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Editorial
An aversive or a well-versed Budget?
L
ooking at the Union Budget from a bird’s eye view, the intent seems crystal clear. This year, the government has set its priorities on controlling inflation, achieving fiscal consolidation and maintaining growth. Unassumingly, it has received reactions stating it a ‘no bold moves’ and ‘no big surprises’ Budget. With the suggested reforms, the Finance Minister expects to contain the deficit at 4.6 per cent of the Gross Domestic Product (GDP) and attain a growth of 9 per cent the next year. Some positives of this Budget include higher allocation on infrastructure, commitment to make Goods & Service Tax (GST) a reality, no change in Excise Duty (ED), promoting research, increasing local manufacturing and promoting inclusive growth while targeting 25 per cent GDP contribution from manufacturing by 2020, commitment on raising governance standards, and reducing surcharge arginally on corporates. From the healthcare sector perspective, it is good to see the healthcare Budget raised by a healthy 20 per cent to ` 26,700 crore. At the same time, government’s spending on healthcare as a percentage of our GDP continues to be minuscule. An enhanced weighted deduction of 200 per cent, an increase from 175 per cent would now be available for
contributions made to approved scientific research programmes. Also, maintaining cold chain is likely to get a boost, thanks to sops on ED on coolers and refrigeration equipment. On the flip side, the introduction of Minimum Alternate Tax (MAT) on Special Economic Zones (SEZs) and the phasing out of Export-oriented Units (EoUs) will impact their growth. Also, the rise in MAT will affect the corporate sector. There is a need to incentivise exports through fiscal measures and maintain the pharma sector’s global competitiveness. Besides, the delay in rolling out GST to June 2012 is likely to adversely impact pharma supply chain due to multiplicity of taxes with high transaction costs. It will be interesting to see whether the intended plans, with seemingly ample scope for inclusive growth, will act as a catalyst in India’s quest to join the league of global economic super powers. For detailed perspectives on Budget 2011-12, turn to ‘Post-Budget’.
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Editor: Manas R Bastia
March 2011 I Modern Pharmaceuticals
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Contents REGUL A R SEC TIONS Editorial .........................................................13 National News...............................................16 World News...................................................20 Events Calendar.............................................58 Product Update .............................................64 Product Index ................................................71 Advertisers’ List.............................................72
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FE AT URES 24
POST BUDGET Impact on pharma: Is it a ‘no budge’ Budget?
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LEADERS SPEAK 'Our major strength will remain in the bulk and generics drug segment' ...says Prakash R Uttarwar, Joint Commissioner (Headquarters), Food & Drugs Administration, Maharashtra
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REGULATORY AFFAIRS EU demand for data protection in India: A matter of concern Daara B Patel, Secretary General, IDMA
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ROUNDTABLE Investment patterns in drug research: Treating diseases with an eye on money?
34
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FACILITY VISIT Thermolab Scientific Equipment Pvt Ltd: Driving quality with zeal
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INDUSTRY UPDATE Pharma packaging: Countering the counterfeit
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MARKET TRENDS Acquistions in lab equipment and analytical instrument market: Following a healthy pattern?
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MARKETING Expiry date: Knowing it better Dr Rajan TD, Pharma Consultant & Practising Dermatologist
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CLINICAL RESEARCH
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Clinical trial feasibility: Analysis and evaluation Nandita S Dingankar, Senior Manager – Medical Services, SIRO Clinpharm
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LEGAL EDGE Bolar provision and the pharma industry: Striking the right balance Anuradha Salhotra, Managing Partner, Lall Lahiri & Salhotra, IP law firm
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REPORT BioAsia 2011: Going clean with green technology
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Highlights of Next Issue Industry Update IT + Automation for pharma Market Trends Biotech
Modern Pharmaceuticals I March 2011
National News Strides Arcolab’s new facility receives US FDA nod to commercialise first sterile product
New quality standards for medicines highlighted at joint USP-IPC
Strides Arcolab Ltd (Strides) has recently announced that it has received approval from the US FDA to commercialise Vancomycin injection from the company’s new sterile injectable complex in Bengaluru. Vancomycin injection is currently facing a significant upswing in demand in the USA and the approval of this product from the new facility offers Strides unconstrained capacities to meet the increasing demand. The first shipments of Vancomycin injection to the USA from Strides’ new facility will commence from this March 2011. Commenting on this development, Venkat Iyer, CEO, Agila Specialties, said, “The US FDA approval for the new site is an important milestone in scaling up our business in the US. With our unconstrained capacity, we are well positioned to take advantage of the significant opportunity for injectable products in the US market. We will follow this with a series of initiatives to include the new facility in all the approved ANDAs thereby facilitating the launch of more products in the US soon.”
Venus Remedies launches ‘Passion Oncobiz’ Venus Remedies Ltd, a research-based pharma company has recently announced that it will enter super specialty oncology segment with launch of a dedicated sub business unit Passion Oncobiz with product basket of 21 products in injectable form for fighting practically all types of cancer. Pawan Chaudhary, CMD, Venus Remedies said, “At present, the anti-cancer drug segment is contributing to 30 per cent of the total sales of the company with more than 100 market authorisations from 25 countries including UK, Germany, Poland, Portugal; and with the launch of Passion Oncobiz, we will further reinforce its industry position and expect growth of 10 per cent in the market share by 2015.” With a well qualified team comprising of 35 professionals, this marketing cell is aimed at offering affordable life-saving medicines to Indian masses.
Establishing new quality standards for medicines— and the technical challenges and opportunities that remain—were among the highlights of the 10th Science and Standards Symposium (SSS) that was held recently in Hyderabad. The symposium was cohosted by the US Pharmacopeial Convention (USP) and the Indian Pharmacopoeia Commission (IPC). In opening remarks, Roger L Williams, MD, Chief Executive Officer, USP announced the startup of a new, free, online USP Medicines Compendium (MC) comprising quality standards for medicine moving in global commerce. Because Indian manufacturers contribute strongly to this movement, USP wishes to work in India and in other countries that manufacture medicines, thus making the MC useful to manufacturers throughout the world. USP has elected an Expert Committee including scientists from India who will assess and approve standards for the MC. This group – the USP Medicines Compendium Expert Committee—is chaired by Dr Antony Raj Gomas and includes 11 additional distinguished Indian scientists. An IPC representative is expected to serve as a government liaison to the Expert Committee, which held its initial meeting this week. Dr Williams noted, “As the pharma industry has become increasingly global, it is important that patients worldwide are protected by the availability of up-to-date, science-based standards of quality, identity, purity and strength of the medicines they take. India has emerged as a leading supplier of medicines and their ingredients worldwide. We look forward to ongoing, additional collaborations with regulators, compendial experts, and manufacturers in India as the MC develops.”
