs to provide them bright, new, trustworthy ideas.” Most serious players in the industry looking to increase their turnover are hoping that the government will take a look at the good figures that the industry is showing on paper, and come forward to help. So, what more can the government do? Says Mehra, “If they can offer incentives to machine manufacturers who invest in development of machines, which distinctly bring about a significant differentiation in the manufacturing process in the pharma industry, thereby boosting the keenness to be innovative and progressive. Something similar to what they offer to R&D’s in the pharma companies.” In the same vein, Khan says, “It is easy for a company in the pharma industry to get a turnover of more than ` 160 crore, but if you consider a company in the pharma machinery industry, they are generally happy with the low turnovers of ` 100 crore or so. They need to understand that they can achieve better growth year after year, provided they can receive good support from the government.” He further adds an ironic twist to the story, “The government spends close to $3.7 billion as aid to develop the world, but a meagre amount of $100 million can suffice for substantive growth of this industry, and we still lack to get the same.”

Growth limiting factors It is a universally acknowledged fact that the industry is doing well. And industry pundits predict sunny days in the near future. However, certain factors are acting as a hindrance, which may turn into potential selling points if acted upon or looked into. So does the industry have any internal problems? Profit-driven manufacturers may look into ways of cutting cost and increasing their margins, but one should not compromise on quality. Says Panchal, “It is sad to see that in an important sector like pharma, people are compromising on quality May 2011 I Modern Pharmaceuticals

of machines for cost. It will be good if people realise the importance of quality over cost and opt for the right choice.” Further, when such machines are exported, it will not present a good picture of the ‘Made in India’ tag on the global front. Babbar presents an almost apologetic view when it comes to this. He mentions that the view point of the industry in general needs a drastic change. And he believes that it is not only the manufacturers to be blamed, it is also the customers. “In our country, companies refrain from going in for new technology. From the machinery point of view, they are not exactly keeping pace with the evolving market. There are several machines available which are US Food and Drug Administration (FDA) compliant, but the industry does not go forward with using them.” Informs an industry insider, “Recently, after developing a new production plant, an MNC refrained using new technology and opted for old technology for its packaging requirements.” Such cases highlight the fact that an increase in the final profit by providing minium inputs is forcing the industry to maintain such options. The industry should definitely think about it and try to opt for new technology. Adding to this, Babbar mentions the need to have better demands from the pharma industry. It is like revising the demand-supply

rule. He avers, “Machines which are high in demand globally are sometimes not in demand in our country. This makes it difficult for some manufacturers when they have to manufacture a new machine with no local distribution. The industry should keep pace with the world.” For that matter, acceptance of new technology also reflects the good frame of mind of the costumer. As Mehra says, “The level of inputs that one provides for the manufacturing of the equipment being offered is also important. Highly sophisticated workshops are fast replacing the age old technologies which reflect the changing mind set of manufacturers.” He further adds, “Inspite of the fact that we have come of age to a large extent we still have to cover the last few miles, which are the most tedious ones. We are still followers and not inventors of technology in many fronts, eg, inspection of products. In India, we always relied and still rely on manpower to do this critical exercise of inspection. No doubt that human eye cannot be replaced for inspection but then the consistency and stability that can be achieved by machines cannot be discounted. Hence, the world realised that way ahead and developed inspection machines that are still being sought after.” Several foreign players are playing shop in India, and giving our manufacturers a tough competition.

Factors that the industry can focus on Creating an in-house knowledge base of the fundamentals of pharmacy applications and its implications on machine manufacturing rather than simple fabrication of equipment Making quality an inherent aspect of all facets of design & implementation and not mere incidental Genuine investment in development of technologies with an open mind People should realise the importance of quality over cost and opt for the right choice Keep pace with new technology and not sustain on old, reliable, methods/ equipment Stop copying, start innovating – be original

Industry Update

Consider mergers! Imagine the growth when two or three 20 – 30 crore companies can achieve by merging together. Aasif Khan Managing Director, Fabtech Technologies Interna onal Pvt Ltd

Informs Khan, “We are still importing several machines, particularly from Europe. There is a high quality conscious part in the industry that still insists on quality over cost. Such players are buying European machines. However, with recent advances in the Indian machines, and cost advantages, even our locally manufactured machines are in demand. One other threat comes from the Chinese market. Due to low labour costs, these machines are cheaper than the Indian counterparts. Thus, cost-conscious people in the industry are still vying for these machines giving some competition to our industry.” The solution lies in gearing up to face such competition. Industry experts strongly believe that the mindset of the present manufacturers need to change for further growth. They cannot be complacent at this stage. What they have acheived over the past few years might be good, but they need to set their vision to be the best. As Mehra says, “The Indian manufacturers need to understand that pharma machine manufacturing is not just fabrication of steel but is knowledge-based manufacturing, which provides solutions rather than just equipment. Our manufacturers will have to develop their knowledge base to support the machines such that the customer gets the feeling that he is supported by a strong company rather than a mere fabricator.” A similar view is echoed by Khan, as he says, “The Indian machinery industry lacks innovation and R&D in the true sense. One can consider the causing factors as lethargic people and costconscious costumer.” He continues 48

on the same note and explains why lethargic. “Once a company has started manufacturing a particular type of machine and is doing well, it typically does not consider innovation or trying manufacturing better machines. After achieving a certain growth, higher capacity machines are not manufactured easily. This results in production of a typical set of machines being produced over a period of time, because some become experts in doing the same over and over again. Next, what it does is, export this machines abroad. It is similar to some good learning institutions that we have in India, wherein they educate and groom the student, and make them valuable enough for the international market. Post studies, the path they take is only international.” Indeed, the observation is on a sad note and needs a thorough retrospection.

What next? Today, the Indian market is equipped with latest technology, enabling availability of a slew of highquality pharmaceutical machinery and equipment, useful right from production to packaging. After some successful decades, the industry should set its vision on further growth. The advantage that they have in terms of price, should be backed by offering more reliability, safety, user friendliness, robotics and containment, noise abatement, documentation, improved external design and validation. Says Panchal, “A good future reckons this industry. People are doing good business and there is an increasing awareness

about quality, which will definitely help the industry.” When this bright industry is surrounded by limiting factors existing so within themselves, what kinds of solutions does one see? Mergers and acquisitions? Says Khan, “Consider mergers! Imagine the growth when two or three 20–30 crore companies can achieve by merging together. At that time, they can think about larger acquisitions, and with the availability of larger funds even innovations and technology development would become easy.” He continues, “We desperately need some sort of approval with this industry, similar in lines to those of ‘ISO’ or ‘GMP’ guidelines, wherein one can be rest assured of the quality. Major part of the industry at the moment is not quality conscious, and this view needs to be changed for achieving better standards. We need laws or policies that encourage regular quality checks. This would make the process smoother and guarantee a good, satisfactory result. Mehra concludes on a bright note. He says, “With the ever-growing pharma industry and India being considered as the next formulations hub of the world, this industry is definitely going to be a force to reckon with.” He also adds the last bit of wisdom when he questions, “If one does not sow the right seed now then how do they expect to reap the fruits in the future?” Time will tell whether the industry has sustained the growth that it managed in this decade. But it is good to see the high hope and expectations that the industry holds. The way the tables have turned over the past years, it will be worth observing the growth of the backbone of the pharma industry. And as we observe, the key to achieving more growth and profit lies in the hands of the industry, who should be supported with better R&D investments, quality and effective management skills. MPh (parita.dholakia@infomedia18.in)

Modern Pharmaceuticals I May 2011

Interface

‘We see a lot of opportuni es in the biopharma space, among others’ …says Rakesh Aggarwal, Director - Opera ons, Cole-Parmer, India. Explaining the business model, he discusses the strategies planned to achieve growth in the next few years in the life sciences segment. Meghna Mukherjee & Arshia Khan with troubleshooting. We also organise How is your business performing? We are a knowledge and solutionsbased business and deal with most of the industries in the scientific and process community. The premier channel through which we reach customers to offer our wide portfolio of products is our product catalog and website. We have an India-specific catalog, which contains more than 2,600 products and a biennial general

various road shows and seminars, and participate in trade shows to meet with customers and understand their business requirements. Our strategy remains in line with our mission to excel as the premier global source of instrumentation to meet individual customer needs. It also underscores our reputation of bringing the latest products to customers, and re-stresses our mantra of ‘Delivering Solutions You Trust’.

We are looking at a growth of 20 to 25 per cent in India. We will be inves ng in hiring people, including in the areas of marke ng, sales and applica on support. And lastly, our focus would be to have stronger e-commerce capabili es in India.

product catalog with more than 10,000 new products listed. In India, we have a strong field sales and service team, which covers the length and breadth of the country and reaches customers with our value-added solutions. We also have a dedicated applications team based in Mumbai, which provides exceptional technical support and customised solutions, assists in selecting suitable products and helps 50

Please tell us about your product por olio. With a mix of proprietary products and strategic partnering with leading manufacturers, Cole-Parmer’s business is highly diversified across a spectrum of products, consumables, services and solutions. Cole-Parmer offers a wide range of products for needs ranging from R&D, pilot plant and production; specialising

in providing scale-up assistance. With more than 50 years of experience, Cole-Parmer is one of the global leaders in supplying fluid handling, life science, general laboratory products, instrumentation and equipment.

What is Cole-Parmer’s strategy for growth? Our parent company has made a number of strategic acquisitions over the years, large and small. We always look for appropriate opportunities whenever they present themselves. Cole-Parmer has been in India for more than 15 years with a direct presence in the last five years. We have a strong presence in the biopharma and bioservices markets. Today, around 40 per cent of the business comes from biopharma, while the remaining 60 per cent derives from food & processing, chemical, automobiles, dyes & pigments industry and governmentowned research labs.

What are the recent developments at Cole-Parmer? Our biennial 2011-12 general catalog recently launched in India contains 10,000 new items with approximately 2,500 brand new products mainly catering to the pharmaceutical, academics, food and agriculture sectors. Our website in India is in the nascent stage and does not represent our full capabilities. So, we have a plan to develop our website, giving it a local perspective based on the feedback received. Every year, we pursue several initiatives to increase customer awareness of the latest technology and trends. The objective is to meet Modern Pharmaceuticals I May 2011

Interface customers and provide them with answers to their demanding application needs.

What are the strengths of your company? At Cole-Parmer, we strive to offer our customers convenience along with their choice of unique products, technical application support and exceptional service, producing value-added solutions. We give our customers complete solutions from expert advice to help in selecting the right product suitable for their application to exceptional pre- and post-sales service to help with troubleshooting and most importantly convenience.

What are your plans in India? We are looking at a growth of 20 to 25 per cent in India. We will be investing in hiring people, including in the areas of marketing, sales and application support. And lastly, our focus would be to have stronger e-commerce capabilities in India.

What kinds of investments are you looking at in India? What is the kind of business poten al you see here? Our expansion plans for India are significant. We are aggressively looking at growth in terms of people, meaning sales resources, application support resources and customer services. In the coming years we plan to develop our Indian website to give it a more local perspective, so this will also be our next level of investment. Another area for expansion is our product portfolio. Presently, we source a majority of our products globally. Yet, with India improving the production of analytical instruments and process-oriented products, we look forward to a potential inclusion of locally manufactured products, which meet our high quality standards. These expansions will give us a broader customer base. With investment-friendly policies in India, companies are expanding their manufacturing capacity as well as investing in R&D and production of new products. We are optimistic about Cole-Parmerâ&#x20AC;&#x2122;s future in India.

Which are the other markets that hold poten al for Cole-Parmer and why? We see a lot of opportunities in the biopharma, automobile and food & beverage industry because these industries are showing double-digit growth year after year. We offer difficult-to-find, unique and breakthrough products and solutions to support their processes especially consumables, which bring annuity to the business. MPh (arshia.khan@infomedia18.in)

May 2011 I Modern Pharmaceuticals

Market Trends

Nutraceu cals market in India

Taking baby steps With the pipeline of modern medicines facing a drought and increase in life style diseases, nutraceu cals hold a lot of poten al. However, the rural Indian popula on is s ll reluctant to go the nutra way due to various reasons. A market check on the prospects that this segment holds...

Chandreyee Bhaumik

he term ‘nutraceutical’ was coined in the 1990’s by Dr Stephen DeFelice, Founder and Chairman, Foundation of Innovation Medicine (FIM), Crawford, New Jersey. He defined nutraceutical as: ‘Any substance that is a food or a part of a food and provides medical or health benefits, including the prevention and treatment of disease.’ Whereas Health Canada, the department of the government of Canada with responsibility of national public health has modified the meaning of the term since its coining by Dr DeFelice. Thus, the definition of nutraceuticals read: ‘A product isolated or purified from foods, and generally sold in medicinal forms not usually associated with food and demonstrated to have a physiological benefit or provide protection against chronic disease, eg, beta-carotene, lycopene.’ Speaking on this, Partha Mukherjee,

VP – Sales, Anglo-French Drugs & Industries Ltd, opines, “Nutraceuticals (often referred to as phytochemicals or functional foods) are natural bioactive, chemical compounds that have health promoting, disease preventing or medicinal properties.” Continuing in this vein, he says, “They have the potential to play a role in healthy eating and contribute in the prevention and treatment of diseases so that now functional components in food could expand the role of disease prevention and treatment.” The definition for nutraceuticals in The Food Safety and Standard Act (FSSA) was specified under Section 22 (1): Plants/ botanicals: Whole or extracts Minerals, vitamins, amino acids, enzymes Substances of animal origin Further, according to various other regulatory bodies, a nutraceutical product should not contain the following:

Drugs defined under the Drug & Cosmetics Act (1940) Drugs that claim to cure or mitigate any health condition or disorder Narcotic/ psychotropic substance defined under the Narcotic Drugs & Psychotropic Substances Act (1985).

