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EDITORIAL
The ‘Green’ signal! t’s no more a mere signal or, a matter of choice… With ever growing concerns for global warming and increasingly stringent environmental regulations, it has become imperative for the pharmaceutical sector to adopt ‘green models’ for its manufacturing process. In other words, it calls for eco-friendly chemical processes that efficiently apply raw material, eliminate waste and avoid the use of toxic solvents in the manufacture & application of chemical processes & products. In fact, green chemistry offers twin benefits, that of the economic & environmental values, as well as opportunities for cost savings, additional revenues and cost avoidance. The ‘Sector Watch’ offers an insight into the fast emerging arena of green manufacturing. On a different note, the CRAMS sector is coming of age, especially in India, as the pressure mounts on MNCs to maintain their profitability amid dwindling product pipelines and a significant shift towards generics. Going by the spurt in risk sharing deals and strategic tie ups in the CRAMS space, outsourcing seems to be moving from being just a tactical option to a more strategic one in line with the global market demand. With regard to the diversification noticed in the CRAMS segment, there is a
i
wide range that includes high-end, complex manufacturing services, drug discovery, custom chemical synthesis, intensive data management, development of biotechnologybased drugs, clinical and bioequivalence support, bioinformatics, medicinal chemistry, regulatory fillings, etc. At the same time, there are several challenges facing the country. The list includes, among others regulatory timelines, increasing costs, process safety standards, project management capability and non-tariff barriers from developed countries. For a detailed perspective on CRAMS, turn to the ‘Market Trends’. Last but not the least, despite growing investments in R&D projects, new drug discovery and development seems to be a long journey before the country attains its potential in innovation. The special section ‘Industry Update’ analyses the latest trends and ongoing transition of Indian pharma from generics to innovator R&D. Take a look.
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Editor: Manas R Bastia
August 2010
Modern Pharmaceuticals
15
CONTENTS
48
53
F E AT URE S 42
LEADERS SPEAK 'In the last four years, funding for research in disease biology has increased 16-fold' ...says Dr Vijay Chandru, Chairman & CEO, Strand Life Sciences; and President, Association of Biotechnology Led Enterprises (ABLE)
ROUNDTABLE M&As in Indian pharma: Rewind or fast forward?
34
36
FACILITY VISIT Bry-Air Asia Pvt Ltd: Solutions for a better tomorrow
34 36 39
SECTOR WATCH Pharma manufacturing going green: Reducing the carbon footprint
MARKET TRENDS CRAMS: India’s next business strategy?
39
68
INDUSTRY UPDATE R&D mantras: In the making of a molecule
BIOTECHNOLOGY
REGULAR SECTIONS Editorial ............................................................. 15 National News................................................... 18 World News....................................................... 24 Tech Updates ..................................................... 30
Gene therapy: Targetting a transformation in medicine Sanjeev Saxena Chairman & CEO, Actis Biologics
RETAIL ZONE Role of the board of directors: Tuning growth the right way Rajendra Pratap Gupta International Retail & Healthcare Expert
INDUSTRY INSIGHT Events Calendar ................................................ 72 Product Update................................................. 74 Product Inquiry ................................................ 83 Advertisement Inquiry ..................................... 85 Product Index ................................................... 87 Advertisers’ List................................................. 88
16 Modern Pharmaceuticals
August 2010
Type I diabetes therapeutics market: Unmet needs propelling growth Courtesy: GlobalData
42 48 53 66 68 70
Highlights of Next Issue Industry Update: Lab Equipment / Analytical Instruments Market Trends: Pharma Packaging Note: ` stands for Indian rupee, $ stands for US dollar and £ stands for UK pound, unless mentioned otherwise
NATIONAL NEWS
WORKSHOP
AIPIAA aims to indenting agents
educate
The All India Pharma Indenting Agents Association (AIPIAA), a deemed association, recently organised a workshop to educate the indenting agents. It was organised by the Central Drug Standard Control Organisation (CDSCO), to help improve regulations & fast registrations of the pharma ingredients.
PARTNERSHIP
Courtesy: Newswise, Inc
Indian and Victorian scientists collaborate for new-generation cancer medications
Victoria’s Deakin the prestigious
University and Indian Institute
APPOINTMENT
Avesthagen welcomes member on board
new
Avesthagen Ltd, India’s knowledge-based life sciences company has appointed Jacques Vincent to the company’s Board of Directors. Vincent is currently on the board of Syngenta, a multinational seed & crop-protection company in Switzerland, Biophytis—a biotech start-up, and Mediaperformance—a media company in France.
NEW VACCINE
Serum Institute Nasovac™
launches
L-R: Suresh Kalmadi, and Dr Cyrus Poonawalla
18 Modern Pharmaceuticals
Dr Surinder Singh, Drug Controller General of India, said that any legitimate inputs falling under the Drugs & Cosmetics Act would be considered during registrations. He also conveyed that all efforts would be made to discipline those who break the law. This year, Dr Singh stressed on the need for e-governance (eg, fillings of documents and approval
of the same online), which would otherwise take 4-5 years.
of Science in Bengaluru have teamed up for a cross-border research project on drug delivery to treat cancer. The collaboration focusses on targeting the roots of cancer cells by developing a new generation of effective cancer medications to kill cancer-initiating cells, with fewer side effects. This is a $ 2.7 billion project funded by the Australia-India Strategic Research Fund (AISRF), and supported by the Indo-Australian Science and Technology Fund.
Wei Duan, Associate Professor & Project Leader and Researcher, Deakin Medical School, said, “Our aim is to develop a safe & novel drug-delivery system that targets the core of cancer, killing the cells responsible for the resistance to current therapies as well as recurrence of the disease.” The success of this project will help us take a step forward to significantly improve the survival rate & quality of life of patients with cancer.
Welcoming the new Board Member, Dr Villoo Morawala-Patell, Founder & CMD, Avesthagen Ltd, said, “It is an honour to welcome Vincent to the Avesthagen Board. He brings to the table experience & commercial knowledge of the MNCs. His advice along with those of other board members would be critical for commercialising Avesthagen’s product pipeline. The new members on the board will play a vital role in catalysing
the process of commercialisation, predictive, preventive & personalised healthcare and environment solutions for agriculture through its various product offerings.”
Serum Institute, the Pune-based vaccine manufacturer has launched Nasovac™ for the prevention of H1N1 infections. The single-dose vaccine, fitted at the top of a syringe is to be sniffed once in each nostril, which makes it a painless prevention mode. The safety and efficacy of the vaccine was established through several clinical trials conducted in India. The vaccine is approved by the Drug Controller General of India (DCGI) for
use in people above three years of age, except pregnant women. It has been priced reasonably to increase availability among the masses. Dr Cyrus Poonawalla, Chairman, Serum Institute of India Ltd, said, “I am pleased that the Serum Institute has effectively contributed to make the country self-reliant in creating vaccines for preventing pandemic influenza in the future.”
August 2010
L-R: B R Sikri, Gautam Shah, Dr Surinder Singh lighting the lamp
NATIONAL NEWS
NEW DISTRIBUTOR
Gautavik named distributor for India’s life sciences, cosmetics, agricultural industries Gelest, Inc, has declared Gautavik International, a Mumbai-based company, an exclusive distributor in India for its line of silane, metalorganic and silicone products for advanced-technology applications
AWARDS
ICICI Lombard & CNBC declare TV18 India’s premier Healthcare Award 2010
ICICI Lombard Company Ltd,
General Insurance a private sector
EU APPROVAL
EU certifies Parabolic’s facility European Union (EU) has certified the Cephalasporin manufacturing facility of Parabolic Drugs Ltd (PDL), a research-based Active Pharmaceutical Ingredient (API) manufacturer in Derabassi, Punjab. The company dominates the antibiotic space and is making its presence felt in the custom synthesis & contract manufacturing segment also. The
NEW FACILITY
Stride’s Brazil facility receives UK-MHRA approval
Strides Arcolab Ltd (Strides) has been certified for Good Manufacturing Practice (GMP) compliance by the Medicines
20 Modern Pharmaceuticals
in the life sciences, cosmetics and agricultural sectors. The targeted life science sectors include pharmaceuticals, biosciences, dental & medical devices. Gautavik International, headed by Dr Vasanti Yadav, successfully serves the high-technology sectors in India. The company has an established logistics & technically trained
staff with the ability to service customer requirements. Gelest is experiencing a worldwide increase in demand in speciality applications.
company, and CNBC TV-18, a business channel, have introduced ‘ICICI LombardCNBC TV18 Healthcare Awards 2010’ for acknowledging the leading healthcare providers of the country. These awards hope to offer a benchmark for the healthcare industry, thus inspiring them to scale-up their endeavours for providing quality healthcare services. “The Indian healthcare industry is growing at a rapid pace & healthcare
providers are looking at ways to enhance overall patient experience with improved operational efficiency. ICICI Lombard is committed towards providing health coverage with a view to meeting the need for quality healthcare in the country, and therefore this proactive initiative by ICICI Lombard and CNBC TV18 aims to reaffirm the effort,” said Bhargav Dasgupta, MD & CEO, ICICI Lombard General Insurance Company Ltd.
company has been approved to market three of its molecules - cefuroxime axetil, cefpodoxime proxetil & cefixime trihydrate. This will help the company sell its products in the markets of Europe, Canada and Australia, thus giving impetus for building its business in regulated markets. Vineet Gupta, Executive DirectorPDL, said, “Parabolic is already approved by the US Food & Drug
Administration (USFDA) for sale of one of its products in the US markets, from its Panchkula facility. With this EUGood Manufacturing Practice (EU-GMP) certification of its Derabassi facility, PDL has expanded its sales reach to the highly regulated markets, positioning itself as a strong API company.”
and Healthcare products Regulatory Agency (MHRA), UK, for its manufacturing site at Campos, Brazil. The facility is dedicated to manufacturing sterile products, such as Carbapenems, a class of beta-lactam antibiotics with a broad-spectrum antibacterial activity, as well as production of Penicillins for the Latin American markets. V S Iyer, Executive Director, Strides Arcolab, said, “This approval
is an important milestone and shall significantly increase our business opportunities in the European region for a niche group of products.” Again, as part of its strategy to highlight on the core specialty injectable business, the Campos facility was acquired by Strides from Aspen, and the ownership of the facility is in the process of transition to Strides. The facility has already been approved by ANVISA, Brazil.
August 2010
NATIONAL NEWS
ACQUISITION
Bilcare AG to acquire INEOS’ Global Films business INEOS Group has entered into an agreement for the sale of its Global Films business to Bilcare AG, one of the providers of research-led packaging, for approximatelyeuros 100 million. Iain Hogan, CEO, INEOS Films,
PATENT APPLICATION
Courtesy: The HKAPI
US appeals court rules Gemzar patent invalid
Gemzar
Sun Pharma announced that the US Court of Appeals for the Federal Circuit
DRUG LAUNCH
Marck Biosciences launches paracetamol IV Marck Biosciences Ltd, India’s manufacturer and marketer of sterile dosages and Blow-Fill-Seal (BFS) specialist, recently launched paracetamol IV in plastic pack manufactured using the BFS technology. It is a ready-toinfuse dosage form of Paracetamol (in 10 mg/ml solution) and is indicated for short-term treatment of moderate CLINICAL TRIAL
Courtesy: Department of Neurosurgery-University of Florida
Avesthagen completes preclinical efficacy trial for AVENT™
Avesthagen recently announced the completion of its pre-clinical efficacy trial
22 Modern Pharmaceuticals
said, “Bringing together Bilcare’s research & development with our own broad production & application knowledge will provide a strong strategic fit.” Mohan Bhandari, Chairman, Bilcare Limited, said, “The acquisition is a paradigm shift in the pharma packaging space & is a significant step towards creating a customer-
centric company in order to offer path-breaking innovations & establish a global leadership”.
affirmed the judgement of the US District Court for the Eastern District of Michigan against Eli Lily and Co, finding certain claims of US Patent No 5464826 (826 patent) invalid. The appeal arose from a lawsuit filed by Eli Lily against Sun Pharma in regards to Sun Pharma’s submission of an Abbreviated New Drug Application (ANDA) for a generic version of Gemzar. In the Michigan lawsuit, Eli Lily had contended that Sun Pharma’s ANDA
infringed certain claims from the 826 patent and US Patent No 4808614 (614 patent). The Appeals Court agreed with the ruling of the District Court, and noted that the Michigan Court had correctly followed the Federal Circuit’s precedent regarding double patenting. The 826 patent, now ruled invalid, would have expired on November 7, 2012, and would have had paediatric exclusivity through May 7, 2013.
pain, especially after surgery, and for short-term treatment of fever urgently when other routes of administration are not possible. Marck has received the approvals for paracetamol IV, which is manufactured at Marck’s facility at Kheda, Gujarat. Bhavesh Patel, MD, Marck Biosciences said, “Paracetamol IV in plastic will have lower freight costs & breakages and help in more competitive pricing compared to glass bottles.”
The company is in the process of registering the innovative product in other markets, and will shortly launch the drug in India.
for one of its biosimilars drugs, AVENT™, at Biomedcode Hellas SA. AVENT™ is recommended for alleviating symptoms in patients with moderate-to-severe rheumatoid arthritis, plaque psoriasis, ankylosing spondylitis, psoriatic arthritis and juvenile idiopathic arthritis. The pre-clinical efficacy trial of AVENT™ was carried out in a human tumour necrosis factor (TNF) transgenic murine model for rheumatoid arthritis, and was accredited by the US Food
& Drug Administration (USFDA). Avesthagen has successfully developed a proprietary expression vector cell line by using this technology. This product is currently being scaled-up for clinical trials at Inno Biologics facility in Malaysia. Dr Villoo Morawala Patell, CMD, Avesthagen Ltd, said, “Avesthagen is making progress in its biosimilars programme as per schedule in order to provide cost-effective healthcare solutions.”
August 2010
WORLD NEWS
ACQUSITION
Eli Lilly acquires Alnara Pharmaceuticals Eli Lilly has recently acquired Alnara Pharmaceuticals, Inc - a privately held company developing protein therapeutics for treatment of metabolic diseases. The transaction has been approved by Alnara stockholders and has received clearance under the HartScott-Rodino Antitrust Improvements Act. Alnara’s lead product undergoing
DRUG DISCOVERY
Envoy Therapeutics, Scripps partner to seek new PD therapy
Envoy Therapeutics, Inc, a new drug discovery company, has recently
RESEARCH COLLABORATION
Bayer Schering Pharma partners with hospital in China Bayer Schering Pharma AG, Germany, recently entered into a collaboration with The People’s Liberation Army General Hospital (301 Hospital) in Beijing, China. This long-term strategic partnership aims at research in the area of women’s healthcare. According to the agreement, 301 Hospital will receive research funding and their scientists can work at Bayer
FDA NEWS
Amgen’s Denosumab receives FDA designation review
The US FDA has granted Amgen a priority review designation for denosumab, a
24 Modern Pharmaceuticals
development is liprotamase, a nonporcine Pancreatic Enzyme Replacement Therapy (PERT). The product is currently under review by the USFDA for the treatment of Exocrine Pancreatic Insufficiency (EPI). As per the agreement, Lilly acquired all outstanding shares of Alnara for an upfront payment of $ 180 million, subject to adjustment based on existing cash at hand during closing. Alnara stockholders will also
be eligible for up to $ 200 million in additional payments contingent upon potential future regulatory & commercial milestones.
collaborated with the Scripps Research Institute for research on identifying new drugs for Parkinson’s Disease (PD) for greater efficacy & safety compared to current therapies. Using funds from Envoy, scientists at the two organisations will apply Scripps - Florida’s high-throughput screening capabilities - to unravel compounds that modulate a target protein discovered by Envoy.
Envoy’s scientists have used proprietary bacTRAP® technology for identifying a protein that is selectively expressed in a specific cell type within the striatum. Scientists believe that modulation of this protein with a small molecule drug will accurately affect specific brain cells, achieving the efficacy of L-DOPA without side effects.
Schering Pharma’s research facilities in Berlin, Germany. Also, Bayer Schering Pharma scientists from the recently established company’s Global Drug Discovery-Innovation Center, Beijing, China, will participate and co-ordinate the research projects. The joint research programmes will initially focus on gynaecological diseases, with the first project on establishment & analysis of disease models & disease understanding. “Working with the experts from the hospital will help
us bring new therapies faster to patients suffering from gynecological diseases, eg, endometriosis and uterine fibroids,” said Professor Andreas Busch, Member of the Board of Management, Bayer Schering Pharma, & Head of Global Drug Discovery.
subcutaneous RANK ligand inhibitor, for treating bone metastases to reduce skeletal-related events in cancer patients. The Biologics License Application submission summarises clinical experience of nearly 6,900 patients across 18 clinical studies, including about 5,700 patients with advanced cancer in three pivotal Phase III head-to-head trials versus Zometa®
(zoledronic acid). This designation is granted to drugs that offer major advances in therapy or provide a treatment where no adequate therapy exists. “In clinical trials, denosumab has shown the ability to reduce complications of skeletal metastases,” said Dr Roger M Perlmutter, Executive Vice President - Research & Development, Amgen.
August 2010
WORLD NEWS
FDA APPROVAL
USFDA approves Glenmark Generic’s theophylline extendedrelease tablets An Abbreviated New Drug Application (ANDA) by Glenmark Generics, Inc, (GGI) - US subsidiary of Glenmark Generics Ltd - has been approved by the US Food & Drug Administration (FDA) for theophylline extended-release tablets, a generic version of LP Uniphyl® from Purdue Pharmaceutical Products.
LAUNCH
Mylan & Medicis launch generic version of Solodyn® ER
Matrix Laboratories Ltd, a subsidiary of Mylan Inc, recently received approval
DRUG MARKETING
Abraxane® for breast cancer approved to be marketed in Japan Taiho Pharmaceutical Co, Ltd, a partner of Abraxis BioScience, Inc - a fully integrated, global biotechnology company - has been approved by Ministry of Health, Labour and Welfare, (MHLW), Japan, to market Abraxane® IV Infusion 100 mg, paclitaxel Injection (suspension with albumin), for breast
RESEARCH STUDY
Molecular mechanism of human immune response to virus tested
A team of biochemists has identified the molecular mechanism that
26 Modern Pharmaceuticals
The tablets are available in strengths of 400 & 600 mg, and indicated for symptoms & reversible airflow obstruction associated with chronic asthma & other chronic lung diseases, eg, emphysema & chronic bronchitis. The company will begin marketing & distribution of the product immediately in the US and anticipates a successful launch due to limited competition in the niche segment. The company’s current portfolio comprises 56 generic
products authorised for distribution in the US market. GGI continues to identify & explore external development partnerships to accelerate growth of existing pipeline & portfolio.
from the US FDA for its Abbreviated New Drug Application (ANDA) for Minocycline Hydrochloride Extended-Release Tablets (Minocycline ER), in strengths 45, 90 and 135 mg. It is a generic version of Solodyn® ER, a treatment for acne, marketed by Medicis Pharmaceuticals Corporation (Medicis). Mylan also announced settlement & licence agreements with Medicis, resolving
patent litigation for Minocycline ER. The company has ceased additional distribution. Pursuant to the terms of the agreements, Medicis will release Mylan from any liability related to the earlier sale of this product, and Mylan will have the right to market Minocycline ER in the US, beginning in November 2011, or earlier, under specified circumstances.
cancer treatment. In 2005, Abraxis entered into a licence agreement with Taiho Pharmaceutical, a company within the Otsuka Holdings Group. Under the agreement, Abraxis granted Taiho the exclusive rights to market and sell the drug in Japan. They are also developing Abraxane in Japan for treatment of lung & gastric cancer & other solid tumours. “Taiho, is in the process to launch Abraxane this year,” said
Dr Patrick Soon-Shiong, Executive Chairman, Abraxis BioScience.
triggers an immune response against invading viruses. Dr Pingwei Li, Department of Biochemistry & Biophysics, Texan A&M University, said, “These findings may lead to development of new therapies for several viral infections like common cold, hepatitis & AIDS. Li & group have studied an enzyme ‘RIG-I’ that senses the presence of foreign RNA and launches an innate immune response by triggering the secretion of interferon. Unlike an adaptive immune
response that may take weeks to be effective, innate immune response gives immediate protection against infection, as it can rapidly respond to a completely new virus or a bacteriological threat. On how RIG-I senses foreign viruses, Dr Li said, “Some laboratories were trying to reveal the mechanism of RIG-I, but our team first showed how RIG-I recognises the terminal triphosphate of viral RNA. We determined the structure almost a year ago and presented the result at the Keystone Symposium for Structural Biology early this year.”
August 2010
WORLD NEWS
ALLIANCE
PharmaNet collaborates with Abacus PharmaNet Development Group, Inc, a global provider of drug development services to pharmaceutical, biotechnology, generic drug and medical device companies, recently announced a strategic collaboration with Abacus International, an independent health economic consultancy in Europe.