Jubilant sets up global scale capaci es for Symtet, the key ingredient for Chlorpyrifos Jubilant Life Sciences Ltd (formerly Jubilant Organosys Ltd) an integrated pharma and life sciences company and the largest Custom Research & Manufacturing player out of India, announced today that it is setting up a manufacturing plant for “2,3,5,6-Tetra Chloro Pyridine” (also commercially known as Symtet/ TCP) of 24,000 TPA capacity and Chlorinated Pyridine derivatives of 5,000 TPA,in Special Economic Zone, at Bharuch, Gujrat. Symtet is used in the manufacturing of Chlorpyrifos, one of the world’s largest and safest, low cost insecticide, having a growth of approximately 7 per cent globally. This facility is 16
expected to be operational towards the end of 2012. The company has received approvals from major customers and is the process of firming up long term arrangements with them. It expects to achieve additional annual revenue of $ 90 million from this facility. Commenting on the development, Shyam S Bhartia, Chairman & Managing Director and Hari S Bhartia, Co-Chairman & Managing Director, Jubilant Life Sciences Ltd, said, “This technology will provide an innovative solution to its customers by providing a penultimate intermediate using single step chemistry leading to a better quality agrochemical product with higher yield.” Modern Pharmaceuticals I March 2011
National News Indian pharma companies find business opportuni es in France Indian pharma companies are now looking at investing in France. As a testimony to the sustained recovery in the global economic situation, France has opened its arm for Indian companies to expand their presence by setting up their units on the European soil. At an event organised by the Confederation of Indian Industries (CII), Guillaume Page, Inward Investment Officer, Invest in France Agency, said, “France investment potential in the field of Information Technology
(IT), pharmaceuticals and renewable energy sectors. Companies wanting to invest in France will get all the necessary support from the government.” Further, France has recently emerged as one of the strongest economies in the entire European Union region having achieved a GDP growth of 1.5 per cent. He further added that Indian pharma giants like Dr Reddy’s, Wockhardt, Zydus Cadila are a few of the companies looking at having their operations in France.
Bharat Biotech announces phase III clinical trials in India
Bayer Material Science inaugurates Color Competence and Design Centre
Bharat Biotech has recently announced that it has initiated a phase III trial in India with THR-100 (Staphylokinase) in patients suffering from an acute myrocardial infarction. The trial is expected to recruit approximately 120 patients. Bharat Biotech has entered into a licence agreement with ThromboGenics for the manufacture, clinical development and commercialisation of THR- 100 with the objective of potentially commercialising THR-100 as a replacement for established thrombolytics, in developing markets in December 2006. Bharat Biotech anticipates that the phase III trial with THR-100 will be completed in the second half of 2011. The results of this trial will pave way for this novel thrombolytic to be filed for marketing approval with the Indian regulatory authorities.
Bayer MaterialScience recently inaugurated its Color Competence and Design Centre in Greater Noida, near New Delhi. This centre would provide products and solutions for polycarbonate compounds, ranging from colour matching and small-scale production, to the broad range of technical services to support injection-molding and compounding processes. It would enable customers to adapt quickly to fastevolving trends, and explore new options for colour, surfaces, geometries and design, while leveraging Bayer MaterialScience’s global expertise and extensive know-how of the local markets. “Our investment is a reflection of Bayer MaterialScience’s commitment to the India market, as well as of our vision to further strengthen our leading position in the polycarbonate market globally. With our Color Competence and Design Centre in Greater Noida, we believe we are in good stead to show how Bayer MaterialScience is delivering the best value for polycarbonate solutions in the market,” ,” said Dr Günter Hilken, Member of the Executive Committee, Bayer MaterialScience AG and Global Head, Polycarbonate Business. The Greater Noida facility is a one stop solution for customers offering four capabilities under one roof: a color competence centre, including a color interaction room; flexible small-scale production and sampling, and pilot production; application development along the value chain and customer management. As part of the global network, experienced specialists will boost the support of customers’ projects by tailored technical advice and consultancy.
Ideal Cures wins pre-grant opposi on under sec on 25(1) against BPSI Ideal Cures Pvt Ltd, a Mumbai-based Indian company having three manufacturing plants, is the leading manufacturer of INSTACOAT range of ready-to-use film coating systems, pharma polymers and other excipients like MCC & Silicon spheres and extended cooling boosters. It had filed pre-grant opposition under section 25 (1) of the Patents Act 1970 against the patent application no - 689/MUMNP/ 2007 Titled “Enteric Film coating composition” of BPSI Holdings Inc. USA. This is a crucial victory for an Indian Pharmaceutical excipient-manufacturing company. Film coating materials which are produced by companies like Ideal Cures Pvt Ltd play an important role in improvement of the shelf life of product, provide physical and chemical protection to drugs, to control release of drug from the tablet, to protect drug from gastric environment in the stomach with an acid-resistant enteric coating, release pattern, ie release of drug in the body as well as to mask taste, odour & colour of the drug. The refusal of grant of a patent against this application of BPSI holdings, will offer cost effective solutions to the Indian pharmaceutical industry. The grant of patent is refused in view of lack of inventive step & as it does not constitute invention under section 2 (1) (j) of Indian Patent Act 1970. 18
Modern Pharmaceuticals I March 2011
National News Alvogen and Natco secure first to file status on generic version of TamifluR
Stempeu cs product gets DCGI clearance
Alvogen has recently announced that with its Indiabased partner, Natco Pharma Ltd, the company has filed an Abbreviated New Drug Application (ANDA) with the United States Food and Drug Administration (USFDA) for the generic version of TamifluR. Robert Wessman, Executive Chairman, Alvogen Pharmaceuticals Ltd, said, “The ANDA filing of Robert Wessman TamifluR represents a significant milestone for Alvogen in the US market. We are confident that the filing will qualify for 180-day exclusivity upon the FDA approval and we expect the product to offer significant value to our customers and patients. While we are steadily growing our product pipeline through partnerships, our internal capabilities still form an important cornerstone of our development strategy. We will continue our journey of growth and expansion as we move towards our goal of positioning Alvogen among the leading global generics companies.” Alvogen has built a dynamic product pipeline of more than 200 products of which 70 are for the US market. It has over 200 marketing authorisations pending regulatory approval representing $21 billion in annual global sales. The company also aims to submit over 100 marketing authorisations in the US and Europe in 2011 and launch over 100 products in these markets.