Drawing the demographics In our country, majority of the population lives below the poverty line and it is extremely difficult for them to afford nutritional food. Further, the modern day living has brought in an imbalance in nutritional intake, which is high on calories and low on nutritional values. This is the primary cause for the increased incidence of lifestyle ailments including cardiovascular diseases, neurodegenerative conditions, osteoarthritis, osteoporosis, AIDS, cancer, diabetes and numerous other health conditions. Commenting in this regard, Mukherjee avers, Modern Pharmaceuticals I May 2011

Market Trends “Nutraceuticals are currently going through a renaissance, and the prospects for alleviating suffering and improving the quality of life are very strong and have generated an excitement the world over. Additionally, the use of innovative nutritional supplements in the prevention as well as treatment of diseases may stand in competition with existing medicines in the near future.” The nutraceutical market in India is witnessing substantial growth. Elaborating on this, V Srividyaranjini, Research Associate - Chemicals, Materials and Foods, Frost & Sullivan, explains, “The total Indian nutraceutical market was valued to be approximately ` 57 billion in 2009. The same is expected to grow at the rate of 18-20 per cent in the forthcoming years.” As Srividyaranjini informs, “The market is mainly driven by the rapid increase in urbanised mass, flourishing industries that in turn pave way for economical growth. Further, product acceptance among the mass has also increased with increasing consumer awareness and preference of natural products over synthetic drugs.” Elaborating on the market scenario, Shruti Pande, Clinical Research Associate, International Clinical Research, Wockhardt Ltd, avers, “Currently, the domestic market for nutraceutical is around `4, 400 crore, which is just 0.9 per cent of the total global business in the category. India’s nutritional supplement market is expected to grow more than double in the next four years at over `9,500 crore.” According to Pande, there are several growth drivers for such market, like, ageing population, changing lifestyle, increasing medical costs, high spending power, awareness of preventive medicine along with the increase in malnutritional diseases. With an increase in the standard of living and industrialisation, lifestyle diseases have become quite prevalent in India. Srividyaranjini opines that this is mainly due to the sedentary lifestyle and mass consumption of junk food that May 2011 I Modern Pharmaceuticals

Western developed countries, the nutraceu cals market is given immense signiﬁcance, where the die cian along with the physician plays an important role in the treatment of the pa ent. Partha Mukherjee VP – Sales, Anglo-French Drugs & Industries Ltd

has led to greater consumer awareness towards nutraceuticals thereby increasing the sales of the same. Again, the soaring industries have an indirect effect on the nutraceutical market. And a large number of working population in multinational companies is experiencing an increasing standard of living and a rise in the

The ingredients used in the manufacturing of the nutraceu cals are considered as one of the premium ingredients in the Indian food ingredient market.

disposable income. Commenting on the Indian market scenario, she says, “Major companies have always maintained high brand equity, and their marketing strategies, involving endorsements by profile actors and media personalities, have been successful in acquiring immense consumer trust.” However, the picture all over India

is not uniform. Unfortunately, the rural population perceive nutraceutical food and drink as western food. They believe that these products are synthetic and therefore lack nutrition. Discussing the difference in mindset, Srividyaranjini reiterates, “They prefer conventional foods and medicines. India houses 72.2 per cent rural population and thus market penetration for such products is a daunting task.” Taking the thought ahead, Gopal Ramourti, MD, Twilight Litaka Pharma Ltd, says, “The nutraceutical market in India is in its infancy and yet to develop. The licensing of these products is either as a food product or as a drug and therefore not yet categorised as a nutraceutical.” He further adds, “The legislation is still underway for a proper identification of this industry. The products available in the market today can be broadly divided into the OverThe-Counter (OTC) range and those marketed ethically.”

Matching the Indian ﬂavour Indian consumers have always believed in traditional food and herbs for daily nutrients, calorie requirements, for remaining fit and preventing themselves from the onset of diseases. Thus,

total Indian nutraceu cal market was valued to be approximately ` 57 billion in 2009. The same is expected to grow at the rate of 18-20 per cent in the forthcoming years. V Srividyaranjini Research Associate - Chemicals, Materials and Foods, Frost & Sullivan

Market Trends

dia’s nutri onal supplement market is expected o grow more than double in the next four years at over ` 9,500 crore. Shru Pande Clinical Research Associate, Interna onal Clinical Research, Wockhardt Ltd

nutraceu cal market in India is in its infancy and to develop. The licensing of these products is er as a food product or as a drug and therefore not yet categorised as a nutraceu cal. Gopal Ramour MD, Twilight Litaka Pharma Ltd

day, there are lots of modern medicines. But as r as safety issues are concerned, people tend to rely more on nutraceu cals as they are made of herbs.

overseas market, Mukherjee shares, “In Western developed countries, the nutraceuticals market is given immense significance, where the dietician along with the physician plays an important role in the treatment of the patient. This concept is slowly catching up in India, but the economic factor of the patient determines the availability of the services of the dietician.” Nutraceuticals is a broad arena. As Srividyaranjini highlights, “Dietary supplements are a mature market when compared to functional food & beverages and is valued at `35 billion with an average annual growth rate of 14-15 per cent per annum.” Key supplement types prevalent in India are Chyawanprash, vitamins and minerals, proteins and herbal supplements. Herbal and nutra based functional foods & therapeutic nutrition help people to become less drug dependent, as also to help them recover from side-effects quickly from other debilitating treatments - like chemo & radio therapy and also the priority sectors like diabetes, hypertension, cardiac, skin, gynaec, paediatric, geriatric, etc.

Dr Pralhad Patki Head, Medical Services & Clinical Trials, Himalaya Drug Company

Legal ma ers

nutraceutical product manufacturers are trying hard to come up with products that would pertain to the Indian palette. Further, the ingredients used in the manufacturing of the nutraceuticals are considered as one of the premium ingredients in the Indian food ingredient market. It is interesting to note that even the ingredients that go in these products, might need an approval from the finance department. Srividyaranjini elaborates, “In order to keep up the margin, the marketers are set to increase the prices in line with ingredient price hike.” Talking about the ways these products attract the consumer, Dr Pralhad Patki, Head Medical Services & Clinical Trials, Himalaya Drug Company, elaborates, “Today, there are lots of modern

For a company in the nutraceutical segment, compliance with the set standards and regulations is extremely essential. Thus, certification is mandatory. Too much content of a particular element in the supplement can also bring about adverse effects. Symptoms of iron poisoning include fatigue, dizziness, nausea, vomiting, headache, weight loss, shortness of breath and many others. The regulations of Prevention of Food Adulteration Act did not cover the functional foods, functional ingredients and other dietary ingredients under the food laws. Later, FSSA, 2006, which was revised during the period of 2008, included the rules and regulations in details. Discussing the mandatory regulations for nutraceutical market, Srividyaranjini

medicines. But as far as safety issues are concerned, people tend to rely more on nutraceuticals as they are made of herbs. As far as nutraceuticals are concerned, efficacy and safety are the main pointers. Once we convince the scientific society about these pointers, the nutraceutical market is sure to grow.” Dr Patki continues, “Interestingly, many of the products like single herb formulation or a nutraceutical having components of energy providers like protein supplements become OTC drugs when it goes overseas.” He adds that the contribution of nutraceuticals is quite sustainable, especially, in the segment of food and food supplements. Further, elaborating the popularity of nutraceuticals in

Modern Pharmaceuticals I May 2011

Market Trends says, “At present FSSA is concentrating on the streamlining the regulations for individual product categories of nutraceuticals. Again, the Good Laboratory Practice (GLP) certificate is a kind of essential for a nutraceutical player. Commenting in this regard, Dr Patki,

avers, “GLP certification ensures that all the tests are done. This is mandatory for evaluating the toxicity study of the concerned product. There are altogether 15 centres in India that have received GLP certification. Further, this certification ensures the acceptance of the product by

Table 1: Key market restraints ranked in their order of impact (India) Rank

Restraint

Order of Impact 1-2 years

Order of Impact 3-4 years

Order of Impact 5-7 years

Cultural aspects and eating habits

High

Medium

The price of the product is relatively high

High

Medium

Low

Less appeal in rural market

High

Medium

Low

Source: Frost & Sullivan

Table 2: Key market drivers ranked in their order of impact (India) Rank

Driver

Order of Impact 1-2 years

Order of Impact 3-4 years

Order of Impact 5-7 years

Sedentary lifestyle and mass consumption of junk foods

High

Medium

Growing Indian economy and change in customer requirements accelerate demands

High

Medium

Presence of all major food companies in this market instills trust

High

Medium

Innovation in terms of health ingredient usage

High

Source: Frost & Sullivan

Table 3: Market quantification for key nutraceutical product categories (India) Product category

Food type

Market size (in `)

Dietary supplements

Functional foods and beverages

Average annual growth rate (in per cent)

Chyawanprash

3,000 million

Vitamins and minerals supplements

28 billion

~20

Protein supplements

2,500 million

6-7

Herbal supplements

1,200 million

8-10

Diabetes management foods

5,400 million

Cholesterol management foods

4,800 million

18-20

Cognitive foods

3,000 million

Digestive segment

10 billion

~15 20-25 Source: Frost & Sullivan

May 2011 I Modern Pharmaceuticals

regulatory bodies and other countries. Again, for clinical practice in this context, Good Clinical Practice (GCP) guidelines also need to be adhered to.”

The next move… Nutraceuticals is an emerging market in India and is expected to witness a lot more competition. However, Dr Patki feels that deciding the area of focus for nutraceuticals is one of the primary concerns though a fact is that nutraceuticals are important for lifestyle diseases management, cardiovascular disease, etc. Besides these factors, one can also consider the lack of new developments in the drug market. Therefore Dr Patki concludes, “Nutraceuticals see a growing prospect since the pipeline in modern medicines is drying up.” However, Ramourti feels that there are some serious concerns as far as the nutraceutical segment is concerned. He elaborates, “Primary challenge is education of the consumers to change their mindset and to counter the misinformation by the interested parties. This involves extreme hard work, supported by deep pockets, strategic planning and execution. Once the consumer awareness is awakened - the demand for nutraceuticals will catch up like wildfire, as it happened in Western countries.” There are several factors that promise the healthy prospects of nutraceuticals. Pande opines, “In Japan, England and other countries, nutraceuticals already have become part of the dietary landscape. Consumer interest in the relationship between diet and health has increased the demand for information on nutraceuticals.” She adds that credible scientific research also indicates many potential health benefits from food components. These benefits could expand the health claims that are now permitted to be identified by the Food and Drug Administration (FDA). MPh (chandreyee.bhaumik@infomedia18.in)

Viewpoint

Pharmaceu cal risk assessments

Weighing the odds Development of a new drug/molecule begins with a lot of ideas and interest and then it enters the long dark tunnel of risks and uncertain es. Pharma companies invest enormous amount of money and me for the development of a drug and bringing it into the market, but it is not without proper risk analysis and assessments that they do so.

n most industries around the world, risk analysis and decisionmaking tools are relevant. In times of recession, patent products expiration, lack of novel technologically advanced skills, pharma companies are relying on sophisticated specialisation for analysing the risks and uncertainties prevalent in the market. This will

not only help them achieve their desired targets but will also ensure or predict the huge stumble or roadblock that their product might face in the long run. By necessity, experts in the field garnering varied solutions are preferred, and Protiviti is one such leading business consulting firm catering to the demands of this sector. Businesses around the world are facing extraordinary challenges. In India, Protiviti commenced its operations in October 2006 and have offices at NCR, Mumbai and Bengaluru. We have rendered services ranging from value added internal audits, Information Technology (IT) effectiveness & control, risk and compliance, finance and accounting excellence, and cost & working capital optimisation across industries ranging from healthcare & life sciences, telecom, industrial products, infrastructure, etc.

