Modern Pharmaceuticals - June 2012 by Infomedia18

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Editorial

Innovation sans patents… ver the recent years, an uptrend is observed in the R&D spending of Indian pharma companies, although the same has been declining globally. This reflects many facets of the fast evolving healthcare needs across the world as well as smart strategies to leverage these. While the global pharma biggies are taking a more cautious approach towards their R&D spending (as clinical trials become extremely expensive with dwindling success ratios), their domestic peers in the race to enter new markets as well as new product segments have stepped up investments in innovation.

The moot question is what’s next? One needs to factor in here the latest significant changes in the age demographics mix of the Indian population primarily driven by a rise in the working-age group population. This has resulted in a distinct shift in the profile of diseases and an increase in the incidence of diseases by which the growing population in the working-age group is getting affected more frequently. The answer to this hopefully lies in a futuristic and holistic system of not only rewarding pharma innovation but also ensuring that such innovations lead to universal healthcare that is affordable and available. This calls for ushering in sweeping changes across the pharma value chain encompassing business models, supply chain strategies and marketing plans. In this context, Nobel laureate Joseph Stiglitz’s advocacy of a shift from the patents regime to a prize-based system for new drugs is quite thought provoking. In essence, it suggests a government-supported prize fund that would reward innovators for new knowledge, although they would have to give up monopoly over its use. This system would reportedly help lower drug prices, enhance availability and encourage research in medicines for social benefit.

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

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

Dr Gopakumar G Nair

Likewise, in the report ‘Research and Development to Meet Health Needs in Developing Countries’, the World Health Organization (WHO) appreciates the financial viability of such prize fund-based model. While it is good to see the WHO’s approach to relook at the current patents regime, it can at best be an encouraging sign. The real impetus to fructify this change will need far more energised efforts by all the stakeholders - the government, the private sector and the academia - towards the unified objective of applying pharma innovation for better healthcare delivery. Stay tuned for more on this seemingly path breaking transition as we move on to our fortnightly avatar from July 2012. Looking forward to having you on board in this exciting journey ahead!

IPR Consultant & Advisor

Dilip G Shah Chairman, IGPA & Secretary General, IPA

Daara Patel Secretary General, IDMA

Manas R Bastia manas@infomedia18.in

June 2012 I Modern Pharmaceuticals

Contents

22 In Conversation With Dr P V Appaji Director General, Pharmaceuticals Export Promotion Council (Pharmexcil)

Special Focus

R&D in Pharma ............................. 25

R&D funding for infectious diseases ............................... 26

REGULAR SECTIONS 7

Editorial

72 Event List

12 News, Views & Analysis

74 Book Review

18 Technology & Innovation 75 Products 19 Technology Transfer

86 List of Products

70 Projects

87 List of Advertisers

Pharmaceutical Innovation Fund..................................... 31 Government schemes to boost R&D ............................... 34 Interface - Prof Samir K Brahmachari .............................. 36

Automation Trends

Roundtable ..................................................................... 37

Case study - API Manager A key tool for pharma project management ...............56 Bharat Gujavarti, Director- Project Engineering, Goose Technologies

Energy Management

Facility Visit Cadila Pharmaceuticals Ltd (Dholka) Banking on state-of-the-art manufacturing

Renewable energy Improvising on alternative ways .................................60

Policies & Regulations Trade secret protection The need to be prudent ...............................................64 Anuradha Salhotra, Managing Partner, Lall Lahiri & Salhotra

Insight & Outlook

Pharma SEZ ........................ 41

Latest amendments in the SEZ Act ................................ 42

Strategy

Evolution of pharma companies in various

Retail pharmacies Role of distributors .....................................................66

SEZs ............................................................................ 44

Rajendra Pratap Gupta, International Healthcare Policy & Retail Expert

SEZs attracting pharma companies ................................. 48 Managing SEZs ............................................................. 50 Interface - Hitender Mehta ............................................ 52 Neuroendocrine carcinoma therapeutics market .............. 54

Tips & Tricks Packaging guidelines Countering the counterfeits........................................69 Ajit Singh, Chariman, ACG Worldwide

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Special Focus: Pharma Logistics

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Note: ` stands for Indian rupee, $ stands for US dollar and ÂŁ stands for UK pound, unless mentioned otherwise Cover illustration: Chaitanya Surpur

June 2012 I Modern Pharmaceuticals

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June 2012 I Modern Pharmaceuticals

News,Views & Analysis Abbott inaugurates first nutrition R&D centre in India in collaboration with Syngene Abbott recently inaugurated its first nutrition R&D centre in the country in collaboration with Syngene. The Abbott Nutrition R&D centre was inaugurated by Dr Sam Pitroda, Advisor to the Prime Minister of India on Public Information Infrastructure and Innovations and Chairman of the National Innovation Council. The state-of-the-art R&D centre will focus on the development of science-based, affordable nutrition products for the country and enable the expansion of Abbott’s nutrition product portfolio. The facility will extend to over 13,000 sq feet and house a range of integrated capabilities including product

development and analytical laboratories as well as a dedicated laboratory for analysing flavour, sensory elements and packaging. More than 50 researchers and scientists will be based at the Abbott Nutrition R&D Centre in India at Biocon Park in Bengaluru. Among the products being developed for the Indian market are meal complements for diabetics and pre-diabetics. John Landgraf, Executive VP, Global Nutrition, Abbott, said, “This new R&D centre in Bengaluru will play a pivotal role in getting us even closer to the Indian market and addressing the nutritional requirements of the Indian consumer.”

“India is a priority market for investment, growth and innovation,” said Robert H Miller, Divisional VP, Global R&D and Scientific Affairs, Abbott Nutrition. “Our strategic collaboration with Syngene will accelerate the design, development and delivery of science-based, affordable nutrition products in India, for India,” he added. Kiran Mazumdar Shaw, CMD, Biocon Group, said, “The combined market insights and nutrition science expertise of our two organisations will enable us to address the healthcare and nutritional challenges of an emerging economy like India across a diverse range of diseases that straddle both infectious and chronic maladies.”

Indoco’s revenues grow by 22.4 per cent Q-o-Q and by 16.9 per cent Y-o-Y

DRL launches ropinirole hydrochloride XR (extended-release) tablets

million over the same During the fourth quarter last year and quarter of FY 2011the EBIDTA for the 12, Indoco Remedies year stood at ` 953.9 Ltd recorded a growth million as compared of 22.4 per cent in the to ` 770.6 million revenues at ` 1476.6 last year. Aditi million as compared Kare Panandikar, to ` 1206.3 million Panandikar Managing Director, over the same quarter last year. For the full year, the said, “Indoco has done fairly company registered a growth of well in spite of a slowdown in 16.9 per cent at ` 5601.3 million the economy. However, we have as compared to ` 4790.6 million a highly optimistic view of the over last year. The EBIDTA for future and are all set to take a big the quarter stood at ` 246.0 leap both in domestic as well as million as compared to ` 200.4 international business.”

Dr Reddy’s Laboratories (DRL) has launched ropinirole hydrochloride XR (extended-release) tablets (2 mg, 4 mg, 6 mg, 8 mg and 12 mg), a bioequivalent generic version of REQUIP XL® tablets in the US market on June 06, 2012 following the approval by the United States Food & Drug Administration (USFDA) of DRL’s (India) ANDA for ropinirole

hydrochloride XR (extended-release) tablets. The REQUIP XL® brand had US sales of approximately $ 58 million for the most recent twelve months ending March 2012 according to IMS Health. Dr Reddy’s ropinirole hydrochloride XR (extended-release) tablets in 2 mg, 4 mg and 6 mg are available in 30 and 90 count bottle sizes, 8 mg and 12 mg are available in 30 count bottle sizes.

Bilcare and CSIR to partner on nonClonableID technology for authentication of drugs Council of Scientific and Industrial Research (CSIR) under its New Millennium Indian Technology Leadership Initiative (NMITLI) Scheme has approved the implementation of the project entitled ‘Customised adaptation of nonClonableID technology to establish authenticity of medical products’ by Bilcare Ltd, Pune. Dr Praful Naik, ED & Chief Scientific Officer, Bilcare Ltd has been designated as the Principal Investigator for the project. One of the key challenges facing India in the pharma space, both in domestic and

export sectors, is that of counterfeit drugs with dire implications to not only the pharma companies but also government authorities and the general public. In this context, product accountability and traceability has been recognised as a critical need for providing quality medical products. The CSIR-NMITLI-Bilcare team has been assigned the challenge of demonstrating the ability of a novel nonClonableID technology to address the unmet needs in medical product

authentication and patient safety. The nonClonableID technology shall create unique non-duplicable fingerprints. These fingerprints when processed, digitised and activated can function as unique identification tags. This PPP will allow CSIR and Bilcare to advance research areas of mutual interest in the healthcare domain, build technical expertise to pursue high science and niche technology for global impact and create technologies that addresses our nation’s concerns.

Modern Pharmaceuticals I June 2012

News,Views & Analysis ORENCIA® demonstrates comparable efficacy to Humira® in patients with moderate to severe RA Bristol-Myers Squibb has released the results of AMPLE (abatacept Versus adalimumab comparison in biologic-naïve Rheumatoid Arthritis (RA) subjects with background methotrexate), a head-to-head clinical trial of 646 patients comparing the Subcutaneous (SC) formulation of ORENCIA® (abatacept) vs. Humira® (adalimumab), each on a background of Methotrexate (MTX), in biologic naïve patients with moderate to severe RA. AMPLE met its primary endpoint (as measured by noninferiority) and demonstrated that ORENCIA plus MTX achieved

Aventis Pharma Ltd renamed Sanofi India Ltd

comparable rates of efficacy for the American College of Rheumatology criteria of 20 per cent (ACR20) response at 1 year of 64.8 per cent vs 63.4 per cent Humira plus MTX. “Results from AMPLE provide important information comparing the efficacy of ORENCIA SC to Humira, including kinetics of response,” said Michael Schiff, University of Colorado, and principal AMPLE study investigator. “The results demonstrate comparability between two agents for the primary end point of ACR20 and provide relevant data on ACR50 and 70,” he added.

Sanofi Group’s listed entity in India announced that the registrar of companies had approved company’s change of name from Aventis Pharma Ltd to Sanofi India Ltd, with effect from May 11, 2012. The shareholders of the company had earlier approved the name change at the AGM held on May 3, 2012. Commenting on the name change, Dr Shailesh Ayyangar, Managing Director, stated, “Just like Sanofi Group, the company in India is also evolving and diversifying at the same time. The new name reflects Sanofi’s ambition to become a diversified global healthcare leader focussed on patients’ needs, and the synergy between the group and local entity.”

Quintiles conducts media workshop on clinical research ndustry

GlaxoSmithKline Pharmaceuticals introduces metered dose inhaler with dose counter

Quintiles with the Indian Society of Clinical Research (ISCR) organised a media workshop on the clinical research industry to create awareness. The workshop discussed the various aspects of clinical research like the current trends in India as compared the other nations, the position India is in today with regard to clinical research, the myths related to clinical research, the concept of patient compensation, the regulatory procedure that one needs to follow before entering into a trial and many more. The panel included esteemed professionals such as Dr Kratish Bopanna, President & Executive Director, Semler Research Centre, Bengaluru and President, ISCR; Dr Arun D Bhatt, President, Clinivent Research Pvt Ltd; Suneela Thatte, Executive Director, Customer Operations, Quintiles India; and Dr P P Bapsy, Sr Consultant, Medical Oncologist, Apollo Hospital, Bengaluru.

GlaxoSmithKline Pharmaceuticals Ltd recently launched an enhanced version of a Metered Dose Inhaler (MDI) with dose counter, for the first time in India. This inhaler has an innovative dose counter that keeps track of number of doses left. This helps the patients to take the right number of drug doses. The inhaler also has a locking system, which prevents drug wastage when the inhaler is not in use. Dr Hasit Joshipura, Managing Director, GlaxoSmithKline Pharmaceuticals Ltd, said,

“We are excited about the launch of this inhaler with dose counter. This enhancement is yet another step in our endeavour to help patients take the appropriate dosage of their medicine as prescribed by their physician.” The technology has been introduced in Seretide® Evohaler®. The inhaler is indicated for management of asthma and Chronic Obstructive Pulmonary Disease (COPD) in patients above 4 years of age.

Mettler-Toledo Safeline receives royal recognition Mettler-Toledo Safeline Ltd has been honoured with The Queen’s Award for Enterprise 2012 in the International Trade category. The leading supplier of metal detection systems for food, beverage and pharmaceutical production lines has received the accolade, which is the highest official award for businesses in the UK, for its outstanding export growth over the last 3 years. The Queen’s Award for Enterprise is a prestigious awards programme for British businesses and organisations that excel at trade, innovation or

Purvis

sustainable development and has been presented each year since 1966. “Award officials cited Mettler-Toledo Safeline’s strong brand strategy, executed through multiple sales channels, a commitment to innovation and an expert support team as drivers for our international success,” said Alan Purvis, Managing Director, Mettler-Toledo Safeline Ltd. Mettler-Toledo Safeline works in collaboration with international standard bodies and multinational retailers to develop guidelines for food and pharmaceutical safety in order to protect consumer welfare and brand reputation.

Modern Pharmaceuticals I June 2012

News,Views & Analysis Omkar Speciality posts 31.67 per cent year-on-year topline growth Omkar Speciality Chemicals Ltd (OSCL) reported a net profit of ` 4.78 crore for the quarter ended March 31, 2012 as against a net profit of ` 2.97 crore for the quarter ended March 31, 2011, OSCL said in a filing to the BSE. This corresponds to 60.66 per cent growth in bottom line. Net sales of OSCL stood at ` 41 crore for the quarter ended March 31,

2012, as against ` 31.14 crore for the corresponding quarter in the previous fiscal. Consolidated net profit of OSCL for the year ended March 31, 2012 stood at ` 16.00 crore, as against ` 10.18 crore for the previous year. Commenting on the results, Pravin S Herlekar, Chairman & MD, Omkar Speciality Chemicals Ltd, said, “Our

Over 20 crore medicine packages protected by PharmaSecure’s technology PharmaSecure has coded over 20 crore packages of medicine for consumers to verify by SMS at 99010 99010. Each medicine package coded by PharmaSecure has a unique, randomly generated alphanumeric code printed directly on the package. When a consumer sends this code by SMS (voice or web), a message comes back verifying the medicine is genuine. “PharmaSecure’s mobile authentication technology empowers the end consumer to check and authenticate his own medicine at an affordable cost of an SMS,” explained Kishore Kar, Vice President Sales and Marketing, PharmaSecure. “This service is easy for the consumer and a simple, but effective solution for manufacturers,” he added. Already ten of the top manufacturers in India have

started using PharmaSecure’s innovative services. Mobile phones are ubiquitous; in India alone there are over 900 million wireless subscribers. Mobile authentication is accessible to the masses and provides patient safety at an affordable cost – an SMS. Nathan Sigworth, Founder and CEO, PharmaSecure, explained, “Mobile authentication has high relevance in a country like India, because it has leapfrogged the landline culture and mobile has become the way of life. The ease of usage is another advantage in popularising the concept and its benefits.” The global anti-counterfeit packaging market is expected to be worth $ 79.3 billion by 2014, growing at an estimated Compounded Annual Growth Rate (CAGR) of 8.6 per cent from 2009 to 2014.

company registered a strong growth for the year with the specialty chemicals and Active Pharmaceutical Ingredient (API) intermediate business growing in excess of 55 per cent. Our exports have grown from ` 11.48 crore in FY 2010-11 to ` 26.08 crore in FY 2011-12, registering a whooping growth of 127.18 per cent.”

Piramal presents positive results of Phase III clinical trial for BST-CarGel® at ICRS Piramal Healthcare Bio-Orthopaedics, a division of Piramal Healthcare Ltd has recently announced that positive data from their pivotal (Phase III) clinical trial is being presented in three podium presentations as well as during an Industry Symposium at the 10th World Congress of the International Cartilage Repair Society (ICRS), held during May 12 - 15, in Montreal, Quebec, Canada. Dr William Stanish, Orthopaedic Surgeon, Professor of Surgery at Dalhousie University in Halifax, Nova Scotia, and Principal Investigator for the trial commented, “The significant level of evidence from the BST-CarGel® clinical trial, using multiple and independent methodologies, truly supports the positive effect of BST-CarGel® over the standard of care on both the quantity and quality of regenerated cartilage tissue. This represents a cost-effective, off-the-shelf surgical alternative that may dramatically improve cartilage repair over traditional methods in a minimally invasive manner.”

Eppendorf launches tissue culture consumables in India Eppendorf has recently launched tissue culture vessels in India for culture of all adherent cell types. The product range includes tissue culture flasks, tissue culture dishes and tissue culture plates. Eppendorf has launched this product line, to complement the range of existing products like CO2 incubators, shakers, centrifuges, microinjector and micromanipulator, for culture labs. All Eppendorf tissue culture consumables

are manufactured according to ISO 9001:2008. ISO 9001 specifications/ guidelines ensure confidence in consistently high product quality amongst customers worldwide. As Eppendorf tissue culture consumables are a result of the customer demands and enforcement of controlled production processes, our customers receive products that comply with constant high quality standards that meets their expectations.

Tissue culture flasks will be available in T25, T75 and T150 formats. Three sizes of tissue culture dishes and 4 formats of tissue culture plates (6-well, 12-well, 24-well and 96-well) will also be available in India. Eppendorf India is an Indian arm of Eppendorf AG, Germany. Head quartered in Chennai, Eppendorf India has branch offices in all the major cities to supply both Eppendorf and New Brunswick range of products.

Modern Pharmaceuticals I June 2012

News,Views & Analysis DRL and Merck Serono collaborate for biosimilar opportunities Dr Reddy’s Laboratories Ltd and Merck Serono have partnered to co-develop a portfolio of biosimilar compounds in oncology, primarily focussed on MAbs. G V Prasad, VC and CEO, Dr Reddy’s Laboratories, said, “We strongly believe that biosimilars is an important area of future growth. With the recent EMA and FDA guidance on biosimilars, it is clear

that any significant player in the field will need strong biologics development, manufacturing and commercialisation capabilities.” “Our partnership with Dr Reddy’s will bring their first-in-market experience in biosimilars, as well as their expertise in generics and emerging markets, to the table,” added Stefan Oschmann, CEO, Merck Serono. Dr Reddy’s will lead

Aurobindo receives final approval for lamivudine +zidovudine tablets

early product development and complete phase I. Merck Serono will take over manufacturing of the compounds and will lead phase III development. Merck Serono will undertake commercialisation globally, outside the US and with the exception of select emerging markets, which will be coexclusive or where Dr Reddy’s maintains exclusive rights.

Ranbaxy announces USFDA approval of Cip-Isotretinoin NDA

Aurobindo Pharma Ltd has received final approval from the US FDA to manufacture and market lamivudine and zidovudine tablets USP 150/300 mg (ANDA 202418) and is ready for launch. Lamivudine and zidovudine tablets USP 150/300 mg is the generic equivalent of ViiV Healthcare Company’s Combivir® tablets USP 150/300 mg and is indicated as part of Antiretroviral (ARV) combination therapy for the treatment of Human Immunodeficiency Virus (HIV) infected adults and children. The annual sale of the product is approximately $ 265 million. The product has been approved out of Unit VII (SEZ) formulations facility in Hyderabad, India. Aurobindo now has a total of 150 ANDA approvals (122 final approvals including 1 from Aurolife Pharma LLC and 28 tentative approvals) from USFDA.

Ranbaxy Laboratories Inc (RLI), a wholly owned subsidiary of Ranbaxy Laboratories Ltd (RLL), announced that the US Food and Drug Administration (FDA) has approved Absorica™ - a novel, patented brand formulation of the acne medication isotretinoin, developed by Cipher, for the treatment of severe recalcitrant nodular acne. Through a business agreement with the Canadian firm, Cipher Pharmaceuticals Inc, RLI is expected to launch Absorica™ in the US in Q4 2012; as per the agreement, Ranbaxy will pay royalties on net sales to Cipher. “We are thrilled to make Absorica available as a valuable option for the dermatologists and patients who need treatment for severe recalcitrant nodular acne. Absorica is a critical milestone in our commitment to

serve the dermatology community and will be the flagship brand for Ranbaxy’s specialised dermatology sales force,” said Venkat Krishnan, Senior Vice President and Regional Director, Americas, Ranbaxy. “Approval of Absorica represents our third FDA approval and most important milestone to date, reflecting the great work by our scientific affairs team at Cipher and our partner, Galephar Pharmaceutical Research,” said Larry Andrews, President and CEO, Cipher. “We look forward to working closely with our partner, Ranbaxy Laboratories Inc, in preparation for the upcoming US launch of the product through its dermatology sales force.” RLI is focused on the promotion of branded prescription products in the US.

