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EDITORIAL

Beyond data analysis ne of the critical challenges facing the pharma fraternity today is to reduce the drug development cycle time, and hence the time to market. The answer to it, many experts believe, lies in the enormous amount of data generated. Welcome to the world of bioinformatics! Though bioinformatics as a discipline has been there for quite some time, its visibility grew significantly after the much-hyped Human Genome Project. Present across the drug discovery & development value chain, bioinformatics, from a functional & structural perspective, has evolved along with new algorithms and various data types. Further, bioinformatics leverages healthcare data by being an important constituent of personalised medicine, as well. Thanks to the latest developments in this field, there are new and more sophisticated ways not only to identify molecular targets such as receptor proteins in any individual, but also faster as compared to traditional methods. With further advances in cutting-edge biological researches involving genomics & proteomics and software database, the pharma healthcare segment is likely to reap the rewards. The ‘Sector Watch’ offers some more promising perspectives on bioinformatics.

Now, let’s look at the Indian pharma space, which as per a recent study is set to touch the $ 20 billion-mark soon and rank among the world’s top 10 drug markets. While there are so much growth opportunities and prospects awaiting to be tapped, on the other hand, there is an urgent need for the industry to overcome numerous key challenges. Some of these include growing competition, stringent guidelines and regulatory issues, dearth of talented R&D professionals, need for higher IT application, among others. All these point to one common factor – having the right human resources. The ‘Market Trends’ highlights as to how a challenging yet exciting time awaits the HR departments of pharma firms. Wondering about a saviour for the global pharma industry, as drug pipelines dry up and blockbusters face the patent cliff? Turn to the ‘Industry Update’ section focussing on ‘Biotechnology’. Also recommended are two New Columns ‘Regulatory Affairs’ and ‘CRAMS Centre’ being introduced in this edition. Read on.

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Editor: Manas R Bastia

October 2010

Modern Pharmaceuticals

CONTENTS

INDUSTRY UPDATE Biotechnology: Building blocks to success

OVERVIEW Biosimilars regulation: Miles to go... Dr K K Tripathi Advisor, Department of Biotechnology, Government of India

SPOTLIGHT Stem cell therapy: Heading towards future medicines

SECTOR ANALYSIS Indian biotech industry: Strategies for sustained growth Jumana Barnagarwala Head – Healthcare Consulting, Datamonitor India

INDUSRY VOICE

57 40

Dr Krishna Ella Chairman and Managing Director, Bharat Biotech

F E AT URE S LEADERS SPEAK 'Acquisition of an Indian CRO is not an attractive business proposition' ...says Dr Arun Bhatt, President, ClinInvent Research Pvt Ltd

ROUNDTABLE 100 % FDI in Indian pharma: Weighing the pros and cons

SECTOR WATCH

Bioinformatics: Aiding in faster drug discovery

MARKET TRENDS Human resource management: Making the right choice

REGULATORY AFFAIRS Indian pharma regulatory practices: Need for a globally compatible approach Dr Ajit Dangi CEO, Danssen Consulting

CRAMS CENTRE CRAMS industry: Showcasing India on a global platform Vikram Gupta CEO, IndiaVenture Advisors Pvt Ltd

REGULAR SECTIONS

RETAIL ZONE

Editorial ............................................................. 15

Visual merchandising: Tips for enhancing product visibility Rajendra Prasad Gupta International Healthcare Policy & Retail Expert

National News................................................... 18 World News....................................................... 24 Tech Updates ..................................................... 30 Events Calendar ................................................ 76 Product Update................................................. 78 Product Inquiry ................................................ 85

CASE STUDY E-Pedigree solutions: The new-age inspection system Didier Lacroix Senior Vice President, International Sales & Services, Cognex

PREVIEW Hi Tech Manufacturing: Envisioning the future of manufacturing

ADVERTORIAL Projecting ‘A promising Pune’

Advertisement Inquiry ..................................... 87

Highlights of Next Issue

Product Index ................................................... 89

Industry Update : Pharma machinery Market Trends : Pharma raw materials and excipients Event Focus : P-MEC/CPhI India

Advertisers’ List................................................. 90

57 58

60 63

34 36 40 45 50 52 55 70 73 74

Details on page no. 13, 14, 31, 32 Note: ` stands for Indian rupee, $ stands for US dollar and £ stands for UK pound, unless mentioned otherwise Cover photo courtesy: Strand Life Sciences (Screen shots)

16 Modern Pharmaceuticals

October 2010

NATIONAL NEWS

EXPANSION

Zydus Nycomed commissions the newly expanded API manufacturing facility Zydus Nycomed, the joint venture company of Zydus Cadila and Nycomed, has commissioned its newly expanded Active Pharmaceutical Ingredient (API) manufacturing facility, at Navi Mumbai. The company is expected to start commercial production of APIs by December 2010. Initially, the plant will manufacture Pantoprazole, Urapidil and

NEW SOFTWARE

Strand releases Avadis NGS software to enable analysis of NGS

Strand Scientific Intelligence, Inc, (Strand), recently declared the worldwide release

TOP BIDDER

Taisho leads bids for Paras Pharmaceuticals Japan’s Taisho Pharmaceuticals has emerged the top bidder for buying a majority stake in Indian drugmaker Paras Pharmaceuticals, which owns popular brands such as anti-cold medication D’Cold and pain relieving ointment Moov.

APPROVAL

Vivimed Labs receives ‘In–principal’ approval

18 Modern Pharmaceuticals

Lornoxicam. Subsequently, by 2011, the company will begin producing eight additional APIs. The new commissioned facility hopes to mark the transition of Zydus Nycomed from an intermediate manufacturer to a full-fledged API manufacturer. Speaking on the occasion, Pankaj R Patel, Chairman & Managing Director, Zydus Cadila, said, “Zydus Nycomed has become a global hub of excellence with its high quality standards, precision in manufacturing and customer service.

The expansion of operations adds new dimensions to this partnership and opens up new avenues for growth and excellence.”

of Avadis NGS, a software application for the Next-Generation Sequence (NGS) analysis. Avadis NGS aims to help biologists in visualising and offering downstream analysis of their NGS data on a desktop computer. Avadis NGS is an application dedicated to the ChIP-SEQ, RNA-SEQ and genetic variation analysis that aims to enable its users to assimilate large amounts of NGS data and ascertain deep biological insights using powerful statistics, interactive data visualisations in a genome browser and downstream

analyses such as GO, pathways and GSEA. François Mandeville, Executive Vice-President, Strand, said, “Avadis NGS represents a milestone in NGS, and, finally, aims to shift the power of analysis from IT and informatics experts to the biologists.” A 20-day trial of Avadis NGS is available for biologists and NGS researchers at the website http://avadis-ngs.com. The software is licensed online by Strand, and hence can also be licensed from the life sciences sales force of Strand’s partner, Agilent Technologies, Inc.

Taisho has offered more than six times the estimated revenues of Paras, which comes to ` 5 - 5.5 billion. Private Equity (PE) firms that own 70 per cent of Paras are seeking bids from global firms that include Pfizer Inc, GlaxoSmithkline, Sanofi-Aventis and Daiichi Sankyo. Girish Patel, Founder, Paras Pharma, and his family, own the remainder 30 per cent. However, Taisho has a different

take on this. A spokesperson of Taisho said, “We are interested in entering the Indian market. But the fact that we have offered to buy PE’s stake is not true.”

Vivimed Labs has declared that it has received ‘In–principal’ approval from Department of Commerce, Ministry of Commerce & Industry, Government of India, for development, operation and the maintenance of a sector-specific Special Economic Zone (SEZ) in Srikakulam District, Andhra Pradesh, for chemicals & pharmaceuticals, all in the form of bulk/Active Pharmaceutical Ingredients (APIs)/formulations.

Recently, the company announced a rise of 40.97 per cent in consolidated net profit year-on-year to be ` 98.14 million, while total income rose 6.83 per cent to ` 850.03 million for the quarter ended June 2010. On August 17, 2010, the board of directors approved the final dividend of 15 per cent, or ` 1.5 per share. The company has an equity capital of ` 9.96 million, with the face value of share being ` 10. It has market capitalisation of ` 3.27 billion as on October 08, 2010.

October 2010

Hakan Bjorklund, CEO, Nycomed, and Pankaj R Patel, Chairman & MD, Zydus Cadila

NATIONAL NEWS

ACCOLADE

Exports & Patents Awards presented during Pharma CEOs Conclave The Export Performance Awards and Patents Awards 2009-10 were presented during the Pharma CEOs Conclave in Hyderabad. The event was organised by Pharmaceuticals Export Promotion Council (Pharmexcil). K Rosaiah, Chief Minister, Andhra Pradesh, was the chief guest and

NEW PLANT

Helvoet Pharma to set up a new facility in Khandala

Helvoet Pharma, part of the Daetwyler Group, plans to set up its first greenfield production facility in Khandala Industrial

INNOVATIVE INITIATIVE

Grundfos launches ‘Incredible Indian Pump Yatra’ Starting from Ahmedabad on September 10, 2010, Grundfos India – a subsidiary of Grundfos, Denmark, one of the largest pump manufacturers in the world – has come up with an innovative initiative, ‘The Incredible Indian Pump Yatra’. This is a fully equipped business lounge on wheels, which will have a series of

CERTIFICATION

Courtesy: AlaCarta

SAP certifies SpectraSoft solution for life sciences Industry

SpectraSoft Technologies, a business solutions specialist for process industries, declared that its SAP Business All-In-

20 Modern Pharmaceuticals

presented the ‘Outstanding Export Performance Awards 2009-10’. Ranbaxy Laboratories Ltd and Cadila Healthcare bagged the Outstanding Exports Award in the Overall & Emerging categories, respectively. Aurobindo Pharma Ltd and Matrix Laboratories Ltd received the Outstanding Exports Award Formulations in the Overall & Emerging categories, respectively. In all, 12 awards were presented for export performance. Rosaiah said, “I am pleased that, after

establishment of Pharmexcil, the exports of our country have seen considerable growth. Formulations exports have grown at 58 per cent, bulk drugs at 41 per cent and herbals at 1 per cent.”

Area, Phase I, on Pune-Bangalore Highway, with an investment of ` 120 crore. This is Helvoet Pharma’s first plant in India. The new plant, spread across 36,000 sq m, will come up in the newly developed Maharashtra Industrial Development Corporation (MIDC) Special Economic Zone (SEZ) near Pune, and will serve as a strategic hub for exports to European countries.

The facility will include a product design and customisation centre. The new facility is expected to become operational by 2012. It also plans to employ more than 100 people. The facility will cater to the needs of the local pharma industry and globally operating pharma customers in India, according to Guido Wallraff, Head - Pharmaceutical Packaging Division, Daetwyler Group.

interactive displays of a wide range of industrial pumps from Grundfos. The vehicle, with a floor space of 800 sq ft will enable visitors to gain hands-on experience of Grundfos products and solutions. Commenting on the initiative, N K Ranganath, Managing Director, Grundfos Pumps India Pvt Ltd, said, “Grundfos India has been directly associated with Indian industrial market for over 10 years. Our intensive research

in the market revealed that in many engineering industries, there exists a great potential for energy saving, even in the small- and medium-range pumps. Grundfos has made energy-efficient pumps that can address this gap.”

One partner solution ‘Spectra:Pharma’ addressing the life science business needs in India has cleared the qualification process and has been certified by SAP. This industry-ready solution has been developed by a team of experienced specialists from the life science industry and is built on the robust SAP ERP 6.0 platform. The certification comes after a stringent evaluation process by SAP, making SpectraSoft the only such qualified solution for the vertical in India at present.

Elaborating on this certification, Nagaraj Bhargava, CEO, SpectraSoft Technologies, informed, “The solution while addressing the business and process needs of formulations, bulk drug, biotech and generics companies allows for a rapid implementation, significantly bringing down the ‘Time to Value’.” Further, Debdeep Sengupta, Vice President, SME and Channels, SAP India, said, “It gives us immense pleasure that Spectra:Pharma, a SAP-certified partner solution will address the life science business needs in India.”

October 2010

(L-R): K Rosaiah and Smitesh Shah, Chairman, Pharmexcil

NATIONAL NEWS

Bafna Pharma gets a nod from Australian regulators As part of its expansion plans, Bafna Pharmaceuticals has received the Australian Therapeutic Goods Administration (TGA) approval on manufacturing of both prescription and non-prescription products in the Australian market. Bafna Pharmaceuticals is a Chennai-based pharma company engaged in the business of

ANDA APPROVAL

STRIDES ARCOLAB receives two more ANDA approvals

Strides Arcolab Limited (Strides) declared that it has received its 50th USFDA Abbreviated New Drug Application (ANDA) approval for two of

NEW LICENCE

Glenmark Pharmaceuticals in-licenses novel anti-TrkA antibody from Lay Line Genomics, Italy Glenmark Pharmaceuticals SA (GPSA), a wholly owned subsidiary of Glenmark Pharmaceuticals Ltd India (GPL) has declared that it has been granted by Lay Line Genomics S.p.A. (LLG), an exclusive,

AGREEMENT

Electrol Specialties Company’s products now in India

Electrol Specialties Company (ESC), the US-based leader for innovative biopharmaceutical Clean-In-Place (CIP)-related products, has signed an

22 Modern Pharmaceuticals

manufacturing pharma formulations of Betalactam and non-Betalactam. Further, the dosage of prescription and non-prescription could be in the form of tablets, caplets & hard gelatin capsules. Commenting on the approval, Bafna Mahaveer Chand, Chairman & MD, Bafna Pharmaceuticals, said, “The TGA process is among the most prestigious and we take immense pride in receiving the approval. This will further help us improve and develop on our plans

for expanding into the Australian market and provide momentum to our expanding business worldwide.” With this initiative in place, the company hopes for a huge profit in its long-term business in Australia.

its products. These two products include Lidocaine Hydrochloride Injection USP, 20 mg/mL (preservative-free), packaged in 100 mg/5 mL single-use vials, and Lidocaine Hydrochloride Injection USP, 0.5 per cent (5 mg/mL) & 1 per cent (10 mg/mL), packaged in single-use vials. Of the 50 approvals received to date, 31 are for sterile products, a segment in which Strides has established itself as one of the leading players worldwide. In 2010, the company received

19 approvals, of which 14 are from the steriles space. According to IMS data, the total US market for Lidocaine injection in 2009 approximated $ 61 million. Again, half of this market will be covered by the two new products, which have received approval. The company expects to launch these products in the near future. Strides has also filed several applications for the balance strengths, and is awaiting their approval.

worldwide licence to LLG’s entire intellectual property portfolio in the TrkA field. The licensed assets include BXL1H5 – a novel monoclonal antibody that binds to TrkA receptors. The deal is of specific significance because Glenmark has the sole licence to commercialise monoclonal antibodies against TrkA receptor for pain. Further, Glenmark Generics Inc., USA, a subsidiary

of Glenmark Generic Ltd, has been granted the final Abbreviated New Drug Application (ANDA) approval from the USFDA for pramipexole dihydrochloride tablets.

agency representation agreement with Salesworth India Private Ltd for representation across India. This development is likely to add an important sales and customer support channel for ESC and is expected to have significant positive effect on the company’s market growth in the region. Further, proprietary design ESC CIP systems, such as the Eductor-assisted and portable models, provide optimum process cleaning with the use of minimum amount of water

and chemicals. ESC is also known for custom directionally drilled CIP spray devices for vessels & process equipment, transfer panels, valve arrays and hygienic design process equipment. Salesworth is one of India’s agencies involved in the sales, service & support of the state-of-the-art Blow-Fill-Seal machines from Rommelag, Switzerland; Inspection machines from Seidenader, Germany; and Sterilisers from Getinge, Sweden.

October 2010

Courtesy: Piper Report

REGULATORY APPROVAL

WORLD NEWS

DRUG APPROVAL

MSD’s new single-dose Ivemend receives EU approval for acute and delayed nausea and vomiting

Merck (known as MSD outside the US and Canada) recently announced that

PHARMA RESEARCH

PharmaJet and Inviragen awarded contract for needle-free vaccine PharmaJet and Inviragen have received a five-year $ 15.5 million contract by the US National Institute of Allergy and Infectious Diseases (US NIAID) to develop a needle-free vaccine for dengue. The new vaccine would provide a more convenient alternative for people from regions inflicted with dengue, and

PRODUCT RECALL

Bottles of Lipitor recalled due to ‘musty odour’ by Pfizer

The US drug giant Pfizer recently announced the detection of low levels of 2,4,6-tribromoanisole in seven lots of

ACCEPTANCE

FDA accepts Aricept Patch NDA for review Eisai, Inc, recently announced that the USFDA has accepted the New Drug Application (NDA) for the Aricept® Patch (donepezil transdermal system) intended for the treatment of mild, moderate and severe stages of Alzheimer’s disease for review. Teikoku Pharma USA, Inc, a subsidiary of Teikoku Seiyaku Co, Ltd, and Eisai are seeking

24 Modern Pharmaceuticals

the European Union (EU) has granted marketing approval for a new, singledose regimen of Ivemend® (fosaprepitant) 150 mg for the prevention of acute & delayed nausea and vomiting associated with Highly Emetogenic Cisplatin (HEC)-based chemotherapy and Moderately Emetogenic Chemotherapy (MEC). The drug is used in adults along with other antiemetic medicines. Unlike previously where fosaprepitant

115 mg, which was given on day 1 of chemotherapy along with aprepitant capsules on days 2 & 3, now a single-dose fosaprepitant 150 mg is administered on day 1 of chemotherapy and does not require administration of ‘Emend’ (aprepitant) capsules on days 2 & 3. The approval of fosaprepitant applies to all 27 countries that are members of the EU, as well as in Norway and Iceland. Fosaprepitant will be available later this year.

eliminate the hazards & costs associated with the disposal of needle waste. PharmaJet and Inviragen have decided to unite their individual responsibilities in vaccines & the delivery system. PharmaJet would apply its needle-free system to delivery of DENVax, a tetravalent dengue vaccine developed by Inviragen. The NIAID contract covers manufacturing & clinical testing of the needle-free dengue vaccine and preclinical regulatory filings.

Jorge Osorio, CSO, Inviragen, said, “Preliminary animal model studies using PharmaJet’s injector to deliver DENVax intradermally have shown that the combination is safe and induces neutralising antibodies to all four dengue serotypes.”.

the cholesterol buster – Lipitor. About 191,000 bottles of the ‘world’s best selling drug’ was reported to be emitting a ‘musty odour’ after the product was opened by some patients. Pfizer spokesperson, Rick Chambers, said, “Very low levels of 2, 4, 6 tribromoanisole was detected in a sample from one of the lots, though it is not yet confirmed whether that is the actual source of the odour.” He also said

that the investigation is going on to find the reason for emission of the musty odour. Chambers further informed that the health problems faced by the consumers were probably unrelated to this incident, and that the medical assessment determined that these problems are not likely to be associated with the odour. The US FDA is currently monitoring the situation.

approval of the weekly Aricept Patch. In early 2009, Teikoku Seiyaku and Eisai had announced that the companies signed agreements regarding the development and marketing of the Aricept Patch in Japan, the US & the rest of the world. If approved in the US, Eisai, Inc, will hold the marketing rights in the US and co-promote the patch along with Pfizer. The acceptance of the NDA indicates that the FDA deems the company’s

submission to be sufficiently complete for review. The NDA was submitted to the FDA on June 30, 2010. The Aricept Patch is a weekly transdermal patch developed to provide an alternative formulation for patients with Alzheimer’s disease.

October 2010

WORLD NEWS

HUMAN RESOURCE

Abbott to axe 3,000 jobs following the Solvay deal Abbott Laboratories plans to cut 3,000 jobs, or about 3 per cent of its workforce, following its purchase of Solvay SA’s pharma business. The job cut will take place over the next two years and the majority will come from onetime Solvay positions, Abbott’s spokesperson Scott Stoffel informed, recently. He further added

ALLIANCE

RXi, EyeGate Pharma collaborate on ocular delivery of RNAi therapeutics

RXi Pharmaceuticals Corporation and EyeGate Pharma, a specialist in non-

ORAL TREATMENT

Novartis’ Gilenya approved by FDA as first oral treatment for relapsing forms of MS Novartis received approval from the USFDA for oral Multiple Sclerosis (MS) treatment GilenyaTM (fingolimod) 0.5 mg daily, a first-line treatment for relapsing forms of MS. The FDA approval makes Gilenya the first oral treatment indicated for relapsing forms of MS, and is available in the US.

AGREEMENT

EMEA and USFDA extend confidentiality arrangements

The European Medicines Agency (EMA) and the USFDA have extended their confidentiality arrangements related

26 Modern Pharmaceuticals

that the reductions will involve research & development, commercial, manufacturing and other staff functions. Abbott, with about 93,000 employees, will also close the former US headquarters of Solvay’s pharmaceuticals unit in Marietta, Georgia, by the end of 2011. About 500 positions at a site in Weesp in the Netherlands also will be removed, so will 300 jobs in Hannover, Germany.

Solvay’s drug unit had more than 10,000 jobs when Abbott had bought it. “The job cuts are part of a series of recent strategic announcements designed to position Abbott’s pharma business for sustained and future growth,” Stoffel said.

invasive ocular drug delivery, recently announced a collaboration for the ocular delivery of RNAi therapeutics. Each company will contribute technology, expertise and resources to the alliance. The collaboration will explore the use of EyeGate’s iontophoresis technology to deliver RXi’s sd-rxRNA compounds to the eye in preclinical models. Once inside the eye, the RXi’s sd-rxRNA compounds enter the retinal

cells and silence disease-causing genes. The technology is currently in a Phase III trial with an anti-inflammatory product (EGP-437). “Combining our RNAi technology with EyeGate’s unique, non-invasive ocular delivery system (EyeGate® II), provides us an opportunity to develop novel treatments for many ocular diseases and improve treatment options,” said Noah D Beerman, President & CEO, RXi Pharmaceuticals.

Gilenya reduces the frequency of MS relapses and slows down the build-up of some of the physical problems caused by MS. In clinical trials, Gilenya has a well-studied safety and tolerability profile, which has been characterised in over 2,600 clinical trial patients, some of whom are in their seventh year of treatment, with more than 4,500 patient years of experience. “This is a significant day for patients suffering with relapsing forms of MS in

the US. A new treatment option offering significant efficacy in the convenience of a capsule is an excellent alternative to frequent injections for individuals living with this chronic disease,” said Nicholas LaRocca, Vice President - Healthcare Delivery & Policy Research, National Multiple Sclerosis Society.

to medicinal products for human and veterinary use. This co-operation will now continue indefinitely without the need for further renewal. The confidentiality arrangements allow both agencies to exchange confidential information as part of their regulatory and scientific processes. They aim to promote public & animal health and protect patients from Europe and the US. These arrangements cover

medicines that are subject to evaluation or authorised under the centralised procedure as well as those authorised at the national level by the EU Member States. These also include medicines that are subject to official European Community arbitrations and referrals. The new commitments are based on the achievements of the previous arrangements between the EMA, the European Commission and the FDA.