Pharma industry: Present and future Adithya Bhat Managing Director, Protiviti Consulting Pvt Ltd 56

The pharma industry in India is poised for a rapid growth over the next few years. Patents for several blockbuster drugs (estimated at over $250 billion in

sales) will be expiring between 2011 and 2015, which will lead to an opportunity for the generic manufacturers in India. Once the drug loses patent protection, the market price of the product falls drastically by around 80 to 85 per cent. Even on a conservative basis of 10 per cent, the market for these drugs over the next five years would be in the range of $25 to 30 billion. Indian companies are leaders in generic manufacturing and have set up state-of-the-art manufacturing facilities in India that are US Food and Drug Administration (FDA) approved. The US FDA has stringent regulatory standards for manufacturing of pharmaceuticals products in the world. Considering the low cost of manufacturing in India, there seems to be a tremendous opportunity for the Indian drug makers. Over the past few years, we have seen several alliances/ takeover between Indian drug maker and foreign MNCs; the latest being the Joint Venture (JV) between Merck and Sun Pharma that was formed with the idea to sell branded generics in emerging markets. Some of the companies that are affected by loss of patent protection would be Pfizer, Eli Lily, Johnson & Johnson, Merck, etc. Since the non-patent protection regime for such products is not lucrative, the best way to retain the market share of this products by these foreign MNCâ&#x20AC;&#x2122;s would be to share the technology/IP with a generic manufacture on a Modern Pharmaceuticals I May 2011

Viewpoint

Companies that invest in R&D make their money during the patent period where they have a monopoly.

profit share basis in form of JVs, contract manufacturing in low cost countries like India. Although opportunities exist for other companies to reverse engineer these products; the ultimate product will be near to the original products in terms of efficacy and effectiveness, but will not be the same. In case of share of Intellectual Property (IP)/ technology by these foreign MNCs, then the products will be similar. Hence, such JVs would hit the ground running from day one. The other huge market in India is dominated by alternative medicines like ayurveda, naturopathy, homeopathy, siddha and unani. These have a great demand specifically in the rural areas of India and is a huge market apart from the urban market. It is estimated that the market size (in terms of consumption) for these alternative medicines is equal to the size of allopathy medicine with ayurveda having a majority share. These medicines are considered more as concepts and beliefs rather than proven by empirical research. These medicines do not have the highest level of regulations and accordingly spurious, counterfeit, poor quality and adulterated herbal ingredients, concerns for patient safety are high. This gives an opportunity for the pharma companies to capture this market by means of educating the rural population and having their products available at a reasonable price in these locations.

Risks and solu ons With the anticipated growth in the pharma industry, there is paramount need to increase the production capability/ facility (for generics) and with that comes the additional risk like: Complex laws in India Environment-friendly facilities Competition from other generic manufactures Availability of good infrastructure and quality manpower Capacity utilisation Acquisitions and takeovers Apart from above, the even larger risk is the discovery of any new product/ molecule for the same disease that makes the existing product redundant. Companies that invest heavily in R&D over a sustained period of May 2011 I Modern Pharmaceuticals

Viewpoint Pharma company: General challenges faced and solu ons oﬀered Any drug manufacturers in India must ensure that their drug reaches customers with uncompromised quality on a timely basis. As companies do not have direct access to retailers data on sales, most pharmaceutical companies depend on clearing and forwarding agents (CFA)/ stockist sales data to monitor their secondary sales. The primary sale culminates when the stock at the CFA is billed to the stockist. The secondary sales is when the stocks transferred from stockist to the retailer is sold to the consumer. Medical representatives who facilitate this process are given predefined sales targets. To meet these targets they are tempted to push inventory on the stockist to levels that exceed the actual demand. When the next level of sale (secondary sale) does not take place, the stockist will either return goods to the company or the stock expires. In India, manufacturers do not retain full control over domestic distribution system as there are many parties involved like factory people, truck operators, courier service, Air transport, CFA, stockists, retailer, branches, etc. Manufacturers are increasingly realising the importance of an effective distribution system, all the way to the end-customer, and are adopting various strategies, tactics and technology to overcome these challenges and meet the overall objectives. Protoiviti assisted the company by looking at the warehouse utilisation, overall transportation costs and reductions that can be sought by innovative arrangements with transporters, merits and benefits for inter branch/inter CFA transfers to avoid loss of sale, optimisation of transportation load by use of technology, performance monitoring and management of CFA’s/transporters and conditions at storage areas to prevent damages with the sole objective of optimisation the overall distribution network in terms of cost as well as operational efficiencies. time (like foreign MNCs) have a better chance of discovering a new molecule. Having done that, they would get that in commercial production in a short period of time. This would lead to discontinuance of the manufacture of generic that they were producing either in-house or through contract manufacturing. Companies that invest in R&D make their money during the patent period where they have a monopoly. After they go off patent then the market belongs to the generic manufactures and cost is a huge factor. Cost cutting is not easy in a pharma company. The main cost is the raw material and production cost, which cannot be comprised or curtailed as these products deal with human life. The other major cost would be selling and distribution that can be optimised through an effective supply 58

chain. All pharma products have an expiry date after which these have to be destroyed. Hence, an effective supply chain would ensure that these products are sold well before their expiry dates. India being such a large country, supply and distribution across India is always a challenge. The right stock in the right quantity has to be at the right place at the right time. For this to happen, the flow of information from the chemist shops (consumers) should flow to the company (manufacturer) on a real-time basis and this is the key to enhance the revenue of any pharma company catering to the domestic market. Further, better storage conditions at warehouses, distributors etc lead to lesser damages thereby adding to the bottom line. This should be the key area that requires attention.

A game changer for life sciences sector? Protiviti in India is led by a team of young individuals in their mid thirties. In late 2010, Protiviti acquired the internal audit and risk consulting arm of a 68-year-old, family-run chartered accountancy firm JC Bhalla and Co. Protiviti’s pharma and life sciences consultants provide solutions that allow organisations to strengthen compliance, improve the auditing process and drive financial performance. Companies within the life sciences industry include pharmaceutical manufacturers, biotechnology companies and medical device manufacturers. These organisations are among the most regulated in the world. They continually face the challenge of complying with a wide and expanding body of laws and regulations, including the numerous requirements of the FDA, the prescription drug marketing, etc. Additionally, they are subject to privacy and data protection laws, corporate governance and consumer protection laws, threats, fraud detection and prevention, and increasingly demanding customers. The life sciences industry experts at the company understand the challenges faced by pharmaceutical & life science sector and have solutions that are designed to help them turn challenges into competitive advantages. Some of its key solutions include: Revenue risk management Supply chain optimisation Enterprise risk assessment Internal audit Development of standard operating procedures Whether it is turmoil in financial markets, introduction of new business models, expansion or consolidation, changing global and local regulation, or the threat of litigation, businesses need a trusted advisor – the company helps them identify and manage both opportunities as well as risks inherent for succeeding in the competitive global markets. MPh (adithya.bhat@protiviti.co.in)

Modern Pharmaceuticals I May 2011

Marketing

The chemist’s counter

Dispensing the right dose? A streamlined chemist-pa ent interac on can ease a lot of burden from the physician, and also helps the less educated pa ent popula on. Using innova ve sales techniques, companies spend a fortune to get their drugs to the consumer, and it is me to u lise the chemist’s counter by making it an eﬃcient and innova ve tool to aid the pa ent popula on.

he marketing manager and his team are always looking for ideal opportunities to make sure that their selling strategies get quickly converted into profits for the organisation. Most of the time

the focus for promoting their products is limited to astounding doctors with in-clinic detailing by the Medical Representatives (MRs), providing great literature and journals, seminars, workshops and gifts. Innovative ideas are applied mainly to impress physicians. The MR may dress like a commando or the manager may request the doctor to inaugurate a pack of new skin cream by cutting the ribbon. Free drug samples are given away to patients under the guise of ‘medical camps.’ Companies also try to modernise the packaging and presentation of their products to magnetise patients who purchase these medicines. Schemes to maintain patient loyalty are publicised in drug packs. Somewhere in between the doctor and the patient, a huge marketing opportunity seems to be lost by most of the industry!

The prescrip on’s voyage

Dr Rajan T D Pharma Consultant & Practising Dermatologist

May 2011 I Modern Pharmaceuticals

Once the sales rep makes his pitch, it is the doctor who is the prime mover of pharmaceutical products. When a patient visits a clinic for treatment, the doctor chooses the appropriate drug to ameliorate the patient’s symptoms. The physician’s prescription makes its journey to the local chemist where the attendant dispenses the drug.

To a general observer the entire scenario looks very simple: the chemist dispenses drugs, the patient consumes it as recommended and the patient is cured. However, in reality, the expedition from the clinic to the first chemist’s shop could lead to varied situations before the patient actually consumes the drug. Here are some possible scenarios that often take place after the prescription leaves the physician’s cabin: The most ideal possibility is that the chemist precisely honours the prescription in toto The patient gets part of the drugs accurately, whereas some are substituted with other brands The chemist is unable to understand the actual names of some medicines prescribed by the doctor and the patient has to hunt for it elsewhere The patient, being not-so-literate, is given some other inexpensive alternative drug by the chemist. In this case, the patient is blissfully unaware of the substitution. This brings us to the primary point that in India just as the average patient trusts his doctor, he also has tremendous faith in the chemist. He assumes that the chemist would interpret the healer’s scrawl accurately and also that the drugs prescribed would be available freely. The patient also believes that his chemist would dispense the drug correctly and substitutions made, if any, would be legitimate and accurate. Obviously, if the drugs dispensed 59

Marketing

Doctor prescribes drugs

Prescription reaches chemist 1

All drugs obtained

Patient gets only some medicines

Substitutes dispensed or recommended

Prescription reaches chemist 2 Figure 1: Prescription journey

are perfect, the consequences are predictable. However, if the chemist oversteps his brief, the patient may have to pay a heavy price.

Chaos at chemist’s counter It is pertinent to note here that despite the statutory requirement to have a D. Pharm or B. Pharm, ie, a qualified person employed in order to be eligible to run a chemist’s shop, the ground reality is completely different. Except in major cities of India where the Food & Drug Administration may visit chemists for surprise inspections, most chemist shops in the country are run by local businessmen who employ school dropouts to man the counters. Some of these staff can barely read a few words in English. It is like placing an auto rickshaw driver in a cockpit! There are several reasons for the confusion across the chemist’s counter. Doctors sometimes scribble prescriptions so casually that even a qualified chemist attendant may not be able to decipher it correctly. The brand written by the physician so closely resembles another drug that it becomes difficult for the clerk to avoid a mistake. For example, Dapsone and Depsonil, Doxy 1 and Droxyl Sometimes, the MR launches a new drug to the doctor but the local 60

chemist is not provided the drug stock. Or the counter, attendant has not heard of the name and sends the patient back to the doctor for an alternative. A brand, which was in good circulation suddenly runs out of stock either due to a glitch in the manufacturing or

With a li le eﬀort, both MRs and their managers can streamline the chemist’s dispensing process, educate chemist staﬀ and help them dis nguish between a variety of drugs.

distribution system. Alternatives are provided by the chemist, which may not be necessarily pharmacologically comparable. Identical packaging for different tablets or lotions, barring some difference in colour code, makes it difficult for the busy chemist boy to pick out the right one. According to a senior dermatologist from Mumbai, “Cetaphil moisturising lotion is often dispensed in place of Cetaphil cleansing lotion.

Imagine the young lady’s plight when she hurriedly tries to wash her face with plenty of water and the moisturising lotion!” The patient returning to the doctor’s cabin simply to clarify if the drug dispensed is correct or whether the substituted drug is legitimate wastes everybody’s time. The physician too is interrupted in his interaction with the subsequent patient.

The vital ‘space’ As they say every problem in life is an opportunity. Likewise, every confusing situation in the pharmaceutical distribution system is a marketing opportunity for the sales team. Considering the chaotic scenario recurring at busy chemist’s counters, there is a major opportunity waiting for the pharma industry to capitalise on. With a little effort, both MRs and their managers can streamline the chemist’s dispensing process, educate chemist staff and help them distinguish between a variety of drugs. A brief outline of the activities that can be undertaken at the chemist’s counter is enumerated as follows: One can take groups of boys working at chemist shops and teach them about the different components of a physician’s prescription. The pattern that doctors follow to write tablets, syrups, injections, their dosages, etc can be elaborated. Explain the significance of the work that they are carrying out and that a small error may have grave consequences for somebody’s health. Knowledge about brand extensions is lacking among chemists. There are instances where any brand extension is dispensed in lieu of the main brand, thinking that the two are identical. Chemists’ attendants can be taught about these differences in simple terms. Modern Pharmaceuticals I May 2011

Marketing Engage qualified chemists by providing higher levels of knowledge about different pharmaceutical products MRs could procure and carry similar brands of other companies and explain the differences in its appearance etc The staff could be shown confusing brands at the counter ‘to light up their eyes’ and avoid any mishaps Make calendars, bumper stickers, ‘flyers’ with important information like emergency telephone numbers on the back and distribute to chemists Provide incentives or complimentaries to chemist staff It is significant to understand that a streamlined chemist-patient interaction saves a lot of trouble to the physician too. The physician will be inundated with fewer phone calls regarding substituted drugs and dispensing errors. Efforts such as the

May 2011 I Modern Pharmaceuticals

above will minimise slipups and consequently would safeguard the patient’s health.

