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Editorial
Winning, the outsourcing way
W
ith patent expiries of several blockbuster drugs looming large on the horizon amid rising costs of R&D coupled with declining productivity, and an increasing shift towards generics or branded generics, global pharma majors have no option but to realign their sourcing strategies. In the process, there is a growing need for outsourcing their research and manufacturing jobs to low-cost geographies, primarily to save cost and time, besides focussing on their core R&D and brand building activities. In fact, as per a recent report, the global Contract Research and Manufacturing Services (CRAMS) market is likely to touch a whopping $ 85 billion by 2012. The report further states that the Indian CRAMS market pegged at approximately $ 3.8 billion in 2010 will be a $ 7.6-billion industry by 2012. While this seems achievable given the country’s current strengths such as more than 100 USFDA-approved plants, skilled human resources, cost advantage, among others, it will be prudent to proactively expand into niche segments by developing novel technical competencies. The good news in pursuing this strategy to ward off competition especially
from countries in East Asia is that it promises higher margins and greater entry barriers. Considering the domestic market scenario, there are expanding opportunities for smaller players in the CRAMS space, owing to outsourcing of manufacturing and packaging services by larger domestic players for the same objectives as seen globally. Further, with value added services such as novel drug delivery systems, combination drugs, etc the value proposition can be enhanced significantly. Simpler said than done, while in one hand, the foreseeable future of Indian CRAMS market has the potential to break bigger grounds, in particular, contract manufacturing outsourcing for APIs and high-end contract research business, there are ample scopes for improvement. Some of the focus areas can be biotechnology related contract research, genomics & proteomics research, pre-clinical research, etc. For further insights into CRAMS, turn to ‘Industry Update’ and ‘Market Scope’. More details will follow as this segment continues to grow.
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Senior Editor: Manas R Bastia
August 2011 I Modern Pharmaceuticals
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Contents 36
FE AT URES 28
LEADERS SPEAK 'I want to see the world evolve into a better place, and with the help of science I am trying to achieve that aim' ...says Dr Robert S Langer, David H Koch Institute Professor, Massachusetts Institute of Technology
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ROUNDTABLE
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INDUSTRY UPDATE
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Drug marketing: Are social networking sites safe enough? CRAMS for APIs in India: Need to move from cost to intellectual arbitrage
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MARKET SCOPE CRAMS market: India moves forward
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GLOBAL TRENDS Indo-Japan trade relations: Attaining new heights Kishor Jagirdhar, Executive Member, India Japan Global Partnership Summit (IJGPS)
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MARKET TRENDS Indian CROs: Achieving global success
INTERFACE
50 52
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'Today, research in tissue has progressed towards regeneration or restoration’ ...says Dr John Fraser, Principal Scientist, Cytori Therapeutics Inc 'Detection technologies will become increasingly popular in the coming years as its price will come down’ ...says Dr Jorma Lampinen, Senior Scientist, Thermo Fisher Scientific, Finland
RETAIL ZONE Suggestive selling in pharma: Understanding the customers and their requirements Rajendra Pratap Gupta, International Healthcare Policy & Retail Expert
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LEGAL EDGE Nuclear medicine patents: Insights into the Indian scenario Anuradha Salhotra, Managing Partner, Lall Lahiri & Salhotra
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INDUSTRY INSIGHTS Major depressive disorder market: Static and weak competitive market Courtesy: GlobalData
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REGUL A R SEC TIONS Editorial ............................................................ 13 National News.................................................. 16 World News...................................................... 22 Tech Updates.................................................... 26 Events Calendar................................................ 68 Technology Transfer ......................................... 70 Book Shelf ........................................................ 72 Product Update ............................................... 74 Product Index ................................................... 89 Advertisers’ List................................................ 90
CASE STUDY Track-and-trace: A new approach utilising unique bottom marking Didier Lacroix, Senior Vice President - Worldwide Sales & Marketing, Cognex Inc
Highlights of Next Edition: Industry Update Biotech Market Trends Clinical Data Management Note: ` stands for Indian rupee, $ stands for US dollar and £ stands for UK pound, unless mentioned otherwise
14
Looking for a specific product? We will find the product for you. Just type MPH (space) Name of the Product and send it to 51818 eg, MPH (space) Bioreactor and send it to 51818. Modern Pharmaceuticals I August 2011
National News Glenmark ini ates Phase IIb human trials globally for its novel molecule revamilast Glenmark Pharmaceuticals has announced that its Novel Chemical Entity (NCE) revamilast (GRC 4039) has initiated Phase IIb human dose range finding trials globally. Revamilast is an orally active, potent and selective inhibitor of phosphodiesterase 4 (PDE 4) that is currently being developed by Glenmark for the treatment of chronic inflammatory disorders such as asthma, Rheumatoid Arthritis (RA) and other
inflammatory diseases. The Phase IIb studies that will be carried out will help establish the efficacy and safety of the molecule and will also provide dose range finding data for revamilast. Dr Steffen Stuerzebecher, President and Chief Medical Officer, Glenmark Pharmaceuticals Ltd, said, “The clinical trials and the animal studies data for revamilast are promising for both indications, ie asthma and RA.
Lilly and Lupin collaborate to fight diabetes
Eli Lilly India (Lilly) and Lupin Ltd (Lupin) have entered into a strategic collaboration to promote and distribute Lilly’s huminsulin range of products, including Huminsulin RTM, Huminsulin NPHTM, Huminsulin 50/50TM, Huminsulin 30/70TM and Humapen Ergo II. Lupin’s formulation business in India will promote and distribute the range of products in India and Nepal, by deploying a sales force of 300 medical representatives to provide education and resources to physicians and patients. Lilly hopes to increase access to HuminsulinTM
products through its relationship with Lupin India, bringing one of the most basic and proven therapies for diabetes treatment to more patients. Eberhard Ludewigs, Vice President, Emerging Markets, Eli Lilly and Company, said, “We will have a stronger footprint with many more sales representatives promoting our diabetes brands, and this will become a foundation to expand our diabetes business not only for current products, but also for our future pipeline. Lupin is well-aligned with Lilly’s goal of expansion in India and other emerging markets.” Shakti Chakraborty, Group President, India Region Formulations, Lupin Ltd added, “This bears testimony to Lupin’s existing market reach and will go a long way in strengthening our leadership position in the Indian diabetes market.”
For Glenmark, this is a significant development as we have built on more than a decade of experience in the PDE 4 space to progress an exciting molecule to phase II human trials.” The objective is to determine the efficacy of three doses of revamilast compared to placebo in the treatment of more than 400 patients with active RA who showed an inadequate response to methotrexate.
Ranbaxy launches letrozole tablets in UK, Romania, France Ranbaxy Laboratories Ltd, (Ranbaxy) has announced the launch of letrozole tablets 2.5 mg in UK, Romania and France. Letrozole is the bioequivalent of Femara, the innovator product of Novartis, that has a market size of $ 58 million in UK (Source: IMS 2010), $ 95 million in France (Source: GERS May 2011) and $ 5.5 million in Romania (Source: Cegedim 2010). Letrozole is an antineoplastics, indicated for the treatment of breast cancer. Commenting on the launch, Debashis Dasgupta, Regional Director, Ranbaxy, Europe, said, “We are pleased to introduce letrozole at the earliest available opportunity in UK, Romania and France with a view to broadening access to medication. The product will be offered through pharmacies, retail and wholesale stores with immediate effect and will benefit the healthcare system in these EU markets.”
Cole-Parmer launches its 5th annual catalogue in the Indian market Cole-Parmer, a global leader with 50 years of experience in fluid handling, life science, general laboratory products, instrumentation and equipment, is launching its 5th annual catalogue for the scientific and process industry in the Indian market. The 272-page catalogue has numerous unique and new products, as well as returning favourites. It is segmented into four key sections: fluid handling, laboratory essentials, process equipment and laboratory equipment. It has more new products and competitive 16
prices, and is designed to help customers in their product scale-up. At the catalogue launch, Rakesh Aggarwal, Director of Operations, Cole-Parmer India, said, “We are working in an arena of customisation, where customers prefer to have solutions tailor-made to their application needs, and we offer this choice. Apart from the products listed in the catalogue, we widen the horizon for the customer by offering this option of customisation to them through our catalogue, along with other exceptional services.” Modern Pharmaceuticals I August 2011
National News Lupin se les li ga on with Medicis and enters into a JV Lupin Ltd, has announced that it and its subsidiary, Lupin Pharmaceuticals, Inc (collectively, Lupin), have settled all ongoing litigation over SOLODYN® (minocycline HCI, USP) extended-release tablets with Medicis Pharmaceutical Corporation (Medicis) and that they would be entering into a research and development agreement with Medicis to apply proprietary Lupin formulation technologies to multiple therapeutic compounds. The settlement entitles Lupin to sell its generic versions of SOLODYN® in 45 mg, 90 mg and 135 mg strengths under a license from Medicis commencing November 2011, or earlier under certain conditions. The settlement also entitles Lupin to sell its generic
versions of SOLODYN® in 65 mg and 115 mg strengths under a license from Medicis effective in February 2018, or earlier under certain conditions. In addition, the settlement entitles Lupin to sell its generic versions of SOLODYN® in 55 mg, 80 mg and 105 mg strengths under a license from Medicis effective in February 2019, or
GlaxoSmithKline launches two drugs GlaxoSmithKline Pharmaceuticals Ltd recently announced the launch of two drugs RevoladeTM and VotrientTM. Both the drugs are targeted towards specific patient categories. RevoladeTM (Eltrombopag) is approved for the oral treatment of thrombocytopenia (reduced platelet count) in adults with the blood disorder chronic immune (idiopathic) Thrombocytopenic Purpura (ITP). Announcing the launch of RevoladeTM, Dr Hasit Joshipura, Vice President South Asia & Managing Director, GSK India, said, “It is an innovative step forward in helping patients and their physicians meet the challenges of managing chronic ITP.” VotrientTM (Pazopanib hydrochloride tablets) is indicated for advanced Renal Cell Carcinoma (RCC), the most common type of kidney cancer. And Votrient’sTM approval in India is based on the results from a pivotal phase III study of patients with advanced kidney cancer who had either received no prior drug treatment, or had failed a cytokine-based treatment.”
earlier under certain conditions. As for the joint development agreement Lupin will receive a $ 20 million upfront payment from Medicis and will be primarily responsible for formulating certain novel therapeutic products for Medicis, utilising several of Lupin’s formulation technologies. Medicis will have global exclusive rights (excluding India) for the products developed under the agreement. Lupin will be eligible for future research, development, regulatory and other milestones of up to $ 38 million, as well as a single digit royalty on sales by Medicis. Medicis will be responsible for further development and commercialisation of the licensed products.
Sun Pharma to expand in the US, emerging markets Sun Pharmaceuticals Ind announced that it is open to acquisitions in both developed and emerging markets to fuel growth. “While organic growth is firmly in place, we also remain interested in inorganic opportunities in developed markets mainly in USA and in other large emerging markets,” said Dilip Shanghvi, Chairman & Managing Director, Sun Pharmaceutical Industries, during an investor call. The large emerging markets would be countries like Brazil, Mexico, Russia and China, Shanghvi said, adding, “We would like to buy a sizeable company rather than a small one.”
Tofflon to establish its subsidiary, Tofflon India, shortly One of the largest pharmaceutical freeze dryer manufacturers in the world, Chinabased Tofflon, is going to establish its subsidiary in India called Tofflon India. The company has already proceeded by renting a place in Bengaluru and has initiated the process to acquire business license. The company is positive about launching its subsidiary in India 6-7 months from now. The office in Bengaluru will majorly function as a unit for 18
maintenance, production and customer service operation. Tofflon has sold approximately 80 products to various pharma companies in India in the past eight years and generates more than 50 per cent of its revenues from the Indian market. The decision to start the Indian subsidiary was announced during a one-day seminar that Tofflon had organised with its Indian marketing and
distributing partner Raj International on lyophilisation in Ahmedabad. “The API sector is exploding in India; most of the API products are either being exported from India or China. Thus, the focus is increasing on automation and isolation techniques as the western regulatory authorities need companies to comply with these techniques,” said Jwalant Rana, CEO, Raj International. Modern Pharmaceuticals I August 2011
National News WHO Geneva approves Mission Vivacare’s Indore facility
World Health Organization (WHO) Geneva had inspected Mission Vivacare Ltd’s stateof-the-art manufacturing facility for oral dosage forms (tablets, capsules, powders and pellets) in March 2011 and has granted approval for Good Manufacturing Practices (GMP) and marketing the products to the developing markets. Prior to the facility approval from WHO, Geneva Mission Vivacare has received approval for ISO 9001, ISO 14001, OHSAS, HACCP. It has also received US
GMP compliance certification from NSF International for its dedicated, ultramodern dietary supplement manufacturing facility at Indore. The WHO, Geneva approval has put Mission Vivacare in a band of select leading Indian pharmaceutical companies who have achieved this milestone paving a way to new businesses of supplying essential medicines to reputed global NonGovernment Organisations (NGOs) and also enter into the new markets of Africa, LATAM and the Middle East. With this facility approval, the company promoted by Akkshay Mehta, Managing Director, is now seeking association with MNCs and large Indian pharma companies, to cater to their export requirements.
Fujifilm and Dr Reddy’s in JV Fujifilm Corporation and Dr Reddy’s Laboratories (DRL) Ltd have signed a Memorandum of Understanding (MoU) to enter into an exclusive partnership in the generic drugs business for the Japanese market and to establish a Joint Venture (JV) in Japan. A definitive agreement will be signed during the course of the calendar year. The new joint venture will have 51 per cent stake owned by Fujifilm and 49 per cent stake owned by DRL. GV Prasad, Vice-Chairman & CEO, DRL, said, “ We are confident that Fujifilm’s advanced R&D capabilities, quality systems and market knowhow backed by Dr Reddy’s cost competitive, high-quality generic drug development & manufacturing and experience as a major global generics player will help the joint venture establish a strong presence.”
Venus launches pain killer injec on Venus Remedies has launched a novel formulation, Achnil a brand of aceclofenac injection in India. Commenting on the development, Manu Chaudhry, Joint Managing Director, said, “This novel formulation based on Novel Drug Delivery System (NDDS) technology will fill in the gap of long-standing demand for better pain management therapies, especially for the aged population.” She further added that the product would not only reduce the number of pricks, but will also drastically reduce the side-effects associated with the use of Non-Steroidal, Anti-Inflammatory Drugs (NSAIDs). The company said it took more than seven years for the successful completion of phase-I, phase-II and phase-III clinical trials and regulatory approvals from DCGI for this product.
Hetero launches dapoxe ne in India Hetero Healthcare Ltd, a leading Indian multi-national drug manufacturer, has announced the launch of Kutub across India. Kutub is now available at medical stores all over India and will be priced at ` 79 for 4 tablets pack of Kutub 30 mg and ` 149 for 4 tablets pack of Kutub 60 mg. Dapoxetine, the generic name of Kutub, is the world’s first and only drug in the pharmaceutical market for on-demand use in Premature Ejaculation (PE). Considering the extensive worldwide trials for dapoxetine and their successful results, Hetero has introduced this drug in India. It heralds a new beginning in the treatment of PE as dapoxetine is a unique medicine (tablet), designed to be taken only when needed, that is 1-3 hours before anticipated intimate activity. The drug is being manufactured for the Indian market at the award winning manufacturing facilities of Hetero in the country.
Claris receives MHRA approval for Ahmedabad unit Claris Lifesciences Ltd, has received approval for its plant at Ahmedabad from the Medicines and Healthcare product Regulatory Agency (MHRA) of the UK. With this approval Claris can re-launch its PVC bag line products in the European Union (EU) and this approval is a big step towards resolving the bag issue in totality, a company 20
statement said. Claris had earlier recalled three of its products sold in bags from
the US in June 2010. Post this recall, the MHRA had inspected the Claris plant in Ahmedabad in October last year, the release said. This approval will benefit Claris as EU is a lucrative market both in terms of revenue and margins. The European Union is the second largest market for injectable in the world, next only to the US, it added. Modern Pharmaceuticals I August 2011
World News Thermo Fisher Scien fic wins R&D 100 Award with UV-Vis spectrophotometer Thermo Fisher Scientific Inc, the world leader in serving science, announced that its Evolution™ 200 series of next-generation UV-Visible spectrophotometers featuring INSIGHT and Customized User Environment (CUE) software has been named one of the most technologically significant products of the past 12 months by R&D Magazine. It Evolution TM 200 is designed for analyses in the QA/QC, life science and material science industries; the instruments combine high performance and straightforward software, enabling personalised operation for greater productivity. This technology has been recognised for its unique nature of the platform for spectroscopy analyses that can be tailored to individual measurements. The INSIGHT software is designed to improve the user experience by simplifying method creation and results interpretation. It includes CUE scripting capabilities, which
J&J announces new sustainable ini a ve On the occasion of J&J’s 125th anniversary, the company announced their five-year plan to move into a sustainable and environmentally friendly direction called Healthy Future 2015. “Today the world is facing a number of complex social and environmental challenges, from the millions of people around the world who lack access to adequate healthcare and medicines, to the rising global demand for natural resources in the face of a burgeoning population,” said William C Weldon, Chairman, Board of Directors & Chief Executive Officer, Johnson & Johnson. “Whether it is the private, public or nonprofit sector, we must all play a role, preferably in collaboration, to ensure a sustainable and healthy future for generations to come,” he added.
Dr Reddy’s acquires business of JB Chemicals in Russia Dr Reddy’s Laboratories recently announced that it has entered into an agreement with JB Chemicals & Pharmaceuticals to acquire their pharmaceutical prescription portfolio in Russia and other CIS regions. The agreement involves acquisition of 20 brands the key ones among them being Metrogyl and Jocet, for a consideration of $ 34.85 million. They have also entered a supply agreement with JB Chemicals for the continued manufacturing and supply of products associated with the acquired brands. Commenting on the acquisition, Satish Reddy, Managing Director & COO, Dr Reddy’s, said, “Russia is one of our leading markets where we enjoy a strong equity with stakeholders. This acquisition will help expand our prescription, hospital and OTC portfolio, complement our existing strong basket of products and add to our growth aspirations in the Russia & other CIS regions.” 22
enables the user to create a dedicated analyser with a simplified, customised user interface to streamline workflows, enforce proper procedures and reduce errors. CUE scripts can be locked from further editing, resulting in custom programmes that can be run in regulatory environments. The Thermo Scientific Evolution 200 instruments feature high quality accessories and application-specific technology to meet a wide range of sampling needs, including Application Focused Beam Geometry (AFBG) technology that optionally tailors the instrument’s optical system to specific applications for microcells, solid sampling and fibre optics. Forward-looking design elements also include a moveable detector, integrated triggering for automation or interaction with other laboratory instruments and a local control module with USB accessory support.
Vanda Pharmaceu cals signs a deal with Biotoscana Farma Vanda Pharmaceuticals Inc, a biopharmaceutical company focused on the development and commercialisation of products for Central Nervous System (CNS) disorders recently announced that they have received exclusive license agreement with Argentinabased Biotoscana Farma SA, a wholly owned affiliate of Biotoscana International, based in Bogota, Colombia, for the commercialisation of Fanapt in Argentina. “We are excited to achieve this step on the path towards making Fanapt™ available in Argentina and are pleased to have Biotoscana as our commercial partner,” remarked Dr Mihael H Polymeropoulos, CEO, Vanda. Under the terms of the agreement, Biotoscana will seek regulatory approval for Fanapt in Argentina and Vanda will supply Biotoscana with Fanapt drug product for packaging and sale and Biotoscanas’ CNS specialty sales force will promote Fanapt to psychiatrists in Argentina. “This marks another important milestone for the Fanapt brand as we continue to grow our presence with Fanapt in Latin America,” added Dr Polymeropoulos. Ricardo Munoz Ridau, Co-founder & CEO, Biotoscana, stated, “We are very pleased to partner with Vanda in Argentina with Fanapt™. Our recently submitted regulatory filing for marketing authorisation for Fanapt marks the first step in the process towards the commercial launch of the drug in Argentina.” Modern Pharmaceuticals I August 2011
World News Merck and Serum collaborate to develop PCV Merck and Serum Institute of India Ltd, an Indian company, recently announced that they have signed an agreement to come together for the development as well as commercialisation of Pneumococcal Conjugate Vaccine (PCV). PCV is used in the emerging and developing world countries, and is estimated that one out of every two children immunised in the world is vaccinated by a vaccine manufactured by Serum Institute. Merck has also developed more than one-third of the world’s vaccines for children, adolescents and adults. Pneumococcal disease is a bacterial infection which leads to pneumonia, meningitis, sepsis and other life-threatening ailments. Approximately one million children - mostly young, die of pneumococcal disease every year. Merck and Serum as a collaborative unit will form a Product Advisory Committee to oversee the activities required to develop and seek approval for PCV and pursue World Health Organization (WHO) prequalification. According to the agreement, Merck will receive a specific right to market PCV in certain designated territories, whereas Serum will receive specific rights in other territories. Both of these will contribute to the development and manufacturing of PCV.
Pfizer provides US regulatory update on Prevnar 13(R) Pfizer Inc announced that the US Food and Drug Administration (FDA) has issued a extension of 90-day to the action date for the Companys’ supplemental Biologics License Application (sBLA) for the use of Prevnar 13(R), (Pneumococcal 13-valent Conjugate Vaccine [Diphtheria CRM197 Protein]) in adults aged 50 and above. In turn this has extended the review period to January 2012. The extension was issued due to the additional data that was presented by Pfizer. This data has been derived from an
additional immune response assay method, which was submitted to support the FDA in its evaluation of the concomitant use of Prevnar 13 and Trivalent Inactivated Influenza vaccine (TIV). The FDA considered this data submission to be a major amendment to the filing. Pfizer’s application to the FDA is based on six phase 3 studies involving approximately 6,000 subjects. Till date, the company has submitted regulatory applications for use of Prevnar 13 in adults aged 50 and more in more than 40 countries.
Big deal for nano biotech company University of Queensland (UQ) start-up company Vaxxas Pty Ltd recently announced that they will be developing a NanopatchTMvaccine delivery technology with an investment of $ 15 million from a syndicate of Australian and international venture capital funds. The Nanopatch vaccine technology originated from the research of Mark Kendall, a professorial research fellow at the Australian Institute for Bioengineering and Nanotechnology (AIBN). The Nanopatch is expected to create a huge impact on the way vaccines are delivered in the future, replacing key factors like pain, cost and refrigeration requirements of many syringe-delivered vaccines. Research conducted on animals has proven that the Nanopatch delivery system is 150 times better than syringe methods that exist in the market as it is more effective and efficient. Negotiated by UQ’s main commercialisation company, UniQuest Pty Ltd, this is one of Australia’s largest first round start-up investment companies. The investment is supported by Brandon Capital, the Medical Research Commercialisation Fund (MRCF), the Brisbane Angels, and Boston-based Health Care Ventures. This is the first ever investment for OneVentures, Brandon Capital and the MRCF in Queensland, as well as the first investment that Healthcare Ventures has made in Australia.