Stempeutics Research has recently announced that it has been granted the clearance from the Drug Controller General of India (DCGI) for the company’s investigational medicinal product, Stempeucel, for conducting Phase II clinical trials in patients with osteoarthritis, diabetes mellitus type 2, liver cirrhosis and chronic obstructive pulmonary disease. This product is developed from mesenchymal stem cells derived from donated bone marrow using Stempeutics proprietary technology. It is the first of its kind stem cell product developed in India and took almost 15 months to get the DCGI clearance. Commenting on the approval granted, B N Manohar, CEO, Stempeutics Research, said, “We are the only company in India which has achieved this significant mile stone. Our team is working towards hitting the first stem cell ‘off the shelf ’ product in the Indian market by the end of 2013. ”
Increased global regula ons forces Indian Life Sciences companies to improve risk Regulatory changes, particularly in India, the US, and the European Union are driving many Indian Life Sciences companies to re-examine their business models and improve their risk management practices. At the recent Marsh Life Sciences Risk Conclave 2011 held in Mumbai, the speakers said that the new regulatory regimes posed serious challenges to their businesses. Among measures that companies need to consider are a new Indian patent regime, a new directive on clinical trials from the Drug Controller General of India (DCGI) and more stringent checks adopted by the USFDA. Indian life sciences companies need to ensure that they have a robust and formally
documented risk management plan and appropriate mitigation strategies. Speaking at the conference, Sanjay Kedia, Country Head and CEO, Marsh India, said, “India has emerged as a leader not only for contract manufacturing of generic pharmaceuticals but also contract research and clinical trials because of the low costs and high skills of researchers. With Indian life sciences companies seeking new business opportunities around the world and also looking closely at mergers and acquisitions, these global regulatory issues will only become more pressing. It is critical these companies understand these risks and take adequate steps towards mitigating and managing them.”
Cole-Parmer hosts seminar for scien fic and process industry Cole-Parmer recently organised a seminar in Pune to share the company’s global expertise with the Indian Scientific fraternity and help them discover how to optimise their existing process and get an inside line on upcoming technology breakthroughs and product releases. The event offered a unique opportunity to meet the global March 2011 I Modern Pharmaceuticals
experts and the eminent speakers from Cole-Parmer who have found profound experience in the field of fluid handling. Speaking on the occasion, Rakesh Agarwal, Director of Operations, Cole-Parmer India, said, “Today, the industry collaborates with Cole Parmer for their discovery, product development and scale up. This
seminar is one of the initiatives we take to come closer to the customers and partner in their R&D and process development. The diversified content of the seminar makes the customer well versed with the latest technology and its advancements, which gives them a perfect opportunity to re-energise their existing process through leading advice from our global experts.” 19
World News Malvern’s new SEC-LS dual integrated detector is dedicated to proteins
Agilent technologies introduces headspace sampler for GC applica ons
Malvern Instruments has launched the Zetasizer µV with OmniFACE and OmniSEC, a new SEC-LS (size exclusion chromatographylight scattering) detector package dedicated to protein analysis. The proven Zetasizer µV offers dual Zetasizer Nano with OmniFACE Dynamic Light Scattering (DLS) and Static light scattering (SLS) capabilities. It can be used as a standalone detector, analysing samples in a cuvette, and now as a fullyfeatured modular chromatography detector. The absolute nature of the measurement means that no column calibration is required. The Zetasizer µV is available as a complete chromatography system or can be added to existing SEC modules. Malvern’s OmniFACE provides the necessary connection that enables the Zetasizer µV to be linked into any third party SEC system and detectors, so that output signals can be used by the OmniSEC software for results calculation. Connecting the Zetasizer µV is simplicity itself. Using standard chromatography tubing it can be added in series with other detectors such as UV and RI. The laser stability and optical set-up of the Zetasizer µV ensure excellent baseline stability and signal-to-noise for maximum sensitivity, while the 8-µL flow cell minimises band broadening.
Agilent Technologies Inc, recently introduced a headspace instrument for gas chromatography (GC) sample analysis, the 7697A Headspace Sampler. It is based on Agilent’s Automatic Liquid Sampler (ALS) technology, and features superior 7697A Headspace Sampler performance without loss or degradation of volatile components found in the gas portion of partitioned GC samples. Headspace sampling allows the introduction of volatile compounds, from virtually any matrix, directly into a GC or GC/MS instrument. The technique is relatively simple when compared to other injection techniques, such as purge and trap, and keeps instruments cleaner than the standard liquid injection.
InDevR signs global distributors InDevR, one the West’s fastest growing biotechnology companies, today announced it has signed six agreements with leading medical device distributors for US and international territories to market the company’s ViroCyt™ 2100 Virus Counter®. The Virus Counter represents a significant technology shift that will dramatically streamline research and development efforts for vaccine
manufacturers, pharmaceutical and biotechnology companies and researchers worldwide. This proprietary, patent-pending technology will allow scientists to expedite the vaccine development process and greatly improve time to market.
Michael Minard, Director of Business Development, InDevR said that the Virus Counter will be actively marketed to scientists in India, China, Japan, Korea, Belgium, Luxembourg, Netherlands, UK and US via selective distributors. Minard adds, “This rapid growth and acceptance by distributors reflects the level of excitement about the new technology.”