Chemist does not stock drug

CSR opportunity All of us have come across Doctor does salesmen at the Nokia, Prescription not prescribe Vodafone or Shoppers Stop dishonoured new drug counter rattling off the virtues of the products at their stalls. If the staff at a chemist’s counter Figure 2: Prescription dishonour cycle is trained to perform at that level of efficiency, the less educated patient will be in a improving their bottom lines but also better frame of mind after procuring would be performing a social duty. Multinational pharmaceutical giants his medicines. An educated, qualified and proactive need not look for old age homes and counter clerk at a chemists’ shop will such other ‘distant’ Corporate Social take a lot of stress away from the less Responsibility (CSR) projects in order educated mass of patients. It will also to gain tax exemptions and earn brownie improve the standards of health in the points. Use the nearest chemist’s shop country. Pharma companies taking and watch your drug sales soar! MPh up such initiative would not only be (rajan.td@gmail.com)

Clinical Research

Electronic data capture

Moving into a paperless world Over the last few years, Electronic Data Capture (EDC) has strengthened its usage and it is predicted that it will replace paper for capturing clinical trial data. Will we see a paperless world in the near future, or certain obstacles such as not realising the true value of EDC will act as a barrier? the system. In case the entry of a value conflicts, the system gives an alert and verification can be done manually. The data in CDMS is then transferred for data validation to check for logical errors. An example is a check of the subjectâ&#x20AC;&#x2122;s age to ensure that they are within the inclusion criteria for the study. These errors are raised for review to determine if there is an error in the data or clarification from the investigator is required. Also, in these systems, during validation the data clarification from sites are done through paper forms, which are printed with the issue description and sent to the investigator site and site responds by answering on forms and mailing it back. This process is labour intensive, slow and involves extensive use of paper forms.

Paradigm shi

lean, high-quality data is one of the most critical elements of any clinical trial and to obtain this most companies engaged in clinical research have a robust Clinical Data Management System (CDMS) in place. CDMS is a tool used in clinical research to manage the data of a clinical

Dr Zubeen Dastur Senior Manager â&#x20AC;&#x201C; Clinical Data Management SIRO Clinpharm

trial and can be broadly divided into paper-based and EDC system. Historically, the collection of clinical trial data has been a very manual, paper-based process. The clinical trial data is gathered at the investigator site in the Case Report Forms (CRFs) and sent to the company for which trial is being performed or to the Contract Research Organisation (CRO) that is managing the trial for a company. The data on forms is transferred to the CDMS tool through data entry. This can be by single or double data entry. The most popular method is double data entry where two different data entry operators enter the data in the system independently and both the entries are compared by

Given the fact that the pharmaceutical industry is under extraordinary economic pressure and the demand to quickly deliver therapies to market intensifies, there is a growing need to implement technology solutions such as EDC to control operational costs and expedite time-to-market. Clinical trials are the most expensive and critical part of drug development and EDC has the potential to significantly decrease time to market and clinical trial costs. In EDC, traditional data management roles have changed, as it is the site staff that enters data into the system and the programmed edit checks will trigger queries at the time of entry or immediately after submitting the data. This instant validation provides a higher Modern Pharmaceuticals I May 2011

Clinical Research level of data quality at reduced cost and without delay. Clinical Data Management (CDM) no longer makes data changes in the system based on site query responses, but rather site staff enters the data changes. CDM can now focus attention on performing data reviews using listings and reports to fully ensure that data are complete, consistent and logical. EDC systems also allow sponsors to gain access into study data for an insight into the conduct of studies. In turn, earlier insights enable study decisions to be made in a timely manner during the clinical development cycle. Implementation of EDC has resulted in reduction of paper consumption and load on clinical research associates to manage large volumes of paper. It has also reduced the risk of loss/damage of CRFs during transit and also the costs associated with transferring CRFs.

attitude are essential to a successful implementation Change management: Handle implementation as a change management process, not just a new technology. Processes and jobs must change Planning: The planning part of a project is often short changed because of timelines, but it is an extremely important stage. PRISM denotes a helpful set of steps for a new EDC process:

Today, companies that decide to go in for an EDC tool have a number of products to choose from but careful considera on has to be given to selec ng the most appropriate product.

Requirements of an EDC system Today, companies that decide to go in for an EDC tool have a number of products to choose from but careful consideration has to be given to selecting the most appropriate product. Some important features to be considered are: Ensure compliance with 21 CFR Part 11 and consistency with the Food and Drug Administration’s (FDA) guidance for industry: Computerised systems used in clinical trials Inbuilt feature to prevent unauthorised access to data and electronic signature The system should support the utilisation of automated data capture, management and archiving It should easily integrate with other systems/ applications Once all important decisions have been made on which product to go ahead with, the next step is successful implementation of the system. Several factors come into play when implementing an EDC tool. The following list is not exhaustive but is a good place to start: Leadership: Strong leadership, management skills and positive open May 2011 I Modern Pharmaceuticals

Planning Resourcing with ‘can do’ personnel and a good leader Implementing according to the plan (with contingency planning included) Supporting standards adequately and Metrics collection to measure success Implementation partner: Companies that do not have in-house capabilities to implement would require support from a good implementation partner to help and guide them during the validation of the system

Challenges faced at inves gator sites for an EDC study There are several challenges facing companies making a shift to EDC. Primarily among them is investigator site staff still have reservations about EDC – this is because (a) they find data entry a tedious task especially if

the system speed is slow. To overcome this issue, companies need to invest some time during site initiations in order to ascertain if site’s network firewall and security systems would interfere with communication between the client and server and ensure compatibility between the two exists before start of study. Helpdesk support should also be provided to sites to address any technical issues during the course of the study. (b) Since investigators typically work with multiple sponsors on multiple studies, it becomes extremely inefficient for them if every study uses a different EDC system. Each system requires a different login, a separate password, different requirements for entering the data and resolving queries and each has its own instructions for using the system. To a certain extent this problem is being addressed at the industry level as there is growing interest in having the pharma industry adopt a common data collection format. This common format could significantly ease the burden on both investigators and research companies. The growing adoption of the Clinical Data Interchange Standards Consortium (CDISC) standards is likely to drive this effort. The CDISC data standards and data models can be applied to the design of data capture screens so that EDC interfaces are more similar between products.

Will EDC replace paper? In view of the challenges and advantages of an EDC system, the question still remains will EDC replace paper? While many pharma companies that have used EDC realise that there is no going back to paper a number of them are not quite ready to completely abandon their paper-based system since that would not only require new technologies but new business processes as well. Although judging by the current industry requirements, advances in technology and FDA’s critical path initiative to standardise data collection at investigative site level, there is a clear trend towards movement to an electronic environment. MPh (zubeen.dastur@siroclinpharm.com)

Industry Insight

Global asthma market

Making waves on combina on therapies Over 300 million people suﬀer from asthma worldwide. The global drug market is es mated to be over $15 billion. While drugs to manage asthma have existed for several decades, pharmaceu cal companies have developed faster ac ng and more eﬀec ve products over the years. Here is a predic on of the business of drugs used for this respiratory condi on un l the year 2017. Asthma therapeutics, global, revenue and market forecast ($bn), 2001–2017 16

CAGR (2009-2017): 1.5%

witness a marginal decline in sales due to patent expiries of major blockbuster drugs like Advair, Singulair and Symbicort.

CAGR (2001-2009): 5.6%

Late stage pipeline

Revenues ($bn)

12 10 8 6 4 2 0 2001

2009

2017

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

ccording to reports of GlobalData, the global asthma market valued at $12.4 billion in 2009 is expected to grow with a Compounded Annual Growth Rate (CAGR) of approximately 1.5 per cent to $14 billion by 2017. Although the respiratory market has expanded considerably from 2004 to 2009, growth in the seven major markets is expected to slow down from 2010 to 2012.The decline in sales during this period would be due to patent expiries of leading brands. Growth is driven by the expansion of sales in existing classes, the launch of major new products with safety and convenience advantages like route of administration, once-

daily administration, combinational therapies, etc.

Strong compe on The current competition in the asthma market is becoming intense due to the increased entry of combination therapies, inhaled corticosteroids and beta-agonists. According to projections Symbicort, Advair and Singulair will be the leading competitors of the global asthma market. GlaxosmithKline, AstraZeneca and Merck will continue to be the market leaders until the patents on their drugs expire in between 2010-2012. Xolair is the only biologic available for the treatment of asthma. The asthma market is expected to

There are over 229 molecules in various stages of the pipeline. Flutiform, MFF258 (Mometasone-Formoterol) Roflumilast and VR315 are some of the late stage pipeline molecules. GSK159797/642444 (Beyond Advair), QMF149, Oglemilast and SB-2405637 are some of the promising therapies in the phase II stage of the pipeline. These pipeline molecules differ in their target of action from existing therapies. In addition to first-in-class molecules, the pipeline has new technology like Potelligent and Morphodoma, which make it strong. The late stage pipeline is strong, phase II and phase I has innovations so it is expected that the asthma market will grow in the near future. A tremendous increase in the prescription of combination products is expected due to increased awareness and ease of administration of these products. The future of asthma market is defined by the product lifecycle management in terms of new combinations, new delivery options and combinations.

Unmet needs with regard to safety and eﬃcacy of the present marketed products Though there are several conventional Modern Pharmaceuticals I May 2011

Industry Insight

Current treatment op ons The available treatment options have been moderately successful in meeting the market demand. Current therapeutics compete to

May 2011 I Modern Pharmaceuticals

Safety

High

Opportunity and unmet need in the asthma provide a rapid therapeutic market, 2010 decrease in asthma attacks, increase Efficacy Forced Expiratory Low High Volume (FEV), Unmet need = 26%X$12.4bn=$3.2n decrease awakening during night, reduce usage of rescue The unmet need is low medications and (26%) provide for better Biologic therapy quality of life. Next steps-Unmet need can Overall, there is Servent Advair be fulfilled by first in class Zyflo diskus diskus strong competition molecules with better safety Singulair Symbicort Generics profile and disease modifying among the current Accolate Foradil Zolair mechanisms marketed products for Note: Size of the bubble represents approximate cost effectiveness of the product unmet need symptomatic treatment indicates the adverse events and efficacy assoiated with the top 8 marketed drugs and Generics of the disease. Source: GlobalData Though asthma treatments are modifying mechanisms providing a only symptomatic, they treat patients better safety profile and good efficacy is effectively. As a result, the market sure to achieve blockbuster drug status for asthma is strong. However, safety and can target the existing unmet remains a concern as asthma drugs are needs. Thus, a strong opportunity associated with serious adverse effects. exists for any drug that offers better There is strong market potential for efficacy and safety than is provided by any new entrant who will cater to these the current players. MPh unmet needs. A product with diseaseCourtesy: GlobalData Low

therapies for the treatment of asthma like oral corticosteroids, long acting beta2 agonists, combination therapies and biologics, combination therapies have gained importance in recent times. They offer substantial efficacy combined with durable response and convenient dosing frequency. Combination therapies rule the market and are preferred first-line therapy for asthma. Asthma drugs do not completely cure the disease, they offer symptomatic treatments and are associated with safety concerns. Thus, the unmet needs within asthma therapeutics exist in terms of efficacy and safety. Any new treatment in the pipeline targeting safety and efficacy with pricing as another prime factor is likely to attain blockbuster drug status.

Case Study

Real- me analysis

Improving quality, reducing me in process development While much effort is spent in op mising commercially opera ng plant, ge ng the process ‘right first me’ can be far more efficient. Real- me analysis of process parameters provides substan al support during development, streamlining and accelera ng the evolu on of successful process designs. A case study for inves ng in real- me process measurement for pilot studies is discussed.

eal-time process analysis systems are used increasingly within the manufacturing environment. Automating analysis dramatically reduces operational variability and its associated inefficiencies. Automation can pay big dividends by

improving product quality and at the same cutting the cost of production. These savings quickly offset installation costs, strengthening the economic argument in favour of investment. The financial case for automation at the pilot scale may be less easy to make. Here, potential benefits are not so immediately obvious, and can be difficult to quantify, but are nonetheless considerable. The scope for more consistent operation, and the efficient correlation of ‘cause and effect’, accelerates and improves product and process development alike, bringing faster and more efficient commercialisation. This drives down Research & Development (R&D) spend, an important goal in many sectors.

Pilot plant trials As a product moves through early stage research towards commercialisation, the impetus is to develop a robust process that will secure consistent, profitable production over the long term. Pilot scale trials 68

often have an important role to play. Operating small scale units, which replicate part or all of a proposed or existing full-scale plant, is a relatively inexpensive way to experiment towards the best processing solution. The term ‘relatively inexpensive’ is, however, used advisedly here, since pilot scale trials are often associated with significant expenditure. Furthermore, they are an upfront investment, cash spent now in anticipation of future, rather than immediate reward. Maximising efficiency is essential. In considering the contribution that real-time analysis can make, it is worth examining possible goals of a pilot scale study. These might include: Identifying the most cost-effective process design Proving the feasibility of a new technology Preparing representative samples for product testing Defining the process operating envelope; the range of conditions that will result in a product that meets the defined specification Developing an effective control strategy Reaching these goals in a timely way demands rapid acquisition of understanding. The pilot scale may follow directly on from fairly basic lab work, designed to simply prove Modern Pharmaceuticals I May 2011

Case Study

Insitec for real-time analysis

the viability of a product. Little may be known about the feasibility of different manufacturing options and it is important to learn fast.