IVI and Inviragen develop new dengue vaccine The International Vaccine Institute (IVI) and Inviragen, have recently signed a memeorandum of understanding with the objective of making a vaccine to cure dengue, which would be accessible to countries where dengue has become an endemic disease. The IVI is in the process of developing strategies to increase the levels of awareness towards the need to invest in R&D of such vaccines, and finance the development and distribution of vaccines. As a part of the collaboration, IVI and Inviragen also plan to strengthen the regulatory and policies to 24
increase the development of the vaccine as well as raise funding to support the middle and lower middle class. Approximately 2.5 billion people out of the world’s population, are at risk of contracting dengue, a mosquito-borne infection. No specific treatment or reliable prevention method exists for the infection whose reach, already endemic in more than 120 countries, continues to grow. The DVI has received a grant of $ 6.9 million from the Bill & Melinda Gates Foundation, and will accelerate the development and utilisation of safe, affordable and broadly protective vaccines to combat dengue. Modern Pharmaceuticals I August 2011
World News Boston Scien fic’s WallFlex® Biliary RX Stent receives Canadian approval Boston Scientific Corp’s WallFlex® Biliary RX fully covered stent has received Health Canada approval for the treatment of benign biliary strictures, which supplements its current indication for management of malignant biliary strictures (narrowing or blockage). “Current management of benign biliary strictures typically includes repeated dilation with balloons and plastic stents, however, this new approval allows to offer a one-step alternative, which may help to reduce the number of procedures patients must undergo, while providing the best possible care and containing costs,” said Paul Kortan, Managing Director,
SDIX introduces two new food pathogen tes ng solu ons SDIX a leading supplier of rapid detection solutions to the $ 1 billion food pathogen testing market introduced two new food pathogen monitoring tools called the RapidChek(R) Listeria Fast Accurate Sensitive Technology (FAST) test system and RapidScanTM Data Management System. The RapidCheck system is a one-step detection of Listeria species from various environmental surfaces in as little as 24 hours. The simplified result would provide food processors with earlier product release, while maintaining highly accurate results. RapidScan system on the other hand has a reader and proprietary software that would allow objective interpretation of RapidChek pathogen detection strips and the electronic integration of the results into Laboratory Information Management System (LIMS), eliminating operator interpretation and transcription errors. This was introduced at the International Association of Food Protection (IAFP) Annual Meeting in Milwaukee, Wisconsin. Tim Lawruk, Food Safety Market Manager, SDIX, said, “The introduction of these new systems marks an important expansion of our Food Safety product portfolio. They will provide food testing laboratories with a cost-effective solution that enhances the simplicity and accuracy of the process monitoring approach, lower storage requirements and extended product shelf-life, both of which provide important economic benefits.” August 2011 I Modern Pharmaceuticals
Gastroenterologist, St Michaels Hospital, Toronto. In the US, the WallFlex Biliary RX fully covered stent is not approved for the treatment of benign biliary strictures. The safety and effectiveness of the stent system for use in the vascular system have not been established. The complete line of WallFlex Biliary RX stents has previously received Health Canada, CE mark and Food and Drug Administration (FDA) clearance for the palliative treatment of malignant biliary strictures. It is the most frequently implanted biliary metal stent in the US, Canada and Europe.
Cadila Pharma’s Ethiopian JV bags WHO cer ficate Cadila Pharmaceuticals (Ethiopia), the Joint Venture (JV) between Cadila Pharmaceuticals Ltd, Ahmedabad, and Almeta Impex Plc, Ethiopia, has bagged the current Good Manufacturing Practices (cGMP) certificate and has become the first pharma formulation manufacturing company in the African nation to comply with cGMP, laid down by World Health Organization (WHO). Primary ministers of the Government of Ethiopia, ambassadors and the management of Cadila were present on the occasion. Commissioned in 2007 and spread over 10,600 square metres of land, this is a leading pharmaceutical manufacturing plant in Ethiopia. It has the capacity to manufacture 390 million tablets, 165 million capsules and 1.44 million litres of liquid per annum.
Prism Ideas CEO acknowledged as one of the 100 most inspiring people Dr James Sawyer, CEO, Prism Ideas, has been selected by Pharma VOICE magazine as one of the 100 most inspirational and influential people in the pharmaceutical industry. He founded Prism Ideas and has contributed to advancement of pharmaceutical research, which has greatly enhanced the management and treatment options for debilitating illnesses. Dr Sawyer has dedicated a lot of time and energy Dr James Sawyer to clinical application of pharmaceutical industry research for 20 years. He has served the life sciences through a number of different roles, including clinical positions in general medicine and anaesthetics as well as in pharmaceutical clinical research. His experience as a specialist pharmaceutical physician spans all phases of clinical research and has resulted in more than 50 publications across a variety of therapeutic areas including migraine, bone metabolism, asthma and HIV. “I am surprised and delighted to have been nominated to receive this prestigious award and to be listed alongside the other recipients. The recognition represented by this award would not have been possible had I not been able to work with such innovative and pioneering individuals who share my vision of developing new strategies that advance processes within the industry to improve healthcare delivery,” said Dr Sawyer. 25
Tech Updates
HP launches authen ca on service to fight counterfeit drugs HP has recently launched its Global Au t h e n t i c a t i o n Service, a cloudbased track-andtrace solution used to fight the global problem of counterfeit and stolen drugs, estimated to claim 700,000 lives every year and representing an illegal $ 75 billion global industry. The HP Global Authentication Service allows pharma companies to monitor the movement of products through their global supply chains with a much higher degree of accuracy. This helps to protect consumers against dangerous or ineffective drugs and thereby enabling pharma companies to protect their revenue and intellectual property from the growing black market. The service’s underlying technology engine was originally developed by HP Labs – the company’s central research arm – and the HP Software Platform Services Cloud Services Innovation Center to monitor goods in HP’s supply chain. It was later adapted for use in product recalls in the food industry.
Pfizer ini ates green journey Pfizer started a green journey initiative to commit itself to a more sustainable future. It recently unveiled a biomass boiler at its Sanford, NC site, taking the company to the next level in reducing its environmental impact. Pfizer plans to utilise this renewable energy to boost its pharma and prescription drug production. The $ 7.9 million project is part of Pfizer’s global manufacturing network. The Sanford site produces key vaccine components and is in the process of becoming Pfizer’s primary site for clinical and commercial launch of new vaccine supplies. The Sanford boiler uses wood chips for feedstock from local sources to generate steam for power and thermal energy. The technology uses a vibratory conveyor to move the wood to a silo and later to the boiler for burning. The boiler generates 20,700 pound of steam per hour.
Visionary Pharmaceu cals introduces BindingSIGHT Visionary Pharmaceuticals has recently created BindingSIGHT, a proprietary computational technology platform that encompasses an advanced suite of structural biology and chemical informatic tools. BindingSIGHT enables sophisticated virtual screening and structure-based drug design for challenging molecular drug targets. It has also created a virtual compound library of more than 22 million compounds that has
been screened against RORBindingSIGHT fingerprints. These compounds are synthesised and screened in cell-based assays providing novel highly ligand-efficient chemical matter to drive structure-based drug discovery. Company spokesperson said that the technological advancements help the company to save time and money in generating the best possible lead stories.
Zebra Technologies launches new mobile printer Zebra Technologies Corporation, a recognised global leader in bar code, kiosk, card as well as real-time location solutions, recently announced the release of its new QLn™ mobile printer family. According to a recently released research, the global mobile worker population exceeded one billion in 2010 and with an increasingly mobile and distributed workforce, is expected to grow by over 10 per QLn™ cent over the next 3 years. Zebra addresses this growing workforce with the QLn™ , the third generation of the QL printer, Zebra’s all-time best selling direct thermal mobile line. The QLn™ builds off of the success of over 700,000 QL printers shipped to date by squarely addressing the primary 26
request made by Zebra’s customers: lower the cost of operation. The QLn™ does this by including the industry’s first Ethernet connection for mobile printers. By enabling remote status collection and better device management, the printer helps to reduce service time and maximises printer uptime, delivering a greater return-on-investment. “Business, particularly in the retail and healthcare sectors, are facing greater challenges in building customer satisfaction and increase their process efficiencies while reducing operational costs,” said Andrew Tay, President, Zebra Technologies - Asia Pacific. “The QLn™ responds directly to the business needs with innovative and expanded features without compromising on the QLn™ printer line’s durability.” Modern Pharmaceuticals I August 2011
Tech Updates
Op brium launches new version of free StarVue App Optibrium, a provider of software solutions for drug discovery, recently introduced a new version of StarVue, its innovative free desktop application that enables scientists to quickly and conveniently view sets of compound structures and related data. StarVue 1.1 is compatible with the recently released StarDrop 5, a software platform that intuitively guides the design and selection of high quality compounds in drug discovery. This compatibility improves the ease with which compound data generated with StarDrop and other sources can be shared without the need for expensive spreadsheet plug-ins. The new version of the StarVue desktop application, specifically designed for scientists searching for a simple way to
explore molecule structures and associated data, has been developed in response to feedback received following its initial launch in February 2010. Improvements have been introduced to the way data can be browsed while retaining the innovative visual interface and capacity for organising, sorting and merging data sets that StarVue previously offered. The close integration of StarVue and StarDrop makes the results of StarDrop’s unique predictions and multi-parameter analysis available to a wider audience, improving the flow of information and a project team’s ability to make effective decisions to quickly target novel molecules with the required balance of properties to become drug development candidates.
Waters Corpora on’s MassTrak™ immunosuppressants XE kit is now CE marked Waters Corporation recently declared that its MassTrak™ immunosuppressants XE kit is now CE-marked, for the quantitative measurement of the immunosuppressive drugs tacrolimus (FK506;Prograf®) in liver and kidney transplant patients and everolimus (Certican®) in adult kidney and cardiac transplant patients from human whole blood samples as an aid in the management of immunosuppressant drug therapy. Waters LC/MS/MS system, consisting of the MassTrak™ Immunosuppressants XE Kit and method, the Waters ACQUITY UPLC® UltraPerformance Liquid Chromatography system coupled to an ACQUITY® TQD tandem quadrupole mass spectrometer, offers enhanced sensitivity and specificity, and measures target compounds at low ng/mL levels (0.5 ng/mL). “LC/MS plays an increasingly important role in many clinical laboratories. Waters is committed to advancing technology-based diagnostic solutions in the clinical laboratory that impact the quality of results in many areas including immunosuppressant drug monitoring,” said Mark Bruns, Senior Director, Clinical Business Operations, Waters Division.
UNC-CH, Duke teams learn how cells stay healthy The team at Duke University and UNC-CH figured out that a protein related to cancer is a crucial link in the chain of events that splits apart the cellular generators - even in healthy cells. It is a connection that nobody has made before, said Adrienne Cox, Professor of Radiation Oncology, Lineberger Comprehensive Cancer Center, UNC-CH. Cox added that it has solved a mystery that had puzzled scientists for the last few years. “Learning its function is a step forward,” said David Kashatus, Researcher, Duke’s Department of Pharmacology and Cancer Biology. “While it is not something that leads directly to cures in one to two years, it is really (one of) the building blocks that help to develop cures further down the line,” he added. Researchers from both schools emphasised the role their collaboration played in the discovery. August 2011 I Modern Pharmaceuticals
Wya Technology launches Möbius™ mobility instrument Wyatt Technology Corporation, the world leader in instrumentation for absolute macromolecular Möbius™ characterisation and software, recently announced that its Möbius™ electrophoretic mobility instrument can measure precise protein charges. The innovative optical design of the Möbius boosts the sensitivity of mobility measurements, enabling protein net charge characterisation at much lower concentrations than previously possible. Protein molecules carry charges that are influenced by their environment, amino acid sequence, ionic strength and the aqueous solvent pH in which they are dissolved. The net charge carried by protein molecules is of enormous scientific interest since it affects the behaviour of the molecules. As the ionic strength of the solution increases, for example, more counter ions are present in the vicinity of the protein molecules and the mobility generally decreases due to the electrophoretic effect. This new application note demonstrates how the Möbius™ overcomes the limitations of traditional Phase Analyis Light Scattering (PALS) methods, eliminates undesirable interactions and facilitates protein charge measurements at low concentrations — all without damaging the protein itself. 27
Leaders Speak
‘I want to see the world evolve into a be er place, and with the help of science I am trying to achieve that aim’
…says Dr Robert S Langer, David H Koch Ins tute Professor, Massachuse s Ins tute of Technology, as he gets candid about his work and the field of drug delivery. Backed by a list of achievements and honours, this drug delivery man’s patents have been licensed or sublicensed to over 220 pharmaceu cal, chemical, biotechnology and medical device companies. He has served as a member of the US Food and Drug Administra on’s (FDA) SCIENCE Board, the FDA’s highest advisory board, from 1995-2002 and as its Chairman from 1999-2002. Among the various awards, in 1998, he received the LemelsonMIT prize, the world’s largest prize for inven on for being ‘one of history’s most prolific inventors in medicine.’ In 2002, Dr Langer won the $500,000 Draper Prize, considered the equivalent of the Nobel Prize for engineers.
©Bachrach Photography
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Leaders Speak Parita Dholakia When one comes across a resume that is divided into three parts and combined runs to more than 60 pages, he/she can only wonder how eventful the person’s life must have been. The man in question, Dr Robert S Langer, is the most cited engineer in history and his list of achievements fades any ordinary person’s achievements. Despite all this, he is known to be humble, and to say I was eager for this interview to ascertain the above would be an understatement. After spending more than three decades in this field, holding more than 800 patents, authoring more than 1100 research papers, only one term defines him aptly - successful. So how has success changed him? “I do not think I have changed much. I have been doing the same things that I used to do ages ago.” But then, with so many successful projects and innovations under his belt, does he feel any pressure to be successful and different each time? “I do not think there is any pressure as such. I want to see the world evolve into a better place, and with the help of science I am trying to achieve that aim. I want to train young people and help them become good scientists. These are the things that are more important to me than anything else.” Talking about his background, this “Hero whose research may save your life” (Parade Magazine, 2004), recollects, “Education has always been important. My parents believed in it, but I guess more than them it was me. I was disciplined when it came to studying.”
The miracle man It is difficult not to be awed by a personality such as Dr Langer. As ‘One of the 100 most important people in America’ (Time Magazine and CNN, 2001) talks about the turning point of his career, I notice the sudden surge in enthusiasm, reflecting how much it means to him, “I think working in the Judah Folkman Lab was the turning point in my career. Most of my classmates joined the chemical and petrochemical
Quick Picks Dr Langer’s ingenious work has led to the ultimate development of transdermal patches, injectable microspheres, slow release implants, and will someday perhaps lead to implantable microchips.
industries, while I went ahead and did research in a hospital.” His job at the lab included isolating molecules that inhibit blood-vessel growth. The journey to break grounds in tissue engineering, achieving the reconstruction of tissue and organs using novel biodegradable materials started here for this chemical engineer. This also shows that following one’s passion may be difficult than following a traditional career path but can bring worthy results.
Impac ul journey A few decades ago, design engineers would not even consider using polymers for implantable medical devices. But Dr Langer has changed it all. Instead
Dr Langer’s idea of ideal research A huge idea: Conceived by recognising a critical need of a society that could be met by inventing a platform product A seminal paper based on research to establish the underlying science of product concept and its efficacy A blocking patent derived from patent disclosures written in parallel with the research process, the goal being to have patent filed before the research papers publication Invivo studies to demonstrate the efficacy of research Source: Harvard Business School Case Study
August 2011 I Modern Pharmaceuticals
of using plastics and materials off the shelf, his lab designs polymers based on specific requirements. Starting with the development of chemo-wafers to treat cancer, drug-eluting stents for cardiac diseases, biorubber, tissue regeneration for organ replacement, a lot has been achieved and much more is in store. So, when I ask him, ‘What is next?’ he talks about some of the projects that are exciting, hold potential and are in clinical trials. “There are several ongoing projects for tissue regeneration. Tissue engineered skin and engineered blood vessels are already used. We are also working on for tissue regeneration in the voice box, thereby making vocal chords. I am hopeful to see this in trials soon. We are also working on creating new biomaterials with shape memory or surface switching properties. Personalised medicine and targeted therapies using nanotechnology are other exciting fields, and we are working on that too.” Polymer technology is gathering momentum, and one of the main drivers for this would be Dr Langer. In the near future, he believes that recyclability will become a major consideration in development of medical devices. Re-fillable drug delivery devices, as promising as they may seem, will probably not stand strong due to issues of liability, contamination and device robustness. Dr Langer’s work has made possible the drug-eluting stent, which is a boon for cardiac patients. It is available globally and has saved millions of lives. His ingenious work has led to the ultimate development of transdermal patches, injectable microspheres, slow release implants, and will someday perhaps lead to implantable microchips that can be triggered to release drugs by remote control, eg, using a wristwatch, among others.
Money ma ers With the success achieved and ideas that have come out of this lab, does he still face difficulty in garnering funds for some very ‘out-of-the-box’ ideas? “At 29
Leaders Speak times we do find difficulty, but luckily it has not been that bad.” This comes from a man whose initial proposals (the first 10 of them) and requests for grants were turned down. How does he feel about it? And what advice would he give to young scientists whose grant proposals have been declined. “I was really disappointed when my proposals were turned down. My advice to young people would be to hang in there; one should keep trying, it is a hard process but one has to live through the criticism. I did what I could do, struggled initially but never stopped trying.” Talking about young scientists, I ask whether he believes that the next generation is geared towards achieving continued success in this field. As ‘one of the 20 most important people in this area’ (Discover Magazine 2002) pauses for an answer, you realise he might be scanning the potential lying ahead. “I think the next generation is well capable of handling this progression. Probably our generation was ok, but this generation is really good. The type of people in my lab, in the campus; there lies a lot of potential out there.” Dr Langer, one of the 15 innovators worldwide who will reinvent our future (Forbes 2002), holds great respect for the work carried out in the field globally. When asked about which work done by others look promising, he is quick to revert to ‘stem cells.’ “Better understanding of the difference between cancer cells and stem cells is an area highly worked upon. The idea of cancer stem cells is very exciting.”
The ‘Langer’ factor Dr Langer’s research lab is the largest biomedical engineering lab in the world maintaining about $10 million in annual grants and over 100 researches. His research lab has been the subject of an interesting case study (The Langer Lab: Commercializing Science) by the Harvard Business School. The description reads ‘Professor Robert Langer’s laboratory at MIT is the source of an unusually large number of published papers, patents, and technology licenses to start-up and established companies in the biomedical industry.’ The study explored Dr Langer’s leadership and
Be er understanding of the difference between cancer cells and stem cells is an area highly worked upon. The idea of cancer stem cells is very exci ng.
other factors that create a successful research enterprise. Biomedical engineers and pharmaceutical experts can only imagine how it must be to work in this lab. He has launched at least a dozen biotech firms and advises several more. More than 200 companies hold licenses to his patents. That means his discoveries reach the marketplace to
A few facts about the man Dr Langer has received honourary doctorates from Harvard University, the Mt Sinai School of Medicine, Yale University, the ETH (Switzerland), the Technion (Israel), the Hebrew University of Jerusalem (Israel), the Universite Catholique de Louvain (Belgium), Rensselaer Polytechnic Institute, Willamette University, the University of Liverpool (England), Bates College, the University of Nottingham (England), Albany Medical College, Pennsylvania State University, Northwestern University, Uppsala University (Sweden) and the University of California - San Francisco Medal. He received his Bachelor’s Degree from Cornell University in 1970 and his ScD from the Massachusetts Institute of Technology in 1974, both in Chemical Engineering.
help people. When asked about how he decides which disease to tackle next or which delivery system to use or make, he clarifies that they rarely target a particular therapeutic area. Talking about how the drug delivery systems have evolved over time, he stresses, “Patient-outcomes based healthcare has opened up several opportunities for managing drug delivery. Hence, some ideas for developing certain drug delivery systems which were considered difficult a few years ago, are now under trials or in use.”
Success will linger… One of the 25 most important individuals in biotechnology in the world (Forbes Magazine & Bioworld, 1999 & 1990) ponders when I quiz about who he believes would be the leaders in biotech in the next decade; he replies, “It might sound biased but I believe it will be the US. There is a lot of innovative research currently going on, it is the current global leader, and the right talent and funds are available.” Probing his views for research carried out in India and Indian companies, he says, “I have heard that a lot of good innovative companies are coming up in India. The generic market is also very strong there.” As someone who believes that the biotech industry globally has done and is doing immensely well, he still believes that there is much more to come. So does he see any Dr Robert Langer Jrs lurking around in the MIT campus? He signs off saying, “Oh, there are many brilliant people in this institute. I am sure there are many here who will be better than me.” After this interaction, what strikes me the most is that he is a man with a mission to change the world and has indeed come too far. There is nothing more satisfying for a person than knowing that everyday directly or indirectly he helps save lives. And who else but Dr Langer can testify for the same. As far as ascertaining his humility factor was concerned, he did come out with flying colours. MPh (parita.dholakia@infomedia18.in)
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Roundtable
Drug marke ng
Are social networking sites safe enough? Social networking sites are not just about celeb check anymore or the way to stay connected. The prevalence of these sites has extended to drug marke ng. But when safety is in ques on, opinions are divided. Experts voice their views whether e-marke ng is all spam, even if handled well. Chandreyee Bhaumik
A
ccording to a formal complaint submitted to the US Federal Trade Commission (FTC) by separate groups, pharma marketing on the Web threatens consumer privacy and engages in unfair and deceptive practices. Further, the British Medical Journal cited the report in an article that big pharma’s online marketing activities pose a great threat to public health. It is interesting to see that direct-to-consumer advertising that includes the name of a prescription drug, health claim and contraindications is prohibited in Canada and highly regulated in the US. Additionally, according to a 2010 report in Pharma Marketing News, there may be hundreds of patients in social networks earning thousands of dollars from drug companies to provide ‘real patient stories’ as part of online branded drug or disease-awareness campaigns. Thus, there are enough chances of ambiguity to discern the usage of social networking sites for pharma marketing.