DIY drugstores in development at the University of Glasgow A new 3D printing process developed at the University of Glasgow could revolutionise the way scientists, doctors and even the general public create chemical products. Professor Lee Cronin, Gardiner Chair of Chemistry at the University, believes his research could lead to the development of chemical fabricators which consumers could use to create medicine at home. A new research paper, published in the journal Nature Chemistry, outlines how the process has been proven to work. Using a commercially-available 3D printer

June 2012 I Modern Pharmaceuticals

operated by open-source computer-aided design software. Professor Cronin said, “Its long been possible to have lab materials custom-made to include windows or electrodes, for example, but it’s been expensive and time-consuming. We can fabricate these reactionware vessels using a 3D printer in a relatively short time. Even the most complicated vessels we have built have only taken a few hours.” By making the vessel itself part of the reaction process, the distinction between the reactor and the reaction becomes very hazy. Although

the technology is still at an early stage, the team, comprised of researchers from the University’s School of Chemistry and School of Physics and Astronomy, is also considering the long-term implications of developments in 3D printing technology. Professor Cronin added, “3D printers are becoming increasingly common and affordable. It is entirely possible that in the future we could see chemical engineering technology, which is prohibitively expensive today filter down to laboratories and small commercial enterprises.”

Technology & Innovation AB SCIEX launches next-generation TripleTOF 5600 system AB SCIEX has launched the second generation of the TripleTOF 5600 System. Its features include: Accurate mass technology that combines high resolution with sensitivity and speed Delivers novel innovation for biomolecule research with MS/MSALL with SWATH™ Acquisition Supports a higher level of selectivity when coupled with SelexION™ Technology TripleTOF 5600 Comes with software that supports 21 CFR Part 11 compliance, making TripleTOF™ technology more accessible for regulated labs Builds on the innovation of the original TripleTOF™ 5600, with added versatility and breakthrough levels of selectivity

Bio-Rad introduces first ProteOn™ sensor chip Bio-Rad Laboratories, Inc has launched two Surface Plasmon Resonance (SPR) kits that, when used with the ProteOn XPR36 protein interaction analysis system, enables for the first time the ProteOn kit accurate analysis of lipids and membrane proteins with peptides and small molecules. The new kits — the novel hydrophilic ProteOn LCP liposome capturing kit and the lipophilic ProteOn GLC lipid kit — stably and selectively capture lipids and lipid assemblies for easier screening and analysis of membrane protein targets during drug discovery. The ProteOn LCP sensor employs memLayer technology to selectively and stably capture lipid assemblies. “The memLayer approach offers an interesting alternative,” said Maria Pavlaki, a senior researcher at Democritus University of Thrace in Greece. “The proteins can be in a more native-like environment (lipoparticles or liposomes) that resembles the cell membrane and are not ‘squashed’ on the surface.” The ProteOn LCP capturing reagent kit, included in the ProteOn LCP liposome capturing kit, is used to activate the LCP sensor chip with a biotinylated DNA tag that then hybridises to DNA-tagged lipid assemblies containing membrane proteins of interest.

Enginasion partners with TransCytos to develop transfection technology Enginasion and TransCytos have announced that their collaboration has resulted in a prototype ‘transfection’ technology that is designed to have a dramatic and positive impact on the drug-research industry. Enginasion’s product development partner, TransCytos, is developing a novel transfection instrument, Cytofector R1(TM), based on a breakthrough, patent-pending hydrodynamic transfection technology. Transfection technology, the introduction of genetic material into living cells, is a fundamental and essential genetic engineering process in biomedical research, drug & gene therapy development. It has worldwide revolutionised the biotech and pharmaceutical R&D, including research into various diseases. “Because the new TransCytos transfection technology is gentle, highly effective, and does not physically damage cells, it is potentially capable of transfecting all cell types. Current transfection techniques represent a considerable bottleneck for biomedical and pharma R&D due to low efficiency, high variability, cellular toxicity, and the inability to introduce genetic material into many of the most important cell types relevant to major diseases,” said Dr Otto Prohaska, CEO, TransCytos.

New technology has potential to transform pharma manufacturing Pfizer outlined its vision for Systems-based Pharmaceutics (TM), a revolutionary model-based approach linking drug process and product engineering to product quality and performance in the human body, at the recent Advanced Process Modelling Forum in London. Ravi Shanker, Senior Research Fellow at Pfizer, said that it is essential that pharma companies develop better methodologies

to ensure the quality and efficacy of their products. This can only be achieved reliably and efficiently by developing a quantitative understanding of how decisions relating to the way the drug is manufactured affect the drug’s behaviour within the body. He added, “Adopting a system-wide modelling approach is essential in this context.” Pharma companies are adopting advanced process modelling technology to rapidly

accelerate value creation as part of Qualityby-Design (QbD) approaches, in particular by facilitating the move from batch to continuous processing and optimising solids process design and operation. Mark Matzopoulos, COO, PSE, said, “The range and diversity of presentations at the forum illustrates the power that the technology has to transform the way the process industries design and operate.” Modern Pharmaceuticals I June 2012

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

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

June 2012 I Modern Pharmaceuticals

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

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

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

Technology Transfer

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

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

Pharma/medical Forms of transfer Others

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

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

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

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

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

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

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

Modern Pharmaceuticals I June 2012

In Conversation With: Dr P V Appaji

“High technology, high orientation, low cost requirement under DPCO, and extremely good entrepreneurship have contributed to the initial growth of this industry in India”

…says Dr P V Appaji, Director General, Pharmexcil, India. Being a part of the pharmaceutical industry for more than three decades now, his efforts for improving the Indian pharma industry remain relentless; he is taking new initiatives to propel further growth. Titash Roy Choudhury

Modern Pharmaceuticals I June 2012

Dr P V Appaji Dr P V Appaji, the first Director General of Pharmexcil India, shares some insights about the growth of the Indian pharma industry. He also provides a glimpse of his past, his journey to the present state and how the industry will move forward in the coming years. Motivation: Past & present It all started with the support of my brother who brought me closer to the field and piqued my interest. With his guidance I completed my B Pharma in 1966 and my real liking for pharma profession developed from there on. Hailing from a small village in Andhra Pradesh my knowledge of pharmaceutical industry was limited. But moving to Hyderabad in 1977 was a turning point in my career. The exposure made me realise what was happening in the Indian pharma industry since most pharma companies were located there. After completion of my post graduate studies under the guidance and persistence of my mentor I went to Delhi and completed my doctorate degree in pharmacy by 1980. During this tenure I got the opportunity to understand the functioning of the pharma industry of the entire nation and witnessed the growth of industry, which was at a budding stage during that time. Transformation of the pharma world from 80s and drivers of growth... During that time Indian pharma market was a small market where companies like Lupin, Wockhardt, Dr Reddy’s, Ranbaxy and Cipla had just started operations. Almost 90 per cent of the drugs used in India were being imported to meet the country’s demand. The Government of India analysed this nascent market and its growth patterns. During this time the government took two very important decisions that boosted the domestic pharma market; one was to not allow product patents in India and in 1979 the announcement of Drug Price Control Order (DPCO). The announcement of the price control gave Indian companies a better position as per drug policy that time and the domestic companies also took advantage of the patent-free

June 2012 I Modern Pharmaceuticals

environment in India during the initial years of development. The price control environment and the favourable policies have helped the spirit real entrepreneurship wake up and I had the opportunity to witness the same. Another driver that propelled the initial growth of the market was the support of the government policies by public sector units particularly Indian Drugs and Pharmaceuticals Ltd, (IDPL) and Hindustan Antibiotics. IDPL with the help of Indian government built manufacturing of bulk drugs capacity in India. High technology, high orientation, low cost requirement under DPCO, and extremely good entrepreneurship have overall contributed to the initial growth of this industry in India. Association with Pharmexcil and challenges faced I was working for the Drugs Control Department of Government of Andhra Pradesh initially and then moved to Central Government in 1981 where I had exposure to government policies. I was involved in the drug policy making and was a part of DPCO. In 2004, Pharmexcil was created by the government who were looking for an Executive Director (ED). Out of the 72 applicants for the post I was selected and was fortunate to have the support of industry leaders such as D B Mody ( J B Chemicals & Pharmaceuticals) and Venkat Jasti (Suven Lifesciences). Some of the issues that we had to tackle during my tenure as the ED were pertaining to counterfeit. Nigerian FDA (Nafdaq) had without any reason blacklisted 10 to 15 Indian companies on their website. This raised question globally on the quality of Indian drugs and we pursued the issue and convinced the authorities to clear the blacklisting. Another such issue was when one of our legitimate consignment for Latin American and African countries was stopped alleging that they were counterfeit, indicating sub-standard quality. This was brought to the notice of the industry and the issue is almost sorted out. Another important issue is the challenge to the bulk drug sector.

Quick takes Spending time with family especially grandchildren Attending pharma conferences and building social networks of pharma professionals to exchange news and views pertaining to the industry The export market for Indian generics The share of our exports in generics is growing. At the moment out of the $ 11 billion export market over 60 per cent of our exports are generics and it is increasing. Fortunately, we are in an advanced position when it comes to exports of generics but developing markets like China, Bangladesh, Brazil and Ukraine can become a threat for India. So we need to firm up our exports by increasing our capacity, improving our standards and upgrading our facilities. We also need to adapt our facilities with ever increasing regulatory requirements of both developed and developing countries. Role of pharma SMEs I believe SMEs are the real growth boosters for Indian pharma industry. Today, every known Indian pharma company has graduated from being a small or medium scale industry. During the last 7 years almost 100 SMEs in pharma has started operating, thus pushing the exports from ` 1 crore to ` 100 crore. The government of India has been ready to help the SME sector, which requires more information on patents, help in regulatory system and financial support. The first Director General of Pharmxecil It has been possible because of the unrelenting support from the government and my Committee of Administration at Pharmexcil headed by N R Munjal. With this new role there comes more challenges to face, and one of the biggest would be to take the Indian pharma market into the global forum. Pharmexcil has launched ‘Brand India Pharma’ campaign at Japan in March this year. The sole initiative of this campaign would be to make the Indian pharma industry strong globally. (titash.choudhury@infomedia18.in)

Special Focus

R&D in Pharma R&D funding for infectious diseases What more can be done? .......................................................26 Pharmaceutical Innovation Fund Catalyst for R&D ................................................................31 Government schemes to boost R&D Need a comprehensive approach ...........................................34 Interface Prof Samir K Brahmachari, Director General, CSIR and Secretary, DSIR, Government of India ......................36 Roundtable Is there actual reversal of brain drain in R&D segment? ................................................................37

June 2012 I Modern Pharmaceuticals

Special Focus: R&D funding for infectious diseases treat a variety of these ailments.” Further, the Global Report shows that infectious diseases place a substantial health and economic burden on the poor population in Africa, Asia, Latin America. For example, malaria is the leading cause of mortality in children under five years of age in Africa, constituting one-tenth of the country’s overall disease burden. In areas with high malaria transmission it accounts for 40 per cent of public health expenditure, 30-50 per cent of impatient admissions, and up to 50 per cent of outpatient visits.

R&D funding: India and global

What more can be done? Every year, the death toll due to infectious diseases is increasing. The question that remains pertinent is in spite of this awareness are we doing enough? More questions regarding the current state of R&D funding for infectious diseases keep hovering around the fraternity. Chandreyee Bhaumik

ccording to Global Report Research for Infectious Diseases of Poverty, infectious diseases remain key agents of the debilitating poverty affecting so many of the world today. Each year these diseases kill almost 9 million people, many of them children under five years, and they also cause enormous burdens through lifelong disability. The report states that stepping up research into their causes and how to effectively treat them and prevent them from spreading could have an enormous effect on efforts to lift people out of poverty and to build a better world for future generations.

Further, the report reveals that infectious diseases are caused by pathogenic microorganisms, such as bacteria, viruses, parasites or fungi. These diseases can be spread directly or indirectly, from one person to another. Looking at the numbers and the large spread and communicability of these diseases, R&D funding is an essential aspect. Talking in this regard, Debabrata Gupta, Director and COO, USV Ltd, says, “As the name suggests, infectious diseases are harmful and avoidable. The good news is that there is a wide spectrum of antibiotics available (especially in the developed geographies) and under development to

Ensuring funds for R&D in infectious diseases is essential. Discussing the structure of R&D funding, Omkar P Herlekar, Whole Time Director, Omkar Speciality Chemicals Ltd, comments, “It is an irony that the current model of R&D investment in India and the world is flawed since there is no module to increase access to medicines for neglected diseases. This fatal imbalance needs to be de-linked from profits from medical discoveries, so that patients are able to afford medical innovations at cheaper price. Further, Indian Council of Medical Research and the federal government should evolve ways for a sustained R&D system in public interest, rather than look at profit booking.” He adds that the overall funding for R&D in neglected diseases in 2010-11 was estimated to be $ 4,063 million, according to a study conducted by the Global Funding of Innovation for Neglected Diseases: G-Finder. The yearon-year investment in R&D substantially reduced by $ 109 million, aggregating a shortfall of 3.5 per cent. However, the situation is not the same in developed countries. Giving a comparative view, Herlekar reiterates, “The nose-dive in investments in the R&D sector was mainly on account of the global financial conundrum, where the research sector witnessed large funding cuts, barring the pharma segment.” He shares some data in order to make the point clear. He says that in 2010, the three top-tier diseases, such as HIV/

Modern Pharmaceuticals I June 2012

R&D funding for infectious diseases

The industry is possibly more focussed towards more complex molecules, which are being developed for a variety of therapy areas that include infectious diseases. Debabrata Gupta Director and COO, USV Ltd AIDS (received $ 1,073 million, which accounts to 35.0 per cent of the overall funding), tuberculosis (TB) (received $ 575.4 million, which accounts to 18.8 per cent), and malaria (received $ 547 million, which accounts to 17.9 per cent). Among the second-tier diseases, which received 1-6 per cent of the overall global funding, dengue and diarrhoea, each received over 5 per cent of the global R&D funding. Ironically, the third-tier diseases did not receive funds, barring leprosy, Buruli ulcer, trachoma and rheumatic fever, each receiving approximately $ 10 million. Similarly, R&D funding in bacterial pneumonia and meningitis witnessed its largest share of funding in 2010-11, which accounted to $ 31.7 million (up 52.9 per cent). However, the increase in funding was barely enough to make up for the large drops in R&D funding for kinetoplastids (down $15.5 million, -9.6 per cent), diarrhoeal diseases (down $ 18.3 million, -10.3 per cent) and malaria (down $45.5 million, -7.8 per cent). Discussing the funding of R&D in infectious diseases, Gupta says, “The industry is spending a fair amount of funding towards R&D for infectious diseases. However, having said that, the industry is possibly more focussed towards more complex molecules, which are being developed for a variety of therapy areas that include infectious diseases.” He adds, “Even in the global scenario, the R&D funding is increasing. The major funding comes from various international non-profit agencies and is definitely on the upswing. Estimates are that there is an improvement over the past few years.”

June 2012 I Modern Pharmaceuticals

It is an irony that the current model of R&D investment in India and the world is flawed since there is no module to increase access to medicines for neglected diseases. Omkar P Herlekar Whole Time Director, Omkar Speciality Chemicals Ltd

Amendments required?

Overcoming obstacles

Research is an ongoing process and adequate investment in it is the dire need. Talking about the changes that are required for R&D in infectious diseases, Herlekar avers, “It is highly unfortunate that we have no model that can meet the needs for new drugs in a sustained manner. One cannot expect companies to invest in large scale and subsequently bleed. Therefore, there is a need for a sustained mechanism

The R&D segment of infectious diseases is continuously facing challenges. Talking about the concerns in this field, Herlekar says “The fallout of the global financial meltdown has turned the investment situation in the neglected diseases R&D sector worst. This substantially affected the flow of the public and philanthropic funding. The rub-off effect of it was that diseases relying on public and philanthropic investors were hit really hard, including HIV/AIDS, malaria, kinetoplastids and diarrhoeal diseases, while diseases with substantial industry funding (TB and dengue) were somewhat protected.” Elaborating on the challenges, Gupta says, “The challenges faced in this area are that funding increasingly comes from nonprofit agencies and is directed towards therapy in the less progressed economies or geographies. Industry tends to fund newer molecules and recently developed therapy areas.” Herlekar highlights, “The Product Development Partnerships (PDP) funding also took a plunge with cutbacks from a wide range of contributors, such as federal agencies. Despite the gloomy situation and unfavourable policy support from the government, several home-grown companies continue to open handedly contribute multi-billion dollar towards creating a cost-effective and innovative neglected disease products for patients in the developing world.” Infectious diseases are a serious concern, and although the situation is not very grim much more needs to be done.

Indian Council of Medical Research and the federal government should evolve ways for a sustained R&D system in public interest, rather than look at profit booking.

where companies can systematically invest in the R&D sector and help the consumers benefit by way of cheaper drugs.” He adds that over the years, the public sector has had a substantial share of investment in the basic research in neglected diseases. It was approximately two-third during 2010-11. Globally, the pharma industry alone invested $ 880 billion during 2010-11. But the federal Government of India has done nothing for the public sector, which puts in millions every year and constantly follows up to seek regulatory approvals for clinical trials.

(chandreyee.bhaumik@infomedia18.in)

MPh (June 2012) 1Tab-29

MPh (June 2012) 1Tab-30

Special Focus: Pharmaceutical Innovation Fund

Catalyst for

R&D While on one hand innovation is the dire requirement and allocating dedicated fund a viable consideration, on the other hand there are certain risk factors that prevent it from materialising. Let us look at the factors that facilitate and deter the prospect of the Pharmaceutical Innovation Fund. Chandreyee Bhaumik

ccording to a new research report ‘Indian Pharma Sector Forecast 2014’ by RNCOS, the Indian pharma industry is projected to show a double-digit growth in the near future owing to a rise in pharma outsourcing and investments by MNCs. A major percentage of pharma products produced in India are exported resulting in the dominant players expanding their reach into the Western nations. Additionally, due to the investments in R&D and the quest for more and more Abbreviated New Drug Application (ANDA) filings, the clinical research market is expected to grow at a blistering pace in coming years. The baseline for optimistic future outlook of the pharma market is improvement in the access to medicines to the Indian population. The focus of the industry will shift towards capitalising the potential of tier-III and rural areas. Emerging sectors such as bio-generics and pharma packaging will also pave way for the pharma market to continue its upward trend during the forecast period (FY 2012-2014). Amid all these growth prospects what emerges as significant is the relevance of fund to back the most vital aspect, ‘innovation!’

June 2012 I Modern Pharmaceuticals

Pharmaceutical Innovation Fund Generating Pharmaceutical Innovation Fund is the need of the hour. Elaborating on the Pharmaceutical Innovation Fund, Nidhi Saxena, Founder, President and CEO, Karmic Lifesciences, explains, “India being such a large pharma and biotech market, our entire focus is still on generics. While there is no doubt that some innovation is happening, it is in pockets as opposed to a country like Israel where the entire country is focussed is on innovation. Risk-based funding has been one major bottleneck to innovation in pharma.” Talking about this fund, Saxena further adds, “If we need to move India from being a generic-based to an innovation-led pharma market, having the right funding, be it by way of research grants, or private

Private Equity (PE) and Venture Capital (VC) activity or through a state backed pharma innovation fund, is going to be highly critical. Also, the fund should have a clear mandate of priority therapeutic areas and technologies to fund.” Discussing the same, Dr R B Smarta, Founder & Managing Director, Interlink Marketing Consultancy Pvt Ltd, comments, “Industry has progressed considerably but for the last 16 years the R&D departments in the industry have not witnessed any significant progress. Thus, the government tends to resolve this issue by providing capital support for design, delivery, development, etc. Therefore, personally I believe that this is a very good idea but there is always a gap between idea and fact.”

Pharmaceutical Innovation Fund

The investors will be looking forward to the success rate and if there is no success the entire investment will be getting blocked.

Challenges are in funding primary research and innovation-led pharma and biotech projects as the gestation periods for innovation are substantial; between 5-8 years. Nidhi Saxena Founder, President and CEO, Karmic Lifesciences

Hurdles on the way Despite the acknowledgement of the need of this fund, there are several hindrances to its establishment. According to Dr Smarta the kind of investment or funding that is required here is always at a risk at this particular moment. He opines, “Funding is a positive thing and it has no issues. However, for this kind of funding the venture capitalist or anybody has risk factors involved. We are not sure about the time that it will take. And, we also do not know what kind of design, delivery and development will happen. And, obviously whoever is funding requires some sort of security or elasticity. It is definitely a good initiative but how to implement it is an important decision.” Discussing the status of the fund and the challenges involved, Saxena says, “As far as I am aware, the government is seeking an advisor to lead the fund.” She adds, “Challenges are in funding primary research and innovation-led pharma and biotech projects as the gestation periods for innovation are substantial, between 5-8 years. Also, the end result could be binary, success or failure and is hence a huge risk. Apart from that, finding or sourcing high potential technologies from India is not easy as the focus has never been innovation, hence there is little Intellectual Property (IP) available.” Commenting on the challenge factor, Dr Smarta says, “I feel even if the government wants to ask the venture capitalists, funding agencies or others to support this, people providing the funding will be very shy. The issue will be like that of the biotechnology sector. The investors will be looking forward to the success rate and if there is no success

Dr R B Smarta Founder & Managing Director, Interlink Marketing Consultancy Pvt Ltd

the entire investment will be getting blocked. Thus, it is extremely important to give security to the investors.”