Eisai to submit marke ng authorisa on applica ons in the US and EU for Perampanel Eisai has reported that it will submit Marketing Authorisation Applications in the US and the European Union (EU) for the investigational compound Perampanel (E2007) based on the results of three phase III pivotal studies. Perampanel is a first-inclass, highly selective non-competitive AMPA-type glutamate receptor antagonist, discovered and being developed by Eisai for adjunctive treatment of partial onset seizures in patients with epilepsy. The clinical development plan for Perampanel consisted of three global phase III studies - Studies 306, 305 and 304; a total of 1,490 patients participated. The key goal of Study 306 was to identify the minimal effective dose and 20
included four treatment arms (placebo, 2 mg, 4 mg and 8 mg). Studies 304 and 305 included three arms (placebo, 8 mg and 12 mg) and were to evaluate a more extended dose range. All studies were global, randomised, double-blind, placebo-controlled, dose-escalation, parallel-group studies. The primary and secondary endpoints were the same in all studies. All studies showed consistent results in the efficacy and tolerability of Perampanel given as an adjunctive therapy in patients with refractory partial seizures. Eisai is committed to the therapeutic area of epilepsy and addressing the unmet medical needs of epilepsy patients and their families. Modern Pharmaceuticals I March 2011
World News Wya Technology Corpora on wins SBA’s Tibbe s Award for advanced technological innova ons Wyatt Technology Corporation has announced that it has received one of the prestigious Tibbetts Awards from the Small Business Administration (SBA) for its role as the world’s leading provider of analytical light scattering instrumentation. The Small Business Administration presents the awards (also known as ‘Tibbies’) to companies and individuals that have advanced technological
innovation and economic growth. “An SBIR award by the Department of Defence in 1982 enabled me to found Wyatt Technology,” said Dr Philip J Wyatt, CEO, Wyatt Technology. “We were able to use the special instruments developed during that programme to form the basis for a new line of laser-based instruments that eventually would revolutionise the means by which
Addi onal informa on on Vorapaxar Merck (also known as MSD) recently reported that investigators in the TRA-2P study of Vorapaxar, investigational cardiovascular medicine, have been provided with additional information about the recommendations of the Data and Safety Monitoring Board (DSMB) regarding the TRA-2P study. The additional information was sent yesterday in a communication to investigators from the Operations Committee of the TRA-2P study of Vorapaxar. As reported by Dr Eugene Braunwald, Chairman, TRA-2P study, to the investigators, “The DSMB has communicated to us that based on all of the data available to them from both trials, subjects with a history of stroke should not receive Vorapaxar. They have observed an increase in intracranial haemorrhage in patients with a history of stroke that is not outweighed by their considerations of potential benefit.”
Teva Pharmaceu cal increases its investment in Rexahn for R&D Rexahn Pharmaceuticals, Inc, has announced that Teva Pharmaceutical Industries Ltd (Teva) purchased 2,334,515 shares of Rexahn’s common stock in a private offering for $3.95 million or $1.692 per share. This investment by Teva was made pursuant to the terms of the Securities Purchase Agreement, dated June 26, 2009, as amended. After this transaction, Teva will own 6.29 per cent of the outstanding shares of Rexahn. The investment money will be used for the purpose of supporting the research and development programme for the pre-clinical stage, anticancer compound RX-3117. RX-3117 is a small molecule, new chemical entity (NCE), nucleoside compound that inhibits DNA methyltransferase, a cyclin-dependent kinase, and DNA synthesis. Potential indications of RX-3117 are solid tumors including colon, lung and pancreatic cancers. RX-3117 has demonstrated its ability to overcome cancer drug resistance in cancer cells, in particular, gemcitabine-resistance in the human lung cancer cell. Rexahn owns the U.S. patent for RX-3117, which claims composition of matter, synthesis, and methods (2008) Dr Chang Ahn, Rexahn’s Chairman and Chief Executive Officer, said, “We are excited by Teva’s increased commitment to this collaboration and the development of RX-3117. It has been promising and we are working to advance the compound into clinical trials in 2011.”
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scientists throughout the world would analyse their samples.” “This is a great day not only for Wyatt Technology and its team members, but also for the city of Santa Barbara. Companies like Wyatt Technology represent the best in American ingenuity,” said Sean Greene, SBA’s Associate Administrator for Investment and Senior Adviser for Innovation.
PRECOS doubles capacity and appoints new senior scien fic staff to accommodate significant growth Preclinical Oncology Services (PRECOS) Ltd, a leading pre-clinical research and development service provider with a specific focus on oncology, announced that it has doubled its capacity to support the strategic growth of the company. Following a successful first six months since its spinout from the University of Nottingham in September 2010, the company has expanded to accommodate existing and anticipated growth in line with its leadership in oncology drug discovery. By adding this extra capacity, PRECOS will be able to provide its leading specialist services to its existing and growing number of prospective customers. PRECOS has recently invested in 200 sq m of new laboratory space, which will see the company expand significantly during 2011. This expansion reflects the continued development of the company as an innovative leader in oncology and confirms PRECOS’ commitment to offer a worldclass service to its clients. As part of the business expansion, PRECOS has appointed two new senior scientists to join its team of experts to support new and existing projects going forward. Both senior research staff have significant experience within the pharmaceutical industry, having both worked for a large pharmaceutical company for several years. Their individual scientific competence will enhance PRECOS’ reputation for exceptional scientific expertise, which complements its cutting-edge technology and innovative approaches.
Modern Pharmaceuticals I March 2011
World News Marina, Debiopharm partner on RNAi-based bladder cancer work The Debiopharm Group (Debiopharm) and Marina Biotech, Inc, has announced their exclusive agreement concerning the development and commercialisation of Marina Biotech’s pre-clinical programme in bladder cancer. Debiopharm and Marina Biotech will work together to advance to market an RNAi-based therapy for the treatment of non-muscle invasive bladder cancer, where Debiopharm will have full responsibility for the development and commercialisation of any products arising from the partnership. Under the terms of the agreement, Debiopharm will pay Marina Biotech up to $25 million based on predefined research and development milestones as well as royalties on the sales of products resulting from the partnership. In addition, all Marina Biotech research and development costs for the bladder cancer program will be funded by Debiopharm beginning in February 2011.