INITIATIVE
Courtesy: Solunetti
Seattle Genetics, Agensys initiate Phase I trial for pancreatic cancer
Gland like structures (arrows) of tumour tissue in pancreatic cancer
Seattle Genetics, Inc, & Agensys, Inc—an affiliate of Tokyo-based Astellas Pharma CLINICAL TRIAL
Ampio Pharmaceuticals begins Optina Phase II clinical trial Ampio Pharmaceuticals, Inc, recently initiated the Phase II clinical trial of Optina™ for the treatment of diabetic macular oedema, an early stage in diabetic retinopathy. The company has completed a formal agreement with St Michael’s Hospital, Toronto, Canada, as a final
EVENT
GEA Pharma Systems concluded seminar on freeze drying at GEA Lyophil
GEA Pharma Systems recently hosted a hands-on seminar entitled ‘Freeze Drying and Automatic Loading and
28 Modern Pharmaceuticals
The strategic collaboration builds on the organisations’ common purpose of supporting the development of research-based evidence throughout the drug/device lifecycle to document a product’s clinical & economic value. PharmaNet contributes to the design & implementation of clinical trials and prospective ‘real world’ research studies, while Abacus provides expertise in health economics, health
technology assessment and market access solutions. The e-registry management system web-based software by Abacus will help serve clients with project & site management, data management & analysis and communications.
Inc - jointly initiated a Phase I clinical trial of ASG-5ME, an antibody-drug conjugate, which is being co-developed by both companies for the treatment of metastatic pancreatic cancer. The single-agent, Phase I, openlabelled, dose-escalation study will evaluate the safety & tolerability of ASG5ME in patients with pancreatic cancer and identify the maximum tolerated dose. It also aims to assess the pharmacokinetics & antitumour activity of ASG-5ME and
identify a recommended dose & regimen for future clinical trials. The antibody attaches to a highly potent, synthetic agent, monomethyl auristatin E via an enzyme-cleavable linker using Seattle Genetics’ proprietary technology. The linker is stable in the bloodstream & releases the cell-killing agent once inside antigenexpressing cancer cells. The approach spares non-targeted cells, reducing toxic effects of conventional chemotherapy & enhances antitumour activity.
step for ethics board approval, which is expected in the next few days. Don Wingerter, CEO, Ampio Pharmaceuticals, said,“We are excited to commence this trial after the final approval of the ethics board and will begin patient recruitment in the next few weeks.” Diabetic macular oedema is the cause of vision loss in a majority of patients with diabetes mellitus. Currently, there is no effective oral medication to treat diabetic macular
oedema or diabetic retinopathy. Optina™ is a repurposed oral drug with an established human safety profile. Pre-clinical studies have shown the potential for Optina™ to significantly reduce diabetic macular oedema in patients.
Unloading Systems’ (ALUS) at the GEA Lyophil facility at Hürth, Germany. The event was attended by about 20 participants from six different countries and three continents. The event included lectures highlighting the latest developments in freeze-drying technology and a tour of the facility with on-going projects in various phases. The final part of the seminar was dedicated to real-life demonstrations of freeze-drying equipment.
The seminar covered a number of important elements of the pharmaceutical freeze-drying process, including the fundamentals of freeze drying, along with optimisation techniques; opportunities for energy saving & reduction of cycle times; leak detection of silicone oil using mass spectroscopy for increased product safety; ALUS® equipment design; and gasket management to optimise plant maintenance.
August 2010
TECH UPDATES
New Xcelolab™ provides rapid solutions Capsugel, a division of US drug giant Pfizer, has launched Xcelolab™ - an addition to its Xcelodose range - which provides a rapid and reproducible solution for dispensing small amounts of pharmaceutical powders at laboratory stage drug development. Xcelolab™ bench-top powder dispensing system is safe & efficient for dispensing small quantities of highly potent Active Pharmaceutical Ingredients (APIs). It is specifically designed to enable laboratories to perform accurate, closed loop, weight dispensing with any powder. This technology can dispense a wide range of drug powders in quantities as small as 100 µg with a Relative Standard Deviation (RSD) typically in 1-2 per cent range. The Xcelolab™ system uses technology that makes the powder in question behave like a liquid and form ‘micro-bridges.’ The firm said, “Xcelolab™ was developed in response to the demand for a way of conducting method development, dispenser head selection and powder characterisation studies in the laboratory rather than in the pilot plant. The data produced and methods developed can then be directly transferred to their Xcelodose system to continue manufacture of clinical trial materials without interruption or Xcelolab™ unnecessary downtime.”
Cellexus launches a disposable bioreactor for a wide cell line Cellexus has introduced CellMaker Plus™, a new, state-ofthe-art, easy-to-use, single-use, disposable bioreactor cell culture control instrument. It features oxygen generation capability, dissolved oxygen and pH sensors that can be adjusted to enable the use of the broadest range of cell types. It is further supported by a variety of lines used during the system’s development, ranging from laboratory standbys like Escherichia coli and Pichia pastoris to ‘more challenging’ insect and mammalian cells. The CellMaker Plus™ includes four components— SupplyHub for incorporating the air pumping system, temperature regulation & data acquisition; controller to enable specifying important user-defined parameters; enclosure in which the CellexusBag is held and which incorporates a Peltier heater to enable control & monitoring of cell culture temperature; and an oxygenator that can fit with the SupplyHub to provide continuous oxygen supply and also be available as a stand-alone unit. The CellMaker Plus™ unit is designed to give biomanufacturers a greater flexibility in their choice of cell lines, and is available in 8 & 50 ltr versions. CellMaker PLUS
Lensless imaging designed to reveal 3D internal structure of whole cell
A versatile tool to achieve high sample throughput
Scientists at the University of California, Los Angeles (UCLA), and their collaborators have demonstrated the use of a unique X-ray diffraction microscope that helps in revealing the internal structure of yeast spores. Researchers have identified the 3D morphology and structure of cellular organelles, including the cell wall, vacuole, endoplasmic reticulum, mitochondria, granules and nucleolus. This finding may open a way in identifying the individual protein molecules inside whole cells with the help of labelling technologies. “Biologists wanted to examine internal structures of the spore but previous microscopic studies provided information on the surface features only. We are excited to be able to view the spore in 3D. Now we can see the structure of other spores like anthrax. Also, yeast spores are of size similar to many intracellular organelles in human cells, which can be examined in the future,” said Dr Fuyu Tamanoi, Professor - Microbiology, Immunology and Molecular Genetics, UCLA. The article was published in the journal Proceedings of National Academy of Sciences (PNAS). The team reported the quantitative 3D imaging of a whole, unstained cell at a resolution of 50 nm - 60 nm using X-ray diffraction microscopy, also known as lensless imaging.
The Ultravap™ blowdown station, developed by Porvair Sciences Ltd, achieves high sample throughput through sophisticated evaporator head technology and an innovative manifold design, which directly injects heated nitrogen into each well of the microplate simultaneously. The system removes most of the popular chromatography solvents in a short time. For heat-sensitive and thermally labile samples, the Ultravap™ may function in a two-stage mode combining rapid initial dry-down with controlled evaporation of the final solvent. The CE-marked compact unit is simple to install, operate and maintain. For installation, it requires connection to a gas supply/cylinder and standard mains socket. Ultravap™ will be of benefit in application areas such as drug metabolism, toxicology, pharmacokinetics and bioanalysis laboratories, where chromatography or solid phase extraction is used for isolating compounds from biologic matrices. Also, lead discovery, medicinal chemistry and combinatorial chemistry laboratories looking to concentrate target compound samples before reconstitution in another solvent, can also enhance the productivity with the help of Ultravap™. Ultravap™ blowdown station
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TECH UPDATES
BioCision presents products made of a novel thermo-adaptive alloy
Thermo Fisher Scientific introduces costeffective handheld decapping instrument
BioCision has introduced thermoconductive CoolRack made with a novel patent-pending thermo-adaptive alloy. This material quickly equilibrates all sample wells or chambers to within 0.1 °C of the source temperature. This holds true even when samples are cooled using cold water, ice, dry ice or liquid nitrogen and when they are warmed using water bath or heating block. Specimen tubes are kept upright at the same temperature. The racked samples can be moved from ice to water bath en masse, giving a rapid identical temperature shift for all samples. CoolRack also provides the investigator with a system for stable, compact and indexed organisation. CoolRack is available in a wide range of formats for using with cryo-storage tubes, microfuge tubes, PCR strips & plates, etc. CoolRack can also be used for short-term sample transfer or transportation along with the CoolBox, which maintains the temperature of CoolRack for up to eight hours. Rolf Ehrhardt, CEO, BioCision, said, “Considering the worldwide effort to standardise common sample-handling processes, CoolRack gives simplicity & reproducibility to a variety of basic research & clinical protocols involving temperature-sensitive biologics, vaccines, RNA, DNA CoolRack M15 1.5ml / 2.0ml and enzymes.”
Thermo Fisher Scientific Inc has introduced the new Thermo Scientific 8-channel decapper for handheld capping and decapping of multiple tubes in a 96-well microplate footprint. It is designed to decap ergonomically and efficiently eight screw caps at a time with multichannel or single-channel pipettes, so as to allow access to specimens to be sampled. The decapper removes and replaces screw caps with precision and ease, thus saving time & labour while reducing the risk of repetitive strain injury. The instrument uncaps a column of eight screw-top tubes in just four seconds, thus reducing the time required to access samples as well as hastening their return to the storage. The caps are tightened uniformly at the optimal torque to prevent spills or leakage, maintain sample integrity and avoid sample loss during cryogenic storage & freeze-thaw cycles. At a mid-point between manual and automated capping, the new handheld decapper enables laboratories to decap a single column as needed and improve efficiency without investing in Thermo Scientific 8-channel capital equipment. screw cap tube decapper
Safe transport containers for biological samples
New synthetic petridish coating for stem cell research
Sterilin Ltd has recently introduced 95-kPa validated containers for safe and reliable transportation of biological samples. This new plastic single-use, disposable container offers flow-seal technology for transport or storage of biological samples in a leak-free condition. During transportation of infectious samples through post, precautions must be taken to prevent the contents from exposure. Therefore, the packaging must comply with transport regulations while moving the potentially hazardous substances. These regulations are designed to ensure that samples reach their destination in good condition and do not present any hazard to those handling the package on the way. As per the regulations, the primary or secondary packaging must withstand an internal differential pressure of 95 kPa without leakage. The 95-kPa compliant product range includes Sterilin 30 mL polystyrene universals and Sterilin 60 mL polystyrene containers with metal caps. All these are available with printed, plain or no labels, depending on customer needs. Sterilin also offers a range of 95-kPa compliant containers to comply with the internal pressure differential test requirements of the Department for Transport (DfT), the International Civil Aviation Organization (ICAO) and the International Air Transport Association (IATA). Sterilin® polystyrene container
A new synthetic petridish coating could overcome a major hurdle to the advancement of human embryonic stem cell research. The unknown factors hamper researchers’ attempts to pinpoint the conditions and the way in which stem cells differentiate. This information is of paramount importance in the development of future stem cell therapies. Dr Joerg Lahann, Associate Professor-Chemical Engineering, and Dr Gary Smith, Associate Professor-Obstetrics and Gynaecology, University of Michigan, et al, have constructed a new stem cell growth matrix that is completely synthetic and does not contaminate stem cells with foreign substances that could interfere with their normal function. The team evaluated six different polymer coatings and found that a water-soluble gel with the acronym pmedsah performed well when attached to the petri dish even after 25 rounds of harvesting stem cells to grow new colonies. Dr Smith said, “We have designed a fully synthetic, fully chemically defined hydrogel that has long-term stability and no batch-to-batch variability. Moreover, we have established that it can be used for long-term growth of human embryonic stem cells while maintaining all of their known normal functions. ” August 2010
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LEADERS SPEAK
‘In the last four years, funding for research in disease biology has increased 16-fold’ …says Dr Vijay Chandru, Chairman & CEO, Strand Life Sciences. An academician-turnedentrepreneur, Dr Chandru believes that the increasing number of returning scientists & funding will fuel biotechnology research in India. The present honorary President of Association of Biotechnology Led Entrepreneurs - the apex body of the Indian biotech industry - he details the company’s plans, briefly touching upon the trends and opportunities in the Indian biotechnology sector, in an interview with Shivani Mody.
Journey so far The journey of Strand Life Sciences can be classified in three phases. The first one was the consulting phase, when we spun off from the Indian Institute of Science. We were then working with the biotechnology industry, solving complex informatics problems. It was a learning phase for Strand, and our skills in computer science were put to test, which helped us decide our direction for growth. Subsequently, we moved on to the second phase where we focussed on developing an analytics platform —AVADIS®—Strand’s award winning proprietary data access, visualisation, analysis & discovery technology platform. At this stage, we needed funding and raised venture capital in 2002. For the next three years, we built and evolved our AVADIS®, platform into a Scientific Intelligence Platform and began testing the market with products catering to specific verticals. In 2005–06, we commercialised two products—Array Assist and Pathway Architect— and introduced them to the market. In 2008, we launched the GeneSpring® 9.0 with Agilent Technologies, meeting the market expectations and needs. Most of our users are scientists; hence, we need specialists in the areas of product management, testing, technology and scientific support. The software product has now evolved and become a science tool. Currently, AVADIS® powers cuttingedge solutions for genomics, proteomics & next-generation sequencing as well as predictive systems modeling and pathway analysis. These capabilities have led us to revive the consulting aspect of our business, and now we work directly with pharma companies in addition to just biotechnology companies.
The problem solving phase Moving to the third phase, we saw a new dimension for the company, ie, impacting science by focussing our tools
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LE ADERS SPEAK on disease biology. Our internal Research and Development (R&D) focusses on biological systems modeling technologies to understand liver diseases and toxicity. We are currently working on molecular model of rat liver cells, which includes computer simulation of the functioning of the liver. We have completed the initial validation process & are now conducting studies on known toxic drugs. Dr Chandru will be serving three years as Honorary President of Association of Biotechnology Led Entrepreneurs (ABLE) - the apex body of Indian biotech industry.
Current landscape The biotechnology sector is currently going through an exciting phase. In 2003, when we started Association of Biotechnology Led Entrepreneurs (ABLE), we hoped to see the sector reach $ 5 billion by 2012. In 2010, the sector has grown to nearly $ 4 billion, at a rate of about 20 per cent. The ecosystem has developed considerably & numerous small innovative companies are also coming up in Pune, Hyderabad, Bangalore and Chennai. Initially, most of the R&D activities in biotechnology took place in government laboratories & academic science centres, but now even private companies are undertaking these activities. Severall bioclusters have also emerged in the country, across sectors like biopharma, agri- biotech, medical diagnostics and devices, environmental bioengineering, biofuels, etc. As biopharma is the largest segment, we expect numerous developments for vaccines and biosimilars in this area. India currently has a good footprint in these areas. Therefore, having made affordable generic medicines for the world, we have cosiderable opportunity in biosimilars as well. In particular, there is a market pull in India for affordable, good-quality biosimilars in oncology.
Trends & emerging areas Currently, there are few potential areas that can fuel growth in the biotechnology segment. One such area includes drug
delivery with the use of Nanotechnology. Besides, there is also a major scope in diagnostics, using genomics, particularly deep sequencing. This is because the cost of sequencing has reduced by half, while the speed of sequencing has doubled every six months or so. For example, Beijing Genomics Institute expects to sequence a human genome for $ 2,000, while there is a competition to prove that this can be done at a cost less than $ 1,000 per genome. This is another exciting area for bioinformatics. More data is now accessible across the world, which can lead to better analysis of disease, and hence scientific discoveries. Also the concept of personalised medicine is gaining momentum, as the notion of ‘one drug fits all’ is diminishing. Therefore, the stage is set for exploration of new drug discovery models, and India is ready to create new models, perhaps using what is referred to as Indian jugaad. These new models will help bring down the cost of discovery research & trials and also serve the cause of affordable healthcare for all.
On pharma companies entering biotech sector The diversification of pharmaceutical companies into the biotech sector is inevitable. Of the 20 drugs approved by the US Food and Drug Administration (FDA), more than half are biologics. Hence, pharma companies cannot afford to be focussed only on small molecule therapeutics but need to look at the biopharma space as well.
Promising R&D in India Research is an on-going process. Disease biology is an area that needs focus today. One way of doing this is the use of modern instruments & technology, which will help gain insights and breakthroughs for various diseases. The situation in Indian R&D has considerably improved and the government is now spending more on research. In the last four years, funding for research in disease biology has increased 16-fold, clearly indicating the immense focus in this area. Besides, the government
has set up translational research centres to enable proper application of research products in healthcare. Although India has an abundant talent pool for scientific research, it is only the MNCs that are now benefitting with the same. Entrepreneurs need to observe this valuable resource and prepare them for scientific discoveries. We should also attract our India diaspora talent in biotechnology to return to India and participate for the success of these initiatives.
Key challenges Today, the biotech segment faces bottlenecks like infrastructure, manpower, risk capital, regulatory issues, etc. In order to improve the availability of industryready trained manpower, the Karnataka state has initiated Biotechnology (BT) finishing schools. These schools will provide academic training & practical hands-on laboratory experience to students, and will have set standards for evaluation, testing methods and certification. However, in the longer term there will still be a need to integrate such finishing institutions with the education system, which will bring more value to the industry.
Growth drivers The return of the diaspora, that is, the reverse brain drain into the country, is a big advantage. Many experts and experienced personnel are now returning to India to improve the conditions here. Although currently, this is a trickle effect, it will become a full-fledged stream in a short time, as the industry has begun to show results already.
Forecast The latest developments in India indicate that the country is a fertile market for the biotechnology sector. Therefore, focussing only on exports will not be enough. Hence, we believe that a thrust is needed on the development of the domestic market to spur innovation. At present, a few enthusiastic entrepreneurs are ready to engage in innovative startups in the near future.
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ROUNDTABL E
M&As in Indian pharma
Rewind or fast forward? With the spate of big ticket acquisitions by global companies, is Indian pharma witnessing a scenario much like the 1970s? Shivani Mody and Chandreyee Bhaumik present the views of some industry experts on the impact of such deals.
Till the early 70s, MNCs dominated the Indian pharma and there were very few home grown Indian companies which were considered competitive, and were manufacturing & marketing their own drugs. That changed with the introduction of the patent regime in 1971, which opened up the market for Indian players and now the Indian market largely constitutes of indigenous branded generic players as compared to the pre-1970s when MNCs accounted for about 75 per cent of the Indian market. After three decades now, in June 2010, the industry fell prey to another acquisition (Piramal Healthcare’s domestic formulations business by Abbott Laboratories. The deal ushered in doubts, queries, interpretations different from Ranbaxy-Daiichi Sanyko deal. These acquisitions make help drugs accessible and affordable, to an extent. Another concern that seems to dominate such deals is the attractive yet proper valuation along with matching of synergies of both the companies. However, taking a positive stance, some may conclude that not only GMP standards are likely to improve but spaces like productivity hence efficient supply chain, imparting of wholesome medical education to the medical professionals, parameters like health, environmental standards, and safety will also see a brighter dawn.
Alok Saxena Director-International, Elder Pharmaceuticals Ltd Indian pharma market is witnessing increased acquisitions by MNCs to gain a foothold in the secondfastest growing market in the world. After the Ranbaxy take-over by Daiichi & Dabur by Fresenius, the latest was the Piramal acquisition by Abbott, which has seen the valuations reach higher numbers. Factors that drive these acquisitions are decreasing R&D output from the global pharma along with the ever-increasing demand for generics in the emerging markets; higher growth rates of these markets as against the developed markets & good manufacturing capabilities of Indian pharma companies, etc. India has the largest number of FDA-approved manufacturing plants outside the
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US. Again, Indian companies with their US/EU FDA-approved, low-cost manufacturing facilities and strong ANDA and para IV pipelines and well-trained field workforce are becoming potential targets. Long-term benefit of this trend to Indian patients is not known. There is a concern that with MNC management in place, the prices of medicines may increase. However, this concern is akin to the phase when India had signed the Patent Act. At this time, many industry leaders believed that the act would harm the Indian generic industry. However, this concern was misplaced and many Indian companies invested heavily in research and, in a few years, new drugs are likely to emerge from the Indian R&D stable. The intense competition in the pharma business coupled with authorities like the NPPA and regulations like DPCO firmly in place, may not let the prices rise. Most MNCs have now realised that aggressive pricing in emerging markets will not only delay market penetration but result in a loss of marketshare. Hence, a trend to adopt India-centric pricing has emerged.