It is unfortunate that as yet the social networking sites cannot be relied upon. E-marketing of drugs is all spam if not handled well. Further, it appears that the sites are used by pharma companies as the podium for selling their brands. In order to make e-marketing successful, we have to make groups on these sites focussed. There should be passwords to restrict the entry of unnecessary people and irrelevant discussions. Further, there are several laws by Food and Drug Administration (FDA) along with the Drug and Cosmetics Act (1940) that prevent random marketing of drugs. Additionally, there are various cyber laws that explain the details of online marketing in details. All these laws should be carefully studied and consulted before taking any action. 32
Further, regulations vary from country to country. In the US, the guidelines are strict and therefore followed religiously. And the regulations of Mexico permit online marketing of drugs. Again, hyper words should not be used in order to facilitate marketing of the drugs. Thus, in order to venture into e-marketing of drugs, the person concerned or the group in question should have sufficient data or required approvals. However, one can be hopeful that the situation will get better in the next 5-10 years, and in this our government has to take the needed initiative. Abhijit Singh Parmar Senior R&D Executive- R&D Analytical, R&D Technical Centre - Mumbai, Johnson & Johnson Ltd Modern Pharmaceuticals I August 2011
Roundtable
Advertising in pharma industry has become a mainstay in marketing of a particular drug or therapy option. These marketing methods are generally aimed at the prescribing physician as he/she is the ‘gatekeeper’ between the consumer (patient) and the manufacturer (pharma company). Advertisements in pharma industry are of different types like Direct-to-Consumer (DTC), prescription drug advertising, Over-the-Counter Drug (OTC) advertising. DTC advertising is permitted only in the US and New Zealand. DTC drug advertisements are not permitted in any other countries of the world. Hence, DTC-related problems are only relevant in the above two mentioned countries. With the advent of the Internet, websites and web pages dedicated to healthcare have sprung up. Many pharma companies have dedicated websites for a particular drug itself or a disease segment or a therapy option. Pharma online DTC spending has diversified to support these third party blogging sites/individuals to keep up high levels of interest in
the therapies offered by generating positive responses. Social networking is the latest in the new online phenomenon that has created a sensation across the world. This instrument is being successfully used by many business sectors for successful advertising, sales, customer feedback and thereby increasing the overall value of the product. Pharma companies are catching on to this phenomenon but are relatively slower. The biggest problem is the relative freedom of speech and the anonymity of the Internet and social networking platforms. Online chat discussions, tweetinars or polls may be seriously compromised by the lack of trust. The nonmoderated forum may spread ideas favouring a particular drug (obviously from the company) or might get ‘flamed’ unjustly by a rival or mischief mongers.
Pharma companies do not contact patients (for non-OTC products) directly to speak to them about products or brands. But, disease awareness campaigns (no mention of the products) are run and conduct activities with the objective of educating patients. The industry realises that it must keep up with the changing communication landscape. Clearly, social networking presents a huge opportunity. Yet, there are no specific guidelines available at this point on the use of social media for drug marketing. The use of social networking sites, therefore, would depend on ‘Who is our audience’ and ‘What are we telling them’? Such sites can be used to reach out to physicians to disseminate information on products, while ensuring that this use is restricted to controlled groups, eg, blogs specifically for physician communities. While the possibilities are immense, it is also imperative that we abide by all legal and regulatory
requirements while participating in social networks, as messaging on the web cannot be entirely controlled. Therefore, checks and balances should be in place to ensure that the information provided is accurate, supported by evidence, does not mislead and is properly communicated. It is also critical to be aware of the implications of the medium on pharmacovigilance and adverse event reporting. The impact can be far reaching. Thus, it is essential for the industry to collaborate with government and regulatory bodies, as well as patient advocacy forums, to develop appropriate guidelines for the responsible use of social media in offering healthcare solutions.
Quite a lot of drugs, almost 70 per cent of e-marketing of drugs on the social networking sites are spam. Compared to the US, India is less efficient in online marketing of drugs. Again, there are some medical professionals like me who are not that net savvy to handle this with expertise. Further, there should be passwords and several other security checks that would prevent the site from hacking and the consequent illegal marketing. Again, the participation of the pharma companies should be well monitored so that it does not appear that they are trying to influence the customers. So, the sites must be maintained well. Thus, the entire system of social websites needs to get more improved. The medical fraternity is also required to get net savvy. Here, we have to
change our mind set. If a drug is prescribed by a physician then social networking sites are safe choice. However, unfortunately, Indian patients have the tendency to self-treat. Thus, if a doctor has prescribed a particular drug for acidity, that becomes the usual medication for it. The patient does not even care about the other health conditions. Thus, the sites should not be considered as the medium for prescription but instead the sites should be used intelligently with adequate knowledge from the Internet.
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Dr Mandar Kubal Consultant - Infectious Disease and HIV AIDS, Infectious Diseases and Pulmonary Care (IDPC)
Dr Pravin Chopra Senior Director- Medical and Regulatory Affairs, Sanofi, India
Dr Satish Kulkarni Gastroenterologist and Hepatologist, MGM Hospital 33
Roundtable
As far as drug marketing is concerned, we should have two way communications. In this context, it can be said that feedback assumes a considerable significance. With the relevant feedback, several attributes of marketing can be worked upon that needs special consideration. Again, when people are voicing their opinion on Facebook and many such sites, pharma companies should read them with careful attention. This will help them to work in future. Thus, drug marketing will become an interactive and therefore an exciting one. For example, if a person is suffering from calcium deficiency and he is not receiving the due benefits even after the medication, then the pharma company should have a reality check. In addition, there can be various surveys, debate forums discussing the packaging of the drugs, the ingredients and many other factors. In social media, some of the discussions can be free and some of them can involve cost.
It should be remembered that social media is not there to push one’s product or a particular brand. Social networking sites should not be considered as the medium for selling a particular brand of a drug but rather to discuss those issues that are worth more discussing. Therefore, if one utilises social media intelligently with caution, then there should not be any reason to be sceptical about e-marketing of drugs. Thus, the sites should be used for spreading awareness and consciousness regarding a particular ailment. The knowledge gained will help the mass in general.
It is true that a lot of marketing activities are taking place on various social networking sites. Today, people are not anymore passive information consumers. They have become extremely aware about the menace of counterfeiting and thereby can protect themselves from the spurious drugs. They vioce their respective opinions and hope that change will definitely come. Therefore, with time there has been a wide acceptance of the social networking sites. And, again, it is mostly seen that the benefits of these sites are reaped by the urban class who are generally considered to have the required knowledge on counterfeiting. Further, in lieu of the actual buying and selling, these sites can also be used as the feedback forum. In addition, there are also several audio clippings on the sites that describe the experience of the customers after they had the pills.
However, if we compare ourselves to the US scenario, one can easily conclude that we need to catch up a lot. People based in the US are more net savvy and thus we see that most of the blog posts are from them. Additionally, these sites should be used to spread awareness regarding a particular ailment. But, it should always be remembered that these sites are not supposed to act as prescription but instead should be used intelligently. Thus, the final call to take the concerned drug depends on the patients’ consultation with the doctor and not the social networking sites. These sites can only help in guiding but not the final decision making.
There should not be too much indulgence in social networking sites as far as drug marketing is concerned. And, especially, if it is a prescription drug there are ample chances of misunderstanding in the said cases. Patients have the tendency to self-treat. Thus, there should be laws to protect the online marketing of the drugs. Further, there can be particular websites that would target a specific group and deal with a particular subject such as cardiology, diabetes, but the access should be restricted to only that concerned group. There should be specified passwords and codes that would prevent the unnecessary and unwanted entry to the sites. An example in this context will make the matter clear. There were some Canadian pharma companies that were trying to market their products in the US. However,
the regulations in the US being strict prevented this. Therefore, there should be such strict defined laws that will ensure the safety and the security of the drugs to be marketed. To be candid, online marketing of drugs can only be safe if the insurance system rather the payment system changes. While in India, the power of treatment is still with the doctors, in the US, the authority is with the insurance companies. Thus, it must be remembered once there is a shift in the Indian scenario, the market will definitely get more structured. This will also drive a change in the economies.
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Faisal Farooqui Chief Executive Officer, mouthshut.com
Tanay Waingankar Field Marketing Manager-India, Life Sciences & Chemical Analysis, Agilent Technologies
Vikram Gupta Founder and Managing Director, IvyCap Ventures Advisors Pvt Ltd Modern Pharmaceuticals I August 2011
Industry Update
CRAMS for APIs in India
Need to move from cost to intellectual arbitrage With outsourcing becoming an ‘in’ concept in the pharma landscape, India and China - the two able pillars, con nue to be compe tors in the Ac ve Pharmaceu cal Ingredients (API) market. However, are the markets, the focus areas and the regula ons in the two countries same? Chandreyee Bhaumik
O
ver the last decade outsourcing has become a strategic issue for pharma companies due to the declining R&D productivity, increased generic competition, various blockbuster drugs going off patent, rising drug development costs and scarce new drug discoveries. Therefore, driven by pressure to protect the margins, innovators are outsourcing non-core activities like manufacturing of intermediates and Active Pharmaceutical Ingredients (APIs) to comparatively low cost destinations like India, which is likely to gain momentum. Thus, Contract Research and Manufacturing Services (CRAMS) have gained prominence in the pharma field.
Working on contract Large 36
pharma
companies
are
increasingly turning to Contract Manufacturing Organisations (CMOs) primarily to achieve efficiency in cost, capacity and time-to-market, or rather to achieve a specific expertise that is unavailable in-house. However, the most unique factor behind the use of CMOs in pharma industry is the innovative, unique and the advanced production technology that they offer. Thus, more pharma companies are moving towards outsourcing to focus on the marketing of the products without spending time in drug discovery and the process of manufacturing. Dipta Chaudhury, Senior Consultant, Pharma and Biotech Practice (South Asia and the Middle East), Frost & Sullivan, avers, “At the end of 2009, the market value of CRAMS in India was $ 1.47 billion and is pegged to be $ 9.47 billion by 2016. There are a lot of consolidations happening and the companies are gaining confidence in outsourcing. Further, with factors like Drug Master
Files (DMF) guidelines, and people gaining expertise in English language, the market is sure to gain a much more momentum.” Discussing the details of the market, Chaudhury elaborates, “As far as the volume is concerned, API assumes 80 per cent of the market and formulation takes 20 per cent. And, when it comes to the value, APIs take up 65 per cent and formulations 35 per cent.”
Dominant players Indeed, India is considered to be a major destination for outsourcing and in this there are several players who win an edge over the others. Dr Ajit Dangi, President & Chief Executive Officer, Danssen Consulting, says, “Many Indian pharma companies such as Dr Reddy’s Laboratories, Lupin Pharmaceuticals, Cipla, Aurobindo Pharma, Piramal Life Sciences, Intas Pharmaceuticals Ltd, etc are dominant players in the manufacturing space while Contract Modern Pharmaceuticals I August 2011
Industry Update Research Organisation such as SIRO, Quintiles, Veeda Clinical Research, Parexel International, ClinInvent, etc have significant share of clinical research business. Internationally, Quintiles and Covance are dominant in the contract business.” According to Vikram Gupta, Founder and Managing Director, IvyCap Ventures Advisors Pvt Ltd, in India, Piramal Life Sciences still continues to be a major player. Companies like Jubilant Life Sciences Ltd, Sun Pharma, and Glenmark Pharmaceuticals Ltd also deserve mention in this field. He adds that Hyderabad is considered as a major hub for the CRAMS market. He opines, “These companies had chosen the partnership model over the competitive model and this has given them an edge over other companies. More so as generic companies such as Ranbaxy, Cipla were busy solving their respective issues on patents; companies such as Piramal were extremely streamlined.”
India vs China The pharma industry in India is emerging as a destination of choice for CRAMS. According to various reports, API market in India is set to grow at a Compounded Annual Growth Rate (CAGR) of 24.07 per cent from 20082020, while China is expected to grow at a CAGR of 32.15 per cent in the same period. The growth rates of these two countries are tremendous as opposed to the single digit global growth rate. However, when comparison between the two countries is drawn, it is seen that the focus of operations of the two countries have been quite different. There are several regulatory issues that need to be followed for manufacturing. The US Food and Drug Administration (US FDA), pharmacopoeia and many others are taking various initiatives in order to ensure that quality is maintained. India has a pharmacopoeia and thus there is a need to focus on both quantity as well as quality. Further, Gupta says, “India and China have always been regarded as the target of big pharma as the major CRAMS market. However, the cost August 2011 I Modern Pharmaceuticals
It has been declared that all the facili es that do not comply with GMP should be shut down. And, it is unfortunate that in this condi on, almost 50 per cent of the companies will have to be closed down in China. Dipta Chaudhury Senior Consultant, Pharma and Biotech Prac ce (South Asia and the Middle East), Frost & Sullivan
advantage that India has been enjoying over China will soon disappear in the next 4-5 years. India has always been a hub for global research as scientists over here conducted research at a low cost. But, this change in the cost may drive the shift towards other countries.” However, he adds that as far as the API market is concerned, definitely China enjoys more than India because of the cost advantage. He comments, “But it must not be forgotten that India has much better control over English language than China, though it is observed that China is gradually picking up with the language.” India’s comparative advantage in this business largely depends on cost competitiveness, abundance of scientific & technical manpower and availability of large pool of genetically diverse and drug naive patients. Dr Dangi says, “Unless we move up the value chain from cost arbitrage to intellectual arbitrage, this advantage is unlikely to last long as many other countries such as China, Korea, Poland, Israel, Ireland, Brazil, etc are becoming aggressive and will give India run for its money. To retain our leadership position in this segment we need a long
term comprehensive strategic response.” He reiterates that India manufactured over 700 APIs with a turnover of $ 11.5 billion in 2009-10 meeting 90 per cent of domestic requirement. Of this, exports are $ 7.5 billion, assuming about 65 per cent of the total turnover. Additionally, the API market is expected to reach $ 17 billion by 2014 with a CAGR of 21 per cent. Depending on the complexity of manufacturing, India has 30 to 40 per cent cost advantage over developed regions such as the US and Europe. However, India is increasingly depending on Chinese imports for manufacturing domestic formulations. Dr Dangi further adds, “Although India has highest number of DMFs US FDA-approved plants outside the US, the balance is gradually tilting towards China.” And experts are of the opinion that quality in China is still an issue. As Chaudhury explains, “Recently, it has been declared that all the facilities that do not comply with Good Manufacturing Practices (GMP) should be shut down. And, it is unfortunate that in this condition, almost 50 per cent of the companies will have to be closed down in China. Further,
Unless we move up the value chain from cost arbitrage to intellectual arbitrage, this advantage is unlikely to last very long as many other countries such as China, Korea, Poland, Israel, Ireland, Brazil, etc are becoming aggressive and will give India run for its money. Dr Ajit Dangi President & Chief Execu ve Officer, Danssen Consul ng
37
Industry Update Hurdles on the way The basic challenge is that India has a short term perspec ve. Everyone over here is looking at quick buck, and their primary work gets directed on how to gain maximum profit in minimum me. Vikram Gupta Founder and Managing Director, IvyCap Ventures Advisors Pvt Ltd
GMP in India is up to date and Indian companies being highly competitive adhere to it. Definitely, in this situation, the quality factor will improve, and therefore, the companies that outsource will come to India. A quick fact check will clarify the situation. While India has 119 FDA-approved facilities, China has only 27 approved ones. Thus, India is a perfect destination for formulation and complex APIs and only the simple ones will be in China.”
protection and its enforcement in the country. Unfortunately, India lags behind China in this respect. For instance, in spite of prolonged deliberations of two important committees (Satwant
Quick Picks Most overseas investors, particularly in pharma industry, give significant importance to quality of Intellectual Property (IP) protection and its enforcement in the country. Unfortunately, India lags behind China in this respect.
Over ruling? Regulations pertaining to product patenting are similar in both India and China. However, the approach towards the law is different for the countries. Gupta reiterates, “China is taking these guidelines extremely seriously. However, in India, the presence of various lobbies is keeping the development processes at a slow manner.” Seconding the above opinion, Dr Dangi says, “Most overseas investors, particularly in pharma industry, give significant importance to quality of Intellectual Property (IP)
Reddy committee and Dr Murali Manohar Joshi Committee), India still has not made any provision for data protection. Further, we also need to strengthen our IP infrastructure by providing adequate number of patent examiners, well trained patent attorneys and judiciary and dedicated IP and courts for effective enforcement of IP Rights.”
World contract research market (2003-2011)
40 34
CAGR 16.6 per cent 29 25 14
2003
16
2004
19
2005
Figures in $billion
47
22
2006
2007
2008
2009
2010
2011
Years Source: Frost & Sullivan
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Indian pharma industry requires adequate patience in order to deal with this field. In a candid manner, Gupta says, “The basic challenge is that India has a short term perspective. Everyone over here is looking at quick buck, and their primary work gets directed on how to gain maximum profit in minimum time.” However, the major challenge that pervades the industry is ensuring that the quality matches the sponsor requirements. Chaudhury remarks, “In order to live up to the set standards, there should be continuous upgradation of technology. In fact, the companies dealing with low end products will face competition from China.” Further, the CRAMS business is also likely to suffer from talent shortage as the new technologies such as biotechnology, nanotechnology, genomics, proteomics, stem cell research, etc begin to dominate R&D landscape. Dr Dangi says, “Unless continuous training in this required skill set is provided India is likely to lose its competitiveness. China’s cost advantage, strong government support in the form of subsidies, tax incentives, etc not so stringent environment control regulations and less bureaucratic approach are making Chinese API market more competitive.” He adds although cost competitiveness is undoubtedly India’s comparative advantage it is unlikely to remain sustainable as factors such as poor infrastructure, rising wage bill for skilled personnel, inflationary economy, increasing real estate prices and interest rates and virtual policy paralysis at the centre will eventually take its toll. However, it is not all grey for this area. Dr Dangi says, “Biosimilars manufacturing is one of the biggest business opportunities knocking at India’s doors as many biologics are likely to lose their patent status in the next few years. According to a McKinsey study, over $ 97 billion worth of drugs are likely to lose their patent status Modern Pharmaceuticals I August 2011
Industry Update The API market is expected to reach $ 17 billion by 2014 with a CAGR of 21 per cent. Depending on the complexity of manufacturing, India has 30 to 40 per cent cost advantage over developed regions such as the US and Europe.
between the years 2011 and 2015. Significant numbers of these drugs are biologics. However, to capitalise on this opportunity we need to harmonise our regulatory practices with those of the developed world, train and develop scientists with required skill set and pass the National Biotechnology Regulatory Authority (NBRA) bill awaiting parliamentary nod, to give one window approach.” Thus, even in the next few years, India will obviously grow, and will still continue to flourish as a consumer market. Gupta says, “People are becoming more health conscious. It can be said that in order to facilitate this, a lot of innovation and investment has to be made. The regulations and the logistics have to be as per the standards and this will improve the entire value chain.” He adds that definitely, the situation is changing but it is taking more time than anticipated. He further comments, “People had expected things to change diametrically but nothing has happened like that. This is a political, regulatory and infrastructure problem. However, the positive thing is that we are going in the right direction though it is taking a lot of time.” Thus, the market will continue to grow. Chaudhury adds, “The contract manufacturing companies will start tying up on a long term basis rather than a simple contract. And once that is accomplished, the value is surely to soar high. In the mean time, there will surely be revenue companies that will move to China, but India will be doing complex manufacturing then.” She further adds that with substantial line of drugs going off patent, CRAMS will remain the only viable option for companies. True, at the moment there might be smaller companies, but the big companies tying up with them will help in leveraging the opportunities. Thus, it is seen that the two countries apparently with the same growth pattern have been following different paths. Therefore, with a substantial line of drugs going off patent, CRAMS will remain the only viable option for companies. Thus, although there are a few smaller companies in the market, tying up with the bigger ones will make survival easier. MPh (chandreyee.bhaumik@infomedia18.in)
August 2011 I Modern Pharmaceuticals
39
Market Scope
CRAMS market
India moves forward Cost containment pressures have prompted global pharma companies to outsource several research related and manufacturing ac vi es from Europe and North America to low cost des na ons such as India. These ac vi es have now emerged as huge business opportuni es to many domes c pharma companies.
T
he global market size for Contract Research and Manufacturing Services (CRAMS) was around $ 55.47 billion in 2007 and was expected to be of $ 76 billion by the end of 2010 with a Compounded Annual Growth Rate (CAGR) of 10 per cent. Further,
contract research market alone was $ 16.58 billion with a CAGR of 13.8 per cent and contract manufacturing at $ 38.89 billion accounted for around 70 per cent of the total global pharma CRAMS market, according to a study done by Piribo, a business intelligence organisation.
The growing de
Tapan J Ray Director General, Organisation Of Pharmaceutical Producers of India (OPPI)
40
India is fast emerging as a key player in the global outsourcing business with its high quality facilities, worldclass services at a competitive cost in various areas of pharma business operations. Further, various Indian pharma companies are scaling up their capacities and investing to create world class CRAM facilities. Currently, India
has over 130 pharma plants approved by the US Food and Drug Administration (USFDA). Incidentally this is the largest number outside the US. The key advantages of India in the CRAMS business are as follows: Familiarity with the regulatory environment and requirements of the developed markets Extensive global operations in the generics business World-class facilities Lower employee wages Large number of young workforce High capacity of skilled labour (350,000 engineers/year) High quality of engineers, process chemists Low communication barriers due to proficiency in the English language Speed of operation Cost-effective IT infrastructure facilitating all key business processes Contract manufacturing in India involves both patented and off-patent Active Pharmaceutical Ingredients (API)s and formulations manufactured with world-class standards conforming to international regulatory norms like the USFDA, Medicines and Healthcare products Regulatory Agency (MHRA)UK, Therapeutic Goods Administration (TGA) - Australia and European Medicines Evaluation Agency (EMEA). Companies such as Divi’s Labs, Jubilant Life Science, Piramal Life Sciences Ltd, Shasun Pharmaceutical, Cadila Healthcare, Aurobindo Pharma are gradually establishing themselves as strong CRAMS players having large global pharma companies such as Modern Pharmaceuticals I August 2011
Market Scope GlaxoSmithKline, Merck, Wyeth, Eli Lilly, Astra Zeneca, Pfizer as their major clients. In the World Investment Report 2011 of the United Nations Conference on Trade and Development (UNCTAD), Piramal Healthcare and Jubilant Life Science rank 5 and 6 in the list of top 10 pharma contract manufacturers with the top spot being occupied by Catalent Pharma Solutions of the US.