Overcoming the challenges Innovation is one of the most essential aspects of pharma industry and thus the concerning issues and challenges must be resolved. Elaborating on the ways to overcome the challenges, Saxena adds, “One of the most potent ways to overcome this situation is to promote the co-development model wherein an Indian company inlicenses and does a technology transfer on promising technologies through the US, EU or Israel and based on the business case, Indian partner garners partial funding and the balance funding is put in by the original innovator and together they add value to the IP. This way, risks are shared and there is more access to funds and one gets to tap a bigger global market. The fund should further partner with VCs and PEs and incentivise them for funding innovation from a financial perspective.” Talking about overcoming challenges, Dr Smarta clarifies with the help of an example. He says that one should look at the situation in Singapore, “Along with providing funds, Singapore also gives due competence to develop people. Further, in our Indian banking system, we have certain principles that needs to be followed. However, we are not following them at the moment. These are the areas that we need to relook at and find ways to resolve several issues.” He explains that the basic challenge is to start with investment. Dr Smarta comments, “This is a risky affair because of the high rate of failure involved. Additionally, the need to utilise public resources for pharma innovation is

based on the factors like delivery, design and development. While inviting investment factors like the role of the investors, the guarantee provided to them need to be comprehended.”

Future prospects From the above discussion it is quite clear that the Pharmaceutical Innovation Fund is an important aspect. Discussing the future of the innovation fund, Saxena says, “If the fund gets operational and makes a few promising and well researched investments under a co-development model, there are chances that this will promote innovation by Indian companies. And the fund will become critical to helping get some early successes for the Indian pharma and biotech industry. Further, it will enhance PE and VC for innovation in India.” Commenting on the future prospects of the pharma innovation fund, Dr Smarta avers, “In my opinion ideas that are involved are really positive. We need to test them thoroughly before finalising. Factors like how will one do it, what are the different steps for it, what are the hazards, etc, need to be evaluated. In few words, one needs to look at the feasibility factor of the whole thing. We must remember that the investment in India has a huge difference with that of the multinationals. It is not that we do not want to do it. But India is generic driven and thus we cannot generate that kind of funds for R&D. So, this is our issue that differentiates us from the multinationals of other countries.” Indeed, innovation is one of the most vital aspect and the initiative is indeed positive but how to validate it, is probably the most significant consideration. (chandreyee.bhaumik@infomedia18.in)

Modern Pharmaceuticals I June 2012

Special Focus: Government schemes to boost R&D

N co ee ap mpred a p

roa hens ch ive

Are several tax incentives and various scientific programmes enough to stimulate the research culture? The answer is: no, we need much better and more. We require more schemes and amendments over all existing ones. Chandreyee Bhaumik

&D forms the core of any successful pharma company and is the key differentiator that plays a pivotal role in deciding the company’s overall performance and profitability. Consequently, it is an important driver of growth for the pharma industry at large. Since the mid-1990s, the government has tried to include adequate incentives and schemes in order to provide the Indian pharma sector the correct impetus. These include tax deductions for expenses related to R&D and other concessions such as reduced interest rates for export financing and a cut in the number of drugs under price control.

Government impetus There are various schemes that aim to improve the R&D structure of the industry. Discussing the existing tax schemes to

promote R&D, Arun Sawhney, Chairman, CII National Committee on Drugs & Pharmaceuticals, and CEO & MD, Ranbaxy Laboratories Ltd, avers, “Under extension of weighted deduction under Section 35(2AB), government offers weighted deduction of 200 per cent for expenditure (not being in the nature of cost of any land or building) incurred on in-house R&D facilities. Further, in the current budget this scheme has been extended for a further period of 5 years, ie, up to March 31 2017.” Sawhney adds, “Department of Science and Technology’s (DST) Drugs and Pharmaceuticals Research Programme (DPRP) was launched in 199495 for promoting R&D in drugs and pharma sector with the objective to forge PPP in drugs and pharma R&D covering both modern and Indian systems of medicine including veterinary drug development, to create stateof-the-art R&D infrastructure in this sector in public funded laboratory/university, extend

loan at 3 per cent simple interest to pharma industry R&D projects and grants-in-aid for clinical trials to pharma industry projects on developing drugs for neglected diseases like malaria, tuberculosis, Kalaazar, filariasis, etc.” Elaborating on the present government schemes that help in promoting the R&D culture, S Ramesh, President - Finance & Planning, Lupin Ltd, discusses, “DPRP promotes collaborative R&D in drugs and soft loans schemes and other grants for clinical trails to pharma industry projects.” He adds, “The New Millennium Indian Technology Leadership Initiative (NMITLI) programme of Council of Scientific & Industrial Research (CSIR) has done much with its Public-Private-Partnership (PPP) effort within the R&D domain in the country. Other PPP models from which the pharma firms benefit is the Small Business Innovation Research Initiative (SBIRI) of the Department of Biotechnology. Another initiative that deserves mention is the Open Source Drug Discovery (OSDD) launched in September 2008.” Ramesh highlights that a welcome move in the Union Budget 2012-13 with respect to R&D in pharma was the proposal to extend the weighted tax

Modern Pharmaceuticals I June 2012

Government schemes to boost R&D

The percentage of weighted deduction on contributions made to an exclusive R&D company for carrying research and development should be increased from 125 to 175 per cent. Arun Sawhney Chairman, CII National Committee on Drugs & Pharmaceuticals, and CEO & MD, Ranbaxy Laboratories Ltd exemption for in-house R&D by another 5 years to 2012.

Must amendments Discussing few concerns of the industry Ramesh clarifies, “Some of the issues faced by pharma companies include the long gestation period in new drug development and the cautious nature of investors owing to the risky environment of the pharma industry. Lack of stringent guidelines tends to make global pharma majors reluctant to opt for India. To create additional growth opportunities, it is recommended that while the government continues to focus on making R&D more viable for a company to invest in, it also looks at creating policies for some of these aspects as they have the potential to positively impact the sector.” Sawhney says, “For tax schemes to promote R&D, we need to have extension for a longer duration under Section 35 (2AB). Further, Sawhney believes that scientific research expenditure incurred outside approved R&D facility should be included under Section 35(2AB). Also, pharma R&D is expensive and time consuming as compared to other industrial research, on account of regulatory requirements of safety, efficacy and quality. Sawhney elaborates, “The current provisions for deduction u/s 35(2AB) are restrictive in nature, so as to cover only expenditure incidental to research carried on at the in-house R&D facility. Some of the activities though directly related to R&D are not eligible for weighted deduction, eg, clinical trials undertaken on patients in hospitals, since the same are carried outside the approved R&D facility.” He continues, “It is therefore, suggested that the aforesaid anomaly should be abolished. All expenditure related to research carried on in the in-house

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A focus on breakthrough research will give the requisite fillip to R&D efforts in the country and give us an edge over other nations. S Ramesh President - Finance & Planning, Lupin Ltd

facility, ie, clinical trials, bioequivalence studies, regulatory and patent approvals should be eligible for weighted deduction, even if these activities are carried outside the approved R&D facility including overseas expenditure.” In the Finance Act 2010, the percentage of weighted deduction allowable u/s 35(2AA) on sponsored scientific research undertaken through an approved National Laboratory University, IIT and other specified institutions was increased from 125 to 175 per cent. Similarly, the percentage of weighted deduction u/s 35(1)(ii) on contributions made to approved scientific research associations, university, college or other institutions was also increased from 125 to 175 per cent. According to Sawhney, similar increase in the percentage of weighted deduction on contributions made u/s 35(1)(iia) to an exclusive R&D company approved by the specified authority, has not been allowed. He avers, “The percentage of weighted deduction on contributions made to an exclusive R&D company for carrying research and development should be increased from 125 to 175 per cent.”

DPRP to be more effective Soft loans for development under DPRP scheme are currently offered at 50 per cent of project cost. Sawhney says, “Under the given circumstances, it should be increased to support complete development programme with a view to taking these programmes towards commercialisation. New Drug Delivery Systems (NDDS) and innovations in the generic space should also be supported under the scheme. Currently, this scheme is being offered for only clinical trials in neglected diseases, mainly the infectious diseases with

high prevalence in India. There should be grant–in–aid to Indian pharma companies for development of newer therapies, and this should be extended to non-communicable diseases as well, as India has high prevalence these diseases as well, eg, hypertension, diabetes mellitus, hypercholesterolemia, cancers. And last but not least this scheme should also be extended to other developmental areas, eg, pre-clinical studies.”

Looking forward The government should enable a policy environment that would encourage and support innovation. Talking in this regard, Ramesh says, “In order to leverage and sustain this opportunity, the government should focus on developing and harnessing the intellectual property potential of the country by incentivising R&D through a weighted reduction in tax breaks to close to 300-350 per cent levels. A focus on breakthrough research will give the requisite fillip to R&D efforts in the country and give us an edge over other nations. Lupin has consistently invested 7-9 per cent of its global consolidated revenues in its research programmes.” He suggests that the benefits of R&D are longterm, and hence, all excisable goods used for R&D purposes, should be exempted from central excise duty. Ramesh remarks, “Another recommendation can be exemption from custom duties on reference standards for R&D purposes. Providing tax incentives for hospitals that assist pharma companies in their R&D activity may also help.” Thus, though the government has been a constant supporter of R&D in pharma in the country, we still need to cover that extra mile to further boost the R&D activities. (chandreyee.bhaumik@infomedia18.in)

Special Focus: Interface - Prof Samir K Brahmachari

“There is no dearth of young people in India. The Indian research environment is young, optimistic and dynamic” …says Prof Samir K Brahmachari, Director General, CSIR and Secretary, DSIR, Government of India. He talks about the Indian research environment compared to that of West and discusses factors favouring the both. Chandreyee Bhaumik

Describe your experience while working in the field of R&D in pharma. I joined the Council for Scientific and Industrial Research (CSIR) 15 years ago as the Director to Centre of Biochemical Technology that later became the Institute of Genomics and Integrative Biology. And since last 5 years I have assumed the position of Director General, CSIR and Secretary, Department of Scientific and Industrial Research (DSIR), Government of India. Thus, in the last 15 years, I have analysed pharma companies and the R&D segment thoroughly. The development of the generic drug industry was catalysed by CSIR laboratories. Thus, these laboratories involved in low cost processes are the backbone of the chemistry-based drug discovery in India. And companies like Ranbaxy, Piramal, Cipla, Dr Reddy’s, Lupin and the like benefitted from the low cost processes of CSIR labs. In 1970s, drugs in India were the most expensive in the world. Additionally, Indira Gandhi’s decision to have process patent over product patent allowed these laboratories to come up with low cost processes, which eventually brought down the cost of HIV drugs. Therefore, CSIR’s knowledge, manpower, people, chemistry helped 1,000s of generic companies that we have today. No doubt that R&D institutions play an important role. Along with this, the recombinant technology by few academic institutes helped companies

like Shantha Biotech, Bharat Biotech, etc. For all the products that have come to the market like the fundamental vaccines for Hepatitis, etc, the majority of the fundamental work was done by the labs of the research and academic institutes including CSIR. India is a unique country where we have public-funded drug discovery institutes, and hence, today we have low cost drugs available since it is not the pharma companies that are spending. On the other hand, in the American model, entire fund for drug discovery is provided by pharma companies. Thus, they call it a shot and fix the price. The research environment in India vs the rest of the world... India has a different research environment as against other countries and the reason is simple. In India, the advantage that we have is we can afford to take risks. Here, we have large number of young people who are hungry to work and are happy to work even with small remuneration. Thus, there is no dearth of young people in India. The Indian research environment is young, optimistic and dynamic. Even if we live in a very materialistic world it is very interesting to note that our scholarship and materialism are counter balanced. I do not know whether it is the Indian philosophy or the childhood upbringing. But here, somebody who is truly aspiring for ‘saraswati’ is disinterested in ‘lakshmi’ unlike

the Western society. The only impediment that we face is infrastructural challenges. However, with Internet connectivity and other computational resources our country is becoming comparable and competitive with respect to the global set up. What initiatives and incentives are required for research culture to develop? We are not able to create large number of entrepreneurs in order to drive innovation. We are unable to create disruptive innovation in our society. We are probably a bit afraid because we are a little bit orthodox in our mindset. We need to incentivise innovation. One might argue that in the present tax incentive structure the companies are having profits. But it is essential to remember that the startups do not make profits. On the other hand, in some of the American models there are grant startups; hence, people are willing to undertake risks. Thus, we are required to encourage direct funding, soft loan and convertible equity for startups. Message to the young talent pool We should be aiming for the stars while remaining grounded on earth. We should be realistic. Yes, we are in India and we are surrounded with a lot of difficulties but we must not be bogged down. We should have the courage to dream and plan big. (chandreyee.bhaumik@infomedia18.in)

Modern Pharmaceuticals I June 2012

Roundtable

Is there actual reversal of brain drain in R&D segment? After several instances of brain drain now has come the time when people prefer to come back to India. But what is the real picture? Is it colourful or marred by impossiblities? Chandreyee Bhaumik

Dr Amrita Bajaj Adjunct Professor and HOD, Pharmaceutics Department, SVKMâ&#x20AC;&#x2122;s -Dr Bhanuben Nanavati College of Pharmacy After decades of brain drain, India is ready to reverse the situation by establishing its own science and technology parks, thus attracting and targetting the drug industry. Generational differences of returnees, differences in working culture of Indian and Western firms, differences between requirements of Indian firms and skills sets of returnees hampered effective knowledge transfer in the past. Currently, the US and other developed countries are battling with recession and debt. Lack of job opportunities and insufficient salaries to maintain a family in a foreign country has led to a reversal of brain drain back to hometown. Reverse brain drain of talented people will accelerate technological upgrading with shifting to higher value-added activities, thus completing the brain circulation process making brain draingain realistic.

Dr Krishna Ella Chairman and Managing Director, Bharat Biotech There is also a perceptible change in the policies to introduce public funded new schemes to make India progress towards supporting new concepts, innovation and R&D including rise in public health budgets conducive for pharma and biotech industrial development. We are witnessing a remarkable improvement in government reforms and policy that has opened gates of hope in life sciences and biotech investments resulting in reverse brain drain even in our industry. In the last few years, several biotech parks in PPP have come up at Bengaluru, Hyderabad and Pune creating demand for talent pool from the industry assisting the reverse brain drain. This home-coming environment is further fuelled by Indiaâ&#x20AC;&#x2122;s growing focus to become an innovation and entrepreneurship hub lead by its central, state government and entrepreneurs.

Dr Sudhir Nambiar Site Head and Vice President, Pharmaceutical Development unit - Bengaluru, AstraZeneca In India and China we have seen senior scientists return to home countries to lead important teams within our R&D organisation after working in places like the US. When I returned to India I felt I was bucking the trend as many of my peers were still interested in forging their careers overseas. What attracted me to join AstraZeneca were the opportunities to performing cuttingedge research back home but doing so as part of a global team. Nowadays, I do not feel as though I am alone in bucking the trend around the so-called brain drain, certainly not within AstraZeneca at least. Recently, another senior scientist returned to Bengaluru to lead our drug metabolism & pharmacokinetics team after completing his doctoral studies in the US and working at two multinational pharma companies over there. I am convinced this trend is set to continue.

Editorial take

Although initially pharma professionals preferred the US and other developed countries, gradually this has taken a reverse turn. Lack of job opportunities and sinking gap in salaries are driving them back to home country, in most cases. The challenge remains how to effectively harness the talent in taking the Indian pharma to the next level.

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Facility Visit: Cadila Pharmaceuticals Ltd (Dholka)

Banking on state-of-the-art manufacturing Over the last five decades, Cadila Pharmaceuticals Ltd has been developing and manufacturing pharmaceutical products in India and selling & distributing these in over 90 other countries worldwide. Spread over 44 acre of land, the manufacturing plant at Dholka, Gujarat, banks on the state-of-the-art facilities. Parita Dholakia

n 1951 what started as Cadila Laboratories, paved way for an image-makeover for the Indian pharma industry. Indravadan Modi along with his friend Ramanbhai Patel started this company in a three-room bungalow with a seed capital of ` 50,000. In 1995, Cadila Laboratories was divided into Cadila Pharma (run by Modi) and Cadila Healthcare (run by Patel). Cadila Pharmaceuticals Ltd - an integrated healthcare solutions provider - with a wide pharmaceutical product basket, caters to over 45 therapeutic areas that include cardiovascular, gastrointestinal, analgesics, haematinics, anti-infectives and antibiotics, respiratory agents, antidiabetics and immunologicals.

The beginning of the empire Reminisces Modi, “We had invested the ` 25,000 each of us had in our

accounts to start the company. Initially we did not hire any workers; our family members used to help us in the work. What we manfactured during the day was marketed and sold in the evening by us.” From a turnover of ` 1,25,000 in the first year of operation, Cadila crossed the ` 100 crore mark in sales in nearly three decades after its launch. Today, the company boasts of being actively present in the entire life sciences value chain from R&D to API to finished formulations to marketing and distribution. It is among the largest healthcare manufacturing groups (global sales: $ 1.5 billion (2010)) and has an asset base of approximately $ 145 million.

Dedicated facilities At Cadila Pharmaceuticals, R&D has been at the core of all its initiatives in the realm of biotechnology, APIs, formulations, plant tissue culture, phytochemistry, etc. This strong R&D forms the backbone of its state-of-the-art manufacturing

facilities at Dholka, Ankleshwar, Kadi and Hirapur in Gujarat; Samba in Jammu & Kashmir; and Addis Ababa in Ethiopia. Through its first overseas subsidiary, Cadila Pharmaceuticals Ltd incorporated at St Louis, United States, the company developed pharma business for catering to market needs in North America and Latin America, besides Europe, and expanded to Moscow, Africa and Japan, propelling the company’s global expansion plans. Its first overseas formulation manufacturing facility commenced operations in Ethiopia a few years ago. The company’s two Active Pharmaceutical Ingredients (APIs) units at Ankleshwar manufacture a wide-range of APIs and intermediates including three US FDA-certified products. The manufacturing facility at Samba, near Jammu, started its commercial operations in August 2006. The first overseas formulation manufacturing facility of Cadila Pharmaceuticals Ltd has commenced its operations in Ethiopia. The company has dedicated facilities for innovative and generics research.