ROUNDTABLE
A S Mohanty Executive Director, Glenmark Pharmaceuticals Ltd A trend that is clearly visible is the shift of Big Pharma from being an innovation-led player to now entering branded generic markets across the emerging economies including India. With strong growth of the Indian pharmaceutical industry, Big Pharma is considering establishing a strong foothold in this market. However, the situation is different from that in the 1970s, when only innovative drugs dominated the market. At that time, the market in India was comparatively small, level of literacy was low & Indian companies were also inferior from the MNCs
N R Munjal President, Indian Drug Manufacturers’ Association (IDMA), and Vice-Chairman & MD, Ind Swift Group Currently, the pharma industry seems to have much uncertainty, both among people and business. People are doubtful regarding the outcome of government’s decision on price control issues, policy standards, etc. Indian pharma cos are now competing with MNCs both in the domestic and global markets. In this regard, many acquisitions are taking place and there is a concern for results not being positive. A constant concern is that MNCs can acquire the top 10 Indian pharma companies that are
P K Gupta President, Belco Pharma, & Co-Chairman, CIPI The smaller players in the pharma space are not affected by the acquisition phenomenon. It is only the larger, well-known players that are seeing more acquisitions. However, this is global and not exclusive to India. Thus, many big players now see the need to move into new areas, explore business opportunities; hence, acquisitions are bound to happen.
in terms of resources. Also, National Pharmaceutical Pricing Authority (NPPA) was not available to monitor drug prices, then in the 1980s, Indian pharma companies had spread across the country and established the branded generics market that drastically reduced costs of medicines without compromising on quality. Today, we not only have funds at our disposal but also a large field workforce. Also, the only positive point is that Indian companies who are selling out will now be part of a big pharma company. Consolidation will continue in Indian pharma and growth of smaller companies will become difficult. In other words, true consolidation (which was long expected) will happen now. The benefit of Indian companies does not depend on these acquisitions, but on the way Government responds with policy changes to create a level playing field for Indian companies. For example, drugs can be imported at any price today, which is a great advantage to MNCs, whereas Indian brands are controlled at every possible level.
in a comparatively weaker financial position and not supported by proper policies. In the 1970s, the pharma industry was comparatively small. Over the years, the government prepared the process patent policy that helped the country to reach its current rank as the third largest global pharma hub. With no proper policy in place at present, there are possibilities for rolling back to the earlier situation, which was dominated by MNCs. Taking a positive stance, these acquisitions might benefit Indian companies by giving access to new technology, better infrastructure and R&D facilities. But on a broader perspective, the country will not benefit much from such acquisitions. The domination by MNCs is now possible in India, as it has become an open market. To prevent such a situation, the government should have policies for safeguarding the interests of the Indian companies and ensuring full compliance with the World Trade Organization (WTO) norms.
The pharma industry will not roll back to the situation in the 1970s, as we have now reached a high position as a result of immense experience & innovation. At that time, only Indian companies dominated the market & there were hardly any MNCs present. This was an advantage for Indian companies to grow organically and reach to current level. At present, with acquisitions, the MNCs will be able to carry out their innovations faster and even access the growing market. Thus, gaining marketshare will be much faster for them than doing it individually, though this will not benefit the country in anyway. The Indian pharma companies are not looking to move ahead in the field, but are actually targeting profits from the sale of the company.
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ROUNDTABL E
Sanjiv Kaul Managing Director, Chrys Capital The last few years have witnessed some large-scale acquisitions though it is too early to term this as a trend. Clearly visible is the fact that these acquisitions are a growing testimony to the acknowledgement & acceptance among Big Pharma about the Indian pharma industry emerging as a major player. The global pharmaceutical market revenue is currently about $ 800 billion and growing at 3-4 per cent. The branded generics segment has revenues of about $ 170 billion and growing at 12-13 per cent. Thus, about
T S Jaishankar Chairman, Confederation of Indian Pharmaceutical Industry (CIPI) & MD, Quest Life Sciences In the pharma industry, acquisitions are currently the most happening activity, with most companies viewing this aspect as their way forward. All investment bankers are eyeing the industry and investing through this route. We have indeed come a long way from the situation in the 1970s. The mergers and acquisition activity has grown
Vikram Gupta Chief Operating Officer, IndiaVenture Advisors Pvt Ltd Envisioning immense value in the Indian consumer market, international players are looking towards establishing themselves in India. They also see value in using India as a manufacturing and research hub for their global operations. Indian generics players foresee increasing competition & pressure on their margins. Many of them are looking to exit these businesses, especially when the values being offered are highly attractive. Acquisitions are done with the following intents: (1) To acquire new customers in
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three-fourths of the incremental global growth comes from branded generics. Big Pharma has a much lower marketshare in this segment than what they have globally. Hence, they would like to increase their base and participation in the fast growing branded generics segment. MNCs now recognise India to be offering the best platform for maximising marketshare. However, in this context, it is important that the rationale for acquisitions by MNCs is not limited to only manufacturing competence. However, the current acquisitions scenario is different from that in the 1970s, when the local pharma industry of India was virtually non-existent. Indian companies began to surface and emerge only after changes were made in the Patent Act. One should not consider the recent acquisitions by MNCs as an indication of a return to dominance akin to the pre-1970 era. Instead, it will be pragmatic to view it as the next evolution of the pharma industry in India.
substantially and even valuations are comparatively high. In the 1980s, the MNCs again began exiting the country, as they could not keep up with the generic drugs. Indian companies will probably benefit from the acquisitions. Companies have now almost come to a saturation point and are finding it difficult to sustain their high growth. This is a natural phenomenon witnessed both in India and the West. Acquisitions and mergers seem to be a way in such cases, thus making it a win-win situation for both companies. However, considering the developments taking place in the pharma sector, the industry cannot go back to the previous levels of 1970s. Also, with our knowledge base and global experience, we are at an advantage to drive the growth forward in drug discovery and R&D activity.
the existing product categories, eg, acquisition of local players in the international markets with a focus on similar therapeutic areas; (2) To acquire new products in the existing customer segments, eg, specific brand acquisitions; and (3) To acquire vertical integration so as to achieve better margins. The biggest transformation in the Indian pharmaceutical industry has been the change from Process Patent to Product Patent regime. After signing General Agreement on Tariffs and Trade (GATT), India has been providing a homogenous protection of Intellectual Capital to innovators for new products, with effect from 2005. This has changed the perspective from the copying model to innovating model. In my view, the recent acquisitions only indicate the changing global landscape for Big Pharma companies in order to play a larger role in the global economy, while, for Indian companies, this is an opportunity to reposition themselves in their respective markets.
FACILITY VISIT
FACILITY VISIT
Bry-Air Asia Pvt Ltd
Solutions for a better tomorrow With a belief of making standards a benchmark for others to follow, Bry-Air has come a long way in being the partner of choice of many companies across sectors, food & pharma being the revenue makers. Geetha Jayaraman profiles the company’s journey and product portfolio. ry-Air Asia Pvt Ltd, growing at a compounded growth rate of 20 per cent, is among the few companies that provide end-to-end energyefficient environmental control solutions to the pharma industry. It manufactures dehumidifiers that help to increase the shelf life of products.
b
The beginning Bry-Air began its journey about 30 years ago, in 1979, with the setting up of Arctic India Sales (now, a division of Bry-Air Asia), as a marketing company for environment control products. Again, Arctic India Sales started out by representing Bry-Air Inc, USA, for its dehumidifiers in India. In 1981, it promoted the first joint venture in the small-scale sector, Bry-Air India (now known as Bry-Air Asia) with Bry-Air Inc, USA. Bry-Air Asia is the first company to
manufacture dehumidifiers in India and South East Asia. The company has now expanded into a group of technologically competent companies under the umbrella of the acclaimed Pahwa Enterprises. The company specialises in technologies & products having a wide range of ‘air engineering’ equipment along with strong brands. The network of the company spans from South Africa to South America encompassing Turkey, West Asia, far East, South East Asia, Indian subcontinent, China, Japan, Australia and Europe. It exports the equipment to more than 40 countries including North America. An ISO 9002:2008 and ISO 14001: 2004 certified company, Bry-Air, with its associate group companies, boasts of seven manufacturing plants in India, with wholly owned subsidiaries in Malaysia, China & Germany, a licensee in Brazil and an associate plant in the US.
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FACILITY VISIT
Dinesh Gupta President, Bry-Air (Asia)
Our motto is to bring the best-in-class facility to India. In 1983, the Research and Development (R&D) centre in this facility was the same as that in the US, well equipped with the latest technology in our operations.
Bry-Air is a global solutions provider for complete environmental control with specialisation in humidity control, dehumidification, drying, storage, preservation, air & gas purification & plastics auxiliaries. These facilities are supported by cutting-edge technologies, worldwide operations and customers in almost all industries. Operating within a broad framework of ‘Environment and Energy’, Bry-Air’s plants based in Gurgoan are among the most modern ones. Its robust infrastructure base is supported by advanced facilities like computerised three-dimensional (3D) design, Computer Numerical Control (CNC) fabrication, powder-coating facilities & automated conveying system. Dinesh Gupta, President, Bry-Air (Asia), says, “Our motto is to bring the best-in-class facility to India. In 1983, the R&D centre in this facility was the same as that in the US, well equipped with the latest technology in our operations.”
Shaping up R&D At Bry-Air, R&D has always been of enormous importance. Here, efforts to improve product design & performance, machinery and production methods are integrated in the everyday work pattern. R&D at Bry-Air is constantly engaged in development of state-ofthe-art products in dehumidification & plastic auxiliaries. This enables physical testing of the performance and design criteria for specific applications.
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The company has also invented rotary silica gel dehumidifier. Efforts are going on in order to improve designs, layouts, machinery and product ion methods and have been integrated into the everyday work pattern. And Gupta emphasises, “As a pioneer in the field of dehumidification, Bry-Air has maintained the initiative, searching for new ways to bring the benefits of research to satisfy customer needs in the field of plastic drying & energy conservation. When the global focus shifted to devising technologies for conserving energy, engineers at Bry-Air, in keeping with the times, developed a more energy-efficient dehumidifier with honeycomb technology that has superior performance capabilities.”
where the moisture is absorbed by a desiccant bed and dry air is released in the areas/process as needed. This is a continuous process where moisture is expelled in the atmosphere in vapour form through regeneration of the desiccants. The dehumidifiers offer the simplest & most cost-effective solution for controlling of moisture/humidity during the coating process. Spray dryer/fluidised bed dryer require large quantities of hot air for drying. The quality of the final product is affected by the quality of air entering the dryer. The air should be dry, odourless and free of contaminants & foreign particles. With the growing emphasis on limiting production losses & downtime, which impacts final product quality and thus profits, the importance of using dehumidifiers, in conjunction with spray dryer/fluidised bed dryer for quality drying, has increased making their use almost mandatory. Moisture hinders free flow of powders/granules, making many downstream operations (eg, packaging, filtering, handling) difficult and expensive. Almost all products in the company have a relevant international certification.
Milestones achieved Solutions at Bry-Air The company has desiccant-based dehumidifiers that allow easy control of humidity in conjunction with mechanical cooling/heating for temperature control. Further, desiccant technologies are relevant in today’s circumstances because of the increasing numbers of pharma products are being processed, & maintenance of appropriate conditions of temperature & humidity have become extremely important. Bry-Air employs nontoxic desiccants for removing humidity, ie, dehumidification. It also follows a simple concept, ie, moisture-laden air is passed through a rotary-fluted desiccant rotor/bed
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In its long span, Bry-Air Asia has pioneered in more than one way in the country for its technology & product range. In 2005, the company instituted the ‘Bry-Air Awards for Excellence in HVAC&R’ for innovative product and system design. In 2006, the company acquired the global business interest &/ marketing rights from Bry-Air Inc, USA. This includes the Bry-Air brand and all trademarks of Bry-Air Inc, USA, and licensed it back to the US for use in North America. In 2007, Bry-Air was the first and only Indian HVAC company to have made an overseas acquisition of A+H, Hamburg, a leading dehumidifier manufacturer from Germany. In 2008, the company
FACILITY VISIT
R&D at Bry-Air, one of the best in the environment control industry, is constantly engaged in development of stateof-the-art products in dehumidification and plastic auxiliaries.
signed a license agreement with Somax Ambiental & Acystica Ltd, leading air-treatment equipment manufacturers in Brazil. Bry-Air (Asia) has been awarded numerous certificates for Export Excellence in its category since 1992 by the Engineering Export Promotion Council (EEPC) including the ‘All India Trophy for Highest Exporters’ from EEPC for the year 1999-2000 and the Star Performer (Small Enterprise) Award in its product group for Engineering Exports in the year 2005-06. The Bry-Air plant is recognised for its consistent safety standards & has been awarded the Haryana Safety Award at numerous occasions. It has also been awarded for having the best safety measures in its plant in 1985, 1989 and 1999. Today, few of Bry-Air’s clients include Cipla, Aurbindo, Ranbaxy, Sun Pharma, Zydus, Piramal, Emcure, etc.
Future prospects Currently, Bry-Air products are effectively used in production, processing, storage & packaging in pharmaceuticals, chemicals, defence, safety glass, food & drinks, seeds, fertiliser, paper & printing, plastics, wood, leather, cement, etc. “Much of Bry-Air’s business comes from the food and pharma segment. These two segments have not been really affected by the recent global economic slowdown. We are confident that the government efforts will help boost these segments,” explains Gupta. Bry-Air will grow in organic as well as inorganic manner. Gupta concludes, “At present we are focussing on introducing new range of dehumidifiers for dry rooms & also looking for M&A in our related field. At the same time, we are also positioning ourselves to address second & third tier clientele in both pharma & non-pharma sectors as with the growth in Gross Domestic Product (GDP) all industrial sectors are investing for upgrading their infrastructure to meet stringent quality requirements.”
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SECTOR WATCH
‘Go Green’ is becoming the talk of the pharma world, as it is not only cost-effective but also an aim towards preserving a healthy future, writes K T P Radhika Jinoy. She gives a macro-view of green chemistry and its advantages.
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SECTOR WATCH
he pharma industry, like many of the manufacturing industries, is also talking green. Concerns for global warming & government efforts to make chemicals more environment friendly have prompted many drug manufacturers to adopt models of green chemistry in their manufacturing process. Green chemistry involves the use of chemistry for prevention of air and water pollution. In this method, chemical processes efficiently utilise raw material, eliminate waste & avoid the use of toxic solvents in the manufacture & application of chemical processes & products. This is an ecofriendly approach in the manufacturing process. “A sustainable chemistry can be called green chemistry. It includes improvement of the existing chemical processes for a better conversion efficiency, with the least amount of byproduct & pollutants at optimum utilisation of energy. This can be achieved by using two basic concepts of chemical engineering—material and energy balance. Further, the balances can be analysed with a view to reduce, if not eliminate, wasteful utilisation of material and energy,” says Y H Gharpure, Chairman, Gharpure Group of Companies. In pharma manufacturing process, these concepts push for sustainable environmental practices while remaining profitable.
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Significance of green manufacturing Our ecosystem is changing due to the effects of globalisation & industrialisation, and there is an increased carbon dioxide level being pumped into the atmosphere. “The implementation of green chemistry & green manufacturing technologies will help decrease the causes of climate change as much as it does to other environmental and human health challenges, that we face today. Green chemistry techniques are now being used across the world to develop new materials in every field including
Dr Paul Anastas Assistant Administrator, Office of R&D, US Environmental Protection Agency
The implementation of green chemistry and green manufacturing technologies will help decrease the causes of climate change as much as it does to other environmental and human health challenges, that we face today.
pharma chemicals,” explains Dr Paul Anastas, Assistant Administrator, Office of Research & Development, US Environmental Protection Agency (EPA). Dr Anastas is known as the Father of Green Chemistry. Green manufacturing will help companies reduce consumption of natural resources, lessen the energy used in production, minimise release of gas & toxic material into the environment and decrease waste created from the manufacturing process. Prof R K Sharma, Coordinator, Green Chemistry Network Centre, University of Delhi, insists, “Green chemistry is a scientifically sound and cost-effective concept & preserves a healthy environment. Better understanding and incorporation of green chemistry principles is the best practice that a company should employ to make the enterprise a sustainable one.” It also helps in cutting the overall cost. Concurs Sanjay Singh, Head F&D, Herbal/Nutra, Plethico Pharmaceuticals Ltd, “Recent research reports show that the pharma industry, at large, is taking tremendous steps into ‘going green’. Due to the recent economic downturn, as well as market uncertainty & overall economic uncertainty plaguing, many pharma companies are adopting all measures for cost cutting, which also include looking for low-cost alternatives. Drastic steps are being taken across the board, to cut down spending, one of which is
adoption of green manufacturing, known as green chemistry. Green chemistry is safe, conserves raw materials & energy and is more costeffective than conventional methods.” In order to promote sustainability and reduce pollution, the Indian government has introduced various acts and rules such as ‘The Environmental (Protection) Act, 1986 and Rules’, ‘The Water (Prevention & Control of Pollution) Act, 1974 and Rules’ and ‘The Air (Prevention & Control of Pollution) Act, 1982 and Rules’. However, companies usually follow these rules for compliance & obtaining licences rather than realising the importance and value of green chemistry. Nevertheless, after a long struggle, pharma manufacturers have now started to recognise the
Courtesy: Gulf Tile & Creations
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SECTOR WATCH
Y H Gharpure Chairman, Gharpure Group of Companies
A sustainable chemistry can be called green chemistry. It includes improvement of the existing chemical processes for a better conversion efficiency with the least amount of byproduct and pollutants at optimum utilisation of energy. economic and environmental values of green chemistry. This importance and self-realisation has now come to mean economic value as well.
Best practices to ‘go green’ In order to achieve significant efficiencies, manufacturers need to follow the 12 principles of green chemistry developed by Dr Anastas and John C Warner. These principles include preventing waste, designing safety products, implementing less hazardous chemical process, using renewable feedstocks, employing catalysts instead of stoichiometric reagents, avoiding chemical derivatives, reducing solvent use or using safer solvents & reaction conditions, improving energy efficiency, designing biodegradability, analysing in real-time to prevent pollution, minimising accidents and recovering all elements. It is always better to prevent waste than to treat or clean-up waste after it is formed; hence, companies can adopt some best practices to accomplish this. Singh avers, “In manufacturing, synthetic methods should be designed to maximise the incorporation of all materials used in the process into the final product. Also, wherever practical, synthetic methodologies should be designed to use and generate substances that possess little or no toxicity to human health & environment. Pharmaceutical chemical products should be designed to preserve efficacy of function while reducing toxicity. Further, the use of
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auxiliary substances (eg, solvents, separation agents, etc) should be made necessary wherever possible and, innocuous when used.” To follow the green way, the raw material or feedstock used should be renewable rather than depleting, wherever technically &
Green manufacturing will help companies reduce consumption of natural resources, lessen the energy used in production, minimise release of gas & toxic material into the environment & decrease waste created from the manufacturing process. economically possible. Also, the analytical methodologies need to be further developed to allow real-time, in-process monitoring and control, before the formation of hazardous substances. Substances and the form of a substance used in a chemical process should be selected to minimise potential for chemical accidents, including releases, explosions and fires.
August 2010
Kiran Das, GM - Exports & Herbal, Anglo-French Drugs & Industries Ltd, explains, “Pharma companies can attain sustainability by adopting eco-friendly approaches in the manufacturing process. Lighting, Heating, Ventilation, and Air-Conditioning (HVAC) systems and boiler operations are the larger energy consumers in the pharma industry. Energy conservation can be achieved by using solar panels, access control lights and optimum utilisation of natural resources. Green building concepts are emphasised to tackle the impact on environment. Recycling, reuse & renewable energy (bio-fuel) are implemented so as to reduce environmental pollution. The gogreen campaign has prompted pharma companies to adopt the use of alternative fuels to fire boilers that produce steam for manufacturing process.” Unlike the last decades, pharma companies are now not only concentrating on hazardous waste management & water treatment but also on treatment of bio-medical and municipal wastes in order to become eco-friendly.
Green benefits Reduction in waste and cost, along with energy savings, are the most significant drivers of manufacturers’ efforts in making their processes green. They represent opportunities for cost savings, additional revenues and cost avoidance. Dr Anastas opines, “The reason the leading visionary companies around the world are adopting green chemistry systematically is, because it allows them to meet their environmental & economic goals simultaneously. The conventional approaches for costly clean-up have been tried for over four decades. Green techniques allow for innovation to be the driving force & empower scientists and engineers to create new products and processes, which are preferable in performance and are also environment friendly.”