Government support The Department of Pharmaceutical recently expressed its intention to make India an R&D hub in the not too distant future. This cannot be achieved just through investment of a few million dollars through Public Private Partnership (PPP). A strong commitment of the government to hasten regulatory reform processes will be the key factor. The new product patent regime for the pharma industry has ushered in a novel paradigm, with the government planning to strike a right balance between Trade Related Aspects of Intellectual Property Rights (TRIPS) compliant Intellectual Property Rights (IPR) regime and the ‘Public Interest’ and not one at the cost of the other. CRAMS business in India is expected to grow at a rapid pace and offer relatively high operating margins to the Indian pharma companies. As a result, companies of various scales of operations with interest in CRAMS business have started initiating all possible measures to prove themselves as the best option for offshore activities of the global players. All these companies are trying to leverage the wide diversity of the country, rich English speaking talent pool and strong manufacturing base in pharma created over last four decades. Thus, it appears that capturing at least 10 per cent of the global CRAMS market by 2015 may not be a big deal for India.
India & the compe on spree In the CRAMS space, the key competitor of India is undoubtedly China driven by its economies of scale. Overall manufacturing costs in China, be it labour or power, are much less than India. This has already made China a formidable competitor to India August 2011 I Modern Pharmaceuticals
in majority of the bulk drugs and intermediates. Even, many domestic Indian pharma companies now source their raw materials from China. Again pharma manufacturers in China, over a period of time, have become proficient in filing Drug Master Files (DMF) and Abbreviated New Drug Applications (ANDAs). Together with significant cost advantage, China, in that process, has started making huge progress to capture a sizable share of CRAMS business from the developed markets of the world. Along with China, countries such as South Korea and Taiwan are also making considerable progress in this field. To effectively combat this threat some Indian pharma companies, nowadays, have started setting up their business in China, collaborating and even acquiring stakes in the Chinese pharma companies. This process is expected to gain momentum significantly in the near future.
CRAMS business in India is expected to grow at a rapid pace and offer rela vely high opera ng margins to the Indian pharma companies.
The Financial Express recently reported that expansion to secondary locations, transformation and innovation in R&D, maturity and expansion of work portfolio have made China one of the favourite R&D destinations for the global innovator companies. Moreover, the fresh talent pool in China is estimated as 56,000 against 45,000 of India, along with faster expansion of tier II cities in China. Since the past 5 years both India and China have made rapid strides in the space of pharma outsourcing. To make India a global hub for pharma
Areas of improvement Biotech contract research as a whole Economies of scale in manufacturing products like, recombinant proteins, small interfering Ribonucleic Acid (siRNAs), vaccines, antibodies etc Fully integrated service offerings in contract research and contract manufacturing In genomics and proteomics research Pre-clinical research outsourcing of all types, the pharma industry of the country has all the ingredients. India has the potential to emerge as a serious contender for global supremacy, in this fast growing sector, especially in contract manufacturing area, having largest number of USFDA approved manufacturing plants, outside the US.
CRAMS on the move Most common investment strategy in the collaborative arrangement of such business is risk-sharing outsourcing of co-development of a NCE/NME. For example, Johnson & Johnson (J&J) signed an outsourcing agreement with Advinus Therapeutics of India in November 2008 with a contract value of $ 247 million including milestone and royalty payments in the areas of inflammation and metabolic diseases. In this contract Advinus will be responsible for development up to ‘the proof of concept’ (Phase II a) and then J&J will take over till commercialisation of the molecule. Overall in the CRAMS business operating margins are usually good. For patented products, margins are generally higher than the products that have gone off patent. The volume of business in CRAMS usually picks up over a period of time. In all these significant areas, the neighbouring country China seems to score over India. MPh (tapan.ray@indiaoppi.com)
41
Global Trends
Indo-Japan trade rela ons
A aining new heights High tech research, qualiďŹ ed human resources and government support create win-win situa ons for the Indian and Japanese pharma sectors. The India Japan Global Partnership Summit (IJGPS), 2011, promises to bring cu ng-edge research at the forefront. that India will be among the top 10 world drug makers in sales terms by 2020. In a report, Booming Generics Drug Market in India, RNCOS sees the Indian generics market as likely to grow at about a Compounded Annual Growth Rate (CAGR) of 17 per cent this year.
Trends in demand
T
he Indian pharma industry is the third largest in the world by volume and 14th in value terms. It has absorbed modern technology and produces a variety of
Kishor Jagirdhar Executive Member, India Japan Global Partnership Summit (IJGPS)
42
drugs meeting high quality standards. Last year, the industry grew at a healthy 16.5 per cent on the back of a pool of qualified and intelligent human resources, IT capabilities, appropriate infrastructure, its understanding of developed overseas markets, and last but not the least, the medley of generic drugs it offers. A McKinsey & Company report, India Pharma 2020: Propelling access and acceptance realising true potential, predicts demand for pharmaceuticals in India to touch $ 55 billion by 2020, up from $ 12.6 billion in 2009. PriceWaterHouseCoopers estimates
Demand for pharmaceuticals in India is being fuelled by the number of people leading sedentary lifestyles in fast moving environments across the country’s urban landscape. High levels of uncontrolled stress and poor and irregular diets are increasing the incidence of lifestyle-related diseases and spurring the use of remedial drugs. To add to that, India has bore the brunt of several outbreaks of epidemics or pandemic diseases (H1N1, SARS, bird flu) in the past few years. Burgeoning demand is attracting leading pharma companies to the country. India also offers global pharma majors excellent Contract Research and Manufacturing Services (CRAMS) and co-marketing alliances aimed at boosting drug development capacity and reducing the time to market new medications. Multinational drug players facing higher costs and lower sales of patented drugs in home markets are turning to the country to cut research costs by outsourcing clinical trials and research. Not surprisingly, Foreign Direct Investment (FDI) by Japan in the Indian pharma industry has surged in the past three years, mostly by way of M&As. Significant investments by Japanese firms in the country have followed Modern Pharmaceuticals I August 2011
Global Trends policy corrections such as India’s Pharmaceuticals Export Promotion Council removing the need for overseas investors to seek a no-objection from their joint venture partner before venturing independently or tying up with another local company. Now, 100 per cent FDI is allowed via the automatic route in the pharmaceuticals and drugs industry. This also applies to the use of recombinant technology. In 2008, Daiichi Sankyo of Japan acquired India’s Ranbaxy Laboratories, kick starting a wave of investments in the country. Last year, Mitsui & Co Ltd revealed plans to acquire a 5 per cent stake in pharmaceuticals ingredient manufacturer Arch Pharmalabs for $ 14.64 million. This calculated move would help Mitsui strengthen its contract manufacturing business in pharmaceuticals while also providing Arch the opportunity to enter the lucrative intermediates and active ingredients Japanese market. Japanese Eisai and Co intends to make India a huge manufacturing hub for its global operations by setting up a massive facility at Visakhapatnam, Andhra Pradesh. Last October, the more than two centuries old Japanese drug maker Takeda announced its expansion strategy into India.
Indian landscape Investments by pharma companies are by no means a one way affair. Several Indian firms have ventured towards Japan as well, some hoping to cash in on the fact that several drugs patented by Japanese firms are set to go off patent. Japan’s healthcare market is worth $ 350 billion and its pharma products imports stand at a mighty $ 13 billion. It presents a promising market for Indian generic drug manufacturers, especially considering that generics are increasingly becoming popular due to Japan’s large ageing population and high healthcare costs. Last year, Prime Minister Manmohan Singh addressed Japanese businessmen at an event by the Japanese business August 2011 I Modern Pharmaceuticals
Some recent e-ups between Indian and Japanese pharma companies India’s Dr Reddy’s Laboratories and Japan’s Fujifilm Corporation (Fujifilm) plan to jointly develop, make and sell generic drugs in Japan using Fujifilm’s quality control technologies and Dr Reddy’s cost competitive production processes. Dr Reddy’s will own a 49 per cent stake in the company with Fujifilm being the majority stakeholder. Tablets (India) Ltd, a leading manufacturer of pharmaceutical and nutraceutical formulations, has entered into an exclusive agreement with TOA Pharmaceutical Co Ltd, Japan for a unique probiotic product. India’s GlaxoSmithKline Pharmaceuticals Ltd has signed a licensing agreement with Japanese pharma Astellas Pharma Inc, for exclusive rights to Astellas’s injectible anti-fungal agent, Micafungin, branded Mycamine, in India. Japanese pharma major Eisai has entered into a marketing agreement with GlaxoSmithKline Pharmaceuticals to co-promote Eisai’s new generation anti-ulcer drug, Paritec - rabeprazole sodium in India. The companies will jointly market the Japanese brand, formulated at the GSK facility in India by importing the bulk from Eisai Japan, in the ` 80 crore rabeprazole market in India. GlaxoSmithKline (GSK) Pharma and Daiichi Sankyo India Pharma Ltd inked a co-promotion agreement for anti-hypertensive drug Olmesartan Medoxomil and its combination products. GSK Pharma has also launched Benitec and Benitec-H anti-hypertensive drug in-licensed from Daiichi Sankyo Company Ltd, Japan. chamber, Nippon Keidanren saying that he believed the Comprehensive Economic Partnership Agreement would ‘create new opportunities for India’s pharmaceutical industry in the Japanese market, helping Japan to meet its demand for high quality and inexpensive generic medicines.’ According to J R Vyas, Managing Director, Dishman Pharma, the Active Pharmaceutical Ingredient (API) market in Japan is currently dominated by the US and European players, which can be slowly replaced by Indian firms who supply regulatory-compliant and cheaper versions. Dishman was recently said to be in talks with 12 generic drug makers from Japan to supply APIs for gastroenterology and anti-hypertensive drugs. Ind-Swift Laboratories, a company from Chandigarh, won the approval of the Japanese government’s Pharmaceutical and Medical Devices Agency (PMDA) to supply Pioglitazone (an anti-diabetic drug) and Risedronate Sodium (an osteoporosis drug) from its manufacturing plant at Derabassi, Punjab.
Promising partnership In the years to come, ongoing cuttingedge research across the spectrum of medicine and medical science is likely to expand the trading avenues for pharma companies. And no where will such opportunities be discussed in greater detail than at the India Japan Global Partnership Summit, slated to be held from September 5-7 in Tokyo. This event, supported by the Governments of India and Japan and apex trade bodies in the two nations, is being organised by the India Center Foundation to mark 10 years of the announcement of India-Japan Global Partnership Agreement and pave the way forward for greater cooperation between the two nations. The summit will offer Indian pharma firms the opportunity to interact one-on-one with potential Japanese collaborators. Beyond doubt, partnerships between Indian and Japanese pharma industries will help both attain new heights in an increasingly flat world. MPh (kishor@indiajapansummit.org)
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Market Trends
Indian CROs
Achieving global success Clinical Research Organisa ons (CROs) in India have become an integral part of the pharmaceu cal sector; their growth has been no ceable but there remains a few loop holes that have inhibited further growth. Though the number of CROs in India has increased with me and they have managed to a ract an interna onal audience, a great amount of poten al lies untouched.
Jasleen Kaur Batra
T
he pharmaceutical sector has been expanding over the years, and its recent entry into innovation has resulted in the growth of the overall sector along with CROs. Outsourcing of trials has developed as a major trend as CROs help the pharma companies in reducing time as well as cost of a trial, and provide reliable results. CROs provide a full spectrum of drug development services like pre-clinical research, clinical research, lab services, regulatory services, among others to not only invent a new drug but also to check the efficacy and safety levels of the drug for pharma as well as biotech companies.
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Several factors have led to the emergence of India as a promising and trustworthy destination for conducting clinical trials on the global map. Expert nuances of conducting a clinical trial, following the regulations and getting the approvals required, skillful manpower and cost advantage are a few factors that have eventually led this sector to come under the limelight, thus helping the pharma sector in its entirety to succeed. Interestingly, some of these factors have also led to the containment of further growth.
Recrui ng the right popula on CROs in India are extremely active when it comes to patient recruitment. It is of utmost importance that the
drug to be presented in the market has been checked for side-effects and is reliable to treat for the mentioned condition. Explains Ajay Bharadwaj, CEO & Founder, Anthem Biosciences, “To launch a drug it is essential that it be tested on the population; the drug should be designed for the needs of the people belonging to any race, region or age. Hence, before a drug is approved it has to go through four phases, which test the drug on every level to check its human consumption level.� Clinical trials conducted on a large group of population are more trustworthy than those involving small group of patients. The high population of India acts as an advantage at this stage. A wide variety of people and large population available for recruitment is one of the reasons why a number of international companies outsource to India. A few CROs manage their own online database of investigators as well as hospitals, clinics and private physicians and professionally active physicians, which help them in their clinical trials.
Deciphering the trial In Phase I of the trial, a basic study determines the metabolism and action of the drugs in humans, the side-effects associated with increased dosage are evaluated to attain and ascertain early evidence of effectiveness of the drug. Phase II is a proof of concept stage where a controlled clinical study is conducted to evaluate the effectiveness of the drug for a particular indication in patients to determine the common short-term side-effects and risks. Modern Pharmaceuticals I August 2011
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Market Trends Phase III is a full scale intermediate phase where clinical trials of the drug are carried out across the world on different patient population to gather additional information to evaluate the overall benefit as well as risk factor of the drug to check the safety and efficacy of the drug according to the standard of care. Phase IV deals with the post marketing studies to delineate additional information on the benefits and the use of the drug. India has a strong hold on phase I and III as these stages have low risk factors. Avers Mahesh Malneedi, President, MakroCare, “There are a number of countries such as France, Germany, Russia, China, Switzerland which perform clinical trials. India in a few ways has a strong hold on only a certain part of the trial due to the risk factors involved.”
Long wai ng period For any organisation to have its hold into the national market, it is extremely important for the government and regulatory bodies to be by their side as a sign of support. It is only with the help of regulatory authorities that Indian companies can set up their units. Over the last few years, the Indian government has been stringent with the laws and regulations, which has affected the CRO industry to a great extent. In India, it takes around a year to receive approval from the regulatory authorities to set up the unit. “The regulatory framework of India is extremely weak; there is no transparency and decisiveness in the system. The government needs to come to terms with the fact that the growth of such sector lies on the shoulders of the government body and they need to work towards making India a better place,” opines Bharadwaj. No company would appreciate waiting for approvals for long once the right trial has been designed and a patient population is ready. This also leads to apprehensions in the industry for new CROs planning to set up in the country.
August 2011 I Modern Pharmaceuticals
The regulatory authority of India is stringent; if a CRO who follows the procedures and rules wants to make the approval process a less difficult than adop ng a PPP model is the way to be. Ajay Bharadwaj CEO & Founder, Anthem Biosciences
The Asian age
Key strategies for development
Countries such as Russia, France, US and many more have been dominating the CRO market. The Chinese market is providing stiff competition to India. It is attracting the market with the trump cards of cheap labour and resources. “Most of the well-established CROs are setting up their branches in China, and other countries. This has resulted in the decline of approximately 25 per cent of the Indian projects. India was not a strong leader in the CRO market, and due to the stepping in of developing countries, the scenario has been further affected and has hampered the growth,” feels Dr Harish S, Director, IC Bio Clinical Research Pvt Ltd. China has been offering a different incentive compared to the Indian market. There has been a noticeable change in the number of foreign companies that have increased the number of pharmaceutical manufacturers in China. The large patient pool helps lower the cost of drug production in China and hence has become an extremely favourable location for CROs and investment. These are a few trends that have dominated over the Indian CRO market and have adversely affected it.
The CRO sector has been picking up pace over the years and holds all the potential to become a booming one in the future. For the same, a number of companies adopt various kinds of strategies that help them grow and hit the market in a unique manner. Pricing is a major concern in any organisation, but the way a company deals with it can vary. For instance, a few pharmaceutical companies establish tie ups with CROs for all their trials, which results in major cost cutting for the company. On the other hand, a few companies believe giving each clinical trial on a contract basis as a fresh assignment would be beneficial and will save their financial resources. Going global is a new trend that has emerged in the market. A number of MNCs go to different countries and establish their units to increase their hold in the market as well as get a hold of the foreign market. These companies also try to form partnerships with the major CROs of the state to create a strong hold on the market. Companies such as Quintiles, Merck, Pfizer and more follow this strategy and have strongly benefitted from it. Consolidation is another aspect
India was not a strong leader in the CRO market, and due to the stepping in of developing countries, the scenario has been further affected and has hampered the growth. Dr Harish S Director, IC Bio Clinical Research Pvt Ltd
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Market Trends
The CRO industry in Asia Pacific is expected to expand rapidly parallel to the growth in the pharmaceu cal sector. An increase in low produc on cost would also be the major reason behind the growth. John J Lewis Vice President of Public Affairs, Associa on of Clinical Research Organiza ons
that has been looked upon; big CROs try to overtake the smaller ones to create a larger base in the market and human resource in terms of doctors and patient population. Mergers between the public and private sector has gradually picked up pace, and this has a direct effect on the CRO. This strategy has been adopted by companies to make regulatory and registration procedures easier and faster. “The regulatory authority of India is stringent; if a CRO who follows the procedures and rules wants to make the approval process a less difficult than adopting a PPP model is the way to be. It helps the organisation gain clarity on what is exactly expected of them, which makes the clinical trials a smooth process,” says Bharadwaj. Another interesting business model that has picked up pace especially in the Indian market is that of specialised CROs. These CROs provide accuracy, efficiency as well as punctuality. A specialised CRO is a unit where the clinical trials of only one disease are carried out. “Setting up a specialised CRO requires an investment of ` 4-5 crore, which is drastically less than setting up a full-fledged CRO, which requires an approximate investment of ` 20-25 crore. These CROs save capital as they do not require a large facility or an R&D set up as the clinical trial is restricted to one drug. The technology and manpower requirement is also minimal,” informs Dr Harish. Due to these reasons this model has been doing fairly well and is benefitting the CRO sector.
The current scenario The Indian CRO market was worth 48
$ 320 million in 2009 but is expected to reach $ 630 million in 2012. There has been development in the market over the past five years. For global pharmaceutical companies working with CROs is a great opportunity as they have a deeper knowledge of the rules, regulations, norms, quality standard, code of conduct and more. The pharmaceutical sector has realised the importance and potential of CRO as a result of which there has been a noticeable growth in the market ever
Se ng up a specialised CRO requires an investment of ` 4-5 crore, which is dras cally less than se ng up a full-fledged CRO, which requires an approximate investment of ` 20-25 crore.
since. “India mainly consists of two groups of CROs. One group is more focussed on full-service organisations and carries out clinical trials from the beginning to the end. The other group performs research in a few segments like chemistry research, medical writing and biostatistics or site management. First group activity depends more on regulations and performance, whereas the other focusses on service,” says Malneedi. A large number of companies have been outsourcing as they lack the capability
as well as the infrastructure to perform clinical trials by themselves. This increase in the number of companies outsourcing has become one of the major factors behind the growth and would continue to broaden. Even the regulatory system that India follows has been a bit less stringent. This predictability and transparency in the system would be a cause of growth which one would witness in the coming 2-3 years.
A glimpse of the future The CRO market has been following the path of expansion and has grown reasonably. The future looks bright for India due to the services it provides. According to an ACRO report, ‘Phase II and phase III trials in particular tend to result in new investment and growth. The western pharmaceutical companies spend only $ 30 million on trials in India in 2004, by 2006 this had reached $ 140 million and by 2010 the total invested was estimated to reach $ 42 billion.’ This represents that Indian clinical research sector is increasing and will catch pace in the future. “The CRO industry in Asia Pacific is expected to expand rapidly parallel to the growth in the pharmaceutical sector. Frost & Sullivan estimated a Compounded Annual Growth Rate (CAGR) from 2010 - 2015 with most clinical research activities in Asia Pacific focussed towards markets such as China, India & Korea; it would also affect the investment by pharmaceutical MNCs and more manufacturing units would be set up. An increase in low production cost would also be the major reason behind the growth,” according to John J Lewis, Vice President of Public Affairs, Association of Clinical Research Organizations. Markets like Indian and China will become increasingly important and would attract a number of international companies as a centre for global clinical trials due to low cost of research and manpower. MPh (jasleen.batra@infomedia18.in)
Modern Pharmaceuticals I August 2011
Interface
‘Today, research in ssue has progressed towards regenera on or restora on’ …says Dr John Fraser, Principal Scien st, Cytori Therapeu cs Inc. He has published more than 40 peer-reviewed papers, holds several patents and has been awarded more than $ 12 million in research contract and grant funding from the Na onal Ins tutes of Health. Chandreyee Bhaumik Discuss the trends observed in the biotech industry.
Cytori Therapeu cs has been involved with the introduc on of Celu on Technology. Please elaborate.
sensors and processing algorithms to ensure consistent handling of the tissue and cells.
Today, research in tissue has progressed towards regeneration or restoration. There is a subtle yet strong shift in the quality of tissue regenerated. Thus, it is not about growing heart but about restoring the parts that are already damaged. When I first started working in this area, we would use tissue for
Cytori has developed the Celution 800/ crs System that has received regulatory clearance in Europe to automate the processing of both fat graft and Adipose Derived Regenerative Cells (ADRC)s. Adipose tissue is introduced into the tissue collection chamber, washed to remove blood and free lipid and then digested with the proprietary enzyme
Explain how Cell-Enhanced Reconstruc on offers solu ons to breast cancer pa ents.
We have partnered with Apollo, For s, Max Health, various government ins tutes ter ary healthcare device companies and many other centres across the ci es.
Cell-Enhanced Reconstruction is a procedure whereby a patient’s fat tissue is enriched with his/ her own ADRCs to create natural filler. This cell-enhanced tissue can then be used to reshape the affected breast during the same surgical procedure. The addition of ADRCs to the fat graft is believed to produce more predictable and stable results when compared to traditional fat grafting. Furthermore, early clinical results demonstrate high patient satisfaction ratings.
Discuss the extensive R&D ac vi es of your organisa on. We have invested $ 300 million in R&D in order to reach where we are today. With our extensive research, we have treated approximately 3000 patients with our devices.