First duplex test for parvovirus B19 and HAV available in US now Roche has announced the availability of cobas® TaqScreen DPX Test for use on the cobas s 201 system in the US. It is the first commercial test to quantify parvovirus B19 and detect Hepatitis A Virus (HAV) simultaneously in one assay in human plasma. “The launch of this test is an important part of our strategy. It is not only an important test for the continued safety of plasma products, but it also indicates our continued commitment to this vital area,” said Paul Brown, Head - Roche Molecular Diagnostics. The test is a state-of-the-art, in vitro Nucleic Acid Amplification Technology (NAT) Test, which offers complete coverage of all human genotypes of parvovirus B19 (genotypes 1, 2 and 3 DNA) and HAV (genotypes I, II and III RNA) in human plasma. The cobas® TaqScreen DPX Test uses multi-dye, real-time Polymerase Chain Reaction (PCR) technology that allows the simultaneous detection and identification of individual viral targets without the use of additional discriminatory tests. This test also facilitates quantification of the parvovirus B19 while detecting extremely low levels of HAV.
Blood-clo ng agent can diagnose fatal gene c diseases Scientists at University of Manchester have shown that a protein involved in blood clotting can be used to diagnose and subsequently monitor the treatment of a group of childhood genetic diseases. In the study, published in the Journal of Inherited Metabolic Disease, the researchers were able to show that the clotting agent, Heparin Cofactor II/Thrombin (HCII/T) complex, could be used as a ‘biomarker’, or biological tell, in individuals with mucopolysaccharide (MPS) diseases. Dr Brian Bigger, Lead Researcher, Manchester’s MPS Stem Cell Research Laboratory, said, “HCII/T complex was originally developed in Canada as a test for patients with MPSI, II and VI. We were able to show that HCII/T complex can clearly distinguish between untreated patients with MPSI, MPSII, MPSIIIA, MPSIIIB, MPSIIIC, MPSVI and unaffected individuals.” Further, he informed, “Two of the sugars that are commonly accumulated in MPS diseases are Heparin Sulphate (HS) and Dermatan Sulphate (DS). Other sugars such as Chondroitin Sulphate (CS) are usually not accumulated in the disease. By measuring the ratio of DS:CS in urine, we can accurately diagnose the disease, but detection of sugars is expensive and technically challenging. Instead, the HCIIT method relies on detection of proteins binding to sugars and is much cheaper to perform.” Simon Jones, a consultant paediatrician, St Mary’s Hospital in Manchester and co-author on the paper, added, “These are difficult diseases to treat and monitor so advances such as this will help us to diagnose and treat patients more effectively in the future.”
EMEA approves X-Excite for ED Global Health Ventures Inc, a specialty pharmaceutical company focussed on sublingual drug delivery, is pleased to announce that regulatory bodies in the European Medicine sAgency (EMEA) have approved the use of their lead therapeutic drug, X-Excite in men similar to the Erectile Dysfunction (ED) drug currently on the market known as Viagra®. EMEA approved Global Health to carry out a small (24 people) clinical trial alongside with the similar ED drug, Viagra®. This study is expected to start within the next few weeks, and will March 2011 I Modern Pharmaceuticals
become the major milestone for X-Excite. The study will approximately take 3 to 4 months to complete. X-Excite is a sublingual formulation of sildenafil citrate, which is used to make one of Pfizer Incorporated’s largest sellers Viagra®. This drug uses the sublingual delivery, which is the fastest proven way to get a drug into the blood and bypass the liver as first passage to the body. Many of the side effects of drugs are due to their metabolism in liver and as it uses liver as the first passage to the body. 23
Post-Budget
Impact on pharma
Is it a ‘no budge’ Budget? With elec ons round the corner, good reforms were expected from the government in the Union Budget this year. Almost all sectors, from healthcare to realty, and the aam aadmi are giving a mixed bag of reac ons post Budget. A few industry experts provide their views on the impact of the Budget on pharma.
‘Bi er pill for the sick and ailing’ Dr Ajit Dangi President & CEO, Danssen Consulting
The Budget 2011-12 can be summed up in one sentence ‘absence of any negative is the biggest positive’. While many people feel that the Budget lacks big ticket reforms, it must be realised that the Budget is basically a statement of account and one single annual event cannot decide the economic future of the nation. Hopefully, in the next few months major policy decisions will unfold. Many of these decisions will require political consensus, which cannot be decided by FM or PM alone and will also depend on international developments such as crude oil prices, economies of the developed world etc. As far as healthcare is concerned, a healthy 20 per cent boost in the healthcare Budget to ` 26,700 crore is welcome. However, government’s spend on healthcare continues to be fraction of our Gross Domestic Product (GDP). The impact of reduction in surcharge on Corporate Tax is marginal. The delay in rolling out Goods and Services Tax (GST) to June 2012 due to lack of consensus among various states will keep pharmaceutical
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supply chain and logistics disruptive due to multiplicity of taxes with high transaction costs, and thus its administration cumbersome. However, maintaining cold chain is likely to be little easier due to sops on Excise Duty (ED) on coolers and refrigeration equipment. Bringing hospitals and diagnostic/ pathological labs under Service Tax will increase burden on patients. Some large corporate hospitals have already announced that they will pass on this burden to the patients. Government should seriously consider rolling back this provision. As far as indirect taxes are concerned, exemption from SAD for P&P medicines imported for retail sale and reduction of customs duty on four specified life-saving drugs and their bulk drugs from 10 per cent to 5 per cent with nil CVD (by way of ED exemption) is a welcome move. The increase in concessional rate of 4 per cent ED to 5 per cent on drugs was uncalled for, particularly for a sector which is price controlled. Medicine prices are likely to go up by 2 to 3 per cent. Pharma units in Special Economic Zone (SEZ) will now be subjected to Minimum Alternate Tax (MAT), which can Modern Pharmaceuticals I March 2011
Post-Budget impact their profitability marginally and affect exports. But more than profits, this is a breach of promise given that SEZs will be tax free. The impact of rationalisation of provisions related to transfer pricing needs to be carefully studied after examining the fine print. Collection of Service Tax from ‘cash’ to ‘accrual’ basis will affect the cash flow. Pharma industry is innovation and R&D based, and one would have expected
increase in tax exemption for investment in R&D and expenses related to patent filing, etc. An enhanced weighted deduction of 200 per cent, an increase from 175 per cent would now be available for contributions made to approved scientific research programmes. Widening the scope of Rashtriya Swastha Bima Yojana (RSBY) will marginally benefit the poor and also the generic drug manufacturers.