SECTOR WATCH
Investors and customers also favour this sustainable process. Improvements in product design and processing complement each another to achieve cost savings. In particular, a more efficient process results in greater production capacity, convenient & more predictable manufacturing, less waste generation and cost savings. Gharpure explains, “Green chemistry plays a vital role in pharma industry, which is under price pressure. Patents have expired or are in the pipeline for a large number of blockbuster drugs, with only few new candidates to replace them. Pharma industry is therefore looking for curbing the cost by adopting green chemistry, among other measures, to reduce cost of production. Companies like Pfizer, Johnson & Johnson, AstraZeneca and GlaxoSmithKline have formed a roundtable for achieving atom efficiency. For example, the use of enzymes can eliminate production of isomers of an inactive compound,
Prof R K Sharma Coordinator, Green Chemistry Network Centre, University of Delhi
Green chemistry is a scientifically sound, costeffective concept and preserves a healthy environment. Better understanding and incorporation of green chemistry principles is the best practice that a company should employ to make the enterprise a sustainable one.
thereby increasing atom efficiency.� Previously, people believed that following green practice is more expensive, which, however, is not the case today. Companies like Pfizer have achieved 66 per cent cost saving by eliminating undesirable solvents like dichloromethane. Moreover, they have completely eliminated the use of diisopropyl. Similarly, Astra Zeneca has achieved substantial cost saving by using enzymes, thereby adopting green synthesis for manufacture of
Pregabalin, the drug used for treatment of neuropathic pain. Improvement of energy efficiency should be a strategic goal for any manufacturing professional working in the pharma industry today. Energy efficiency reduces overall manufacturing cost, as well as environmental emissions. Das explains, “Consider Process Analytical Technologies (PAT) because it offers environmental as well as efficiency benefits. PAT is about timely
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SECTOR WATCH
Sanjay Singh Head F&D, Herbal/Nutra, Plethico Pharmaceuticals Ltd
In manufacturing, synthetic methods should be designed to maximise the incorporation of all materials used in the process into the final product. Also, wherever practical, synthetic methodologies should be designed to use and generate substances that possess little or no toxicity to human health & environment. measurement of process, with the goal of understanding and controlling pharma processes. For example, using PAT for drying operations can reduce energy consumption by 80 per cent while eliminating a major share of chemical waste and its attendant solvent and waste.”
On the green path Many tools are becoming available for manufacturers who are serious about sustainability. Also, various applications & software are being offered, which help measure sustainability. Many pharma consulting firms and large pharma companies are doing their best to bring green chemistry to the forefront. Companies in the pharma industry are starting to put green projects on the top of their priority lists. “Over the years, many companies have speculated that going green is more expensive and not practical in times of economic crisis. However, recent studies have shown that not only is going green often the low-cost option, but it may also help companies to survive longer
as the nature of business changes in the 21st century,” adds Singh. In line with the above statement, many leading companies have developed enhanced tools towards green efforts. Gharpure elaborates, “For example, Pfizer has published a solvent selection guide, with the help of which solvents can be evaluated using factors such as worker safety, process safety, environmental and regulatory assessments. Similarly, GlaxoSmithKline (GSK) has developed tools for selection of green solvents. GSK’S Eco Design Toolkit provides bench-level chemists and engineers with green chemistry information and tools for process Research & Development (R&D) and manufacturing. The toolkit has five modules, viz, green chemistry and technology guide; material guide to solvents & bases; health & safety data, lifecycle assessment; green packaging guide as well as legislative guide.” Adding to this Prof Sharma says, “Hyderabadbased SMS Pharmaceuticals Ltd has developed a catalytic green method for the conversion of foul smelling toxic
Kiran Das GM - Exports & Herbal, Anglo-French Drugs & Industries Ltd
Energy conservation can be achieved by using solar panels, access control lights and optimum utilisation of natural resources. Green building concepts are emphasised to tackle the impact on environment. Recycling, re-use and renewable energy (bio-fuel) are implemented so as to reduce environmental pollution.
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gases (methyl mercaptan generated during manufacture of ranitidine (daftmen) base), and similar emissions from other drugs/intermediates useful by-products recyclable in the same process. In the process, methyl mercaptan is first converted to dimethyl sulphide, which is catalytically converted to the odourless Dimethyl Sulphoxide (DMSO; raw material used in the manufacturing of ranitidine HCl) in a quantitative manner. This process not only helps to achieve sustainable goals but also reduces the total cost of production by nearly 40 per cent.” However, industry experts believe that there are no appropriate economic incentives & motivation for companies to go ahead and make long-term investments in their green efforts. While validation and regulatory concerns are becoming crucial obstacles, lack of time & qualified people is also a concern. Nevertheless, industry experts believe that the benefits of the green approach will over-ride these small obstructions and more manufacturing facilities will turn to green practices.
Green future Green chemistry includes the chemistry of today as well as that of future. In line with this thought, many leading companies have developed enhanced tools towards green efforts. Green chemistry aims to conserve both raw materials and energy. In practice, this means that ‘green’ processes are often inexpensive than conventional methods. Some current pharmaceutical manufacturing processes have already turned ‘green’. According to industry experts, in pharma production, green manufacturing methods will continue to grow because it is environment friendly, and also helps attain international standards, the ultimate aim of which is to reduce pollution.
MARKET TRENDS
CRAMS
India’s next business strategy? The largest generics maker in the world, India is now riding on the Contract Research and Manufacturing Services sector, as a business strategy that will set the growth wheels turning. Saloni Vora writes on the factors fuelling the growth, business models & the various roadblocks to overcome and make most of the opportunities.
he Contract Research and Manufacturing Services (CRAMS) market is currently experiencing a strong growth momentum. The market, which faced the brunt of the global economic slowdown in 2008, is now gearing up. Providing an insight, Harish Shah, Managing Director, Signet Chemical Corporation Pvt Ltd, says, “Globally, the pharmaceutical outsourcing market is expected to grow at a Compounded Annual Growth Rate (CAGR) of 10 per cent and reach $ 76 billion by 2010 from the modest value of $ 57.2 billion in 2007. Giving the break-up further, the CRAMS market, with a share of $ 55.48 billion in 2007, was broadly composed of $ 16.58 billion under
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contract research and a major $ 38.89 billion under contract manufacturing. Additionally, India also has an actively growing outsourcing market. At a CAGR of 37.6 per cent, the Indian pharmaceutical outsourcing market is expected to reach $ 3.33 billion by 2010. Further, the CRAMS market is expected to reach $ 3.16 billion in 2010. This is not unusual because, today, India is one of the most preferred destinations for outsourcing manufacturing services for both multinationals and global pharma companies on account of several US Food & Drug Administration (USFDA)-approved plants as well as the cost advantage.” Seconding the thought, Sandip Parekh, Executive Director, Unimark Remedies Ltd,
MARKET TRENDS
avers, “In the past 15-20 years, pharma companies have been increasingly outsourcing their core areas of drug discovery, development and manufacturing. India has become a fast growing CRAMS outsourcing destination. This is due to the differentiating cost value proposition achieved by its lower manufacturing cost and strong technical capabilities achieved by its experiences in producing generics.”
Harish Shah Managing Director, Signet Chemical Corporation Pvt Ltd
The liaisons between the innovators and their CRAMS partners have immense scope for learning. These basic research skills will help Indian CRAMS companies to develop & sustain the drying pipeline of blockbuster drugs.
Growth propellers Although the CRAMS market was said to be affected to some extent due to the recent economic downturn, currently there are many factors that aid healthy growth prospects in this sector. Suggests Joseph Manoj Victor, Industry Analyst – Healthcare, South Asia & Middle East, Frost & Sullivan, “The Indian CRAMS segment has withstood the effects of the economic slowdown. There was a dip in the overall outsourcing pie, but on the whole, India continues to be a significant player in this segment. The Indian pharma contract manufacturing industry continues to witness strong growth, driven by the escalating cost pressure on global pharma giants, drying pipeline with R&D productivity touching the decade’s lowest and patent losses including blockbusters.” He further adds, “In the last five years, Indian participants have been able to build confidence among global pharmaceutical companies with respect to their drug discovery research, clinical research & contract manufacturing capabilities and quality services. This is reflected in the increasing number of risk sharing deals and strategic tie ups in the CRAMS space.” Aditi Kare Panandikar, Executive Director - Business Development & HRD, Indoco Remedies Ltd, takes the thought further, “Since late 1990s, CRAMS has gained more importance, as MNCs have come under pressure to maintain their profitability & over the last few years, the need for outsourcing has increased considerably for big pharma companies. Further, outsourcing is gradually
moving from being just a tactical or opportunistic option to a more strategic one in order to sustain the demand from the markets moving into the generic phase. Globally, drugs worth $ 70 billion would be going off-patent by 2011, and Indian companies providing contract manufacturing services are expected to garner approximately 30-40 per cent profits from this opportunity. Further, the pre-patent regime in India has given an impetus to the existing reverse engineering skills. This was critical to supply drugs at a low cost for domestic consumption, leading to adjacencies such as superior chemistry, regulatory and manufacturing skills. Benefits like availability of skilled labour at a low cost, capital efficiency in setting up of worldclass facilities in line with USFDA norms at a reduced cost are passed on directly to MNCs seeking to market drugs at a lower cost.”
Business models Indian pharma companies are in the process of adopting several business models and incorporating multiple features in the same. In case of Indoco Remedies Ltd, where CRAMS account for about 15-20 per cent of the turnover, Panandikar highlights, “Indoco ventured into the CRAMS space seven years ago as a pure contract manufacturer and has since moved up the value chain. We now provide contract research, contract dossier development and, in many cases, even license out our technology to various geographies. While our Indian business model is of branded or value-
added generics, CRAMS also form a part of our international business.” Explaining the regulated market startegy, Panandikar explains, “For the regulated markets, we offer a complete solution, from development of non-infringing Active Pharmaceutical Ingredients (API), manufacturing of API, formulation development and dossier compilation to final manufacturing of the product in internationally approved finished dosage form facilities.” In other words, Indoco serves the entire back operation from development to manufacturing & supply along with the regulatory support and seeks for a partnership with companies having a strong marketing front offshores. Going ahead, Panandikar feels since semi-regulated or Rest Of The World (ROW) markets present maximum growth potential for the pharma industry, Indoco is present with branded formulations in these markets. Further, we intend to collaborate with established players in these geographies and license out our dossiers to leverage the growth potential.” India is a fast growing CRAMS outsourcing destination due to factors like cost value proposition that are achieved by its experiences in producing generics. Parekh believes that considering these factors, “Unimark’s business model would be to differentiate by continuously enhancing the depth and breadth of its complimentary technological capabilities that serve both its generics and CRAMS aspirations.”
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MARKET TRENDS
Sandip Parekh Executive Director, Unimark Remedies Ltd
India has become a fast growing CRAMS outsourcing destination. This is due to the differentiating cost value proposition achieved by its lower manufacturing cost and strong technical capabilities achieved by its experiences in producing generics.
Nevertheless, Signet Chemical Corporation Pvt Ltd plans to venture into the contract research module in the near future, considering the bright prospects of this business. Adds Shah, “We are not into CRAMS at present, but are seriously evaluating the contract research module. We hope to add ‘application support’ to our pharma excipient business.” He further says, “This is because contract research is a serious & demanding proposition with high stakes and immense scope. We are doing our calculations and may begin the activity in the near future.”
Emerging trends & developments In India, CRAMS can be seen across the value chain in pharma, from basic research to pre-clinical trials, to API & formulation development and manufacturing for generics.
Diversification In Shah’s opinion, currently, much diversification is observed in the CRAMS area, ranging from high-end, complex manufacturing services, drug discovery,
custom chemical synthesis, intensive data management, development of biotechnology-based drugs, clinical and bioequivalence support, bioinformatics, medicinal chemistry, regulatory fillings and so on.
Changing role of India in drug discovery Partnering seems to be the solution in Indian pharma space. As Shah rightly points it, “The liaisons between the innovators and their CRAMS partners have immense scope for learning. These basic research skills will help Indian CRAMS companies to develop & sustain the drying pipeline of blockbuster drugs. For innovators, it would mean an opportunity to maintain their hold on the market. Such associations began with formulations like Cipro-OD from Ranbaxy, and the trend is slowly moving towards drug moieties as well. The agreements between Jubilant–Syngenta (for pyridines), Wockhardt–Aventis (for several molecules) are examples of this trend. Similar trends are also observed
Joseph Manoj Victor Industry Analyst – Healthcare, South Asia & Middle East, Frost & Sullivan
Business strategies that companies can adopt today involve providing integrated services from early-phase discovery research to target validation to kilo lab capabilities to full-fledged contract manufacturing services.
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in the biopharmaceuticals with Serum Institute & Lipoxen PLC joining hands over polysialic acid.”
Alliances & collaborations In Victor’s opinion, companies are also moving away from conventional deals to more risk-sharing deals. Moreover, Indian companies have started strengthening their relationships with sponsor companies by forming long-term partnership deals. On similar lines, Panandikar opines, “From deals on a single product or service, as was done earlier, the trend is to move towards larger collaborations, for a particular dosage form or therapeutic capability, and at an organisational level too. While five years back, the scenario was of M&As, today it is one of alliances and collaboration.”
Constraints Although the Indian CRAMS sector is on a growth trajectory, there are a few bottlenecks that need to be overcome. Opines Panandikar,“India faces challenges like regulatory timelines, increasing costs, a culture of quality, process safety standards, project management capability and non-tariff barriers from developed countries.” Another important constraint to overcome is to strengthen the Intellectual Property Right (IPR) environment and competition posed by the Asian countries. Avers Shah, “It is important to build in capacity and offer intellectual capital, which no other country can offer and for that we would require a competitive edge, a sharp vision and an ability to swiftly turn things or situations to our advantage.” He elaborates with examples of countries that could mean competition to India, “Asian countries like China, Taiwan and Korea pose a threat to the success and profitability of the Indian CRAMS companies by virtue of their ‘low cost’ manufacturing, government subsidies and policies or more proficiency skills. Also, China’s strength in contract manufacturing of APIs is well known and attributed to good process chemistry
MARKET TRENDS
knowledge. The country is picking up fast, and it appears that it will surpass India in the value chain by venturing into highend intermediates and formulations.” However Panandikar offers a solution, “These challenges can be overcome by constant improvements in all the areas of concern. First, the customers need to be assured of protection and confidentiality of their intellectual property through proper practices and controls within the organisation. Second, the costs have to be pruned down constantly by improving efficiency at all levels and the personnel need to be trained to enable them utilise the latest technologies and be updated with the latest changes in the regulatory guidelines.” Panandikar further stresses on the need for government support, “At the government level, a proper cell needs to be created to protect the Indian pharma companies from botheration by developed countries by invoking non-tariff barriers. The awareness of IPR exists, but the establishment of special courts for trials of IPR-related cases and the infrastructure for processing patent application needs to be strengthened.”
Government initiatives Government of India is said to have realised the business potential of CRAMS, especially in the Contract Research Organisation (CRO) sector, and has taken several initiatives to boost the growth of the pharma and CRAMS business in the country. Opines Shah, “Several areas being addressed by the government include service tax exemption for pharma R&D; VC funding to set up large CROs; simplifying the approval procedures; faster customs clearance of materials, equipment, clinical trial samples and frozen biological samples handled by CROs for select audience; and customs duty exemption for Department of Scientific & Industrial Research (DSIR)-approved units.” However, Shah feels there is still more scope for government help, “The government should initiate infrastructure growth in an area before declaring it as a designated zone. For instance, Baddi
Aditi Kare Panandikar Executive Director - Business Development & HRD, Indoco Remedies Ltd
India and China would form major markets for the companies to outsource their R&D & manufacturing activities. Moreover, India’s expertise in the R&D segment of pharma industry and the low cost of manufacturing capabilities will make it the most attractive market. was designated as a ‘pharma zone’ but on account of lagging infrastructure, the companies that moved in early faced tremendous difficulties. Shah continues, “The government should extend a fiveyear tax holiday as incentives for business investment in these zones. However, considering the high investments and efforts involved in setting up a pharma unit, longer tax holidays have become the need of the hour. “ Moving forward, another major area of concern with respect to the growth in this market involves prolonged and timeconsuming procedures that are required for product approvals from the various Drug Controller Generals of India (DCGI) and local FDAs. Avers Panandikar, “Along with this, India also faces challenges of handling controlled substance drugs and needs government support for their exports and imports as well as on the heavy duty charged on these. In addition, increased income tax benefit for R&D and simplification for customs procedures for exports & imports is of prime importance.”
Success mantra In today’s competitive scenario, it is important for companies to have a strategic blueprint in place to effectively achieve their goals and objectives. Opines Victor, “Business strategies that companies can adopt today involve providing integrated services from early-phase discovery research to target validation to kilo lab capabilities to full-fledged contract manufacturing services. Further, companies are
basically aligned to therapeutic alliance. They do not enter this business purely as chemistry service providers but also focus on creating targets for therapeutic platforms in oncology, metabolic disease, Central Nervous System (CNS) and infectious diseases. This drives the growth because most pharma companies today are realigning their own therapeutic research.”
Going forward Indian CRAMS segment has a long way to go in the near future. Suggests Panandikar, “India and China would form major markets for the companies to outsource their R&D & manufacturing activities. Moreover, India’s expertise in the R&D segment of pharma industry and the low cost of manufacturing capabilities will make it the most attractive market for big pharma companies to invest in, & hence promising a tremendous growth in the next few years.” Victor quips, “Indian companies have started strengthening their relationships with sponsor companies by forming long-term partnership deals, eg, Pfizer–Aurobindo Pharma, GlaxoSmith Kline–Dr Reddy’s Laboratory, with many more expected. Also, Indian companies are collaborating with their MNC clients to provide more than just low cost service. This can also be termed as a combined scientific entrepreneurship.” Hence, CRAMS is likely to shape up well in the future, as there is tremendous potential and space for growth, considering India’s efficiency, infrastructure and precise planning.
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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,
INDUSTRY UPDATE
R&D mantras
In the making of a molecule
Indian pharma companies have created strong bases of R&D facilities & have attracted the interest of several MNCs and academic institutes. The interest of MNCs is an impetus to innovate. However, the market still remains dominated by generics because of its affordability and the fact that many blockbusters are likely to go offpatent in the near future. Nevertheless, the hope that innovation would emerge & research would pick up pace does seem like a reality that can be achieved in a few years. Modern Pharmaceuticals gives you a sneak-peak into the developments so far and likely ones in the future.
Inside Market Scope................................................54 Interface..........................................................58 Dr Shoibal Mukherjee, Senior VP and Head, Clinical Development, GVK Bio R&D Compass ...............................................62 August 2010
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MARKET SCOPE
The R&D business
Money matters India has most of the advantages to conduct drug discovery studies. However, money is ‘the concern’, as investors are weary of taking the risk, coupled with a lax regulatory scenario, which has led to a sluggish growth. Arshia Khan tracks pipeline potential & business mantras of pharma companies to tackle this inadequacy. ample this: There has been a noted increase in the R&D spending capacity of pharma companies. The R&D expenditure of the top 25 drug companies has increased from ` 27.47 billion in 2007-08 to ` 32.1 billion during 2008-09, an increase of almost 17 per cent. Yet, the pharma industry in India reports a lower R&D spending, ie, about 1.9 per cent of the industry’s turnover. This spending is low compared to the investment on R&D by foreign research-based pharma companies, which is about 10-16 per cent of their turnover. Total R&D spending by drug makers reached $ 683 million in 2008-09 (or 7.75 per cent) of their sales. Among those that boosted R&D spending by more than 40 per cent in this period were Jubilant Organosys, Matrix, Sun Pharma Advanced Research Company Ltd (SPARC), Ind-Swift, Stride Arcolab and Piramal Healthcare. Besides these pharma/biotech companies, Dr Reddy’s, Daiichi Ranbaxy Life Sciences Research, Glenmark Pharmaceuticals Ltd, Biocon, AstraZeneca Research India, Lupin, Torrent, etc, are also carrying out research studies.
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Status quo Despite companies pumping in money for R&D projects, new drug discovery & development has still not reached its full potential in India. As Hitesh Gajaria, Executive Director, KPMG, avers,“Indian companies still lack the financial strength to compete with MNCs.” To tackle the financial crunch, the government is also
Glenn Saldanha CEO & Managing Director, Glenmark Pharmaceuticals
We believe that in the new world order, boundaries will blur and it is going to be one global market, one set of regulatory guidelines, with one talent pool.
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infusing money to fasten drug discovery. As of now, India is reported to be spending about ` 20 billion every year on R&D. While the government contributes ` 5 billion, the remaining comes from the private sector. Hence, funding is the core issue that needs to be tackled. Gajaria further informs, “As of July 2010, the government had planned to set up ` 100 billion Venture Capital (VC) fund for financing new drug discovery projects in India.” More so, India’s share of public healthcare R&D to total public R&D spending is mere two per cent, as compared to 23 per cent in the US. Hence, there is a need for policies that encourage more investment in healthcare, believes Gajaria. Striking a similar chord, V K Singh, CEO, Ethypharm Pvt Ltd, says, “R&D is a capital-intensive activity. Even though we are not in New Chemical Entities (NCE) research where sometimes more than science, serendipity plays a critical role & financing serendipity calls for a real appetite in R&D. Further, it demands immense patience & financial muscle.” He explains, the complexion of Ethypharm’s R&D is more of nature of incremental innovation. But, this type of R&D is iterative by nature. Creating value differentiators is expensive in this model as well. Ethypharm is globally positioned as a preferred partner for Life Cycle Management. The company ploughs back up to 25 per cent of sales revenues in R&D.