The Dholka plant The manufacturing operations of the company are carried out at the state-ofthe-art plant located at Dholka, which is around 50 kms from Ahmedabad, the pharma capital of Gujarat. This facility is spread over 44 acre of verdant, picturesque surroundings, amidst lush green lawns and thick foliage, thus becoming an

Courtesy: Cadila Pharmaceuticals Ltd

Modern Pharmaceuticals I June 2012

Cadila Pharmaceuticals Ltd (Dholka)

We have a strong pipeline of blockbuster drugs. In the next 4 - 5 years the release of these drugs in the market is sure to change the position of India on the global pharma map. Indravadan Modi Chairman healthcare. The formulations include tablets, capsules, oral liquids, dry syrups, sachets; sterile products namely, dry powder injections, ampoules and vials. The full-fledged R&D centre at the plant was established at a cost of ` 200 million. This plant, built upon the GMP guidelines of the European Community, deploys seven colours of the rainbow (Indradhanush) for total segregation of activities. This novel concept, introduced for the first time in India, totally eliminates the possibilities of crisscrossing and contamination. Other unique features of the plant include designing without wood or asbestos component, each zone has separate Air Handling Units (AHUs), dehumidification unit, and dust extraction systems. Separate sanitary water circulation loops for purified water and water for injection with on-line monitoring and control for TOC, conductivity, pH, temperature and microbial counts, as per USP standards have Leading innova ons been installed. Risorine: A product that has revolutionised the Leaping ahead treatment for TB by reducing the dose of Rifampicin Cadila Pharmaceuticals has and increasing patient compliance also entered into strategic Polycap: Pill that reduces the risk of cardiovascular disorders by 68 per cent and stroke by 42 per cent as alliances to broaden its per t he L ancet E ditorial (September 2009) horizons. The newly Next generation influenza vaccine: Virus-Like launched CPL Biologicals Particle (VLP)-based vaccine for seasonal and is a joint venture with H1N1 Influenza Novavax, Inc USA, which Novel formulations: Some examples; Rabeloc IV: will be developing and Rabeprazole sodium for intravenous administration manufacturing vaccines, by rapid onset of action, sustained and long term biological therapeutics lowering of gastric pH; Scat eye drops: Sparfloxacin and diagnostics in eye drops – for treating complex eye infections India. In addition, CPL Immuvac: Immunomodulator that not only enhances Biologicals will establish the immunity but also helps patient combat side manufacturing facilities in effects of chemotherapy India and develop, produce

envied pharmaceutical installation in the Asian sub-continent. The habitat is free from any risks of air pollution, fumes, industrial wastes and pests. The facility has been approved by various regulatory agencies including the UK-MHRA, TGA-Australia and African regulatory agencies like MCCSouth Africa and NDA-Uganda. The site is ISO 9001 and 14001 certified, and follows the most stringent cGMP norms. The huge spread houses four major buildings – manufacturing, R&D (formulation development - novel dosage form development, novel drug delivery systems), chemical research (API) (anti-hypertensive, anti-histaminic, anti-diabetic, anti-ulcerants, antidepressant, anti-tb), and CRO (clinical pharmacology, pharmacokinetics, toxicity, bio equivalence). The manufacturing unit produces over 350 products, covering 45 therapeutic groups in human and animal

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and sell products such as seasonal influenza vaccine and potentially other novel vaccines against dengue fever and chikungunya fever based on Novavax’s Virus-Like Particle (VLP) vaccine technology. Stemcyte India, which is into umbilical cord blood stem cells banking is a joint venture of Cadila Pharmaceuticals with Stemcyte Inc USA and Apollo Group. Cadila Pharmaceuticals has also entered into a joint venture with Apollo Group to manage Apollo Hospitals, Ahmedabad. Recently, the company has entered into strategic alliance with the Swedish Bactiguard, which provides world-leading solutions preventing hospital-acquired infections. The current therapeutic segment that ranges over 45 categories majorly focusses on cardiovascular and gastrointestinal drugs. The pipeline targets a few particular areas including: cancer vaccine - improving immunogenicity of cancer antigens, management of sepsis - immune correction in management of sepsis to improve survival, adjuvant development - use of novel immuno-modulator, development of small molecule adjuvant. Delivering high quality and affordable treatment. Avers Modi, “We have a strong pipeline of blockbuster drugs. In the next 4 - 5 years the release of these drugs in the market is sure to change the position of India on the global pharma map.” Achieving the motto of providing high quality and affordable treatment, Cadila has several Corporate Social Responsibility (CSR) activities also to its credit, including a charitable hospital, ‘Kaka-Ba’ located in the area of Hansot village in Bharuch district. It also works closely with NGOs by way of assistance and support for mid-day meal programmes. After changing how the world views India’s capability of manufacturing medicines, Cadila Pharmaceuticals Ltd has now set target to put India on the global map. By bringing unique products every few years, and a strong pipeline of blockbuster drugs, Cadila will act as the catalyst for Indian pharma’s growth story in ways more than one. (parita.dholakia@infomedia18.in)

Insight & Outlook

Pharma SEZ Latest amendments in the SEZ Act Will they make or mar? .......................................................42 Evolution of pharma companies in various SEZ Sketching the growth story .................................................44 SEZs attracting pharma companies Focussing on the Southern and Western regions .................48 Managing SEZs Expectations from the central government...........................50 Interface Hitender Mehta Co-chairman, Special Task Force on SEZs, ASSOCHAM ........52 Neuroendocrine carcinoma therapeutics market Pipeline candidates to intensify future competition .............54

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Insight & Outlook: Latest amendments in the SEZ Act

Will they make or mar? Established with an aim of driving the economy of a developing nation like India, are the changes in the SEZ Act proving otherwise? With recent amendments in the Act and its implementation, the industry is not too optimistic regarding the future of SEZs in India.

Act that has encouraged the growth of pharma companies in the country, some latest amendments and the decision to continue with them have severely affected the SEZs in India. But before delving into the negative side let us catch a glimpse of the features and outcome of the SEZ Act over the years.

The salient features

Titash Roy Choudhury

he concept of Special Economic Zones (SEZs) had existed in developing countries such as China, Bangladesh, and India followed the footsteps of its competitor and developed such zones in the country. To develop such special zones that would increase the exports of the country along with attracting investment among other factors, the Indian government took the initiative to develop a policy framework under the SEZ Act. In May 2005, a comprehensive Special Economic Zones Act 2005 was passed by the Parliament. The SEZ Act 2005 and

the rules of the SEZ Act came into force from February 10, 2006. Investment of the order of ` 100,000 crore over the next three years with an employment potential of over 500,000 was also expected from the new SEZs. When we talk about SEZ we refer to a geographically enclosed area managed by a single body, offering certain incentives to businesses, which are situated within the zone, while an Export Processing Zone (EPZ) is a type of SEZ, which is legally defined as a ‘policy enclave’ within the state where distinct custom and trade regulations apply. To regulate SEZs, the Act was brought into action and since its inception many changes have followed. Along with the positive aspects of the

There are various stakeholders in developing an SEZ; the developer and operator, occupant enterprise, out zone supplier and residents, and this Act provides a comprehensive SEZ policy framework to satisfy the requirements of all the stakeholders. “With the introduction of the Special Economical Zone Act in India in 2006, SEZs have grown at a vigorous rate driven by its goal of providing an internationally competitive and hasslefree environment for exports,” says Bodh Raj Sikri, Vice President, BDMA and IDMA. Another major feature of the Act is that it claims to provide expeditious and single window clearance mechanisms. The responsibility for promoting and ensuring orderly development of SEZs is assigned to the board of approval, which is to be constituted by the central government. The Act also ensures exemption from custom duties, central excise duties, Service Tax, central sales taxes and securities transaction tax to the developers and the units. Sector-specific SEZs with a focus on pharma and biotech offer infrastructure required by these industries such as R&D facilities and opportunities for international business. “The SEZ Act gives many benefits to the developers as well as the companies, which set up units in the area, Income Tax exemption on profits earned through exports of goods out of India to the extent of 100 per cent for first five years and 50 per cent for next five years. Then, there is exemption from all indirect taxes, such as customs, excise, Value-Added Tax (VAT), Sales Tax, etc on capital and other goods and services required for manufacturing or service activities, exemption from capital Gains Tax on transfer of assets and land on relocation from an urban area to SEZ and simplified procedures for assessment and

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Latest amendments in the SEZ Act

SEZs have grown at a vigorous rate driven by its goal of providing an internationally competitive and hassle-free environment for exports. Bodh Raj Sikri Vice President, BDMA and IDMA

examination of export import cargo and reporting with a single window clearance for all requirements,” mentions Sikri.

The outcome The Act has also been successful in creating more SEZs in India and encourage the growth of the same. Prior to the enactment of the SEZ Act, 2005, there were 19 SEZs across India, while the government has now approved 581 SEZs according to SEZ India, 2011 with a further 154 with in-principle approvals. Of all the sectors, IT and IT-enabled services sector has a 61 per cent share of SEZs, while the biotech, pharma, textile sector and multi-product SEZs have less than 10 per cent share each. And these increased SEZs have also directly increased the exports percentage; the Ministry of Commerce and Industry claimed that the value of exports from functioning SEZs increased from £ 1.9 billion in 2003-04 to £ 30.6 billion in 2009-10. While the growth rate of exports have increased to 52 per cent from 25 per cent before the SEZ Act, 2005, and it stands at 121.40 per cent in 2009-2010 (SEZ India, 2011a, export performances). And as for the pharma industry specifically, “These SEZs have been beneficial for the growth and development of the Indian pharma industry, as due to nil rate of central excise duty most of the big brands in the country have set up their plants in these areas; majority of the plants are as per the latest requirements, are GMP compliant and having huge capacities; the outlook of SSI pharma industry has been totally changed in these areas. Due to these SEZs, huge

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Due to nil rate of central excise duty most of the big brands in the country have set up their plants in these areas. Vinod Kalani Chairman, MSME, Sub-Committee, IDMA

production capacities to manufacture pharmaceutical formulations have been added in our country, and this will help in increase of exports from our country,” avers Vinod Kalani, Chairman, MSME, Sub-Committee, IDMA.

Amendments and repercussions Over the years, several amendments have been made to the Act. They have primarily revolved around specifying the provision of infrastructure and requirements for establishment of SEZs.

Prior to the enactment of the SEZ Act, 2005, there were 19 SEZs across India, while the government has now approved 581 SEZs.

But during Budget 2011-12 suddenly the Indian government declared the imposition of Minimum Alternate Tax (MAT) and Divident Distribution Tax (DDT) and this year’s Budget continued to follow that decision. The negative aspect of the government’s sudden imposition of MAT is a great set back to the industry and the decision to impose MAT on proprietor ship and partnership companies shall affect their cash flow and profitability. Earlier no MAT was charged but in Budget 2011-

12, the government announced levying of MAT at the rate of 18.5 per cent on profits for SEZ developers and industry, effective from April 2012. “There should not be MAT in these SEZs, as on one side you are free from paying Income Tax for certain period , while on the other hand you have to pay MAT; the funds are blocked which otherwise can be used for more productive work,” says Kalani. He further adds, “Pharma companies are getting the required incentive for operating in SEZs but due to reduction of central excise duty in past few years the overall benefit to operate out of these SEZs have been wiped off, as the cost of production is more in these areas. While now the benefit of central excise is very minimal, practically now they are at par with the rest of the country.” While Sikri believes that this move is betrayal on behalf of the government and says, “Industry criticises this proposal stating that such move would lead to either companies opting out or putting their projects on hold, challenging the inflow of capital funds and investments and stifling exports from these zones.” Another change that has resulted in further setback is that various state governments keep on increasing the electricity tariff from time to time, which affects the profitability of the unit concerned. Thus, it is unanimously believed that government should not deviate from its commitment to SEZs by bringing in additional burden instead should work more concretely to promote the growth of SEZs. (titash.choudhury@infomedia18.in)

Insight & Outlook: Evolution of pharma companies in various SEZs

Sketching the growth story Special Economic Zones (SEZs) established by the government have helped the pharmaceutical industry grow enormously. With the SEZ Act in place along with various benefits offered by the government, participation in SEZ has increased. We trace the evolution of various pharma companies that exist in the SEZ sector.

Capital investment subsidy of 15 per cent on plant and machinery subject to a ceiling of ` 3 crore Adequate allotment of cheap land and faster clearances from all government departments Creation of the necessary basic infrastructure These incentives helped the government pool in a number of companies to enter SEZ. â&#x20AC;&#x153;The factor that helped lure pharmaceutical companies into the SEZ was the redemption from tax and other duties. All companies want to save on the money they spend of export and import duty and more, hence, a number of companies came forth after the enactment of the SEZ Act,â&#x20AC;? informs Kayvanna Shah, CEO, J B SEZ Pvt Ltd.

Companies in abundance

Jasleen Kaur Batra

EZ is primarily an area that has been demarcated as enclave, which is duty free and is treated as a foreign territory for various purposes such as tariffs, trade operations and duties. Today, the SEZ sector in India has evolved from what it was a few years back as the government has made a number of provisions, which have not just attracted the domestic companies but also the ones from abroad.

the Government of India announced the introduction of the SEZ policy in April 2000. The category SEZ covers a broad range of more specific zone types, including Export Processing Zones (EPZ), Free Trade Zones, Industrial Estates, Free Zones and Free Ports. After the policy was announced the government formed an act called the SEZ Act. The Act listed a number of provisions for the companies who would be a part of the SEZ.

Incentives provided How it all started The Ministry of Commerce and Industry in the Government of India, in a policy initiative to boost exports encouraged the setting up of SEZs across the country. To augment foreign investment as well as promote exports from the country,

Exemption from payment of excise duty on all products manufactured at new units set up 100 per cent exemption from payment of income tax for the first 5 years and 30 per cent exemption for the subsequent 5 years

By tracing the origin of SEZs, one would learn that it was as early as 1965 that India experimented with the concept of such units in the form of EPZ. However, a revolution came in 2000, when Murlisone Maran, then Commerce Minister, made a tour to the southern provinces of China. After returning from the visit, he incorporated the SEZ into the Exim Policy of India. Five years later in 2005, the SEZ Act was introduced, which was amended in February 2006. The first EPZ was set up in Kandla in Gujarat as early as in 1965. It was followed by the Santacruz EPZ in Mumbai, which came into operation in 1973. Today, several states in India have set up SEZ with the intention of promoting investments in production facilities that would generate substantial local employment and help develop the relatively backward areas. One of the much hyped schemes was the one set up by the Government of Himachal Pradesh, a state in North India, in 2003 at Baddi, situated about 45 kilometers from the city of Chandigarh. The BaddiNalagarh-Barotiwala belt was designated an SEZ and several financial and tax incentives were announced to encourage development in that area. Many companies have consequently set up new plants in the Baddi-Nalagarh-Barotiwala belt. These include well-known names like Ranbaxy,

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Evolution of pharma companies in various SEZs

All companies want to save on the money they spend of export and import duty and more, hence, a number of companies came forth after the enactment of the SEZ Act. Kayvanna Shah CEO, J B SEZ Pvt Ltd

Instead of giving 100 per cent tax exemption for 5 years they brought in MAT, which is about 25 per cent. Hence, a number of people are questioning their decision to re-establish themselves in an SEZ. P C Nambiar Group Direct, Poonawala Group of Companies and National Vice Chairman, Export Promotion Council for EOU and SEZ

facilities, especially an assured supply of pure water to the industrial units and the surrounding areas. “In addition to this IL & FS in association with MIDS signed a Project Development and Promotion Partnership agreement with the latter for development of the proposed four SEZs in Maharashtra through the unique Public-Private Partnership model in 2006,” informs P C Nambiar, Group Direct, Poonawala Group of Companies and National Vice Chairman, Export Promotion Council for EOU and SEZ. Hyderabad has several major bulk drug as well as pharmaceutical units like Dr Reddy Labs, Aurobindo Pharma and more. To effectively address the issue of migration of state-based pharma units to Himachal Pradesh, Uttaranchal and Jammu & Kashmir due to heavy tax incentives, Case Study the Andhra Pradesh J B SEZ Pvt Ltd, Gujarat Government decided to Challenges: We took a clear title land from GIDC develop an SEZ exclusively that was the first starting point so we did not for pharma formulations in have any problem in acquiring land. We got fast 2006. Aurobindo Pharma clearances from the Gujarat government so it was and Hetero Drugs are not a problem. The single window mechanism was a part of this SEZ and a great help. They were very positive and helpful. have acquired 240 acre for We got water and power from the local providers so it was not an issue. the same. Investment: Total investment made since the time At the same time, of inception is ` 200 crore. pharmaceutical SEZs have Poonawala Group of Companies, Maharashtra witnessed a few turbulences. Challenges: Even though we bought the land The Government of India and have not taken any physical support from had made various provisions. the government it took 4 months to obtain the Unfortunately, the Finance clearance. The land is well connected with the Ministry was not pleased highway so there was no problem. with the exemptions given Investment: Total investment made since the time to SEZs. “This is when in of inception is ` 1200 crore. Budget 2011 the finance

GSK, Cadila, Torrent, Alembic, Panacea Biotec, Sun Pharma, Dr Reddy’s Labs, Nicholas Piramal, Wockhardt, Zydus Cadila and more. Another region that is leading in the pharmaceutical SEZ space is Maharashtra. Studies and surveys conducted by IL & FS have shown that SEZs together are expected to attract a huge total investment of around ` 17,000 crore, creating more than 50,000 jobs. Maharashtra Industrial Development Corporation (MIDC) too wanted to create SEZ in its region. Hence, with the objective of spreading industrial culture and create employment, Maharashtra, in the very first year of its establishment, came up with plans to develop 14 industrial areas. Today, MIDC provides acquisition and disposal of land, maintenance of infrastructure

ministry introduced Minimal Alternate Tax (MAT) of 5 per cent as well as Dividend Distribution Tax (DDT). This made a number of companies question the motive of the government, and hence a downfall was witnessed,” says Shah. Further elaborating on the issues faced, Nambiar, says, “Initially, the central government made a mistake in calculating the factory profit limit, which was corrected after the SEZ law was passed. Hence, instead of giving 100 per cent tax exemption for 5 years they brought in MAT which is about 25 per cent. Hence, a number of people are questioning their decision to re-establish themselves in an SEZ.”

More shall prosper? Inspite of these challenges, a number of companies have been stepping into SEZs as it is one of the most profitable ventures. Today, India has 1,022 units in operation in nine functional SEZs, each with an average size of 200 acre. Eight EPZs have been converted into SEZs. The capital generated from pharmaceutical SEZ exports in 2009-19 was ` 1505 crore, which is an achievement. “Places like Maharashtra, Gujarat, Andhra Pradesh, Tamil Nadu and Karnataka have set up pharmaceutical SEZs primarily due to the advantages that a company can avail in terms of exemption of duty and tax. However, if the Government of India provides a stronger support the SEZ sector in India would definitely grow as it would not just attract the local but international players as well,” explains Shah. (jasleen.batra@infomedia18.in)

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Insight & Outlook: SEZs attracting pharma companies

Focussing on the

SouthernandWestern regions

Having developed SEZs for attracting pharmaceutical companies, a few states in India are slowly becoming major pharma hubs. Equipped with better infrastructure and state policies these SEZs have evolved into pharma zones generating sizeable exports for the Indian pharma industry. Titash Roy Choudhury

he evolution of Special Economic Zone (SEZ) in India has been fast paced and has made considerable efforts to drive the exports of the developing nation. But the concept of SEZ has developed from the concept called Export Processing Zone (EPZ) and India’s first EPZ was in 1965 at Kandla, Gujarat; in fact it was the first EPZ of Asia. Though the performance of Indian EPZs was considered languid in comparison with their counterparts in other parts of Asia, the EPZ scheme was continued through the 1970s and the ‘80s. But then the Indian government wanted to have one window clearance and at the same time attract foreign investment, so

they decided to develop SEZ policy in 2000. “Following the success of SEZs in China, India was prompted to follow the same route to launch SEZ regions. The idea behind setting up the manufacturing SEZ regions was to encourage investments from India and overseas across different regions and states, promote exports, create employment, infrastructure, attract superior technology and boost the exports from India. The policy has proven to be a huge success and made SEZs the growth engine for the country’s exports and creating quality infrastructure,” states Kayvanna Shah, CEO, J B SEZ Pvt Ltd. Exports to the tune of ` 3 lakh crore from the SEZs registered a growth of over 43 per cent over the previous year. The numbers speak for themselves in indicating the success of the SEZ model in boosting the

economy. For pharmaceuticals, there are 6 to 7 operational SEZs in India of which SEZs in Andhra Pradesh and Gujarat have attracted the maximum pharmaceutical companies over the years.

The Southern glory: Andhra Pradesh The biggest SEZ for pharmaceuticals in the state was developed by the Andhra Pradesh Industrial Infrastructural Corporation Ltd (APIIC), a state government body in Pollepally village, Jedcharla, Mandal, Mahaboobnagar District, Andhra Pradesh. This SEZ developed in 2007 is meant specifically for pharmaceutical formulations and covers 101 hectare. Since its development in 2007 many pharmaceutical companies have opened their units here. Considered as an immense boost for the pharmaceutical industry two major pharma companies Aurobindo and Hetero Drugs had come forward to set up their formulations units and boost exports. Aurobindo Pharma, which had been allotted 75 acre, commenced its operation from this SEZ in 2009 with an

Modern Pharmaceuticals I June 2012

SEZs attracting pharma companies

Various pharma SEZs have provided several beneﬁts to the country along with a direction and encouraged in creating an environment, which is investor friendly.

The inclusion of Minimum Alternate Tax (MAT) and Dividend Distribution Tax (DDT) on developers and unit-holders came as a surprise to many in the industry. Kayvanna Shah CEO, J B SEZ Pvt Ltd

Bejon Misra Founder, Partnership for Safe Medicines (PSM) India

investment of ` 157.63 crore. This SEZ has been attracting many companies and has turned out to be a huge promoter of growth for the formulations market. AP Healthcare has been allotted 26 acre, while Hetero Drugs has got 66 acre, Hetero Labs 9 acre and Raichem Pharma 6.28 acre. Epsilon Pharmaceuticals, MSN Laboratories, Glochem Industries and Smilax Laboratories have been given 5 acre each at the SEZ. Reevax Pharma has been allotted 2,400 sq yards. Another area within the state, which has also been developed as a SEZ, and attracted pharma companies is Vishakhapatnam where more than 20 pharma companies are operating. The Jawaharlal Nehru Pharma City, developed by Ramky Group in collaboration with APIIC, has 17 pharmaceutical companies. Global giants such as Eisai Pharma of Japan and Pharmagel of Germany have also made their mark in this area. This location has attractions of goof infrastructure facilities, large talent pool and easy access to global destinations due to presence of ports. At the Vizag SEZ, Dr Reddy’s Labs has been allotted 10 acres of land and the company has made an investment close to Rs 44 crore for the formulations unit. Gland Pharma has also set up a manufacturing unit in the SEZ. “Andhra Pradesh has become a pharma hub for excellent infrastructure and prompt processing time for approvals and mandatory requirements,” says Bejon Misra, Founder, Partnership for Safe Medicines (PSM) India.

biotechnology and chemical hub for such industries. “The respective state governments have had a bigger role to play in such cases as they recognised the potential of these locations and took the initiative to set up industrial regions there. Factors such as pro-activeness from the state government, availability of clear title land, quality infrastructure and fiscal incentives were instrumental in making these regions as industrial pharma hubs to operate from,” says Shah. Gujarat is set to register tremendous benefits from the development of SEZs, as it already has an established pharma environment. Through these SEZs, pharma companies in Gujarat will further facilitate India’s integration in the global pharma industry. There are four operational pharma SEZs in Gujarat; Pharmez developed by Zydus covering a total area of 49 hectare at Ahmedabad, the SEZ is meant for pharmaceuticals and R&D. Also, there is JB SEZ spread across 312 acre at Panoli, Gujarat, Pahez SEZ developed by CPL Infrastrcuture Pvt Ltd at Ahmedabad covering 200 hectare and lastly there is Dishman SEZ developed by Dishman Infrastructure Ltd at Ahmedabad, an SEZ meant for pharmaceuticals and chemicals. “In all these states, establishment of such SEZs is growing due to availability of infrastructure, manpower and commercial incentives. The state governments are ensuring prompt attention towards the projects and all the required mandatory approvals,” says Misra.