‘A play-it-safe Budget with no bold reforms’ Kiran Mazumdar Shaw Managing Director, Biocon
Striving to augment growth in the face of rising inflation and falling investor confidence, India needed Finance Minister Pranab Mukherjee to deliver a 2G Union Budget – a bold statement from the UPA government that addressed Growth and Governance. Unfortunately, all he has delivered is a ‘play-it-safe’ Budget by balancing his books, containing the deficit, averting subsidies and creaking open the door to foreign investment in Indian mutual funds. The Indian growth story has been sustained by Foreign Direct Investment (FDI), as investors across the world clamoured to partake in the dividend offered by the country’s growth. The plot seems to be lost – even as other emerging markets are managing to garner higher foreign investment, we are failing to compete and seem to have lost our policy momentum. The result? In the past 2 months alone, $2 billion dollars have been taken out of the stock market. In 2010, FDI reduced 30 per cent to $24 billion. These are very dangerous signs, reflecting a reality where investors are losing confidence and we cannot afford to be complacent.
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What is deeply distressing is that he has taken several retrograde decisions in this Budget. Not only has he increased MAT for the corporate sector, but he has also brought SEZs under the MAT ambit. SEZs augur well for exports, enabling development by generating employment and attracting investment. However, today SEZs are lost in the maze of ad-hoc policies and questionable practices. This Budget has let down the healthcare sector, which has not seen anything concrete beyond the increase in allocation and the extension of health insurance to National Rural Employment Guarantee Act (NREGA) workers. Instead of taking measures such as extending health insurance to all Indians and setting up an integrated healthcare system to ensure affordable and accessible healthcare for all, Pranab Mukherjee has taken pot shots at easy targets such as bringing health check-ups and diagnostics under the service tax net. He has totally excluded the promising biotechnology sector, failing to make provisions for the funding the industry requires.
‘Pricing to end consumer is set to rise with increase in excise from 4 per cent to 5 per cent’ Partha Mukherjee Vice President, Sales, Anglo-French Drugs & Industries Ltd
From a long term perspective, the prospects for the sector appear bright led by increasing focus of governments across the world to reduce healthcare costs and many drugs going off patent. In fact, the next 2-3 years are expected to be strong ones for domestic companies focusing on generics with several branded drugs having huge sales losing their patents. Further, as the developed world recovers, tie-ups in the R&D space would also go a long way in enhancing the fortunes of the Indian pharmaceutical industry. Pricing to end consumer is set to rise with increase in excise from 4 per cent to 5 per cent. Some tinkering in tax proposals are as follows: Rate of MAT proposed to be increased from
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March 2011 I Modern Pharmaceuticals
18 per cent to 18.5 per cent of book profits. Surcharge on domestic companies reduced to 5 per cent from the current 7.5 per cent. Weighted deduction on payments made to National Laboratories, Universities and Institutes of Technology to be enhanced to 200 per cent from 175 per cent. Although MAT has been increased by 0.5 per cent to 18.5 per cent, the reduction in surcharge for domestic companies comes as a relief. Inclusion of units operating in SEZs under MAT would negatively impact companies, which presently have or are planning to set up manufacturing units in SEZs. Implementation of GST is the only positive. Besides, we will have to keep an eye on new RBI norms for banking and its impact. 25
Post-Budget
‘This could certainly have been a legacy budget for the UPA, but the opportunity has been lost’ Ranjit Shahani President, Organisation of Pharmaceutical Producers of India
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Enhancement of scope of weighted deduction on payments made for scientific research to National Laboratories, Universities and Institutes of Technology to 200 per cent is a welcome step. Besides, following tax and other proposals of the Finance Minister could benefit
the industry: National Innovation Council to prepare road map for innovation in India. Liberalisation of the FDI Policy Infrastructure status to cold chains: Capital investment in creation of modern cold chain capacity will be eligible for viability gap funding of the Finance Ministry.
Corporate surcharge has been reduced from 7.5 to 5 per cent, although corporate MAT has gone up to 18.5 per cent. Introduction of ‘Self Assessment’ in customs, wherein importers and exporters will themselves assess payment of duties. Service tax will now cover some categories of hospitals and diagnostic tests, which may increase healthcare cost of individuals availing such facilities. Thus, in our view, the healthcare concerns of the country have not been given adequate importance in the Union Budget proposals for 2011-12 to help improve the healthcare needs of the nation. This could certainly have been a legacy budget for the UPA - particularly given the enormity of the healthcare challenge with two-thirds of our population having no or very limited access to modern healthcare, but the opportunity has been lost.
‘MAT on SEZ is a hur ng point for pharma and IT companies ’ Sanjay Pai Chief Financial Officer, Plethico Pharmaceuticals Ltd
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Primarily the provisions of the Budgets on MAT on SEZ units would be definitely an unfortunate factor for pharma & IT companies and basically, is not in line with the commerce ministry nor in line with SEZ Act, which clearly emancipates that the Special Economic Zone would
not be burdened with any tax liability. Based on this, many companies would have invested their monies into building infrastructure in awkward / backward places and this could lead to loss of confidence in the investor community on the road map of the taxing authorities in India. Clarity on GST & DTC as to content would have gone a long way.
‘It would have been good to see funds in the form of equity fund for non revenue-genera ng companies’ Sanjeev Saxena Chairman & CEO, Actis Biologics
It is an interesting and a good Budget for the economy. Problem appears when you look at things like the healthcare sector; if there are more than 25 air-conditioned beds in a hospital it comes under the Service Tax regime, which will either force hospitals to have less than 25 AC beds. It is interesting to note when a person is unwell a better and more relaxed environment is required including ACs and so people will not get that good quality of care in hospitals or hospitals will try to create work arounds, which will probably result in additional black markets or additional bureaucracy.
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From the biotech stand point, we needed to see decrease in import duties and other excise duties and taxes for equipment which are not made in India, besides reducing TDS payment requirements for equity against tech transfer. More investment for new drug development both in reduction of taxes and also more funds being allocated for new drug development for biotech and nanotech to companies involved in innovation should have been emphasised. It would also have been good to see funds in the form of equity fund for non revenue-generating companies involved in innovation. This would help not just fuel but accelerate the growth of the economy. Modern Pharmaceuticals I March 2011
Post-Budget
‘The Budget, simply put, is long on intent but short on content’ S Ramesh President, Finance and Planning, Lupin Ltd
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The FM’s Budget, simply put, is long on intent but short on content. While the strategic focus of the Budget on various matters such as fiscal consolidation is explicit, the process by which it will translate into a tangible outcome is still to be made unequivocal.