October 2010

WORLD NEWS

ACCOLADE

Lilly recognised with World Business and Development Award for TB initiative An eminent international panel of judges has selected Eli Lilly and Company to receive a World Business and Development Award for demonstrating what can be achieved through successful partnerships in the battle against Multidrug-Resistant Tuberculosis (MDR-TB).

COLLABORATION

Shire and Acceleron Pharma collaborate to treat orphan muscle diseases

Shire, plc recently announced the expansion of its Human Genetic Therapies

CLINICAL TRIAL

Boehringer begins Phase III trial with novel oral agent in advanced breast cancer Boehringer Ingelheim has initiated the Phase III clinical trial to investigate one of its most advanced oncology pipeline compounds, afatinib, for treatment of patients with advanced breast cancer. This trial, called the ‘LUX-Breast 1 Trial’ is the first to evaluate afatinib in breast cancer, and the investigation widens

AUTOIMMUNE DISEASE

Development programme for ofatumumab in autoimmune indications refocussed

GSK and Genmab have announced plans to refocus the development programme for subcutaneous delivery of

28 Modern Pharmaceuticals

“We are honoured for this recognition, just as we are inspired daily by the dedication of the organisations and individuals who are part of the Lilly MDRTB Partnership. There is still much work to be done, but we believe that over time we can make a tangible difference in eliminating a disease that is taking millions of lives,” said Jacques Tapiero, President - Emerging Markets, Lilly. The World Business and Development Awards, given every two years, showcase the creative efforts of the

private sector in applying their core business expertise to help achieve the goals. Winners of past awards, together, have improved the lives of millions of poor people throughout the world.

pipeline through the exclusive licence, in markets outside of North America, for the activin receptor type IIB (ActRIIB) class of molecules. These molecules are being developed by Acceleron Pharma, Inc, a private biotechnology company based in Cambridge, Massachusetts. The alliance will initially investigate ACE031, Acceleron’s lead ActRIIB drug candidate, currently in Phase IIa trial for treatment of patients with Duchenne Muscular Dystrophy (DMD). Shire and Acceleron will collaborate

for a worldwide development programme to advance ACE-031 into a global Phase II/III clinical programme designed to demonstrate disease modification in DMD patients. Shire will utilise its Lexington, Massachusetts manufacturing facility to produce commercial supplies of the product for both parties. If marketing authorisation is received, Acceleron will commercialise ACE-031 in the US and Canada, and Shire will have the exclusive right to globally commercialise the therapy.

the scope of potential cancer types for which Boehringer Ingelheim’s oncology portfolio may be suitable. LUX-Breast 1 is a global, openlabelled randomised Phase III study in advanced breast cancer patients (after prior treatment with trastuzumab), who have an over-expression of the HER2 protein. The trial investigates whether afatinib treatment can extend the lives of these patients before their cancer progresses, as compared

to continuing treatment with trastuzumab when both are added to standard chemotherapy treatment vinorelbine. The study will also assess overall survival, tolerability and safety of the drug.

ofatumumab in autoimmune indications. Based on the positive results from the Phase I/II study in Multiple Sclerosis (MS), GSK plans to begin a Phase IIB dose ranging study in MS by using the subcutaneous administration of the drug in 2011. Further, work in Rheumatoid Arthritis (RA) with a subcutaneous administration of ofatumumab is under review.

“Although intravenous delivery of ofatumumab has previously shown positive results in MS & RA studies, the autoimmune programme is refocussing on subcutaneous delivery of ofatumumab. This is because GSK believes that this route of administration has the potential to offer added convenience and improved tolerability,” said Ian Tomlinson, SVP Biopharmaceuticals R&D, GSK.

October 2010

TECH UPDATES

Waters introduces Ostro™ sample preparation products

New Mettler Toledo Garvens weigh cells offer compliance with industry standards

Waters Corporation has recently introduced the new Ostro™ sample preparation plate, representing a novel approach for the removal of phospholipids from biological samples. When compared to other phospholipid removal devices and conventional Liquid-Liquid Extraction (LLE) methods, Ostro™ removes up to 30 times more phospholipids. Phospholipids have been cited as a major cause of matrix effects in the Liquid ChromatographyMass Spectrometry (LC/MS) analysis of biological samples. Ostro™, with its proprietary, patent-pending design, was specifically created to overcome this hurdle by offering a ‘best-in-class’ solution that removes multiple families of phospholipids. The Ostro™ 96-well plate format utilises in-well protein precipitation with a single, rapid, pass-through method that provides a quick, reliable and reproducible solution. “Ostro™ will be a valuable tool for researchers working on phospholipid interferences, and for providing a complimentary solution to Oasis® SPE products – Waters premier solid-phase extraction solution,” commented Dr Diane Diehl, Director, Sample Preparation, Waters Division.

Mettler Toledo Garvens has launched two new Electromagnetic Force Restoration (EMFR) weigh cells for improved diagnosis and accuracy of both static and dynamic weighing processes during pharma production. The two new weigh cells, TF10 & TF20, include productivity and accuracy enhancing features and comply with stringent industry standards. TF10 and TF20 can be easily integrated into the checkweigher family and production lines. The efficiency increases due to the fast reaction time of the TF10 and TF20, which allows for shorter weigh cycles, facilitating higher throughput while ensuring rigorous quality assurance. The compact size of TF10 and TF20 allow maximum utilisation of limited plant space. “Continuous innovation is a key component of Mettler Toledo Garvens’ strategy, and we constantly seek feedback from our customers to ensure that we are meeting their evolving needs. With pharma manufacturers’ ongoing focus on quality and productivity, we focussed our R&D efforts in further enhancing our weigh cells in these areas,” said Dirk Bettels, Product Manager, New electro magnetic Mettler Toledo Garvens. force restoration

Novel ultrasound-assisted co-crystal service from Prosonix

Single-use Bio-Pak® culture bags by Charter Medical

Prosonix has launched a co-crytsallisation service for the production of active pharmaceutical ingredients for inhaled drugs and oral medicines. The new service will offer Prosonix’ range of ultrasound-assisted processing and production technologies to drug industry customers wishing to develop co-crystallisation for industrial-scale application. In key contrast to conventional solution-based co-crystallisation, this novel approach overcomes the need for critical matching of solubility during nucleation and growth of the co-crystal. In addition, the risk of crystallising single components is significantly reduced. The stoichiometric composition of the components is maintained throughout the process, and the conditions for nucleation and growth of the co-crystal is generated within the process. Dr Graham Ruecroft, CTO, Prosonix, said, “This is yet another demonstration of how Prosonix is using several years of learning to tackle another key emergent area in pharmaceutical product development by designing protocols for controlled crystallisation and manufacture of pharma cocrystals in a robust & efficient manner. The methods developed by us allow control of both the fundamental co-crystallisation and the desired particle size.”

US group Charter Medical Bio-Pak® culture bags provide a stable environment that enhances cell growth and viability. The new Bio-Pak bags are made from the firm’s Clear-Pak® single-web, multi-layer film, which provides ‘superior gas barrier properties’. This superiority, according to data on Charter’s website, is based on the fact that the Clear-Pak® film technology has oxygen and CO2 transmission rates of less than 0.003 and 0.01 cm3/100 in 2 day atm, respectively. These Bio-Pak® culture bags are produced in a recently expanded ISO Class 7 cleanroom at Charter’s facility in North Carolina. Peter Ferris, President, Charter Medical, said, “This new product offering is a perfect fit for our Life Sciences growth initiative, as it rounds out our Bio-Pak® line in an exciting space. The biotech single-use market continues to grow at double-digit rates and the cell culture bag is a key product targeted with our recent capital investments. Bio-Pak® cell culture bags join Charter’s other new Bio-Pak® products – the 3D Gusset and small volume single-use systems – which together offer a comprehensive solution in the range of 50 ml-3,500 ltr.”

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October 2010

TECH UPDATES

CDC’s trace express viewer

Intelsius introduces new packaging temperature-controlled system

CDC Software has launched a trace express viewer that helps in identifying the suspect materials besides providing Current Good Clinical/Laboratory/ Manufacturing Practices (cGCP/GLP/GMP) compliant transaction processing and meeting the ePedigree requirements for users. CDC believes that its trace express viewer, an addition to its Ross ERP lot trace application, can help users tackle these problems by tracking active pharmaceutical ingredients, intermediates and finished products. The system can track these materials through receipt, manufacture, inventory, sales and delivery. CDC claims that the system is ‘highly intuitive’, as it reduces the time taken by the user to identify, review and process data related to a particular lot throughout the supply chain. Users managing their materials, manufacturing and financials using the system will be in compliance with the regulations. Also, Ross ERP and trace express viewer allow users to provide an ePedigree for a drug on request from an inspector. This will give a detail on the product’s movements through the supply chain to provide evidence of its quality and legitimacy.

Intelsius, formerly DGP Group, has introduced Orcatherm to address the increasing pharma industry’s need for temperature-controlled packaging and regulatory compliant sample transport solutions. The company claims to have created a reusable, heavy-duty temperature-controlled shipping system with encapsulated Vacuum Insulated Panels (VIPs) incorporated into its design. This allows Orcatherm to insulate up to seven times more effectively than other materials of same thickness, such as styrofoam, extruded polystyrene and expanded polyurethane. Orcatherm is one of its most innovative packaging solutions to date, as the range has been designed to ensure maximum thermal protection for distributing highly valuable, temperature-sensitive materials and finished products for testing, analysis & immediate storage. Andrew Mills, CEO, Intelsius-Americas, said, “There is a rising global demand for temperature-controlled packaging for storage and transportation of drugs. As the development of today’s advanced therapeutics relies on these materials, the need for innovative temperaturecontrolled packaging systems will continue to grow.”

Bosch launches its new range of infeed systems

Thermo Fisher Scientific demonstrates software for simplified bioanalytical workflows

The German-based company claims that its Pack Feeder 4 portfolio has been designed in response to the trend for shorter product lifecycles. It includes both in-line and crossed-belt infeed systems, which can support high production volumes with belt speeds of up to 120 m/min. The machines are targeted at packaging bakery and confectionery items such as biscuits, chocolate and bar-type products, as well as products in plastic, cardboard trays & pharma goods. It has features that reduce the total cost of ownership, maximise uptime and optimise the efficiency of the system. A gear-free belt drive system simplifies maintenance, while the hinged sides enable easy removal of product jams. Parts like belts, nose rollers and deck plates can be dissembled without the need for tools, allowing for trouble-free cleaning. The equipment had been designed to enhance flexibility and allow product manufacturers to meet the everincreasing demands from their customers. The systems are available with conveyor belts in various layouts and lengths to meet individual production needs. The new infeeder has standardised interfaces to enable it to be easily integrated into its existing wrapper systems, allowing for lower start-up costs and lead-in times.

Thermo Fisher Scientific, Inc, recently announced the launch of a new online demonstration of its TSQ Module™ software for Watson™ Laboratory Information Management System (LIMS). This industry-first integration of LIMS and instrument control software coupled with the Thermo Scientific TSQ series Liquid Chromatography-Tandem Mass Spectrometry (LC-MS/MS) system is designed to significantly increase efficiency by enabling data from the entire bioanalytical workflow to fit in a single database. It is designed to provide increased regulatory control by managing the complete workflow with data review, processing, reporting and archiving all under the control of Thermo Scientific Watson™ LIMS. The Thermo Scientific TSQ Module works with Watson™ LIMS and TSQ series mass spectrometers to enable direct LC/MS data acquisition. The TSQ Module enables LC-MS/MS methods to be part of worklists created in Watson LIMS that can be directly submitted to any configured TSQ series mass spectrometers via the network. This functionality allows laboratory managers to balance workloads among multiple resources.

October 2010

Modern Pharmaceuticals

LEADERS SPEAK

‘Acquisition of an Indian CRO is not an attractive business proposition’ …says Dr Arun Bhatt, President, ClinInvent Research Pvt Ltd. He identifies the gaps in the Indian clinical research market, in conversation with Saloni Vora, and also suggests some key focus areas to lead from the front.

Evolution of clinical research

Difficulties before CROs

The regulations for clinical research have become complex and challenging to regulate diversity of New Medicinal Entities (NMEs) – biotechnology, genomics, vaccines, stem cell therapies, etc. Each of these advances brings new ethical issues and has placed clinical research in centre of media focus. In parallel, challenge for the industry is to complete the drug development in a fast & economic manner, while at the same time complying with global regulatory requirements. This has resulted in the emergence of outsourcing clinical trials by global pharma to emerging economies like India and China. Further, the industry is involved in developing new models to improve the predictability of early clinical development like micro-dosing studies, proof-of-concept studies, adaptive designs, use of biomarkers, etc. The industry has also embarked on major IT-driven initiatives to capture clinical trial data such as utilising Electronic Data Capture (EDC) and in pharmacovigilance and electronic regulatory data submissions.

In the last five years, clinical trial protocols have become complex. Owing to the intense competition and only a few

Increasing focus on clinical research Integration of a hospital’s services for clinical trials in a central streamlined set up, such as a Site Management Organisation (SMOs) is beneficial to pharma and Contract Research Organisation (CRO) industry. However, according to our experience, this model has not been successful so far due to the inefficient coordination between the central office and individual hospital investigator. Also, the individual hospital investigator, who is responsible for the regulatory compliance and safety & well being of his/her patient, is dissatisfied with the additional burden of internal bureaucracy and reduced opportunity of financial gains.

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October 2010

LE ADERS SPEAK

compounds in the pipeline, the pharma industry is looking for niche indications. Hence, this has increased the number of selection criteria for clinical trials and medical procedures. On the flipside, this has increased the burden of work for clinical trial investigators. Further, only 10 per cent of patients, as seen by an investigator, are eligible for recruitment in today’s complex trials. This indicates a prolongation of trial completion and increase in the investigator site budgets. Further, the complexity of trial protocols also requires big investments in the training of investigator teams and inhouse teams of the CRO.

M&As and future trends

Quick bites

The current record of Mergers & Acquisitions (M&A) in clinical research is not encouraging. If an Indian CRO acquires a foreign CRO, the manpower, which is the most important asset in the management of pharma clients and investigators, usually leaves the company. Also from the business perspective, there are issues regarding the Indian CRO’sability to manage a global operation and procure new business in a If not in the field of clinical research, you would have been... A practising medical consultant, treating patients probably in a corporate hospital You spend leisure time... Reading biographies and philosophy, listening to Indian classical music and Ravindra Sangeet, travelling Your motto in life... Integrity and quality The greatest turnaround factor... Leaving big pharma to join a small biotech and ultimately becoming a consultant in pharma medicine You gain inspiration from.... Lives of leading people For you, success and failures are... Just milestones on the highway of life

Dr Bhatt’s Journey with ClinInvent I began my career at CIBA Research Centre as a Clinical Research Scientist, where I worked on Phase I-II studies and later, I handled Phase III-IV studies as well. I also worked as President at the Indian Society for Clinical Pharmacology & Therapeutics. This early interest continued when I became Medical Director of Novartis and managed some of the early global trials. Later, I ventured into herbal clinical drug development and joined as consultant with Contract Research Organisations (CROs). This experience helped me when I joined The Chatterjee Group (TCG) to establish ClinInvent – the Clinical Research Organisation. In the seven-year journey of ClinInvent, we have managed several global trials in diverse fields like oncology, cardiology, neuropsychiatry, gastroenterology, respiratory, infectious diseases, etc. Today, the organisation has become a leading Indian CRO, recognised for its trained and talented manpower as well as its quality of service. foreign country. In contrast, for a global CRO, it is relatively easy & cost-effective to set up a greenfield operation. Thus, acquisition of an Indian CRO is not an attractive business proposition.

incorporate transparency and accountability into the system. Another urgent requirement today is to assess the quality of Indian trials through effective regulatory inspections.

Drawing and retaining clinical talent pool

Gap analysis in scaling resources for clinical trials

The government & industry need to develop joint training programmes in order to train and accredit new investigators in clinical research methodology. It is also essential to include clinical research in the graduation syllabus of medicine, pharmacy and other disciplines of life science. For the industry, it would be desirable to partner with educational institutions in setting up quality standards, developing industry-focussed training programmes & providing opportunities for onthe-job-training to students. The industry also needs to focus on development of leadership skills in middle management.

There is a need for gap analysis every 3-5 years, as the problem here is that the current data is based on guestimates provided by financial consultants. Hence, it is desirable that such an analysis be undertaken by a credible organisation that can obtain real data from all stakeholders on an ongoing basis and periodically release its findings to allow industry, government & academia to take appropriate decisions.

Current in India

regulatory

scenario

The Indian regulatory system & processes are all set to become globally acceptable in the future. However, there still are several government departments involved in the regulatory processes, which necessitate having a single window system. Also, there is a need to

Next generation market The major focus for the next few years will be to shift towards earlyphase clinical trials with the use of new tools like genomics, biomarkers, etc. As these trials will decide the fate of NMEs early in development, the market may be actually smaller than the current market of large late-phase trials. Keeping in mind the developmental trends we therefore aim to take progress beyond what it is now with the help of our people and better performance in the road ahead for the organisation.

October 2010

Modern Pharmaceuticals

ROUNDTABL E

100 % FDI in Indian pharma

Weighing the pros and cons Though FDI in Indian pharma may bring with it the spill-over effects, which may prove beneficial to the industry, the controlling stakes in the hands of foreign companies is something that rings an alarm. Though the Indian government is of the view to sustain the controlling stakes with the local companies, industry experts and veterans have a different opinion. Chandreyee Bhaumik presents the case. The Department of Pharmaceuticals has proposed to limit the Foreign Direct Investment (FDI) in domestic pharma manufacturing to 49 per cent, arguing in inter-ministerial consultations that acquisitions of domestic drug companies were increasing. However, the Department of Industrial Policy and Promotion (DIPP) has rejected the proposal of limiting the investment to 49 per cent, stating that apprehensions about the industry were misplaced. Further, the Finance Ministry has objected to suggestions made by the Commerce and Health Ministries to consider FDI in the pharma sector. The Commerce Ministry was of the opinion that this investment might further trigger the existing trend of acquisitions of the Indian pharma companies by Multinational Companies (MNCs). Therefore, this might threaten the healthcare system. The Finance Ministry advocates that any restriction if imposed might distort the image of India from being a desirable investment destination.

Dr Ajit Dangi President & CEO, Danssen Consulting One of the major challenges of doing business in India is inconsistencies in government policies. Whether it is Union Budget or economic reforms, continuous policy tinkering not only makes India less competitive but also increases cost of performing business activities in India, thereby making long-term business planning a difficult task. This is a reason why India has dropped to the 51st rank in global competitiveness ranking, whereas China has improved to the 29th position. However, once a policy decision is taken after due deliberation with all the stakeholders, it should remain stable for a reasonable period of time. The proposed reversal of 100 per cent FDI policy through automatic route is a classic example of this. Today, India is becoming a destination of choice for foreign investments because

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October 2010

of the rapid growth of our economy. One of the reasons given for considering reversal of 100 per cent FDI policy is that, if MNCs acquire Indian companies, prices of drugs are likely to rise, making them unaffordable to the common man. Again, with time, most MNCs have realised that aggressive pricing in emerging markets do not work but only delays market penetration. Increasing numbers of MNCs are thus adopting country-specific pricing. Further, Indian pharma market is highly fragmented, with over 10,000 companies, leaving less than six per cent marketshare for the market leader. Hence, going forward, consolidation is a natural course. MNCs are not acquiring Indian companies only to boost domestic sales but also to increase their footprint in the global generics market. MNCs will also bring with them state-of-the-art technology, international regulatory practices like cGMP, GLP, quality assurance, NDDS, supply chain management, etc. Therefore, adopting such protectionist measures is uncalled for. Thus, to protect the interest of Industry, the government can modify certain clauses and make takeovers of Indian companies by foreign firms difficult rather than reversing the policy of 100 per cent FDI in pharma through automatic route.

ROUNDTABLE

Dr Amrita Bajaj Professor of Pharmaceutics, C U Shah College of Pharmacy, SNDT Women’s University Currently, FDI upto 100 per cent is permitted on automatic route for manufacture of drugs and pharmaceuticals, provided the activity does not attract compulsory licensing or involve use of recombinant DNA technology and specific cell/tissues-targeted formulations. Unfortunately, Indian pharma industry, as it stands today, is highly fragmented in that, while about 10,000 companies represent 70 per cent of the market, only 250 large companies control the remaining 30 per cent. However, with poor standards of healthcare in India, large capital infusion seems a good idea to upgrade the standards

Dr Mandar Kubal Consultant, Infectious Diseases and HIV Aids, Infectious Diseases and Pulmonary Care (IDPC) FDI is considered beneficial for the host economy for its continuous and ongoing progress. It leads to many positive outcomes in the form of technology transfer, increased competition, drive for innovation, better managerial policies, etc, which are occasionally termed as ‘spill-over effects’ of FDI in any sector. Indian pharma companies are majorly in the business of formulation and bulk supply of good quality generic drugs. Therefore, the relative interest and investment into R&D and Innovation has been less. Also, the growing generic formulation market was creating domestic competition within, and led to the creation of low cost yet good quality generic versions of drugs for the Indian consumer. This enabled Indian manufacturers to enter global African, Latin American markets with their low-cost emulations of patented molecules. As compared to the total FDI coming to India, the pharma sector receives a relatively low percentage of the share. But of late, due to recent takeovers of Indian pharma majors by MNCs, this issue has been revisited. The positive spillover effect of FDI is expected to be technology transfer, setting up of new formulation facilities, more investment into R&D, development for needs specific to Indian

as well as to cut down on consumer costs, as a consequence of employing higher scalability of operations. The critical mass will definitely make the drug affordable for all sections of the population. Further, according to a McKinsey study, spending on healthcare in India will witness the highest growth rate among all spending categories over the next two decades. If this happens, MNCs with their money power can essay an important role, and thus become an effective agent of change. Again, with more flow of money, there will be a stimulus to the economic activities and while employment opportunities will increase, it is hoped that the benefits of low-cost, essential drugs will percolate down to the common man. However, the downside is that many domestic firms may suffer as they may become less competitive, and that the country may also become too dependent on them. Thus, it is essential to impose some regulatory framework on them in order to enable them to become long-term players committed to Indian healthcare.

scenario, and generate competition for local industry, just to cite a few. MNCs should not be encouraged to acquire Indian formulation facilities simply to meet their international goals. These facilities should look into the needs and issues of India and work to address them. MNCs should also be advised to continue the bulk drug & formulation business in India. In terms of R&D, the areas of innovation should be centred on India rather than just using the low-cost, highly skilled professional workforce for clinical research activities and Indian population for research subjects as an outsourcing destination. Regulations must be enforced to cap the price of the drugs/formulation with respect to intellectual property rights when marketed by MNCs. Another way to tackle such problems is to increase the contribution of public sector companies into the pharma market, and increase the spending in basic research by apex bodies like the Indian Council of Medical Research (ICMR) and support Indian companies through incentives or grants. As a doctor or a patient, the only matter of concern is a steady and continuous supply of good quality, inexpensive and state-of-the-art drugs, drug formulations & drug delivery systems. If any of these parameters is disturbed, the healthcare delivery system fails. With the current state of the world’s economy, no industry can stand in isolation and afford progress. This is a world of collaborations and joint ventures. Here, one cannot remain averse to FDI in the Indian pharma. But 100 per cent investment luxury granted to these MNCs should not prove costly to the common man, and the country in general.