Bright Western region

Potential SEZ: Maharashtra

States such as Gujarat and Andhra Pradesh have always been a pharmaceutical,

Maharashtra is the potential pharma hub to be in the future with more than

June 2012 I Modern Pharmaceuticals

four respective pharma SEZs situated within the state. We have Wockhardt Infrastructure SEZ at Aurungabad along with Ajanta Projects SEZ. In Pune there is Serum Bio-pharma Park, and MIDC has developed two pharma SEZs one in Ratnagiri and other at Nanded. This state has been witnessing influx of many upcoming pharma companies and has been contributing to the increased pharma exports of the country.

Benefits and drawbacks “Various pharma SEZs have provided several benefits to the country along with a direction and encouraged in creating an environment, which is investor friendly. Indian companies can take full advantage of all such incentives to make themselves globally competitive. Government has also invested in modern laboratories to support innovation and good manufacturing practices among small and medium scale pharma industries,” states Misra. But in the recent past certain decisions of the government has adversely affected the pharma SEZs in India. “The inclusion of Minimum Alternate Tax (MAT) and Dividend Distribution Tax (DDT) on developers and unit-holders came as a surprise to many in the industry,” says Shah. In spite of the imposition of these taxes, the general view is that SEZs would still continue to be the engine drivers for the economy in terms of boosting exports and attracting investments in various industries. (titash.choudhury@infomedia18.in)

Insight & Outlook: Managing SEZs

Expectations from the central government It is the responsibility of the central government to take all the decisions pertaining to SEZ. The state government has no role in it. A look at the expectations from the Centre. Chandreyee Bhaumik

n April 2000 the Special Economic Zones (SEZs) policy was first introduced in India as a part of the Export-Import (EXIM) policy of India. Comprehending the requirement to enhance foreign investment and promote exports from the country and realising the need that level playing field must be made available to the domestic enterprises and manufacturers to be competitive globally, the Government of India in April 2000 declared the introduction of SEZ policy in the country. SEZs are considered to be foreign territory for the purposes of trade operations, duties and tariffs. In order to provide an internationally competitive and problem-free ambience for exports, units were allowed be set up in SEZ for goods and services. Further, all the operations (import and export) of the SEZ units are on a self-certification basis. And the units in the zone are required to be a net foreign exchange earner but they would not be subjected to any pre-determined value addition or minimum export performance requirements. Next, sales in the domestic tariff area by SEZ units are subject to payment of full custom duty and as per import policy in force.

Governing policy The policy concerning SEZs provides for setting up of SEZs in the public, private, joint sector or by state governments. Additionally, it is said that some of the existing export processing zones would be converted into SEZs. Accordingly, the government has converted Export Processing Zones (EPZs) located at Kandla and Surat (Gujarat), Cochin (Kerala), Santa Cruz (Mumbai-Maharashtra), Falta (West Bengal), Madras (Tamil Nadu), Visakhapatnam (Andhra Pradesh) and Noida (Uttar Pradesh) into SEZs. In addition to the above, three new SEZs are also approved for establishment at Indore (Madhya Pradesh), Manikanchan – Salt Lake (Kolkata) and Jaipur. Now, these SEZs have also started with their operations. Explaining in this regard, Manish Doshi, President, Indian Drugs Manufacturers Association & Managing Director, Amoli Organics Pvt Ltd, says, “As far as SEZs are concerned most of the policies are formulated by the Centre. It is the responsibility of the Centre to give approvals. The state government does not take part in any decision making or in bringing any changes in the policies.” Elaborating on the role of

As far as SEZs are concerned most of the policies are formulated by the Centre. It is the responsibility of the Centre to give approvals. Manish Doshi President, Indian Drugs Manufacturers Association and Managing Director, Amoli Organics Pvt Ltd

the central government for managing the SEZs, T S Jaishankar, Managing Director, Quest Life Sciences (P) Ltd, avers, “All policies are created by the central government only. The state government has no role to play. Every decision and changes are taken by the Ministry of Commerce, Delhi. We have copied the model from China.”

Changes expected from the Centre It is the central government that is responsible for all the decision-making process. Talking about the policies regarding SEZs, Doshi says, “With SEZs coming under Minimum Alternate Tax (MAT) one of the major incentives of SEZ is lost. Now, with MAT, the units will have to pay the taxes.” Elaborating on the changes expected, Jaishankar adds, “SEZ is a good concept. Primarily there are two factors (infrastructure and units) that form SEZ. The infrastructure segment is responsible for road improvement, land development, lights, etc. That is, they are responsible for providing the SEZ workable conditions. The government on the other hand is responsible for setting up of customs house and controls the entry and exit of goods in the SEZ.” He highlights, “At present, an SEZ should have a minimum area of 100 acre or more. But, practically speaking this is not a feasible number. With this rule in place, several small SEZs are not allowed to establish. Hence, the government is rethinking on this.” (chandreyee.bhaumik@infomedia18.in)

At present, an SEZ should have a minimum area of 100 acre or more. But, practically speaking this is not a feasible number. With this rule in place, several small SEZs are not allowed to establish. T S Jaishankar Managing Director, Quest Life Sciences (P) Ltd

Modern Pharmaceuticals I June 2012

Insight & Outlook: Interface - Hitender Mehta

“The kind of infrastructure that is available to Indian SEZs is outstanding” …believes Hitender Mehta, Co-Chairman, Special Task Force on SEZs, ASSOCHAM. Holding years of experience in the SEZ sector, he has also authored a book called ‘Law & Practice relating to Special Economic Zones.’ Here, he opines on the current SEZ scenario. Jasleen Kaur Batra

How important and relevant is the SEZ Act? The Special Economic Zone (SEZ) Act is a treasure for the Indian pharmaceutical industry. Today, there is no other Act as strong as that of the SEZ Act and definitely no sector as strong as the SEZ. What one generally comes across is an Act passed by the government, which can be easily amended. But this is not the case with the SEZ Act. For instance, the other schemes/Acts that are present in India were announced by the foreign trade policy, but their tax incentives were contained in the Income Tax Act separately. There was no separate law for those schemes, so their quality contained the broad provisions for those schemes and different provisions were provided in different schemes. But all these benefits have been provided in the SEZ Act. After the enactment of the Act, amendments were made in the corresponding enactments like Service Tax, etc, which were included in the law. Hence, if any benefit of the SEZ Act needs to be retracted, the government would not just have to make the necessary changes in the SEZ Act but in the actual Act. This Act is definitely relevant in today’s date. The reason the SEZ Act was passed was to provide a stable

policy framework in the country. If any investor wants to come to India and set up a factory in the SEZ unit they need to have trust and faith in the government and their policies. As the parliament guarantees all these benefits, national as well as international companies have been coming forth to set up their unit in SEZs. What was the purpose of setting up SEZ? How has been the growth of SEZs? There were multiple reasons behind setting up SEZs. First was to earn foreign exchange money. Today, out of the total turn over of the SEZ, 87 per cent of it is exported; only 13 per cent is being sold in the Indian market. Second, was the creation of infrastructure - the kind of infrastructure that is available to Indian SEZs is outstanding; it would not have been possible for the Indian government to provide such infrastructure without support of the private sector. Third, was creation of employment – the SEZ sector has created more than 8 lakh jobs across the nation over the years. Another criterion was to increase the business activity. SEZ is the only sector that has been growing year after year even in the time of recession.

Before the SEZ Act was established there was an Act called Export Procession Zone (EPZ). This Act was operated in India for 35 years from 1965-2000. When the government decided to discontinue the EPZ Act, the SEZ Act came into being. Over the past 10 years the SEZ market has grown from ` 8,000 crore to over ` 3,15,000 crore. Hence, the growth has been tremendous. Looking at the increase in the number of SEZs, the state of SEZ has definitely increased from the time it started; however, the industry has witnessed a setback over the past 2-3 years due to alterations made by the Government of India. The primary reason behind the setback is the lack of support provided by the Finance Ministry as they are not in favour of the SEZ sector. Due to this, over the years they have taken away a few benefits, for instance - there was exemption from dividend distribution for the developers, which they have retracted. This further created a sense of uncertainty among the SEZ stake holders. However, today there are around 580 SEZs approved, out of which 154 are operational and 380 are notified. This is for all SEZs across industries put together.

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Hitender Mehta What kind of government support is provided to pharma SEZs? An SEZ cannot be set up without the support of the government. The area requirements are quite sizable. The developer develops that particular SEZ area but the surrounding area needs to be maintained and brought up by the government. They have to provide basic civil facilitiesroad, power, telecom, water supply, rail or air infrastructure and all logistics. Also, no SEZ can be set up without receiving a no-objection as well as confirmation from the state government. Besides these the SEZ are entitled for a few exemptions like VAT, Customs and Excise, Income Tax, Foreign Direct Investment, Service Tax and more. What role is played by ASSOCHAM? ASSOCHAM is the only chamber in India that has an SEZ council constituted within the chamber. The SEZ council at ASSOCHAM is involved in a number of activities like creating awareness, representing the industry in front of the government, acting as an inter-mediator and many a times proactively raising issues with the government. Over the past seven years we have organised seven international SEZ conventions, where a number of international investors have been invited from different parts of the world. This year too we would be organising the convention in July and fi ve countries have already confirmed. What does the future of pharma SEZs in India look like? This depends on the business scale; if a pharma company wants to set up a new factory then SEZ is the best opportunity as all the material you bring in is duty free and so the cost of setting up a factory will be 15-20 per cent less than what is required in a domestic area. Today, out of 380 notified SEZs only 154 are operational, which contribute to almost 30 per cent of Indiaâ&#x20AC;&#x2122;s exports. There is a gap of 226 SEZs, hence when they come into being the state might change. Exports from SEZ might come to half of what India exports. But there are a few challenges in terms of the finance ministry. The environment is no longer SEZ friendly; hence, it is likely that not all will become operational. However, the mindset and approach of the government towards SEZ need to change. I feel the finance ministry has to understand that tax collection is not the only important factor, one needs to look beyond. If this change is made, only then will the industry witness the growth it is expected to. In pharmaceuticals, India has a huge opportunity as intellect is available for R&D space, but the problem lies when the investors come in India and see the state of the provisions made for the SEZ. We need to ensure that all the provisions made by the government are being given to the SEZ; this is the only way this sector will blossom in India. (jasleen.batra@infomedia18.in)

June 2012 I Modern Pharmaceuticals

Insight & Outlook: Neuroendocrine carcinoma therapeutics market

Pipeline candidates to intensify future competition Neuroendocrine carcinoma represents a large class of cancers. A report investigating the therapeutics market for neuroendocrine carcinoma provides valuable insights on the prevalent competitive landscape and the emerging players expected to alter the market till 2017. Neuroendocrine carcinoma therapeutics market, global, revenue and forecast ($ million), 2005-2017 200 CAGR (2010-2017):11.0%

Revenues ($ million)

150 CAGR (2005-2010):4.5%

100

2005

lobalData assesses the neuroendocrine carcinoma market until 2017 and reveals a strong competition in the pipeline. It identifies the key trends shaping and driving the global neuroendocrine carcinoma market. The report also provides insights on the prevalent competitive landscape and the emerging players expected to significantly alter the market positioning of the current market leaders. Most importantly, the report provides valuable insights on the pipeline products within the global neuroendocrine carcinoma sector.

2010

2017

cent over the next seven years, to value $ 187.9 million by 2017. The high growth is primarily attributed to the advent of approved drugs Sutent (sunitinib), Afinitor (everolimus) from 2011 onwards and the promising drugs Avastin (bevacizumab) for Gastrointestinal (GI) carcinoids and pancreatic Neuroendocrine Tumours (NETs), pasireotide (SOM 230) and Somatuline Autogel/Depot only for GI carcinoids NETs, which are expected to be launched in 2015. These factors will accelerate the growth of the neuroendocrine carcinoma therapeutics market.

Present high unmet needs Therapeutic market forecast to show high growth until 2017 GlobalData has estimated that the global neuroendocrine carcinoma therapeutics market was worth $ 90.7 million in 2010, and is forecast to grow at a Compounded Annual Growth Rate (CAGR) of 11 per

The GI carcinoids and pancreatic neuroendocrine carcinoma therapeutics market has high unmet needs due to high adverse effects of the current drugs in the market. To satisfy the high unmet needs in the existing market, a product would need to overcome the prevailing product

weaknesses and adverse effects of the current marketed products used in the treatment of GI carcinoid tumours and pancreatic NETs. The promising drugs in the pipeline can increase the scope for treatment of neuroendocrine carcinoma therapeutics market by being more efficacious and safer than the current approved drugs.

Intense competition for pipeline candidates GlobalData research indicates that the neuroendocrine carcinoma therapeutics pipeline has 16 molecules in different stages of clinical development. The late stage (Phase III) clinical development contains three promising molecules, including one First-in-class (FIC) molecule Avastin (bevacizumab) for GI carcinoids and pancreatic NETs, and two me-too molecules SOM 230, Somatuline Autogel/ Depot for GI carcinoids. These drugs are expected to take approximately seven years to reach the regulatory filing stage. In summary, the global neuroendocrine carcinoma therapeutics market is heading towards a strong competitive landscape.

GI carcinoids and pancreatic NETs: Weak vs strong market GlobalData found that the current competition in the GI carcinoids NETs is weak as Sandostatin LAR (octreotide acetate) is the only approved drug recommended for patients with this tumour. On May 5, 2011 Afinitor was approved by the FDA for the treatment of advanced pancreatic NETs. On May 21, 2011 Sutent was approved by the FDA for the same indication. Hence, the pancreatic NETs market is strong with two approved drugs. Some off-label drugs such as 5-fluorouracil (5-FU), adriamycin (doxorubicin), eposin (etoposide, VP-16), dacarbazine (DTIC), zanosar (streptozocin), cisplatin and cytoxan (cyclophosphamide) are also used for the treatment of gastroenteropancreatic NETs (GEP-NETs). Any drug that would successfully cater to these patient segments is expected to bring in revenues from the neuroendocrine carcinoma therapeutics market. (Courtesy: GlobalData)

Modern Pharmaceuticals I June 2012

Automation Trends: Case study - API Manager

A key tool for pharma project management By providing procedural compliance, cross-functional collaboration, improved operational performance, reduced cycle time and increased customer satisfaction, Goose API Manager is a business solution that streamlines the API manufacturing workflow.

ver the past few decades, the Active Pharmaceutical Ingredient (API) industry has been grappling with new challenges, wherein the market and the regulators have put significant pressure to adopt new regulatory changes and streamline business operations in alignment with global pharmaceutical regulations and setting international benchmarks within the API industry. Today, it is important for pharmaceutical companies to work closely with its technology providers and seek new improved ways to enhance their market and manufacturing competitiveness. Asian companies have stepped up their efforts to find new ways to ensure quality and safety in pharmaceutical products especially to tap market opportunities in regulated markets. With the rising

costs of pharmaceutical products and the emergence of low-cost competitors, manufacturing efficiency is becoming more important to developing nationâ&#x20AC;&#x2122;s API manufacturers as they eye regulated markets for growth - which means complying with GMP. The issue of cost and safety for API manufacturing firms has also become a key driver for growth in this industry. According to a Global Insights report â&#x20AC;&#x2DC;Challenges & Opportunities in the Global APIs Market: Latest Developments and Future Outlookâ&#x20AC;&#x2122;, published in early 2010, the global API market was projected to grow by around 7.3 per cent to an estimated market value of $ 139.2 billion by 2014. Hence, good drug manufacturing practices, reduction in time-to-market timelines, bringing down costs in pharmaceutical production, along with consistency in incorporating

regulatory and safety requirements, API manufacturing and market challenges have become more demanding than ever.

Understanding the needs The pharma industry has its share of troubled projects, and most pharma professionals know the impact of budget over run or failed projects hindering business growth. Most importantly, project management within the pharmaceutical industry has never been simple. Combined with the recent spate of downsizing initiatives, the thought to become leaner, more efficient and maintain productivity pose a big test for many pharma companies. On the other hand, getting products to market quickly and efficiently is crucial in pharmaceutical industry. One of the proven ways to reduce the risk of failure is to adopt result-oriented highly innovative global manufacturing methodologies as well as enhance production, distribution process that can be applied to each project. Improving the management of projects is one of the main areas for realising productivity gains. According to statistical data based on inspection observations, some of the major areas of GMP deficiencies by category are: Quality system elements/procedures documentation Process validation Procedures and facilities sampling

Screenshots of API Manager

Modern Pharmaceuticals I June 2012

Case study - API Manager Manufacturing documentation Potential for product contamination Specification and testing documentation Supplier and contractor audit and technical agreements Equipment validation Hygiene Duties of key personnel Potential for chemical/physical contamination Also, GMP guidelines aim to ensure the quality and consistency of APIs, vary between markets. In the US, current GMP (cGMP) guidelines allow for inspection of API producers worldwide, though the majority of inspections appear to be for domestic manufacturers, despite concerns about poorly regulated facilities elsewhere. Proposed legislation will be tighter, calling for mandatory inspections of cGMP facilities worldwide every two to four years. Hence, there is need for significant push to enhance process within many of the API manufacturing businesses, which can be driven by implementing new technology.

Goose API Manager: Advantage Goose API Manager is a business solution that streamlines the API manufacturing workflow. It provides procedural compliance, cross-functional collaboration, improved operational performance, reduced cycle time and increased customer satisfaction. It brings in GMP and maximises business value. It helps to communicate project objectives more effectively internally or with third party partners. It leads to operational excellence and develops strong project management culture. The solution seamlessly connects all the departments such as packaging, analytical, quality, manufacturing, supply chain, warehouse, regulatory affairs, business development and project management into one platform for the daily tasks of approval, rework, rejection, uploads, etc. It focusses on clientâ&#x20AC;&#x2122;s key business challenges and gives them customised solutions. The online system simplifies the workflow and helps in smooth data flow from one department to other.

It gives clear visibility of action points related to a project in terms of completion time, reasons for delay and when it could be completed. The solution offers better control and efficiency, ensuring successful completion of projects on time, thereby saving both time and money.

Simplifying API manufacturing process Goose API Manager accomplishes the indenting process, receipt & approval of raw materials for the labs and it easily visualises the status at every stage. Regulatory affairs department users manage their Drug Master Filing (DMF) preparation with ease using this application. It tracks the phases & tasks as it enables automated periodic reminders to the task owner for task completion. It minimises the follow-up chain. It helps to maintain DMFs, feasibility, optimisation, lab validation and stability detail reports. The dashboards and predefined KPIs such as schedule, critical milestone, submission batch hit rate, filing hit rate, cross-selling dossier, biostudy, evaluation, etc help in real-time decision making.

Salient features Goose API Manager is a web-based easyto-use interface. It can assign tasks and sub tasks (multiple-levels) with escalation matrix. It provides electronic change control, change request and deviation handling process. The application manages electronic reviews and approval process with workflow engine. It gives real-time statistical reports for all projects. It ensures full control over the project, improves quality, adds transparency and addresses regulatory concerns. It follows cGMP guidelines with 21 CFR Part 11 compliant access control. It also incorporates additional features like document schedule, audit trail, task monitoring, version control, search and retrieval functionalities and project archival. Goose project manager helps user to plan their work for the day/week/month based on the sorting system available.