The Budget has little for the pharma industry; whilst the weighted deduction on R&D is a necessary fiscal incentive given to the entire sector in several parts of the globe, there was also a need to incentivise exports through fiscal measures to maintain the sector’s global competitive situation, which unfortunately is not the case with the MAT introduction on SEZs and the phasing out of EOUs.
‘Healthcare concerns of the country have not been given adequate importance in the budget’ Tapan Ray Director General, OPPI
In its Pre-Budget Memorandum, OPPI proposed budgetary/fiscal measures and support in the following five key areas: Infrastructure building Improving access to medicines Reduction in transaction costs Incentivising R&D Reduction in tax burden and other measures Overall, there is nothing significant in this Budget for the healthcare sector. However, we appreciate the following announcements of the FM in his budget speech with reference to the above areas: A. Plan allocation for health has been increased by 20 per cent. A significant part of which, we hope, will be utilised to build appropriate healthcare infrastructure. B. The scope of RSBY has been expanded to widen its coverage, which is expected to have an impact in
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improving access to medicines to the marginalised section of the population. C. The Industry expected that the government will take measures to make all imported life-saving drugs more affordable to the patients by eliminating the import duty. Unfortunately, this has not come true. However, the basic Customs Duty has been reduced to 5 per cent with nil CVD on four life-saving drugs along with the bulk drugs used in the manufacture of these drugs. These four drugs are: 1. Rasburicase (Anti-cancer) 2. Nilotinib (Anti-cancer) 3. Prevenar (Anti-pneumococcal paediatric vaccine) 4. Micafungin Sodium (Anti-fungal) Thus, the healthcare concerns of the country have not been given adequate importance in the Union Budget proposals for 2011-12 to help improve the healthcare needs of the nation.
‘Increase in per month remunera on to the anganwadi workers and helpers; is a good step in mo va ng rural healthcare provision’ Dr Vivek Desai Managing Director, Hosmac India Healthcare Consultancy, Chairman Healthcare Committee, CII
“The increase in the healthcare budget by 20 per cent to ` 27,600 crore is encouraging. Also, inclusion of unorganised workers like mining and construction workers will help people avail better healthcare facilities. This could also be linked to NREGA. Repatriation of money from abroad with a reduced 15 per cent tax will have a good impact on investments in healthcare. Increase in per month remuneration to
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the Anganwadi workers and helpers is a good step in motivating rural healthcare provision. The ` 500 crore outlay for National Skill Development Council is a welcome inclusion as this presents enormous scope to train manpower in healthcare like lab technicians, nurses, radiographers, etc. However, the 5 per cent Service Tax on centrally air-conditioned hospitals of more than 25 beds is a dampener as the bills for patients may go up.” 27
Leaders Speak
‘Our major strength will remain in the bulk and generics drug segment’ With the Indian pharmaceu cal sector poised to grow at double-digit in the coming years, the industry should look at Mergers & Acquisi ons (M&As) in order to strengthen its global foo ng, feels Prakash R U arwar, Joint Commissioner (Headquarters), Food & Drugs Administra on, Maharashtra, who is conďŹ dent of Indian pharma products emerging as the best interna onally. Anwesh Koley Please give an overview of the Indian pharma industry The Indian Pharm market is currently valued at approximately $22 billion. Pharma exports are about $8.5 billion of which active pharmaceutical ingredients and bulk drugs comprises the major share. This volume is almost second largest in the global scenario. There are about 20,000 manufacturing units in India of which about 3000 are in the state of Maharashtra. India has the largest number of United States Food and Drug administration (USFDA)-approved facilities outside the US. Majority of the pharma industry in India has focused on generics and bulk drugs, while MNCs have relied upon specialty products and patented molecules. M&As are a part of this growth. At present, the biotechnology industry is booming in India. The developed economy, the increase in high-income groups, increasing number of middle class individuals and their income have made MNCs and big Indian multinationals influx expensive drugs. But still the low-priced generics will remain popular because of the large population. The projected growth of the Indian pharma industry is well over 12 per cent over the next few years, which is optimistic compared with the growth rate of global pharma industry. The major strength will remain in the bulk and generics drug segments that will continue to dominate globally. 28
Modern Pharmaceuticals I March 2011
Leaders Speak
By 2014, the growth rate of formulations will witness a rapid expansion of about $15 billion. It will be noteworthy that the organised sector is looking at the highly potential business of pharmacy retail segment. This segment is expected to expand at double the pace of overall growth of pharma sector in the next five years. This sector, which has traditionally been dominated by small retailers, is all set to see a change with leading drug manufacturers planning to open exclusive stores. At present, outsourcing of diagnostics and clinical trials is not new and these will see a further growth as the confidence level in the minds of the global players has increased and is expected to grow by 20 per cent over the next few years. The developments in R&D set-ups have encouraged Indian players to take up new product development. Further, the Government has encouraged the pharma industry by giving tax breaks to certain areas, product developments and clinical procedures.
which includes Indian Pharmacopoeia, British Pharmacopoeia, United States Pharmacopoeia and European Pharmacopoeia. As far as cosmetics are concerned, the Bureau of Indian Standards has its own standards prescribed.
Which are the regulatory bodies in India looking a er the quality of pharma products? At the central government level, there is the Central Drug Standard Control Organisation headed by Drugs Controller General (India). It regulates the import, permission for clinical trials and for new drugs. It is also the licence-approving authority
Government has encouraged the pharma industry by giving tax breaks to certain areas, product developments and clinical procedures.