In the making of a blockbuster Indian companies such as Dr Reddy’s Laboratories (DRL) and Ranbaxy have a number of molecules in different phases of product development. A blockbuster drug is no small feat & the sheer financial commitment that could go into the research of one NCE with therapeutic efficacy & demand could stretch to more than $ 1 billion. As Glenn Saldanha, CEO & Managing Director, Glenmark Pharmaceuticals, informs, “We have eight molecules undergoing clinical trials. Each of our molecules is either best-in-class or first-inclass & is being developed for worldwide usage. If commercialised, each of them has peak sales potential of at least $ 1 billion.” Saldanha underlines the strategy
MARKET SCOPE
behind the R&D plan, “All our molecules are targeting unmet medical needs. And we have been able to conclude five out-licensing deals in discovery R&D collecting over $ 140 million (` 600 crore) in upfront & milestone payments so far.” Glenmarks’ total expenditure in R&D (discovery & generics) has been in the range of 3-5 per cent of is net sales, according to Saldanha. “Pharma companies have always used the model of pursuing drug discovery & development by themselves, thus taking all the risks to reap the rewards solely. However, this model is proving to be increasingly unsustainable over time,” underlines Gajaria. He believes that one of the most effective business models used by companies like Pfizer, Eli Lilly, Roche, AstraZeneca & Merck is ‘insourcing’ to India for their research efforts. Also, these companies have set up their R&D centres in developing countries like India & China that offer many cost advantages along with technical skill & legal bandwidth. These centres focus little on de novo discovery, instead they target efforts on converting molecules to medicine or ‘translation research’. Mumbai-based Centaur Pharmaceuticals (with revenues of $ 40 million till March, 2010) is working on similar lines. The company has in-licensed the development & distribution rights for Sorivudine, a topical anti-viral drug from aRigen, a Japanese company, to market it in India & neighbouring countries, like Nepal, Sri Lanka and South Africa. Sorivudine is a drug for local application, for Herpes Zoster. Explaining the rationale S D Sawant, Managing Director, Centaur Pharmaceuticals, says, “The Phase I trials for the molecule have been completed in US, with Phase II & III in the pipeline. Therefore, we requested to in-license the molecule from aRigen for the Indian market. Centaur has already invested ` 1 crore through internal accruals, and will be investing ` 80-200 crore for phase II & III trials. Explaining the idea, Sawant says, “The idea is to take the promising molecules & work on them. This way we share the profits, though the risks rest with us.” He quips, “For them (the partnering companies), Indian market is like peanuts, with low margins; therefore, we follow this strategy.”
K V Subramaniam President & CEO, Reliance Life Sciences
The need of the hour is investment in R&D facilities & improving levels of basic research in universities by encouraging them to pursue top notch research. Public-private partnerships and industry-academia partnerships can help achieve this.
However, aRigen, the Japanese company with a drylab business model, has also partnered with companies in the US, EU and Korea. Dr Gensuke Tokoro, President & CEO, aRigen Pharmaceuticals Inc, explains the scenario in Japan, “Discovery research in Japan is only up to Phase I trials; therefore, we are always looking at partners after Phase I. Likewise, most pharma companies in Japan, EU and the US are looking for drug candidates that have concluded Phase I stage. So this is the missing link.” aRigen raised $ 60 million from PE, VCs and High Networth Individuals (HNIs) to develop six molecules & has received milestone payments upto $ 25 million through its various out-licensed molecules, to companies from Switzerland, US, Japan & India. Lundbeck followed a similar approach, which outsources entire projects to Contract Research Organisations (CROs) based out of Shanghai. However, the main challenge that these companies face, according to Gajaria, is integrating the in-house discovery work from its R&D laboratories with the collaborated work in developing countries. Although another trend is to work with external entities including academia, CROs & other pharma service providers. The
common driving factor that supports this model is playing by the strength of each involved entity, while, at the same time, optimising cost and time. Therefore, according to Gajaria, the model that could work best in India includes expanding expertise to cover all areas of drug production. India enjoys various advantages, cost effectiveness being the key factor & the ease of establishing research centres. These factors should be leveraged in order to put a system in place that is capable of performing activities of the entire value chain that aid drug production. Of course, the quality of research taking place cannot be overlooked and it is important that expensive research should yield efficacious products for the companies to continue their interest in NCEs & not simply depend on generics, a model that has always been adopted in India. As Nilesh Gupta, Group President & Executive Director, Lupin Ltd, says, “At the heart of Lupin’s success is its R&D initiative. Lupin has developed sound capabilities in developing complex APIs to formulating value-added, difficult-to-make products to a highly evolved drug delivery & drug discovery programme.”
Nilesh Gupta Group President & Executive Director, Lupin Ltd
The government is promoting pharma R&D by providing more Standing Operating Procedures (SOPs) and incentives & supporting investment for R&D through increased weighted deduction and the like. This makes India an attractive destination to a company looking to invest in innovation.
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MARKET SCOPE
Dr Gensuke Tokoro President & CEO, aRigen Pharmaceuticals Inc
GSK & Pfizer alone do not have the capability to bring out a blockbuster molecule, as each stage requires critical assessment. Therefore, new drugs will only come out through alliances and never from ‘a company’ alone.
He further informs that Lupin invested 7-9 per cent of its overall net sales into its R&D programmes over the past seven years. Lupin’s strong growth, specifically in the advanced markets is a direct outcome of these investments. The expenditure on R&D during the last fiscal stood at ` 4,119 million, which was 8.7 per cent of the net sales, according to Gupta. Explaining Glenmark’s approach, Saldanha notes, “We believe that in the new world order, boundaries will blur and it is going to be one global market, one set of regulatory guidelines, with one talent pool.” Therefore, the quality of products required across markets will need to be uniform because consumers & governments even in the least developed economies will demand the best for their own people. Saldanha further continues, “We have built Glenmark keeping this changing landscape in mind. And it is for this reason that we have always focussed on building significant presence in emerging markets, including India, and a fast-growing US generics business. Not only are we operating at both ends of the spectrum, ie, branded generics & pure generics, but are also running a successful drug discovery programme.”
Explaining the business model at the company, Saldanha says, we plan to go to various places to attract the best talent in a particular area. For this, Glenmark has set up its discovery R&D centre for NCEs in India, the biopharmaceutical research centre for NBEs (Novel Biological Entities) in Switzerland and its clinical research facility in the UK. Glenmark has over 450 scientists working at its four R&D centres spread in these three countries.
India shining? Though the competencies today are pretty much global, international companies are sourcing or even conducting R&D in India more for skill set & speed than for the lower cost. As Singh believes, “They gain much more in time value of molecule to market, than in terms of the cost of development. By compressing the development time by even 10 per cent they increase the effective marketable life of the product or the patent, & therefore the returns manifold.” Earlier, Indian companies, except the Indian MNCs like Ranbaxy & DRL, had good skills in chemistry and formulation. But for the softer skills like regulatory expertise &
V K Singh CEO, Ethypharm Pvt Ltd
There are limits to Cartesian reductionism but never to innovation. There may be a perceived stagnation in New Drug Discovery Research (NDDR) but there is still immense scope for innovation in NDDS.
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intellectual property they had to depend on overseas partners or local experts. In the last decade, there has been immense on-the-job learning & soft skills. On the contrary, K V Subramaniam, President & CEO, Reliance Life Sciences says, barring a few examples of innovative R&D efforts towards new product development, this is still at a nascent stage in India. He remarks, “The need of the hour is investment in R&D facilities & improving levels of basic research in universities by encouraging them to pursue top notch research. Publicprivate partnerships & industry-academia partnerships can help achieve this.” Gupta adds to this, “The Indian government is promoting pharma R&D by providing more Standing Operating Procedures (SOPs) and incentives & supporting investment for R&D through increased weighted deduction and the like. This makes India an attractive destination to a company looking to invest in innovation.”
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Thorns in the way While protection of IP in India does not seem to have any direct relation with the placement of research projects in the country, the poor sentiment resulting from a failure to fully recognise & protect intellectual property is sufficient to negatively influence MNCs to conduct research in India. There is divided opinion on this as well. And Singh believes this to be true. He justifies the reason, “There is a negative perception about India in this regard, which may have in some measure hampered Foreign Direct Investment (FDI) in R&D in the country. Novartis overlooking India and going to China for R&D can be an example of this.” He also stresses on the need for a publicprivate-partnership (PPP) initiative. Counting on the hurdles in the way, Gajaria enumerates such as limited funding from FIs, VCs & the government are likely to decelerate the expansion of R&D efforts in India. Collaborations between the big drug companies in the Indian market to control the cost benefit & large reserve sources will further intensify competition. Although Indian companies complain of the lax regulatory scenario, Dr Tokoro, remarks, “It cannot be worse than Japan.
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We are good in discovery projects other than making formulations. He stresses on alliances to be the next in thing, and cites an example. “GSK & Pfizer alone do not have the capability to bring out a blockbuster molecule, as each stage requires critical assessment. Therefore, new drugs will only come out through alliances and never from ‘a company’ alone.” He explains drug discovery success in Japan. All Japanese companies put together have 14 blockbuster molecules, 10 of which can be attributed/identified with some scientist/individual. The distressing part is that only three of them have been promoted within the organisation, while others had unsuccessful careers.” Pointing towards the lack of sense to focus on important areas, Dr Tokoro reminds that, globally, companies are working on cancer drugs, diabetes and other lifestyle-related drugs. He stresses on the need for Indian companies to focus on these areas. Also many of India’s regulations relating to pre-clinical & clinical trials are conservative, for instance, the prevention of first-in-man testing for drugs developed outside India. India needs to make some harmonising effort in this respect to reduce ambiguity & simplify the process of compliance. Likewise, there is a need to sort out the large number of patent applications that are pending and also make arrangements for data protection. Indian patent law should also define ‘incremental innovation’, which is still an ambiguous subject & leads to misunderstandings between global pharma firms & authorities, says Gajaria.
Success strategies R&D collaborations are an upcoming trend in the pharma industry. A recent example is the collaboration between the Indian Council of
S D Sawant Managing Director, Centaur Pharmaceuticals
The idea is to take the promising molecules and work on them. This way we share the profits, though the risks rest with us. For them (the partnering companies), Indian market is like peanuts, with low margins; therefore, we follow this strategy. Medical Research (ICMR) and Federal Ministry of Education and Research (BMBF), Germany, to initiate joint R&D projects in areas of oncology, regenerative medicine, neurosciences and infectious diseases. Going ahead, companies will focus on Advance drug delivery and Novel Drug Delivery System (NDDS). Singh highlights the future trends, “In the post-genomic era, target-specific therapy & personalised medicine will open a whole new realm for application and innovation. A lot of the traditional medicines of Indian and Chinese systems will also be finding their way back to consumers through the multinationals.” On companies rolling out blockbuster molecules, Singh avers, “There are limits to Cartesian reductionism but never to innovation. There may be a perceived stagnation in New Drug Discovery Research (NDDR) but there is still immense scope for innovation in NDDS. I see good potential for some of our platform technologies like Flashtab, Locktab, Organogel and Lipid Nanocapsules (LNC). Highlights Gupta, “Having identified Advanced Drug Delivery Systems (ADDS) as a future growth driver, Lupin has made significant investments in the drug delivery systems space over the last four years. “
Hitesh Gajaria Executive Director, KPMG
Pharma companies have always used the model of pursuing drug discovery & development by themselves, thus taking all the risks to reap the rewards solely. However, this model is proving to be increasingly unsustainable over time.
Now nevertheless using PE or VC funds to invest in R&D is not a new concept and has been in practice since long. The difference will come in for deal structuring, which depends on company profile, as the target companies are not in distress. As Abhinav Mehra, Senior Consultant, Healthcare Consulting, Datamonitor India, says, “The most popular way of obtaining funding is to spin off some of the research into a new outfit. While the company owns a minority stake, the majority is owned by investors.” He further highlights, the competition for fund-raising is also becoming tough. Overall, there are 78 India-focussed funds on the road looking to raise $ 24 billion, according to data compiled by Prequin, a UK-based fund tracker. There are about 117 pan-Asia private equity funds - which have India as one of their geographies - currently targeting to raise aggregate capital of $ 59.2 billion. With the high cost of drug development, there is always a pressure to reduce the R&D time and cost without compromising on clinical success rate. Therefore most leading drug makers have recently undertaken or are in the process of implementing broad cost reduction programmes, notes Mehra. Also, companies are likely to undergo broad cost initiatives to maintain sustainability, along with adoption of right technology & science. Drug development alliances will gain momentum to leverage resources & cut R&D costs, and deal values are expected to increase over the next few years. Mehra hints, “India can aspire to become an innovation hub by 2020. However, this will require globally competitive research infrastructure, world-class talent, funding, PPP.” Significant research can also come from industry academic partnerships.
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INTERFACE
‘I would rank India ahead of most other developing countries and in league with many developed ones’ From laying the foundation of Indian Society for Clinical Research (ISCR), to Pfizer, Ranbaxy and now GVK Bio, Dr Shoibal Mukherjee has seen the changing strides of the Indian Pharma Industry (IPI). He believes that the change of pace of the IPI has been admirable, and is optimistic that India will be soon be at the nucleus of the pharma world. He reiterates his experiences, in conversation with Arshia Khan. To begin with, what are the reasons for your interest in the life sciences space? Thirty years ago, not many career opportunities were available in India, as there are today. People with an inclination for professional careers in science had few good options other than engineering, medicine or pharmacy. I found myself studying medicine but with little interest in actually practising it. Research domains interested me more, and the discovery & development of new medicines presented an opportunity for a meaningful career that could potentially have an impact on millions of lives – more than what the average physician or surgeon can hope to treat in a lifetime.
What are the key similarities in the roles that you have been associated with/as, till now? As a physician in the pharma industry my career has revolved around the development & commercialisation of medicines. What has come as a revelation is the extent to which commercial factors and economics govern the science of drug discovery & development, and how regulatory action (or inaction) can profoundly influence the development of new therapies.
From being an examiner to heading clinical development functions & a committee member of OPPI, what binds you into all these segments? Ultimately, it is all about preventing disease, restoring health, saving lives, bringing relief to those in pain or distress and hoping for a long & healthy life for everyone. But often, the journey turns out to be more exciting than the elusive destination. Besides learning on the way, the joy of working together, the exhilaration of achievement from team effort & the satisfaction of contributing to a worthy cause, make it all worthwhile.
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INTERFACE
Leading a team on a challenging mission is perhaps the most exciting work for me, but, generally, I am energised by any endeavour that demands out-of-box thinking and marshalling of knowledge from multiple domains in research & business.
Any incidence that makes you closer to a company/organisation you have worked with. Many years ago, at the Scindia School, my history teacher Hughes, a British Indian, used to take us on trekking trips. On such trips, he would urge us on to dangerous trails, knowing well that he would be blamed for any accidental injury to the students. Some of the trails were risky, which with even a single wrong step could send you down several metres to the bottom of the moat. But Hughes would still urge us to take the risk & would do it himself as well, instilling in his students a spirit of adventure that we would never have acquired without him. People like these, who are ready to take the blame if things go wrong, allow companies and organisations to achieve extraordinary feats.
With an extensive experience in managing global clinical trials, how would you rank India in the way clinical trials are conducted here, vis a vis globally? India is performing reasonably well, considering the state of infrastructure in the country (compared to other countries we compete with). This includes the state of our public hospitals and public health infrastructure; inadequacy of educational institutions (in teaching & research in the science of drug discovery & development); lack of modern rational regulation and archaic state of laws, rules & guidelines (including those drafted recently). India has great potential and will advance with the strength of the sheer energy of its workforce, and the inclination of our entrepreneurs towards making the best of opportunity even in the face of formidable adversity. I would rank India ahead of most other developing countries
Off - track
Enjoys doing… I do not have much leisure time, unfortunately, to pursue my interests. I have a passion for driving. I also like reading books, though lack of time made me discontinue it. However, I keep myself updated on news and current events. I occasionally enjoy bird watching trips as well.
Childhood reminisces… I have spent my childhood in army cantonments and boarding school. We have always been on move throughout the country. I can personally relate to all parts of the country, with friends from diverse regions and a national outlook that comes from an army upbringing. My mother narrates many childhood stories from a world different than the one that we live in today - a world that holds the roots to what we are and what we are capable of doing.
If not the life sciences industry… Science has always been a passion, and I probably would have ended up in the research domain in whatever field I pursued. I have recently developed an interest in economics and wish I had an opportunity in this field.
Dreams of… Every scientist dreams of participating in the discovery or development of a breakthrough product. I wish to be instrumental in creating something of lasting value that would exist for ever. and in league with many developed ones in terms of quality, diligence and process orientation. However, the country has failed to create an environment of innovation, and we are far behind when it comes to creating wealth from putting new ideas to work on a global scale. Generally, any work that involves government’s support needs improvement. Besides, even our private institutions need to focus on building world-class quality before thinking of scale up. The world can perhaps learn the volume game from India, while we must learn from world leaders to strive for excellence & achieve it.
Since you have also been associated with the development of clinical research as a specialty, what trends have you observed in this segment? During my term with the pharma industry in India, I have seen clinical research grow from an unknown concept, even within the industry, to a recognised and respected specialty. However, it has become difficult for the
country to maintain the momentum, & we seem to have lost some vigour in the last two years, due to a number of reasons. According to me, the current years seem as a period of consolidation before a second and qualitative phase of growth ensues.
Your views on the regulatory environment in the Indian pharma industry. The laws and regulations in India are poorly written. The Drugs and Cosmetics Act of 1940 & the Rules of 1945 have been amended in parts over the years to resemble a patchwork, much like the way our potholed roads are repaired. Thus creating an urgent need for a thorough re-writing of the law & the rules thereof. But, of course, this is nearly impossible, because by the time we come to an agreement on the need to carry out these steps, the world would have changed significantly & a new consensus would have to be worked on. Therefore, it is difficult to imagine that we would ever be able to complete the task.
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INTERFACE
The need of the hour is building of regulatory infrastructure, including staffing strength & expertise to ensure that regulatory decision-making can be based solely on independent expert evaluation of science & ethics. The regulatory agency needs to educate even as it regulates. To do this, the agency needs to explain its decisions and provide clear & cogent reasons for its actions, similar to that done by the US Food and Drug Administration (US FDA). The statutes themselves must prescribe robust and detailed internal procedures and guidelines for the agency, as much as external rules for the industry.
How do you envision the Indian pharma landscape by 2020? Being an optimist, I find it difficult to believe that the industry is not capable of overcoming the current hurdles and obstacles to boost growth of life sciences R&D in the country. With some help from the establishment by way of decisive and progressive regulations, it can meet the challenge of emerging as a world leader in quality and value. Even without that help, the industry will find ways to surpass itself. By 2020, India will be a leader in the pharma world in many ways. Further, India’s emergence, as much as that of other regions in Asia & the developing world, will usher in a new era in the history of modern bioscience and its impact on people’s lives.
How has been your experience while working for different companies, like Pfizer & Ranbaxy? I have had the opportunity to work for the world’s and India’s largest pharma companies, & will cherish the experiences gained. Perhaps even more stimulating is the fact that I can now take the learnings from these great organisations to other companies, for employers as well as clients. People learn more from their own experiences than from those of others, so I am not sure how much use my experiences will be to others. But, I hope that I can put these experiences to good use every day at the workplace. Foremost among them is to respect the ideas, opinion and expertise of one’s colleagues.
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The industry involves teamwork as it is impossible to achieve anything on one’s own. However, the most challenging obstacles can be overcome by the oft-repeated but infrequently understood word – teamwork.
What led to the foundation of the Indian Society for Clinical Research (ISCR)? At the turn of the century, following the footsteps of Pfizer and Lilly, several pharma companies and Contract Research Organisations (CROs) had set up clinical research units in the country, although there was still great resistance within MNCs to establish studies in the developing world. Knowing the advantages that India offered, including a large patient pool and a competent medical profession, the local affiliates strived hard to bring more trials to India. However, regulatory and infrastructural bottlenecks were beginning to stifle the growth, necessitating the need for a professional body to represent the clinical research community & take collective initiatives. Pfizer’s clinical research unit in Mumbai was, at that time, the country’s largest unit. The question of taking the initiative resulted in the Society being registered in 2004. In its formative years, the Society was a mere 6 member organisation & less than 30 individual members.We looked up to the role NASSCOM played for the Information Technology (IT) industry and conceived Indian Society for Clinical Research (ISCR) to play a similar role in the years to come. The society played an important role, urging the framing of regulations, disseminating clinical research education and stimulating discussions & debate within the clinical research community on issues of quality & ethics. It is extremely satisfying to see the broad base of membership the Society enjoys today, and the learning & discourse it enables.