What are your expecta ons from the Indian market?
replacement and generate stem cells in muscles, and found it beneficial. Here, stem cells did not regenerate the muscles but they healed the injured ones. Various doctors, be it from Japan, UK or India, specialising in spine, cosmetic surgeries can use tissues and cells for regenerative medicine and wound healing. 50
reagent (Celease TM 835/CRS) to release the ADRCs. The ADRCs are then concentrated by short centrifugation and wash cycles before being mixed with the washed fat graft material (also concurrently prepared by the Celution 800). The cell-enhanced graft is then ready for transplantation into the patient by the physician. The process is controlled through automated
We indeed have significant expectations from the Indian market. World Health Organization estimates reveal that approximately 20 per cent of the cardiac patients are from India. Thus, we can say that we have partnered with Apollo, Fortis, Max Health, various government institutes, tertiary healthcare device companies and many other centres across all the cities. We are designed to cater not only the hospitals but also day care centres. MPh (chandreyee.bhaumik@infomedia18.in)
Modern Pharmaceuticals I August 2011
Interface
‘Detec on technologies will become increasingly popular in the coming years as its price will come down’ ...believes Dr Jorma Lampinen, Senior Scien st, Thermo Fisher - Finland, who has been in the biotechnology field for 25 years. He has worked for several universi es in Europe and the US and has been associated with Thermo Fisher for more than 20 years for key responsibili es such as instrumental design, valida on and assays development. Titash Roy Choudhury How can fluorescence and luminescence help in drug discovery? These two technologies have many possibilities starting from the fact that they are still the most commonly used technology in drug discovery area. In the last 10 years, many technologies have
they are very popular in all those places where one needs to analyse very low concentration. Again, being a commonly used and popular technology, both of these are an economical choice compared to the later and newer technologies. Another big reason behind the use of these two technologies is their ease to use and a wide variety of applications.
Earlier, launching a new drug in the market would approximately cost $ 100 million, whereas today it is $ 800 million.
evolved and experts have commented that they would replace luminescence and fluorescence but for the last 15 years luminescence and fluorescence remain the most commonly used detection technologies in this area. Several new technologies are cropping up now and then but none of them have been able to generate success in the proportion of luminescence and fluorescence. Being highly sensitive technologies 52
Drug development is moving towards proteins and GPCR. Where do you see this growing in the next five years? The drug discovery research is moving towards cell-based assays, which includes living cells and their biochemical components. This trend has been there for some time now and researchers want to assay with living cells especially for GProtein Couple Receptor (GPCR) because
isolated GPCR does not give the complete data. So cell assays will increase that is a clear trend. In the area of GPCR, people will want to go for natural cells instead of cloned cells for research, such as stem cells, isolated cells or primary cells. A UK pharma company had stated that ‘using cloned cells is practical but using not cloned cells is reasonable’ and at this moment we are in a conflict situation where we do not know whether to go for practical ways or reasonable ways because that is more of a complicated way. This strong effort in the area of using natural cells for assays is a clear growth in the area of GPCR. And the main reason for this trend to develop is that if we clone certain things they may not remain relevant for humans any more.
What was your last project at Thermo-Fisher Scien fic? A screening instrument , which is a basic microplate photometer designed based on our customer needs. The product has to be cost-effective as well as economical to buy. Hence, we excluded from putting anything extra that the customers would not need. Second, it has to be simple, easy to use and should be reliable, full proof and robust that includes all the internal diagnostic of the instrument so that the user can rely on the research that will happen.
Upcoming trends in detec on technology area... The new instruments will come, the key drivers for the new models will be that they will be multi-technology instruments. Today, you can buy instruments that have 5 to 6 technologies but by next 5 - 10 years Modern Pharmaceuticals I August 2011
Interface Types of products Product name Thermo Scientific Accucore HPLC column range
Product details Provides a unique chromatography solution to enhance laboratory workflow and efficiency.
Thermo Scientific Heratherm ovens, available in three different models: General Protocol, Advanced Protocol and Advanced Protocol Security.
Each unit is available in 60-, 100and 180-litre sizes with a choice of gravity or mechanical convection. With a focus on energy efficiency, sample safety and ease–of-use, these benchtop heating and drying ovens maximise capacity while optimising laboratory footprint
Thermo Scientific Heratherm microbiological incubators, available in three different models: General Protocol, Advanced Protocol and Advanced Protocol Security
Each unit is available in 60-, 100and 180-litre sizes and combines superior sample protection, ease of use, efficiency and an inner glass door that maintains temperature uniformity
there will be more than 10 technologies in a single instrument. Another clear trend is that lot of efforts will be put to make these instruments more and more user friendly and self-diagnostic of instrumentation will increase drastically. Also, the basic size of the instrument will be reducing with time, it may be difficult and affect the price but this is another trend that will gradually occur in this field.
There are various detec on technologies and applica ons available. Is there a way to characterise these to speciďŹ c market segments? It is extremely difficult or not possible to categorise these detection technologies and applications into any specific segments. They are universal in nature, and we cannot say that this instrument or this technology is only dedicated for any one segment of the market like the GPCR or DNA binding and likewise. These detection technologies are much more general. Also, I see it as a trend from technology instrument vendor side who would not like to create any instrument that August 2011 I Modern Pharmaceuticals
Features Founded on state-of-the-art Core-Enhanced Technology Increased sensitivity and peak resolution, providing excellent return on investment Allows high-speed, high-resolution separation The advanced bonding technology results in excellent peak shapes through high bonding coverage and minimised secondary interactions All models include an easy-to-use use interface, automatic over temperature alarm and data monitoring. As a result, these ovens meet all laboratory, clinical and industrial heating and drying needs The program function can store up to 10 pre-defined cycles making it easy to undertake processes involving complex temperature ramping and holding steps The user-friendly units feature a small footprint, making them stackable without the use of tools, an easy-to-clean rounded interior, and an intuitive display. In addition, a compact 18-litre model incorporates Peltier technology to provide temperature conditions around or below ambient for space-restricted labs
would have restricted or limited use. If they create more general or universal technologies and applications, then their market possibilities also increase. I do not think there would be such technologies that would be suited for a niche market only. There can be segregation based on different kinds of assays but not markets.
The detec on technologies and drug discovery scenario in the Indian market... General detection technologies are available in India. Our company launched its first microplate reader in 1976 and I think some of those readers were sold in India in the same year. This microplate technology is about 40 years old, hence India has never lagged behind in this field. I would not say that any new technology will come to India later than any other country. If some new technology comes to Europe or the US. it will be adopted in the Indian market within that same year. As for the condition of drug discovery in India, I do not have any specific data to speak of, but what I feel after several visits to India for the last 10 years is that the Indian pharmaceutical and healthcare
is growing drastically. Ten years ago there were few pharma companies and drug discovery institutes that are present today. My feeling is that pharmaceuticals and drug discovery is probably one of the most rapidly growing in India of all places in the world. Also, a lot of the work in this field has been transferred from Europe and the US because of the lower cost of skillful resources. Many of the European and American pharma companies have opened research centres here in India and these are proof enough to show the growth this country is encountering.
Is there a way to reduce the cost of drug disocvery in developing countries? Earlier, launching a new drug in the market would approximately cost $ 100 million, whereas today it is $ 800 million. There has been a significant rise in the cost but from the technology or research side not much would be possible in cost reduction. Drug discovery involves a lot of other regulatory processes; I do not think as a technologybased company, we can make any difference in the cost of the instruments. MPh (titash.choudhry@infomedia18.in)
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Retail Zone
Sugges ve selling in pharma
Understanding the customers and their requirements Pharmacy is a unique business because it largely depends on how one increases the business. If one wishes to increase his/her stores’ sales, there are some good op ons and one among them is striking a conversa on with the customer and doing what is called, ‘Sugges ve Selling’. without being reminded! Asking a definite question that is relevant to his/her purchase makes it easier for the customer to decide and go for another purchase! This is not just followed by McDonalds, Starbucks, Subway or the Dominos but even the top most retailers such as Apple follow the same tactic, ie, ‘ Suggestive Selling’ to help one buy more.
Lesson to learn
‘W
e do not sell, but help you buy!’ is the tagline of a leading retailer in India. How true!! Suggestive selling is aptly represented by this – one is just not selling the customer what they ask for, but are taking care of their extended needs and helping them make the right choices at the right time.
Rajendra Pratap Gupta International Healthcare Policy & Retail Expert
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Remember a visit to McDonalds? While one is busy ordering, the cashier promptly suggests, ‘Sir , would you like to have coffee as well?’ or if one is ordering at a Starbucks , he/she would be asked ‘ Sir , would you like to go for a cookie?’ , and most of the times, one gives in to these suggestions!! Over 40 per cent of the times, a customer would say, okay go ahead and get me a medium coffee! Similar choices are offered by a host of retailers across the world. In contrast, imagine if one were asked just a question, ‘Sir , do you need anything else?’ The answer to this question most of the times is ‘No. Thanks.’ A customer does not know what else to buy, or else he would have certainly bought it on his own
There is an important point to learn from these retailers and implement it effectively in the pharmacy retail business. Some common scenarios encountered in any shop almost daily gives a better idea. Scenario 1: A woman enters a shop with the requirement for baby food. Does one ever think what else this lady might need? Have one thought of suggesting to this customer baby soap, oil or powder or some new type of diapers that have been recently launched? A few years ago, I was standing in a retail pharmacy counter at Panjim, Goa, and asked the same questions to such a customer and finally ended up selling ` 700 worth of products over and above her requirement of just baby food. In one hour, post interacting with just 5 customers, the pharmacy booked orders worth ` 1440, which would have not happened had the customer been just given the products for which they came in for! Scenario 2: A diabetic patient who regularly buys insulin or oral Modern Pharmaceuticals I August 2011
Retail Zone medications. How about talking to this customer about his/her sugar levels, and if one finds it higher, suggesting the available sugar-free products to him/her or maybe some ayurvedic/herbal product that can help improve the immunity or tone up the system or help in control of blood sugar or manage it better ? Scenario 3: A customer who works mostly in a field in summer requires a sunscreen with an SPF of above 30. Same does not apply for a person who spends more time in an air-conditioned environment. Such a person is more likely to suffer from dehydration of skin and would rather need a moisturiser. So, the salesperson has to analyse his/her customer and then suggest products to him accordingly. His suggestions cannot be arbitrary. He has to realise that the needs of everyone visiting the shop is not the same nor is the spending capacity the same. So, depending on the customers, the suggestions have to be appealing and affording to the customer. Scenario 4: A regular customer has weak eyesight. One can guess what best to recommend for better eyesight and suggest the same, thus showing care and concern for their customers and building trust. So, it is clear that not just servicing the prescriptions and demands but going for suggestive selling is a good way to understand a customer. This process also helps to increase one’s business not just for one time but forever, since in the process he/she also becomes successful in gaining the trust and confidence and become their preferred destination stop for all their needs.
How to sell sugges vely? First, knowledge is important. Not just product knowledge but also a knowledge and understanding of the correct requirements of the customers. One cannot suggest a product without knowing about it, and also one cannot suggest the product to the customer without understanding his needs. So the staff has to be trained on understanding 56
the various classes of customers. They should be aware of different products mapped to various classes of product purchases or diseases and lifestyle. Knowledge about the various products available for the same condition and the market movement of these products should be known to the sales person to help a customer make right choices. Similarly, an understanding of the customer type, in way of their preferences, their lifestyle and their spend capacity should be looked into before any suggestions are given. Second, employees must be trained on how to strike the right note in conversation in less than 30 seconds & then, what to suggest, why and to
Sugges ve selling means that one will have to understand the customer well, and will have to interact o en with them regarding their health and needs.
whom? A cardiac & a diabetic patient do need low fat and high fibre food. But one needs to understand why and how much and which products can help the customer in his needs? One cannot be overzealous in their help to suggest something, which at a later time can make a customer think that this was unnecessary. A person with hypertension needs low sodium salt. But educating a customer would need a lot of information about how a low sodium salt is beneficial for him/her, and then which products can help in achieving the same. Third, technology can help. There are software available which map a product to be recommended to a customer based on his/her past and current purchases. Also, one can always have a head of suggestive selling in the
organisation who maps the products to be suggested to customers based on their purchases. Also, it is important to remember that while suggesting one should not sound to be too persuasive and pushy. Remember, a suggestion should be just that, customer cannot be forced to follow it and here comes the need of one’s knowledge and demeanor. At no point in time , the customer should feel that he is being suggested something with some ulterior motive of the salesman in mind but that the salesperson is genuinely and truly concerned about him and his safety and well–being and his pockets. Do not limit the suggestions to customers to the products one stocks. Do suggest them natural ways of keeping fit and fine. Being fit is not about consuming vitamins, but it is also about maintaining a disciplined lifestyle with proper exercise and diet. If one misses these points in their suggestions, they are just a salesman!
Produc ve and effortless medium Suggestive selling means that one will have to understand the customer well, and will have to interact often with them regarding their health and needs. One should be able to strike a conversation within less than 30 seconds and then let the customer ask for more. Also, suggestive selling works on credibility of staff. Credibility is established when one shows genuine concern for their customers and educate them for the need to make healthier choices. If one’s suggestions are just aimed at pushing sales, it would eventually backfire and bring the credibility to zero. So be extremely careful in making the right suggestions after properly analysing the customer and his need and the products. Thus, suggestive selling has multiple benefits. It shows that one understands his/her customer and is aware of their needs. MPh (office@rajendragupta.in)
Modern Pharmaceuticals I August 2011
Legal Edge
Nuclear medicine patents
Insights into the Indian scenario The diagnosis of pa ents has become quick and accurate with nuclear medicine. It uses radia on to provide diagnos c informa on about the func oning of an individual’s specific organ. The Indian Patents Act needs amendments to include patentable inven ons rela ng to nuclear medicine beneficial for the mankind. diagnostic purposes. Most common radioisotope is technetium-99,that is used in over thirty million procedures a year accounting for over 80 per cent of all medicine procedures in the world. Technetium-99 and other commonly used diagnostic radioisotopes such as chromium-51, cobalt-58, gallium67, iodine-123, iron-59, sodium-24, thallium-201 are all relatively safe, having short half lives and are used in small amounts in such diagnostic and therapeutic procedures.
Indian legal provisions
T
he research on radionuclides has witnessed an enormous growth. Nuclear medicine uses radiation to provide diagnostic information about the functioning of an individual’s specific organs, or to treat them. Diagnostic procedures are now routine. Radiotherapy can be used to treat some medical conditions, especially cancer, using radiation
to weaken or destroy targeted cells. Tens of millions of nuclear medicine procedures are performed each year, and demand for radioisotopes is growing exponentially. With the advancement in any field of medical technology, there arises a need for enabling protection of the new inventions as a reward to the efforts involved in the research.
Ballooning demand
Anuradha Salhotra Managing Partner, Lall Lahiri & Salhotra
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The prime reason for widespread and expanding employment of radioisotopes for the purpose of diagnosis and medicine is that the diagnosis of an ailing patient is quick and accurate. It is considerable that more than ten thousand hospitals across the globe use radioisotopes in medicine. About 90 per cent of these uses are for
Section 4 of the Indian Patents Act, proscribes inventions related to atomic energy and states that ‘No Patent is granted in respect of an invention relating Patents Act to atomic energy falling within sub-section (1) of Section 20 of the Atomic Energy Act, 1963.’ According to Section 20(1) of Atomic Energy Act, atomic energy means energy released from atomic energy nuclei as a result of any process including the fission and fusion processes. Under this Act, Indian Central Government has been empowered to notify ‘prescribed substances’, which in its opinion is or may be used for the production or use of atomic energy or research into matters connected therewith and includes uranium, plutonium, thorium, beryllium, deuterium or any of these respective derivative or compounds or any other materials containing any of the aforesaid substances. The Act defines the term ‘radioactive substances’ or ‘radioactive material’ as any substance or material, which spontaneously Modern Pharmaceuticals I August 2011
Legal Edge emits radiation in excess of the levels prescribed by notification by the Central Government. ‘Prescribed Substances, Prescribed Equipment and Technology’ have been notified by the Government of India, Department of Atomic Energy vide S.O.61(E), published in the Gazette of India (extraordinary, Part II, Section 3, sub-section (ii), dated January 20, 2006. Furthermore, Section 18 of the Atomic Energy Act provides for restriction on disclosure of information, which relates to producing, developing or using atomic energy. Moreover, Section 30 of the Atomic Energy Act provides for the Central Government’s power to make rules to provide for declaring any information not so far published or otherwise made public as restricted information and prescribing the measures to be taken to guard against unauthorised dissemination or use thereof. The Patent Act imposes further obligations to an applicant for filing of patent applications related to atomic energy outside India. Accordingly, any person desiring to apply for a patent abroad for an invention relating to or which he has reason to believe relates to atomic energy shall obtain prior permission from the Central Government before making the application abroad or communicating the invention to any person abroad, unless six weeks have elapsed since his request for permission was made to the Central Government and no reply was received by him. After filing in Indian Patent Office, each application is screened. If an application is prima facie found to be falling within the purview of the Atomic Energy Act, the Controller refers the application to the Department of Atomic Energy for issue of directions, which are binding on the controller. According to the statistics provided in the Intellectual Property Office Annual Report 2009-2010, 28 applications were referred to the Department of Atomic Energy during the period of April 2009- April 2010. Out of which August 2011 I Modern Pharmaceuticals
14 applications were allowed to proceed for natural course of office action, 10 are still pending with the Department of Atomic Energy and 4 were refused. Thus, any application that includes any radionuclide may take a longer period of processing than usual. Further, the Indian patent system does not provide for any remedy against the directions of the Central Government issued under the Atomic Energy Act. Also, it is notable that the inventions related to defence or atomic energy are not permitted to be submitted directly to the International Bureau by the applicants from India. A request for early publication filed in the Indian patent office is considered only if the application does not pertain to subject matter relevant for defence or atomic energy.
While considering intellectual property protec on of inven ons based on such radioisotopes, the unpatentability of such inven ons also arises on the grounds of protec on of na onal security.
Need for cau on Considerable medical research is being conducted worldwide into innovative uses of radioisotopes for medical diagnosis and treatment. However, radionuclides can also present both real and perceived dangers to health, particularly if they are excessively used during treatment or in other ways applied to living beings due to radiation poisoning. Consequently, while considering intellectual property protection of inventions based on such radioisotopes, the unpatentability of such inventions also arises on the grounds of protection of national security.
Exclusions on the grounds of protection of national security are outlined under Article 76 of Trade Related Intellectual Property Rights (TRIPS) Agreement of World Trade Organization (WTO). A number of countries have used this exception for defence-related inventions. Inventions related to substances by means of nuclear transformations, ie radionuclides, can also be excluded and such exclusion provisions have been incorporated in patent laws by countries such as Brazil, China, Cuba, India, Japan, Mexico, Korea and the US.
Global provisions Article 73 of TRIPS permits exclusions on grounds of protecting national security. Many developing countries like to use this exception for defencerelated inventions. Inventions related to substances obtained by means of nuclear transformations also can be excluded. Thus many countries like Brazil, China, Cuba, India, Mexico, Japan, Korea and the US have provisions for this exclusion. According to the UK Law, under Section 22 (6) of the Patents Act, 1977, the Secretary of State is required to refer patent applications for atomic inventions to the appropriate authorities in order to determine whether the publication of that patent is detrimental to national security or public interest. There is, however, no explicit bar against patents for inventions related to atomic energy or weapons in UK as of now. Further, list of technologies considered military or prejudicial to national security or public safety has been clearly provided under UK laws for clarity. Said list does not include inventions in the field of healthcare treatment and diagnosis. According to Chinese Patent laws, Article 25 proscribes substances obtained by means of nuclear transformation, for patentability. Korea dropped the exclusion on substances obtained by means of nuclear transformation in its law with effect from July 1, 1996. 59
Legal Edge Australian Patent Office also has a provision for binding the applicant for inventions related to atomic energy. Under section 184 a person to whom section 71 of the Safeguards Act applies must not disclose information about a matter that has been or is being dealt with under this Act or the 1952 Act unless required or authorised to do so by the Safeguards Act, this Act, a written direction of the Director or an order of a court. USA has special provisions on such inventions. In its Section 2183, the Atomic Energy Act vests the Nuclear Regulatory Commission with the power to declare a patent to be ‘affected with public interest’ if it is of primary interest in the production or utilisation of special nuclear material or atomic energy and the licensing of such an invention is of primary importance for the purposes of the Atomic Energy Act. This provision of US law came under dispute in the TRIPS Council review, but the US cited Article 73(b) (i) of TRIPS in defence stating that they consider it necessary to protect its essential security interests with regard to the use of fissionable materials and the materials from which they are derived. The US law also puts limitations on the applications related to atomic energy. Section 151(a) (42U.S.C. 2181(a)) reads in part as follows: No patent shall hereafter be granted for any invention or discovery, which is useful solely in the utilisation of special nuclear material or atomic energy in an atomic weapon. However, the US law bars the inventions wherein the radioactive material is used for production of atomic weapon. This provides a window for inventions utilising radioisotopes for use in nuclear medicine and radiotherapy. Sections 151(c) and 151(d) (42 U.S.C. 2181(c) and (d)) set out categories of pending applications relating to atomic energy that must be brought to the attention of the Department of Energy. Applications for patents, which disclose or which appear to disclose, or 60
which purport to disclose, inventions or discoveries relating to atomic energy are reported to the Department of Energy and the Department is given access to such applications, but such reporting does not constitute a de termination that the subject matter of each application so reported is in fact useful or an invention or discovery or that such application in fact discloses subject matter in categories specified by the Atomic Energy Act. All applications received in the U.S. Patent and Trademark Office are screened by Technology Center (TC) work group. Papers subsequently added are inspected promptly by the examiner when received to determine whether the application has been amended to relate to atomic energy and those so related must be promptly forwarded
Quick Picks The rejec on of patents for atomic weapons is understandable, however, the logic underlying rejec ng patents for any radioisotopes even for the use in medicine/radiotherapy is difficult to understand. to Licensing and Review in TC work group. All rejections based under the Atomic Energy Act must be made only by TC work group. Patents for other inventions related to atomic invention maybe granted after scrutiny by the Department of Atomic Energy.