October 2010

Modern Pharmaceuticals

ROUNDTABL E

Sanjiv Kaul Managing Director, Chrys Capital Indian pharma has shown brilliant performance over the last few decades and is also seen as a formidable player in the global pharma market. Under the new guidelines of Securities and Exchange Board of India (SEBI) that are aiming to make the market more investor-friendly and also transparent, open offers would acquire 25 per cent ownership (earlier it was 15 per cent), and also need to be issued for the entire 100 per cent (earlier it was 20 per cent) equity of the target company. With these changes in the norms both the pharma and the biotech sectors might improve. There would hopefully be better norms, timelines and pricing. In fact, FDI has significantly emerged only recently, and that too for a peculiarity that exists. Currently, the top 10 Big pharma companies have half the marketshare in the branded generic segments as compared to what they account for in the global pharma market. Further, the branded generics segment is growing 3 times faster than the overall market. Therefore, this notion does not make sense.

Dr Shirish Kulkarni VP, Advanced Drug Delivery Systems, Lupin Research Park When one compares Indian pharma industry to the global pharma scenario, Indian pharma has many strengths. There is healthy cost-competitiveness and well developed industry. The industry also has the advantage of a strong manufacturing base along with a well trained research team and efficient scientists. The domestic pharma sector has access to this pool of resource, both in Indian as well as globally. There is also the advantage of strong marketing and distribution network, with biodiversity and chemistry that is both rich and competent, facilitating further R&D, thereby aiding progress and growth. Now considering this situation, 100 per cent Foreign Direct Investment (FDI) is considerably good. The investment can be utilised in both manufacturing and non-manufacturing activities. Again, manufacturing activities will include supply

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October 2010

Coupled with poor R&D productivity and imminent genericisation of their leading blockbusters, the Big pharma companies are further looking aggressively at enhancing their presence in this segment. With the recognition of product patents in the country, the share of MNCs in the Indian pharma is increasing. Further, the proposal of Indian Government to allow 100 per cent is expected to usher new hope for the industry, as it aims to bring in increased investment in R&D infrastructure by MNCs in India. Moreover, India is the only country that can offer them great leverage in other branded generic markets like Brazil, Russia, Eastern Europe, South Africa, Mexico, etc. India offers the best platform in terms of formulation development, API sourcing, regulatory skill sets, economies of scale in manufacturing and, above all, sales & marketing strengths. All these have led to Big pharma companies willing to pay a good market cap valuation for select Indian pharma players. The overall Indian pharma industry stands to benefit with heightened FDI inflows, which is characterised by being ‘exorbitant’ for Big pharma companies and ‘great value’ for Indian players. In addition, we hope that this FDI inflow will cascade and trigger a huge momentum for doing innovation pharma research in India, which can be seen as one of the biggest value creators in the coming decade.

chain management along with the process of technology process. In a few words, manufacturing process involves tangible activities and a lot of paper work is needed to achieve success. The non-manufacturing process concentrates on R&D, regulatory rights, Intellectual Property (IP) and other processes. Thus, to accomplish these purposes, 51 or 100 per cent, ie, the majority stake, should be with the foreign countries. This situation will hopefully benefit both domestic and overseas markets. In fact, the investor would obviously want to have a controlling stake. The investment can offer favourable aspects like initiation of new enterprises and better employment opportunities, thereby creating competition. And with regard to the manufacturing process, 80 per cent is low-end, whereas the remaining 20 per cent is high-end work. On the other hand, the non-manufacturing process involves 80 per cent high-end and the remaining 20 per cent low end. With Indian pharma companies going global, 100 per cent FDI will facilitate the latest technology and skill, benefitting not only the FDI companies but also Indian companies. However, more critical evaluation of utilisation of the investment is needed. In some cases, the acquisition of Indian pharma companies by MNCs should not hamper the competitiveness of the industry, nor should it tamper the R&D facility.

An invite that rewards as well...

Dear Reader, ‘Modern Pharmaceuticals’ solicits original, well-written, application-oriented, unpublished articles that reflect your valuable experience and expertise in the pharmaceutical industry. You can send us Technical Articles, Case Studies and Product Write-ups. The length of the article should not exceed 3000 words, while that of a product write-up should not exceed 200 words. The articles should preferably reach us in soft copy (either E-mail or a CD). The text should be in MS Word format and images in 300 DPI resolution & JPG format. The final decision regarding the selection and publication of the articles shall rest solely with ‘Modern Pharmaceuticals’. Authors whose articles are published will receive a complimentary copy of that particular issue and an honorarium cheque. Published by Infomedia 18 Limited, ‘Modern Pharmaceuticals’ is the leading monthly magazine exclusively meant for producers and user fraternities of the pharmaceutical industry. Well supported by a national readership of over 80, 000 and our strong network of 26 branch offices across India, this magazine reaches out to key decision makers among the Indian manufacturers of pharma products, machinery and allied sectors. Brought out in association with Hong Kong-based Ringier Trade Media Ltd (one of the world’s largest trade publishing houses with more than 200 special interest titles and offices in every major country), it ensures that advertisers are able to promote their products and services across the globe at no extra cost. So get going and rush your articles, write-ups, etc… Thanking you, Yours sincerely,

SECTOR WATCH

Cover photo courtesy: Strand Life Sciences (Screen shots)

Bioinformatics has experienced extraordinary growth over the past decade, largely due to the vast amount of complex data generated by the Human Genome Project, and globally, a trend is emerging towards merger of informatics companies and discovery-based companies. Geetha Jayaraman explores the emerging trends and opportunities that can be leveraged, to fasten the drug discovery process. 40 Modern Pharmaceuticals

October 2010

SECTOR WATCH

ioinformatics combines the principles of information sciences with technology and utilises it to transfer vast, complex and diverse life science data into a coherent form for wider applications. It provides the means to collect & process data, enhance data standardisation and harmonisation for scientific discovery. Population scientists and informatists are developing such innovative solutions to accelerate human health research across the world so as to prevent, diagnose and treat diseases. Prof A S Kolaskar, Vice Chancellor - Kalinga Institute of Industrial Technology (KIIT), avers, “Bioinformatics aims to enhance the understanding of biological processes. Bioinformatics includes the establishment of databases, algorithms, computational and statistical techniques and theory to solve formal and practical problems arising from the management & analysis of biological data.” In future, this information can be collected on individual and regional basis for the development of a personalised medication. As J Sairamkumar, Vice President - Life Sciences Practice, Cognizant, states, “Bioinformatics has been in existence for several decades, but gained momentum after the Human Genome Project (HGP). The HGP has made way for the development and commercialisation of a number of high-throughput technologies in biology, eg, microarrays. Bioinformatics, from a functional as well as structural perspective, evolved significantly with new algorithms and different data types. It is pervasive across the drug discovery and development value chain.” Bioinformatics being an emerging field finds applications in various areas of research. As Sairamkumar explains, “Bioinformatics provides support across the value chain, from target identification to target validation and clinical trials. It is also a key component of personalised medicine, thus leveraging healthcare data as well.”

Bioinformatics in drug discovery As

part

molecular

biology,

Prof A S Kolaskar Vice Chancellor - Kalinga Institute of Industrial Technology (KIIT)

Bioinformatics includes the establishment of databases, algorithms, computational and statistical techniques and theory to solve formal and practical problems arising from the management & analysis of biological data.

bioinformatics involves working with biological data, typically using computers, with the goal of enabling and accelerating biological research. Highlighting this Sairamkumar remarks, “Our understanding of biology has significantly changed in the last decade due to several breakthrough technologies such as microarrays and next-generation sequencing. Bioinformatics has kept pace with the changes in technology, different data types and the associated analysis requirements, and is also a key for data analysis and helps in generating insights.” A key challenge in the way of reducing the drug development cycle time is gleaning insights from the data generated. Bioinformatics helps address this challenge. “Bioinformatics is the key driver of the success and evolution of these technologies. As researchers understand the data better, they further evolve the technology and the cycle continues, benefitting the overall drug discovery and development timelines and costs,” highlights Prof Kolaskar. Bioinformatics has experienced extraordinary growth over the past decade, largely due to the vast amount of complex data generated by the HGP and the concomitant need for sophisticated approaches to data storage, retrieval, analysis and sharing. Dr Annie George, Vice President - Tech Services, Actis Biologics Pvt Ltd, says, “Bioinformatics can make inroads to the discovery of new drugs. Pharma industry has adopted genome sequences of microbes, identification of drug targets, high-throughput screening, high

content screening, etc to identify novel molecules. Companies are now adopting automated technologies to manufacture effective therapies and drugs due to increasing concern about drug safety and stringent regulations that govern clinical trials for drug discovery.” Bioinformatics tools find use in the development of biomarkers, which is an important milestone in the development cycle of a molecule in preclinical stage. Dr George avers, “Bioinformatics plays a crucial role in molecular medicine. Pharmacogenomic and pharmacodynamic ADMET properties of a molecule can be derived from the database and based on this information, molecular modelling can be achieved and the possibility of success or failure of a molecule be predicted before entering actual in vivo/large animal studies. On the basis of genetic information from the databases, in the near future, it is possible to use genes instead of medicine to cure the diseases. Gene therapy is one such technique.” In the drug discovery process, a complete human genome data can help explore the molecular basis of different diseases in a better way. Also, a better insight into the molecular mechanisms enables better treatment, cure and development of preventive tests. “Personalised medication is a model that emphasises the use of information about a patient so as to select/optimise the preventive and therapeutic care. The response to drug varies from one person to another, similar to the variation in genetic code. The advent of pharmacogenomics has made clinical

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Modern Pharmaceuticals

SECTOR WATCH

J Sairamkumar Vice President - Life Sciences Practice, Cognizant

Bioinformatics provides support across the value chain, from target identification to target validation and clinical trials. It is also a key component of personalised medicine, thus leveraging healthcare data as well.

medicine more personalised,” states Dr George. She further informs, “Based on the data available, one can design or develop machines or software for diagnosis or detection of various diseases. A CAD-based technology – Telesto, which is a part of Actis Biologics, is in the process of developing a technology for real-time diagnosis/drug delivery for breast cancer and select types of cancers. In future, we may enter into other disease segments as well.” Bioinformatics spans a wide range of activities — data capture, automated recording of experimental results; data storage & access using a multitude of databases and query tools; data analysis; as well as visualisation of raw data & analytical results. Elaborating further, Manas Thakre, Research Analyst - South Asia and Middle East, Pharma and Biotech Practice, Frost & Sullivan, explains, “Although the first two categories rely solely on computer skills, the others require additional skills in mathematics, molecular biology and biochemistry. For designing new molecules, many databases exist, such as SWISS-PROT, Clustr, which hold millions of protein sequences, structures, etc across animal species. These databases can be instantly assessed and compared by researchers working on drug discovery across the globe. Also, there exist a number of tools like search engines – BLAST – which can search any sequence and give its structural and functional details.”

Target identification and drugtarget validation Bioinformatics

new

research

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field has been created to address protein function at the level of regulation of enzyme activity. A specific sector of bioinformatics called ‘chemical proteomics’ or ‘activitybased proteomics’ makes use of small molecules that can covalently attach to catalytic residues at an enzyme active site. Thakre avers, “The selectivity of the chemically reactive group allows specific proteins or protein subsets to be tagged, purified, and analysed. As a

The use of bioinformatics is increasing in discovery research, especially in biotech companies. result, this technique helps to identify novel enzymatic proteins and has the potential to accelerate the discovery of new drug targets.” Advances in genomics and sequencing have made target identification easier through the use of bioinformatics tools. The focus of bioinformatics in drug discovery process has thus shifted from target identification to target validation. Dr George says, “The cost for target discovery and validation together accounts for a little over 42 per cent of the total drug discovery expense. This is because the process of target discovery and validation depends on the robustness of the software that is developed to model the desired range of products for the purpose of drug discovery.”

October 2010

Impact of structural bioinformatics Structural bioinformatics plays a key role in protein modelling, structure prediction and docking, among others. Sairamkumar explains, “Advancements in structural biology have been slower as compared to functional genomics primarily because of the availability of resources. Structural biology still relies immensely on heuristics-based approaches.” Supporting this statement, Dr George adds, “The success of a drug discovery experiment depends on the effectiveness of the in silico tools employed to assess the varied aspects of the drug. These include three-dimensional (3D) structures of the ligand and the protein, assessing the Absorption, Distribution, Metabolism, Elimination & Toxicology (ADMET) profiles; docking affinities and; most importantly, interaction of the drug, ligand and pharmacology profiles. All these components are integral to the drug discovery space and can be effectively determined through the use of specific in silico software.”

Emerging trends The use of bioinformatics is increasing in discovery research, especially in biotech companies. While companies are now spending more resources on discovering new molecules, in the past 10 years, the number of software dedicated to modelling and aligning chemical structures for developing a new protein or amino acid sequence has also increased dramatically. “The software developed include Genscan, Noeclone, Modeller, Utopia, Raptor, etc. Also, a number of new databanks are being developed for different classes, eg, a dedicated Plant Proteome Database (PPDB), Molecular Modeling Database (MMDB), etc to help researchers involved in drug discovery,” points out Thakre. Cost and time are two important factors that determine the successful launch of a new product in the market.

SECTOR WATCH

Bioinformatics can consolidate data, analyse and optimally manage and disseminate tools to help drug companies to save on cost and time. Highlighting the take aways, Dr George informs, “Integration is the buzzword in the new bioinformatics era of experimental data from different sources, results & supporting products as well as the laboratories & collaborators. Globally, a trend is emerging towards merger of informatics and discovery-based companies.” Interestingly, India and South-East Asian companies have a comparative advantage in terms of low-cost labour, which can offer database solutions for biotech companies globally. “India is emerging as world’s capital of knowledge-based industries and many Indian companies like Dr Reddy’s Laboratories, Ranbaxy Laboratories, etc are collaborating with software companies like TCS, Infosys, etc,” says Dr George.

Opportunities Numerous opportunities exist for leveraging bioinformatics, though it needs to keep pace with the developments in science and technology for making these advancements meaningful. Both technology and bioinformatics need to work in conjunction for best results. As Dr George underlines, “Bioinformatics will have serious applications in the therapy segment as well. There are a variety of segments in the healthcare industry where bioinformatics methodologies will find useful and rewarding applications.” The use of this technology will increase the accuracy and pace of drug discovery. Companies can now develop new and more sophisticated ways of identifying molecular targets like receptor proteins in any individual and also faster as compared to traditional methods. At the same time, Thakre says, “The idea of customised medicine, depending on patient types and their biology is expected to rise, wherein the patients will be given therapies based on their genotype and individual needs. The cost of discovering a new drug will reduce through use of bioinformatics, since most of the simulation will be done on computer to establish the structure and functioning of the drug.”

Challenges As technology evolves, so do challenges. Starting from issues surrounding the adoption of bioinformatics, the challenges have moved on to the repeatability and reliability of certain applications of bioinformatics. Applications such as systems biology rely heavily on modelling and predictions.“Modelling and predictions inherently have a certain success rate associated with them. The challenge here lies in having ways for validating some of these results and guiding researchers on the use of results derived from various algorithms and associated applications. People have adopted several approaches for achieving this and these will be addressed in a matter of time,” informs Sairamkumar.

October 2010

Modern Pharmaceuticals

SECTOR WATCH

Dr Annie George Vice President - Tech Services, Actis Biologics Pvt Ltd

Integration is the buzzword in the new bioinformatics era of experimental data from different sources, results & supporting products as well as laboratories & collaborators. Globally, a trend is emerging towards merger of informatics and discovery-based companies. The bottleneck in drug discovery has moved from data generation to data analysis. Further, the scale and heterogeneity of the available data make their automatic integration challenging. “There is a need for better data integration tools to facilitate analysis of data from different sources. Tools must be adaptable, readily configurable to support access to new data sources, instruments, tools and new functionality requirements. Creating integrated databases with requisite metadata and annotation to facilitate data sharing is a major challenge before the scientists working in the field of life sciences,” points out Dr George. The data acquisition management and analytical techniques of bioinformatics are key factors in providing a lens for viewing the accumulated datasets. Dr George says, “In order to accomplish this, a highly sophisticated information technology is needed. The existing information technology/software would be outdated soon. Hence, smart high-end machines with high storage capacity,

high performance computing, high performance network and higher grade graphic display systems, will become necessary in the next 5-6 years.”

Growth drivers The two key growth factors in the development of bioinformatics are cutting-edge biological researches like genomics & proteomics and computerbased software database development. Countries like the US and Europe have already established their lead in genomics, whereas countries like India & China are emerging in proteomics. “An amalgamation of these two blocks will help in drastically transform the pharma healthcare segment. Commercial aspects and international co-operation in the segment will help accelerate its growth,” avers Dr George. At the same time, technologies such as ‘omics’ and NGS serve as key drivers of bioinformatics. Sairamkumar says, “These technologies are redefining the approach to drug discovery, development and delivery. Bioinformatics is an integral part of this

Manas Thakre Research Analyst - South Asia and Middle East, Pharma and Biotech Practice, Frost & Sullivan

The idea of customised medicine, depending on patient types and their biology is expected to rise, wherein the patients will be given therapies based on their genotype and individual needs. The cost of discovering a new drug will reduce through use of bioinformatics.

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initiative and is currently undergoing significant advancements to address these new technologies.”

Redefining the future The era of blockbusters is coming to an end and bioinformatics will play a key role in defining sub-population strategies and personalised medicine. Bioinformatics is an integral part of the overall drug discovery and development strategy and has a promising future with vast opportunities. Thakre says, “The scope of bioinformatics is definitely expected to increase in the coming years. Bioinformatics has played a key role in initiating the HGP for decoding the entire genomic structure of human DNA. As further research explores the complexities of human and animal structures, bioinformatics will become a key tool in analysing and understanding the same. Bioinformatics will act as a bridge to connect the understanding of computers and mathematical algorithms with biology.” The market for bioinformatics platform is growing at a significant pace with increasing demand from the US and Europe. The trend is supported by the rising demand for sequencing platforms with increasing research in the field of life science, utilising techniques such as gene expression analysis, sequence analysis and protein expression analysis. “The global market is expected to reach $ 8.3 billion by 2014 at a Compounded Annual Growth Rate (CAGR) of 24.8 per cent during 20092014. While knowledge management formed the largest submarket in 2009, the bioinformatics platform is expected to have the greatest marketshare in 2014 as a result of rising demands from the US & Europe. The future focus of bioinformatics is target validation, translational medicine and proteomics,” points out Dr George. Therefore, pharma companies are now moving towards a global healthcare corporation and a paradigm shift is observed from traditional inpatient care to a homebased personal care medication.

MARKET TRENDS

Human resource management

Making the right choice The Indian pharma sector has progressed by leaps and bounds; however, companies have faced numerous obstacles in the way, for attaining this goal, one of which is high attrition of workforce. Saloni Vora highlights some ways to attract and retain the talented workforce, which are the asset for a company, and ways to prevent them from migrating to other destinations. he Indian pharmaceutical industry has made significant strides over the last few years, with the key involvement of the domestic manufacturers, multinationals and biotechnology-based companies. This sector has always been in a state of constant dynamism and, recently, the various changing trends in the market landscape have propelled the Indian pharma and biotech companies to leverage their intrinsic strengths and accordingly develop distinctive business models. For example, there are many companies producing high-quality, low-cost generics for developed as well as developing nations. At the same time, there are also companies providing Contract Research & Manufacturing Services (CRAMS) in various areas related to drug discovery & research, clinical trials, manufacturing operations, etc. With so much of business activity, growth opportunity and prospects being witnessed in this vibrant sector, Mckinsey and Company predicts that Indiaâ&#x20AC;&#x2122;s pharma market would touch the $ 20 billion mark by 2015 and would feature among the worldâ&#x20AC;&#x2122;s top 10 drug markets. On the other hand, the Indian pharma sector faces a set of challenges like growing competition, stringent guidelines and regulatory issues, dearth of talented Research and Development (R&D) professionals, need for increased penetration in the IT, etc, which need to be overcome in order to sustain its growth momentum. Taking into consideration the nature of this sector, having the right talent in the right place at the right time that are capable of performing the right functions is extremely vital to this sector. Although last year, the pharma industry emerged relatively unscathed from the adverse

Courtesy: hrcareerbuilder

effects of the global economic meltdown, a slowdown was witnessed with regard to hiring new talent. Today, the scenario is completely different and the employment opportunities in this sector are still wide and diverse. In fact, the pharma industry is currently considered to be a sector that is likely to spearhead the job market in India and also add a significant number of opportunities in the coming year. With job trends in this industry showing such positive signals, a challenging yet exciting time and task awaits for the HR departments of companies.

Changing HR practices with time Frequency of hiring: Over the years, many developments have

October 2010

Modern Pharmaceuticals

MARKET TRENDS

Sanjay Mishra General Manager – HR & Administration, Unimark Remedies Ltd

Hiring has become a full-time round-the-year job. The load of hiring is now felt by all HR professionals in the pharma industry. In fact, while placing an HR vacancy, we have to clearly lay down the percentage of hiring job the incumbent is supposed to handle. taken place in the process of recruiting employees in the pharma industry. One of the key changes observed is that, earlier, recruitment was carried out at a particular time of the year but, today, with the gradual increase in the pace of business operations and activity, recruiting talent has become an year-round activity for HR professionals. Sharing his thoughts on this, Sanjay Mishra, General Manager – HR & Administration, Unimark Remedies Ltd, says, “Hiring has become a full-time round-the-year job. The load of hiring is now felt by all HR professionals in the pharma industry. In fact, while placing an HR vacancy, we have to clearly lay down the percentage of hiring job the incumbent is supposed to handle.” Selection methods: Besides the frequency of hiring, the methods used to select the right candidate have also undergone transformation. In order to gain a competitive advantage, pharma companies are constantly channelising their efforts to strengthen their R&D, marketing, sales, production and quality assurance & maintenance teams. Elaborating on the candidate selection methods, Surina Iyer, Associate Vice President – HR, Inventia Healthcare Ltd, avers, “Apart from using the different scientific methods of selection like psychometric tests, case studies, group discussions, presentations, panel interviews, etc, pharma companies are now emphasising on the need to check the employees’ past credentials & references with respect to confidentiality, professional integrity, commitment and value addition for key strategic & operational roles.”