What are the key changes you have brought in the way the team at GVK Bio functions? GVK BIO had a strong presence and established operations in clinical
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pharmacology & clinical research long before I joined. But, it is still a relatively young organisation, having started operations in 2001, with clinical pharmacology and clinical research being set up in 2003 & 2006, respectively. Thus, the organisation is still in the phase of early evolution. Building a stable & sustainable business in the research services domain is a challenging proposition that may take years in this environment of global financial turmoil. My approach has been to build a stable client base while strengthening internal systems and processes, particularly the system of continuous training and development of staff. Acquiring the right people for the right jobs and making everyone to work together is, in itself, a rewarding experience. However, at GVK Bio, the clinical research unit is beginning to build a reputation for expertise in vaccine trials, tropical diseases and oncology while the clinical pharmacology unit is now involved in bioanalytical work for global big pharma sponsors. We are also gaining a reputation of being able to think out-of-box and undertake studies that are unusual and outside the ordinary.
What is next for Dr Mukherjee? GVK BIO presents a challenge at present, making it difficult for me to back away. The company is already among Asia’s largest CROs, but there is significant opportunity for clinical development up front. In the decade ahead, Asia will represent the centre of gravity for the pharma industry, and India must find a prominent place at its centre. Thus, there are still many more milestones to achieve.
Any advice to the industry? Although we may not realise, but we are in the midst of a revolutionary change in the pharma world, particularly in R&D. At the moment, things may seem slow, but looking back, the pace of change will be something to admire. Bigger opportunities are awaited in future, and now is the time for Indian industry to prepare for leveraging from these opportunities.
R&D COMPASS
R&D in Indian pharma
Scope for improvement India lags behind China in terms of scientific researchers as well as R&D spending. Besides, as pure chemistry is disappearing from EU and US, global pharma majors are looking at emerging countries. Hence, to tap these opportunities, India needs to build on several areas, as this article rightly explains. several increasing their investments by over 40 per cent, according to a survey by a pharma portal. Total R&D spending by the drugmakers reached $ 683 million in 2008-09 (or 7.75 per cent) of their sales. Among those that boosted R&D spending by more than 40 per cent during the year were Jubilant Organosys, Matrix, Sun Pharma Advance, Ind-Swift, Stride Arcolab and Piramal Healthcare. The Indian drug discovery market has grown from $ 470 million in 2005 to $ 800 million in 2007, with clinical trials underway across 34 molecules. The market is growing at about 30 per cent annually, spurred by the high cost advantage of up to 50 per cent for clinical trials as compared to those in western countries.
R&D capabilities Abhinav Mehra esearch and Development (R&D) intensity, which is R&D expenditure (across all industries) as a percentage of Gross Domestic Product (GDP) in India is only 0.89 per cent compared with 1.4 per cent for China, 3.2 per cent for Japan, 2.7 per cent for the US and about three per cent for other developed countries. Of the 0.89 per cent expenditure in India, 80 per cent is made by the public sector, while the private sector share is only 20 per cent. In China and the US, the public sector share is 30 per cent each, while it is only 18 per cent in Japan. Many sources have quoted that the R&D spend by the Indian pharma industry is about 1.9 per cent of the industry’s turnover, which is low compared to the investment on R&D by foreign research-based pharma companies that spend 10-16 per cent of their turnover. R&D spending by India’s 25 biggest drug makers grew nearly 17 per cent in 2008-09, with
r
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India’s R&D capabilities have been attracting the attention of several global pharma & biotech companies because of its strengths in technical human resource, chemistry expertise and bioinformatics ability. The infrastructure of research laboratories and increasing inter-university research efforts as well as institute & industry collaborations are an added advantage. Among the leading pharma/biotech companies carrying out research are Dr Reddy’s, Piramal Healthcare, Daichi-Ranbaxy Life Sciences Research, Sun Pharma Advanced Research Company Ltd (SPARC), Glenmark Pharmaceuticals Ltd, Biocon, AstraZeneca Research India, Lupin and Torrent, to name a few. India’s leading research laboratories are Centre for Cellular and Molecular Biology (CCMB) Hyderabad, Indian Institute of Science (IISc), National Centre for Biological Sciences and Jawaharlal Nehru Centre for Advanced Research in Bangalore. The country’s process re-engineering expertise, strengths in medicinal chemistry and ability to deliver biology-related research have made India an integral part of global drug discovery programmes.
R&D COMPASS
With pure chemistry literally disappearing from the US and Europe, global pharmabiotech majors are focussing on India to accelerate the development of their drug pipelines. The crunch in R&D investments has resulted in off-shoring drug discovery projects to India because it is almost 30 per cent lower compared to the costs in the West. Major therapeutic areas of drug discovery & research in India include metabolic disorders—primarily diabetes, obesity and dyslipidaemia; inflammatory diseases that include Chronic Obstructive Pulmonary Disease (COPD); Rheumatoid Arthritis (RA); psoriasis; osteoarthritis; ulcerative colitis; atherosclerosis; and infectious diseases.
Chemical entities Ranbaxy has developed a new antimalaria drug, Arterolane + PQP, which is currently in phase III trials. Ranbaxy’s in-house Novel Drug Delivery System (NDDS) programmes are primarily focussed on the oral segment. Inhalation (patented devices) & trans-dermal (patented adhesive polymers) programmes are also being pursued through collaborations. Piramal Life Sciences Ltd’s (PLSL’s) lead chemical compound, a Cdk-4 inhibitor, has completed two phase I studies and is being tested in other phase I/II trials for multiple myeloma. Lupin has a pipeline of six Investigational New Drugs (IND) addressing five different disease areas—migraine, psoriasis, tuberculosis, type 2 diabetes and rheumatoid arthritis. These drug candidates are in various phases of clinical development. Zydus has 16 New Chemical Entities (NCEs) in development, of which four are being developed via collaborative programmes. Of the 16 entities, 14 are beyond the lead optimisation stage. Glenmark has overall eight NCEs in its research pipeline. Suven Life Sciences has eight drug candidates in the pipeline, though only one is in clinical development (phase I). WCK 771—one of Wockhardt’s most advanced NCEs—has commenced phase II human clinical trials. WCK 771 is a broad-spectrum antibiotic, which
7000
Total R&D expenditure in ` million
Ranbaxy®
6000
DRL
5000
Aurbindo
4000
Sun Pharma
3000
Zydus
2000
Piramal
1000
Torrent
0
Lupin
2004
2006
2008
2010 Source: Company annual reports
has proven effective in treating diverse staphylococcal infections like Methicillinresistant Staphylococcus aureus (MRSA) and Vancomycin Intermediate Staphylococcus aureus (VISA). WCK 1152, a promising lead molecule to treat respiratory tract infections, including hospital-acquired infections, is undergoing phase I clinical trials. Bexel Pharmaceuticals, Orchid’s US-based subsidiary, has progressed well on the development of a novel antidiabetes lead (BLX-1002), with a unique anti-weight gain property. Orchid and its discovery subsidiary in the US are engaged in a synergistic research endeavour that combines the chemistry, molecular modelling and pre-clinical capabilities of Orchid & Bexel’s innovative structure design & biological experimentation to yield a richer pipeline of potential new drugs.
Biologics In the Biologics space, Indian companies, such as Biocon, Intas, Ranbaxy, Dr Reddy’s and Wockhardt, have been producing 8
generic biologics for Asian markets. Manufacturing biologics is considered more difficult than making small molecule-based drugs, as biologics are large recombinant proteins produced by bacterial or cell cultures. Purity of the final product is another issue for generic biologics, as residual material from bacterial fermentation could affect a product’s immunogenicity. In developed markets, the Indian companies need to comply with stricter safety standards, as the regulatory bodies might require companies to perform additional clinical trials and demonstrate stringent manufacturing controls in order to obtain regulatory approval for follow-on biologics to be eligible for sale in the country. The Indian biosimilars market in 2008 was estimated to be worth about $ 200 million and forecasted to reach $ 580 million by 2012. There are more than 130 companies in the biopharmaceutical market in India; however, only 7-10 of these are involved in the manufacture of recombinant products. India has
Number of drugs in clinical trials
6 4 2 0 Ranbaxy
Dr Reddy’s
Piramal
Lupin
Zydus
Wockhardt
Torrent pharma
Glenmark
Suven Life sciences
Source: Company websites
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R&D COMPASS
Investment in million dollar VC investment
150
100
50
0 2004
2005
2006
2007
2008
2009 Source: MedTRACK, Datamonitor
commendable domestic expertise in gene manipulation and fermentation, but bioprocess development and cell-line development are still in nascent stages. Locally manufactured biologics include insulin, epoetin, filgrastim, streptokinase and rituximab. Over 40 biologics are marketed in India, of which approximately 25 are biosimilars that are manufactured locally. Another 25 biosimilar products are in the final stages of development. India is a semi-regulated market with respect to biosimilars. Phase I-II trials are typically not required for biosimilar approval in India, unless it is found necessary in special cases. Phase III trials with a minimum of 100 patients are mandatory for establishing bioequivalence. The
total cost to develop a biosimilar in India can thus be in the range of $ 10-20 million, which allows Indian companies to offer their products at a price that is 25-40 per cent lower than the original biologics. However, the Indian Government is planning to make process patents for biosimilar products mandatory, which, if happens, will impact the profitability for Indian biosimilar companies. The R&D costs associated with biologics are high because biologics are structurally complex & difficult to manufacture. Some major Indian pharma companies like Dr Reddy’s, Lupin and Wockhardt are also involved in biologics research. Dr Reddy’s markets two biologics that
are generic versions of Roche’s Rituxan and Amgen’s Neupogen. Currently, research on monoclonal antibodies is leading the way in biopharmaceutical research, with Biocon and Glenmark having promising candidates for certain therapeutic areas. Reliance Life Sciences’ candidates are in oncology, cardiology and anti-viral segments. Glenmark has one New Biological Entity (NBE) in Phase I, while Biocon has seven novel candidates in the pipeline (four in pre-clinical and three in phase III). Vaccine maker Indian Immunologicals Ltd is working on a novel oral vaccine against Human Papillomavirus (HPV) that causes cervical cancer. Further, this drug is unlikely to reach the market before 2014 because of the elaborate validation it requires. Shantha Biotechnics Ltd, the first Indian company to develop, manufacture & market recombinant human healthcare products in India is also focussing its R&D efforts on the development of novel vaccines like HPV and novel therapeutic antibodies. Intas Biopharmaceuticals Ltd (IBPL), a fully integrated European Union–Good Manufacturing Practice (EU GMP)–certified biopharmaceuticals company with the capability to provide a wide range of development & manufacturing services is focussed
Funds entering the healthcare sector Fund name
Fund size
Boehringer Ingelheim Venture Fund
Evolvence Fund II
India
Baring PE Partners
Comments The fund will have a global investment focus, targeting research start-up fields including stem cells, RNA silencing, disease-related biomarkers, and new-generation vaccine, protein and antibody solutions.
100 M
2010
Biotech and companies
$ 400 M
2010
This new fund from Evolvence Capital follows the successful Mid-market growth capital closing of Evolvence India Fund I in 2007 and Evolvence India segment Life Sciences Fund, a healthcare and life sciences fund in 2008.
2010
Baring has a fund size of $ 550 million to be invested over the 3-4 drug contract next 8-9 years. Healthcare is a focus area for the firm and about manufacturing companies 20 per cent of these funds are planned to be deployed in the healthcare space.
$ 150 M
Spring Healthcare ` 2,500 M (Sabre Capital)
India Value Fund
Year of Target company/ formation sub sector
$ 725 M
2009
2009
To invest in mid-sized, specialised hospitals which have 100-200 beds Pharmaceuticals & healthcare, retailing and supply chain management, outsourced services and media and entertainment
It is also looking at path labs, dialysis labs, in vitro fertilisation (IVF) labs and CROs. This is IVF’s fourth fund. IVF had closed its third fund at $ 400 million in January 2007. Prior to this, IVF had closed its second fund in 2005 at $ 175 million. The firm’s first fund was a $ 35 million fund, which it closed in 2000, the year it was established. Source: News articles
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R&D COMPASS
on developing NDDS for proteins, a cloning facility, novel production platforms, monoclonal antibodies and recombinant products (cytokines, hormones and blood factors). Bharat Biotech manufactures a Haemophilus influenzae b conjugate vaccine for Wyeth Lederle, and a human lactoferrin product for Agenix, Inc. Panacea has five R&D centres focussing on different areas of development, and the focus of its Biopharmaceutical Research Centre is to develop novel products that will respond to infections or diseases prevalent in the Indian population.
India as investment destination One of the main reasons for investing in R&D activities in China and India is the cost factor. Pharma companies face increasing developmental costs (more than $ 1.0 billion) while being pressurised from health authorities to decrease prices. This has given rise to a cost-driven shift towards outsourcing to low-cost countries, particularly to Asia. Indian companies are offering world-class manufacturing services, both in finished products and the API sector, as well as R&D. For medicinal chemistry work within the R&D sector, chemistry process research & clinical testing have been the strongest areas. However, chemical and pharmaceutical development including comprehensive analytical services is also emerging. Foreign Direct Investment (FDI) equity inflows during financial year 2009-10 were $ 26 billion. The cumulative amount of FDI equity inflows from August 1991 to March 2010 stood at $ 132.4 billion, according to the latest data released by the Department of Industrial Policy and Promotion (DIPP). Thus far, the Indian drug and pharma sector has attracted nearly $ 2.3 billion in FDI in cumulative value. The sector has been able to attract FDI amounting to $ 1.7 billion from April 2000 to April 2010.
Investments from PEs and VCs Using private equity (PE) or venture capital (VC) funds to invest in R&D is not a new concept and has been in practice
since long. The difference comes in deal structuring, which depends on company profile, as the target companies are not in distress. In 2005, Dr Reddy’s Laboratories at Hyderabad spun out four drugs at various levels of testing to a company predominantly owned by Private Equity (PE) firms ICICI Venture & Citigroup Venture Capital. Since then, Mumbai’s Sun Pharma & Chennai’s Orchid Chemicals & Pharmaceuticals have also separated their generic business from the part that is involved in drug discovery, with the intention of attracting a different set of investors into the latter. Industry estimates show that in the past five years, over 100 Indian healthcare and life sciences companies received about $ 2 billion in PE and Venture Capital (VC). Among the investors are Warburg Pincus, Sequoia Capital, IFC, ICICI Venture and IDFC Private Equity. In the biotechnology space, there are about 20 Indian & foreign VC firms, which are active. Kotak Private Equity Group (KPEG), which started investing in biotech in 2000 with companies like Biocon, Avesthagen and Syngene in its portfolio, today, hold three types of funds, namely, India Growth Fund I & India Growth Fund II and VC for Life Sciences. It has allocated approximately $ 100 million (about ` 479 crore) into the life sciences sector. Later, it also looked at companies specialising in global manufacturing & services. Today, its current investments include Siro Clinpharm, Metahelix Life Sciences, VLife Sciences, Rubicon Research and Indus Biotech. Some of the other firms investing in the life sciences sector include Nadathur Holdings and Investments, Actis Capital, HSBC Investments in Glenmark, Tamasek, New Bridge Capital, ChrysCapital in Matrix Labs, Claris Life Sciences has Carlyte Asia Pacific as their investor, Ocimum from IFC, Sai Advantium from ICICI Ventures, GVK BioSciences from Sequoia, Sphaera Pharma from Barring Equity and Cellworks from Artiman Ventures.
Future outlook India lags behind China in spending on R&D as well as in the total number of scientific researchers. Number of persons doing R&D in Scandinavian countries is 7,000 per million of population, while it is 4,700 per million of population in the US. In India, there are 156 researchers per million of population. With the high cost of drug development, there is always a pressure to reduce the R&D development time and cost without compromising clinical success rate. An important factor influencing R&D cost is the adoption of right technology and science. Drug development alliances are also increasingly being used to leverage resources and cut R&D costs. Drug development deal values are expected to increase over the next few years as developers seek partners to reduce in-house spending. India needs to devise a strategy of promoting its R&D agenda. Life sciences seem to be the next big growth story in India after the success of IT and telecom, as the market is looking attractive for outsourcing and off shoring. CRAMS seem to be the current growth drivers. It has been estimated that by 2020 India could possibly achieve almost $ 8-10 billion from R&D alone. There is a strong need for research collaborations both within the industry and with the Government institutes in the form of PPPs. Significant research can also come about with collaboration between the industry and the academic institutions. Abhinav Mehra is a Senior Consultant at Datamonitor, and has significant experience working on a diverse range of projects. He has worked for some of the leading Indian and global pharma companies as well as with the Strategy and Operations team of Deloitte Consulting. His client portfolio includes J&J, Astellas, Ford, Alberto Culver, Rohm and Haas. Email: asundheep@datamonitor.com
August 2010
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B I OT E C H N O LO GY
Gene therapy
Targetting a transformation in medicine Intensive research in the field of genetics has created a number of approaches for treating genetic disorders, various infections as well as cancers. Thus, it is now possible to treat the cause of diseases at the genetic level by replacing defective cells or genes with normal or cured ones. The article discusses two new approaches of gene therapy - gene delivery and gene silencing - that are being used for correcting gene defects.
In vivo gene theraphy Ex vivo gene therapy
Proliferation
Direct injection
including cancer, cardiovascular disorders, neurological disorders, acquired diseases like Acquired Immune Deficiency Syndrome (AIDS) and inherited diseases such as Severe Combined Immune Deficiency (SCID) are targeted with the help of various gene carriers (ie, vectors). Two new approaches of gene therapy, ie, gene delivery and gene silencing, are currently used to correct such genetic defects.
Genetically cured cell
Gene delivery
Abnormal cell Vector production
Ex vivo gene transfer
Schematic view of in vivo and ex vivo gene therapy
Sanjeev Saxena he field of gene therapy has undergone rapid growth. It has only been 10 years since the first federally approved gene therapy trials were carried out with human subjects. Today gene therapy is considered one of the most promising methods of management in treating several incurable diseases. Gene therapy is simply the correction of either a gene or its output, and hence, its results. Various methods can be used for this correction, such as inserting a missing or damaged gene through direct route (ie, in vivo gene therapy), delivering the genetically modified cells in vitro (ie, ex vivo gene therapy) or interrupting the signals sent by the gene. A variety of diseases,
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In general, the biological agents used for gene therapy are cloned DNA sequences, but they can also include oligonucleotides or ribozymes. An important aspect of gene therapy is development of efficient DNA delivery systems. A delivery system should be target specific, gene expression should be at an appropriate level for a prescribed time and the delivery & expression of the gene should be achieved safely. Scientists have used three major means for delivering genes - viral vectors, non-viral vectors and physical gene transfer. Viral vectors are currently the most effective means for gene transfer. Scientists, like Dr French Anderson (also known as the Father of Gene Therapy), first demonstrated that a virus, which was generally harmful to the body, could be used as a ‘Trojan horse’ by encoding it with the relevant gene and delivering into the body. This virus was termed as a ‘vector’. While the experiment was successful, it gave rise to a number of problems due to the pathogenic nature of the virus. Since then, scientists like Dr Inder Verma and Dr Noriyuki Kasahara have been working tenaciously to develop safe & effective vectors with the highest efficiency for gene delivery but at the same time have minimal-to-no toxic effects. Thus, a number of viruses have been cloned and modified in laboratories to get safe & effective vectors.