Patent protec on in India Indian law as of now makes no distinction between atomic weapons and atomic energy. The rejection of patents for atomic weapons is understandable, however, the logic underlying rejecting patents for any radioisotopes even for the use in medicine/radiotherapy is difficult to understand. The disadvantage of barring almost all inventions, which even hint the use of a radioisotope could be devastating for Indian future commerce related to field of nuclear medicine. Foreign innovating
companies might feel reluctant entering the market with their inventions in the related field, in absence of protection of intellectual property rights awarded to their inventions. Indian researchers in the field also may not have sufficient motivation to carry out inventions. It is worth pondering that how rational it is to include inventions in the field of health care using radionuclides as against national security and discriminate against them for patenting. Indian government should consider amending Indian Patents Act to include in patentable inventions relating to nuclear medicine beneficial for the mankind. The provisions relating to nonpatentable inventions should be should be modified so as to deny protection only to such inventions that are harmful to public However, the inventions in the field of nuclear medicine should be allowed to be patented. The provision about referring the inventions to the Department of Atomic Energy for scrutiny and directions already provides several checks and balances to protect the national interests. On a closer reading of the Atomic Energy Act, the term ‘radioactive substances’ or ‘radioactive material’ are defined as any substance or material which spontaneously emits radiation in excess of the levels prescribed by notification by the Central Government. This could be construed so as to mean that the presence of any reference to radioisotopes in a patent application will attract section 4 of the Indian Patent Act only if it emits radiation in excess of the levels prescribed by notification by the Central Government. Generally, nuclear medicine employs radioisotopes in minute quantities for medical purposes, which emit radiations below the prescribed levels and hugely benefit mankind. There appears to be no plausible reason for not allowing protection to such inventions. The flip side is the potential hazards in indiscriminate use of such radioactive materials. Though the dose in nuclear medicine is kept small enough to Modern Pharmaceuticals I August 2011
Legal Edge minimise the risks, yet radiation from the nuclear medicine may build up in the patient due to frequent use over a period of time and may result in development of cancer. Other hazards associated with the radioactive materials relate to their disposal and possible use of the radioactive materials by terrorists in a dirty bomb to spread radioactive material in an area. A number of applications relating to inventions in the field of radio-nuclides and which employ use of radioisotopes for medical diagnosis are filed in Indian Patent Office. The Controllers generally allow the applications after deletion of any reference to radioisotope in the description and claims. However, many such applications lose the essence of the invention after the deletion and become commercially irrelevant. The applicants desirous of protecting their inventions in India should incorporate some non-radioactive alternatives in the description and claims so that invention is commercially viable even after deletion of the radioactive materials. A few applications can still retain the basic inventive concept even after deletion of reference to radionuclides. For example, an invention may relate to a novel and inventive complexes which bind with a radioisotopes or the application may propose novel non-radioactive luminescent molecules for the purpose. Under such circumstances, even after the deletion of reference to radioisotopes, the application is patentable in view of said complex or the luminescent molecules. However, it would be necessary to provide in the description teaching about therapeutic efficacy of such complex compounds duly supported by examples comprising luminescent molecules attached thereto. In various instances of inventions related to tissue specific disease imaging for diagnostic purposes or image-guided therapies, which used radio-nuclides, the patent applications were allowed, if found meeting the requirements of novelty, inventive step and industrial applicability, once all references to radionuclides were deleted while the other components of the invention were retained.
Conclusion It is evident that solution lies in exercising adequate caution as far as production, handling, storage and transportation of radioisotopes used in nuclear medicine are concerned, but not in exclusion of nuclear radioisotopes from patent protection. India is fast developing as an R&D hub for pharmaceuticals. Already a large number of leading multinational drug companies have set up R&D centres in India. Indian drug industry has also now started competing in innovations with its multinational counterparts. The Indian patent system should be suitably modified to offer incentive for research in the important sector of nuclear medicine. MPh (salhotra@lls.in)
August 2011 I Modern Pharmaceuticals
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Industry Insights
Major depressive disorder market
Sta c and weak compe ve market A few treatment op ons for Major Depressive Disorder (MDD) include psychotherapy, medica on and electroconvulsive therapy. Under medica on, an -depressants are the most widely used. However, more category of drugs are required and the current market is compara vely sta c. MDD therapeutics, global, revenue and market forecasts, ($ million), 2001-2017 12,000 CAGR (2009-2017): 2%
Revenues ($ m)
10,000
CAGR (2001-2009): 7%
8,000 6,000 4,000
greater impact on the market with its late stage first-in-class molecule. Companies like Clinical Data Inc, Astrazeneca and Lundbeck are expected to attract investor’s attention to some extent with technologically advanced products in their pipeline portfolio. However, they fall into ‘me too’ and product extension categories and the launch of these products is not expected to bring a significant transformation in the treatment approach. This would translate into a static or weak competitive landscape.
2,000
Mee ng current demands 0 2001
2009
2017
Source: GlobalData, GlobalData Epidemiology-based Market Forecasting Model, Primary Research Interviews, KOL Interviews
M
ost suicides in the world are related to depression, and currently more than 120 million people in the world are under depression. With the recent approval of Viibryd for treating symptoms of MDD, this case study analyses the pipeline of drugs and predicts the future. The global MDD therapeutics market was valued at $ 11.02 billion in 2009. With an estimate to decline by 3 per cent, it will reach $ 9.0 billion in 2017, which is attributed to patent expiry of Lexapro and Cymbalta in 2012 and 2013. However, the MDD market is anticipated to stabilise with the expected approval of Vilazodone and TC-5214 and the increasing public awareness. 62
The downward curve With a negative growth estimated in the market, MDD is one of the few therapeutic areas with such predictions. This low growth is primarily attributed to successive patent expiries of major therapeutic drugs from 2012. GlobalData observed that Forest Laboratories, Eli Lilly, Lundbeck, Wyeth (Pfizer), GlaxoSmithKline (GSK), AstraZeneca and Merck & Co were the major players in the global depression market. Together, these companies account for 93 per cent of the global depression market share in 2009. Wyeth has a 32 per cent share of the MDD market for its products, Effexor and Pristiq. However, Effexor is an off-patent drug, and its new brand Pristiq may help in generating revenues. Targacept Inc is likely to compete with the existing market players and have a
GlobalData finds that depression disorders currently have safe and effective treatments available as a combination of pharmacotherapy and psychotherapy. Pharmacotherapy with medications such as Selective Serotonin Reuptake Inhibitors (SSRI), or ‘new generation’ antidepressants, along with Cognitive Behavioral Therapy (CBT) provides symptomatic relief for most patients with depression. In addition to this, Direct-to-Consumer (DTC) advertising has played a key driving role in creating patient awareness of MDD and differentiating the safety profiles of drugs, and has resulted in higher sales of antidepressants. Approximately 50 per cent of the market is constructed from generic substitutes enabling the entrance of cheaper alternatives into the market.
MDD pipeline GlobalData analysed that products for MDD in the developmental pipeline are strong, with 66 molecules in various phases of clinical development. The pipeline is crowded with ‘me too’ products and these Modern Pharmaceuticals I August 2011
Product Inquiry Card
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Industry Insights
August 2011 I Modern Pharmaceuticals
Opportunity and unmet need in the MDD market, 2010 Efficacy
Safety
High
Low
High
Unmet Need = 24% X $11.04bn = $ 2.65bn Unmet need is low (24%) for Major depressive disorder
Low
products have better safety and efficacy profiles compared to existing molecules. This explains why there are less first-inclass molecules in the pipeline as many fall in the ‘me too’ category. Of the total, approximately nine are in the ‘me too’ class and four product extensions are in the phase III stage of clinical development. Many companies in the pipeline are developing medications with multiple mechanisms of action to effectively treat severe depression and relieve the patients without causing side-effects such as sexual dysfunctions, which are common with current products. Vilazodone, Seroquel XR and LU AA21004 are the key products currently in phase III, with features such as better efficacy, better tolerability and safety profiles. Studies show that they may work without the side-effects common to SSRIs and Serotonin and Norepinephrine Reuptake Inhibitors (SNRIs). They also seem significantly more effective in treating patients with MDD, which is providing a niche in the depression market.
Lexapro
Cymbalta
Pristiq
Symbyax
Next steps- Unmet need can be fulfiled only by efficacious and safe products which are likely to be me too drugs in SSRI/SNRI class.
Note: Size of the bubble is approximately proporational to the cost Source: GlobalData, GlobalData Epidemiology-based Market Forecasting Model, Primary Research Interviews, KOL Interviews
Need more than ‘me too’ GlobalData finds that the prevailing market landscape remains dominated by a few key market players, and none of their products seem to be satisfying the unmet needs that exist in the market. More than three products currently under clinical investigations are slated to receive regulatory agencies’ marketing approval by 2017. However, considering the fact that a majority of these
products are ‘me too’ products and product extensions, the depression market is a low growth market with moderate opportunities for which technologically innovative products will be required for value capture. The market is likely to decline and is expected to remain a declining market until 2017, with few opportunities for value capture. MPh Courtesy: GlobalData
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Case Study
Track-and-trace
A new approach u lising unique bo om marking Courtesy: Cognex Inc
One of the measures for countering counterfei ng and brand protec on include e-Pedigree and secure Track-n-Trace programmes. A case study reveals how a new method of serialisa on aids the process. while being able to identify the actual containers within bundled labels. “Cognex In-Sight® ID readers meet the challenging requirements of the application such as being able to read the 12 unique bottom codes at a time while the bundle is held by a robot,” informs John Scholes, Special Projects Manager - Omega Design.
Ensuring the safety of the supply chain
T
he US has recently experienced two highly publicised examples of counterfeit drugs within its distribution system: Lipitor tablets, a cholesterol-lowering medication
Didier Lacroix Senior Vice President - Worldwide Sales & Marketing, Cognex Inc
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and Procrit, an injectable drug used to stimulate red blood cell growth. Trackand-Trace programmes designed to enable and support e-Pedigree record-keeping requirements assign a unique serialised label to each container that can be read at each level of the supply chain to trace the changes of ownership of the product from its manufacture to its use. Omega Design, a packaging machinery manufacturer located in Exton, Pennsylvania, US, has proposed a new method of serialisation that utilises a serialised side label and a unique synchronised marking on the bottom of each container. This approach offers the advantage of using low-cost printed labels
The World Health Organization estimates that up to 30 per cent of prescription drugs in developing countries are counterfeit and, in developed countries, counterfeit drugs make up as much as 1 per cent of the market. The US Congress passed the Prescription Drug Marketing Act (PDMA) in 1987, creating a chain of custody tracking requirement for distributors of prescription drugs and related products. Enforcement of these requirements rests with the US Food and Drug Administration (USFDA). This requirement has become known as an electronic pedigree or e-pedigree: a statement of origin that identifies each prior sale, purchase or trade of a drug. The FDA is expected to eventually follow the e-pedigree specifications set by GS1, a leading global organisation dedicated to the design and implementation of global standards and solutions to improve the efficiency and visibility of supply and demand chains globally and across sectors. The GS1 Healthcare automatic identification standard includes a Global Trade Item Number (GTIN), Global Location Number (GLN) and Global Data Synchronization Number (GDSN). The Modern Pharmaceuticals I August 2011
Case Study
GS1 Healthcare user group recommends ‘investing in camera-based code scanners to address specific needs for automatic identification in healthcare.’ The pharma industry is considering several methods of complying with these upcoming requirements. All Track-andTrace programmes assign each container a unique serialised label that stays with it throughout its use. Soon after it is filled, the container becomes part of a series of larger packaging — usually bundles, boxes and pallets — each package must be linked in a parent-child relationship. Most pharmaceutical companies use Radio Frequency Identification (RFID) tags for higher levels of packaging such as pallets and boxes. However, using RFID tags at the container and bundle level substantially increases packaging costs. Also, the high cost of the RFID interrogators that must be used by pharmacists to verify the pedigree of the container used to fill each prescription. In comparison, printing a digital code on a paper label has the advantage of much lower costs for both the label and the reader, high print speeds, negligible failure rates and easy implementation.
integrity and then identify its containers. But side labels pose a challenge for packagers trying to identify containers after a bundle has been created. For instance, how do you scan the codes on the middle containers in a 3x4 bundle since the labels are blocked from all sides? Omega Design’s answer is to print a unique ID on the bottom of every empty container to complement — not replace — the serialised label affixed to the side of the container. The side label is referenced throughout the life of the container, providing the unique container ID as well as all of the relevant consumer information such as product identity, manufacturer, dosage, quantity, etc. When a bundle is created, the serialised side labels would be difficult to see but the unique ID
Prin ng a digital code on a paper label has the advantage of much lower costs for both the label and the reader, high print speeds, negligible failure rates and easy implementa on.
Containers & Bundles In a typical pharmaceutical manufacturing line, packaging processes, such as unscrambling, desiccant insertion, filling, cottoning, sealing and capping, occur before a container finally receives its serialised label or RFID tag. Therefore, packagers must confirm, and not assume, that a container belongs on the packaging line before a serialised label is affixed to the side of a container. Even after receiving its label, the way in which containers flow through other processes can compromise the downstream effort to link higher-level aggregate codes with individual units. To create a bundle, containers must flow through a shrink-bundling system that collates, wraps and unitses the containers. A single misplaced or rejected container, extracted after its place in the sequence if established, might corrupt the integrity of every subsequent bundle. The only way to guarantee the contents of a bundle is to first establish a bundle’s August 2011 I Modern Pharmaceuticals
on the bottom of the container is visible through the transparent shrink wrap film. Omega Design offers a solution for implementing this Track-and-Trace approach with a single unscrambler that can maintain full control over each container — its speed, height and orientation — while passing under the print head and over the verification and rejection stations. The unscrambler accepts bulk bottles and orients them sequentially on the production line. Omega unscramblers print and verify a unique ID on the bottom of every empty container. This unique ID contains enough information to keep track of the container temporarily on the packaging line. Once a larger, permanent and fully serialised label is applied to the container, a camera and serialised software management system put the label code and bottom code in sync. When it is time
for final packaging, the shrink bundler groups and wraps the specified number of containers into a bundle. A robot lifts each bundle and passes it over another ID reader that identifies the containers in the bundle. A new label is then placed on the bundle that is linked to each package.
Demanding vision system applica on The two ID readers used in this application must meet demanding requirements. The ID reader used on the unscrambler must accurately read Data Matrix codes while keeping up with a line that runs at 50 to 300 bottles per minute. The bundler provides an even more challenging application because the ID reader must read all of the bottles in the bundle with one image. In-Sight vision systems incorporate Cognex IDMax® Data Matrix code reading software, based on PatMax® technology, to handle a wide range of degradations to the appearance of the code and provide robust and reliable decoding under all conditions. Omega Design uses the InSight 5410 ID reader on the unscrambler and the higher performance In-Sight 5603 on the bundler application. Cognex also provides a full line of fixed and handheld ID readers that can be used to verify the origin of the bottle at any point in the supply chain. “The primary goal of FDA standards and e-pedigree laws are to protect consumers from contaminated medicine and counterfeit drugs,” Scholes concludes. “To do this, companies must keep track of their products along the supply chain down to the unit or container level. Although compliance dates and final standards are constantly changing and vary per state, the pharmaceutical industry widely accepts that the definitive requirement will involve serialisation. The new approach described here is a cost-effective, easy-to-implement method of incorporating 2D Data Matrix serialisation within new and existing packaging lines without compromising machine speeds or accuracy.” MPh (sales.in@cognex.com)
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Events Calendar
National RUDRAPUR: Uttarakhand, Sept 23-26, 2011, Gandhi Park AHMEDABAD: Gujarat, Oct 14-17, 2011, Gujarat University Exhibition Hall PUNE: Maharastra, Nov 18-21, 2011, Auto Cluster Exhibition Centre CHENNAI : Tamil Nadu, Dec 8-11, 2011, Chennai Trade Centre INDORE: Madhya Pradesh, Jan 6-9, 2012, Poddar Plaza, Nr Gandhi Hall AURANGABAD: Maharashtra, Feb 17-20, 2012, Garware Stadium India’s premier industrial trade fair on products and technologies related to Machine Tools, Hydraulics & Pneumactics, Process Machinery & Equipment, Automation Instrumentation, Packaging & Auxiliaries, IT Products, Electrical & Electronics, Material Handling and Safety Equipment.
For details Infomedia 18 Ltd,
Ruby House, 1st Floor, J K Sawant Marg, Dadar (W), Mumbai 400 028. • Tel: 022 3003 4651 • Fax: 022 3003 4499 • Email: engexpo@infomedia18.in
Future Supply Chain Strategies: The Way Ahead This workshop emphasises the need for a combined effort from the logistics end users and service providers through collaborations, trust, and building relationships. The Frost & Sullivan event aims to deliver a roadmap for this. The workshop will also discuss the practical, feasible and sustainable supply chain models essential for organisations; September 14-16, 2011, The Zuri White Sands Resort, Goa For details contact: Frost & Sullivan Tel: +91 44 6681 4371 Fax: +91 44 2431 4264 Email: priyag@frost.com Website: www.frost.com
2nd Pharmac India The three-day event will cater to the pharma and healthcare industry in the country. It aims to attract reputed professionals from the fields of pharmaceutical formulation, herbal products, veterinary drugs, medical & disposal products and pharmaceutical machinery & equipment. The event will have exhibitors such as contract manufacturers, liaison agents, sourcing companies, generic and OTC manufacturers & wholesalers, government suppliers, etc; September 17-19, 2011;
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Gujarat University Exhibition Hall, Ahmedabad, Gujarat For details contact: Orbitz Exhibitions Pvt Ltd Tel: + 91 22 2410 2801 Fax: + 91 22 2410 2805 Email: info@pharmacindia.com Website: www.pharmacindia.com
14th IDMA-APA PAC This event aims to cater to the pharma and research professionals. It will serve as a platform to the professionals in government laboratories and research institutions, approved testing laboratories, machinery manufacturers, academicians and many others. There will be discussions on how to prepare and face the WHO GMP audit, the validation of legacy systems, the regulatory flexibility in acceptable stability studies along with several other aspects; September 23-24, 2011, Hotel InterContinental The Lalit, Mumbai For details contact: Indian Drug Manufacturers’ Association Tel: + 91 9867634383 Email: ppr@idmaindia.com Website: www.idma-assn.com
Analytica Anacon 2011 Analytica Anacon 2011 is the 6th international trade fair and conference for analytical instrumentation, biotechnology, laboratory technology and services, which
aims to bring together the international exhibitors and market leaders. This event will provide an excellent opportunity to showcase innovative products and solutions in the industry; October 1214, 2011; Bombay Exhibition Centre, Mumbai For details contact: Sonia Prashar Indo-German Chamber of Commerce Tel: +91 11 26878721 or 26111730 Email: soniaprashar@indo-german.com Website: www.analyticaindia.com
CPhI India 2011 The event will feature key decision makers in the pharma industry from 92 countries, including India, China, US, UK, France, Italy, etc. The CPhI conference will include updates on latest innovations, technologies, trends and developments in the pharmaceutical industry in India; November 30 - December 2, 2011; Bombay Exhibition Centre, Mumbai For details contact: UBM India Pvt Ltd Tel: + 91 22 6612 2600 Fax: + 91 22 6612 2626-27 Email: info.india@ubm.com Website: www.ubmindia.in
Pharmapack Bombay The event aims to provide an innovative platform to showcase the latest information, technology and products to a focussed and target audience. The event promises to cater to the exporters, importers, biotechnology companies, medical device manufacturers, biopharmaceuticals, etc; February 23-25, 2012, Bombay Exhibition Centre, Mumbai For details contact: Intel Trade Fairs & Expositions Pvt Ltd Tel: + 91 22 2862 8126 Fax: + 91 22 2281 9008 Email: intelexpo@vsnl.net Website: www.intelexpo.com
Modern Pharmaceuticals I August 2011
Events Calendar
International BioProcess International China BioProcess International China will be the 3rd annual event organised in China. The main topics of discussion will be on cell culture, cell line engineering, purification and recovery, process characterisation, process analytics, formulation and disposables technologies. The event will be attended by the biopharma companies, scientists, and executives from all over the world; August 22-24, 2011, Grand Hyatt Shanghai, China For details contact: IBC Life Sciences Tel: + 65 6508 2401 Fax: + 65 6508 2407 Email: register@ibcasia.com.sg Website: www.ibclifesciences.com
CPhI South America This event aims to be a platform where several pharmaceutical manufacturers, biopharmaceutical, biotechnology companies & API manufacturers will display a variety of products & services. The event will enable business partnerships, new product launches and showcase innovations. The event will be attended by the experts from the entire industry; August 24-26, 2011; Transamerica Expo Center, Sau Paulo, Brazil For details contact: CPhl South America 2011 UBM International Media Tel: +31 0 204 099 561 Fax: +31 203 0632 616 Email: rob.sahi@ubm.com Website: www.cphi-sa.com
Medipharm Vietnam Expo 2011 The event aims to offer an unparalled opportunity for biotechnology and
pharma companies, academic research institutions and investors around the world. It will also provide delegates with business opportunities and knowledge transfer; August 24-27, 2011; TBECC, Ho Chi Minh City, Vietnam For details contact: FAST Syst & Mgmt Services Tel: + 84 4 3825 5546 Email: fastsyst@signet.com.sg Website: www.medipharmexpo.com
Inter Med Pharm 2011 This event aims to provide opportunity for the pharma professionals. Key policy makers, trade visitors, pharma analysts, scientists and researchers are expected to gather here. Thus, this event hopes to offer solution to any pharma related query; September 15-17, 2011; Tashkent Republic of Uzbekistan For details contact: TNT Productions Inc Tel: +1 703 4060 010 Fax: +1 703 4068 543 Email: mariya@tntexpo.com Website: www.tntexpo.com
Nigeria Pharma Manufacturers Expo 2011 The three-day international exhibition will be an excellent opportunity that aims to ensure focussed promotions and meaningful interaction for business. The show will be a catalyst to develop new business opportunities, technology and trade sources, new tie-ups and technology transfer. This event will serve as a unique platform to showcase pharma processing and packaging machinery and materials, API and bulk actives, analytical lab instruments and supplies, environment control systems and utilities, etc;
September 19-21, 2011; Federal Palace, Victoria Island, Lagos, Nigeria For details contact: PMG-MAN and GPE Expo Pvt Ltd Tel: +91 79 4000 8233 Fax: +91 79 2687 1390 Email: INFO@NigeriaPharmaExpo.com Website: www.NigeriaPharmaExpo.com
Public Health 2011 This international event will be focussing on pharma, techpharm, medical laboratory, emergency medicine, beauty and health products. This exhibition will be catering to various industry needs; October 1114, 2011; Kiev International Exhibition Center, Kiev, Ukraine For details contact: Premier Expo Tel: +380 44 968645 Fax: +380 44 4968646 Email: monishchenko@pe.com.ua Website: www.publichealth.com.ua
ICSE Europe The ICSE Europe aims at targeting the top leaders of the pharmaceutical industry. The event will organise an exhibition along with concurrent conferences. The exhibitors profile includes biotrails, pharmacology, pre-clinical, biotechnology, pharma equipment and machinery, production equipment, clinical research, patient safety monitoring, etc; October 25-27, 2011, Messe Frankfurt, Frankfurt, Germany For details contact: UBM Live Tel: + 31 20 409 9544 Fax: + 31 20 363 2616 Email: icse@ubm.com Website: www.icseexpo.com
The information published in this section is as per the details furnished by the respective organiser. In any case, it does not represent the views of Modern Pharmaceuticals
August 2011 I Modern Pharmaceuticals
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Technology Transfer
Technology Offered As part of our endeavour to spread the technology culture, this section provides a means to promote and facilitate exchange of select technologies. We strive to bring together suppliers of such technologies with suitable users for negotiations and industrial collaboration. Natural preparation for anxiety relief A company offers food supplement in the form of tablets that effectively relieves mild to moderate anxiety problems. The ingredient is an herbal extract, which has been scientifically proved for its efficacy. Efficient decrease of anxiety symptoms, quick onset of action and no side effects are reported to be the advantages of this product. Moreover, this product has already been launched in American market. Areas of application Pharmaceutical industry Forms of transfer Equipment supply Anti-ulceritic APIs An Indian company offers anti-ulcer drugs like omeprazole, pantaprazole, omeprazole sodium, omeprazole magnesium and esomeprazole magnesium for operations in manufacturing processes. Areas of application Formulation industries Forms of transfer Consultancy Clorsulon and its intermediates An Indian company offers clorsulon, a highly potent anthelmintic drug, which is administered to de-worm the intestines of sheep and cattle. Areas of application Pharmaceutical industry Forms of transfer Consultancy
Filter cleaning system An Indian company offers an automatic filter media cleaning equipment with drying system. It consists of air wash, water wash and drying facilities. Areas of application Filter media cleaning Forms of transfer Joint venture, equipment supply Herbal formulation for psoriasis and eczema An Indian company offers an innovative herbal formulation that has the ability to control & cure psoriasis and eczema within one month of application of the formulation. Areas of application Herbal medicine Forms of transfer Joint venture, technical services, technology licensing Intravenous fluids An Indian company offers the technology for the production of intravenous fluids (IV). The company has a large volume IV plant and can offer complete support for setting up a new IV plant. Investment required for the fully automatic plant is around ` 15 crore. The company can offer consultancy services/ technical support to set up an IV plant on loan and license basis initially. Later, the collaborating party can set up its own factory when it is ready for investments.