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Mode to recruit at different positions: Another highlight is the mode employed to fill the different level positions and the shift with respect to industry verticals as far as fresh talent is concerned. Also, those professionals involved in the hiring process are expected to have knowledge of the same and should be able to tentatively suggest from where a particular suited profile would be located. Mishra explains this with the help of examples, “At the bottom, pharma hiring has predominantly become walk-ins & campus hiring, as volumes are high while middle management hiring is supported by placement consultants. On the other hand, business leaders are hired through references. A few years back, freshers would be given the first preference in the Quality Assurance department unlike today, where freshers are seeking place in the regulatory, Intellectual Property Rights (IPR) or business development segments.”

HR trends in pharma Improvement in the job market scenario has necessitated redesigning of some of the hiring strategies in most organisations. Thus, workforce planning in line with the business goals of the organisation has become an important feature in the agenda of most pharma companies today.

Workforce planning: An important tool With the pharma sector depicting a strong growth rate over the past few years, workforce planning has become paramount to the success of this industry. Sharing his views on the same, Vijay

October 2010

Dalvi, Deputy General Manager – Human Resources, Elder Pharmaceuticals Ltd, says, “To support & sustain the growth, the HR will have to face challenges to quickly adapt to the demanding scenario. An organisation – large or medium scale – must design a futuristic workforce plan based on a short-term (less than five years) & a long-term plan (more than five years). These plans are essentially based on the objectives set & the market demand and are directly linked to the strategic plan of the organisation. In such a case, the workforce planning is not limited to recruiting & retaining talent but also anticipating the future workforce requirement linked to the business needs of the organisation.” Today, though the scenario of talent recruitment is comparatively better than that during the IT or the BPO boom, the process is certainly more complex than it appears to be because it involves developing skills & competencies of existing employees to meet the needs of the challenging times. He further adds that the blueprint of workforce planning needs to be reviewed every month to check the status of position requirement, joining, separation and surplus employees, if any.

HR as a strategic partner Taking into account the current situation, it is important to have a strong link between the HR and the higher levels of the management who are responsible for setting strategic goals as well as undertaking important policies & decisions in an organisation. Hence, many organisations today consider the HR as their strategic partners who would, in turn, help the organisation in reaching the pinnacle of success. Revealing her thoughts on the same, Meenu Gautam, Group GM - HR & Administration, The Yash Birla Group, avers, “Till recently, the HR has never been recognised as a strategic partner for business, especially in the Indian pharma industry, but lately, many organisations have started realising the importance of having a strong link between the HR and its strategic goals. In today’s scenario, money & machine

MARKET TRENDS

are on time investment but manpower is the base for its optimal use as well as for positioning any company as a brand. Thus, balancing manpower to enable them to deliver organisational goals is the need of the hour across all industry sectors. Creating a funnel & inculcation of talent pool is necessary for the pharma industry.” In order to be a strategic partner, the HR must understand the capabilities of their talent base and the steps required in order to hone & develop the much-needed skills for success. Opines Navjeet Gill, Deputy Manager – HRM, IOL Chemicals & Pharmaceuticals, “Multiple opportunities, influx of talent from diverse fields, along with unheard salary hikes have changed what normally was the citadel of the industry. The ability to respond to the impact of governmental changes requires innovative and agile thinking beyond the traditional view of pharma. Understanding the capabilities of our talent pool and the manner in which they are positioned to support the evolving business strategy has become essential today.” Further, in her opinion, by taking a look at talent in this manner, the HR professionals can easily understand the gap and take some time to develop & recruit talent that the company would need in for the fulfilment of its business strategy.

Redefining certain skill sets With multiple challenges to overcome and new areas to target in the industry, many companies are considering redefining certain skill sets like expanding their sales & marketing force, giving more importance to soft skills while recruiting an employee, etc. On the same lines, Gautam suggests, “Nowadays, many companies are paying more attention to soft skills in a prospective employee, as it is an essential investment for a company in the long run, besides technical skills, team orientation & organisation fit. This is also because every employee is a brand ambassador of his/her company and one’s positive attitude can reflect upon the company’s growth.”

Surina Iyer Associate Vice President – HR, Inventia Healthcare Ltd

With MNCs buying out generic Indian companies and setting up Contract Research Organisations (CROs) or CRAMS directly or as a third party, this sector will continue generating good employment opportunities. On the other hand, a few months ago, it was reported that many companies are trying to expand & increase the number of their sales and marketing representatives for garnering a better markershare and tapping rural areas, which have not been paid adequate attention in the past. Unveiling her thoughts on this trend, Gill avers, “Increase in affordability & accessibility of healthcare has made rural India an attractive and key growth segment. Whenever new markets are to be tapped or a new product is to be launched, the sales team must be expanded. At the same time, extending these teams is not always the right solution, rather getting the best and the most out of the sales team is essential in achieving full potential of the company. Hence, getting the right sales personnel, monitoring their efforts, motivating and rewarding them are the different strategies to get the most out of the team.” In Mishra’s opinion, the domestic urban market has hardly any elbow space and is now saturated in all therapeutic segments. Moreover, strategies are in place in most companies for regulated and semi-regulated markets, from where most profits are emerging. He believes

that new skills are required to venture into the Indian rural market, as some companies have made some gains while others have tried and withdrawn. Hence, much remains to be done to tap the full potential in these areas.

Hiring fresh talent: A trend picking up pace Many opportunities are currently available for freshers intending to make a career in the pharma industry. In fact, the industry is willing to recruit and is welcoming the fresh wave of talent. Freshers are being recruited across various pharma verticals like manufacturing, quality control & assurance, regulatory affairs, clinical research, marketing, Intellectual Property Rights (IPR), etc. Opines Iyer, “With MNCs buying out generic Indian companies and setting up Contract Research Organisations (CROs) or CRAMS directly or as a third party, this sector will continue generating good employment opportunities. Also, while the automation sector is axing jobs, increasing regulatory standards and IPR are adding jobs. Moreover, international and rural marketing will keep generating employment. In addition, almost all

Meenu Gautam Group GM - HR & Administration, The Yash Birla Group

Till recently, the HR has never been recognised as a strategic partner for business, especially in the Indian pharma industry, but lately, many organisations have started realising the importance of having a strong link between the HR and its strategic goals.

October 2010

Modern Pharmaceuticals

MARKET TRENDS

Navjeet Gill Deputy Manager – HRM, IOL Chemicals & Pharmaceuticals

Multiple opportunities, influx of talent from diverse fields, along with unheard salary hikes have changed what normally was the citadel of the industry. The ability to respond to the impact of governmental changes requires innovative and agile thinking beyond the traditional view of pharma. pharma companies have R&D that will continue growing to maintain a healthy product pipeline. All this action will continuously generate fresher vacancies across multiple disciplines.” Further, although job prospects for freshers look bright, it is important for universities & educational institutions to realise that placement depends on industry requirement. Therefore, it is important for institutions to develop a focussed programme to suit the needs of the industry and equip students to counter the challenges in their respective function & capacity. Elaborating on this, Dalvi suggests that the institute should consider that, with Mergers & Acquisitions (M&A), the industry has access to candidates having relevant experience, and therefore it is more challenging for a fresh candidate to be extremely sound regarding knowledge, communication skills, ability to work as a team, problem solving, focussed knowledge, etc. Therefore, it is important that institutions help students with preplacement preparation to give them an additional advantage, and hence prepare them to face competition in the industry. Highlighting the example of their philosophy of providing opportunities to freshers in their organisation, Gill states,“At IOL, we constantly provide opportunities to young talent in order to equip them with the right skills, enabling them to learn, perform and succeed. Coupled with guidance and motivation, we aim to groom the leaders of tomorrow.”

Obstacles Despite the planning & designing of

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orderly strategies, HR departments in pharma companies face multiple challenges, the biggest and the most common being higher attrition rates, and thus the difficulty in retaining the critical talent. Recently, pharma companies are said to be witnessing attrition rates that are higher than normal, ie, about 20-25 per cent. Opines Dalvi, “Talented employees are assets for the organisation, as they are a source of new ideas that drives research, marketing and business dynamics.” Hence, keeping the workforce motivated, committed, engaged, aligned with the company’s goals is one of the biggest challenges faced by HR professionals. Experts suggest various reasons for the increased attrition rates seen in recent times. Increase in better opportunities & prospects in other segments due to globalisation, lucrative packages combined with incentives, a conducive work environment, hunt for more challenging roles, competitive compensation plans, etc are some of the common reasons for migration of the workforce from one organisation to another. Also, pharma being more R&D oriented, the level of technological expertise and upgraded skill sets are always high. Hence, this is viewed as a hotbed of talent for other companies. Occasionally, companies are unable to identify the training needs for a particular candidate and provide him/her with timely training to enhance one’s skill sets. At the same time, there is a considerable onus & pressure on the recruiters who are identifying talent, taking into account the fact that the

October 2010

cost of employee engagement and development is comparatively high in pharma companies. Hence, nowadays while recruiting, companies critically measure retention options for the candidate. Avers Iyer, “Considering the stiff competition to hire and retain talent, pharma companies are using compensation as the differentiating factor by linking it with different incentive schemes, fringe benefits, etc. Besides countering attrition, people budget is also critical and substantial, considering that people are key drivers in this sector. In Iyer’s opinion, this is one of the reasons for the high attrition. It is important for HR professionals to continuously align the expectations of the management and employees, taking into account the budget, the process & result outcomes as well as business & people factor. At the same time, some other hurdles faced by the HR is aligning the employee goals with the organisation, stretched performance, performance linked awards & incentives, addressing non-performance issues, etc.” Today, HR professionals play an important role in data security & management systems. Considering the high employee mobility, HR professionals are facing issues related to knowledge management and confidentiality.

Combating challenges For any company, whether big, medium or small, employees are the most valuable possessions/resources. Whenever a well-trained and experienced employee quits, the company loses on vital skills, knowledge and business relationships and, sometimes, it may be extremely difficult to find the right substitute. Today, well-qualified as well as skilled employees are on the lookout for better opportunities and new horizons. Gone are the days when an employee would consider one organisation for years and retire with the same one. Today, companies and HR departments are working in unison to design strategies to attract, nurture and retain specialised talent. An internal referral mechanism is useful in reducing

MARKET TRENDS

attrition rates. Moreover, conducting a thorough analysis of a candidate’s background, behaviour pattern, adaptability or liking can also help organisations, besides having feedback mechanisms and polls to maintain consistency in performance. Also, in today’s modern era, it is essential for companies to be empathetic towards employee needs, understand them and cater to them accordingly. This approach is also known as the ‘talent management strategy’. In many cases, money is no longer the sole reason for the employee to shift jobs or in other cases remain in a company for a long time. As Gill rightly puts it, “As an HR professional, it is important to figure out ‘what floats their boats, and then accordingly make waves.’ Also, a favourable work environment, good work culture (creation of an open, vibrant and dynamic culture where there is enough space to communicate, share thoughts and ideas), training & career growth with adequate salary compensations are some of the provisions that can go a long way in battling attrition.”

Future trends As pharma sector is buzzing with activities, HR professionals need to keep themselves abreast of the various changes in the industry and accordingly hire resources that will churn out favourable results in a short span of time for the company. According to experts, the top five trends in hiring include outsourcing (consultants & third party), direct hiring (through job portals/headhunting), employee referral schemes/databank, social networking sites (Linked In) and advertising (newspapers). Moving forward, the criteria for hiring may undergo modifications so as to match up with industry standards and requirements. According to Iyer, “Going forward, talent acquisition & retention will purely hinge on how sensitive an organisation is towards human capital. The significant trends shall include demand for specialised skill sets with enough scope in the organisation for job enrichment & job sculpting, more focussed training & development programmes & rewards that are constantly in tune with the market.” Moreover, there would be more flexible & forward looking policies and work-life balance shall not remain merely a cliched statement. With regard to skills, the hiring manager should be on the look out for soft skills to grow and develop competencies. “Good listening skills, presenting ideas and brainstorming new ways of doing things, working across cultures, time management, negotiating conflicts, understanding the growth capability, etc would be some of the essential requirements of the industry,” concludes Gautam. Hence, with intense competition & low margins, the victor in today’s modern age would be the organisation that can envisage and take the necessary proactive steps, formulate policies and constantly review & nurture them.

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Modern Pharmaceuticals

REGULATORY AFFAIRS

Indian pharma regulatory practices

Need for a globally compatible approach Though the Indian pharma industry has come a long way in terms of recognising the demands of the international regulators, it still needs some focus on the way these regulations are implemented in India. The article highlights a few recommendations that will make Indiaâ&#x20AC;&#x2122;s regulatory practices at par with those prevalent in the developed world.

Dr Ajit Dangi he Indian pharma industry has crossed $ 20 billion in domestic and export sales in the year 2009, and is also showing a double digit growth It has increased its global footprint not only through exports but also through overseas acquisitions of a number of companies, and also by making alliances with many MNCs. Since the countryâ&#x20AC;&#x2122;s Food and Drug Administration, apart from its regulatory mandate, plays an important role in development of the pharma industry, it is important that our regulatory practices are harmonised with those in the developed world. Following are some of the recommendations.

Central Drugs Authority (CDA) The Indian Drugs and Cosmetics Act and its

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several periodic amendments have served the countryâ&#x20AC;&#x2122;s public health reasonably well over the past several years. However, multiplicity of State FDAs has resulted in varying degree of implementation of Manufacturing Standards. This has resulted in hundreds of manufacturing units being shut down after Schedule M of the Drugs Act made GMP mandatory. It has also increased the number of irrational Fixed Dose Combinations (FDCs) in the marketplace. To harmonise the enforcement nationally, it is important to consider formation of Central Drugs Authority on the lines of US FDA as recommended by Dr Mashelkar Committee. This recommendation has received considerable resistance from various states, quite naturally, as there is a fear of losing control over state manufacturing units, their licensing revenue and making hundreds of well-trained state Drugs Inspectors redundant. Similar thing has happened in the past, eg, whenever uniform sales tax (VAT) or a similar legislation was passed. But this was resolved through dialogue with all the state stake holders and a viable solution was found. Ministry of Health should form a task force of all the state stake holders and take the implementation of CDA forward so that there is consensus on the issue. Various responsibilities of the FDA such as new drug approval, inspection and licensing of manufacturing facilities, oversight of retail pharmacies, monitoring the quality of medicines in the marketplace, approval of clinical trials, issuing of GMP certificates, etc need to be well defined. Above all, deploying and utilising the expertise of well-trained state drug inspectors and other manpower without

REGULATORY AFFAIRS

them losing their monetary and career prospects should be considered on priority. For India to achieve a dominant position in the global pharma market, these reforms need to be considered on high priority.

Intellectual property protection The pharma industry spends years of painstaking research to discover and develop new drugs. The scientific data generated in this research is the intellectual property of the innovator, and should be protected from unfair commercial use by the copier. The research data submitted to the FDA should therefore get at least 5 years of data protection from the date of launch of the new product in the country as is the practice in most developed countries including China. This will also have impact on protecting the public health as only a well researched new drug will enter the marketplace without affecting the rights of the generic drugs manufacturer to introduce the generic version when the patent expires. Of late, there have been cases where marketing approval was granted by the DCGI to the generic manufacturer for a new drug which had valid patent in the country. This has resulted in time consuming and expensive litigations between the patent holder and the copier. The global practice of ‘Patent Linkage’ should therefore be adopted by Indian FDA to avoid such litigations and delay in introducing new drugs.

Biosimilar regulatory pathway Pharmaceutical R&D is gradually moving from Chemistry to Biology. In the year 2009, out of 25 new drugs approved by the US FDA more than six were biologics. This is likely to increase, and it is estimated that more than 40 percent of the new drugs entering the market in next 5 years will be biologics. The research and regulatory pathway for biologics is complex and

the outcome is often uncertain. With several blockbuster biologics on the verge of losing their patent status, India stands to gain considerably by developing biosimilars. To accelerate this process, FDA needs to come out with biosimilar regulatory guidelines as defined by the European Medicines Agency (EMEA) and now by US FDA.

Global clinical trials India is increasingly becoming a destination of choice for conducting global clinical trials on new drugs because of the availability of large and diverse pool of patients, trained medical professionals and cost competitiveness. The recent report of Frost & Sullivan projects the global CRO market at $ 20 billion with India’s share at about $ 485 million, which is projected to cross $ 1 billion by 2015. India should seize this opportunity by harmonising regulatory practices for conducting clinical trials by laying down standards for Good Clinical Practices (GLP), monitoring of Adverse Drug Reactions (ADRs), allowing Phase I trials on new drugs discovered outside India etc.

One window approach Presently there are multiple agencies, particularly for approval of new biologics. These include, apart from the DCGI, Institutional Bio safety Committee (IBSC), Review Committee on Genetic Manipulation (RCGM), Genetic Engineering Approval Committee (GEAC), Indian Council of Medical Research (ICMR) and in case of narcotics and psychotropic drugs, Bureau of Narcotics etc. This not only increases the time cycle for approval but often results in duplication of efforts. A one window approach for approval of new drugs including biologics will go a long way in making Indian R&D efforts more productive.

Well-defined OTC policy Responsible self medication using OTC drugs for minor ailments is an accepted practice world over to reduce

the healthcare burden. Unfortunately we do not have a well defined OTC drugs policy and drugs, which do not fall under schedule G,H or X of the Drugs Act are considered as OTC drugs by default. There is a need for a well defined list of OTC drugs, which have a good safety and efficacy profile. These drugs should be allowed to be sold without selling licence or one time registration. The archaic rule of exempting villages with less than a population of 1000 from selling licence needs to be scrapped, as it has no relevance in a country of 1.2 billion people. Such a policy will go a long way in conserving scarce resources such as medical professionals, nurses etc, which are often used for treating minor ailments such as cough & cold, acidity, minor skin afflictions, pain, headache, etc.

Good distribution and storage practices It is estimated that over 15 per cent of medicines in developing countries and particularly those requiring cold chain often become subpotent because of poor storage or break in the cold chain. This is particularly important in storage of thermolabile products like vaccines, insulin, erythropoetin etc. A Good Distribution and Storage Policy which is part of the Drugs Act will help in maintaining the quality of such drugs throughout the supply chain. In the past few years significant progress has been made by the office of the DCGI in streamlining and computerising several administrative procedures. Implementation of some of the recommendations made above will make India’s regulatory practices at par with those prevalent in the developed world. Dr Ajit Dangi is CEO, Danssen Consulting and former Vice President, OPPI. He is also on the Advisory board of US P.harmacopoeia. Email: avdangi@gmail.com

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CRAMS industry

Showcasing India on a global platform The Indian pharma industry has evolved considerably to compete with the global economy. But, it still needs to leverage on the growth drivers, and eliminate the bottlenecks, so as to sustain in this space. While the CRAMS sector presents a promising opportunity for Indian pharma, innovation

Courtesy: alliancebiotech

and R&D will go a long way to help the industry emerge as the winner.

Vikram Gupta ontract Research and Manufacturing Services (CRAMS) is increasingly becoming a promising opportunity for the Indian pharma industry. India remains one of the most preferred outsourcing destinations and is playing a vital role in manufacturing as well as drug development value chain of various innovator pharma and biotech companies. Some analysts have estimated that the worldwide revenues for pharmaceutical industry CRAMS segment totalled $ 100 billion in 2004 and about $ 160 billion in 2009. The global market for contract manufacturing of prescription drugs has been estimated to increase from a value of $ 26.2 billion in 2004 to $ 43.9 billion in 2009. This business is projected to grow at a Compounded Annual Growth Rate (CAGR) of about 11 to 12 per cent over the next 4 - 5 years. India

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and China could potentially account for 35-40 per cent of the outsourced marketshare for Active Pharmaceutical Ingredients (APIs), finished dosage formulations and intermediates. A worldwide structural trend is evolving in the pharma industry, and Indian companies are playing an important role in contributing to these changes. Over the years, the Indian pharma industry has demonstrated its supremacy to the world through its high-quality biotechnology practice & drug synthesis skills, vertically integrated manufacturing assets, differentiated business models and optimal costs. The Indian pharma industry is currently the largest among the developing nations and one of the flagship sectors of the Indian economy. The domestic pharma output has increased at a CAGR of about 14 per cent per annum. At present, the global manufacturing outsourcing opportunity is estimated at $ 25 billion and is expected to reach $ 40 billion by 2015.

Sustainable growth In order to witness a sustainable growth, the Indian CRAMS industry needs to address all growth drivers. These drivers need a boost through initiatives at various levels in the industry. The key drivers for growth of this industry are as follows: Research & Development (R&D) budget: R&D budget defines the potential for sustainable growth. Global pharma companies spend more on R&D than many other industries. Globally, the pharma industry spends about 9-10 per cent of their sales on R&D, while Indian companiesâ&#x20AC;&#x2122; spending averages just about 2 per cent. Contract research offers significant opportunities

CRAMS CENTRE

to the Indian pharma industry helping it become a global R&D hotspot for innovator pharma companies. Declining R&D productivity, coupled with an increasing number of products going off patent is expected to drive the growth of the contract research segment. New products in the pipeline: Pharmaceutical development can take up to 12-15 years, adding significant pressure on the product pipeline, costs, timelines and market choices. Therefore, it is extremely important for innovationdriven pharmaceutical companies to carefully balance their product pipeline with their growth objectives. In order to successfully launch new products in the market, the innovators have to undergo detailed clinical trials from Phase I to Phase IV in order to prove the efficacy, safety and viability of the product. At present, a majority of clinical trials conducted in India are for Phase II and Phase III. Indian companies have an opportunity to increase business across the value chain of clinical trials. Time to market: Reducing time to market is critical to the pharma industry. Long development period times can add competitive pressures along with cost of the product. Similar research is often being simultaneously conducted across competitors and the first one to receive the patent gets the rights to launch the product. A measure of cross-functional cooperation can lead to interesting results and have a significant impact on improving the overall time to market. Quality & standard conformance: Apart from investment in original research, the need to upgrade manufacturing facilities is becoming critical. Complying to Good Manufacturing Practices (GMP) standards and approvals from international bodies such as the US Food and Drug Administration (USFDA), the Medicines and Healthcare products Regulatory Agency (UK MHRA; erstwhile UK MCA), the South African Medicines Control Council (MCC) and the like are becoming necessary. Government policies: The government plays a critical role in

the growth of this industry. The most important aspects that drive the industry include price control, participation in R&D initiatives, policies for Multinational Companies (MNCs), control through custom and excise duties, etc. The government seems to be making efforts to promote the growth of this industry by providing tax exemptions on all services carried out by the contract research and clinical trials industry. This step is likely to further boost clinical trial outsourcing to India. Allowing Phase I clinical trials for the drugs discovered overseas has been an active area of debate. CRAMS industry is expected to benefit if Phase I trials of drugs discovered in other countries are allowed in India.