The role of real-time measurement The real-time measurement of key process or product parameters eases pilot plant control and increases experimental efficiency. Consider the example of a trial designed to establish optimal milling conditions. When milling, particle size is a defining characteristic of the product so it is useful to examine what happens when using periodic particle size measurement compared with applying real-time analysis. Periodic, off-line analysis provides a snapshot of the process each time

a sample is taken. Material is extracted from the plant, taken away for analysis and the results returned some time later. Time lags between extraction of the sample and the return of results are unavoidable. Returning to milling. A change is made to a mill parameter and there is an immediate impact on existing particle size. Sample is extracted from the exit stream, worked up and the results obtained perhaps an hour later. Careful correlation enables assessment of the impact of the initial change. However, it may prove necessary to take multiple samples to precisely quantify the result. Furthermore, if the mill does not normally operate smoothly it may be difficult to differentiate the effect of the change from baseline steady state variability. Continuously monitoring the particle size of the exiting material provides a number of benefits. Firstly, because the operator can properly observe how the plant is running, it can be operated with greater smoothness, establishing an improved baseline for experimentation. More consistent steady state operation also makes it easier to provide representative material for product testing. Most importantly, as soon as a change is made the results are

Quick take The case study provides an in-detail analysis for investing in real-time process measurement at the pilot studies stage. While much effort is expended in optimising commercially operating plant, getting the process correct in the first time can be far more efficient. Real-time analysis of process parameters provides substantial support during development, streamlining and accelerating the evolution of successful process designs. Taking on-line particle size analysis as an example, this paper considers the rationale for investing in real-time measurement for pilot-scale work. Case studies are used to illustrate the various ways in which on-line systems promote efficient process development, easing the transition into profitable manufacturing.

May 2011 I Modern Pharmaceuticals

immediately obvious. Cause and effect can be rapidly quantified in a statistically relevant way and the rate of experimentation becomes limited solely by the dynamics of the process, by how long it takes changes to filter through the plant. The unit can be moved swiftly and efficiently from one experimental condition to another, and the results of each experiment captured rapidly and completely.

The automated solu on, proven at the pilot scale and now commercialised, is applicable to any number of manually operated mills.

This capability of real-time measurement to deliver steadier pilot plant operation, and precisely capture even the subtle effects of a process change can accelerate as well as improve developmental work and increase confidence in the resulting solution. The following study provides practical illustrations of the potential benefits.

Case study: Developing a generic processing solution The pharma industry is currently engaged in a very critical analysis of its manufacturing practices. With a legacy of relatively inefficient batch production the sector is working to transform operations, increase its use of continuous processing and move closer to the goal of real-time product release. Catalysed by the FDAâ&#x20AC;&#x2122;s Process Analytical Technology (PAT) initiative, pharmaceutical manufacturers are actively seeking analytical techniques that will underpin the development of more efficient processing strategies. 69

Case Study

For pharmaceuticals, milling is a common unit operation, used to process active and excipient particles to a defined size for the production of, for example, tablets or inhalable formulations. Here, the commercial availability of reliable real-time particle size measurement systems provides opportunities for automation that are less accessible for processes where relevant continuous analysis is not yet feasible. Exploiting this potential, a global pharmaceutical manufacturer has recently commercialised a generic automated milling solution with widespread applicability. The developed solution, which uses a comminutor mill, is simple but effective. Material entering the mill via the throat is broken up by rotating blades, which simultaneously apply cutting and impacting actions. Particles within a defined size range exit via the screen while oversized material is retained for further comminution. Although blade profile and screen specification both influence the size of the exiting particles, rotor speed is the principal control variable. Pilot scale trials with an Insitec on-line particle size analyser provided convincing evidence that this system could efficiently and continuously monitor, in real-time, material exiting the mill. Having identified this solution, steps were taken to integrate

the mill and analyser such that the particle size data could be used to automatically control mill speed. A closed control loop was implemented to automate mill operation. The operator interacts with the automated mill through the mill Human Machine Interface (HMI), which runs on a dedicated computer.

Quick Picks This automated solution, proven at the pilot scale and now commercialised, is applicable to any number of manually operated mills.

From here it is possible to input particle size set points for the control loop, remotely start and stop the analyzer and mill, perform background tests and receive particle size results. Using the particle size set point, the mill programmable logic controller (PLC) will adjust speed within a defined control range to maintain the particle size specification. The loop was tuned using proportional (P) control. The chosen feedback parameter was average Dv50 with a 30 second rolling average. In tests, set point was reduced from an initial value of 58 microns down to 50 microns and then back up to the original value. The mill stabilised at

the first set point after about a minute, reached the second approximately 30 seconds after the change had been made and completed the final transition in less than 2 minutes. This performance highlights the effectiveness of the control system. This automated solution, proven at the pilot scale and now commercialised, is applicable to any number of manually operated mills. In pharmaceutical production, a widespread task is to mill a batch of material, from, for example a crystallizer, to establish a uniform particle size. Using manual control this is a potentially lengthy task that involves first setting processing conditions to hit the size specification, and then maintaining tight control in the event of variation across the batch. In contrast, the automated solution rapidly identifies suitable operating conditions, and then automatically adjusts them in response to feed variability. In this example, pilot studies were used to prove the on-line technology and the feasibility of automation, generating the confidence necessary to commercialise an efficient processing solution. There is clearly potential for this pilot scale work to be very amply rewarded if the solution is rolled out to both pilot and manufacturing plant across the company.

Benefits galore... In the production environment, real-time process analysis supports the manufacture of better quality product, at competitive cost. With pilot studies the output is knowledge rather than tonnes through the gate. Here, real-time analysis supports the attainment of better understanding, at competitive cost. Continuous process analysis enables more controlled pilot plant operation and enhances investigative research. The result is a faster, more confident transition to profitable manufacture. MPh Photo by: Mexy Xavier

Courtesy: Malvern Instruments Ltd

Modern Pharmaceuticals I May 2011

Events Calendar

National RUDRAPUR: Uttarakhand, Sept 23-26, 2011, Gandhi Park AHMEDABAD: Gujarat, Nov 14-17, 2011, Gujarat University Exhibition Hall PUNE: Maharastra, Nov 18-21, 2011, Auto Cluster Exhibition Centre CHENNAI : Tamil Nadu, Dec 8-11, 2011, Chennai Trade Centre INDORE: Madhya Pradesh, Jan 6-9, 2012, Poddar Plaza, Nr Gandhi Hall

together the international exhibitors and market leaders. This event will provide an excellent opportunity to showcase innovative products and solutions in the industry; October 12-14, 2011; Bombay Exhibition Centre, Mumbai

AURANGABAD: Maharashtra, Feb 17-20, 2012, Garware Stadium India’s premier industrial trade fair on products and technologies related to Machine Tools, Hydraulics & Pneumactics, 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

Biosimilars: Drugs for Life This event aims to be a platform to learn and explore the future of the industry in the next few years. It will provide an opportunity to examine and understand the regulated and semi regulated markets for product development and commercialisation. The event aims to be a hub for the delegates from pharma, biotech industry, research organisations, etc; June 1, 2011, Hotel Shivalik View, Chandigarh For details contact: ASSOCHAM Tel: + 91 11 4655 0581 Fax: + 91 11 4653 6481 Email: assocham@nic.in Website: www.assocham.org

Pharma Technology Show This event aims to bring together world renowned companies as well as newly established companies on one platform. The profile for exhibit includes plant and equipment for pharma production, packaging machinery and materials, lab equipment, analytical instruments, labware, process control and instrumentation, effluent treatment and waste management systems, refrigeration, bulk drugs, drug intermediates, excipients, and additives. There will also be pharma consultants, pharmacists from trade and professions, professionals from R&D institutions, etc; July 1-4, 2011,

May 2011 I Modern Pharmaceuticals

Hyderabad International Exposition Centre, Hyderabad

Trade

For details contact: Print Packaging.Com Private Ltd Tel: + 91 22 2781 2619 Website: www.print-packaging.com

2nd Pharmac India The three-day event will cater to the pharma and healthcare industry in the country. It aims to attract reputed professionals from the fields of pharmaceutical formulation, herbal products, veterinary drugs, medical & disposal products and pharmaceutical machinery & equipment. The event will have exhibitors such as contract manufacturers, liaison agents, sourcing companies, generic and OTC manufacturers & wholesalers, government suppliers, etc; September 17-19, 2011; Gujarat University Exhibition Hall, Ahmedabad, Gujarat For details contact: Orbitz Exhibitions Pvt Ltd Tel: + 91 22 2410 2801 Fax: + 91 22 2410 2805 Email: info@pharmacindia.com Website: www.pharmacindia.com

Analytica Anacon 2011 Analytica Anacon 2011 is the 6th international trade fair and conference for analytical instrumentation, biotechnology, laboratory technology and services, which aims to bring

For details contact: Sonia Prashar Indo-German Chamber of Commerce Tel: +91 11 26878721 or 26111730 Email: soniaprashar@indo-german.com Website: www.analyticaindia.com

CPhI India 2011 The event will feature key decision makers in the pharma industry from 92 countries, including India, China, US, UK, France, Italy, etc. The CPhI conference will include updates on latest innovations, technologies, trends and developments in the pharmaceutical industry in India; November 30 December 2, 2011; Bombay Exhibition Centre, Mumbai 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

Pharmapack Bombay The event aims to provide an innovative platform to showcase the latest information, technology and products to a focussed and target audience. The event promises to cater to the exporters, importers, biotechnology companies, medical device manufacturers, biopharmaceuticals, etc; February 23-25, 2012, Bombay Exhibition Centre, Mumbai For details contact: Intel Trade Fairs & Expositions Pvt Ltd Tel: + 91 22 2862 8126 Fax: + 91 22 2281 9008 Email: intelexpo@vsnl.net Website: www.intelexpo.com

Events Calendar

International The Third Global Helsinki Chemicals Forum The event aims to discuss the current issues within chemical controls and chemistry. The forum will witness representatives from industry, authorities, NGOs, academia and also consumers. The event hopes to offer participants new opportunities and visions of the future operating environment for the chemical industry. It will also provide scope to the stakeholders to get involved in influencing future trends and decisions related to the industry; May 19-20, 2011; Helsinki Exhibition & Convention Centre, Helsinki, Finland

3rd PharmSciFair This event with around 1000 expected delegates, aims to help in understanding the different approaches and perspectives among the different players in pharmaceutical sciences represented by experts and delegates from academia, industry and regulatory. Further, the event also hopes to ensure a consolidated movement towards common goals and targets, and thus hopes to create synergy within the array of different disciplines, all having the objective to better serve the health; June 13-17, 2011; Prague Congress Centre, Prague, Czech Republic For details contact: Congrex Sweden AB Tel: +46 8 4596600 Fax: +46 8 6619125 Website: www.pharmscifair.org

CPhI China 2011 China

platform

For details contact: CPhl China 2011 UBM International Media Tel: +31 0 204 099 593 Email: haohao.chen@ubm.com Website: www.cphi-china.com

Bio 2011

For details contact: Chemicals Forum Association Tel: +358 50 530 5958 Email: henna.koppala@helsinkicf.eu Website: www.finnexpo.multiedition.fi

CPhl

pharmaceutical manufacturers, biopharm aceutical, biotechnology companies & API manufacturers will display a variety of products & services. The event will enable business partnerships, new product launches and showcase innovations; June 21-23, 2011; Shanghai New International Expo Centre (SNIEC), Shanghai, China

where

The event aims to offer an unparalled opportunity for biotechnology and pharma companies, academic research institutions and investors around the world. It will also provide delegates with business opportunities and knowledge transfer; June 27-30, 2011; Walter E Washington Convention Center, USA

For details contact: IBC Life Sciences Tel: + 65 6508 2401 Fax: + 65 6508 2407 Email: register@ibcasia.com.sg Website: www.ibclifesciences.com

CPhI South America This event aims to be a platform where several pharmaceutical manufacturers, biopharmaceutical, biotechnology companies & API manufacturers will display a variety of products & services. The event will enable business partnerships, new product launches and showcase innovations; August 2426, 2011; Transamerica Expo Center, Sau Paulo, Brazil For details contact: CPhl South America 2011 UBM International Media Tel: +31 0 204 099 561 Fax: +31 203 0632 616 Email: rob.sahi@ubm.com Website: www.cphi-sa.com

ICSE Europe For details contact: Biotechnology Industry Organization Tel: + 1 202 962 6655 Email: reg2011@bio.org Website: www.convention.bio.org

BioProcess International China BioProcess International China will be the 3rd annual event organised in China. The main topics of discussion will be on cell culture, cell line engineering, purification and recovery, process characterisation, process analytics, formulation and disposables technologies. The event will be attended by the biopharma companies, scientists, and executives from all over the world; August 22-24, 2011, Grand Hyatt Shanghai, China

The ICSE Europe aims at targeting the top leaders of the pharmaceutical industry. The event will organise an exhibition alongwith concurrent conferences. The exhibitors profile includes biotrails, pharmacology, pre-clinical, biotechnology, pharma equipment and machinery, production equipment, clinical research, patient safety monitoring, etc; October 25-27, 2011, Messe Frankfurt, Frankfurt, Germany For details contact: UBM Live Tel: + 31 20 409 9544 Fax: + 31 20 363 2616 Email: icse@ubm.com Website: www.icseexpo.com