The online system allows tracking and monitoring all aspects of the workflow with customised logins. It provides a safe environment to store electronic documents related to API activity. Alerts and escalations help to trigger slippages, which help management to take necessary remedial steps. It gives a better visibility to the management regarding each project status through dynamic trending. It helps to maintain DMF with relevant information, API details, reference materials, stability details, lab validation reports etc. The user dashboard, project home pages and comprehensive reporting allow for early detection of issues, thus helping to ensure that projects are delivered on time and within budget and control of projects and programmes, which is essential for good governance. Task approvals and workflow ensures relevant tasks are signed off before the project can continue. Project templates saves significant setup time and cost and ensures each project is set up correctly without missing important tasks and risks. Access rights ensure users can see projects assigned to them and to all, based on options. Goose API Manager is one central place to identify, record, manage and maintain risks and ensure that the projects run smoothly in excellent governance. It is a fully integrated online system, which supports the manufacturing process of the API industry. Through the adoption of Goose API Project Manager, it will help the API organisations proactively identify the key issues and improve the likelihood of success in all projects, large and small. (bharat@goose.co.in)

Bharat Gujavarti Director- Project Engineering, Goose Technologies

Modern Pharmaceuticals I June 2012

Energy Management: Renewable energy

Improvising on alternative ways Renewable energy plays a critical role in addressing the growing energy demand and solving various energy-related issues. Experts talk about renewable energy as a suitable solution to energy-related challenges of utilisation and hazards. Chandreyee Bhaumik

oday, for any pharma plant manager or manufacturing professional improving energy efficiency is a goal. Energy efficiency not only reduces overall manufacturing costs it also usually reduces environmental emissions, thus establishing a strong foundation for a corporate greenhousegas-management programme. For most pharma manufacturing plants, Heating, Ventilation and Air Conditioning (HVAC) is typically considered the largest consumer of energy. Motors and drives are used throughout the pharma industry in order to operate HVAC systems, to drive laboratory or bulk manufacturing equipment, including mixers, pumps, centrifuges and dryers, and to move and operate filling and finishing equipment. In order to prioritise areas for improvement, it is best to take a systematic approach and look at the entire motor system, including pumps, compressors, motors and fans, instead of examining each component individually. The following steps should be taken: Identifying all motor applications (eg fans, pumps) in the facility Documenting the specifications Compare the requirements with the actual use of the system to determine the energy consumption rate Collecting information on potential upgrades or updates to the motor systems, including implementation costs and potential annual savings.

Renewable energy With the development in technology and the imperative of using alternative energy, types of renewable energy are increasing. Further, global warming has aided to make renewable energy an attraction. Though there are many niche renewable energy types, the three major forms of renewable energy are solar energy, wind energy and biomass energy. Different types of renewable energy have their own advantages and disadvantages, which are specific to that type of alternative energy. While solar and wind are intermittent in nature, geothermal energy has no such problems; however, geothermal energy suffers from a lack of

good sites and takes a long time to get installed. Thus, in few words, renewable energy technologies are clean sources of energy that have a much lower environmental impact than conventional energy technologies. Giving details about energy consumption rate, Dr Razia Sultana, Director (Programs), EPTRI, Hyderabad, avers, “In 2008, a total of 596,943 GWh were consumed in India. The largest consumer was industry with 274,531 GWh (46 per cent), followed by households with 124,562 GWh (21 per cent) and agriculture with 107,835 GWh (18 per cent). In the commercial sector (eg, offices and shops), 48,047 GWh (8 per cent) were consumed, 11,615 GWh (2 per cent) in rail traffi c and 30,353 GWh (5 per cent) in various other sectors. Between 1980 and 2009, energy consumption increased by almost seven times from 85,334 GWh to 596,943 GWh, which corresponds to an average annual growth rate of approximately 7.1 per cent. The growth in power consumption was seen in the industrial sector at 5.9 per cent per year, which corresponds to a five-fold increase.” The main drivers for the strong growth in the demand for power are the overall economic growth, power-intensive manufacturing industry that is growing disproportionately fast, rapidly rising consumption in households. Explaining the need of renewable energy, Dr Sultana highlights, “The total power generation capacity in India in March 2010 was 159 GW. Of this, 64.3 per cent was fossil fuel fired power plants (coal, gas, and diesel), 23.1 per cent hydropower, 2.9 per cent nuclear power and 9.7 per cent renewable energy. Renewable energy includes small hydropower plants (<25 MW ), biomass gasification, biomass energy, urban and industrial waste energy, solar energy and wind energy.” She adds, “For sustainable development of pharma industries comprehensive

Illustration: Sachin Bhogate

Modern Pharmaceuticals I June 2012

Renewable energy Comprehensive energy management, energy conservation, energy audit, energy balancing and identiﬁcation of alternative energy sources should be explored and carried out. Dr Razia Sultana Director (Programs), EPTRI, Hyderabad

energy management, energy conservation, energy audit, energy balancing and identification of alternative energy sources should be explored and carried out.”

The need to find alternatives Energy requirements have risen sharply in recent years, and this trend is likely to continue in the near future. For a Gross Domestic Product (GDP) annual growth of 8 per cent, the planning commission estimates that the commercial energy supply would have to increase at the very least by three to four times by 2031– 2032 and the electricity generation capacity by five to six times. In 2031– 2032, India will require approximately 1,500–2,300 Million Tonnes of Oil Equivalent (MTOE) to cover its total commercial energy needs. Dr Sultana says, “The Indian government by itself does not have sufficient financial resources to solve the problem of energy shortages. It must rely on co-operation with the private sector to meet future energy requirements. This opens up interesting market opportunities for international companies. In order to achieve this, the speed with which new capacities are built must increase five-fold. Such a massive increase requires a fundamental restructuring of the entire power market, which the government has begun through enactment of the Electricity Act.” In the present context renewable energy is gaining importance for various reasons such as to mitigate climate change and over come shortage of power/

The challenge is in the mindset that needs to be worked upon. Enough education is required in this context and as a result more technologies will usher in. Dr Anurag S Rathore Associate Professor, Department of Chemical Engineering, Indian Institute of Technology, Delhi

electricity etc. The source of energy that automatically gets renewed and which will not get depleted is the renewable energy. Dr Anurag S Rathore, Associate Professor, Department of Chemical Engineering, Indian Institute of Technology, Delhi, says, “Pharma companies are considerably thinking about renewable energy. With advancement in technologies the concept will be further improved.

The renewable energy has the potential to improve energy security and reduce dependence on imported fuels and electricity while striving to meet the goals.

As far as the role of the government is concerned, I believe if the government gives tax break and other incentives then the situation will improve. If the client wants to make major changes there is a cost associated with it and if somehow that can be subsidised then the majority of the problems will be solved.”

Future ready India has great potential to accelerate the use of its endowed renewable resources to power its growing economy with a secure and affordable energy supply.

The Government of India recognises that development of local, renewable resources is critical to ensure that it is able to meet both its economic and environmental objectives, and it has promoted this development through policy action. Dr Sultana says, “The Indian economy has experienced tremendous growth over the past several years. For the Indian economy to continue there is a need to address its energy challenges, which cross all sectors and impact all citizens. The renewable energy has the potential to improve energy security and reduce dependence on imported fuels and electricity while striving to meet the goals. The off-grid renewable energy as a practical, cost-effective alternative to an expansion of grid systems is a good option. The Indian government is aware of the size and importance of the challenges and that success will depend on structural changes in the industry and on new technologies and business models.” There are indeed challenges in the way ahead. Discussing the challenges, Dr Rathore explains, “I think the challenge is in the mindset that needs to be worked upon. Further, there are technical problems, which if solved, the situation will definitely improve. Additionally, enough education is required in this context and as a result more technologies will usher in.” Renewable energy is one of the many ways to solve energy-related issues. (chandreyee.bhaumik@infomedia18.in)

Modern Pharmaceuticals I June 2012

Policies & Regulations: Trade secret protection

The need to be prudent If one is in the pharmaceutical business, information such as formulae, compositions, ingredients, designs, drawings, innovative techniques, proprietary compounds, clinical trial data, test results or new inventions for which patent applications have not yet been filed, must be kept confidential. Trade secrets are a form of Intellectual Property (IP) that pharmaceutical companies should not ignore.

What is a trade secret? A trade secret may be data or information having commercial value to a business, which is not in public domain and which the owner reasonably attempts to keep secret and confidential. As laid down by Article 39.2 of the Agreement on Trade Related Aspects of Intellectual Property Rights (TRIPS), there are three important criteria for regarding any information as trade secret, viz: (i) It must have commercial value as a secret. For a secret to have a commercial value, the test is not whether the secret has independent commercial value in general, but whether it has independent commercial value by not being known to other persons who can benefit commercially from its disclosure. (ii) It must not be generally known or readily accessible to people who normally deal with such types of information. Information which is in the public domain cannot be considered a trade secret within the meaning of this article. However, a trade secret can include a combination of elements that are in the public domain, if the trade secret constitutes a unique, effective, successful and valuable integration of the public domain elements. (iii) The lawful owner must take reasonable steps to keep it secret. For a trade secret to be considered protectable, information intended to be kept secret must be subject to reasonable efforts under the circumstances to maintain secrecy.

The Indian scenario

rade secret is any valuable information that has commercial value for your business. Especially considering the fact that drug discovery and development is such an expensive and time consuming process, with long screening processes, high attrition rates of unsuitable molecules and little guarantee of developing that blockbuster drug, which will provide much more than a return on investment, a leakage could translate into losses

of huge proportions. In vitro/animal testing results leaked before filing a patent application would result in loss of opportunity to obtain patent protection for lack of novelty. Clinical trial results leaked in an untimely manner could introduce bias into drug trials and adversely affect the development of life-saving drugs. In fact, as opposed to other forms of IP, the protection provided by a trade secret is perpetual, as long as you can keep it confidential.

India does not have a specific law for protection of trade secrets yet. But that is not to say that trade secrets have not been protected in India. Indian courts have creatively interpreted the common law by reading into contractual law, breach of confidence, and principles of equity to uphold protection of trade secrets in India. However, no remedy under criminal law is available in India, unlike the US wherein in addition to the Uniform Trade Secrets Act, trade secrets are also protected under the Economic

Modern Pharmaceuticals I June 2012

Trade secret protection Espionage Act, which make theft of confidential information a crime under certain circumstances. The law of breach of confidence is concerned not with the acquisition of information, but with its subsequent use or disclosure to his own advantage or to the prejudice of the lawful owner. An obligation of confidence arises where there is either a fiduciary relationship, a contractual relationship or an employeremployee relationship between the parties. A contractual relationship may be established between two parties by entering into non-disclosure agreements before the party which is the lawful owner of confidential information discloses some it to another party during the course of business. However, for there to be breach of confidence, there must exist information which is of a confidential character. A trade secret, once in public domain, loses its confidential character. India, being a signatory to the TRIPS Agreement, is under an obligation to bring its intellectual property laws in conformity with international standards, and to this effect, new laws are being proposed for the protection of trade secrets in India in the form of the National Innovation Bill, 2008.

Reasonable security measures The law requires that reasonable measures be taken by the proprietor of trade secrets to keep the information confidential. Some of the measures which can help establish a claim that such measures were indeed adopted are mentioned below: Trade secret policy: Every pharmaceutical business must identify what information should be kept confidential based on their value and sensitivity, and accordingly, formulate an ideal policy to preserve the confidential character of the information. Pharmaceutical scientists must also maintain records of their experiments and results to show that the trade secret was indeed developed by them and belongs to them. Non-disclosure agreements: It is advisable for the employers of a

June 2012 I Modern Pharmaceuticals

pharmaceutical company to enter into non-disclosure agreements with the employees to provide contractual remedy to them in case of misappropriation of such confidential information. Such agreements should define ‘confidential information’ and the exceptions to confidentiality. An even stronger remedy may be provided by adding non-compete clauses to such agreements to restrict the use of confidential information and trade secrets obtained during employment and to ensure that the employees do not compete unfairly upon termination of their employment. For example, if a few scientists employed by a pharmaceutical company decide to start their own pharmaceutical company, the non-compete clauses would pre-empt them from using the confidential information, which had come to their knowledge during the course of employment. However, such non-confidentiality agreements should be drafted keeping in view the limitations posed by Section 27 of the Indian Contract Act, 1872, which states that every agreement by which a person is restrained from carrying on any trade, business or profession, is invalid. Contract of employment and exit interviews: Contract of employment should, either expressly or impliedly, include the duty of fidelity to the employer, which can act as a measure to prevent breach of confidence by an employer during the course of employment. Exit interviews are a good way of reminding the employee of his obligation with respect to the company’s trade secrets. During such an interview, a form to this eff ect may be signed and kept on record along with the contract of employment and non-disclosure agreement previously signed by the exiting employee. Strong internal processes: To maintain the confidential character of trade secrets, it is advisable to have strong internal processes and appropriate security procedures. All

confidential information should be clearly marked ‘Confidential’ in all communications. If possible, only certain senior employees should be privy to such information and have access to specific sensitive areas of workplace where such information might be stored. Access to such specific sensitive areas of workplace should be allowed only after proper security checks. Information documented and accessed electronically should be protected using adequate software programs, firewalls and other online security systems to keep the information safe. In any case, all employees should be educated and be contractually bound to protect confidential information. These measures, though not absolute or full-proof, would be of evidential value in case of a dispute and enable the lawful owner to prove that ‘reasonable steps’ were taken to maintain secrecy.

Right step forward The National Innovation Bill is still at the stage of debates and discussions and it is to be seen what shape the Bill takes when enacted as a law. However, as is clear from the above mentioned discussion, such an Act will only give statutory force to the common law principles already being followed by our courts. Therefore, in any case, it makes tremendous business sense for pharmaceutical companies in possession of trade secrets to be prudent and take reasonable steps to ensure that the law is on their side in case of a challenge to their right of keeping vital business information confidential. (salhotra@lls.in)

Anuradha Salhotra Managing Partner, Lall Lahiri & Salhotra

Strategy: Retail pharmacies

Role of distributors If we retrospect and evaluate the pharmacy retail scenario, it has not been a rosy picture for the business. There are over 10 chains in India but none of them have scaled up nationally, and yes, 25 years is too long a time for any business to mature & take off. Are the roles not clearly defined?

ndia started its organised retail pharmacy journey way back in 1987, much before its Fast-Moving Consumer Goods (FMCG) retail journey (which started in 2000). It has been about 25 years of organised pharmacy retail in India now. If we look at the few top pharmacy retailers in this space; this is how the scene looks like... A retail pharmacy chain that started in 1987 has about 1,200 pharmacies today, but the pharmacy chain has been making money only in the hospital pharmacies, which helps to subsidise the loss from stand-alone pharmacies. The group had to shut down a good number of pharmacies last year due to severe losses. The chain grapples with its wrong strategy to open up 100â&#x20AC;&#x2122;s of pharmacies in a

short time, besides issues related to store formats and inefficiencies in supply chain. Another leading chain that started off in 1990s was an international pharmacy chain major that pulled off a good story by reaching about 140 stores pan India and making profits, but due to internal issues & supply chain problems had to wind up operations in 2009. Supply chain mismanagement was a significant reason in its downfall and subsequent closure. Overall, the scene is not a good one for pharmacy retail. Knowing well that every family spends on medicine regularly, still this segment (organised pharmacy retail) has literally failed to take off. Let us evaluate the role of distributors (wholesale supply chain) in the success of pharmacy retail.

Defined roles to play First, all pharmacy retailers failed to manage relationship with the fragmented distributorâ&#x20AC;&#x2122;s community in India. On one hand, in the US, there are about 200,000 retail selling points that include doctors, pharmacies, clinics, hospitals, nursing homes, and others that care for patients and consumers, there are three major pharmacy distributors sharing between 90-95 per cent of the total revenue, and supply to all the retailers across the US. On the other hand, in India, we have over 700,000 retailers and about 60,000 distributors (ie, about one distributor for about 11.66 retailers) and this is the key deterrent to the growth of retail pharmacy scenario in India. Having been the CEO of a leading pharmacy retailer/distributor in India and having advised five pharmacy chains in the region, I realised that one of the big problems is - managing procurement from 100â&#x20AC;&#x2122;s of distributors and trying to manage relationships with them. Still the replenishment never even reaches 80 per cent! The industry association of retailers and distributors has been a big barrier to the success of pharmacy retail &

Modern Pharmaceuticals I June 2012

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Retail pharmacies distribution. Which is ironical! The association has always boycotted (cut off or restricted supplies) to pharmacy chains on the pretext of safeguarding the interest of small retailers in India. But the same industry body initiated its own retail chain in 2007, which has so far failed to take off. Seeing that all the major retailers have faced supply chain issues, which leads to prescription bouncing and dwindling sales and reputation, finally leading to a struggle to keep the business afloat, it is clear that till the supply chain issues are sorted, none of the pharmacy retailers can succeed in India.

More number of distributors: Not helping retailers? With the mergers that have happened within the pharma industry, there has been a disproportionate increase in the number of distributors, rather than a decrease, while the number of retailers has remained the same! For example, if a company X merged or acquired Y and later acquired or merged with Z, distributors of all the three companies started getting products of X, Y & Z. So earlier, one distributor could supply the retailers for company X, but now three distributors can do that. Thus, retailers have more bargaining power and this has been used (rather abused) by retailers. Now the retailers buy a product of company X from distributor A, and does not pay for the product, and when distributor A refuses to supply, retailer goes to distributor B. He repeats the same (buys the product and does not pay) and when B stops supplies , retailer goes to distributor C. When the retailer sells the product taken from the distributor C, he finally then pays A, and so on the cycle continues. Retailer knows well, that with each company having 6 or more distributors, he will always have some distributor standing at the door ready to supply him! Another practice that has come up in India is that the retailers do not want to pay the entire amount in one go, but pay in weekly installments to

the distributors. Since the number of distributors are more and are fighting to get the market share, they succumb to the demands of the retailers. Some distributors are working at a meager <1 per cent trade margins to stay afloat in the business. This has led to the prevalence of unethical practices in pharmaceutical distribution space that calls for immediate attention. Also, since there is barely any margin left with a majority of distributors, there is no incentive and money left with these distributors to implement and leverage the best practices as also the latest technology in the business. As a result, retailers are also losing big time with inconsistent supplies and prescription bouncing becoming a regular feature in pharmacy retail.

The industry association of retailers and distributors has been a big barrier to the success of pharmacy retail & distribution.

Way forward … It is clear that if the retail pharmacy has to succeed, it needs to work closely with national level distributors. With Goods and Services Tax (GST) to become a reality latest by 2014, pharmaceutical companies would not need state wide CFA (company’s warehouses/supply chain arm that supplies to distributors, who in turn supplies to retailers or dispensing points), and this would lead to a more consolidated distribution model across the nation. Top pharmaceutical companies come together and form a national logistical & distribution venture that removes the inefficiencies in the pharmaceutical distribution, forecasting and recall. Pharmaceutical industry can also

look at working together and reduce the number of distributors and then impart best practices training and invest in technology for these distributors. Great work is being done by International Federation of Pharma wholesalers (www.ifpw.com) and some of the best practices and knowledge sharing can be had from IFPW, which now has presence in over 26 countries and is a global association of leading pharma wholesalers & distributors. Forward looking distributors come together and form regional clusters in towns and upgrade their services and standards and cater to the retailers more efficiently. Tamil Nadu Medical Supplies Corporation has already started supplying to state run healthcare facilities with direct procurement from manufacturers, and this model is likely to be copied by other states. A few local companies are attempting to start national distribution chains and this could be a good change to happen for the retailers as this will take the biggest headache off from managing 100’s of distributors. Technology is available and is not expensive, hardware cost is coming down and with distribution serving retail 99 per cent of its needs daily, the retail pharmacy will take off faster and profitably. Writing on the wall is clear that the retail pharmacies need to work hand in hand with pharmaceutical distributors. For retailers – distributors relationship, it is apt to say ‘United we stand, divided we fall!’ (office@rajendragupta.in)

Rajendra Pratap Gupta International Healthcare Policy & Retail Expert

Modern Pharmaceuticals I June 2012

Tips & Tricks: Packaging guidelines

Countering the counterfeits

significant volume of the drugs sold worldwide is counterfeit. These medicines pose serious risks to consumers, economic consequences to companies including loss of revenue and reputation, damage to brand image and potential liabilities. Counterfeiting does not only target famous brands, but any product that will sell.

ACG Worldwide, through its group companies presents next generation anticounterfeiting, security and brand protection solutions for the global pharmaceutical industry. We provide cutting-edge technology to secure the safety of the consumer and also safeguard the image of other company.

1 T

Use customised printing on capsules: ACG Associated capsules offers potent anticounterfeit solution and an outstanding brand differentiator with Brandshield. This solution involves fourcolour circular oriented printing on hard capsules and all around printing on hard capsules. It is an ideal anti-counterfeit solution, which provides security right upto the end user and establishes a unique brand identity and also offers variety of colour choices.

Use holographic films for blister packaging: Holographic films are advanced anticounterfeiting solutions providing secure protection for a brand. The hologram is embedded in the film, thus cannot be tampered with, duplicated or copied.

Chariman, ACG Worldwide

(info@acg-world.com)

ips ricks

Ajit Singh

Tips& Tricks

Adopting the track and trace system : This system empowers the end user to authenticate the genuineness of a product at the point of purchase via an SMS. Verif-I, an anticounterfeit solution does an accurate check across the full supply chain track and trace solutions through a single point. It provides solution for capturing and managing end-to-end supply chain events.