Technology innovation: An important dimension India has a huge advantage over western countries with respect to R&D in pharma. Its highly skilled talented scientists, make Indiaâ&#x20AC;&#x2122;s R&D capacity second only to the US, at one-fifth of the cost. Moreover, the strength of India is that these cost savings are not at the expense of quality. India is also the third most popular location for R&D investment and is further expected to develop with a number of domestic institutions beginning to evolve. Cost savings are sometimes as high as 85 per cent on R&D conducted in the West, with India having the highest number of FDA-approved drug manufacturing plants outside the US. Further in order to attract business from the world over capability is rapidly becoming more important. Research and innovation are dependent on a framework that fosters innovation through the following: v Acceptance of new technologies and a general willingness to accept economic risk determine the extent to which a country can pursue innovative R&D v Incentives and rewards for innovation through pricing and patents to protect the fruits of innovation v Incentives to create venture capital and encourage private investment in research.

This innovation-friendly framework requires constant adaptation to new requirements. The prospects for pharma research are becoming more promising.

Impact of patent regime on the growth In general, sustainable growth of the industry will depend on new product introductions, which fulfill unmet therapeutic needs. Hence, the ability to innovate and develop new products is critical to the success of this industry. Patent protection encourages new product development and increases the confidence of innovators on the Indian manufacturing and R&D companies. The Indian pharma industry, after adopting the Product Patent regime in 2005, has undergone rapid restructuring so as to accelerate the growth by tapping its inherent strengths. The signing of the Trade Related Intellectual Property Rights (TRIPS) agreement in 1995, which committed India to honour the World Trade Organization (WTO), began a fresh chapter in the industryâ&#x20AC;&#x2122;s evolution. The product patent regime will make it obligatory for Indian companies to compete in their own R&D and respect the product patents of originators if they want to survive. However, the legal framework for the industry needs to further support innovation, mitigate the weaknesses, void off the threats and cash in on the opportunities.

Major trends affecting growth Demographic change: Rapid growth of the economy and the ageing population will drive up demand for healthcare. Today, about 450 million people worldwide are aged over 65 (7 per cent of the global population). This figure will virtually double by 2020, or more than triple by 2050 (to 17 per cent of the global population). In the US alone, more than 80 million people are aged over 65. Globally, about 400 million people will be over 80 years of age. The ageing population represents a growing challenge for the pharma companies. (per capita healthcare spending is the highest among people

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CRAMS CENTRE

over 65 years because the death rate is the highest in this age group.) Innovation in biotechnology: Modern biotechnology is a key technology of the 21st century. Together with automation and IT, it has begun to open up new perspectives for all areas of life sciences, especially for medicine. As an example, highly potent, selective biopharmaceuticals have already proven successful, especially in the treatment of cancer. In future, the treatment selected will depend on the genetic pattern of the tumour. The knowledge of genetic differences between patients can also aid the development of new drugs. MNCs showing greater interest in India: The share of MNCs in the Indian pharma market has been increasing after the recognition of product patents in the country in 2005, as they have been able to more freely introduce top of the line, patented products in the domestic market. The decision by Government of India to allow 100 per cent Foreign Direct Investment (FDI) into the pharma industry is expected to bring in increased investment in R&D infrastructure by MNCs in India. Growth of FDI in the sector: Foreign pharma companies have been increasing their stake in domestic pharma companies through automatic route as permitted in the FDI policy in this sector. Large global pharma companies are expected to further consolidate their position in the Indian market. This will bring about some important changes in the CRAMS industry, as many global pharma companies may be outsourcing their research and manufacturing services to their Indian counterparts.

Changing regulations with respect to capital markets Securities and Exchange Board of India (SEBI) has been working at making the markets more investor-friendly and transparent. Under the new guidelines, open offers would require 25 per cent ownership (instead of 15 per cent as per the earlier guidelines) and also need to be issued for the entire 100 per cent

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equity of the target company, instead of 20 per cent earlier. These regulations are expected to provide a transparent and investorfriendly regulatory structure for acquisitions. This is expected to have a positive effect on the overall healthcare and life sciences industry. The pharma & biotech sector could witness better norms, pricing and timelines. However, this may lead to some funding constraints in the pharma and biotech sector. There are a few companies in the healthcare and life sciences space where at least a single public shareholder holds 10 to 14.99 per cent of stake. For such investors, this upward revision of takeover threshold limit can give time and space to increase their holdings to 25 per cent without any need of an open offer.

Future prospects In comparison with the global pharma industry, the Indian pharma industry has a number of strengths. These include cost competitiveness, well-developed industry with strong manufacturing base, access to a pool of highly trained scientists, both in India & abroad, strong marketing & distribution network, rich biodiversity as well as competencies in Chemistry and process development. However, the industry needs to overcome some weaknesses in order to continue with a sustainable growth in the global pharma industry such as lower investments in innovative R&D, lack of resources to compete with MNCs for new drug discovery research and to commercialise molecules worldwide, lack of strong linkages between industry and academia and low medical expenditure and healthcare spend in the country. With regard to the strengths and weaknesses of the industry, the pharma industry can tap various opportunities, some of which are as follows: v Significant opportunity for innovation through focussed R&D v Significant export potential v Potential for new licensing deals with MNCs for New Chemical Entities

October 2010

(NCEs) and Novel Drug Delivery System (NDDS) v Contract research and manufacturing arrangements with MNCs v Potential for developing India as a centre for international clinical trials. The global economic environment is changing rapidly. The Indian pharma industry needs to overcome many challenges that can pose significant threat to the growth of the industry. China, for example, is becoming a major competitor to India, especially in exports of APIs. Chinaâ&#x20AC;&#x2122;s pharma industry ranks seventh in the world and is expected to become the worldâ&#x20AC;&#x2122;s fifth largest by 2010. Following are some of the other challenges faced by the Indian pharma industry: v R&D efforts of Indian pharma companies are hampered by lack of enabling regulatory requirement v The government has limited participation in R&D funding v Drug Price Control Order puts unrealistic ceilings on product prices & profitability and prevents pharma companies from generating investment surplus v The new MRP-based excise regime threatens the duty existence of many small-scale pharmaceutical units.

Climbing up the value chain Indian pharma industry has come a long way to compete in the global economy. The achievements of the Indian pharma industry have been spectacular in recent times and are praiseworthy, which have evolved as a model industry of the country in terms of performance. However, as we move forward, the pharma value chain would depend on the ability of pharma companies to come up with innovative business and technology models necessary to maintain & increase their competitive positions. Vikram Gupta is CEO, India Venture Advisors Pvt Ltd. Email: vikram.gupta@piramal.com

RETAIL ZONE

Visual merchandising

Tips for enhancing product visibility People believe in a product that they see themselves rather than on descriptions provided by other people or the retailer. Thus, to grasp the customer attention, efforts have to be made by the retailer to increase the visual appeal of the products by displaying them in attractive and innovative ways. Rajendra Pratap Gupta here are a number of ways to increase the sales in pharmacy retail business. One of the most interesting ways to grow the business without further investments in additional stocks is by way of a good visual and behavioural merchandising. A good visual merchandising can grow the business by almost 25 per cent. Although in pharmacy retail, ideally, merchandising is an odd term, as the products sold here are prescription-driven. However, with time, the product mix has undergone a change. Earlier, the product mix ratio was 80:20, with 80 per cent of pharma products and 20 per cent non-pharma (which includes Over-The-Counter [OTC] medicines & fast moving healthcare goods or even the daily consumption items). In comparison, the product mix has now changed to a ratio of 70:30. In the next three years, the product mix ratio is expected to become 60:40. Moreover, as the pharmacy retail market matures, the product mix ratio is expected to change to 40:60, ie, 40 per cent pharma and 60 per cent nonpharma, which is a logical progression. Therefore, merchandising plays an important role here.

Why visual merchandising? For pharmacy retail, merchandising means maximising product sales using product selection, product placement and product display that stimulates customers to buy the product. In recent times, merchandising has gained importance for a number of reasons: 1. Rentals are higher today due to which retailers need to have a faster inventory turn while optimally utilising the available space. 2. There is a shift from pure pharmacy to pharmacy and wellness, as customers now prefer to spend on not just in the retail space but also on wellness.

Courtesy: Al Wahda Mall

3. Toiletries are a â&#x20AC;&#x2DC;must haveâ&#x20AC;&#x2122; in a pharmacy, though the margins are less by approximately 10 per cent. 4. New products are coming every now and then, and the customer needs to see the product to recall it. 5. About 30 per cent of the sales & growth in organised retail comes from new products and products that need visibility. 6. A good display changes the shopâ&#x20AC;&#x2122;s visual appeal of products, and attracts more customers. 7. Certain categories of products do not sell unless prominently displayed. 8. OTC as a segment is getting increasingly bigger, and brands are moving from ethical to OTC. 9. Shop-in-shop model has started in pharmacy retail, and this not just earns revenues but generates sales for a particular category or company. 10. Merchandising also receives display revenue and enhances the sales.

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RETAIL ZONE

An instance of the need for visual appeal in stores In August, I visited a leading pharmacy chain in Kolkata. I observed that on the front racks, there was immense scope to neatly organise the racks, and hence requested the Chief Executive Officer (CEO) to permit me to reshuffle the rack product mix. I then organised the entire rack in less than five minutes. Later, I discussed with the CEO that if the staff at his shop paid attention to visual merchandising, it could increase the sales by about 20-25 per cent without any further investment in stocks. While we were engrossed in the discussion, a woman entered the shop and stopped by the rack that I had re-arranged, and picked up a bottle of Suthol. After she left the shop, I asked the staff about the total value of the bill, and it was ` 96. Thus, of ` 96, we had managed to sell a product worth ` 25 (which is 26 per cent of her total purchase) simply by increasing the visibility and appeal of the product.

Options before pharmacy retailers Merchandising in pharmacy depends on the size of the pharmacy. The size of a majority of pharmacy retailers in India is about 150 sq ft. Hence, the challenge is to effectively utilise the space such as that on the counter, above the fridge, behind the billing area and also the front ceiling (by creating transparent shelves). Moreover, merchandising applies not only to large retailers or modern trade but to all categories of retailers in all places. It is just a matter of applying the right formula for merchandising. For example, creating a glass enclosure in a small area is an excellent way to exhibit the products to customers, and also leverage the display for revenue generation. For retailers with a store of size 200 sq ft and more (quite common with a majority of new pharma retailers), the opportunity to leverage merchandising is phenomenal. There are a various options before the retailers to ‘encash’ every bit of retail space available to them. For medium-sized retailers (about 200 sq ft), the categorisation might not be possible on the merchandise, but the ‘impulse’ purchase items should be displayed prominently and neatly, and not cluttered, close to the entrance and billing counters. Retailers of size 300 sq ft or more have the freedom to categorise the shelves or have a shop-in-shop display for products. Today, based on the user trends in different towns, one can safely add categories to display, eg, hair care, sun

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screens & moisturisers, health drinks & nutrition, herbals & natural products, organic foods, baby care, oral care, skin creams, men’s care, vitamins & tonics, diet foods (to focus on diabetics and health conscious individuals & families). There can also be separate displays for mosquito repellents, glucometers & blood pressure monitors, new launches (this category is rarely seen, but could be a good opportunity to display new launches & serve as a revenue generator for the pharmacy) and best or smart deals (a dedicated rack space for best deal of the week or day can attract a lot of shoppers. Retailers can use this categorisation to drive a good bargain in retail from the manufacturer or seller of the product. Besides the category segmentation, it is also important to keep relevant product mix next to each other (behavioural merchandising or suggestive merchandising), so that impulse buying happens without any external push. Some examples for this may include shaving cream with shaving blades and after shave lotion, sunscreen lotion with night cream, baby diapers with baby massage oil, etc. All these depend on the location of the shop, the customer mix, paying ability of the customers and size of the store. It has been observed that men’s care and baby care are ‘quicker decision categories’ as compared to other categories. Hence, these categories certainly need an ‘appealing’ visual display.

October 2010

Companies like Himalaya started shop-in-shop service, which has done well as a business opportunity. Multinational Fast Moving Consumer Goods (FMCG) companies now spend much on ‘Eye Level’ display space (shelves that are at the eye level of customers) and also pay properly for stocking the products. Although the display is a great opportunity for retailers, it is important that the quality of the products and the company credentials are checked thoroughly. Some new market entrants might deceive retailers into a shelf space for products that do not match up the claims. The product display should not be based only on monetary considerations but on the ‘fitment’ of the products and categories as well. Moreover, since the racks with OTC products are handled directly by customers, the products and racks should be cleaned on a regular basis to avoid dirt and dust on the products. Else, the customer is likely to lift the products and keep it back instead of buying. A most important consideration is that merchandising not only helps in increasing the sales but also adds to the aesthetics of the shop and enhances the overall ambience. This adds to the customer experience and loyalty, thereby leading to increased sales. Therefore, the chemist must dedicate afternoon hours to analyse and attend to the merchandising aspects of the store, as this usually is the lean period for pharmacy business. Hence, visual merchandising differentiates the retail counter from either being appealing or appalling for a customer. Rajendra Pratap Gupta is an International Healthcare Expert & Speaker, and is on the board of several companies in the US & India across retail, hospital chains, disease management, pharma R&D, diagnostics and biotechnology, among others. Email: mail@rajendragupta.org

INDUSTRY UPDATE

Biotechnology

Building blocks to success The biotechnology sector, though still in its nascent stages, is one of the fastest growing sectors among the knowledge-based industries in India. A CII-Yes Bank report pegs the Indian biotech sector at $ 8 billion by 2015, with an annual growth rate of 20 per cent. And, this can be achieved only through a combination of industry, academia and public sector partnerships. This section highlights a few key growth areas, government initiatives, and strategies that will revolutionise Indian biotechnology sector. It also gives a preview of the breakthrough technologies, and the most promising ones as well.

Inside Overview.................................................58 Spotlight.................................................60 Sector Analysis.................................63 Indusry Voice.............................66 Dr Krishna Ella, CMD, Bharat Biotech

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OVERVIEW

Biosimilars regulation

Miles to go... Biosimilars, follow-on biological medicinal products that are manufactured by recombinant DNA technology, have brought in an era of low-cost, better efficacy drugs for treating a variety of illnesses. These are produced in complex living systems, and hence are sensitive to even minor modifications during the manufacturing process. Besides, several factors like patient safety, specific regulatory pathway and a sound understanding of the processes involved are also required

Courtesy: www.smi-online.co.uk

while producing biosimilars.

Dr K K Tripathi odern biotechnology medicine has played an important role in reducing morbidity and mortality rates for almost all diseases worldwide. Until a few decades ago, modern medicine implied pharmaceutical preparations derived from chemical small molecule drugs. However, since the 1970s, with the advent of recombinant DNA technology and development of biopharmaceuticals, a growing number of therapies are being performed with biologics drugs, with the development of biotechnology processes and products. Biologics have ushered in low-cost and better cures for a number of ailments, including some life-threatening ones. But a covert threat on patient safety looms large, as by the time some of the biologics or biotech medicines reach the patent stage they have expired. To understand this, it is important to grasp the basics of biologics and biosimilars.

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Conventional chemical drugs and biologics have clear differences. Chemical drugs are typically prepared via chemical synthesis, wherein specific chemical ingredients are combined in a pre-determined process. Biologics are created in living systems such as a micro organism, plant or animal cell. Unlike chemicals, most biologics are large, complex molecules. Since drugs generally have welldefined chemical structures, these can usually be tested in a laboratory to determine their various ingredients. It is almost impossible to characterise complex biologics through testing methods that are presently available in laboratories. Therefore, some components of finished biologics may remain unknown. These hurdles indicate that manufacturers need to ensure that the manufacturing process is always substantially the same, so as to maintain consistency, quality and purity of the product. As a result of biologicsâ&#x20AC;&#x2122; inseparable process linkage, it is said that the product is the process. Conversely, chemical drug makers can extensively modify the manufacturing process and still produce a finished product identical to the original. Thus, generics are also reverse-engineered in this manner without flouting process patents. Living systems that produce biologics are sensitive to even minor changes in the manufacturing process. Minor process differences could significantly alter the nature of the final biological product and thus change their functioning in the human body. Therefore, biologics makers stringently control the source and nature of the initial materials to ensure that the manufacturing process remains

OVERVIEW

unchanged over time. Hundreds of unique process controls are used to ensure predictable manufacturing outcomes. Even after taking into account most of the parameters, it is difficult, and sometimes even impossible, to produce the ‘same’ biologic drug without utilising the in-depth knowledge and experience of the innovator’s process. Besides, the immunogenicity of biologics poses additional challenges. Immunogenicity refers to the tendency of biologics drugs to trigger an immune response in the patient’s body with varying consequences. The antibodies may neutralise the drug molecule, making it therapeutically ineffective, or no clinical effect or serious clinical consequences may be observed. Rare but serious autoimmune responses could even be life-threatening. Immunogenicity of biologics is unpredictable, as even minor changes in a macromolecule can completely alter its immunogenicity profile. Manufacturing biologics or biotech medicine is a time-consuming and cost-intensive process, especially if patient safety is paramount. Substantial efficacy studies and clinical trials conducted over the years ensure that the risks to patients are overcome or minimal. But after a biologic drug loses patent protection, biosimilars based on it are open to manufacture by other players. This gives rise to the real, unmitigated risks to patient safety and patient lives.

Incorrect comparisons Although biosimilars are generally compared with innovator’s product and generics, such comparisons are untenable, given the differences between conventional drugs and biologics as well as between biologics and generics. For instance, less than 100 product quality tests are typically required for a small molecule drug, while more than 2,000 tests come into play in the manufacturing of biologics. According to European Medicines Agency (EMEA), ‘Biosimilars’ are

medicines similar to – but not the same as – innovator biologics drugs. Also called follow-on biologics (by US Food and Drug Administration (USFDA), biologics are not like generics drugs, which can be analysed in a laboratory to confirm that they are exact copies of chemical drugs. As biologics are more complex than conventional medicines, producing an exact replica of an existing biologic is not possible. Biosimilars are therefore only marketed after the patent on the original biologic drug expires.

Biologics have ushered in low-cost and better cures for a number of ailments, including some life-threatening ones. Most small molecule drugs are taken orally, and these act by working within the body cells. As biologics drugs are comparatively larger in size, these are generally injected in the body, which then interact/enter in the bloodstream or on the surface of cells, rather than within cells. The manufacturing processes for biologics and small molecule drugs differ greatly as well. Generally, small molecule drugs are synthesised via chemical reactions, whereas biologics are typically produced through specially engineered cells. As small molecules are well-characterised, these can be purified and analysed by routine laboratory tests. Biologics, especially the largesized molecules, are usually produced as diverse mixtures or molecules, with only minor differences from one another, making them difficult to characterise. The properties of biologics often directly depend on the type of manufacturing process used.

marketing of biosimilar drugs. With comprehensive regulatory norms for biosimilars still under evaluation in India, biosimilars can at present be approved with minimal clinical trials, conducted over a few months, unlike the stringent norms applicable for chemical or biologic drugs. Complex safety and efficacy concerns have made the USFDA maintain that each biologic is unique and linked inextricably to its manufacturing process. The EMEA’s approval process also distinguishes between ‘biosimilars’ and generic drugs, stating that ‘due to the complexity of biological/biotechnologyderived products, the generic approach is scientifically not appropriate for these products’. Moreover, the EMEA adopts a case-by-case approach to ‘biosimilars’, contending that any differences between similar biological medicines and innovator products need to be supported by relevant studies, including clinical trials.

Hence the need for... Although a specific regulatory pathway is yet to be created by overseas regulatory agencies, caution, confirmation and checks are their watchwords. Biosimilars in India could follow a similar path. The biosimilars market in India was pegged at about $ 200 million in 2008. By 2012, it is estimated to touch $ 580 million. As low costs and large application areas increase the popularity of biosimilars, a well-defined regulatory pathway is imperative. If not, low-cost biosimilars could extract a high cost in patient well-being. Indian healthcare must avoid this perilous path. It would further be required to define ‘biopharmaceuticals’. It is proposed to call the biopharmaceuticals or biotech medicines as ‘geneticeuticals’, as they are produced using genetic engineering route.

Safety concerns It is these differences between biologics that create challenging issues relating to the development, approval and

October 2010

Dr K K Tripathi is Advisor, Department of Biotechnology, Government of India Email: kkt@dbt.nic.in

Modern Pharmaceuticals

SPOTLIGHT

Stem cell therapy

Heading towards future medicines Owing to the immense thrust on research in stem cells over the past few years, India has seen a surge in the stem cell therapy business. In this article, KTP Radhika Jinoy outlines the opportunities in the field of stem cell therapy, which has given a new hope to patients suffering from incurable diseases.

Courtesy: MD Becker Partners LLC

tem cell banking and stem cell therapy in India has steadily gained momentum in the past few years. With more players coming up in stem cell research and banking, this market is poised to experience enormous developments in the coming years. Reports show that over 40,000 stem cells transplants are performed worldwide each year, thus providing relief and recovery from fatal diseases. Stem cells are found in all multicellular organisms. These cells are characterised by their remarkable potential to develop and differentiate into a variety of cell types in the body during early life and growth. These are unspecialised cells having two important characteristics, which distinguish them from other cells in

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the body. First, stem cells are capable of renewing themselves through cell division and under certain physiological or experimental conditions for long periods. Second, these can be induced to develop into tissue- or organspecific cells having specialised functions. “Owing to their regenerative property, stem cells can be used to regenerate the areas of the body that are not functioning properly,” says Chaitanya Purandare, Chairman & MD, StemOne. Adding to this Dr Parijatha Rao, Director - Laboratory Operations, Cryo Save India, says, “Stem cell therapy is popularly known as regenerative therapy. It is used to regenerate lost or damaged tissue of the body, and hence the term regeneration. After removing the damaged tissue, the stem cells are applied, which adopt the characteristics of that particular tissue of the body.”

Sources of stem cells Mammalian stem cells are broadly categorised into two types: embryonic stem cells, which are isolated from blastocysts (4 to 5-day-old embryos) and adult stem cells, which are extracted from adult tissues. Dr Geeta Shroff, Founder and Director Nutech Mediworld, explains, “Human embryonic stem cells are capable of dividing and growing into any body part. The cells follow the normal division pattern that is initially inherent in an embryo. It is said that the complete effect of embryonic stem cells transplanted into a patient is closely linked with the time frame of the development of human embryo.” Adult stem cells are undifferentiated cells found in small numbers in most

SPOTLIGHT

Dr Parijatha Rao Director - Laboratory Operations, Cryo Save India

Stem cell therapy is used to regenerate lost or damaged tissue of the body. After removing the damaged tissue, the stem cells are applied which adopt the characteristics of that particular tissue of the body. adult tissues. “Stem cells can be extracted from almost all parts of an adult body. Till date, adult stem cells have been identified from many parts of the human body, including brain, bone marrow, peripheral blood, blood vessels, skeletal muscle, skin, teeth, heart, etc. However, bone marrow is the most widely used body part for extracting stem cells. Stem cells are also extracted from umbilical cord blood, which have a comparatively wider range of functions,” says Purandare. Research on adult stem cells has created great enthusiasm among the scientists involved. Scientists have discovered adult stem cells in many more types of tissues than they once believed was possible. An important advantage of using adult stem cells from a patient is that the patient’s own cells could be expanded in culture, treated to differentiate into the desired cells and then reintroduced into the patient.