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 May 2011

Report

Inauguration in the traditional way

Bangalore INDIA BIO 2011

Release of programme document

Driving biotech led innova on Curtains came down on the eleventh edi on of India’s premier biotechnology event Bangalore INDIA BIO, when the plethora of par cipants and several global organisa ons came together on this pla orm. It reﬂected promising prospects in biopharma, agri-biotechnology and industrial biotechnology, as well as called for greater government-industry interac on, especially in the regulatory landscape. A report… Manas R Bas a

elcome to the new world order! Global biotechnology market is increasingly looking at emerging economies like India, Brazil, China as the destination next to drive growth of the industry. The Indian biotechnology sector, especially buoyed by promising prospects in biopharma, agribiotechnology, industrial biotechnology, among others is likely to reach the $10-billion revenue milestone by 2015. To put this in perspective, the biotech sector in the country is currently pegged at around $4 billion of which nearly 40 per cent is contributed by more than 180 companies based in Karnataka. However, when one considers the $180-billion global biotech industry vis-à-vis India’s minuscule share in it, the potential opportunities and the enormous efforts needed to tap it call for strategic vision and well-planned execution, to begin with. These marked some of the key reflections from the recently concluded Bangalore INDIA BIO 2011. May 2011 I Modern Pharmaceuticals

Grand inaugura on Aptly themed as ‘Biotech for a better tomorrow’, the eleventh edition of India’s premier biotechnology event was inaugurated by B S Yeddyurappa, Chief Minister of Karnataka and Dr V S Acharya, Minister for Information Technology and Biotechnology, Higher Education, Planning & Statistics, Muzrai, Government of Karnataka. Addressing the august audience, Yeddyurappa said, “Bangalore offers favourable ecosystem for biotechnology industry in the state. The government will make every effort to further boost growth of this industry. We will open four biotechnology parks in various parts of the state.” On the state’s initiative in promoting biotech finishing schools to create skilled workforce for the industry, he added, “Around 12 finishing schools will begin their next academic session in a few months, which will impart the required skill to the students.” The guests of honour included Dr Vishwa Mohan Katoch, Secretary to the Government of India, Department

of Health Research, Ministry of Health & Family Welfare and Director General, Indian Council of Medical Research; Jerome Bonnafont, Ambassador of France to India and Freddy Svane, Ambassador of Denmark to India. Among other dignitaries present were M N Vidyashankar, IAS, Principal Secretary to Government, Department of IT, Biotechnology and S&T, Government of Karnataka; Dr Kiran Mazumdar-Shaw, Chairperson, Karnataka Vision Group on Biotechnology, and CMD, Biocon Ltd. On this occasion, Vidyashankar observed, “This event has truly become a gateway to India for the international biotech community. I am glad that the Bangalore Helix project will be put on fast track with the completion of selection process.” In the words of Dr MazumdarShaw, “The biotech world is all about partnering, collaborations, leveraging each other’s strengths and synergising them to deliver affordable innovation. It is also about making sure that entrepreneurs are recognised, celebrated and born every day.” 73

Report According to a few dignitaries present at the event, the approach towards biotechnology should be as a ‘holistic science’ rather than merely ‘genetic science’. Stressing on India’s need for better laboratories in the biotech sector, Dr Katoch said, “Although we have already shown great progress in the field, there is still huge scope for improvement and development.”

An array of events Bangalore INDIA BIO 2011 comprised multi-track conferences, international trade shows, BioPartnering India, CEO Conclave, Bio Excellence Awards and a host of other events. These were organised by the Department of Information Technology, Biotechnology and Science & Technology, Government of Karnataka, Vision Group on Biotechnology, MM Activ Sci-Tech Communications Co and the Association of Biotechnology Led Enterprises (ABLE). The concurrent exhibition with about 140 participating organisations witnessed 5,000 visitors representing delegates, industry, research and

academia during the three Vital stats days of Bangalore INDIA BIO 2011. The Best International Focal theme: Biotech for a better tomorrow Multi-track conference: 21 sessions with Exhibitor Award was bagged 116 speakers by UBI France and EBTC while Attendees: 815 delegates from 22 countries the other prominent winners Podium presentations: By 12 start-ups were Xcelris Labs, Eppendorf, and innovators Merck-Millipore, GE Healthcare Large business delegations: From European and Nvidia. Business and Technology Center, France, The BioPartnering India Belgium, Denmark and USA initiative received an Over all participatation: 450 organisations extraordinary response with over 530 business meetings. A promising pla orm Bio Excellence Awards were presented in On a concluding note, Dr Satya Dash, the categories of bio-pharma, agri-bio, COO, ABLE, said, “This conference was bio-services, industrial-biotech and bio- indeed a huge success which showcased the informatics after the selection process was innovations and frontier technologies such conducted by ABLE. as regenerative medicines in this sector. Over 70 young researchers representing It was also a platform for governmentleading Indian and international research industry interaction, especially in the laboratories and institutes participated regulatory landscape.” in the poster session and displayed their Next year, Bangalore INDIA BIO will innovations. The poster award was bagged be held during February 6-8 with a focus by Angshuman Biswas from the Stem Cell on ‘Safety, Security and Sustainability’. Research Lab, West Bengal University of Let the Indian success story ascend to Technology, Kolkata for his work on cord the next orbit! MPh blood banking. (manas@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 3000 words, while that of a product write-up should not exceed 200 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 receive a complimentary copy of that particular issue and an honorarium cheque. Published by Infomedia 18 Limited, ‘Modern Pharmaceuticals’ is the leading monthly magazine 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 So get going and rush your articles, write-ups, etc… Thanking you, Yours sincerely,

Modern Pharmaceuticals I May 2011

Report

PharmaTech Expo 2011

A feather in cap for SMEs Vijayvargiy inaugurating the expo

Chandreyee Bhaumik

ith a wide range of exhibitors, participants and visitors, PharmaTech Expo 2011 a three-day event made its debut in the state of Madhya Pradesh. The state shares its boundary with the adjoining pharma hubs Maharashtra, Gujarat and Goa. â&#x20AC;&#x153;The Indian pharmaceutical industry is witnessing a spectacular

May 2011 I Modern Pharmaceuticals

Pharma Tech Expo made its debut this year in Madhya Pradesh. It served as a common pla orm for the varied segments of the pharma industry, especially, pharma machinery. With an aim to become a bi-annual event, it was a booster shot for the SMEs. growth phase and Madhya Pradesh, the second largest Indian state, led by Indore is increasingly becoming a part of this growth story. The Indian pharma market is likely to undergo a major transformation and is expected to rise from present size of `100,000 crore ($21 billion) to `225,000 crore ($50 billion) by 2020, remarked N R Munjal, President - Indian Drug Manufacturersâ&#x20AC;&#x2122; Association (IDMA),

Vice Chairman Pharmexcil, Vice Chairman and Managing Director, Ind - Swift Laboratories Ltd, at the debut of PharmaTech Expo that was held during April 22-24, 2011, at Indore, Madhya Pradesh. The expo was jointly organised by Pharma Technology Index.com Pvt Ltd (a KNS group company), IDMA, and Indore Infoline Pvt Ltd in association with Pharmexcil and BDMA. The event served a

Report

(L-R): Ramesh K Shah; Daara Patel; N R K Agrawal, Indore Infoline Pvt Ltd; Kailash Ravi Wig - ASSOCHAM

platform for ideas and knowledge transfer and brought together buyers and suppliers on a common platform.

Unveiling the expo... The expo showcased the latest international products by exhibitors who aim to bring a revolution in the pharma industry. The event was inaugurated by Kailash Vijayvargiy, State Industry Minister, Madhya Pradesh in presence of Chief Guest Ashish Trivedi from FDA, Daara B Patel, Secretary – General, IDMA. Highlighting the development of the state, Munjal further remarked, “Madhya Pradesh is fast catching up with neighbouring states like Maharashtra & Gujarat due to the presence of pharmaceutical manufacturers such as IPCA Laboratories, Lupin, Cipla, Ranbaxy, Pentagon, ACG etc, and many others who are on verge of joining the growing list of Indore’s top 100 pharma companies making a beeline for Indore, with a boost provided by Indore Special Economic Zone (SEZ). “We would be happy to have a State Board in Indore so that we can work closely with the small and medium companies for their well deserved growth,” he said. Spread over 48 acres of land and 70,000 sq. ft. floor area ‘PharmaTech Expo 2011’ was supported by Madhya Pradesh Pharmaceutical Manufacturers Organization (MPPMO), Pithampur Audhyogik Sangathan, Govindpura Industries Association, Association of Industries Madhya Pradesh and 76

MPSIDC. The event was sponsored by Cemach, ACG Worldwide, Choksi Labs and Spectra Soft. More than 150 exhibitors were present in the exhibition from all over the country. Though not in large numbers a few international companies from Korea, Singapore R Munjal; Vijayvergiy; & Belgium made their presence felt by showcasing their latest technologies and products. The exhibitors mainly consisted of processing plant & machinery, packaging materials & machinery, lab equipment & lab wares. There were also participants from the arena of healthcare products, environment & pollution control as well as trade, associations & promotion bodies. Making its debut, Pharma Tech Expo 2011 highlighted the latest advancements, achievements, modern technology and trends within the industry in manufacturing, packaging, R&D etc. The expo also showcased latest products, machinery, equipment for business generation and upgradation. It had projected quality controls and government regulations & controls. Besides, it projected the brand value of organisations, joint ventures, partnerships, project collaborations, technology transfer, investments and R&D.

Another booster shot? Along with the exhibition, full day seminars were organised on ‘Pharmaceutical stability Study’ and ‘Pharmaceutical innovation and Technology’, sponsored by Thermolab Scientific Equipments Pvt Ltd. The seminar was inaugurated by Dr Saranjit Singh, Professor and Head, Department of Pharmaceutical Analysis and Dean, NIPER, SAS Nagar (Mohali) and Chief Guest Omprakash Sadhwani, JT Commissioner (Law), FDA Maharashtra and Sandeep Mhatre,

Group Managing Director, Thermolab Scientific Equipments. Speaking at the opening ceremony, Patel informed that IDMA was celebrating Golden Jubilee Year with year-long activities such as seminar, workshops, training sessions etc. Citing the motive he said, “IDMA is eager to educate and enhance the technical skills & knowledge of the pharma technical professionals. During his keynote presentation, Sadhwani highlighted the regulatory requirements in stability data. Dr Singh explained ‘WHO guidelines on stability testing’. This was followed by presentation of K L Chandramouli, Global Industry Technical Consultant - Life Science Verticals, Rockwell Automation on ‘automation of pharma stability testing’, followed by ‘status of stability study in Indian scenario’ by Dilip Chincholikar, Controlling Licensing Authority, FDA, MP. International delegates also visited the exhibition and made good business deals. Overall, the exhibition was a good platform for the pharma industry in Indore for aiding the development and growth of the Indore pharma market. The event concluded on a healthy note and provided fruitful businesses to the industry leaving remarkable footprints in Indore. In his concluding remarks, Ramesh Shah, Chairman, PharmaTechnologyIndex.com Pvt Ltd, thanked all the participants, visitors and keynote speakers. He offered special thanks to Munjal, Patel and the foreign visitors for their cooperation and joint efforts in making the event a grand success. He further said that that PharmaTech Expo should be organised every two years for promoting small and medium companies so that they can exhibit their latest and most innovative machinery for pharma, packaging, and laboratory equipment industries. MPh (chandreyee.bhaumik@infomedia18.in)

Modern Pharmaceuticals I May 2011

Technology Transfer

Technology Offered 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. 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. Moreover, this product has already been launched in American market. Areas of application Pharmaceutical industry Forms of transfer Equipment supply 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

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 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 Intravenous fluids An Indian company offers the technology for the production of intravenous fluids (IV). The company has a large volume IV plant and can offer complete support for setting up a new IV plant. Investment required for the fully automatic plant is around ` 15 crore. The company can offer consultancy services/ technical support to set up an IV plant on loan and license basis initially. Later, the collaborating party can set up its own factory when it is ready for investments.

Areas of application Pharmaceutical industry Forms of transfer Joint venture, services

technical

Purified microfine red sanders wood powder An Indian company offers red sanders wood, which is a precious crude drug in the ayurvedic system of treatment. Pulverising by conventional technologies generates very high temperature, which in turn leads to high ash in the sanders wood powder. Red sanders powder so produced will be rich in drug and colour values. The powder will be microfine and free from ash and other impurities. Red sanders wood powder is used to apply on the face and skin to remove chicken pox marks, marks from burns, skin discolourations and pimples. It is also used to add in several drugs, processed foods, cosmetics and toiletries. The powder can be exported in large quantities as a value added item. The technology for microfine pulverising of red sanders wood was developed with the support of DSIR, under the Ministry of Science and Technology. Areas of application Ayurvedic pharmaceutical, food and cosmetics industries Forms of transfer Turnkey, others

Share Your Technology Propositions The mission of Modern Pharmaceuticals is to spread the technology culture. We offer you an opportunity to participate in this endeavour by publishing the best technology ideas. Technology developers/sellers are invited to furnish the techno-commercial details (with environmental benefits, if any) for publication in the Technology Transfer column of Modern Pharmaceuticals. R&D organisations, technical consultancy organisations and individuals assisting small and medium enterprises may send the relevant literature, indicating the scope & services and the areas of specification. Contact: Modern Pharmaceuticals Infomedia 18 Ltd, â&#x20AC;&#x2DC;Aâ&#x20AC;&#x2122; Wing, Ruby House, J K Sawant Marg, Dadar (W), Mumbai 400 028. Tel: 022-3003 4669/4671 Fax: 022-3003 4499 Email: spedit@infomedia18.in

May 2011 I Modern Pharmaceuticals

Technology Transfer

Technology Requested I V Fluid manufacturing as SME An Indian company needs new and best technology to start manufacture of I V Fluid. Areas of application Medical technology, I V fluid, manufacturing Forms of transfer Technical services, others Disposable Syringes An Indian company is interested in cost effective production line for disposable syringes for both ribbon and blister options. Areas of application Medical industry Forms of transfer Others Biotechnology for wastewater treatment system A Thailand-based company, a wastewater service provider, is involved in the research and development 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; which includes cleaning canals, removing sediments from waterways, biogas, microbiology detector and treated system quality. Areas of application Biotechnology, engineering, new technology Forms of transfer Consultancy Calcium gluconate An Indian company requires the technology to manufacture calcium gluconate.