Tips& Tricks

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

Manas Bastia Senior Editor Infomedia 18 Limited ‘A’ Wing, Ruby House, J K Sawant Marg, Dadar (W) Mumbai 400 028 India

D +91 22 3003 4669 T +91 22 3024 5000 F +91 22 3003 4499 E manas@infomedia18.in W www.infomedia18.in

June 2012 I Modern Pharmaceuticals

Projects

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

Caplin Point Laboratories Ltd Project type New facility Project news Caplin Point Laboratories Ltd is planning to set up a new pharmaceutical project that would involve manufacturing of ampoules. Project location Thiruvallur, Tamil Nadu Project cost Unknown Implementation stage Planning Contact details: Caplin Point Laboratories Ltd No. 3, Lakshmanan Street T. Nagar, Chennai – 600 017 Tamil Nadu Tel: 044 2815 6653, 2815 6905 Fax: 044 2815 4952 E-mail:exim@caplinpoint.net Website: www.caplinpoint.net/ contactus.htm --------------------------------------

Capsugel Healthcare Ltd Project type New facility Project news Capsugel Healthcare Ltd is planning to set up a new pharmaceuticals project. The project involves manufacturing of Vcaps Hpmc (Hypromellosed) capsules. Project location Rewari, Haryana Project cost Unknown Implementation stage Planning

Contact details: Capsulgel Healthcare Ltd 21, Joniawas, Dharuhera, Rewari - 122100, Haryana Tel: 01274 267092/93/97/99 Fax: 01274 267168 E-mail: darshak.pandya@pf izer.com Website: www.capsugel.com ------------------------------------

Claris Lifesciences Ltd Project type New facility Project news Claris Lifesciences Ltd is planning to set up a new pharmaceutical project. It involves manufacturing of large volume parenterals.

Project location Xi’An city, China Project cost Unknown Implementation stage Planning Contact details: General Electric Co (GE) Building 7A, 4th Floor Sector 25A, DLF Cyber City Phase III, Gurgaon – 122 002 Haryana Tel: 011-41555303 E-mail:purnima.sahnimohanty@ge.com Website: www.ge.com ------------------------------------

Ipca Laboratories Ltd Project location Ahmedabad, Gujarat Project cost Unknown Implementation stage Construction Contact details: Claris Corporate Headquarters Nr. Parimal Crossing Ellisbridge Ahmedabad - 380 006 Tel: 079-26563331 Email: investorservices.corp@ clarislifesciences.com Website: www.clarislifesciences.com -------------------------------------

General Electric Co (GE) Project type New facility Project news General Electric Co (GE) plans to open its second innovation centre to be closer to customers in fastergrowing regions.

Project type New facility Project news Ipca Laboratories Ltd is planning to set up a new pharmaceutical project, which would involve manufacturing of artesunate. Project location Vadodara, Gujrat Project cost Unknown Implementation stage Planning Contact details: Ipca Laboratories Ltd Gala No. 3, 4, 5 Luthria House Sativali Main Road, Sativali Vasai Road (E) Thane 401 208 Maharashtra Tel:250-2450 009 E-mail: allwyn@ipca.com, Website: www.ipcalabs.com -------------------------------------

Modern Pharmaceuticals I June 2012

Projects

K V Aromatics Pvt Ltd

Neuland Laboratories Ltd

Sajjan India Ltd

Project type New facility Project news K V Aromatics Pvt Ltd is planning to set up a new pharmaceutical project, which would involve manufacturing of menthol BP/USP/IP.

Project type New facility Project news Neuland Laboratories Ltd is planning to set up a new pharmaceutical project, which will involve manufacturing of moxifloxacin hydrochloride.

Project type New facility Project news Sajja India Ltd is planning to set up a new pharmaceutical project, which would involve manufacturing of methoxybenzoly and amino sulfony.

Project location Gautam Buddha Nagar, Uttar Pradesh Project cost Unknown Implementation stage Planning

Project location Medak, Andhra Pradesh Project cost Unknown Implementation stage Planning

Project location Bharuch, Gujarat Project cost Unknown Implementation stage Planning

Contact details K V Aromatics Pvt Ltd D - 212 - 215, E. P. I. P. Site - 5, Surajpur, Industrial Area, Kasna Greater Noida - 201 306, Uttar Pradesh Tel: 120-2341969/ 2341793 E-mail: sales@kvaromatics.com Website: www.kvaromatics.com -------------------------------------

Contact details: Neuland Laboratories Ltd 204, Meridian Plaza, 6-3-854/1, Ameerpet, Hyderabad â&#x20AC;&#x201C; 500 016, Andhra Pradesh Tel: 040-30211600, 040-23412934 E-mail : neuland@neulandlabs.com Website: www.neulandlabs.com --------------------------------------

Contact details: Sajjan India Ltd Matulya Centre, #2 Ground Floor, Senapati Bapat Marg, Lower Parel (W), Mumbai - 400 013 Tel. : 022-2497 4400, 2497 4401 Fax : 022-2495 1098 E-mail : sil@sajjan.com Website: www.sajjan.com --------------------------------------

Nestor Pharmaceuticals

Provimi Animal Nutrition India

Vensub Laboratories

Project type New facility Project news The Delhi-based pharmaceutical company Nestor Pharmaceuticals is all set to grow organically in both domestic as well as international markets. The company plans to set up new manufacturing facilities.

Project type New facility Project news Provimi Animal Nutrition India is in the process of expanding its bulk drug unit for Halquinol BP-80 (from 30 TPM to 80 TPM).

Project type New facility Project news Vensub Laboratories is in the process of setting up a bulk drugs manufacturing project unit with the capacity of 2 TPM bulk drugs.

Project location Doddaballapur, Bengaluru, Karnataka Project cost Unknown Implementation stage Planning

Project location Tallapudi, dist. West Godavari, Andhra Pradesh Project cost Unknown Implementation stage Planning

Project location Rajasthan and Nigeria Project cost ` 300 crore Implementation stage Planning Contact details: Nestor Pharmaceuticals B-24/3, Okhla Industrial Area Phase II, New Delhi -110020 Tel: 011-41616377- 78, Fax : 011-26385380 E-mail: nestor3@airtelmail.in Website: www.nestorpharma.com ---------------------------------------

June 2012 I Modern Pharmaceuticals

Contact details: Provimi Animal Nutrition India Pvt Ltd I. S - 40, K. H. B. Industrial Area, Yelahanka New Town Bengaluru- 560 001 Karnataka Tel: 080-33680002 E-mail: directmarketing@provimi.in Website: www.indiamart.com --------------------------------------

Contact details: Vensub Laboratories Plot No 158 & 170, S V Co-Operative Industrial Estate, Jeedimetla, Hyderabad - 500055 Tel: 040-23140649 E-mail:vensalab@rediffmail.com Website: www.vensalabs.com --------------------------------------

Event List

NATIONAL AHMEDABAD

PUNE

CHENNAI

LUDHIANA

Gujarat, Oct 5-8, 2012

Maharashtra, Nov 2-5, 2012

Tamil Nadu, Nov 22-25, 2012

Punjab, Dec 21-24, 2012

INDORE

AURANGABAD

RUDRAPUR

Madhya Pradesh, Jan 11-14, 2013

Maharashtra, Feb 1-4, 2013

Uttarakhand, Feb 23-26, 2013

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

For details Infomedia 18 Ltd

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

Lab Expo & Conferences Coimbatore This event focusses on various aspects related to lab equipment manufacturing as well as promoting good lab practices among the fellow professionals. The trade show will be a two-day affair and will witness attendance from a considerable number of professionals who have been involved with this profession for a long time. This expo will also be supplemented with informative sessions and workshops. This is an excellent platform for the lab equipment manufacturers and distributors to display their latest technological innovations and creations in front of an international audience. Moreover, this event also takes care of a number of important issues related to lab automation and labware equipment; June 15-17, 2012, Codissia Intec Technology Centre, Coimbatore For details contact: Paramount Exhibitors Tel: +91 172 2274801 Fax: +91 172 2274803 Email: contact@paramountexhibitors.com Website: www.paramountexhibitors.com

Pharma Rural Marketing 2012 This is one of the dedicated platforms that will bring together senior level decision makers from across marketing and strategic planning functions within the Indian pharmaceutical industry. During these action packed three days, with high value networking and business content, Indian and multinational

pharma companies, marketing consultants, communication agencies, supply chain and logistics management companies will identify the key challenges within the industry and discover business critical solutions to overcome them; June 21-22, 2012, Holiday Inn, Mumbai 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

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

Email: arokiaswamy@iedcommunications.com Website: www.iedcommunications.com

Pharmac India It is a-three-day event that aims towards highlighting several issues of the industry. This will be large hub of reputed professionals from pharma formulation, herbal products, veterinary drug, medical & disposal, pharma machinery and many other sectors. There will be visitors from pharma company marketing/purchase/ export executive, marketing company & consultant, merchant exporters, contract manufacturers, pharma distributors, generic & OTC manufacturer & wholesalers, Government supplier, liaison agents, sourcing companies, production & purchase professionals, and international business representatives; September 8-10, 2012, Gujarat University Exhibition Hall, Ahmedabad For details contact: Orbitz Exhibitions Pvt Ltd Tel: +91-22-24102801 Fax:+91-22- 24102805 Email: ramesh.v@orbitexhibitions.com Website: www.orbitzexhibitions.com

Indian Lab Automation conference and exhibition ILA 2012 will feature three technical conference tracks; Drug Discovery and Development, Advances in Bioanalysis and Advances in Genomics and Informatics. Each track will provide attendees with the opportunity to listen to presentations on cutting edge research in specific application areas, with an underlying theme of automating the technique, equipment or associated informatics; October 30-31, 2012, Renaissance Hotel & Convention Centre, Mumbai For details contact: Select Biosciences Ltd Tel: +44 1787 315110 Fax: +44 1787 315111 Email: enquiries@selectbiosciences.com Website: www.selectbiosciences.com Modern Pharmaceuticals I June 2012

Event List

INTERNATIONAL Conference on Social Media in the Pharmaceutical Industry This event aims to focus on keeping the audience up-to-date with developments in the ever-changing social media sphere. With this industry moving at a rapid pace, and with more patients and healthcare professionals becoming more tech-savvy, the pharmaceuticals industry need to embrace social media; July 9-10, 2012, Copthorne Tara Hotel, London, UK For details contact: SMi Group Ltd Tel: +44 0 20 7827 6000 Fax: +44 0 20 7827 6001 Email: client_services@smi-online.co.uk Website: www.smi-online.co.uk

ICBLS 2012 The aim of the International Conference on Biological and Life Sciences (ICBLS) conference is to provide a forum for laying the foundations of a new principled approach to Biological and Life Sciences. To this end, the meeting aims to attract participants with different backgrounds, to foster crosspollination between different research fields, and to expose and discuss innovative theories, frameworks, methodologies, tools, and applications; July 23-24, 2012, River View Hotel, Singapore For details contact: Asia-Pacific Chemical, Biological & Environmental Engineering Society (APCBEES) Tel: +852 3069 7291 Fax: +852 2180 1366 Email: icbls@cbees.org Website: www.icbls.org

JCBBB 2012 The 3rd Journal Conference on Bioscience, Biochemistry and Bioinformatics ( JCBBB 2012) aims to provide a forum for researchers, practitioners,

and professionals from the industry, academia and government to discourse on research and development, professional practice in bioscience, biochemistry and bioinformatics. This is one of the leading international conferences for presenting novel and fundamental advances in the fields of bioscience, biochemistry and bioinformatics. It also serves to foster communication among researchers and practitioners working in a wide variety of scientific areas with a common interest in improving bioscience, biochemistry and bioinformatics related techniques; September 1-2, 2012, Phuket, Thailand For details contact: International Journal of Bioscience, Biochemistry and Bioinformatics Tel: +91 422 2611146 Fax: +91 422 2611043 Email: ijbbb@vip.163.com Website: www.ijbbb.org

International Symposium on Pharmaceutical Reference Standards The event aims to discuss current topics and future approaches related to pharma reference standards. Pharmaceutical reference standards are essential for the quality control of medicines. The symposium will bring together stakeholders involved in the production, characterisation and use of reference standards to exchange their views and opinions on the different issues related to the subject; September 3-4, 2012, EDQM Premises, Strasbourg, France For details contact: EDQM Public Relations Division & Documentation Tel: +33 0 3 88 41 31 50 Fax: +33 0 3 88 41 27 71 Email: beatrice.barth@edqm.eu Website: www.edqm.eu

NCCR 2012 The 6 th National Conference for Clinical Research 2012 (NCCR 2012) aims to serve as a platform that aims to bring together clinical investigators, industry professionals, regulatory agencies and policy makers in order to address the issues and challenges of the industry. By gathering people from various research disciplines, the event aims to foster constructive and forward looking discussions, sharing of experiences, and mutual commitment towards the betterment of humanity; September 23-25, 2012, Sunway Pyramid Convention Centre, Malaysia For details contact: Association of Clinical Registries, Malaysia (ACRM) Tel: +603 4044 3060 Fax: +603 4044 3080 Email: contact@acrm.org.my Website: www.nccrconference.com.my

CPhI Worldwide The event hosts over 1900 exhibitors and is the market leader for the global pharmaceutical ingredients industry. CPhI Worldwide has three co-located events: ICSE, P-MEC Europe and InnoPack. These events focus on specific sub-sectors of the pharma ingredients industry and provide visitors and exhibitors with additional capability to network and do business in dedicated areas; October 9-11, 2012, Feria de Madrid, Spain For details contact: UBM India Pvt Ltd Tel: +91 22 6612 2600 Fax: +91 22 6612 2626-27 Email: info.india@ubm.com Website: www.ubmindia.in

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

June 2012 I Modern Pharmaceuticals

Book Review AYURVEDIC MEDICINE: The Principles of Traditional Practice Editor : Sebastian Pole Price : ` 4,200/There is a growing interest among people, medical practioners, health organisations and the pharmaceutical industry regarding traditional medicines in general and Ayurveda in specific. The author, who is a certified expert in Ayurveda, yoga and Chinese medicine has managed to capture the essence of the underlying philosophical principles of these therapies and has applied them to modern principles of physiology. The first part of the book deals with the ancient history of the Ayurveda, the basic principles of Ayurveda, and the different formulations and therapies in the same. The reader feels at ease understanding complex principles even if he is a casual reader, or an herbalist or a practitioner or even an entrepreneur. Intended for a Western audience, the author manages to lay out ancient Ayurveda principles, which may hold even an Indian Ayurveda practitioner in rapt attention. The chapter on the scientific basis of Ayurveda is interesting to a western medicine practitioner as it attempts to relate modern principles of medical physiology to the ancient Ayurveda principles. The second part of the book is a vast herbal pharmacopeia, listing the major and common herbs and their properties, active principles, indications and dosages. The second part is particularly designed for the Ayurveda practitioner and also the drug industry, which can look at potential formulations to diversify/or expand their portfolio. Overall this is an excellent book to kindle interest in Ayurvedic medicine and to assist practitioners with common ayurvedic herbs. Publisher: Churchill Livingstone Elsevier Distributor: 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

THE MODERN AYURVEDA: Milestones Beyond the Classical Age Editors : C P Khare, Chandra Kant Katiyar Price : ` 8,700/The authors have brilliantly attempted to take Ayurveda out of its ‘ancient’ ‘traditional’ medicine tag and have positioned the therapy in light of modern medicine and the pharmaceutical industry. The authors portray the parallels between Indian Ayurveda and traditional Chinese medicine in the initial chapters, and also the challenges both have faced in gaining mainstream acceptance and western scrutiny. The authors have highlighted the need for Ayurveda to provide more scientific data and compatible studies to take on western medicine on its benchmarks. The majority of the book deals with factual information regarding herbs, their bioactive constituents, chemical constituents, interactions, toxicities, formulations, etc. Most of the information is in the form of structured s, which make this book a ready reference for practitioners and/or herbalists. The concluding chapters of the book take on two topics which are of utmost importance in the life cycle of any drug/or formulation: quality control – safety and international regulations. The concluding chapters are insightful to pharmaceutical or ayurvedic drug manufacturing companies who intend to market internationally traditional herbs and formulations. This is a great book for stakeholders in the drug manufacturing/marketing industry. Publisher: CRC Press Distributor: 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 Reviewer: Dr Mandar Kubal Director, Infectious Diseases & Pulmonary Care Pvt Ltd

Modern Pharmaceuticals I June 2012

Products Vacuum tube lifter The JumboFlex 35 vacuum tube lifter designed for loads of up to 35 kg. The tube lifter is equipped with a quick-change adapter for taking up different suction pads. The system is completed by a suction pad for handling sacks and one for cardboard boxes, as well as an aluminum single-beam crane system. The vacuum is generated by a dry-running pump with a suction capacity of 40 m³/h that provides a vacuum of -600 mbar. It is easily operated with its ergonomic handle for one-finger control and enables the user to control the up and down movement as well as the lifting and lowering speed at all working heights. The suspension height of the lifter can be adjusted so that the tube lifter can be adapted to the user’s individual requirements. J Schmalz GmbH Germany Tel: +49-7443-24030 Email: schmalz@schmalz.de Website: www.vacuworld.com

Disposable bioreactor These are single use systems made of medical grade plastics, which are presterilised and ready for use, therefore not needing cumbersome SIP and CIP. Agitated by means of an external gyrational motion, which uses gravity naturally to make the contents flow in a uniform circumferential direction in a specially shaped round bag. Lablinks Biotech Pvt Ltd Bengaluru - Karnataka Tel: 080-32440830 Mob: 09343748099 Email: ravindranath@lablinksbiotech.com Website: www.lablinksbiotech.com

Nitrile Gloves This nitrile gloves are highly economical than standard nitrile as well as latex gloves.These nitrile gloves are soft, latex-free and powderfree. They are formulated with 100 percent nitrile which contains no natural rubber latex which relieves one from allergic reactions. It provides

maximum barrier protection. The gloves are available in 9.5” length and three sizes – small, medium and large, in two colors – white and blue. The textured fingertips enhance wet or dry grip. The gloves are ambidextrous with beaded cuffs. They are best suited for liquid protection. Cole-Parmer India Mumbai - Maharashtra Tel: 022-6716 2222 Email: vinita.singh@coleparmer.in Website: www.coleparmer.in

Universal supermixes The two iTaq Universal supermixes, the iTaq Universal SYBR® Green supermix and the iTaq Universal Probes supermix, are compatible with any realtime PCR instrument. The SYBR® Green supermix is optimised for dyebased qPCR and contains SYBR® Green I dye whereas the Probes supermix is formulated for probe-based qPCR (simplex or duplex). Key benefits include broad dynamic range and sensitivity, optimized buffer formulation, overcomes challenging duplex qPCR & antibody-mediated hot-start DNA Bio Rad India Pvt Ltd Gurgaon - Haryana Tel: 0124-2398112 Website: www.bio-rad.com

Vial inspection machine In the vial inspection machine (model SMPLAIM-72) all contact parts are made of stainless steel and approved engineering plastics. Magnified view with back lighting is available and rotation of spinners can be adjusted to give desired vortex in liquid. The vial inspection machine has separate counters for placing good and rejected products. Snowbell Machines Pvt Ltd Thane - Maharashtra Tel: 0250-6456141, Mob: 09322777625 Email: marketing@snowbellmachines.com Website: www.snowbellmachines.com

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

eg, MPH Laboratory software and send it to 51818

June 2012 I Modern Pharmaceuticals

Products Multi-purpose trolley The specially designed multi-purpose trolley is used for ICU/hospital/surgery. It comes with multi-purpose aluminum extruded legs, heavyduty designed castor wheels, MDF monitor top with anti-skid rubber mat, lockable MDF, scratch-proof painted drawer box. Different boxes or trays are adjusted according to needs due to the specially designed profile of tapped strip. Because of aluminium metallic structure, earthing is affirmative and provides safe working for electrical and electronic appliances. Envair Electrodyne Ltd Pune - Maharashtra Tel: 020-30688117 Email: envairelectro@vsnl.net Website: www.envairelectrodyne.com

Sieves These are silicon-moulded sifter sieves, fluid bed dryer (FBD) sieves and FBE dryer sieves. Silicon moulded sifter sieves are available in various sizes from 12â&#x20AC;? to 48â&#x20AC;? diameter. The silicon, which is of foodgrade quality, transparent in appearance & nontoxic, is moulded on the stainless steel ring. These are available in rivetted and special non-rivetted design. The mesh size varies from 4-500 mesh

June 2012 I Modern Pharmaceuticals

with ASTM & BSS standards. The FBD sieves are available in various sizes, from 30-200 kg. FBE dryer sieves are available in various sizes from 125 ltr to 800 ltr. Atlanto Enterprises Mumbai - Maharashtra Tel: +91-022-23096098, Mob: 09819942853 Email: atlantoent@yahoo.co.in Website: www.atlanto.net

Mini bilayer press The mini bilayer press is designed to represent twolayer tablet productions at a small scale. With its larger turret diameter, variable speed allows for realistic scale up to larger rotary presses. It is provided with two force feeder system, which helps in maintaining uniform die fill and represents production equipment. It is provided with pressure compensation hydraulic system. Tablet thickness and weight adjustment settings are outside the machine. It is designed as per cGMP norms. All parts in the compression zone are of SS-304 or electroless nickel-plated. Aayush Techno Pvt Ltd Ahmedabad - Gujarat Tel: 079-25898901 Email: contact@aayushtechno.com Website: www.aayushtechno.com

Products Freezer

Stoppering machine

The MDF-C2156VAN freezers provide stable and highly uniform ultra-low temperatures for the longterm preservation of viable cells, tissues and biological materials. Offering significant advantages, these large capacity 150°C freezers combine exceptional performance and durability with reduced energy consumption and quiet operation. The freezers incorporate patented third-generation VIP PLUS insulation panels.