BIOTECHNOLOGY
Types of vectors Different types of vectors are now available, with different sizes and ability to carry genes of particular sizes. Some of these vectors show promise for certain types of diseases over others. Adenovirus vectors: Adenovirus infections are common and relatively mild in human beings, often causing symptoms in the upper respiratory system. Moreover, adenovirus vectors are widely used in gene therapy because they exhibit the highest transduction efficiencies both ex vivo and in vivo in most cells. Adenovirus vectors for therapeutic applications can be replication-deficient for all cells or replication-competent for tumour cells (oncolytic viruses, eg, delivering p53). In either case, the adenoviral vector does not integrate into host chromosomal DNA and remains an episome in cells. Adenovirus vectors often encounter circulating neutralising antibodies, thus triggering a cytotoxic T-lymphocyte response directed at transduced cells expressing adenovirus proteins. These two characteristics of adenovirus vectors permit only transient expression of therapeutic genes and limit long-term gene expression by repeated administration. Adeno-Associated Virus (AAV) vectors: Gene therapy scientists also use AAV vectors because they infect a wide variety of cells including the dividing and non-dividing cells. About 85 per cent of adults are seropositive for AAV, but no specific pathology has been linked to this virus. Although the wild-type virus integrates at a specific site on human chromosome 19, the recombinant AAV vectors integrate randomly into the host chromosome. Because of its small genome size and packaging constraints, the AAV vector cannot accommodate complementary DNAs (cDNAs) of size greater than 4.5 kb. Retrovirus vectors: Retrovirus vectors derived from Moloney Murine Leukemia Virus (MMLV) are the most widely used vectors in gene therapy, and these do not require helper
viruses for replication. Retroviruses infect only dividing cells and integrate into the chromosomes of dividing cells, providing sustained gene expression. These vectors are not effective for non-dividing cells, thus limiting their usefulness to only ex vivo therapies in which cells are removed from the body, stimulated to divide and then re-implanted. Retrovirus vectors generally accept inserts of size 8 kb and do not elicit a strong immune response. In many cases, the expression of transgenes declines after one to two weeks. Lentivirus vectors: Lentiviruses, such as Human Immunodeficiency Virus type 1 (HIV-1), are a subclass of retroviruses and can infect both non-dividing and dividing cells. Lentiviruses infect a variety of cells, like T and B cells, monocytes, macrophages, neurons, glia muscle, retinal, cochlear, heart, liver and haematopoietic stem cells. Recently, lentivirus vectors have been used to achieve long-term gene transfer into haematopoietic stem cells. These vectors show promise in correcting inherited genetic disorders in blood cells as these cells are derived from stem cells. However, as the earliest lentivirus vectors were derived from HIV-1 (a replication-deficient vector) is critical for the success of gene therapy. The need for a sustained delivery system for transducing non-dividing cells has resulted in this system undergoing significant refinement. Third-generation lentivirus constructs have only 10 per cent of their original DNA and use up to four separate helper plasmids for the preparation of recombinant virus with the use of mammalian cells as additional safety measures. A high-titre conditional packaging cell line developed for lentivirus vectors was engineered by stably transfecting several viral genes and the Vesicular Stomatitis Virus (VSV) envelope gene under the control of a tetracycline-inducible promoter. This cell line appears suitable for commercial
production of high-titre lentivirus vectors for use in gene therapy and dramatically reduces the probability of generating replication-competent virus. Other safety features of lentivirus vectors include the removal of HIV accessory genes. The properties of lentivirus vector that make it appropriate for the current approach include: v Efficient in vivo delivery v Long-term, stable expression v No toxicity as demonstrated in mice, rats and dogs v Active in non-dividing and slowly dividing cells v No immune response to vector
Delivering transgene by retrovirus For a retrovirus to successfully infect a target cell, each step involved in retroviral transduction must be followed effectively. The steps can be distinguished as extracellular and intracellular processes. Extracellular process includes random retroviral movement in virus-containing medium, non-specific binding of retrovirus to the surface of target cell, receptor-mediated specific binding of retroviral envelope protein to receptor of target cell and internalisation of retrovirus into cytoplasm by membrane fusion. Expression of a transgene is completed inside the target cell by release of retroviral RNA into cytoplasm, reverse transcription of retroviral RNA to double-stranded DNA, permeation into nucleus of target cell, integration of retroviral DNA into host chromosome and, finally, expression of transgene followed by transcription & translation of the newly inserted gene. Sanjeev Saxena is Chairman & Chief Promoter of Actis Biologics Group of Companies. He has over 18 years of business development and sales & marketing experience in the bio-pharmaceutical industry. Email: ssanjeev@actisbiologics.com
August 2010
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RETAIL ZONE
Role of the board of directors
Tuning growth the right way Considering the dynamic and the upbeat nature of the pharma retail business, a board of directors having rich knowledge & experience is important in enabling the CEO or the COO for taking the right decisions and thereby helping the company move towards maximising its sales and profits. This article explores how the presence of a board of directors can contribute to the success of a pharma retail organisation.
Courtesy: Finish Line Catering
Rajendra Pratap Gupta ith the retail market undergoing a rapid change, the role of Chief Executive Officer (CEO) is increasingly becoming multifaceted, and thus complicated. On one hand, the CEO is expected to manage the people & processes, and on the other hand, he has to remain updated on the market movements and accordingly adapt his organisation to keep pace with the changing times. Clearly, a single person cannot handle all these functions. The role of a board of directors comes into play at this important juncture, where the efficiency of the board decides whether the CEO is making the right decisions. It also decides whether the organisation would thrive in the turbulent times. Professional or pharmacy chain retailing is more than two decades old, but none of the
w
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pharmacy chains has a board of directors that can be a differentiator for the business. All retail pharmacy chains are family driven or promoter driven. These usually have a board of directors that comprises friends or family members, thereby decimating the actual role of the board. In India, till date, only one company has set a new benchmark in corporate governance by handing over the control to a professional, who took over as Chairman, and the promoter stepping down from the board. Pharmacy retail is the most challenging sector. The upside of being in a pharmacy or healthcare retail business is that, due to its need-driven nature, it is an evergreen business, and the footfalls are easier to get. The only adverse factor is that the returns can be positive or negative. Most Indian retail companies focus only on appointing an aggressive CEO or the Chief Operating Officer (COO) or the President. They believe that, if the man at the top position is efficient, the rest will automatically fall in place. But the world has so far produced only a handful of people like Jack Welch, Bill Gates, Steve Jobs, Akio Morita, Jeff Immelt, Warren Buffet, Lee Lacocca, Ratan Tata, etc, who were capable of working with great teams and taking their organisations to the top even in turbulent times.
Organisational structure A typical structure of an organisation is top-down driven, with investors or promoters at the top, followed by the board of directors (more for fulfilling the regulatory requirement and is done by appointing immediate family members or close friends or business partners on the
RETAIL ZONE
board). The next level includes head of the organisation, who can be a CEO or COO or President. Below this level come people from the senior, middle and junior management. Today, most retailers are struggling because they have failed to realise the importance of the role of the board of directors. To have a successful retail organisation, a diverse and experienced board is needed, which can effectively equip the head of the organisation with useful insights, enabling wiser decision making, and thereby preventing failures. It is rightly said that ‘two heads are better than one’. Ideally, a retail organisation must have a vibrant board of directors coming from different specialisations that can lend support to the CEO with their experience & expertise.
Need for diversity on the retail boards All retail organisations have 10 critical components that need specific insights and expertise besides that of the CEO. These components include marketing, sales, logistics, human resources & training, geographic & sector-specific expertise, Information Technology (IT), finance & administration, customer service, Research and Development (R&D) and continuous innovation. Last but not the least, specialised retailers like pharmacy retailers need to consider having a pharmacist on board or an individual with a deep understanding of the developments in the domain. It is always in the best interests of organisations to have on board individuals with diverse experience in the retail, marketing, operations, Human Resource (HR), IT and sales. People should be drawn from across different sectors and geographies so as to bring a new dimension to the thinking of the CEO and the organisation. The board members must have a high degree of integrity and assertiveness, to ensure that the organisation does not digress from its goals as well as in values & ethics.
The value of the board member comes in the form of strategic insights & tactical understanding that these experienced professionals bring in for the CEO. The paradigms in retail pharmacy are changing rapidly, and the market horizons are expanding every 3-5 years. In the next three years, the horizons will undergo drastic expansion. If Foreign Direct Investment (FDI) is allowed in pharmacy retail, the market will change in only 18 months. Even developed markets like the US or Europe (where pharmacy business has evolved and existed for decades, with the big fortune 20 companies running the show) are trying fresh models of pharmacy, taking
Ideally, a retail organisation must have a vibrant board of directors coming from different specialisations that can lend support to the CEO with their experience & expertise. into account the changing paradigms of healthcare & the evolving customer. Even if the CEO is an extraordinary & knowledgeable individual on all fronts, it is better to have interactive sessions for testing new ideas and obtaining deeper insights from these board members who are professionals with experience in diverse areas and have brought about paradigm shifts in the industry. Else, in these dynamic times, it may be risky to run an organisation based only on the impulses of an individual. The pharmacy retailers should look at the company not only through the eyes of a CEO but also through a prism of the boards, and figure out the right prescription for sustainability and growth.
Frequency of a board meet Normally, the board of directors meets once every three months, but retail organisations cannot wait for a quarter to discuss their performance. It is best advised that the retail organisation forms a steering committee of select board members who can meet the CEO or the head of the organisation every month to review the targets versus performance and submits its report to the board of directors. The board of directors have the ultimate responsibility to give directions and set the broad strategies & goals, and the CEO or head of the organisation is the implementer of decisions taken by the board. Besides the strategic insights, the board members also bring in strong networks, which can add tremendous value across functions for the organisation. India has witnessed the failure of many organisations, only because they failed to act on the suggestions from the board or lacked an active board of directors. Passive boards bring more loss to organisations than over-zealous CEOs. Today, in India, a majority of retailers are struggling to figure out a profitable way for expansion. Further, the expectations from CEOs of today are very high, without much support in the form of diverse and competent boards. It is high time that the retailers understood the significance of having independent board members with domain expertise. As we always say, ‘bottlenecks are always at the top and not at the bottom’. Thus, the time has now come to broaden the ‘top’ and remove bottlenecks. 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
August 2010
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INDUSTRY INSIGHTS
Type I diabetes therapeutics market
Unmet needs propelling growth
Courtesy: www.diabetes-today.info
The therapeutics market for type I diabetes has shown spiraling growth in recent times. This growth is attributed to increasing prevalence of the disease, escalating therapy cost, and rising number of people seeking treatment. Also, lack of generic insulin products has created huge lacunae in the therapeutics market. These lacunae, termed as unmet needs, are driving the growth in this segment. demand, leading to a moderate level of unmet need. Hence, there is a significant market potential, which can be exploited by any new entrant that will cater to the unmet needs for more convenient products having better efficacy and safety. The emerging therapies for this disease are expected to capture a small portion of the unmet need. Despite the high proportion of first-in-class drugs in the pipeline, the pipeline for type 1 diabetes is not strong as the products in developmental stages cannot cater to the needs of all patients with type 1 diabetes. While the pipeline products are not strong enough to affect the current market, the success of these products will further drive the market in the long term.
Growth forecast Monitoring glucose with glucometer
ype 1 diabetes is an autoimmune disease condition and generally found in young adults and children. In 2009, the value of the global type 1 diabetes therapeutics market was estimated at $ 2.7 billion. In the next seven years, the market is forecast to grow at 6.1 per cent annually to reach $ 4.4 billion by 2017. This growth is primarily attributed to the increase in the average cost of therapy for type 1 diabetes & increase in population with the disease, along with those seeking treatment. The available treatment options are fairly successful in meeting the market
t
The value of global type 1 diabetes therapeutics market in 2009 was estimated at $ 2.7 billion. The market is expected to further grow at a Compounded Annual Growth Rate (CAGR) of 6.1 per cent to reach $ 4.4 billion by 2017. This growth is primarily attributed to an increase in the average cost of therapy with the existing treatment options and increased rate of treatment-seeking behaviour. Currently, Novo Nordisk and Eli Lilly are the leaders within the global type 1 diabetes therapeutics market. The type 1 diabetes affects only about eight per cent of the total population with diabetes. Curently, the prevalence of type 1 diabetes is about 0.6 per cent, which, in
Curently, the prevalence of type 1 diabetes is about 0.6 per cent, which, in 2009, accounted for diabetes in a total population of 4.2 million. 70 Modern Pharmaceuticals
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INDUSTRY INSIGHTS
Type 1 diabetes therapeutics market, global, revenues ($bn) 2001-2007 5 4.5 CAGR (2009-2017): 6.1%
4
Opportunity & unmet needs in type 1 diabetes therapeutics market, 2010 Efficacy Low High High
3
2.5
CAGR (2001-2009): 7.7%
Unmet need=23% X $2,726m=$627m Unmet need is (23%) for Type-1 diabetes
Safety
Sales value ($bn)
3.5
2
Low
1.5 1 0.5 0 2001
2009
2009, accounted for diabetes in a total population of 4.2 million.
Key market drivers Between 2009 and 2017, the number of people with type 1 diabetes is estimated to increase at a sluggish rate of 1.2 per cent. During 2001-09, the number of patients with type 1 diabetes increased at a rate of 1.5 per cent, which is considerably high. Therefore, the increase in the average cost of therapy will be the key factor for growth in the market. The average cost of therapy is expected to increase at a CAGR of 4.5 per cent over the period of 2009-17. This increase will primarily be driven by the higher cost of insulin analogs. The increase in awareness for type 1 diabetes due to awareness programmes organised in key countries will continue to improve the treatmentseeking behaviour of people. The increase in the number of people who seek treatment could lead to an increase in the prescription population, made possible by the effective diagnostic tests currently available in the market.
Competition due to products with similar efficacy & lack of generics Insulin and insulin-analog products dominate the current market. These products have similar efficacy and safety profiles with only marginal variations. This further increases the competition
2017
Humulin Novolin Apidra Levemir
Next steps unmet need can be fulfilled by efficacious products with better safety which are likely to be me-too drugs or first-in class products
Humalog Lantus Novolog
Note: Size of the bubble represents opproximate cost effectiveness of the product unmet needs indicate the efficacy and safety associated with top marketed drugs
The value of global type 1 diabetes therapeutics market in 2009 was estimated at $ 2.7 billion. The market is expected to further grow at a Compounded Annual Growth Rate (CAGR) of 6.1 per cent to reach $ 4.4 billion by 2017. in the market. The manufacturers are forced to compete on pricing or on improving the dosage requirements of their currently marketed products. In addition, the presence of a few promising drugs, such as Oral-lyn and monoclonal antibodies, in the latestage pipeline means that successful launch of these products in the market will significantly increase the competition. Also, the current market lacks any generic insulin product despite the expiry of patents of two insulin products. This is due to a lack of efficient guidelines for the introduction of biogenerics. For instance, in Europe, where proper guidelines exist for the approval of biosimilars, Marvel LifeSciences had filed an application for an insulin biosimilar, but it was
later withdrawn as it did not fulfill the required guidelines.
Unmet needs The type 1 diabetes therapeutics market has unmet needs in terms of efficacy as well as safety. These needs imply that the existing drugs do not serve the market completely. The market has moderate scope for new entrants that could capture value from the under-served segments. The efficacy of the current product offerings in the type 1 diabetes therapeutics market is moderate, as there is no cure for the disease. However, the current products are able to achieve better glucose control in most cases. This process of controlling diabetes-related symptoms is generally painful and requires strict compliance to a treatment regime. The current products available are relatively inconvenient in terms of the mode of delivery, which impacts patient compliance. All products in the market show adverse reactions such as hypoglycaemia, local injection site reactions and allergic reactions. These adverse reactions indicate that none of the products offer a completely safe profile. Therefore, the market also faces unmet need in terms of the safety of products. With the exception of human insulin such as Humulin and Novolin, other insulin products (insulin analogs) are relatively expensive. Thus, the high cost of drugs increases the average cost of therapy for these analogs.
August 2010
Courtesy: GlobalData
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EVENTS CALENDAR
National
Pune
Ahmedabad
Indore
Maharashtra
Gujarat
Madhya Pradesh
Chennai Tamil Nadu
Nov 19-22, 2010
Dec 17-20, 2010
Feb 18-21, 2011
Mar 04-06, 2011
India’s premier industrial trade fair on products and technologies from machine tools, fluid power, instrumentation & control, electrical & electronics, material handling, plastics, rubber, packaging, chemical, CAD/CAM, auto components, and general engineering.
For details contact:
Engineering Expo Infomedia 18 Limited, Ruby House, 1st Floor, J K Sawant Marg, Dadar (W), Mumbai 400 028. Tel: 022-3003 4649, Fax: 022-3003 4499 Email: shamal@infomedia18.in, Website: www.engg-expo.com
SCM Pharma India 2010 A conference on specific supply chain management issues affecting Indian pharma companies; August 26-27, 2010; at The Westin Mumbai Garden City, Mumbai For details contact: UBM India Pvt Ltd, Mumbai Tel: +91-22-6612 2600 Fax: +91-22-6769 2462 Email: jennifer.tsao@ubm.com Website: www.scmpharma-india.com
machinery for an array of industries including the pharmaceutical industry; October 01-04, 2010; at Bangalore International Exhibition Centre, Bengaluru For details contact: Bangalore International Exhibition Services Pvt Ltd, Bengaluru Tel: +91-80-6583 3234 Email: dayanand@bies.co.in Website: http://www.promach.co.in
Biosimilars India 2010 GIL 2010: India Frost & Sullivan’s Global Community of Growth, Innovation and Leadership (GIL) event brings together a global network of today’s best thinkers, visionaries and thought leaders to deliver fresh perspectives, innovative ideas and practical solutions that will assist in staying ahead of the curve; September 1, 2010, The Leela Palace, Bengaluru For details contact: Frost & Sullivan Tel: +91 44 4204 4517 Fax: +91 44 24314264 Email: ravinder.kaur@frost.com Website: www.frost.com
For details contact: UBM India Pvt Ltd, Mumbai Tel: +91-22-6612 2600; Fax: +91-22-6769 2462 Email: jennifer.tsao@ubm.com Website: http://www.biosimilars-india.com
P-MEC India 2010
PROMACH 2010 An exhibition featuring cutting-edge technologies and process plant &
72 Modern Pharmaceuticals
The 2nd Annual Biosimilars India 2010 conference, a two-day strategic event that will provide an opportunity to assess the market, determine the right technical strategy and drive the development and registration of biosimilars products both in India and overseas; September 30-October 01, 2010; at Le Royal Méridien, Mumbai
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
August 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.pmec-india.com
2nd India Lab Expo 2010 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 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 Analytica China 2010 A conference devoted to laboratory technology, analysis/quality control, biotechnology and life sciences, which brings together decisionmakers from leading biotechnology, pharmaceutical and investment companies. The event will assemble a large number of visitors and exhibitors related to laboratorytechnology sector from all over the world; September 15-17, 2010; at Shanghai, China For details contact: Messe München, Germany Tel: +49 (89) 9 49-2 07 20 Fax: +49 (89) 9 49-2 07 29 Email: info@messe-muenchen.de Website: http://www.analyticachina.com
8th Annual Cold Chain Distribution for Pharmaceuticals Global Forum This event organised by Pharma IQ features insights from pharmaceuticals, logistics partners and non-profit agencies on streamlining distribution operations and overcoming challenges involved with managing temperature controlled medicines for both domestic and international supply chains; September 20-23, 2010, Pennsylvania Convention Center, Philadelphia, PA For details contact: IQPC Tel: +91 80 4322 4100 Fax: +91 80 4322 4103 Email: info@iqpc.com Website: www.coldchainpharma.com
SIPEC 2010 A pharmaceutical trade show that provides a good opportunity to network and generate new clients, while gaining an insight into the developments in
the industry; September 28-30, 2010; at Parc des expositions d’Orléans, France For details contact: Sipec, France Tel: +33 (0)2 38 95 30 49 Fax: +33 (0)2 38 95 24 29 Email: infos@sipec.net Website: www.sipec.net
For details contact: WUV (Werbe- und Vertriebsgesellschaft Deutscher Apotheker mbH), Germany Tel: +49 (0)6196 - 928 412 Fax: +49 (0)6196 - 928 404 Email: besucher@expopharm.de Website: www.expopharm.de
FoodPharmaTech 2010
BIOTECHNICA 2010 An event for the biotechnology and lifesciences industry. It covers various elements in the field of biotechnology, including f u n d a m e n t a l s, equipment and bioinformatics & services. An opportunity for associated people to find new customers and partners for their products & services, and to network with various professionals from the industry; October 05-07, 2010; at Deutsche Messe Hannover, Germany For details contact: Deutsche Messe AG Hannover, Germany Tel: +49 (0)511 89 0 Fax: +49 (0)511 89 32626 Email: info@messe.de Website: www.messe.de
Expopharm 2010 An exhibition highlighting the current trends and developments in the pharmaceutical sector. More than 500 exhibitors from diverse fields catering to the pharma industry are expected to be present at the event. The event presents an ideal opportunity to network with different visitors and generate new contacts; October 07-10, 2010; at Munich, Germany
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 02-04, 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
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) 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
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
August 2010
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73
PRODUCT UPDATE
High-shear fluid processor
Sterilisers
TTL Technologies offers 100 hp, stainless steel M-710 Series ‘Microfluidizer®’ high-shear fluid processor. With this processor, pharmaceutical companies can produce products ranging from two Gallons Per Minute (GPM) at 40,000 psi to eight GPM at 10,000 psi in batch or continuous mode. The intensifier pump’s synchronous operation keeps product flowing at high velocities and near-constant pressure. It uniformly de-agglomerates, disperses and distributes particles to create stable emulsions and solids-in-liquid suspensions. The processor comes with an optional ultra-clean-in-place (UCIP) feature that thoroughly cleans the system between batches or before storage. It also includes a Level I or Level II steam-in-place option designed to meet the regulatory requirements for eliminating microbiological contaminants for injectable pharmaceutical formulations in cGMP manufacturing environments.
Pharmalab India offers sterilisers, which are used for non-porous loads, porous loads, rubber stoppers, terminal sterilisation of vials & ampoules, laboratory use, etc. These sterilisers are designed in compliance with ASME guidelines for construction of pressure vessels, according to ISO 9001:2008 Quality Management System procedures, following cGMP and cGAMP requirements, FDA guidelines, European standards EN 285 and HTM 2010. These are provided with ‘Dimple’ jacket of SS-316L materials for enhanced/uniform temperature distribution. These sterilisers are equipped with accessories like multiple validation ports, bioseal (biological safety barrier), trolleys & carriage, etc. These are PLC-operated fully automatic systems whereby separate cycle for sterilisationin-place (SIP) of air filter can be specially programmed on request along with standard steriliser cycles.