Areas of application Pharmaceutical industry Forms of transfer Technical services, project reports, others

Areas of application Manufacturing industries, especially rubber industry and latex industry Forms of transfer Consultancy

Cell lines Thailand-based, ANH Scientific Marketing Co Ltd has been working in the field of life sciences in the country for more than 20 years. In order to complete the companyâ&#x20AC;&#x2122;s product lines and service customers/ researchers/scientists from the beginning to the end of the process, it would like a company to provide commercial cell lines of human and animals. Areas of application Cell culturing - molecular biology Forms of transfer Material supply

Kite grading engineering technology A Fiji-based company offers the technology of kite grading, which is a subservient of genetic therapy research particularly for the cardiovascular novice. It seeks assistance from a potential partner to provide equipment and technical support staff. Areas of application Medical research Forms of transfer Joint venture, partnership

Extract of medicinal and aromatic plants An Indian 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 Glove automation equipment An Indian company requires technology to produce glove by automation process.

Medical products An Indian company wants to manufacture intravenous fluids, saline, dextrose and related products used in the medical field. The company is involved in non-medical activities at present. The only medical involvement is its general practice in the UK. It plans to commence a nursing home project in Sri Lanka and would be interested in a joint venture with a suitable partner for its saline project. The project has been approved for tax concessions and its partner is expected to contribute in machinery production and know-how. Areas of application Medical and surgical 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.

Modern Pharmaceuticals I May 2011

Book Shelf

Impact of TRIPS in India Editor : Prabodh Malhotra Price : ` 5200 The drug prices in India have declined from one of the highest to one of the lowest in the world under the current healthcare system, still only around 35 per cent of people in India have access to medicines. Further, when Trade Related Intellectual Property Rights (TRIPS) was introduced in India, there were apprehensions about the drug prices rising under the new regime, which would further restrict access to medicines. Divided into several chapters and sub chapters, the book gives an idea of the impact of TRIPS on drug prices and exports of drugs and pharmaceuticals in India. While one chapter deals with the Indian approach to health insurance, the other chapter talks about how effective have the price control in India been in providing access to medicines until now and what form of price controls is India likely to have in future. Further, there are also discussions on whether the TRIPS Agreement fair to developing countries and how India can extend access to medicines to its entire population. There is also an interesting chapter on how the business model of domestic firms changing after TRIPS. The book is helpful for all interested in development economics, intellectual property rights in developing countries, pharmaceutical markets and health systems.

Intellectual Property Rights and the Life Science Industries Editor : Graham Dutfield Price : ` 3370 This book offers an account of the co-evolution of the patent system and the life science industry since the mid 19th century. It discusses that the pharma industry has its origin in advances in synthetic chemistry and in natural products research. Both approaches to drug discovery and business have shaped patent law, and in turn, patent law has influenced the life sciences industries. Divided into various chapters, this book concentrates on specific business, products and technologies of companies like Bayer, Pfizer, GlaxoSmithKline, and also molecules like aspirin, penicillin, monoclonal antibodies and polymerase chain reaction. This book also focusses on areas like stem cell research, biology and synthetic biology. While one chapter discusses patent on steroids, another details the controlling of the antibiotics market. One of the chapters shows the similarities and differences between antibiotics and hormones. Further, a section answers few of the very significant questions like ‘Are patents appropriate for biotechnological inventions?’ In order to hold the attention of the readers, one chapter, interestingly named as ‘Mr Pharma Goes to Geneva’, discusses the policies of the TRIPS agreement, life science industries and similar topics. Covering the issues that are quite relevant, this book is useful for pharma company professionals, researchers and students for both academic and professional purposes.

Available at: Wisdom Book Distributors, Hornby Building, 1st floor, 174, D N Road, Mumbai 400 001 • Tel: 022-2207 4484/6631 8958 • Telefax: 022-2203 4058 • Email: thadam@vsnl.com

May 2011 I Modern Pharmaceuticals

Product Update Machinery for tablet/granula on

Photoelectric gap sensor

Ratnakar Pharma Machinery offers single and double rotary press and Mega Mark-II and IV. Available from 16-81 station press it suits large and small size batch and various shapes of the tablets. Also, there is a mini tab press for R&D model, fully automated and PLC-operated, semi-automated and manually operated tablet press. These ranges with the following details: single rotary tab press– 16 -23 station with output of 40,320-57,860 tablet/hr, available in D and B/D tooling; double rotary tab press- 25-45 station with output of 136,080-226,800 tablet/hr, available in B and BB/B tooling; Mega Mark-II available in 37 to 61 station with output of 222,000-366,000 tablet /hr; and Mega Mark-IV, available in 37 to 81 station with output of 325,000-583,200 tablet/hr.

Lubi Electronics offers ‘Sunx’ RT-610 series photoelectric gap sensor. It is ideal for gap sensing, mark sensing and address reading. In this sensor, the beam axis alignment is not required as the emitter and receiver are integrated in a single body. It has a sensing range of 10 mm, 20 mm and 50 mm. The models with a sensing range of 10 mm and 20 mm are available in red LED type and green LED type for mark sensing. This sensor provides high reliability as the housing material is made of diecast aluminum. It can be used effectively in typical applications such as packaging, pharma and machine tool industry.

Ratnakar Pharma Machinery - Ahmedabad - Gujarat Tel: 079-2289 2614/094270 31284 Email: ratnapd@yahoo.co.in, Website: www.ratnakarpharmamachinery.com

Air-cooled compressor Elgi Equipments Ltd offers a unique range of air-cooled compressors for industries that demand oil-free air at their application point. These nonlubricated compressors offer customers the advantages of low energy consumption and low running costs. The air-cooled design eliminates the need for water cooling systems, thereby saving industrial water costs. The two-stage air cooled after cooler has a 0.25 kW single phase motor driving a cooling fan. This eliminates the need for cooling towers, water circulation pumps and the associated piping, thus reducing the initial investment. This also reduces the installed power. The two-stage design increases the efficiency of compression because it facilitates inter cooling. It also reduces the load on the moving parts by reducing the compression ratio of any stage. These features result in the life of the compressor being enhanced. The motor of the compressor fits within a space of 1.74 square metres and the motor rests on antivibration pads. A typical Elgi package consists of a motor, air end, air-cooled cooler, 500 litre air receiver with associated piping and control panel. Elgi Equipments Ltd - Coimbatore - Tamil Nadu Tel: 0422-258 9326, Fax: 0422-257 3697, Mob: 097900 39326 Email: enquiry@elgi.com

82 82

Lubi Electronics - Ahmedabad - Gujarat Tel: 079-2220 5471, Fax: 079-2220 0660, Mob: 093274 97006 Email: info@lubielectronics.com

PTFE lined valves Supremo line & Control offers the fluoropolymer FEP, PFA, PTFE, lined SGI / WCB / SS pipes, valves & fittings using technical know how and raw material for appropriate application of the resin for successful results with international quality for chemical industry. The features are low co-efficient of friction, chemical inertness, non-toxic approved by international food & drugs regulatory authorities, non-inflammable, self-sealant, excellent weathering resistant, zero water absorption. Supremo Line & Control - Ahmedabad - Gujarat Tel: 079-2220 5282, Fax: 079-2220 5181, Mob: 097245 05282 Email: supremoproduct@gmail.com

Leak test apparatus Jicon Machines offers leak test apparatus. It is ideal for checking sealing integrity of blister, strip & pouch packs, capped bottles, etc. The leak test apparatus is extremely compact in construction and has low noise level. It is provided with polycarbonate vacuum dessicator, which sustains vacuum for long durations. The apparatus is made of stainless steel (GMP). It is equipped with built-in vacuum gauge and isolation valve and is provided with 0-5 minute timer for auto-stop. The leak test apparatus has a vacuum level of 550 mm Hg. Jicon Machines Pvt Ltd - Mumbai - Maharashtra Tel: 022-2851 0398, Fax: 022-2851 6488 Email: jicon.ind@vsnl.com Modern Pharmaceuticals I May 2011

Product Update Vial & bo le cap sealing machines Anju Pharmaceuticals offers vial and bottle cap sealing machines that are compact, versatile and elegantly finished devices for sealing vials & bottles of various sizes and BT (transfusion) bottles or similar containers with aluminium or plastic caps. The vials ready for sealing are placed one-by-one on the selflifting stainless steel platform. This platform lifts upward automatically. As a result, the vials touch the sealing head. Sufficient time is provided to remove the vial platform after the completion of sealing operation. The features of the machine include: perfect & uniform sealing, therefore no manual involvement; no repeated setting required; sealing rollers rotate on bearings to give smooth motion for uniform sealing; minimum time require for changeover from one size of vial to another and does not require lubrication. Anju Pharmaceu cals - Indore - Madhya Pradesh Tel: 0731-252 3968/7415, Fax: 0731-285 6142 Email: anjupharma@hotmail.com

May 2011 I Modern Pharmaceuticals

Product Update Digital temperature & humidity data loggers

Hea ng and drying benchtop oven

BSK Technologies offers temperature and humidity measuring metres of different types. Portable temperature/humidity meters have the feature of data recording facility. The recording can be configured from 1 sec to 24 hours based on the needs. Humidity recording and transferring the data to PC is an added advantage of these types of meters. Hygrometers of economically priced models are useful for pharma companies, green houses, corporate offices, posh bungalows, etc. It has 2” & 4” big display temperature & humidity indicators for longer distance visibility for all pharma, process industries, textiles & polymer industries. The company has temperature/humidity transmitters of various models, on-line temperature infrared (IR) transmitters. With IR thermometer with data logging facility, the data stored can be transferred to a PC. Multichannel thermometer with and without data logging facility are also available. The company offers Ph, tds, cond, ORP indicators, controllers at reasonable prices. Other products offered are indicators, controllers, transmitters, batcher, transmitters and digital battery-operated flow rate indicator cum totalisers, dosing pumps, process pump and safety valves.

Thermo Fisher Scientific offers Heratherm ovens, available in three different models: general protocol, advanced protocol and advanced protocol security. Each unit is available in 60-, 100- and 180-litre sizes with a choice of gravity or mechanical convection. These benchtop heating and drying ovens maximise capacity while optimising laboratory footprint. Special insulation and a heatdecoupled door reduce energy consumption and minimise heat transfer to the environment. All models include an easy-to-use use interface, automatic over temperature alarm and data monitoring. As a result, these ovens meet all laboratory, clinical and industrial heating and drying needs. General protocol ovens are ideal for everyday heating and drying applications, operating up to 250°C with outstanding temperature stability. Advanced protocol ovens operate as high as 330° C, while providing superior temperature uniformity. An extended timer function offers the choice of weekly, real-time or hour-driven settings for advanced flexibility. The programme function can store up to 10 pre-defined cycles making it easy to undertake processes involving complex temperature ramping and holding steps. The auto-dry function shuts the oven down upon completion to maximising energy efficiency, and an optional stainless steel exterior makes it ideal for use in pharmaceutical and clinical laboratories.