Potential treatments Today, stem cells are extensively applied for the treatment of blood-related disorders. Also, diseases like diabetes, neural degenerative diseases and heart ailments have embraced treatment using stem cells. Dr Manjul Joshipura, Director – Research, Education and Training, Apollo Hospitals International Ltd, explains, “Stem cell therapy can be used to address a condition which the conventional therapy is unable to treat. These include life-threatening blood disorders, such as multiple myeloma, chronic lymphatic leukaemia and thalassaemia. Stem cell therapy is strengthening in a buoyant way with more promising treatment methods.” Scientists across the world are carrying out research on the potential of human embryonic stem cells. “Embryonic stem cell therapy has caught the attention of the world because of its potential to benefit many people suffering from conditions presently labelled as incurable and terminal,” says Dr Shroff. She further continues, “The human body undergoes considerable

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SPOTLIGHT

Dr Manjul Joshipura Director – Research, Education and Training, Apollo Hospitals International Ltd

Stem cell therapy can be used to address a condition which the conventional therapy is unable to treat. These include life-threatening blood disorders such as multiple myeloma, chronic lymphatic leukaemia and thalassaemia.

wear and tear during its lifetime. A balance is maintained within the body to fight against this; however, with advancing age, the capacity for regeneration declines. Also, if the cells or body parts start malfunctioning, the disorderly nature and depletion of body cells lead to incapacitating and incurable disorders. These disorders have no cure at present, and medicine offers only symptomatic treatment. In such a case, cell replenishment and regeneration would cure the disorder; thus, human embryonic stem cell therapy plays an important role here,” she adds. Immense research is going on in stem cell therapy to obtain better results and apply this revolutionary treatment method to several other diseases that are currently considered incurable. “We must ensure that the effects of stem cell therapy are localised to that particular tissue function as acquisition of new properties could change the inherent characteristics of the tissue type.

The concern of stem cells becoming uncontrolled and cancerous is always at the back of the researchers’

Besides several foreign companies, the industry has also witnessed the mushrooming of small domestic firms. The current domestic market size is ` 100 crore and growing at an annual rate of 40 per cent. minds and all efforts must be taken to prevent such an occurrence,” opines Dr Rao.

Promise for the future Counting on opportunities Apart from treating incurable diseases, experts believe that stem cell

Dr Geeta Shroff Founder and Director, Nutech Mediworld

Human embryonic stem cells are capable of dividing and growing into any body part. The cells follow the normal division pattern that is initially inherent in an embryo.

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therapy will reduce the cost of drug discovery. “In any drug discovery practice, a drug has to undergo experimentation at the bench level, animal level and three rounds of clinical trials. Only then, it is released as a reliable drug for human application. If stem cells are used for preliminary experimentation, then we can overlook steps 1 and 2 and proceed directly to clinical trials. This would ensure lesser time investments on the drug,” says Dr Rao. The stem cell market in India is undergoing large-scale expansion. Besides several foreign companies, the industry has also witnessed the mushrooming of small domestic firms. According to industry estimates, the current domestic market size is ` 100 crore and growing at an annual rate of 40 per cent. However, the major challenge faced by the stem cell therapy industry is lack of proper regulation. “Currently, there are only guidelines but no regulations governing the usage of stem cells in India. The industry is expecting proper rules and regulations to come up in 4-5 years,” says Purandare. The Ministry of Health has recently approved and notified an 11-member committee to look at therapies utilising stem cells and genes.

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As stem cells have the capacity to develop and differentiate into a diverse range of tissue type, they have a tremendous future application value. However, as with any transplant procedure, the surgeon and researcher should ensure that the stem cells do not metamorphose into a tissue type other than what is intended. Experts believe that as research advances, stem cell therapy could become a hope for people currently battling life-long debilitating diseases.

SECTOR ANALYSIS

Indian biotech industry

Strategies for sustained growth As biotechnology-based products are likely to enhance pharma companies’ pipelines, nearly all major global pharma companies have entered into partnerships or acquired biotech companies to help augment their flagging pipelines. This article presents a perspective of biotechnology on the world at large, and, particularly its potential in India. It also highlights the deals in this segment, and the growing interst of the public sector. Jumana Barnagarwala

Number of biotech deal & alliances by Indian companies (2006 to 2010) 35

ccording to Biotechnology Industry Organization (BIO), biotechnology helps our planet by ‘Healing the world, fuelling the world and feeding the world’. The significance of biotechnology to the human lifecycle has grown rapidly in the last few decades. The diverse fields in which biotechnology can be applied have enhanced its appeal in today’s world, making it a multifaceted technology platform that has the potential to solve the myriad problems plaguing our planet. Considering the variety of end applications that biotechnology finds, it is often referred to in terms of colour, such as red (used for finding cures for diseases, eg, insulin, vaccines, antibiotics, etc), white/grey (as applied to industrial processes, eg, use of microorganisms to shorten industrial processes such that they consume less energy and create less harmful waste products), green (when applied to agricultural sciences, eg, genetically modified crops) or sometimes blue (as applied to aquatic or marine life) biotechnology. Biotechnology has already replaced chemical technology in several fields, particularly medicine. It not only helps produce well known and existing medicinally active products through natural biological substrates and processes but also helps create new medicinally active products that could not have been produced by any chemical process or technology (eg, use of stem cells in the treatment of several degenerative disorders). As drug pipelines dry up and blockbusters face the patent cliff, the global pharma industry has found a new saviour in the form of biotechnologybased research. The role of biotechnology has evolved from agricultural and food processing

33 31

30 25

27 25

20 15 10 5 0 2010

2009

2008

2007

2006

Source: MedTRACK, Datamonitor

industry applications to its current avatar of elucidating disease pathways and creating solutions for elimination of diseases or alteration of disease outcomes. It now combines disciplines such as biochemistry, genetics, embryology, cell biology and molecular biology along with other technologies such as chemical engineering, biorobotics and information technology.

Global perspective The global biotechnology market is reported to have grown by 4 per cent in 2009 to reach a value of $ 200.9 billion. By 2014, this market is forecast to have a value of $ 318.4 billion, an increase of 58.5 per cent since 2009. The largest segment of this market, accounting for more than 66 per cent of its value, is the healthcare market, and the US represents nearly 50 per cent of this market. New players are expected to enter, as this market grows rapidly. But, the competitiveness in the market would be moderate since most players are likely to be small- or medium-sized dedicated biotech

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SECTOR ANALYSIS

companies. Currently, the global biotech industry includes about 1,500 companies and employs nearly 180,000 people. The offerings of the global biotech industry are broadly classified into agricultural, therapeutic, chemical & environmental services, diagnostics and biosuppliers. As biotechnology-based products are likely to enhance pharma companies’ pipelines, nearly all major global pharma companies have entered into partnerships or acquired biotech companies to help augment their flagging pipelines. Despite the recent financial crisis in the world economy, biotech companies have managed to run their research laboratories and many will again rise up to their past potential, with the economy recovering. As Willy De Greef, Executive Director, IBRS and Former Secretary General, EuropaBio, puts it, “Biotech is back from the brink”. A few years ago, Jim Greenwood, President & CEO, BIO, said, “Biotechnology has the potential to play a key role in improving the standard of healthcare in third world countries and underserved populations worldwide. The industry can already boast of developments like the discovery and use of ‘golden’ rice, which can help combat Vitamin A deficiency, a leading cause of blindness; production of pest-resistant foods, which are designed to improve crop yields; and aggressive and innovative new partnerships to ensure the delivery of life-saving therapeutics to difficult-to-reach patients.” These and other innovations in almost every area of biotechnology application have changed the way the world is trying to combat its health and energy issues in the near future.

Potential of biotech industry The Indian biotech sector, though still in its nascent stages, is one of the fastest growing sectors among the knowledgebased industries in India. It has achieved revenues of up to $ 4 billion in 2009-10, with an average annual growth rate of about 30 per cent in the last five years. Although Indian biotechnology revenues account for only 3-4 per cent of global biotechnology revenues, the rapid growth of this sector

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is expected to reach $ 5 billion by 2010-11. The CII-Yes Bank report pegs the Indian biotech sector at $ 8 billion by 2015, with an annual growth rate of 20 per cent. Dr Peter Singer, McLaughlin-Rotman Center for Global Health, University of Toronto, avers, “India is manoeuvring its way out of poverty. With a massive and increasingly well-educated workforce, India is poised to revolutionise biotechnology just as it did in the IT industry.” Currently, India boasts of over 350 biotech companies providing employment to approximately 20,000 people. Indian biotech industry ranks among the top 12 countries globally and is the third largest biotech player in the Asia-Pacific region in terms of number of biotech firms. While the top 20 biotech companies in India account for 50 per cent of the revenues of the biotech sector in India, 55 per cent of these revenues come from exports. More than 60 per cent of the biotech industry’s revenues in India are accounted for by biopharma products ($ 1.9 billion); nearly 20 per cent by bioservices ($ 573 million); about 11 per cent by bioagri ($ 420.4 million); and the remaining 6 per cent by bioindustrial ($ 122.5 million) & bioinformatics ($ 50.2 million) segments.

Key growth drivers The Indian biotech sector has a number of achievements to boast of: 1) In the bioagri sector, India is the fourth largest cultivator of genetically modified crops in the world and has recently overtaken China in the production of Bt cotton. 2) The biopharma sector, which has been the major growth driver of the biotech sector, began its successful journey with the launch of recombinant vaccines. The sector is now poised for an explosive growth into the biosimilars arena, with several biogenerics already available in the Indian market. 3) From small biotech services-based firms, Indian biotech industry has now grown into a full-fledged Research & Development (R&D)-based sector. 4) Based on its low-cost, highly qualified

October 2010

workforce and its world-class laboratories & production facilities, the sector is now playing a vital role in the global supply chain of major biopharma companies across the world. 5) The importance of India as a key clinical trial destination has long been established. Moreover, as the biosimilars markets open up across the globe, this capability will provide additional benefit to Indian companies looking at foraying into regulated markets. 6) Contract biotech research is another area of growth because of India’s diverse flora and fauna combined with qualified research scientists & engineers and globally acceptable research facilities. 7) The Government support for stem cell research in India has opened up new avenues for biotech firms and allowed increased collaborations with foreign companies for pioneering research in this area. 8) India’s Bio-fuel Policy is also likely to drive innovation and development of alternative sources of energy. By 2017, it is likely that 20 per cent blended fuel will be available, which translates into production of 15-16 million tonne of bio-diesel from 30 million acre of plantations. These growth areas in the biotech sector in India have drawn a large number of global biotech and biopharma companies towards partnerships with Indian companies or making investments in Indian ventures. Indian companies have also become increasingly active in seeking foreign partners to fund their R&D initiatives or collaborate with them in commercialising their biosimilars projects.

Alliances Indian biotech companies have entered into a number of deals and alliances over the last five years. This indicates that although the global biotechnology scenario was hugely affected by the economic downturn, Indian companies continued to find partners and their dealing activities did not slow down significantly.

SECTOR ANALYSIS

Types of deals and alliances during the last two years v In-licensing of cell lines for vaccine production v Co-marketing agreements for manufacturing and sales of human recombinant therapeutic proteins and biosimilars v In-licensing of development and distribution rights for monoclonal antibodies v Marketing agreement for sales and distribution of DNA-based security solutions v Long-term supply agreements for commercial manufacturing of biological drugs v Distribution agreements for commercialisation of in-vitro diagnostic cancer tests v Service agreements to avail of genomic referencing services v Development agreement for nanoparticle-based formulations of existing drugs v Clinical trial agreement for vaccine therapy of non-small-cell lung cancer v Development collaboration using in-licensed technology platform for biosimilars development v Contract research agreements for new biological therapeutics for cancer v Collaboration agreements on advanced biofuels v Joint venture for developing seed technologies, hybrids and environmentadjusted crops v Development and commercialisation agreement for a vaccine for H1N1 flu v Joint development, commercialisation and manufacture of novel peptide therapeutic for the treatment of diabetes v Agreement for provision of integrated drug discovery services

Government support The Indian Government recognised the significance of the biotech industry in boosting the Indian economy fairly early. Thus, the Central and State governments have undertaken a number of initiatives to maintain and expand India’s presence on the global scene. Some of these initiatives include the following: v As part of the National Biotechnology Policy, the government has announced setting up of the National Biotechnology Regulatory Authority, which would be an autonomous, professional body governing the biosafety clearance of genetically modified products and processes. v In order to encourage flow of funds and boost innovation in this sector, a Biotechnology Industry Partnership Programme (BIPP) has been launched. v Expansion of the Small Business Innovation Research Industry (SBIRI) scheme has been announced to promote innovation in small businesses. v In order to enhance original research

and support innovation in the private sector and promote public-private partnerships, the Biotechnology Industry Research Assistance Council (BIRAC) has been launched. v National Policy on Biofuels and setting up of the National Biofuel Coordination Committee and a Biofuel Steering Committee are likely to help enhance India’s capabilities in the production of biofuels. v Many state governments (Karnataka, Andhra Pradesh, Maharashtra, Tamil Nadu, Himachal Pradesh, Haryana, Punjab, Kerala, Madhya Pradesh, Uttar Pradesh, Rajasthan and Gujarat) have instituted biotechnology policies to encourage biotech research and industries. Bioclusters have been formed in the capital cities of these states, with the establishment of biotech parks that can house industries, academic institutions and R&D laboratories. v Several tax benefits have been announced for the pharma and biotech industries to enhance R&D. These include reduction in customs

duties, reduction in central taxes, 150 per cent weighted average tax deduction on amounts spent on R&D, concessions to companies located in biotech parks like income tax holidays for 100 per cent exportoriented companies, etc.

Towards sustained growth Although the Indian biotech sector is growing rapidly, it must incorporate some changes and improvements to help sustain this growth. v Encourage financial assistance to start-up biotech companies having promising research agendas. v Streamline the regulatory mechanism to allow approval of biotech-related products with minimal hurdles and through qualified personnel so as to ascertain safety & efficacy of the products being approved. v Support and increase the number of platforms for disseminating advanced biotechnology training. v Create an environment that allows academic researchers to explore the commercial potential of their research by enabling private sector companies to fund their research or collaborate with them for commercialisation opportunities. v In order to attract foreign investments, Indian biotech companies need to focus on specialised technology platforms that can be applied to a variety of substrates such that they could attract multiple partners for their developmental programmes. v Indian biotech companies can exploit biosimilars by investing in research, and develop ‘advanced’ biosimilars by using drug delivery devices or technologies or variations in processes such that they reduce the toxicity or immunogenicity of the ‘original’ biologic drug. Jumana Barnagarwala, is Head – Healthcare Consulting of Datamonitor India. Email: asundheep@datamonitor.com

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INDUSRY VOICE

‘We invest ` 30-35 crore per year in R&D’ Dr Krishna Ella, Chairman & Managing Director, Bharat Biotech and also the President of the recently formed Vaccine Manufacturers’ Association, lists the key areas that need immediate attention to make vaccines (healthcare) affordable to the world’s poorest regions. He highlights Bharat Biotech’s role and agenda in doing so, in an interview with Arshia Khan. What are the challenges faced by the vaccine manufacturers in India? How is India placed on the global scenario? Currently, 0.9 per cent of India’s total Gross Domestic Product (GDP) is spent on vaccination. Although our vaccines are supplied to 140 countries, the utilisation in India is quite low. The challenge for our country is to build a strategy to manage difficulties in the way of maintaining proper public health for its 1.2 billion population in the future. Another impediment is the minimal budgetary allocation for the industry from the Healthcare Budget. The government has allocated only ` 500 crore to the vaccines and immunisation sector from the Healthcare Budget of ` 25,000 crore. In comparison, the spending is ` 800 crore in Pakistan and ` 9,000 crore in China. Even if the allocation is increased by 10 per cent from the current level, it will give a boost to the vaccine manufacturers. According to a World Health Organization (WHO) report, India stands second highest in the prevalence of communicable diseases, next to Africa. From 1975 to 2010, only five vaccines have been introduced in India, covering 52-53 per cent of immunisation. In contrast, Africa has already achieved 90 per cent of its Millennium-4 immunisation goal. With regard to the vaccine purchase by Governments, Pakistan spends $ 175 million and China spends $ 2 billion, whereas India spends a mere $ 100 million. On the other hand, the US spending on healthcare is 14 per cent of its GDP.

What is the current status of vaccine research and development (R&D)? What are the opportunities for vaccine R&D within WHO review of new vaccine technologies? The development and registration

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October 2010

INDUSRY VOICE

of a new vaccine can take more than 10 years and cost about $ 200 $ 500 million. The world vaccine market is estimated at approximately $ 6.5 billion, a meagre 2 per cent of the global pharmaceutical market. Many of the diseases for which new vaccines are urgently needed mainly affect developing countries whose market characteristics is less encouraging for R&D of vaccines. New safe and effective vaccines should be developed for a variety of infections against which no effective preventive intervention measure is currently available or practical. The world’s poorest regions still suffer from a heavy toll of premature deaths and disabilities from infectious diseases for which vaccines do not exist or need improvement. Three major infectious diseases are still responsible for at least 15 million deaths every year. Some of the fields of current vaccine development globally include diarrhoeal diseases, acute respiratory infections, RSV – a yearly winter and spring epidemic of bronchitis & pneumonia, malaria, typhoid, meningococcal meningitis, HIV/AIDS and human papillomavirus.

What will be ‘the business model’ for Bharat Biotech in terms of promising markets and disease areas? At Bharat Biotech, we focus on creating new molecules, new ideas and innovation through R&D, with an emphasis on driving innovation and consistently delivering world-class technologies. We want to become a major player in the domestic market, which is also our strategy for growth. We are performing well in the Latin America, Africa and the Indian subcontinent. We are now aiming to develop and patent one molecule completely indigenously and sell it on a global level as a ‘Made in India’ product. Our target is to serve our vaccines in all emerging markets as well. We would also like to identify social public health problems wherever they exist and

develop solutions for them at our research laboratories. Our target for the next 10 years is to have 40 patents and introduce 8 new molecules. The first three IND molecules were from Bharat Biotech International Ltd (BBIL).

What percent of your revenues (profits) are reinvested into R&D? Please quantify the company’s profits both from the domestic and exports markets. Bharat Biotech’s current turnover exceeds ` 250 crore. BBIL invests ` 30-35 crore per year in R&D. It has chalked out an aggressive approach towards patenting technologies such as rotavirus and chikungunya vaccines. Bharat Biotech has recently won patent

Currently, 0.9 per cent of India’s total GDP is spent on vaccination. Although our vaccines are supplied to 140 countries, the utilisation in India is quite low. rights for lysostaphin, an antibacterial enzyme against staphylococcal infections from leading markets including the US, Europe, China and Australia. Moreover, we plan to spend $ 50 million on clinical trials in the next two years.

Of the neglected disease areas, which areas would Bharat Biotech take up and why? At Bharat Biotech, the primary focus is on innovation and providing healthcare to region-specific diseases to populations that need it the most, with a concerted focus on neglected diseases. Some of the neglected diseases include typhoid, hepatitis, rotavirus, cholera, other diarrhoea, Japanese Encephalitis (JE), dengue, chikungunya and malaria.

We have recognised healthcare problems that require attention and are working towards resolving them across continents. Malaria, chikungunya, typhoid, JE vaccines, etc are some of the good examples of our efforts in resolving health problems of people in the Indian continent. Today, the rabies vaccine developed by Bharat Biotech is the first IND in India. Its product Revac-B+™ is known as the only vaccine available globally and is free of toxic heavy metals. We will continue to introduce new molecules, new ideas and innovation through R&D for solving public health problems. We aim to become a research and innovation-driven company than the one that focusses on developing products only for commercial use.

Role of Vaccine Manufacturers Association (VMA) in India... Our vision is to provide affordable vaccines to reach every citizen of the country. Our mission is to ensure that no human being or animals die in India from preventable disease or due to lack of vaccine. Our members include all human & veterinary vaccine manufacturers and both Indian and multinational manufacturing facilities located in India. Further, the role of VMA is to advocate the following: v Strengthen our vaccine research and delivery mechanism v DCGI and CRI/NIBSC should be an independent national regulatory authority v NTAG or NVP should be an independent agencies from Health Ministry v ICMR should strengthen the surveillance on disease burden v DBT or DST or MOH should support on Most Neglected Diseases (Leishmania, Malaria) v Make all research institutes or medical colleges accessible for Indian vaccine manufacturers on preference v Income Tax benefit (long gestation and risky).

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CASE STUDY

E-Pedigree solutions

The new-age inspection system e-Pedigree Solutions, a machine vision system with 2D bar code technology provides unparalleled security in the pharma supply chain by way of recording the movements of products in the supply chain. Some companies have collaborated to develop such a system to manage e-pedigree data, while also overcoming hurdles like resolution, lighting and diverse product packaging. beverage industries, has emerged as the primary method for encoding the required information. This matrix holds large amounts of data, but their incorporation into the existing pharma manufacturing flows involves placement of data on a package not originally designed to accept this information. This must be done in a permanent, legible manner, while accounting for the need to use this information at various user and distribution points.

Challenges

Didier Lacroix roduct security concerns and regulatory pressure have led to gradual adoption of electronic pedigree (e-pedigree) solutions throughout the industry. A secure e-pedigree file stores data about every move of the products across the supply chain, to allow for tracking and verification of pharma products from the time of manufacture to end use. As with many new technologies, e-pedigree data also have their own set of difficulties. One of them is the creation of machine vision inspection systems that can reliably identify & decode the complex markings on bottles and caps that carry e-pedigree information without impeding the flow of manufacturing. A two-dimensional (2D) data matrix, widely used in the automotive and food &

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The restrictive nature of pharma packaging does not allow much material changes for easy accomodation of new markings that must have high contrast so that scanners & imaging systems can read them. Another challenge is that markings may be located anywhere on the bottle and cap, and in different forms, ranging from black-on-white inkjet markings on paper to silver-on-black markings on a metallic cap. Further, a given manufacturing line (subsequently, the inspection system) must be able to accommodate different bottle sizes, label placements, materials and even colour schemes to handle different production runs. Such constraints make it difficult to design a machine vision system that can automatically detect and read the 2D matrix.