TTL Technologies Pvt Ltd - Bengaluru - Karnataka Tel: 080-2525 1859, Fax: 080-2529 1285 Email: analyticaldirect@ttlindia.com
Pharmalab India Pvt Ltd - Mumbai - Maharashtra Tel: 022-6622 9900, Fax: 022-6622 9800 Email: mkt@pharmalab.com
CIP/SIP module
Tunnel bottle rinsing machine
Vyanktesh Fabricraft offers Clean-InPlace (CIP) module and SterilisationIn-Place (SIP) module. The CIP module ensures that process lines, vessels, reactors, process equipment such as fermentors, media preparation vessels, downstream processing blending vessels, etc are cleaned in place. The SIP module is provided with Programmable Logic Control (PLC) with touchscreen Man-Machine Interface (MMI), condensate system with steam trap & strainer, temperature sensor for online temperature monitoring and user-definable sterile recipe. Its features include time maintenance, multi-level authorisation password logging and fault message displays by MMI, etc. The advantages of the module include lower facility-operating cost, minimum dismantling of equipment & piping, reduced turnaround for cleaning and elimination of exposure to hazardous activities or entry into tank. The company also offers fluid bed dryer, rapid mixer granulator, vibro sifter, blending vessel, double-cone blender, etc.
S S Packaging Industries offers automatic tunnel bottle rinsing machine, which is ideal for round bottles. It finds wide application in pharma and food industries. The automatic loading arrangement facilitates loading of bottles on to SS wire mesh conveyor through feed conveyor or bottles are pushed manually from feed table. The automatic unloading mechanism consists of unloading bottles on to a wire mesh conveyor, which continues on to the turn table. Three cycle rinsing allows flexibilities of various rinse cycles such as fresh water & demineralised water, as per the rinsing requirement of bottles. The total rinsing cycle is smooth and limit switches/sensors are in-built at every stage to sense bottle, reversal or bottle obstruction and stop the machine. The quality of rinsing is ensured through three sets each of inner and outer nozzles accurately placed to direct the jet at the centre of the bottle.
Vyanktesh Fabricraft Pvt Ltd - Nashik - Maharashtra Tel: 0253-660 2691/238 3603, Fax: 0253-660 2691 Email: vyankteshen@yahoo.co.in
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S S Packaging Industries - New Delhi Tel: 011-4705 2942, 6545 8134, Fax: 011-4507 2943 Mob: 9810279831 Email: info@sspackaginggroup.com
PRODUCT UPDATE
Hose reels Cris Engineering Works offers stainless steel hose reels that are designed for heavy-duty use with a canvas-reinforced r u b b e r / Te f l o n - b r a i d e d stainless steel water hose. Using a heavy-duty internal spring, the reel quickly and easily rewinds the hose. These are provided with a ratchet assembly, which locks the reel when the desired length of hose has been pulled out. All hose reels are preset with enough force to fully retract the hose. Hose reels can be conveniently installed on the pillar, wall or ceiling, for easy access & maintenance and are offered in fixed or swivel designs. Each hose reel includes a hose stop to prevent damage to the hose reel rollers and water-saver nozzles. These self-rewind hose reels are manufactured for pharma, food, chemicals, dairy, beverage and allied industries. These are available in 5-, 10- or 15- long hose with diameter of ½“ or ¾ “, having a maximum working pressure of 10 bar and maximum working temperature of 100°C. Cris Engineering Works - Mumbai - Maharashtra Tel: 022-2685 9440 , Fax: 022-2685 9440 Email: roque_ferns@rediffmail.com
August 2010
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PRODUCT UPDATE
Linear vial washing machine Shree Bhagwati Pharma Machinery Company offers SBVW-150 automatic linear washing machine. This machine is devised to ensure simple and modular operation, where each vial is positively washed with a maximum of seven washes. All contact parts with DM water and distilled water are made of SS-316 construction and are argon arc welded. The unit is built on SS square pipe frame and totally encompassed with SS coverings in matte finish to avoid corrosion and ease of cleaning even from inside. The washing tray is covered with acrylic cabinet and collecting trays, which ensure complete removal of water in the drain of re-circulation tank. The machine is equipped with six change parts, which can be changed in few minutes. All exposed parts are made of SS-304 or hard chrome-plated brass for corrosion-free long life. The company also offers high-speed tunnel-type vials/bottles washing machine, automatic filling and stoppering machine, automatic cap sealing machine, etc. Shree Bhagwati Pharma Machinery Company Ahmedabad - Gujarat Tel: 079-2277 0475, Fax: 079-3041 7645 Email: contact@bhagwatipharma.co.in
Static pass box GMP Technical Solutions offers static pass box to allow material transfer without much personnel movement. It also aids controlling ingress of particulate contaminants into cleanroom and between different classified areas. The pass box is available in powder-coated mild steel, SS-304, SS-316, SS-316L or a combination of both. It is provided with doors with double-walled flush-glass view panels, SS handles, SS hinges, etc. The internal covering ensures ease of cleaning. It is equipped with electromagnetic interlocking and indicator on either side. Its design feature includes double-walled construction with door-release switch on either side. The company also offers dynamic pass box, vertical laminar air flow unit, bio-safety cabinet, garment storage cabinet, air shower, etc. GMP Technical Solutions Pvt Ltd - Mumbai - Maharashtra Tel: 022-6608 3700, Fax: 022-6608 3737 Email: enquiry@gmptech.net
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PRODUCT UPDATE
Vacuum conveyors International Marketing Services offers ‘PIAB’ vacuum conveyors, which are specially designed for conveying powders/granules from bins to the hopper of processing machines. These vacuum conveyors work on multi-stage ejectors, which generate vacuum by flowing compressed air at 4-6 bar. These are designed for close-loop conveying and conform to the GMP & FDA standards. There are no moving parts so the downtime for maintenance is minimum. Several variants of these conveyers are available with capacities ranging from 100 to 7,000 kg/hr. The control unit is pneumatically operated and do not require any type of electrical input. Several accessories like feed nozzle, PVC hose & fluidised cone are available as an option. The material of construction is SS-316L and the contact parts comply with USFDA standards. These vacuum conveyors are used in pharma companies for formulations and in food processing industries. International Marketing Services - Bengaluru - Karnataka Tel: 080–2331 0124, Fax: 080–2344 0604 Email: ims_blr@sify.com
August 2010
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PRODUCT UPDATE
CIP/SIP modules Industrial Equipwash Inc offers clean-in-place (CIP)/steamin-place (SIP) modules. The CIP/SIP technology offers significant advantages to manufacturing facilities, from efficient cleaning of process equipment & piping at lower costs to improved product quality. The CIP systems are fully integrated incorporating tanks, pumps, valves, spray-cleaning devices, heat exchangers, piping & controls without the need to disassemble all or part of the system. This system significantly reduces cleaning costs and minimises the handling of chemicals to provide a safer environment for plant personnel. The CIP process involves a sequence of cycles that includes an initial & final drain step and a pre- & post-rinse step. The CIP process may include a sanitise cycle to reduce the levels of bacterial contaminants. This cycle uses aqueous solutions of strong oxidants such as hydrogen peroxide, ozone and chlorine-containing compounds. The controls incorporated in CIP systems are critically important and provide a variety of cycle times, temperatures and composition of cleaning solutions. Fully automated Programmable Logic Controller (PLC)-based CIP systems are offered to suit customer specifications. Industrial Equipwash Inc - Mumbai - Maharashtra Tel: 022-2679 7941, Fax: 022-2679 2936 Mob: 098692 31815 Email: iewi@vsnl.net
Flexible enclosures Capcon offers flexible enclosures manufactured by ILC Dover. These enclosures save time and money by allowing to retrofit to the existing processing equipment while achieving nanogram containment levels. All materials meet FDA standards and the design accommodates cGMP as well as operator ergonomics. These allow the operators to work in shirt sleeve environment, thus increases efficiency. The design makes use of flexible enclosures of existing DoverPac containment details such as crimps, bag/out sleeves and O-ring interface canisters. The features include economical, fast turnaround/installation, ergonomics, third-party validated nanogram containment levels using SMEPAC guidelines, etc. Capcon - Thane - Maharashtra Tel: 022-2537 7263, Fax: 022-2542 2493 Email: capcon_thane@yahoo.com
78 Modern Pharmaceuticals
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PRODUCT UPDATE
Rapid mixer granulator Umang Pharmatech offers rapid mixer granulator, which is designed for mixing granulates. The rapid mixer granulator consists of axles of agitator and chopper, impeller, chopper device and binder feeding device. The agitator and chopper both have double-sealing structure, ie, Teflon packing and air sealing over it. This structure prevents the axles from the inflow of the powder and other particles. The impeller’s surface is specially polished so as to prevent sticking of powder. These impellers are simple in construction and can be easily and quickly dismantled and reassembled. The chopper shaft is connected straight to driving motor. This reduces vibration and noise. The binder is fed in the way of down-fall from the tank placed on the top of the vessel. The feeding quantity is controlled by opening and shutting the valve with the help of the handle. Umang Pharmatech Pvt Ltd - Mumbai - Maharashtra Tel: 0250-645 0835-7 Email: info@umangpharmatech.com
August 2010
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PRODUCT UPDATE
Vacuum pumping unit Acmevac Sales offers vacuum pumping unit, which consist of rotary vane pump twin-lobe pumps as fore-pump and rotary vane pump or liquid ring pump as backing pump. The fore-pump picks up oil necessary for its lubrication from the backing pump. The exhaust from the forepump is connected to the suction side of the backing up, thereby giving an advantage of high pumping speed at higher vacuum. These units are energy efficient and consume less power than conventional single vacuum pumps. These pumping units have a compact design and are mounted on base frames ready for use. The units are tailor-made and are offered to suit user’s requirements. These pumping units are used in chemical, pharmaceutical, dye, fertiliser, petrochemical, lubricant, power, metallurgy, electrical and allied industries. Acmevac Sales Pvt Ltd - Mumbai - Maharashtra Tel: 022-2837 5837, 2838 1053, Fax: 022-2836 4977 Email: acmevac@vsnl.com
Membrane filtration unit Nishotech Systems offers manual and semi-automated skid-mounted membrane filtration unit. It is constructed of complete stainless steel body with all wetted parts made of SS-316L. Its compact design reduces holdup volumes and gives better space utilisation. The PLC-based system helps in online monitoring and recording of process parameters. The membrane filtration unit is used in depyrogenation of dextrose and amino acids, fermentation broth clarification & enzyme concentration, desalting & concentration of peptides and other similar proteins, and in downstream processing for antibiotics, vaccines & therapeutic proteins. Nishotech Systems Pvt Ltd - Navi Mumbai - Maharashtra Tel: 022 -4151 5151, Fax: 022 - 2778 1484 Email: info@nishotech.com
The information published in this section is as per the details furnished by the respective manufacturer/ distributor. In any case, it does not represent the views of
Modern Pharmaceuticals
80 Modern Pharmaceuticals
August 2010
Tel: +91-22-3003 4684 / 4640
Fax: +91-22-3003 4499 E-mail: b2b@infomedia18.in
GMP heat exchangers
Safety light curtains
Analytical instruments
GMP reactors
Scraped surface crystalliser
Annular centrifugal extractor
Heart valve frames
Screening machine
Bearings
High-shear fluid processor
Self adhesive tapes
Biotech & pharmaceutical products
Hose reels
Separators
Cable carriers
HPLC
Short path distillation unit
Cable connectors
Hydrogenator/autoclaves
Silicone carbide heat exchangers
Capping machines
Industrial control & sensing devices
Skid mounted systems
Chains
Informatics
Sludge dryer
CIP/SIP module
Injectable powder filling machines
Spherical paddle chopper dryers
Columns & chemistries
Invertor/variable frequency drives
Spray analysers
Complete tablet bottle
Knife mill
Spray control unit
Level controllers
Spray fabrication
Conical screw dryers
Linear vial washing machine
Spray nozzles and accessories
Connectors
Liqid food processing First Fold Here
Static pass box
Counters & power supplies
Liquid filling lines
Sterilisers
Crushers
Liquid filling machines
Sticker (self-adhesive) labelling
Dehumdifiers
Liquid-liquid extractor
Double sided rotary tablet press
Measuring & monitoring relay.
Switching relays
Drives
Membrane filtration unit
Tablet press machine
Dry syrup powder filling lines
Motion controls
Tableting machinery
Empower
Mullers
Tempurature controllers
Encoders
Multi-function mill
Timers
Exhibition - ADEA - Automotive
Multiple effect evaporator
Tunnel bottle rinsing machine
Dealership Excellence Awards
Packaging machines
Turnkey projects
Exhibition - Biosimilars India 2010
Photo electric sensors
Turnkey systems for dust
Exhibition - Engineering Expo
Pneumatic component
Exhibition - Healthex 2010
Process heat exchangers
Twin-screw co-rotating extruders
Exhibition - India Chem 2010
Process reactors
Twin-screw elements
Factory automation
Programmable logic controllers
Twin-screw extruders
Falling film evaporator
Programmable terminals
UPLC
Filters
Vacuum conveyors
Filtration equipment
Pumps
Vacuum pumping unit
Filtration system
Rapid endotoxin detection system
Vacuum technology
Flexible enclosures
Rapid mixer granulator
Ventilators
Food analysing & testing machine
RFID
Vision sensors
Forced circulation evaporator
Rising film evaporator
Washing and air jet cleaning
Gas conditioning and fire protection
Rotary gear pumps
Gear pumps
Rotary tablet press
Wastewater treatment equipment
Geared box
Rotary vacuum dryers
Wet glue labelling machine
Geared motor
Rotocone dryers
packaging lines
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machines
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ADEA
International Marketing Services
Alfa Laval India Ltd
Live Wire
ANI Engineers
Misumi India Pvt Ltd
Arctic India Sales
Modern Pharmaceuticals
First Fold Here
Bangalore International Exhibition
Omron Automation Pvt Ltd
Bonfiglioli Transmissions (Pvt) Ltd
Premium Transmission Ltd
Brothers Pharmamach (India) Pvt Ltd
Shimadzu Analytical (I) Pvt Ltd
Chamunda Pharma Machinery Pvt Ltd
Smart Logistics
Charles River
Spraying Systems (India) Pvt Ltd
Dipesh Engineering Works
Sreelakshmi Traders
Engineering Expo
SSP Pvt Limited
Fette Compacting Machinery (I) Pvt Ltd
Steer Engineering Pvt Ltd
FICCI
Techno Force Pvt Ltd
Guan Yu Machinery Factory Co, Ltd
UBM India Private Limited
Igus India Pvt Ltd
Waters (India) Private Limited
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PRODUCT INDEX
Product
Pg No
Product
Pg No
Product
Pg No
Agitated thin film evaporator ...................................45
GMP heat exchangers.....................................................5
Rotary vacuum dryers ....................................................5
Analytical instruments ...........................................17, 27
GMP reactors ..................................................................5
Rotocone dryers..............................................................5
Annular centrifugal extractor ......................................45
Heart valve frames .....................................................21
Safety light curtains ........................Front inside cover
Bearings.........................................................................6
High-shear fluid processor...........................................74
Scraped surface crystalliser ..........................................45
Biotech & pharmaceutical products..............................7
Hose reels ......................................................................75
Screening machine........................................................11
Cable carriers................................................................6
HPLC .............................................................................27
Self-adhesive tapes ........................................................77
Cable connectors ............................................................6
Hydrogenator/autoclaves ...............................................5
Separators ......................................................................11
Capping machines ..........................................................9
Industrial control & sensing devices .......Front inside cover
Short path distillation unit ..........................................45
Chains..............................................................................6
Informatics ....................................................................27
Silicone carbide heat exchangers ...................................5
Injectable powder-filling machines ...............................9
Skid mounted systems..................................................45
Invertor/variable frequency drives ... Front inside cover
Sludge dryer ..................................................................45
Knife mill ....................................................................11
Spherical paddle chopper dryers ...................................5
Level controllers ..............................Front inside cover
Spray analysers..............................................................25
Linear vial washing machine .......................................76
Spray control unit.........................................................25
Lipid food processing ...................................................11
Spray fabrication...........................................................25
Liquid-filling lines ..........................................................9
Spray nozzles and accessories ......................................25
Liquid-filling machines ..................................................9
Static pass box...............................................................76
Liquid-liquid extractor.................................................45
Sterilisers .......................................................................74
Measuring & monitoring relay.......Front inside cover
Sticker (self-adhesive) labelling machines ....................9
Membrane filtration unit.............................................80
Switching relays ................................. Front inside cover
Motion controls ................................. Front inside cover
Tablet press machine .................................................90
Mullers...........................................................................11
Tableting machinery...................................... Back cover
Multi-function mill ......................................................11
Temperature controllers ................... Front inside cover
Multiple effect evaporator............................................45
Timers................................................. Front inside cover
Packaging machines .....................................................9
Tunnel bottle rinsing machine ....................................74
Photoelectric sensors ......................... Front inside cover
Turnkey projects.............................................................5
Pneumatic component .................................................11
Turnkey systems for dust suppression........................25
Process heat exchangers .................................................5
Twin-screw co-rotating extruders ...............................21
Process reactors...............................................................5
Twin-screw elements ....................................................21
Filters .............................................................................11
Programmable logic controllers ....... Front inside cover
Twin-screw extruders ...................................................21
Filtration equipment ....................................................11
Programmable terminals................... Front inside cover
UPLC ...........................................................................27
Filtration system ...........................................................11
Proximity sensors .............................. Front inside cover
Vacuum conveyors .....................................................77
Flexible enclosures........................................................78
Pumps............................................................................75
Vacuum pumping unit.................................................80
Food analysing & testing machine ..............................11
Rapid endotoxin detection system............................79
Vacuum technology......................................................75
Forced circulation evaporator .....................................45
Rapid mixer granulator................................................79
Ventilators .....................................................................77
Gas conditioning and fire protection .......................25
RFID ................................................... Front inside cover
Vision sensors .................................... Front inside cover
Gear pumps...................................................................75
Rising film evaporator..................................................45
Washing and air jet cleaning machines......................9
Geared box ....................................................................23
Rotary gear pumps .......................................................75
Wastewater treatment equipment ...............................11
Geared motor................................................................23
Rotary tablet press ........................................................90
Wet glue-labelling machine ...........................................9
CIP/SIP module ......................................................74, 78 Columns & chemistries................................................27 Complete tablet bottle packaging lines.........................9 Conical screw dryers.......................................................5 Connectors ......................................................................6 Counters & power supplies............... Front inside cover Crushers.........................................................................11 Dehumdifiers..............................................................41 Double-sided rotary tablet press .................................90 Drives................................................... Back inside cover Dry syrup powder-filling lines.......................................9 Empower .....................................................................27 Encoders ............................................. Front inside cover Exhibition - ADEA - Automotive Dealership Excellence Awards ..........................................................8 Exhibition - Biosimilars India 2010 ............................29 Exhibition - Engineering Expo..............................13, 31 Exhibition - Healthex 2010..........................................10 Exhibition - India Chem 2010.....................................12 Factory automation.............................. Front gate fold Falling film evaporator.................................................45
COMPLETE ENGINEERING UNDER ONE ROOF @ August 2010
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Modern Pharmaceuticals
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ADVERTISERS’ LIST
Advertiser’s Name & Contact Details
ADEA
Pg No
8
Advertiser’s Name & Contact Details
Pg No
Engineering Expo
13,31
Advertiser’s Name & Contact Details
Premium Transmission Ltd
23
T: +91-22-30034650
T: +91-9920401226
T: +91-20-27488886
E: prachi.mutha@infomedia18.in
E: engexpo@infomedia18.in
W: www.premiumtransmission.com
W: www.engg-expo.com
Shimadzu Analytical (I) Pvt Ltd
FETTE Compacting Machinery (I) Pvt Ltd
T: +91-22-29204741
Alfa Laval India Ltd
7
W: www.alfalaval.com ANI Engineers
75
T: +91-2752-241479 E: anivarya@sancharnet.in W: www.anivaryapumps.com Arctic India Sales
41
T: +91-11-23906777
BC
T: +91-9867168123
E: rajnish@shimadzu.in
E: srane@lmtfette.in
W: www.shimadzu.com
W: www.fette-compacting.com
Smart Logistics
FICCI
T: +91-22-30034650
12
Spraying Systems (India) Pvt Ltd
W: www.indiachem.in
T: +91-80-39853200 11
10
T: +91-80-65833234
BIC
6
W: www.sreelakshmitraders.com
T: +91-80-39127800 SSP Pvt Limited
E: info@igus.in
E: sales@bonfiglioliin.com
19
T: +91-129-4183700
W: www.igus.in
E: info@sspindia.com
W: www.bonfiglioliindia.com
International Marketing Services 9
T: +91-79-40213213
75
T: +91-80-23310124
Live Wire
W: www.brothers.co.in
Misumi India Pvt Ltd
E: info@steerworld.com W: www.steerworld.com
FGF
Techno Force Pvt Ltd
45
T: +91-79-25841491
T: +91-20-66470000
T: +91-22-25564098
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88 Modern Pharmaceuticals
August 2010
Modern Pharmaceuticals
August 2010