B S K Technologies - Secunderabad - Andhra Pradesh Tel: 040-3912 4339, Fax: 040-3912 6177 Email: info@bsktechnologies.com

Thermo Fisher Scien ﬁc India Pvt Ltd - Mumbai - Maharashtra Tel: 22 6716 2200/ 59, Fax: 22 6716 2244 Email:meenal.shinde@thermofisher.com

PFA lined valve Dip-Flon Engineering offers perfluroalkoxy (PFA) lined valves. For many chemical plants, linings made of well known thermoplastic fluoroplastic PFA have been utilised as an alternative to exotic alloy, expensive metal for valves, pumps, control valves, etc. PFA is an injectable type of thermoplastic, which is processed in pressure sintering process. Its success is due to several higher permeation resistances combined with high chemical resistance for most of the chemicals used in industry and also temperature resistance from –60 0c to 200 0c (-75 to 400 0f). PFA has generally much lower permeation rates than PTFE with the same wall thickness but it has the same chemical and thermal resistance properties. Dip-Flon Engineering & Co - Ahmedabad - Gujarat Tel: 079-2562 4003, Fax: 079-2562 5665 Email: dipflon@satyam.net.in 84 84

Modern Pharmaceuticals I May 2011

Product Update Ultrasonic processors Cole-Parmer India offers highintensity ultrasonic processors. These ultrasonic processors can safely process a variety of organic and inorganic materials in a range of volumes. Typical applications include sample preparation, cell lysing, disaggregation, homogenisation, particle size reduction, soil testing and acceleration of chemical reactions. These are capable of delivering 500 or 750 watts at 20 kHz. The 500-watt models are recommended for smaller volumes, andfor probes of 1/2-inch or less. The 750-watt models are recommended for larger volumes, 3/4-inch probes and the continuous flow cell & cup horn. These compact units fit on any laboratoryâ&#x20AC;&#x2122;s existing bench space. The timer controls processing from 1 second up to 10 hours and monitors the elapsed time as well as duration of processing. The sealed converter protects the unit from humidity, dust, dirt and fumes. These units monitor both power (watts) & energy (joules), and feature 100 per cent automatic tuning. The ultrasonic processors with temperature controller prevents overheating of harmful sample by terminating the ultrasonics when the sample temperature reaches a predetermined limit. Cole-Parmer India - Mumbai - Maharashtra Tel: 022-6716 2222, Fax: 022-6716 2211 Email: response@coleparmer.in

Chill roll ďŹ&#x201A;aker unit Steer Engineering offers chill roll flaker unit. It has a pair of adjustable roller, which cools and squeezes the molten material into a thin continuous band. The cooled extrudate is then passed through flaker, thereby reducing the material to small-sized chips suitable for feeding into the fine grinding machine. The squeeze roller in the unit is made of quality raw material and can be easily cleaned. It is made of heavy-duty robust mild steel sturdy structure, with stainless steel squeeze roller. Its features include easy cleaning process, consistent speed, etc. Steer Engineering Pvt Ltd - Bengaluru - Karnataka Tel: 080-2372 3310, Fax: 080-2372 3307 Email: info@steerworld.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 May 2011 I Modern Pharmaceuticals

Product Index Sl No Product

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

Pg No

Accelerated ageing test......................................... 57 Access controll system............................................ 83 Air filter ............................................................. 25, 27 Air shower controller ............................................. 83 Air-cooled compressor........................................... 82 Aluminium extrusion system ............................... 84 Analytical instrument ............................................ 88 Analytical instrumentation ................................... 37 Autoclavable gasket ................................................ 75 Autoclave ................................................................... 7 Banking services................................................... 51 Biodiesel................................................................... 57 Biological safety cabinet .................................. 25, 27 Blow/fill/seal machine........................................ 9, 10 Blower ...................................................................... 63 Braided hose............................................................ 75 Capsule filling machine......................................... 7 Cartoner..................................................................... 7 Chill roll flaker unit ............................................... 85 Chromatography system ....................................... 88 Clean room clock ................................................... 21 Clean room door.............................................. 25, 27 Clean room monitor.............................................. 21 Coloumns & chemistries....................................... 37 Compositional & trace metal analysis ................. 57 Conical screw dryer.................................................. 5 Cord ......................................................................... 75 Counters & power supplies.......Front Inside Cover Diesel- fuel ............................................................ 57 Digital clock ............................................................ 21 Digital differential pressure indicator .................. 21 Digital differential pressure transmitter .............. 21 Digital temperature & humidity data logger...... 84 Digital temperature controller.............................. 67 Dispensing booth ............................................. 25, 27 Door interlock system............................................ 83 Drive....................................................Back Cover, 67 Dynamic controller ................................................ 67 Electrical turnkey project.................................... 83 Elemental analysis .................................................. 88 Empower ................................................................. 37 Encoder........................................Front Inside Cover Exhauster ................................................................. 63 Exhibition-Engineering Expo-2012 ....................... 8 Exhibition-Pharmac India- 2011 ......................... 49 Factory automation system ..........Back Gate Fold Failure analysis ....................................................... 57 Fan filter unit .................................................... 25, 27 FBD gasket .............................................................. 75 Ferrous casting/non-ferrous casting .................... 84 Filler compositional analysis................................. 57 Financial services.................................................... 51 Fire alarm ................................................................ 83 Flameproof clock.................................................... 21 Forged component................................................. 84

Sl No Product

56 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

Pg No Sl No Product

Fuel........................................................................... 57 Gases ...................................................................... 57 Gasket....................................................................... 75 Gear oil .................................................................... 57 GMP heat exchanger................................................ 5 GMP reactor ............................................................. 5 GPS clock ................................................................ 21 Heating and drying benchtop oven................... 84 HEPA filter terminal housing ......................... 25, 27 Horizontal form-fill-seal-packaging machine .... 31 HPLC ................................................................. 37, 88 Humidity & temperature transmitter.................. 21 Hydrogenator/autoclave........................................... 5 Industrial control & sensing device ...................................... Front Inside Cover Informatics .............................................................. 37 Injectable manufacturing line......................... 25, 27 Inspection system ................................................... 13 Invertor/variable frequency drive ...........................................Front Inside Cover Laminar air flow workstation....................... 25, 27 Leak test apparatus................................................. 82 Level controller ...........................Front Inside Cover Liquid sterile filling machine .................................. 7 Lubes- engine oil .................................................... 57 Machined component.......................................... 84 Machinery for tablet/ granulation........................ 82 Mass spectroscopy system ..................................... 88 Material identificaton............................................. 57 Measuring & monitoring relay............................................Front Inside Cover Mechanical vacuum booster ................................. 63 Metallography system ............................................ 57 Modbus.................................................................... 67 Molecular spectroscopy system ............................ 88 Motion control ...........................Front Inside Cover Moulding system .................................................... 75 Online B2B marketplace ............................... 15, 86 Passbox ............................................................ 25, 27 Passbox interlock system ....................................... 83 Peristaltic pump...................................................... 85 Petrol & fuel oil ...................................................... 57 PFA lined valve ....................................................... 84 Pharma manufacturing solution.......................................Back Inside Cover Pharma packaging solution .......Back Inside Cover Pharmaceutical grinding & dispersion system ... 35 Photoelectric gap sensor........................................ 82 Photoelectric sensor ...................Front Inside Cover PID controller ......................................................... 67 PLC........................................................................... 67 Polymer characterisation....................................... 57 Pre-engineered & pre-fabricated modular panel ................................................................ 25, 27 Process heat exchanger ............................................ 5

106 107 108 109 110 111 112 113 114 115 116 117 118 119 120 121 122 123 124 125 126 127 128 129 130 131 132 133 134 135 136 137 138 139 140 141 142 143 144 145 146 147 148 149 150 151 152 153 154 155 156 157 158 159

Pg No

Process reactor .......................................................... 5 Product assemblies ................................................. 84 Profile controller..................................................... 67 Programmable logic controller...Front Inside Cover Programmable terminal ............Front Inside Cover Proximity sensor.........................Front Inside Cover PTFE lined valve..................................................... 82 Pure steam generator ............................................... 7 Quick change terminal house....................... 25, 27 R&D solution.............................Back Inside Cover Rapid endotoxin detection system....................... 83 Return air riser.................................................. 25, 27 RFID.............................................Front Inside Cover Rotary vacuum dryer............................................... 5 Rotocone dryer ......................................................... 5 Safe change housing....................................... 25, 27 Safety light curtain .....................Front Inside Cover Sampling booth ................................................ 25, 27 SEZ developer ..................................Front Gate Fold Sheet......................................................................... 75 Silicon rubber sleeves............................................. 75 Silicone carbide heat exchanger.............................. 5 SME finance ............................................................ 51 Spherical paddle chopper dryer ............................. 5 Sponge product ...................................................... 75 Sterilising/ depyrogenating tunnel ................. 25, 27 Strips ........................................................................ 75 Switching relay............................Front Inside Cover Synchronised digital clock..................................... 21 Temperature & differential pressure indicator.... 21 Temperature controller........Front Inside Cover, 67 Testing system ......................................................... 57 Three parameter display........................................ 83 Timer............................................Front Inside Cover Transmission fluid.................................................. 57 Transparent sleeves................................................. 75 Transparent tube..................................................... 75 Tri lobe roots blower.............................................. 63 Tricover gasket ........................................................ 75 Turned component ................................................ 84 Turnkey project......................................................... 5 Twin lobe roots blower.......................................... 63 UHPLC .................................................................. 88 Ultrasonic processors............................................. 85 Universal controller................................................ 67 UPLC........................................................................ 37 Vacuum technology ............................................. 85 Ventilator ................................................................. 20 Vial & bottle cap sealing machine........................ 83 Vision sensor...............................Front Inside Cover Vision sensors and industrial ID reader.............. 19 Vision software ....................................................... 19 Washer ................................................................... 75 Water for injection generation stills....................... 7

Modern Pharmaceuticals I May 2011

Advertisers’ List Advertiser’s Name & Contact Details

Pg No

Ace Instruments T: +91-40-23078848 E: sales@aceinstrumentshyd.com W: www.aceinstrumentshyd.com

ACG Worldwide BIC T: +91-22-26780127 E: shabir.badami@acg-worldwide.com W: www.acg-worldwide.com Acme Air Equipment Co Pvt Ltd T: +91-79-25831985 E: info@airequipments.com W: www.acmeairequipments.com

Bonfiglioli Transmissions (Pvt) Ltd T: +91-44-24781035 E: sales@bonfiglioliin.com W: www.bonfiglioliindia.com

Bosch Limited T: +91-80-41768218 E: narendra.S@in.bosch.com W: www.boschindia.com/pa

Charles River T: +91-80-25588175 E: india.customercare@crl.com W: www.criver.com

Cognex Sensors India Private Ltd T: +91-80-40224118 E: sales.in@cognex.com W: www. cognex.com

Heattrans Equipments Pvt Ltd T: +91-79-25840105 E: info@heattrans.com W: www.heattrans.com IndiaMART InterMESH Ltd T: +1800-200-4444 E: pr@indiamart.com W: www.indiamart.com International Marketing Services T: +91-80-23310124 E: ims_blr@sify.com J B Sez Pvt Ltd T: +91-22-66210000 E: aparadkar@jbsez.com W: www.jbsez.com Mifa Systems T: +91-79-26870825 E: sales@mifasystems.com W: www.mifasystems.com Misumi India Pvt Ltd T: +91-20-66470000 E: sales@misumi.co.in W: www.misumi-ec.com/in Network 18 Ltd W: www.ita.moneycontrol.com

Dipesh Engineering Works T: +91-22-26743719 E: sales@dipeshengg.net W: www.dipeshengg.com

Eltech Services Pvt Ltd T: +91-40-27759895 E: sales@eltechservices.com W: www.eltechservices.com

Engineering Expo T: +91-9819552270 E: engexpo@infomedia18.in W: www.eng-expo.com

Fabtech Technologies Intl Pvt Ltd T: +91-22-61592900 E: mails@fabtecheng.com W: www.fabtecheng.ae

Advertiser’s Name & Contact Details

25, 27

Pg No

15, 86

FGF

Pg No

Ravel Hiteks Pvt Ltd T: +91-44-24961004 E: sales@ravelhiteks.com W: www.ravelhiteks.com

Salesworth Synergies Pvt Ltd(Rommelag) T: +91-80-25274495 E: mail@salesworth.com W: www.rommelag.com

Salesworth Synergies Pvt Ltd(Seidenader) 13 T: +91-80-25274495 E: mail@salesworth.com W: www.seidenader.de Shiva Analyticals (India) Ltd T: +91-80-27971322 E: gupta@shivatec-india.com W: www.shivatec-india.com

Siemens Ltd W: www.siemens.com/pharma

17 20

BGF

Sreelakshmi Traders T: +91-44-24343343 E: sreelakshmitraders@gmail.com W: www.sreelakshmitraders.com

Standard Chartered Bank T: +91-22-39401616 E: sme.custoercare@sc.com W: www.standardchartered.co.in Suresh Enterprises T: +91-2762-224814 E: sevitsil@sancharnet.in W: www.sevitsil.com

Thermo Fisher Scientific SID Divisi T: +91-22-67429494 E: pradeep.kumar@thermofisher.com W: www.thermofisher.com

Waters (India) Private Ltd T: +91-80-28371900 E: waters_india@waters.com W: www.waters.com

Weiler Engineering Inc T: +847-531-6733 E: creed@weilerengineering.com W: www.weilerengineering.com

Netzsch Technologies India Pvt Ltd 35 T: +91-44-42965121 E: anton.benjamin@nti.netzsch.com W: www.netzsch-grinding.com/pharma Nichrome India Ltd T: +91-20-66011001 E: marketing@nichrome.com W: www.nichrome.com

Omron Automation Pvt Ltd T: +91-80-40726400 E: in_enquiry@ap.omron.com W: www.omron-ap.com

FIC

Orbitz Exhibitions Pvt Ltd T: +91-22-24102801 E: sanjeev@orbitzexhibitions.com W: www.orbitzexhibitons.com

Advertiser’s Name & Contact Details

Our consistent advertisers

COMPLETE ENGINEERING UNDER ONE ROOF @ www.engg-expo.com

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