This servo rotary stoppering machine is crafted for cleanroom productions. The compact size allows for a sideby-side configuration, doubling the speed and matching the speed of the liquid filling machines for over 200 vials per minute side. This system perform full and partial insertion and can be easily changed over to different stopper and bottle sizes.

Sanyo E&E Europe BV Etten-Leur – Netherlands Tel: +31-76-5433833 Email: sales.nl.seee@sanyo.com Website: www.eu.sanyo.com

Automated Machine Technologies, Inc North Carolina – USA Tel: +1-919-3610121 Email: office@amtliquidfilling.com Website: www.amtliquidfilling.com

Coating pan Starch paste kettle This is specially designed for preparation of binder materials. The hemispherical kettles with jacket are mounted on trunion supports with the help of shaft. These kettles have a small cylindrical top shell with a spout for pouring out binder mass. The starch paste kettles are made of SS-304/SS-316. These come with anchor type beater for paste mixing. Bombay Pharma Equipments Pvt Ltd Mumbai – Maharashtra Tel: 022-28594877 Mob: 09820124804 Email: bombaypharma@vsnl.net Website: www.bombaypharma.com

This coating pan is totally enclosed with stainless steel cladding and are available with standard gearbox, motor and hot-air blowing arrangements. The coating pans are provided with interlocked electrical circuit so that the heaters can be operated only after the blowers are switched ON to avoid burning of the heaters. The coating pan is manufactured from the SS-304 AISI 2B prime material quality with adequate mouth opening and depth. Allegro Pharmachem Equipment Thane – Maharashtra Tel: 022-40146872 Email: allegro@allegroindia.com Website: www.allegroindia.com

Linear vial washing machine This high-speed linear vial washing machine is totally fabricated from SS materials, including the basic frame. The machines are suitable for handling wash of 5 ml to 30 ml vials without changing parts. These are provided with highpressure spray nozzles that enter into the vials during washing time. The linear vial washing machines are equipped with safety devices to ensure smooth and silent operation. Laxmi Industries Ahmedabad – Gujarat Tel: 079-22893810 Email: laxmiindustries_ad@yahoo.com

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Bottle cappers Rotary chuck style bottle cappers are designed to apply and rotate a presorted cap on a container, based on a predetermined applied torque. The containers are fed onto the rotary chuck style capper and are separated and positioned on individual capping stations. Caps are pre-sorted and fed on the sliding table of the machine. US Bottlers Machinery Company North Carolina – USA Tel: +1-704-5884750 Email: info@usbottlers.com Website: www.usbottlers.com

Modern Pharmaceuticals I June 2012

Products Bottom discharge centrifuge This centrifuge is fitted with a cake scrapping arrangement, which can be motorised or hydraulically operated to enable to scrape the stickiest of cakes. The cake is discharged through the bottom chute provided. This results in reducing manual labour, less cake handling loss and uniform cake washing. The centrifuge is offered in vapour-tight construction with nitrogen blanketing for hazardous chemicals. CIP design with built-in cleaning nozzles ensures no product cross-contamination. The centrifuge is offered in three-point pendulum suspension and fourpoint inertia plate mounted designs to suit application considerations. United Engineering Enterprises Mumbai - Maharashtra Tel: 022-23083990, Mob: 09820761808 Email: uenggent@gmail.com Website: www.united-centrifuges.com

Sanitary tubes fittings A wide range of stainless steel sanitary tube fittings for pharma, food, beverages, breweries, cosmetics and allied industries are offered. The range includes bends, Tees, reducers, pipe, support and sight glass, etc. These are available in tube OD sizes ranging from ½” to 6”. End connections available are tri-clamp, DIN

June 2012 I Modern Pharmaceuticals

and SMS. These fittings are manufactures from SS-304, 316 and 316L, duly electro polished. All these products confirms to cGMP and FDA standards. Elastomers offered are of food grade and can be offered in EPDM, neoprene, silicon and viton. Cris Engineering Works Mumbai - Maharashtra Tel: 022-2685 9440, Mob: 09892273314 Email: roque_ferns@rediffmail.com Website: www.criseng.com

Pallets These pallets are offered as per GMP & USFDA norms and are used for multifarious applications in different industries. Designed for optimal load bearing capacities, the pallets are manufactured on state-of-the-art plants. The pallets have many outstanding features and can also be tailor-made to meet customers’ special requirements. Sintex Industries Ltd Kalol - Gujarat Tel: 02764-253500 Email: icontainers@sintex.co.in Website: www.sintex-plastics.com

Products Industrial panel PC

Gas flow adsorption analyser

The stringent standards required in the IPPC8151S 15” XGA TFT LCD Celeron M fanless is designed with 316L stainless steel, food-safe sealing materials and an anti-corrosive and chemical resistant touchscreen. Its fanless design and NEMA4X/IP66 waterproof and dustproof protection ensure reliable operation in most hazardous environments. With the optional enclosure kit and IP66 I/O connector kit, the IPPC8151S can provide a fully enclosed IP66 protection for all sides. This find application in food, beverage, clinical, chemical or pharmaceutical industries.

The model SGA-100 is a continuous gas flow adsorption analyser is specially designed for the study of water or organic vapour isotherms at temperatures ranging from 0°C to 80°C (standard version), 250°C (high-temperature version), at an ambient pressures. The term symmetrical refers to a design feature where by both the sample side and the reference side of the microbalance is subjected to identical temperature, relative humidity and flow rate. This provides significant stability and accuracy and allowing the possibility of performing absolute or differential adsorption experiments. The instrument is used in industries such as catalyst, chemicals, pharmaceuticals, foods, electronics, etc.

Advantech India Bengaluru - Karnataka Tel: 080-23374567 Email: info.in@advantech.com Website: www.advantech.in

Smart Instruments Company Thane - Maharashtra Tel: 0251-2801123, Mob: 09323509969 Email: smartins@vsnl.net Website: www.smartinsrument.com

Walk-in-cooling chamber The walk-in-cooling chamber has double walled insulated PUF modular panels, which can easily be assembled at site without any major hassles. Interior is made of stainless steel and exterior is either made of mild steel finished with powder coating or stainless steel. The unit is provided with perforated stainless steel trays. Newtronic Equipment Company Pvt Ltd Mumbai - Maharashtra Tel: 022-28679326, Mob: 09821089932 Email: nmehta@newtronic.in Website: www.newtronic.in

Liquid-ring vacuum pump The single and double-stage liquid-ring vacuum pump is silent in operation. Design of the mechanical shaft seal ensures adequate protection to the shaft and provides for ease of maintenance. This leads to minimal time required for servicing thereby cutting down time to the barest minimum. The pump is rugged in design, reliable in performance and easy to maintain. Acmevac Sales Pvt Ltd Mumbai - Maharashtra Tel: 022-28375837, Mob: 09223388105 Email: acmevac@vsnl.com Website: www.acmevac.com

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Liquid filling/capping and sealing machine The monoblock piston filling/ROPP-cumsealer is a combination of rotary multiheads volumetric liquid filling and rotary multi-heads RO/ROPP capping and sealing machine. Due to its compact model it reduces space and manpower utilisation. A single synchronised drive mechanism couples the multi-heads filler and sealer on a common base. It is suitable for glass, tin and PET bottles/containers. The machine is provided with no-bottleno-fill and no-bottle-no-cap mechanism and with attachments suitable for any one size bottle and cap. The Master Mechanical Works Mumbai - Maharashtra Tel: 022-26493459 Email: mmworks@vsnl.com

Pellet The multi-unit pellet of vitamins and minerals and medicine in capsules include those of vitamins and minerals, pellets of cough and cold preparations, pellets of hyperacidity, antiulcer, anti-flatulant, anti-emetic preparations, pellets of cardiovascular drugs, pellets of antimicrobials & adjuvants, pellets of anti-asthamatic drugs, pellet of NSAIDS, pellets of anti-malarial drugs, etc. Pelltech HealthCare Mumbai - Maharashtra Tel: 022-28662980 Email: pelltech@vsnl.net Website: pelltech-healthcare.com

Modern Pharmaceuticals I June 2012

Products Temperature and process controller

Spectrophotometer

Fuji Electric’s self-tuning temperature and process controller has low-cost options that include RS485 communications, digital input, timer function, heater burnout alarm, dual outputs, and programmable alarms. The faceplate is watertight and corrosion-resistant. The three-button keypad allows programming and the screw-terminal on the back eliminates the need for sockets. In addition to auto-tuning and fuzzy control, it has self-tuning control, which automatically retunes the controller under certain conditions, without the need to revert to autotuning. It accepts temperature & process inputs and offers two control outputs and two programmable alarms.

The spectrophotometer is designed for versatility in various applications. It is a portable integrating sphere spectrophotometer incorporating numerical gloss control. It simultaneously measures specular component included and specular component excluded and displays the data on the LCD in only 1.5 seconds. The relativity gloss value can be displayed by using numerical gloss control. The spectrophotometer finds applications in pharmaceuticals, cosmetics, printing, building materials, textiles, food, etc.

Procon Technologies Pvt Ltd Ahmedabad- Gujarat Tel: 079-27492566, Mob: 09824310188 Email: info@procon.co.in Website: www.procon.co.in

Pallet shrinking tool

Spheroidiser The spheroidiser consists of a round disc mounted on a vertical shaft spinning at high-speed at the bottom of a cylindrical chamber or drum. The cylindrical drum is called the bowl and the spinning disc is called the chequered plate. The chequered plate has a grooved pattern to increase the friction with the product and break the extrudates to length. When the extrudates are charged into the spheroidiser, they are thrown on the edge of the spinning plate by centrifugal forces.

Jay Instruments & Systems Pvt Ltd Mumbai - Maharashtra Tel: 022-23526207 Email: ctpsales@jayinst.com Website: www.jayinst.com

The pallet shrinking tool is used for shrink wrapping. Shrink wrapping of export pallets, giant pallets, giant articles, big articles/machinery are used to avoid damage during transportation. Boxes on pallets and other products can be shrinkpacked within minutes. It provides five-sided protection for any size or shape load from small uneven pallets to large machinery and more strength than stretch wrapping. The tool is compact, portable and handy weighing 950 g. Dharmesh Enterprises Mumbai - Maharashtra Tel: 022-55233591 Email: heatgun@vsnl.com Website: hotairguns.com

Lyophiliser Umang Pharmatech Pvt Ltd Dist Thane - Maharashtra Tel: 0250-6450835, Mob: 09764998260 Email: info@umangpharmatech.com Website: www.umangpharmatech.com

Digital temperature indicator The digital temperature indicators is available with features, such as auto shut-off circuit, built-in-lineariser, open sensor indicator, low battery indicator, 3½ digital 0.5” LCD display, low power cosumption, compact moulded ABS cabinet, etc. Instrument Research Associates Pvt Ltd Navi Mumbai - Maharashtra Tel: 022-61484000 Email: subrat@agsinfotech.com

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

Modern Pharmaceuticals I June 2012

Products Electric blanket Aristocrat electric blankets are waterproof, shockproof, autocut, soft underlay to provide constant slow motherly warmth. It is a relief for the patients of asthma, goutarthritis, backaches, bodyaches & pains, patients of diabetes, low blood pressure, and the aged alike. These blankets supplement the much needed body energy and are useful for senior citizens. Medico Pharmaceuticals Processors Amritsar – Punjab Tel: 0183-2258586 Mob: 09356000059 Email: info@medico.co.in Website: www.medico.co.in

Conductivity meter The mhoCounter CT-10 is a conductivity indicator and mhoCounter CT-11 is the meter with relay output option, which is programmable. Microprocessor-based electronics allow wide operating range and long term signal stability. Optional relays provide control for adjustment or alarms. These meters come with saddle mounting option or standard fittings to adopt to any process flow solution. Vatturkar Industrial Pune – Maharashtra Tel: 020-25380568 Mob: 09422320551 Email: response@vatsmeter.com Website: www.vatsmeter.com

Digital flow meter With these digital flow meters and digital conductivity meters, operators can easily install and recalibrate the meters online. The flow meters are proven in harsh industrial environment and are service free units based on the state-of-the-art advance microprocessor technology. Both fieldmounted as well as panel-mounted meters are available. MTS Engineers Pvt Ltd Ahmedabad – Gujarat Tel: 079-26400063 Mob: 09879407970 Email: sanjay.prajapati@mtsengrs.com Website: www.mtsengrs.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 June 2012 I Modern Pharmaceuticals

List of P Products

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

eg, MPH Laboratory software and send it to 51818 Product

Pg No

10 Stn Pilot press ................................8 A pharmaceutical packaging solutions............................................6 Acoustic enclosure ..................................29 Activated carbon fitter ...........................59 Agitators .................................................21 Air treatment ..................................... FGF Alpha press ...............................................8 Analytical instrumentation ..............33, 45 Analytical instruments ...........................88 Aid pumps ..............................................24 Autoclaves ...............................................13 Barcode patient Id bands................... 53 Batch disperser .......................................21 Bearing....................................................51 Blow-fill seal machines .......................FIC Bottle cappers .........................................78 Bottom discharge centrifuge..................81 Cable carrier ..................................... 51 Cable connector......................................51 Caboratory & medical equipments .......61 Caboratory gas generation .....................69 Calorimeters ...........................................21 Capsule filling machines ........................13 Cartoners ................................................13 Cartridges ...............................................13 Chain ......................................................51 Chromatography ....................................88 Clean technology....................................24 Coating machine ......................................8 Coating pan ............................................78 Colloid Mill Std/Gmp Model ................8 Columns .................................................88 Columns & chemistries ...................33, 45 Comfort conditioning ............................24 Comminuting mill ...................................8 Compact pneumatic cylinder...............BC Conductivity meter ................................85 Connector ...............................................51 Controllers ..............................................24 Cooling tower.................................... FGF De-dusting & De-burring ..................8 Demineralization plant ..........................59 Digital flow meter ..................................85

Product

Pg No

Digital temperature indicator ................84 Disperser .................................................21 Disposable bioreactor .............................75 Double rotary tableting machine.............8 Double sided rotary................................30 Drainage pumps .....................................24 Drying oven..............................................8 Drives ......................................................15 Dry van pump ........................................29 Dust extractor...........................................8 Eco wrap bagging machine................ 63 Electric actuator & Gripper ................BC Electric blanket.......................................85 Electro-de-ionization .............................59 Elemental analysis ..................................88 Empower ..........................................33, 45 Extra heavy duty bagging machine .......63 Flow technology ............................... 24 Fluid bed processor ..................................8 Fluid bed system ......................................8 Freezer.....................................................78 Gas flow adsorption analyzer ............ 82 Gear pump .............................................40 Giga press .................................................8 Guided compact pneumatic cylinder ...............................................BC Heating bath ..................................... 21 High pressure homogenizer...................21 Horizontal flow wrap machine..............63 Hot plate.................................................21 Hplc ........................................... 33, 45, 88 Industrial coolers ..........................FGF Industrial panel PC ................................82 Informatics........................................33, 45 Infrastructure water projects ..................24 Inline disperser .......................................21 Ionizer ...................................................BC Kneading machine ............................ 21 Lab equipments manufacturers ......... 69 Labels ......................................................53 Laboratory reactor ..................................21 Laboratory software ...............................21 Large diameter welded pipes .................85 Linear vial washing machine .................78

Product

Pg No

Liquid filling/capping and sealing machine ................................................82 Liquid sterile filling machines in vials .... 13 Liquid-ring vacuum pump ....................82 Lyophiliser ..............................................84 Machines and plants for dry and wet preparation ...................................... 81 Magnetic drive pumps ...........................24 Magnetic stirrer ......................................21 Mass mixer granulator .............................8 Mass spectroscopy ..................................88 Mega press................................................8 Mill ........................................................21 Mini roll compactor .................................8 Mini cm mill ............................................8 Molecular spectroscopy ..........................88 Mfgrs of thermoplastic valves & Piping system from polypropline ........10 Multi track sachet pacer.........................63 Multipostion stirrers.................................5 Nitrile gloves..................................... 75 Overhead stirrer ................................ 21 Packaging solutions ..................................6 Pallet shrinking tool ...............................84 Pallets ......................................................81 Pellet .......................................................82 Pilot plant ...............................................21 Pneumatic bagging machines ................63 Prefilled syringe components ...................6 Pressure boosting systems ......................24 Pressure sand filters ................................59 Print and packaging solutions ...............24 Printer .....................................................53 Processing & packaging .........................67 Puches & Dies .........................................8 Pumps ...............................................29, 40 Pure steam generators ............................13 Rapid endotoxin detection system ..... 85 Refrigerated compressed air dryer .......BC Reverse osmosis unit ..............................59 Roll compactor .........................................8 Roots blower...........................................29 Rotary evaporator ...................................21 Rotary gear pump ..................................40

Product

Pg No

Rotary tablet press..................................30 Rapid mixer std ........................................8 Sachet packer .................................... 63 Sanitary tubes fittings ............................81 Scientific instrument dealer ...................69 Seamless pipes ........................................85 Semi automatic filing system.................63 Sensors. ...................................................47 Shaker .....................................................21 Single rotary tableting machine...............8 Softening unit.........................................59 Solid-liquid mixer ..................................21 Spectrophotometer .................................84 Spheroidiser ............................................84 SS sheet metal pumpsets .......................24 Stainless Steel Pipes ...............................85 Starch paste kettle ..................................78 Stick pack sachet packer ........................63 Stoppering machine ...............................78 Stirring hot plate ......................................5 Syringes & Ampoules ............................13 Tablet press machine ......................... 30 Tefzel Hhs Isotactic P P Material ........10 Temperature and process controller ......84 Thermostat & vacuum dryer / mixer ....21 Thunder continuous motion bagging machine ................................................63 Tissue culture consumables....................55 Tubes.......................................................85 â&#x20AC;&#x2DC;Uâ&#x20AC;&#x2122; Tubes ........................................... 85 Uhplc ......................................................88 Ultra filtration systems ...........................59 Universal supermixes ..............................75 Uplc ..................................................33, 45 Vacuum tube lifter ............................. 75 Vacuum booster pump ...........................29 Vacuum system .......................................29 Vial inspection machine.........................75 Walk-in-cooling pump ...................... 82 Wastewater .............................................24 Water for injection generation stills ......13 Water treatment .....................................24 Welded pipes ..........................................85 Zero liquid discharge effluent treatment......................................BIC

BC-Back cover, BIC-Back inside cover, FIC-Front inside cover

Modern Pharmaceuticals I June 2012

List of Advertisers Advertiser’s Name & Contact Details

Ani Engineers

Pg No

Advertiser’s Name & Contact Details

Everest Transmission

Pg No

Advertiser’s Name & Contact Details

Salesworth Synergies Pvt Ltd (Rommelag) FIC

T: +91-2752-241479

T: +91-11-45457777

T: +91-80-25274495

E: anivarya@sancharnet.in W: www.anivaryapumps.com

E: info@everestblowers.com

E: mail@salesworth.com

W: www.everestblowers.com

W:www.rommelag.com

Ask Me 28 T: +91-3555 5555 E: twitter.com/AskMe_35555555 W: www.facebook.com/AskMe.nfomedia18 Ate Enterprises Pvt Ltd T: +91-022-6676 6100 W: www.ateindia.com

Bonfiglioli Transmissions (Pvt) Ltd

Great Eastern Impex Pvt Ltd T: +91-011-2347431/32

T: +91-80-39127800

T: +91-79-25841491

E: info@cadmach.com W: www.cadmach.com Chamunda Pharma Machinery Pvt Ltd

E: pradeep.kumar@thermofisher.com W: www.thermofisher.com

E: process@ika.in

TSA Process Equipments

W: www.ika.in

T: +91-0250-3293221

JB Sez P Ltd

FGF

T: +91-422-3267800

W: www.tsawatersystems.com

E: sales@gemindia.com

UNP Polyvalves India Pvt Ltd

W: www.gemindia.com

T: +91-265-2649248

E: shahil@cm1981.com W: www.cm1981.com

Mack Pharma Tech 85

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