Areas of application Pharmaceutical industry Forms of transfer Joint venture, technical services Smart Syringe A company offers technology to manufacture single use safety syringe with spring actuated needle stick injury prevention and auto disable mechanism. The design is adaptable to all sizes of syringes commonly used for injection purpose. Areas of application Healthcare industry Forms of transfer Technology licensing, funding, others Herbal nutraceutical formulation for preventive cardiology – obesity A company offers a nutraceutical formulation comprising probiotics that essentially includes Lactobacillus acidophilus and Lactobacillus sporogenes, and medicinal plants, which essentially includes Commiphora weightii & Terminalia belerica. The present formulation functions in a synergistic manner resulting in enhanced curative properties. Areas of application Pharmaceutical industry, healthcare industry Forms of transfer Consultancy, technical services, technology licensing, research partnerships
Share Your Technology Propositions The mission of Modern Pharmaceuticals is to spread the technology culture. We offer you an opportunity to participate in this endeavour by publishing the best technology ideas. Technology developers/sellers are invited to furnish the techno-commercial details (with environmental benefits, if any) for publication in the Technology Transfer column of Modern Pharmaceuticals. R&D organisations, technical consultancy organisations and individuals assisting small and medium enterprises may send the relevant literature, indicating the scope & services and the areas of specification. Contact: Modern Pharmaceuticals Infomedia 18 Ltd, ‘A’ Wing, Ruby House, J K Sawant Marg, Dadar (W), Mumbai 400 028. Tel: 022-3003 4669/4671 Fax: 022-3003 4499 Email: spedit@infomedia18.in
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Modern Pharmaceuticals I August 2011
Technology Transfer
Technology Requested I V Fluid manufacturing as SME An Indian company needs new and best technology to start manufacture of I V Fluid. Areas of application Medical technology, I V fluid, manufacturing Forms of transfer Technical services, others Disposable Syringes An Indian company is interested in cost effective production line for disposable syringes for both ribbon and blister options. Areas of application Medical industry Forms of transfer Others Biotechnology for wastewater treatment system A Thailand-based company, a wastewater service provider, is involved in the research and development of new technology for water, wastewater and waste treatment. It requires new ideas related to technology for developing its strength in the field of wastewater; which includes cleaning canals, removing sediments from waterways, biogas, microbiology detector and treated system quality. Areas of application Biotechnology, engineering, new technology Forms of transfer Consultancy Calcium gluconate An Indian company requires the technology to manufacture calcium gluconate.
Areas of application Pharmaceutical industry Forms of transfer Technical services, project reports, others Cell lines Thailand-based, ANH Scientific Marketing Co Ltd has been working in the field of life sciences in the country for more than 20 years. In order to complete the company’s product lines and service customers/ researchers/scientists from the beginning to the end of the process, it would like a company to provide commercial cell lines of human and animals. Areas of application Cell culturing - molecular biology Forms of transfer Material supply Extract of medicinal and aromatic plants An Indian company is interested in putting up a multi-purpose herbal extraction plant for the extraction of medicinal and aromatic plants and herbs like artemisinin/quinine sulphate and other alkaloids. Areas of application Pharmaceutical industry Forms of transfer Others Glove automation equipment An Indian company requires technology to produce glove by automation process.
Areas of application Manufacturing especially rubber latex industry Forms of transfer Consultancy
industries, industry and
Kite grading engineering technology A Fiji-based company offers the technology of kite grading, which is a subservient of genetic therapy research particularly for the cardiovascular novice. It seeks assistance from a potential partner to provide equipment and technical support staff. Areas of application Medical research Forms of transfer Joint venture, partnership Blood Grouping Device An Indian company needs technology for manufacturing blood grouping biomedical device. Areas of application Biomedical Forms of transfer Joint Venture, technology licensing Manufacturing technologies for Montelucast, Rosuvastatin, Ursodeoxy cholic acid, D-biotin An Indian company needs Active Pharmaceutical Ingredient (API) or bulk drug manufacturing technologies for Montelucast, Rosuvastatin, Ursodeoxy cholic acid and D-biotin. Areas of application Pharmaceutical industry Forms of transfer Others
Information courtesy: Dr Krishnan S Raghavan, In-Charge, Technology Transfer Services Group, United Nations - Asian and Pacific Centre for Transfer of Technology (APCTT), APCTT Building , C-2, Qutab Institutional Area, New Delhi 110 016 Tel: 011 - 2696 6509, Fax: 011 - 2685 6274, Email: krishnan@apctt.org, Website: www.apctt.org
For more information on technology offers and requests, please log on to www.technology4sme.net and register with your contact details. This is a free of cost platform provided by APCTT for facilitating interaction between buyers and seekers of technologies across the globe. After submitting technology offer or request to this website, you are requested to wait for at least two weeks for receiving a response from a prospective buyer / seeker through this website, before contacting APCTT for further assistance. August 2011 I Modern Pharmaceuticals
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Book Shelf Oral Bioavailability: Basic Principles, Advanced Concepts, and Applica ons Editors: Ming Hu and Xiaoling Li Price: ` 7000 Considering the difference in rate and extent between a drug taken orally and the actual amount of a drug reaching the circulatory system, oral bioavailability is an essential parameter for determining the efficacy and adverse effects of new and developing medications, as well as finding an optimal dosing regimen. This book provides a much-needed one-stop resource to help the readers better understand and appreciate the facets and complex problems of oral bioavailability, including the basic barriers to oral bioavailability, the methods used to determine relevant parameters and the challenges of drug delivery. Additionally, this book discusses biological and physicochemical methods for improving bioavailability. It integrates physicochemistry with physiology and molecular biology, and includes several state-of-the-art technologies and approaches Caco-2 cell culture model and other cell culture models that are used to study the science of oral bioavailability. Divided into several chapters, this book reviews barriers to oral bioavailability, physiochemical characterisation of pharmaceutical solids, solubility of pharmaceutical solids, etc. Further, the book includes chapters on invitro dissolution of pharmaceutical solids, biological and physiological features of the gastrointestinal tract relevant to drug absorption.
Oral Controlled Release Formula on Design and Drug Delivery Editors: Hong Wen and Kinam Park Price: ` 5100 As the use of drugs employing oral controlled release formulations continues to grow in popularity, the pharma industry must adapt to new developments in order to select the most stable and scalable technology for achieving desired pharmacokinetic profiles. The book ‘Oral Controlled Release Formulation Design and Drug Delivery’ encompasses every aspect of oral controlled release formulations, including controlled release mechanisms, preformulations, biopharmaceuticals, invitro-invivo correlations (IVIVC), Quality by Design (QbD) and regulatory affairs. Comprehensive in scope, the chapters in the book are written by some leading experts in the field. It offers additional details through a mixture of figures, tables and references to provide further information. While one chapter deals with the evolution of oral controlled release dosage forms, another chapter shows the biopharmaceutical consideration and assessment for oral controlled release formulations. Further, these also give an idea about the polymers in oral modified release systems, coating systems for oral controlled release formulations and many others. Extending beyond traditional coverage of oral controlled release formulations based solely on design process development, this book covers everything a pharmaceutical practitioner or student needs to know about the exciting and progressive drug delivery field to advance medicinal benefits for patients worldwide. Available at: Wisdom Book Distributors, Hornby Building, 1st floor, 174, D N Road, Mumbai 400 001 • Tel: 022-2207 4484/6631 8958 • Telefax: 022-2203 4058 • Email: thadam@vsnl.com
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Product Update Laboratory bath and circulator
Steam boiler
Cole-Parmer India offers Polystat® circulating water baths and immersion circulators. It offers excellent temperature stability for a range of laboratory applications. High-stability Polystat heating immersion circulators provide temperature control up to 200°C and inlet/outlet connections for circulation to external open- or closedloops. They feature PID control with an easy-touse LCD (0.01° resolution) and programmability in three languages and up to five temperature set points. Polystat open heating circulating baths offer an economical alternative to stainless steel baths and are operated by a two-speed pump with adjustable nozzle. Their high-temperature cut-off protects samples and equipment. One can choose from acrylic or PPO tank styles, in volumes up to 21 litres. These are driven by a two-speed pump, these units are available in standard & advanced models. The advanced model includes a force/suction pump with up to 21-litre capacity. For broad temperature ranges from -35 to 200°C, these baths include a powerful refrigeration system. Their two-speed industrial grade circulating pump runs up to 21 L/min flow and delivers extra pressure for more efficient heat exchange, better temperature uniformity, and enhanced reservoir agitation. These baths are available in standard digital or advanced digital models.
Aero Thermo Systems offers fully automatic package steam boiler (IBR) having capacity ranging from 100 kg/hr to 2000 kg/hr with operating pressure of 10 kg/cm2 g. Smoke tube & water tube version is also available. Coil is made from seamless tube of asthma 106 GR-B pipes. The unit is equipped with high efficiency oil/gas burner with air pre heater arrangement which gives high thermal efficiency 86±2 per cent on NCV. It is easy and economical in operation. Its application lies in industries such as dyes, chemicals, textiles, fertilizer, petrochemicals, rubber, wood, pharmaceutical, metal finishing, oils, dairy and construction industry.
Cole-Parmer India - Mumbai - Maharashtra Tel: 022-6716 2222/ 209, Fax: 022-6716 2211 Email: vinita.singh@coleparmer.in
Automa c burner Vacunair Engineering offers fully automatic pressure jet oil/ gas/ dual fuel burners. These have capacity of 10 to 500 litre/hr. The fully automatic burners have a matchless performance for steam boiler, thermic fluid heaters, hot water boilers, air heaters, asphalt tanks and aggregate hot mix and recycle road making machinery plants. Vacunair Engineering Co Pvt Ltd - Ahmedabad - Gujarat Tel: 079-2291 0771, Fax: 079-2291 0770, Mob: 099040 03010 Email: info@vacunair.com
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Aero Therm Systems Pvt Ltd - Ahmedabad - Gujarat Tel: 079-2589 0158, Fax: 079-2583 4987 Email: contact@aerothermsystems.com
Rotocone vacuum dryer Ahlada Industries offers rotocone vacuum dryers. In direct heat rotary dryers, a continuous feed of wet particulate material is dried by contact with heated air, while being transported along the interior of a rotating cylinder, with the rotating shell acting as the conveying device and stirrer. The company offers rotary dryers in co-current (parallel) and countercurrent operation. In the former, the wet material is exposed to the hottest air, which enables heat sensitive or sticky materials to be dried successfully. In the counter-current operation dried material is exposed to the hottest air helping to achieve low moisture content. The hot gases may enter the dryer at high temperature. Ahlada Industries Pvt Ltd - Hyderabad - Andhra Pradesh Tel: 040-2309 4301/302, Fax: 040-2309 4300 Email: industries@ahlada.com Modern Pharmaceuticals I August 2011
Product Update Bo om discharge centrifuge United Engineering offers bottom discharge centrifuge with cake scrapping arrangement for chemicals, pharma and process industry. The centrifuge is fitted with a cake scrapping arrangement which can be motorised or hydraulically operated to enable to scrape the stickiest cakes. The cake can be discharged through the bottom chute provided. This results in reducing manual labour, less cake handling loss and uniform cake washing. The centrifuges can be offered in vapour tight construction with nitrogen blanketing for hazardous chemicals. The CIP design with built in cleaning nozzles ensures no product cross-contamination. The centrifuges are offered in three point pendulum suspension and four point inertia plate mounted designs to suite application considerations. The centrifuges are available in MS, SS at point of contacts, complete SS, MS rubber/ halar-lined, with batch capacities of 40 kg to 600 kg. United Engineering Enterprises - Mumbai - Maharashtra Tel: 022-2308 3990, Fax: 022-2308 9445 Email: uenggent@gmail.com
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Product Update Gas generator Peak Scientific India offers Genius range of gas generators. These are designed specifically as a stand-alone system to provide gas to single LCMS applications, which require a high nitrogen flow. Its higher output and small footprint makes it the perfect prodigy. The Genius range of gas generators have the unique benefit of double the gas flow, supporting multiple instruments with individual control, all built into the one, space-saving casing. Peak Scien fic India - Secunderabad - Andhra Pradesh Tel: 040-2780 0663, Fax: 040-2780 0663, Mob: 098660 55177 Email: skarra@peakscientific.com
Crate washing conveyor SS Engineers offers crate washing conveyor. The conveyors’ body is made up of stainless steel and has self-cleaning individual tank filters. It offers heavy construction design, stainless steel chain conveyance, hiperformance pumps, rotating spray jet nozzles, toughened glass windows, operational panel board with safety controls. SS Engineers & Consulants - Rajahmundry - Andhra Pradesh Tel: 0883-2426 845, Fax: 0883-2430 819 Email: info.ssengrindia@gmail.com
Time is accurately maintained even in the case of power cut by virtue of built in battery. GPS master clocks lend the whole time keeping operation the accuracy of 1 second per year & the same accuracy is maintained in all the slave clocks also by virtue of time synchronisation. The flameproof clocks are available in two size options: 2” high & 4” high display sizes. Ace Instruments - Hyderabad - Andhra Pradesh Tel: 040-2307 8848, 3290 1226, Fax: 040-2307 8848, Mob: 093940 30848 Email: sales@aceinstrumentshyd.com
Turbo rotary dryer Alpha Process Engineers offers Alpen turbo rotary dryers. As the name suggests, operating in a batch mode, this dryer reduces the drying time significantly (about 15 per cent) over comparative venuleth drying method. It utilises vacuum drying effectively, while also utilising fluidising technique to expose the wet particulates’ surface to quicken evaporation of moisture. Complete drying system can be offered, including solvent recovery. Its typical application includes pharmaceuticals, bio-drugs, dyestuffs, dye intermediates, organic chemicals, pesticides and solvent recovery. Alpha Process Engineers - Chennai - Tamil Nadu Tel: 044-2811 1351, Fax: 044-2811 2371 Email: apeepa@vsnl.com
Digital DP gauge Flameproof digital clock Ace Instruments offers flameproof digital clocks suitable for all pharma industry applications. The clocks are available in standalone & synchronised master & slave communication versions. Synchronised clocks are especially suited for pharmaceutical industry following USFDA norms as per 21 CFR Part 11 for good time management practices. These clocks can have up to 120 of number slaves connected to one master & can be connected to the master clock via a two core communication cable on RS 485 multidrop network & the master clock time is synchronised with all the slaves. The communication between the master & slave clocks can be either wired (RS485) or wireless (RF communication). All the clocks in the synchronised clock network show the exact same time right up to the seconds. 76 76
Polmon offers digital DP gauge (DPI-53). This is designed to measure difference between two pressures in clean rooms replacing the conventional analogue gauge to eliminate the inherent problems. This works with AA, 1.5, four batteries and has a minimum of 18 months battery life with one second update rate. This has optional clean room compatible SS flush mountable faceplate. The gauge ensures long-term stability and has temperature compensated DP measurement. This also offers software calibration. Polmon Instruments Pvt Ltd - Hyderabad - Andhra Pradesh Tel: 040-2305 3046/5970, Fax: 040-2305 5425 Email: hyd2_polmon@sancharnet.in Modern Pharmaceuticals I August 2011
Product Update Metal door set Ahlada Engineers offers metal door sets. These cleanroom doors/ fire doors are designed and manufactured to meet individual project requirements, with special features incorporated within a flexible system with the highest standards of hygiene in cleanroom applications and other areas. Door frame is pressed from 1.2 mm thick hot dipped galvanised steel skin, light cromated zero spangle with zinc coating and with mitred and welded construction. Door leaf is manufactured from 0.8 mm thick galvanised steel sheet lock formed edges. Insulated & bonded with infill of honeycombed paper core for general and scientific doors / rockwool for fire doors, forming a rigid flush fitting stress free level leaf that will withstand high levels of duty without failure. Innovated flush double glased vision panels available is constructed of vacuum sealed clear toughened glass unit. Ironmongery has a range of indigenous and imported hardware in stainless steel. Door frames and door shutters are coated with epoxy based polyurethane powder coating/ polyurethane liquid paint as per customer requirement.
The control panel of the machine is equipped with PLC system, enabling visual display of the operating parameters besides ensuring accuracy, reliability and reduced operator fatigue. Karishma Pharma Machines - Mumbai - Maharashtra Tel: 022-2380 5979, Fax: 022-2381 1849, Mob: 9821069064 Email: zabinmenon@vsnl.com
Octagonal blender Febchem Engineering Works offers octagonal blender, which is a very useful machinery for pharmaceutical industry wherein gentle blending of dry granules or powder is to be done. It is provided with baffles for fast and efficient mixing, charging port and outlet with butterfly valve. The entire unit is mounted on a sturdy stand, complete with electric motor and gear box. It can be supplied with bin charging system and can be designed for vacuum for dust-free charging and discharging of product (optional).
Ahlada Engineers Pvt Ltd - Hyderabad - Andhra Pradesh Tel: 040-2319 5923, Fax: 040-2319 5924, Mob: 098496 33515 Email: engineers@ahlada.com
Febchem Engineering Works - Indore - Madhya Pradesh
Automa c capsule filler
On-line TOC analyser
Karishma Pharma Machines offers ‘Model-A25’ highspeed automatic capsule filling machine. All the powder contact parts are made in stainless steel 316. The main body of the machine is fabricated out of SS-304. It is compact, sturdy, covered with stainless steel panels, and the hood is covered with acrylic guard. It is provided with tamping mechanism for powder filling, which enables capsules to be filled with a weight variation within 2 per cent. The variable AC frequency drive for main motor ensures speed adjustment. The faulty capsule and filled capsule ejection stations are equipped with individual air controls. This machine is simple to operate and easy to maintain. The special purpose gauges ensure quick and easy changeover. The appropriate sensors ensure continuous flow of powder and empty capsules for uninterrupted operation of the machine.
MeasureTest Corporation offers On-line TOC analyser from Anatel of USA. This can be measured both on and off-line. Offline measurements (laboratory methods) are typically used for high concentrations (>1 ppm). On-line measurements are typically used for sub-ppm (<1000ppb) detection and quicker response than the lab methods. Most industries particularly pharmaceutical and semiconductor manufacturing now use on-line measurements due to the faster response, which is required for process control. Online TOC analysis comes with complete sample oxidation. Its complete regulatory compliance is USP <643>, <645>, and EP 2.2.44 and has wide dynamic range of 1 to 1,000 ppb. There is no requirement of reagents or chemicals.
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Tel: 0731-2721951, Fax: 0731-272 3087, Mob: 09893256418 Email: response@febchem.com
MeasureTest Corpora on - Mumbai - Maharashtra Tel: 022-2202 7982, Mob: 098690 12701 Email: measuretest@yahoo.com Modern Pharmaceuticals I August 2011
Product Update Vacuum homogeniser Alpha Process Engineers offers Alpen vacuum mixers. These are ideally suited for fluid, semi-fluid, viscous pasty, creamy products, ointments, usually encountered in pharmaceutical, personal products, cosmetics, toiletries, food paint, chemicals (like shoe polishes, car cleaners, silicone rubber-based sealing compound, perfumery, flavour, textile dyes and pigments, inks) etc. This multi-agitator system usually comes as a 3-in-1 configuration, the range of agitators selected from emulsifier, homogeniser, disperser, toothed colloid mill, sinus mixer and scraper stirrer, depending on the mixing ingredients and functions to be carried out. These vacuum mixers are available in stainless steel construction and in capacities of 30 litres to 2000 litres. They are also offered in jacketed versions with working temperatures upto 1500 C, operating pressures from atmospheric to full vacuum. Alpha Process Engineers - Chennai - Tamil Nadu Tel: 044-2811 1351, Fax: 044-2811 2371 Email: apeepa@vsnl.com
Rotary high vacuum pump Acmevac Sales offers a wide range of oil sealed rotary high vacuum pumps. These series of vacuum pumps are rotary sliding vane; oil immersed type and are available in single and double stage construction. These pumps are ideal for handling dry and clean air. Exhaust valve is designed to eliminate â&#x20AC;&#x2DC;rappingâ&#x20AC;&#x2122; noise. Unique construction of the pump totally eliminates the sucking of air through the shaft seal. These pumps can also be operated with SAE30 motor oil. Application of these pumps include chemical, pharmaceuticals, electrical, electronics, air conditioning and refrigeration, research, metallurgy, space research, etc. The pumps are available in wide range of models with free air displacement of 50 LPM to 10,000 LPM. Acmevac Sales Pvt Ltd - Mumbai - Maharashtra Tel: 022-2837 5837, Fax: 022-2836 4977, Mob: 092233 88105 Email: acmevac@vsnl.com August 2011 I Modern Pharmaceuticals
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Product Update Digital USB microscope Cole-Parmer India offers digital USB microscope. The digital USB microscope is based on the active pixel technology which produces crisp, sharp images and accurate colour reproduction. Six LEDs illuminate the object - turn the LEDs on or off and adjust the brightness using the control wheel on the body. For versions with the 10x to 200x magnification range, magnification automatically adjusts based on the distance from the object. Units include a basic stand with adjustable height; optional boom stand can be ordered for greater flexibility.The handheld digital microscopes find their applications in science and engineering, digital microscopy, laboratories, pathology or other biomedical labwork. Cole-Parmer India - Mumbai - Maharashtra Tel: 022-6716 2222; Fax: 022-6716 2211 Email: response@coleparmer.in
Vibratory finishing system Niraj Optical Machinery offers vibratory finishing systems, which incorporate a rubber or polyurethane lined bowl of ‘U’ cross section mounted on accurately calculated springs. These systems are driven by a highly efficient vibratory motor. The open top of the bowl can be loaded with suitable ceramic/plastic or steel media and parts to be processed. Vibratory finishers shake parts and media at high speeds, causing the media to scrub the surface of the parts in an action similar to lapping. Since the parts and the media are moving at small increments on each stroke, the parts are not subject to severe stress or damage. Vibratory finishers produce very smooth surfaces, are safe for delicate or heavy (metallic/ non-metallic) parts, and have good action inside recesses & holes. Vibratory finishing is preferred for general deburring, finishing, pre-plate finish, etc of delicate or heavy parts and for precision deburring/finishing. Vibratory finishing is also safer for threaded parts. Niraj Op cal Machinery - Ahmedabad - Gujarat Tel: 079-2929 5747, Fax: 079-2583 3659 Mob: 9825554860, 9909904148 Email: badrakia@rediffmail.com August 2011 I Modern Pharmaceuticals
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Product Update Machinery for tablet/granula on
Photoelectric gap sensor
Ratnakar Pharma Machinery offers single and double rotary press and Mega Mark-II and IV. Available from 16-81 station press it suits large and small size batch and various shapes of the tablets. Also, there is a mini tab press for R&D model, fully automated and PLCoperated, semi-automated and manually operated tablet press. These ranges with the following details: single rotary tab press– 16 -23 station with output of 40,32057,860 tablet/hr, available in D and B/D tooling; double rotary tab press- 25-45 station with output of 136,080-226,800 tablet/ hr, available in B and BB/B tooling; Mega Mark-II available in 37 to 61 station with output of 222,000-366,000 tablet /hr; and Mega Mark-IV, available in 37 to 81 station with output of 325,000-583,200 tablet/hr.