Looking for a solution Engineers from different companies, in this case, the packaging equipment designer and manufacturer FP Developments (Williamstown, NJ), with the support of Edmund Optics (Barrington, NJ) and Cognex Corporation (Natick, Massachusetts) took the

CASE STUDY

initiative to confront these challenges by attempting to develop a machine vision system that could thoroughly and accurately inspect e-pedigree data. The system was required to efficiently move hundreds of bottles per minute from a filling and labelling area to a gross packaging area while ensuring that each bottle was labelled and marked correctly. The labelling on the caps, and in some instances, on the bottles, needed to be read with a high degree of accuracy at all times. Further, the material handling portion of the system had to target a tool-less changeover, which means that it should be able to handle different containers quickly and easily without the need to install new fixtures or make complex changes to the line. A key consideration for manufacturing engineers that can impact the machine vision system is the placement of 2D barcode. Barcode placement must reflect the fact that everyone, from distribution companies to doctors & hospitals should be able read the barcodes. A common choice is to mark the cap skirt so as to avoid re-designing of labels. The marking technique can range from imprinting a code with a printer and burning in the code with a CO2 or Yttrium Aluminium Garnet (YAG) laser, to the use of markings that can only be seen under UltraViolet (UV) rays. Each method has its pros & cons that must be considered in light of factors such as the type of cap used on bottles and the speed at which they pass through the system, as well as the cost, intended product use & bottle materials. A critical issue is producing enough contrast in the printing so as to allow viewing from almost any angle. The higher the contrast, the more accurate will be the vision system data interpretation. Another issue is that the system does not know in advance exactly where in its Field Of View (FOV) the marking will be located. Not only label placement and bottle size varies from

one product line to another but the orientation of the bottle also varies when it reaches the inspection stage. Manufacturing systems that move bottles typically have at least one stage where the bottle rolls or spins for an indeterminate time. Creating a means of ensuring that all bottles have a consistent orientation would be costly; hence, the vision system must be able to accommodate this uncertainty. FP Developments addressed this problem by designing its system to use multiple cameras that look at all sides of the bottle simultaneously. While it seems fairly simple to set up three or four cameras to inspect an object, it

A secure e-pedigree file stores data about every move of the products across the supply chain, to allow for tracking and verification of pharma products from the time of manufacture to end use. can be difficult to extract the resulting information. The marking may wrap around the edges of the object, and thus have sections that appear spread across two different images, each distorted by the curvature of the surface. Cognex has addressed this problem in its Omni View platform, which uses four high-resolution cameras & proprietary software algorithms to take multiple images and create a three-

dimensional (3D) surface model image of an object, and then flatten it. From this flattened or unwrapped image, the machine vision system can extract a host of information by using standard image analysis algorithms. Camera and lens selection & lighting were the next issues to resolve. Cameras must be fast enough to capture images, as bottles move past at production speeds, have a wide FOV to encompass the marking and also have enough resolution to enable reading of the 2D code. Lens selection is critical because distortions or blurring across the cameraâ&#x20AC;&#x2122;s FOV, including insufficient depth of field to accommodate the bottle curvature, can affect the accuracy of the image analysis algorithm. Similarly, variations in lighting intensity across the FOV, and the presence of shadows, highlights & reflections, can compromise the algorithmâ&#x20AC;&#x2122;s ability to reliably extract information. Following system factors need to be considered in the selection of camera, lens and lighting for a specific manufacturing line. v Bottle size v Bottle position relative to camera position v Depth of field relative to the curvature of the cap v Object area to be imaged (in some instances, only the cap or both cap and label on the bottle need to be imaged) v Potential for the cap, cap skirt & label to be made in different colours, textures and materials

The 2D code (upper left of label) can contain significant amounts of information regarding content, dosage and production history

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CASE STUDY

v Striking a balance between single large FOV that can image bottles of any size and obtaining enough detail from the relatively small, potentially low-contrast 2D barcode v Speed of the production line v Amount of room available to fit four cameras and lenses into the production line v Ability to insert the inspection station into the flow without significantly altering the remaining equipment.

bottle with an aluminium lid, are some of the most difficult objects to illuminate evenly without hotspots or glare. This is especially true when the bottle is required to be viewed from all sides. Bottles can be both clear and highly reflective at the same time and, if filled with liquid (having different indices depending on what is being run), can act as a lens for the lighting. Thus, a light illuminating on one side of a bottle may reflect or be lensed to form a hotspot in the image on another side. Moreover, the reflectivity of the surface with the marking can vary from

Selecting the components Based on the dimensions of installation, the camera selected had a two-megapixel resolution with pixel size of 4.4 Âľm. But the number of lens options reduced quickly. The lenses needed to provide sharp images with an adequate depth of field, a two-inch FOV and a wide enough aperture to obtain high levels of contrast at short distances in order to take full advantage of the software algorithms. Many lenses used in machine vision today were designed earlier for multipurpose use or industries that do not necessarily address high-resolution imaging at short distances. The demands of this application required lenses specifically dedicated for high-resolution machine vision at short conjugates. The resolution of a lens, which affects the sharpness of fine details, should match the camera pixel size and also remain uniform across the FOV (yet it is typically only specified for the centre of the FOV). Further, small changes such as dilating the iris within the lens can affect resolution. Engineers from FP Developments and Edmund Optics had worked to match lenses and cameras. The team was able to select a stock EO product that had the right combination of FOV and working distance for use in the space available with lens resolution to match the camera and imaging detail requirements. Lighting was one of the trickiest parts of the application. Objects that seem simple, such as a small clear

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Engineers from FP Developments and Edmund Optics had worked to match lenses and cameras. The team was able to select a stock EO product that had the right combination of FOV and working distance for use in the space available with lens resolution to match the camera and imaging detail requirements. part to part and run to run. Also, the use of any type of directional illumination creates hotspots. Therefore, diffuse illumination is required. Diffuse illumination that is large relative to the object creates a â&#x20AC;&#x2DC;cloudy dayâ&#x20AC;&#x2122; effect that does not produce any hotspots or lensing. Glare, however, remains a problem with curved surfaces even with diffuse illumination. Thus, diffuse lighting needs to have a curved geometry similar to that of the bottles & caps so as to flatten glare off the surfaces. In order to provide this curved geometry, the design uses a large diffuse dome light that is positioned directly above the bottles to create the desired effect. The dome bathes each bottle with diffuse illumination from a large curved

October 2010

light source, creating even illumination from all directions. Unfortunately, the intensity of diffused light sources can drop off quickly, as the distance between the light source and object increases. Increasing the dimensions of the light source can compensate to some extent; however, in this case, space constraints in the installation area limited the implementation of this step. Thus, with lighting from the dome alone, the bottom of the bottle remained darker than the top and incompatible with the image analysis algorithms. In an unconventional lighting method that utilises the bottle carrier mechanism, the bottles move on a flat carrier, while a vacuum system holds them from below so that they can fall over or fly off while moving through the viewing area. The vacuum connection makes it impossible to place a lighting system directly below the bottles. Thus, the carrier can be converted to a secondary light source to illuminate the bottle from the bottom. Fiberoptics directs the light to the edges of the carrier as it moves in front of the cameras and the translucent material scatters that light in all directions, thus serving as a diffuse light source from beneath the bottle. By balancing the intensity of the dome light with the light piped into the carrier, the system can achieve highly uniform illumination across a variety of bottle sizes. Therefore, the resulting vision system was flexible enough to accommodate bottles of varying sizes holding 2D codes set in various places by using different marking techniques. Such a flexibility was essential to meet the need for a tool-less changeover while maintaining the accuracy needed in imaging & extracting the data codes off the pharma products. Didier Lacroix is Senior Vice President, International Sales & Services, Cognex. Email sales@cognex.com.sg

PREVIEW

Mumbai | 17-19 Feb, 2011

Envisioning the future of manufacturing Indian manufacturing sector has proved its calibre through the tough times of recession and emerged a winner. But, merely depending on the past achievements won’t suffice, and if India has to live the dream of becoming a hub for the global market, then its manufacturing growth should be innovation-led and technology-driven. The HiTech Manufacturing Show to be held in Mumbai on 17-19 February, 2011 at NSE, Goregaon, is one such platform that will be the flag bearer for the futuristic manufacturing processes & practices. Here’s a window to gaze through the future of manufacturing technology… Shibani Gharat veryone wants a glimpse of the future, to know what it holds, to witness growth and prosperity. This theory holds true for the manufacturing sector, as well. The blooming manufacturing environment in India today desires, as well as deserves a promising future.

Indian manufacturing coming of age India is fast emerging as a global manufacturing hub with huge investments across industry verticals. India is no longer merely ‘a sweat shop’ or ‘cheap labour market’ but is fast positioning itself as innovation and technology driven manufacturing hub. Indian companies are fast developing increasingly sophisticated manufacturing technology to match global standards. But, in order to achieve a world-class stature, the industry needs to inculcate self-sustainable habits with minimal pollution levels, maximise recycling, and optimise energy supplies, along with being responsible towards the society. There is a need for a collaborative effort in this direction from various industry verticals in order to accomplish a common goal. For the first time in India, there is an event that promises to deliver future solutions for

the complete manufacturing & engineering industry. With HiTech Manufacturing Show (HMS) as a backdrop for the entire value chain, the show also has HiTech Material Handling and HiTech Automation as concurrent shows to compliment the growth process and future of the industry. It intends to bring the entire manufacturing and engineering industry under one roof to provide a conducive environment for sharing ideas, smart strategies and pooling strengths for a better manufacturing future. HiTech Manufacturing Show, a Network 18 event, is a dedicated platform for initiatives like sustainability, design innovation, green manufacturing and automation that will be drivers of growth in the coming years.

Automation driven productivity Need for automation in manufacturing process is increasing by the day. “Automation will play a crucial role in helping manufacturing companies achieve economies of scale, global competitiveness, and meet stringent quality/safety standards,” says R Narayanan, Head Discrete Automation and Motion Division, ABB India. The HiTech Automation show will do justice to the field that will demand a lion’s share in the future.

Designing a growth map An outstanding design can provide companies an edge over their

competitors. It is a strategic activity in many organisations as innovative products contribute significantly to the sales revenue. Keeping this in mind, the event will have a specialised Design Zone where visitors can design their products with the help of design software on display.

Green manufacturing: Leading the way forward The most important goal of green manufacturing remains the same – designing, manufacturing and delivering products that minimise negative effects on the environment. At the show, a committed platform Green Zone will help the industry come together and discuss their green initiatives by way of seminar and interactive sessions. These factors will not only aid individual organisations but the entire manufacturing industry and help pave way for a luminous manufacturing outlook. “Integrating futuristic processes across the manufacturing value chain will give Indian manufacturers an edge over their global competitors,” says Frank Khoshnoud, Sr VP & Head - Manufacturing, Retail & Distribution (MRD), Patni. With HiTech Manufacturing Show, India is finally set to give shape to its futuristic aspirations of smart manufacturing with an intention of achieving a leadership position globally.

October 2010

Modern Pharmaceuticals

Projecting ‘a promising

Pune is emerging as a preferred manufacturing hub owing to massive investments and lucrative projects that the region has attracted during the past one year. These projects have had a major impact on the local industry and have also played a pivotal role in changing the dynamics of the region. Assisting the trade & industry and keeping the growth spiral alive in Pune are trade shows like Engineering Expo that help the entire industry to converge effectively under one roof. Shibani Gharat hat does General Motors, Mercedes Benz, Bajaj Auto, Volkswagen, Tata Motors, Apollo Tyres, Alpha Laval, Force Motors, Piaggio Vehicles, Bharat Forge, Mahindra & Mahindra, Kirloskar Oil Engines, ThyssenKrupp, TCS, Wipro, Patni, Honeywell, Whirlpool, Matsushita, LG have in common? Besides being colossal in their respective industry verticals, they all have a manufacturing facility in Pune. Pune, once known as the ‘Oxford of the East,’ is growing strength by strength to become the ‘Detroit of the East.’ From educational institutions to foreign institutional, as well as direct investments, the city has a new face and identity today. Presently, almost every foreign company wants to be a part of Pune’s flourishing manufacturing belt.

Pune as an investment hub The city has been a favourite destination for several MNCs since time immemorial. It has a vast pool of engineering and management talent. Its propinquity to Mumbai, favourable climate and a cosmopolitan culture have contributed to the growth of this city. Moreover, the opportunities that Pune offers in infrastructure and its allied sectors are tremendous. Besides, the distribution of SME clusters in Pune follows a logical pattern of proximity to industries.

During the last few years, this region has seen a plethora of gigantic investments. In the last year alone, three massive new plants owned by General Motors, Volkswagen and Mahindra & Mahindra were inaugurated here. The new projects include Fiat-Tata joint venture at Ranjangaon with a proposed investment of ` 4,000 crore, GM’s ` 1,400 crore investment with a further ` 900 crore expansion, Volkswagen’s project of ` 3,800 crore, Mercedes’ ` 250 crore investment and Mahindra & Mahindra planning a huge investment of ` 5,00,00 crore by 2012. Also, Bajaj Auto has proposed ` 300 crore investment in two- & three-wheelers and a further ` 1,000 crore investment in a car plant. In January, automotive component manufacturer ZF India inaugurated a manufacturing facility in Pune. In April 2010, China-based SANY Group, a leading global major in construction machinery industry, inaugurated its first manufacturing facility at Chakan, near Pune. These companies usually zero in on Pune component manufacturers for localisation of their products to suit the Indian conditions. From engines to raw materials, hydraulic parts, auto components, material handling and storage equipment, everything is local. This has helped the industry at Pune massively with generation of significant employment opportunities for the local populace. They set up their manufacturing

Mangesh Agarwal GM, CFFI India

Vibrant competition has helped in increasing competitiveness, spur innovation and boost efficiency. units in various industry clusters like automobile, auto components, engineering and machining, electronics, plastic and rubber components, etc, located in satellite towns of Ranjangaon, Pimpri-Chinchwad and Talegaon.

SMEs gaining momentum Pune SME clusters are the ones that have benefited the maximum from these investments. Apart from economic gains, these big manufacturers have helped the industry by bringing in latest technologies, and efficient management system to the region. There is a dramatic impact on technology upgradation in the region over the past few years. Companies like Volkswagen apply the latest manufacturing technology in their units. They demand products that are compatible with their technology. This has resulted in an increasing demand among the local companies to match the quality and technology standards of these big organisations. “They have started accepting automation in a big way,” says Milan Supanekar, Director, Welding Technologies India.

Pune | 19-22 Nov, 2010 Engineering Expo, organised by Infomedia 18, is one of the engineering industry’s biggest events in the country. The 2009-10 edition of Engineering Expo saw business transactions worth over ` 150 crore. Launched in Ahmedabad in the year 2002, the event today boasts of a fabulous visitor turnout. The Expo is a preferred destination for SMEs and manufacturing & engineering companies to transact, network, tie up, and exchange ideas for the growth of the industry. The Engineering Expo 2010-11 is scheduled to take place in four cities, starting off at Pune in November 2010 and proceeding to Ahmedabad, Indore and Chennai in subsequent months.

SMEs have some inherent advantages as compared to large enterprises in terms of greater flexibility in operations for responding efficiently to changing customer needs. Vibrant competition among the local companies to attract the attention of big companies is now being seen in this region. “This competition has helped in increasing competitiveness, spur innovation and boost efficiency,” says Mangesh Agarwal, GM CFFI India, Durr Ecoclean. He believes that there is a notable change in the quality of the products, especially after the big manufacturers have turned their attention to Pune.

Surviving in a competitive setup The SMEs in Pune operate in a dynamic business environment where growth has become a necessary objective for the survival and viability of the enterprises. The challenge for any company in a competitive setup is to remain competitive and consistently deliver value to customers. “It is also necessary for a manufacturer to deliver proper post-sales services and back-up support,” opines Supanekar.

One of the strategies these companies can implement to remain competitive and deliver customer value despite their small-scale of operations is by way of promoting their products and services. Jagdish Gajjar, Manager – Operations, J K Automation, explains, “Spreading awareness about your products and services will surely help your organisation in getting that extra edge over your competitors. Word of mouth publicity is not enough.” There are several channels for promoting one’s organisation and products. Creating product presentations and catalogues, advertising in B2B publications are some of the tried and tested methods to spread product awareness. “We offer in-house seminars with references and case studies; we also get our prospective clients to come and visit our plants,” says Agarwal. But there is a common point of agreement that the most efficient way of spreading awareness about products and services is by participating in exhibitions. Exhibitions and trade shows have been used as an effective marketing medium to find new customers, improve business relationships with existing customers, introduce new products and services, and deliver many other meaningful and tangible business outcomes.

An ideal platform to showcase business Engineering Expo is a complete manufacturing & engineering trade fair to display one’s products and services. It is one of the most preferred platforms to grow business, as selected by 1000+ companies that participated in the previous editions of the Expo. More than 55,000 industrial buyers benefit from Engineering Expo, every year. Over the years, it has become one of the most lucrative platform for business growth. “Engineering Expo has helped us in spreading awareness about the products that we offer,” points out Anand Rajadhayaksha, ManagerAdvertising, Nilkamal.

Milan Supanekar Director, Welding Technologies India

There is a dramatic impact on technology upgradation in the region over the past few years. Companies like Volkswagen apply the latest manufacturing technology in their units. They demand products that are compatible with their technology. This has resulted in an increasing demand among the local companies to match the quality and technology standards of these big organisations. “Every year, we introduce new designs and sizes of material handling crates & bins to suit diverse applications in various industries like automobiles, pharmaceuticals, engineering, electricals & electronics, hospitality & catering, logistics, textiles, supermarkets, retail, food & beverages, agriculture & seafood, etc. Expo brings all the industry verticals together under one roof, making it easy for us to market our products effectively to various organisations,” he adds. Seconding Rajadhayaksha’s point, Supanekar states, “Participating in the Expo has helped to create awareness about our five-year old company. Moreover, we were able to acquire bulk purchase orders in the past,” says Supanekar, whose company supplies almost 90 per cent of their materials to JCB. With the flourishing industrial environment, the opportunities for businesses are budding in Pune. Efforts in the right direction will help the domestic industry in Pune to amalgamate with the global market and be a driving force for the industrial growth of Maharashtra, and hence, India. Initiatives like Engineering Expo will prove to be principal platform for this thriving industry to attain unlimited heights.

EVENTS CALENDAR

National MUMBAI PUNE

AHMEDABAD

INDORE

CHENNAI

Maharashtra Nov 19-22, 2010

Gujarat Dec 10-13, 2010

Madhya Pradesh Jan 7-10, 2011

Tamil Nadu Mar 11-13, 2011

Auto Cluster Exhibition Ctr, Chinchwad

Gujarat University Exhibition Hall

Maharaja Shivajirao School Grd, Chimanbaug

Chennai Trade Centre

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

For details Infomedia 18 Ltd Ruby House, 1st Floor, J K Sawant Marg, Dadar (W), Mumbai 400 028. • Tel: 022 3003 4651 • Fax: 022 3003 4499 • Email: engexpo@infomedia18.in

Concurrent Shows

Maharashtra February 17-19, 2011 Bombay Exhibition Centre

One of the largest advanced design and manufacturing events in India featuring Machine Tools, Material Handling and Safety Equipment, Automation & Instrumentation, Hydraulics & Pneumactics, Process Machinery & Equipment, Packaging & Auxiliaries, IT Products, Electrical & Electronics.

For details HiTech Manufacturing

India Chem 2010 An international exhibition & conference on pharmaceuticals, chemcials, plastics and process plant machinery; October 28-30, 2010; at Bombay Exhibition Centre - NSE Exhibition Complex, Mumbai For details contact: FICCI (Federation of Indian Chambers of Commerce & Industry), New Delhi Tel: +91 11 23738760-70 Fax: +91 11 30910411 Email: ficciexhibition@ficci.com Website: www.indiachem.in

P-MEC India 2010 An exhibition showcasing state-of-theart pharma machinery and equipment for pharmaceutical operations; December 01-03, 2010; at Bombay Exhibition Centre - NSE Exhibition Complex, Mumbai For details contact: CMP India (UBM India Pvt Ltd), Mumbai Tel: +91 22 66122600, Fax: +91 22 66122626 Email: deepalim@ubmindia.com Website: www.pmec-india.com

CPhI India 2010 An exhibition on the pharmaceutical ingredients and allied industries. The event is an opportunity for the exhibitors to display their novel and innovative

76 Modern Pharmaceuticals

technologies that are useful for formulation of pharmaceutical dosage forms; December 01-03, 2010; at Bombay Exhibition Centre - NSE Exhibition Complex, Mumbai

Ruby House, 1st Floor, J K Sawant Marg, Dadar (W), Mumbai 400 028. • Tel: 022 3003 4650 • Fax: 022 3003 4499 • Email: hitech@infomedia18.in

2nd India Lab Expo 2010 For details contact: CMP India (UBM India Pvt Ltd), Mumbai Tel: +91 22 66122600 Fax: +91 22 66122626 Email: deepalim@ubmindia.com Website: www.cphi-india.com

A scientific and laboratory instruments exhibition in India, this expo will have more than 250 exhibitors from different countries showcasing their innovative products; December 10-12, 2010; at Pragati Maidan, New Delhi

ICSE India 2010 An international contract services and pharmaceutical outsourcing exhibition. Companies providing research, development and production services would showcase their products and services. This would be the ideal place to find the right outsourcing partner. The expo would provide the platform to meet and network with outsourcing experts; December 02-04, 2010; at Bombay Exhibition Centre - NSE Exhibition Complex, Mumbai For details contact: CMP India (UBM India Pvt Ltd), Mumbai Tel: +91 22 66122600 Fax: +91 22 66122626 Email: deepalim@ubmindia.com Website: www.icsexpo.com

October 2010

For details contact: Scientificdealers.com Tel: +91 11 2760 4500, Fax: +91 11 2760 4600 Email: info@indialabexpo.com Website: www.indialabexpo.com

Plastivision India 2011 An exhibition organised by AIPMA, Plastivision India 2011 is the 8th in series, and this event will highlight the key developments & growth of the plastics industry; January 20-24, 2011; at NSE Complex, Mumbai For details contact: AIPMA, Mumbai Tel: +91 22 67778899, Fax:+91 22 28252295 Email: marketing@plastivision.org Website: www.plastivision.org

EVENTS CALENDAR

International FoodPharmaTech 2010 An international trade fair for machinery, packaging and ingredients of the pharma as well as food industries. This year’s event will focus on four areas: efficient production, product safety, energy & environment and knowledge sharing. Professionals from the pharmaceutical, biotechnology and cosmetic sectors are expected to be present at the event; November 0204, 2010; at Exhibition Centre Herning, Denmark For details contact: Messecenter Herning, Denmark Tel: +45 99 26 99 26 Fax: +45 99 26 99 00 Email: mch@mch.dk Website: www.foodpharmatech.dk

For details contact: WBR (Worldwide Business Research) Tel: +44 020 7368 9400 Fax: +44 020 7368 9401 Email: pives@wbr.co.uk Website: www.wbresearch.com

Arab Health Arab Health is the premier exhibition and congress in the Middle East. The event will showcase the new products, innovations and technologies to one of the fastest growing healthcare markets in the world; January 2427, 2011, Dubai International Convention & Exhibition Centre, United Arab Emirates For details contact: IIR Middle East Tel: +971 4 407 2410 Fax: +971 4 336 4021 Email: terri.delia@iirme.com Website: www.arabhealthonline.com

For details contact: Bio (Biotechnology Industry Organization) Tel: +1 (202) 962 9200 Fax: +1 (202) 488 6301 Email: cbeckman@bio.org Website: www.ebdgroup.com

LOGIPHARMA ASIA 2010 This event will focus on pharmaceutical supply chain across Asia and bring over 200 international and domestic key players together this year; November 30 - December 02, 2010, Hilton Hotel, Singapore

For details contact: JSC Expo-Biochim-Technologies Tel: +7 (495) 933-90-51 Fax: +7 (495) 933-90-54 Email: atv@biomos.ru Website: www.mosbiotechworld.ru/eng

DUPHAT 2011 Dubai International Pharmaceuticals and Technologies Conference and Exhibition (DUPHAT) is an annual pharmaceutical event since its inception in 1995; March 22-24, 2011, Dubai International Exhibition Centre, UAE

Bio-Europe 2010 Considered to be one of Europe’s largest partnering conferences, the event attracts biotechnology and pharmaceuticals professionals. It provides an ideal opportunity to identify and enter into strategic relationship with companies of interest; November 15-17, 2010; at International Congress Centre, Munich (ICM)

wide range of biological preparations for pharmaceutical, food industry, agricultural sector and also biological agents, bioactive additives, test-systems, alternative energy sources, nanomolecular energy converters, specialised devices of the industrial and laboratory safety; March 21 - 24, 2011, The House of Moscow Government, Russia

ARABLAB 2011 ARABLAB is the global buying source for tomorrow’s decision reaching technology makers & end-users, as well as being a truly unique research source. Connecting people from over 75 countries, this expo showcases the very latest lab and instrumentation equipment from the world’s leading manufacturers; March 7-10, 2011, Dubai International Convention & Exhibition Centre, United Arab Emirates For details contact: The ARABLAB Group Tel: + 971 4 397 5418 Fax: + 971 4 397 5419 Email: info@arablab.com Website: www.arablab.com

BIOTECH WORLD 2011 The exhibition will show processes and devices for biotechnological productions and laboratory researches,

For details contact: Index (Conferences and Organisation Est) Tel: +971 4 3624717 Fax: +971 4 3624718 Email: index@emirates.net.ae Website: www.duphat.ae

Exhibitions

Bio-Europe Spring 2010 Bio Europe Spring 2011, a three day exhibition, is a forum to promote business development between pharmaceutical, financial and biotechnology companies in Italy; November 14-16, 2011, Milano Convention Centre, Milano, Italy For details contact: BIO (Biotechnology Industry Organization) Tel: +1 202 962 9200 Fax: +1 202 488 6301 Email: cbeckman@bio.org Website: www.bio.org/events

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

October 2010

Modern Pharmaceuticals

PRODUCT UPDATE

Digital USB microscope Cole-Parmer India offers digital USB microscope. The digital USB microscope is based on the active pixel technology which produces crisp, sharp images and accurate colour reproduction. Six LEDs illuminate the object - turn the LEDs on or off and adjust the brightness using the control wheel on the body. For versions with the 10x to 200x magnification range, magnification automatically adjusts based on the distance from the object. Units include a basic stand with adjustable height; optional boom stand can be ordered for greater flexibility.The handheld digital microscopes find their applications in science and engineering, digital microscopy, laboratories, pathology or other biomedical labwork. Cole-Parmer India - Mumbai - Maharashtra Tel: 022-6716 2222; Fax: 022-6716 2211 Email: response@coleparmer.in

Solid state timers Omron Automation offers ‘H3DEZ’ solid state timers. This 22.5 mm width timer can operate with different power supply voltage ranging from 24 to 240 VAC/DC and offer time settings from 0.1 seconds to 120 hours. The H3DEZ series solid state timers consist of 2 models:‘H3DEZ-A’ on-delay timer and ‘H3DEZ-G’ star-delta timer. Both H3DEZA and H3DEZ-G timers conform to international industrial standards such as CE, IEC-600947-5-1 and EN61812-1 requirements. Omron Automation Pvt Ltd - Bengaluru - Karnataka Tel: 080-4072 6400, Fax: 080-4146 6403 Email: in_enquiry@ap.omron.com

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

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PRODUCT UPDATE

Dryer Bombay Pharma Equipments offers fluid bed dryer and tray dryer. The fluid bed dryer is a process equipment used for uniform and efficient drying of products. It is available with or without PLC-based control, with capacities in the range of 5-500 kg. The fluid bed dryer is provided with stainless steel interconnecting duct lines with flanges for connecting remote mounted heating and fan motor modules. It is equipped with lifting and tilting device for easy handling, bag shakers, intrinsically safe earthing arrangement and bucket-type bottom chamber above ground level. The tray dryer is available with 6, 12, 24, 48, 96 and 192 trays with double wall construction. Made of SS framework, with glasswool insulation, this unit comes with an air inlet, air filter and adjustable damper (outlet). It is also equipped with single insulated & self-locking door, and one fan for air circulation inside the area. The sophisticated control panel is with on/off push buttons and indicating lights. Bombay Pharma Equipments Pvt Ltd - Mumbai Maharashtra Tel: 022-2859 4877, 2852 1608, Fax: 022-2852 1608 Mob: 098201 24804, 98201 20086 Email: bombaypharma@vsnl.net

October 2010

Modern Pharmaceuticals

PRODUCT UPDATE

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

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

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October 2010

PRODUCT UPDATE

Vibratory finishing systems Niraj Optical Machinery offers vibratory finishing systems, which incorporate a rubber or polyurethane lined bowl of â&#x20AC;&#x2DC;Uâ&#x20AC;&#x2122; cross section mounted on accurately calculated springs. These systems are driven by a highly efficient vibratory motor. The open top of the bowl can be loaded with suitable ceramic/ plastic or steel media and parts to be processed. Vibratory finishers shake parts and media at high speeds, causing the media to scrub the surface of the parts in an action similar to lapping. Since the parts and the media are moving at small increments on each stroke, the parts are not subjected to severe stress or damage. Vibratory finishers produce very smooth surfaces, are safe for delicate or heavy (metallic/non-metallic) parts, and have good action inside recesses and holes. Vibratory finishing is preferred for general deburring, finishing, pre-plate finish, etc of delicate or heavy parts and for precision deburring/finishing. Vibratory finishing is also safer for threaded parts. Niraj Optical Machinery - Ahmedabad - Gujarat Tel: 079-2929 5747, Fax: 079-2583 3659 Mob: 9825554860, 9909904148 Email: badrakia@rediffmail.com

October 2010

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PRODUCT UPDATE

Strip seals Novoflex Marketing offers pilfer-proof strip seals, which prevent imitation of branded & quality products and help control adulteration & pilferage, thus protecting a companyâ&#x20AC;&#x2122;s reputation & brand image. These have a tamper evident locking action in a one-piece construction and are precision moulded from durable, tough, high-strength, weatherresistant engineering Nylon 66 material. These strip seals are light in weight, corrosion effective, economical and cost-effective. The companyâ&#x20AC;&#x2122;s name/logo can be permanently hot stamped on it. These seals can be used in the pharmaceuticals industries, bulk drugs, airlines baggages, postal department, chemical industries, bank lockers, courier bags, containers, drums, etc. Novoflex Marketing Pvt Ltd - Kolkata - West Bengal Tel: 099031 63634, Fax: 033-2229 7814 Email: sales@novoflex.co.in

Centrifuges United Engineering Enterprises offers full-lid opening centrifuges, which conform to GMP standards for active pharmaceutical ingredients, herbal extracts, flavours, colours, chemicals and allied process industries. These centrifuges are of four-point suspension type in stainless steel construction. The entire body can be lifted & opened hydraulically. Thus, the basket and drain platform are exposed, facilitating easy & quick cleaning. The body is hydraulically lowered into the closed position and clamped to the lower portion of the casing by means of quick clamps. These centrifuges are suitable for manufacturing facilities that require frequent product changeover. These centrifuges are available in various designs, depending on cake characteristics and customer requirements, viz, standard top discharge, top discharge with bag lifting arrangement & bottom discharge with/without scrapper. The centrifuges can also be offered in vapour tight construction with nitrogen blanketing for hazardous chemicals. The CIP design with built-in cleaning nozzles ensures no product cross-contamination. These centrifuges are manufactured in batch capacities in the range of 5-600 kg. United Engineering Enterprises - Mumbai - Maharashtra Tel: 022-2308 3990 Email: uenggent@gmail.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

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October 2010

Rotary tablet press

Analytical instruments

Geared box

Rotary vacuum dryers

Banking services

Geared motor

Rotocone dryers

Bearings

GMP heat exchangers

Safety light curtains

Biodiesel

GMP reactors

Safety monitors/controls

Cable carriers

Heart valve frames

Screening machine

Cable connectors

HPLC

Self-adhesive tapes

Capping machines

Hydrogenator/autoclaves

Separators

Centrifuges

Industrial control & sensing devices

SEZ developers

Chains

Informatics

Silicone carbide heat exchangers

Chemical storage cabinets

Injectable powder ﬁlling machines

SME ﬁnance

Chill roll ﬂaker unit

Invertor/variable frequency drives

Solid state timers

Clean-in-place systems

Knife mill

Spherical paddle chopper dryers

Columns & chemistries

Laboratory benches/cabinets

Spray devices

Compositional & trace

Leak test apparatus

Sticker (self-adhesive) labelling

Level controllers

First Fold Here Liquid ﬁlling lines

machines

Conical screw dryers

Strip seals

Connectors

Liquid ﬁlling machines

Sweetness enhancer

Counters & power supplies

Liquid food processing system

Switching relays

Crushers

Lubes - engine oils

Tablet bottle packing lines

Dehumidiﬁers

Masking agent

Tablet/capsule section machine

Digital USB microscope

Material identiﬁcaton unit

Tablet press machine

Double-sided rotary tablet press

Measuring & monitoring relays

Tableting machinery

Drives

Metallography

Temperature controllers

Dry syrup powder ﬁlling lines

Mono ammonium glycyrrihizinate

Testing equipment

Dryer

Motion controls

Timers

Ducting and vav system

Mullers

Transfer panels

Exhaust blowers

Multi-function mill

Transmission ﬂuids

Exhibition - Engineering Expo

Ointment/cream/

Turnkey projects

Exhibition - Plastivision India 2011

Twin-screw co-rotating extruders

Exhibition - India Lab Expo 2010

Packaging machines

Twin-screw elements

Failure analysis system

Petrol & fuel oils

Twin-screw extruders

Filler compositional analysers

Photoelectric sensors

Ultrasonic processors

Filters

Pneumatic component

ULV fogging machine

Filtration equipment

Polymer characterisation

UPLC

Filtration systems

Valves

Financial services

Process reactors

Ventilators

Flavour enhancer

Process skids

Vibratory ﬁnishing systems

Fogging machine

Programmable logic controllers

Vision product

Food analysing & testing machine

Programmable terminals

Vision sensors

Fuels - diesel

Proximity sensors

Washing and air jet cleaning

Fume extractors

Pumps

Fume hoods

Rapid endotoxin detection system

Wastewater treatment equipment

Fumigation unit

Restricted by-pass

Wet glue labelling machine

Gases

RFID

Tel: +91-22-3003 4684 / 4640

Fax: +91-22-3003 4499 E-mail: b2b@infomedia18.in

Gear oils

metal analysers

How to use this form:

paste section machine

Second Fold Here Process heat exchangers

machines

Send your inquiries at: Tel: +91-22-3003 4684 / 4640 • Fax: +91-22-3003 4499 E-mail: b2b@infomedia18.in

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Ruby House, ‘A’ Wing, J.K. Sawant Marg, Dadar (W), Mumbai 400 028, INDIA.

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BR Permit No. 555 Bhavani Shankar Post Office, Mumbai 400 028.

Business Reply Inland

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ADVERTISER INQUIRY FORM

se this form for FREE additional Information on advertisements published in this issue. We will send your inquiries to the advertisers and ask them to send you the details or contact you directly.

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Tel.: +91-22-3003 4684

Fax.: +91-22-3003 4499 Email: b2b@infomedia18.in

All India Plastics Manufacturer’s Association

Jicon Industries

Arctic India Sales

J B Sez Pvt Ltd

Bonﬁglioli Transmissions (Pvt) Ltd

Livewire

First Fold Here

Brothers Pharmamach (India) Pvt Ltd

Omron Automation Pvt Ltd

Cadmach Machinery Co Pvt Ltd

Premium Transmission Ltd

Charles River

Radiant Enterprise

Cognex Singapore Inc.

Salesworth India Pvt Ltd (Esc)

Dipesh Engineering Works

SD (India) Corporation

Engineering Expo

Shiva Analyticals (India) Limited

Fette Compacting Machinery (I) Pvt Ltd

Sreelakshmi Traders

Gordhandas Desai Pvt Ltd

Standard Chartered Bank

Grundfos Pumps India Pvt Ltd

Steer Engineering Pvt Ltd

Guan Yu Machinery Factory Co., Ltd.

Unicorn Natural Products Pvt Ltd

Igus India Pvt Ltd

Waters (India) Private Limited

Second Fold Here Please complete the following & get a quick effective response from suppliers: 1. Your company’s business function is ( one only) Wholesalers Manufacturer Distributor Agent Other, please specify ______________ 2. Your role in your company’s buying process can best be described as: I buy I identify potential suppliers I approve purchases I negotiate contracts I select suppliers. 3. Your line of business Name: Designation: Company Name:

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10/ 2010

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Third Fold Here

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NO POSTAGE STAMP NECESSARY IF POSTED IN INDIA

Special Projects

INFOMEDIA 18 LIMITED Ruby House, ‘A’ Wing, J.K. Sawant Marg, Dadar (W), Mumbai 400 028, INDIA.

PRODUCT INDEX

Product

Pg No

Product

Pg No

Product

Pg No

Accelerated ageing test system ..................................61

Gases............................................................................61

Rapid endotoxin detection system............................83

Analytical instruments .................................................23

Gear oils ........................................................................61

Restricted by-pass .........................................................83

Banking services .........................................................49

Geared box ....................................................................21

RFID ................................................... Front inside cover

Bearings ...........................................................................6

Geared motor................................................................21

Rotary tablet press ........................................................17

Biodiesel ........................................................................61

GMP heat exchangers.....................................................5

Rotary vacuum dryers ....................................................5

Cable carriers................................................................6

GMP reactors ..................................................................5

Rotocone dryers..............................................................5

Cable connectors ............................................................6

Heart valve frames .....................................................27

Capping machines ..........................................................9

HPLC .............................................................................23

Centrifuges ....................................................................84

Hydrogenator/autoclaves ...............................................5

Chains..............................................................................6

Industrial control & sensing

Safety light curtains ........................Front inside cover Safety monitors/controls ..............................................83 Screening machine........................................................11 Self-adhesive tapes ........................................................79 Separators ......................................................................11

Chemical storage cabinets............................................83

devices ............................................Front inside cover

Chill roll flaker unit......................................................80

Informatics ....................................................................23

Clean-in-place systems...................................................7

Injectable powder filling machines ...............................9

Columns & chemistries................................................23

Invertor/variable frequency drives ........ Front inside cover

Compositional & trace metal analysers ......................61

Knife mill ....................................................................11

Conical screw dryers.......................................................5

Laboratory benches/cabinets.....................................83

Connectors ......................................................................6

Leak test apparatus .......................................................78

Sticker (self-adhesive) labelling machines ....................9

Counters & power supplies............... Front inside cover

Level controllers................................. Front inside cover

Strip seals.......................................................................84

Crushers.........................................................................11

Liquid filling lines...........................................................9

Sweetness enhancer ......................................................25

Dehumidifiers.............................................................43

Liquid filling machines...................................................9

Switching relays ................................. Front inside cover

Digital USB microscope ...............................................78

Liquid food processing system ....................................11

Tablet bottle packing lines ..........................................9

Double-sided rotary tablet press .................................17

Lubes - engine oils........................................................61

Tablet/capsule section machine...................................80

Drives................................................... Back inside cover

Masking agent.............................................................25

Tablet press machine....................................................17

Dry syrup powder filling lines.......................................9

Material identificaton unit...........................................61

Tableting machinery...................................... Back cover

Dryer..............................................................................79

Measuring & monitoring relays ....... Front inside cover

Temperature controllers ................... Front inside cover

Ducting and vav system ...............................................83

Metallography ...............................................................61

Testing equipment........................................................61

Exhaust blowers..........................................................83

Mono ammonium glycyrrihizinate .............................25

Exhibition - Engineering Expo................. 13, 14, 31, 32

Motion controls ................................. Front inside cover

Exhibition - Plastivision India 2011............................10

Mullers...........................................................................11

Exhibition - India Lab Expo 2010.................................8

Multi-function mill ......................................................11

Failure analysis system ..............................................61

Ointment/cream/paste section machine ..................80

Filler compositional analysers .....................................61

Packaging machines ...............................................9, 80

Filters .............................................................................11

Petrol & fuel oils...........................................................61

Filtration equipment ....................................................11

Photoelectric sensors ......................... Front inside cover

Filtration systems..........................................................11

Pneumatic component .................................................11

Financial services ..........................................................49

Polymer characterisation..............................................61

Flavour enhancer ..........................................................25

Process heat exchangers .................................................5

Ventilators .....................................................................79

Fogging machine...........................................................79

Process reactors...............................................................5

Vibratory finishing systems .........................................80

Food analysing & testing machine ..............................11

Process skids....................................................................7

Vision product ........................................................68, 69

Fuels - diesel..................................................................61

Programmable logic controllers ....... Front inside cover

Vision sensors .................................... Front inside cover

Fume extractors ............................................................83

Programmable terminals................... Front inside cover

Washing and air jet cleaning machines......................9

Fume hoods...................................................................83

Proximity sensors .............................. Front inside cover

Wastewater treatment equipment ...............................11

Fumigation unit............................................................79

Pumps............................................................................19

Wet glue labelling machine ...........................................9

SEZ developers.........................................Front gate fold Silicone carbide heat exchangers ...................................5 SME finance ..................................................................49 Solid state timers ..........................................................78 Spherical paddle chopper dryers ...................................5 Spray devices ...................................................................7

Timers................................................. Front inside cover Transfer panels................................................................7 Transmission fluids ......................................................61 Turnkey projects.............................................................5 Twin-screw co-rotating extruders ...............................27 Twin-screw elements ....................................................27 Twin-screw extruders ...................................................27 Ultrasonic processors.................................................80 ULV fogging machine ..................................................79 UPLC .............................................................................23 Valves ..........................................................................83

BC - Back Cover, BIC - Back Inside Cover, FIC - Front Inside Cover

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

October 2010

Modern Pharmaceuticals

ADVERTISERS’ LIST

Advertiser’s Name & Contact Details All India Plastics Manufacturer’s Association

Pg No 10

Advertiser’s Name & Contact Details Fette Compacting Machinery (I) Pvt Ltd

Pg No BC

Advertiser’s Name & Contact Details

Pg No

Radiant Enterprise

T: +91-22-28271678

T: +91-9867168123

T: +91-79-66615344

E: marketing@plastivision.org

E: srane@lmtfette.in

E: radiant_enterp@rediffmail.com

W: www.plastivision.org

W: www.fette-compacting.com

W: www.fogstarindia.com

Arctic India Sales

Gordhandas Desai Pvt Ltd

Salesworth India Pvt Ltd (Esc)

T: +91-11-23906777

T: +91-265-2340795

T: +91-80-25274495

E: bryairmarketing@pahwa.com

E: labexcel@gdpl.com

E: mail@salesworth.com

W: www.bryair.com

W: www.gdpl.com

W: www.esc4cip.com

Bonfiglioli Transmissions (Pvt) Ltd

BIC

T: +91-44-24781035 E: sales@bonfiglioliin.com

E: salesindia@grundfos.com

E: indialabexpo@gmail.com W: www.indialabexpo.com

Guan Yu Machinery Factory Co., Ltd.

Igus India Pvt Ltd 17

T: +91-79-25841491

W: www.shivatec-india.com 6

W: www.sreelakshmitraders.com Standard Chartered Bank

T: +91-80-25588175

T: +91-22-28510398

W: www.standardchartered.co.in

W: www.jicon.com Steer Engineering Pvt Ltd

W: www.criver.com

J B Sez Pvt Ltd 68, 69

E: aparadkar@jbsez.com

E: herlinda.xu@cognex.com

W: www.jbsez.com

W: www.cognex.com.sg

Livewire 5

FGF

T: +91-22-66210000

T: +65-6325-5947

E: info@steerworld.com W: www.steerworld.com Unicorn Natural Products Pvt Ltd 29

E: livewire18@infomedia18.in

T: +91-40-27817191 E: foods@unicornnature.com

Omron Automation Pvt Ltd

E: sales@dipeshengg.net

T: +91-80-40726400

Waters (India) Private Limited

W: www.dipeshengg.com

E: srirams@ap.omron.com

T: +91-80-28371900

W: www.omron-ap.com

E: waters_india@waters.com

13,31

T: +91-80-23723309

T: +91-22-26743719

Engineering Expo

T: +91-22-39401616 E: sme.custoercare@sc.com

E: jicon.ind@vsnl.com

E: india.customercare@crl.com

Dipesh Engineering Works

E: sreelakshmitraders@gmail.com

W: www.igus.in JICON INDUSTRIES

Cognex Singapore Inc.

Sreelakshmi Traders T: +91-44-24343343

T: +91-80-39127800

W: www.cadmach.com Charles River

E: gupta@shivatec-india.com

E: info@igus.in

E: info@cadmach.com

Shiva Analyticals (India) Limited T: +91-80-27971322

W: www.gy-1000.com.tw

W: www.brothers.co.in

T: +91-11-27604500

E: guanyeu@ms39.hinet.net

E: brothers@usa.net

SD (India) Corporation

T: +91-44-24966800

T: +886-4-896-5198

T: +91-79-40213213

Cadmach Machinery Co Pvt Ltd

W: www.grundfos.in

W: www.bonfiglioliindia.com Brothers Pharmamach (India) Pvt Ltd

Grundfos Pumps India Pvt Ltd

FIC

W: www.unicornnature.com 23

T: +91-9920401226

Premium Transmission Ltd

E: engexpo@infomedia18.in

T: +91-20-27488886

Web 18 Software Services Ltd.

W: www.engg-expo.com

W: www.premiumtransmission.com

W: http://ibnlive.in.com/siemensecovatives

W: www.waters.com 12

Our consistent advertisers

SOURCE PROCESS PLANT MACHINERY & EQUIPMENT @ www.engg-expo.com

90 Modern Pharmaceuticals

October 2010

Modern Pharmaceuticals

October 2010