Lubi Electronics offers ‘Sunx’ RT-610 series photoelectric gap sensor. It is ideal for gap sensing, mark sensing and address reading. In this sensor, the beam axis alignment is not required as the emitter and receiver are integrated in a single body. It has a sensing range of 10 mm, 20 mm and 50 mm. The models with a sensing range of 10 mm and 20 mm are available in red LED type and green LED type for mark sensing. This sensor provides high reliability as the housing material is made of diecast aluminum. It can be used effectively in typical applications such as packaging, pharma and machine tool industry.
Ratnakar Pharma Machinery - Ahmedabad - Gujarat Tel: 079-2289 2614/094270 31284 Email: ratnapd@yahoo.co.in, Website: www.ratnakarpharmamachinery.com
Air-cooled compressor Elgi Equipments Ltd offers a unique range of air-cooled compressors for industries that demand oil-free air at their application point. These nonlubricated compressors offer customers the advantages of low energy consumption and low running costs. The air-cooled design eliminates the need for water cooling systems, thereby saving industrial water costs. The two-stage air cooled after cooler has a 0.25 kW single phase motor driving a cooling fan. This eliminates the need for cooling towers, water circulation pumps and the associated piping, thus reducing the initial investment. This also reduces the installed power. The two-stage design increases the efficiency of compression because it facilitates inter cooling. It also reduces the load on the moving parts by reducing the compression ratio of any stage. These features result in the life of the compressor being enhanced. The motor of the compressor fits within a space of 1.74 square metres and the motor rests on antivibration pads. A typical Elgi package consists of a motor, air end, air-cooled cooler, 500 litre air receiver with associated piping and control panel. Elgi Equipments Ltd - Coimbatore - Tamil Nadu Tel: 0422-258 9326, Fax: 0422-257 3697, Mob: 097900 39326 Email: enquiry@elgi.com
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Lubi Electronics - Ahmedabad - Gujarat Tel: 079-2220 5471, Fax: 079-2220 0660, Mob: 093274 97006 Email: info@lubielectronics.com
PTFE lined valves Supremo line & Control offers the fluoropolymer FEP, PFA, PTFE, lined SGI / WCB / SS pipes, valves & fittings using technical know how and raw material for appropriate application of the resin for successful results with international quality for chemical industry. The features are low co-efficient of friction, chemical inertness, non-toxic approved by international food & drugs regulatory authorities, non-inflammable, self-sealant, excellent weathering resistant, zero water absorption. Supremo Line & Control - Ahmedabad - Gujarat Tel: 079-2220 5282, Fax: 079-2220 5181, Mob: 097245 05282 Email: supremoproduct@gmail.com
Leak test apparatus Jicon Machines offers leak test apparatus. It is ideal for checking sealing integrity of blister, strip & pouch packs, capped bottles, etc. The leak test apparatus is extremely compact in construction and has low noise level. It is provided with polycarbonate vacuum dessicator, which sustains vacuum for long durations. The apparatus is made of stainless steel (GMP). It is equipped with built-in vacuum gauge and isolation valve and is provided with 0-5 minute timer for auto-stop. The leak test apparatus has a vacuum level of 550 mm Hg. Jicon Machines Pvt Ltd - Mumbai - Maharashtra Tel: 022-2851 0398, Fax: 022-2851 6488 Email: jicon.ind@vsnl.com Modern Pharmaceuticals I August 2011
Product Update Mo on horizontal cartoner ACG Pampac offers ‘K-120i’, an intermittent motion horizontal cartoner for automatic transfer of blisters or bottles into cartons. This eco-friendly solution is ideal for single as well as multiple blisters. Built to meet upcoming norms of secure cartons, ‘K120i’ can handle tuck-ins, glue in cartons, leaflet folding and insertion, and offers multiple choices of on-line inspection. Capable of handling blister, tubes, bottles and customised applications, this cartoner delivers impressive performance and versatility. This cartoner has the advantage of a balcony design that helps easy cleaning of the machine without removing its parts. Its output is up to 120 cartons per minute with leaflet folding and carton insertion. It is integrated with a camerabased inspection system to detect and check barcodes, pharma codes and 2D matrix codes. K120i offers: GMP balcony design; easy and quick change over; reliable product feeding; compliance to EC regulations & GE standards; flexibility to handle various packaging containers such as blisters, bottles, tubes, vials etc; and ability to handle tamper-evident cartons.
circuit so that the heaters can be operated only after the blowers are switched on to avoid burning of the heaters. The coating pan is manufactured from SS-304 ‘AISI’ 2B prime material quality with adequate mouth opening and depth. The coating machine is also provided with the control panel, which comes with indicating lamps, coating pan main on-off switch, blower on-off switch, thermostat, heater switch, etc. The entire panel can be mounted on the stand. The machine is designed as per GMP standards, with all arrangements inside the enclosure, except electric control panel and SS pan. Allegro Pharmachem Equipment - Thane - Maharashtra Tel: 022-4014 6872-73, Fax: 022-4014 6874 Email: allegro@allegroindia.com
Medical refrigerator
Schmalz India offers vacuum suction cups. This helps in solving the application to handle blister packs. The foil suction cups SGPN is made of natural rubber and suits very thin blister films. A low inner volume guarantees short evacuation time. The requirements on vacuum suction cups for handling blister packs are constantly growing. There is a trend to handle finer films at shorter cycles. With the suction cups designed and produced by the vacuum specialist Schmalz, you play safe. Due to the large product line the company offers the possibility to choose between different materials and geometries with specific benefits securing your competitive advantage.
Sigmatech Scientific Products offers ‘Sigmazk’ medical refrigerator with glass door manufactured by Zhongke Meiling Cryogenics Ltd, China. The medical refrigerator is a specialised equipment for cold storage of pharmaceutical and biological products. It is suitable for hospitals, drugstores, pharmaceutical factories, sanitation & anti-epidemic stations and clinics. This medical refrigerator is provided with microprocessor-based temperature control system, combined with two sensors monitoring the chamber temperature and one sensor monitoring the ambient temperature. A stable and accurate chamber temperature can be maintained at ambient temperature ranging from 0°C to 32°C. Forced air circulation system provided with this refrigerator ensures temperature uniformity.
Schmalz India Pvt Ltd - Pune - Maharashtra Tel: 020-4072 5500, Fax: 020-4072 5588 Email: schmalz@pn3.vsnl.net.in
Sigmatech Scien fic Products - Hyderabad - Andhra Pradesh Tel: 040 - 6453 4491, Mob: 098496 32904, Fax: 040-4003 1896 Email: s_tech07@yahoo.com
ACG Worldwide - Mumbai - Maharashtra Tel: 022-2287 2557-59, Fax: 022-2287 2560 Email: rajendra.khimsaria@acg-world.com
Vacuum suc on cup
Coa ng pan Allegro Pharmachem Equipment offers coating pans, which are totally enclosed with SS cladding and are available with standard gear box, motor and hot air blowing arrangement. These coating pans are provided with interlocked electrical 86 86
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
Modern Pharmaceuticals I August 2011
Product Index Sl No Product
1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 25 26 27 28 29 30 31 32 33 34 35 36 37 38 39 40 41 42 43 44 45 46 47 48 49 50 51 52 53 54 55 56 57 58 59 60 61 62 63 64 65 66 67 68 69 70 71 72 73 74 75 76 77 78
Pg No
Accelerated ageing test.....................................................39 Access control system......................................................... 75 Acoustic enclosure.............................................................. 77 Air filter ..........................................................................21,23 Air shower controller......................................................... 75 Air treatment system.......................................................... 15 Air-conditioner................................................................... 31 Air-cooled compressor....................................................... 84 Analytical instrumentation ............................................... 51 Antiallergic .......................................................................... 73 APFC panel ......................................................................... 31 Automatic burner............................................................... 74 Automatic capsule filler..................................................... 78 Automation software ......................................... Back Cover Axial flow fan...................................................................... 83 Bag filter ............................................................................35 Bearing................................................................................... 6 Biodiesel............................................................................... 39 Biological safety cabinet ...............................................21,23 Blower .................................................................................. 83 Booklet & leaflet label.......................................................... 9 Bottom discharge centrifuge............................................. 75 Cable carrier .......................................................................6 Cable connector.................................................................... 6 Carbon filter........................................................................ 35 Cartridge filter .................................................................... 35 Centrifugal air blower........................................................ 85 Centrifugal monoblock pump.......................................... 83 Chain...................................................................................... 6 Chlorine gas cylinder /tonner........................................... 83 Clean room door...........................................................21,23 Coating pan......................................................................... 86 Coloumns & chemistries................................................... 51 Compositional & trace metal analysis............................. 39 Compressor......................................................................... 83 Conical screw dryer.............................................................. 5 Connector.............................................................................. 6 Conveying blower............................................................... 83 Cooling tower ..................................................................... 15 Counters & power supplies.................. Front Inside Cover Crate washing conveyor .................................................... 76 Crusher ................................................................................ 11 Diesel..................................................................................47 Digital DP gauge ................................................................ 76 Digital USB microscope .................................................... 83 Dispensing booth ..........................................................21,23 Distribution transformer................................................... 31 Door interlock system ....................................................... 75 Drives................................................................................... 17 Dry van pump .................................................................... 77 Dust collector system......................................................... 83 Electrical turnkey project................................................79 Electronic chlorine dosing system & chloroscope ......... 83 Empower ............................................................................. 35 Encoder................................................... Front Inside Cover Exhibition - Engineering Expo - 2012 .......................45,46 Exhibition - India Chem Gujarat - 2011 .......................... 8 Exhibition - India Healthcare Awards ............................. 87 Exhibition - Pharmac Iindia - 2011................................. 88 Failure analysis .................................................................39 Fan........................................................................................ 83 Fan filter unit.................................................................21,23 Filler compositional analysis............................................. 39 Filter ..................................................................................... 11 Filter housing & assembly................................................. 41 Filtration system................................................................. 11 Fire alarm ............................................................................ 75 Fire protection system ....................................................... 57 Flag label................................................................................ 9 Flameproof digital clock.................................................... 76 Food analysing & testing machine................................... 11 Force feed lubricator.......................................................... 49 Fuel burner.......................................................................... 83 Fuel diesel............................................................................ 39 Gas chlorinator.................................................................83 Gas conditioning nozzle ................................................... 57 Gas generator...................................................................... 76 Gases .................................................................................... 39
August 2011 I Modern Pharmaceuticals
Sl No Product
79 80 81 82 83 84 85 86 87 88 89 90 91 92 93 94 95 96 97 98 99 100 101 102 103 104 105 106 107 108 109 110 111 112 113 114 115 116 117 118 119 120 121 122 123 124 125 126 127 128 129 130 131 132 133 134 135 136 137 138 139 140 141 142 143 144 145 146 147 148 149 150 151 152 153 154 155 156
Pg No Sl No Product
Gear oil ................................................................................ 39 Geared box .......................................................................... 19 Geared motor...................................................................... 19 GMP heat exchanger............................................................ 5 GMP reactor ......................................................................... 5 Hanger label........................................................................9 Heating range...................................................................... 35 HEPA filter terminal housing ......................................21,23 HPLC ................................................................................... 51 Hydraulic buffer ................................................................. 49 Hydraulic cylinder.............................................................. 49 Hydraulic jack..................................................................... 49 Hydrogenator/autoclave ...................................................... 5 Industrial chilling equipment ........................................65 Industrial control & sensing devices... Front Inside Cover Industrial cooler ................................................................. 15 Informatics.......................................................................... 51 Injectable manufacturing line......................................21,23 Invertor/variable frequency drives ...... Front Inside Cover Isolation transformer......................................................... 31 Knife mill...........................................................................11 Lab equipment..................................................................35 Label....................................................................................... 9 Laboratory bath and circulator ........................................ 74 Laminar air flow workstation......................................21,23 Leak test apparatus............................................................. 84 Level controller ...................................... Front Inside Cover Liquid filler.......................................................................... 85 Liquid food processing machine...................................... 11 Liquid ring vacuum pump ............................................... 83 Lubes- engine oil ................................................................ 39 Machinery for tablet/ granulation.................................84 Material identificaton system............................................ 39 Measuring & monitoring relay ........... Front Inside Cover Medical refrigerator............................................................ 86 Metal door set..................................................................... 78 Metallography system ........................................................ 39 Motion control system ......................... Front Inside Cover Motion horizontal cartoner .............................................. 86 Muller................................................................................... 11 Multi-function mill............................................................ 11 Multistage centrifugal air blower...................................... 83 Nutrition ...........................................................................73 Octagonal blender............................................................78 Oil / gas firing equipment................................................. 83 On-line analyser ................................................................. 78 Online B2B marketplace ................................................7,89 Optical range ..................................................................... 35 Pallet...................................................................................79 Passbox............................................................................21,23 Passbox inter-lock system.................................................. 75 Petrol & fuel oil .................................................................. 47 Pharma manufacturing solution...........Back Inside Cover Pharma packaging solution ............ 85, Back Inside Cover Photoelectric gap sensor.................................................... 84 Photoelectric sensor.............................. Front Inside Cover Platinum cured silicon tubing .......................................... 35 Pleated filter ........................................................................ 35 Pneumatic component ...................................................... 11 Pneumatic conveying system............................................ 83 Polymer characterisation................................................... 39 Portable loader.................................................................... 83 Power pack unit.................................................................. 49 Power saver.......................................................................... 31 Pre-engineered & pre-fabricated modular panel ......21,23 Process heat exchanger ........................................................ 5 Process reactor ...................................................................... 5 Programmable logic controller............ Front Inside Cover Programmable terminal ....................... Front Inside Cover Proximity sensor.................................... Front Inside Cover PTFE lined valve................................................................. 84 Pump..............................................................................77, 83 Quick change terminal hose......................................21,23 R&D solution........................................Back Inside Cover Rapid endotoxin detection system................................... 75 Return air riser ..............................................................21,23 RFID........................................................ Front Inside Cover Roots blower ....................................................................... 77
157 158 159 160 161 162 163 164 165 166 167 168 169 170 171 172 173 174 175 176 177 178 179 180 181 182 183 184 185 186 187 188 189 190 191 192 193 194 195 196 197 198 199 200 201 202 203 204 205 206 207 208 209 210 211 212 213
Pg No
Rotary gear.......................................................................... 79 Rotary high vacuum pump .............................................. 79 Rotary Lobe pump............................................................. 79 Rotary vacuum dryer........................................................... 5 Rotocone dryer ..................................................................... 5 Rotocone vacuum dryer.................................................... 74 Safe change housing....................................................21,23 Safety light curtain ................................ Front Inside Cover Sampling booth .............................................................21,23 Sanitary centrifugal pump ................................................ 79 Screening machine ............................................................. 11 Screw pump ........................................................................ 79 Self-adhesive tape ............................................................... 61 Self-priming monoblock pump ....................................... 79 Separator.............................................................................. 11 Services - Institute of pharmaceutical education & research....................................................... 55 Servo driven auger filler machine .................................... 85 Servo stabiliser .................................................................... 31 SEZ developer............................................. Front Gate Fold Side channel blower ........................................................... 83 Silicone carbide heat exchanger.......................................... 5 Single acting hydraulic cylinder ....................................... 49 Slide filler............................................................................. 85 Spherical paddle chopper dryer ......................................... 5 Spray nozzle and accessories............................................. 57 Spun filter............................................................................ 35 Stainless steel filter.............................................................. 35 Steam boiler ........................................................................ 74 Sterilising/ depyrogenating tunnel ..............................21,23 Submersible pump............................................................. 83 Switching relay....................................... Front Inside Cover Telescopic cylinder ...........................................................49 Temperature controller......................... Front Inside Cover Testing system..................................................................... 39 Three parameter display.................................................... 75 Timer ...................................................... Front Inside Cover Transmission fluid.............................................................. 39 Trim handling system ........................................................ 83 Triplex plunger pump........................................................ 79 Turbo rotary dryer ............................................................. 76 Turnkey project...............................................................5, 31 Turnkey systems for dust suppression............................. 57 UPLC..................................................................................51 UPS ...................................................................................... 31 Vacuum booster pump....................................................77 Vacuum homogeniser........................................................ 79 Vacuum pump.................................................................... 85 Vacuum suction cup.......................................................... 86 Vacuum system................................................................... 77 Vane damper....................................................................... 83 Ventilator ............................................................................. 61 Vertical inline pump .......................................................... 79 Vibratory finishing system ................................................ 83 Viscous paste filler.............................................................. 85 Vision sensor.......................................... Front Inside Cover Wastewater treatment equipment .................................11 Water ring vacuum pump................................................. 83
Looking for a speciďŹ c product? We will ďŹ nd the product for you. Just type MPH (space) Name of the Product and send it to 51818 eg, MPH (space) Bioreactor and send it to 51818.
89
Advertisers’ List Advertiser’s Name & Contact Details
ACG Worldwide
Pg No
BIC
T: +91-22-26780127 E: shabir.badami@acg-worldwide.com W: www.acg-worldwide.com
Aqua Services
83
75
87
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Danfoss Indus Pvt Ltd
17
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Dev Engineers
79
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Engineering Expo
46
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Fabtech Technologies Intl Pvt Ltd
21,23
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FICCI
8
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Shashwat Systems Pvt Ltd
65
6
7,89
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Shiva Analyticals (India) Limited
39
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Siemens Ltd
BC
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79
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Sreelakshmi Traders
Institute Of Pharmaceutical Education And Research 55
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Vacunair Engineering Co Pvt Ltd
83
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FGF
Waters (India) Pvt Ltd
51
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FIC
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85
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88
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19
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10
49
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Spraying Systems (India) Pvt Ltd
T: +91-11-47168888 E: tanu@indo-german.com W: tanu@indo-german.com
Orbitz Exhibitions Pvt Ltd
35
T: +91-22-43560400 E: coupling@shahbros.com W: www.shahbros.com
Sintex Industries Ltd
T: +1800-200-4444 E: pr@indiamart.com W: www.indiamart.com
Premium Transmission Ltd
T: +91-11-23765081 E: mehul@ficci.com W: www.indiachemgujarat.com
Frost & Sullivan
11
T: +91-80-39127800 E: info@igus.in W: www.igus.in
Omron Automation Pvt Ltd
31
Shah Brothers
T: +91-2764-291022 E: icemake1@gmail.com W: www,icemakeindia.com
J B Sez Pvt Ltd
Pg No
Servomax India Ltd
73
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T: +91-9819552270 E: engexpo@infomedia18.in W: www.engg-expo.com
Everest Transmission
Ic Ice Make Refrigeration Pvt Ltd
Advertiser’s Name & Contact Details
T: +91-40-44436666 E: dharmesh@servomax.net W: www.servomax.net
T: +886-4-896-5198 E: guanyeu@ms39.hinet.net W: www.guan-yu.net
Indo-German Chamber Of Commerce 75
T: +91-40-27759895 E: sales@eltechservices.com W: www.eltechservices.com
Engineering Expo
Guan Yu Machinery Factory Co Ltd
IndiaMART InterMESH Limited 5
T: +91-22-26743719 E: sales@dipeshengg.net W: www.dipeshengg.com
Eltech Services Pvt Ltd
Gracure Pharmaceuticals Ltd
Igus India Pvt Ltd
T: +91-79-26403839 E: info@devpumps.com W: www.devpumps.com
Dipesh Engineering Works
15
T: +91-11-47770900 E: Info@gracure.com W: www: gracure.com
T: +91-80-25588175 E: india.customercare@crl.com W: www.criver.com
CNBC TV 18
Gem Equipments Ltd
Pg No
T: +91-422-3267800 E: sales@gemindia.com W: www.gemindia.com
T: +91-265-2331748 E: aquaas@satyam.net.in W: www.aquaservicesindia.com
Charles River
Advertiser’s Name & Contact Details
Reynders Label Printing India Pvt Ltd T: +91-149-3305400 E: india@reynders.com W: www.reynders.com
BC-Back cover, BIC-Back inside cover, FGC-Front gate fold, FIC-Front inside cover
9
Looking for a specific product? We will find the product for you. Just type MPH (space) Name of the Product and send it to 51818 eg, MPH (space) Bioreactor and send it to 51818.
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90
Modern Pharmaceuticals I August 2011
Modern Pharmaceuticals
RNI No: MAHENG / 2008 / 27125 Postal Regd No: G / NMD / 122 / 2011 - 13 Posted at P.C Stg. OfďŹ ce, GPO, Mumbai 400 001 On 19th & 20th Of Every Month Date Of Publication: 16th Of Every Month
August 2011
92