What are the quality standards that the Indian pharma industry should follow? There are various laws relevant currently for the pharma industry. The Drugs and Cosmetics Act of 1940 & Rules 1945, the Drugs (Prices Control) Order 1995 issued under the Essential Commodities Act and the Drugs and Magic Remedies (Objectionable Advertisements) Act, 1954 and Rule 1955 all lay down the essentials for this sector. The standards are prescribed in these Acts. For ayurvedic, siddha and unani drugs there are authoritative books given in the First Schedule of the Act, and it also includes ayurvedic aharmacopoeias. For homoeopathic drugs, there are homoeopathic pharmacopoeias. Other than the above-mentioned drugs, there are standards prescribed in the Second Schedule of the USFDA, March 2011 I Modern Pharmaceuticals
for certain categories of drugs such as blood and blood products, DNA products, vaccines, sera, large volume parenterals, some medical devices such as orthopaedic implants, scalp vein sets, drug-eluting stents, catheters, etc. At the state level, there are drug control offices or Food and Drug Administration headed by the directors or commissioners or drugs controller. These bodies regulate the sampling of drugs, licensing and inspections of manufacturing and selling premises. Some states regulate all types of drugs, while some have different authority for licensing and regulation of drugs under the Indian system of medicines, such as ayurveda, siddha, unani drugs and also homoeopathic drugs.
What are the various measures taken by industry to ensure quality? The pharma industry has been constantly upgrading its infrastructure and manufacturing facilities as per the global standards. Various drives are undertaken by conducting stability studies on all products and using validated processes and conducting bioavailability and bioequivalence studies. Extensive and authentic documentation is undertaken so as to increase the confidence level of the auditors. The registration of inventions for patents also helps researchers along with registering brands, marks, artworks, etc under the Trademarks and Copyright Acts. This includes conducting thorough search for brands, patents, etc before offering products in international markets. Pharmaceutical companies also enter into trademark, patent user/assignment agreements with the owners/inventors along with establishing their own research and development and clinical trial setups.
What are the current challenges faced by industry? The pharma industry in India needs to have a lot of things in place. There is an urgent need for recognition of harmonised laws in importing countries. Research houses need to have liberal policies and the government regulatory bodies must ensure speedy clearances. However, there are various concerns regarding the reduced margins for essential drugs in India and the diversified environment in different states such as tax holidays, surplus and economical power and low expenditure on labour. These things if taken care of will go a long way in ensuring global standards for the Indian pharma industry. MPh (anwesh.koley@infomedia18.in)
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Regulatory Affairs
EU demand for data protec on in India
A ma er of concern According to a news report, India–European Union (EU) Free Trade Agreement (FTA) nego a ons are at a crucial stage. While an FTA would open the European market for Indian exports and vice versa, there are some issues that are extremely worrisome and need a definite resolu on.
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he most important point of concern relates to the EU demand of inclusion of Intellectual Property Rights (IPRs) and data protection in the FTA. Despite an assurance from the Department of Industrial Policy and Promotion (DIPP) that it will not accept the EU draft on IPRs to be included in the FTA, still there is great pressure on the Indian government from the EU. Further, one cannot rule out a possibility of the Indian government buckling down under pressure from EU and MNCs. With the recent developments such as seizure of Indian made generic medicine
Daara B Patel Secretary General, IDMA
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consignments at foreign ports, takeover of key Indian companies and the conclusion of AntiCounterfeiting Trade Agreement (ACTA) negotiations between Europe, the US and Japan, the insistence of EU for creation of ‘exclusive rights’ over pharmaceutical test data (data exclusivity) in FTA negotiations raises big concerns for India. The demand that data exclusivity (euphemistically called ‘Data Protection’) be accepted by India as a part of the FTA is a matter of great concern for India because it will adversely affect people here by raising the prices of less expensive generic drugs to the level of monopoly prices, which are generally very high. Monopoly prices, as is well known, can be several times more than the ordinary or ‘generic’ prices. This would create serious difficulties for people in India, particularly those from the poor socio-economic strata. While Trade-Related Aspects of Intellectual Property Rights (TRIPS) does not require data exclusivity, the European Commission (EC) has insisted in FTA negotiations that India provide at least several years of data exclusivity. The European demand is that when any clinical data is submitted by any company to the Drug Regulator (Drugs Controller General, incase of India), that company should get the monopoly status or exclusivity on that product and that no other company should
be allowed to work on that product for a certain duration (generally five years). If this is accepted then generic competitors must repeat costly trials for marketing approval, which deters generic production. The most serious impact is likely to be on drugs that are not under patent. In such cases, data exclusivity will create a ‘patent-like’ barrier that will prevent entry of generic forms of new formulations during the entire period of exclusivity. If this demand were to be accepted by India, the result would be that the price of that product will be decided by the monopoly holding company on which the government will have no control. The price will increase many times the true value. Therefore, before this demand of data exclusivity is taken up seriously in FTA negotiations or even otherwise, the government must consider the effect and impact on local generic drug production and prices. This will be disastrous for people in India as well as the Indian pharma industry, which currently supplies reasonably priced and affordable medicines. If the generic industry is affected, the public will also be affected because of the non-availability of low-cost medicines. The Indian government must support the generic manufacturers to domestically produce and supply medicines at prices far lower than the EU and US-based pharma companies. Therefore, Europe’s demand for data exclusivity in FTA negotiations should be completely rejected. MPH (daara@idmaindia.com)
Modern Pharmaceuticals I March 2011
Roundtable
Investment pa erns in drug research
Trea ng diseases with an eye on money? The global healthcare industry is caught between the prevalence of infec ous diseases on one hand and lifestyle diseases on the other. Thus, while affluent countries can afford high quality treatment due to economical feasibility, backward na ons are o en le at the mercy of Interna onal Organisa ons to provide basic healthcare. Anwesk Koley
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he onus of developing drugs lies in the hands of the researcher or pharma companies. We tend to believe that drugs are manufactured depending on the prevalence of disease or patients’ requirement. However, it is interesting to note that certain private pharma companies might be completely profit driven and may be reluctant to invest in manufacturing drugs curing infectious diseases like malaria in economically backward countries. Under these circumstances, such countries are at the mercy of International Organisations for basic healthcare. We ask few industry experts to give a clearer picture, and to prove whether these companies really have an eye on money or are there some other hindrances.
Almost half of all deaths in developing countries are due to infectious diseases. Global pharmaceutical industry has been rather insensitive towards the under-developed and developing countries as far as medical initiatives are concerned. But this is not without reason. The geographical position of economically backward countries does not provide a viable proposition for pharma companies to carry out R&D as few medical practitioners and researchers are willing to carry out operations there. One in two deaths caused due to malaria can be prevented if people have ready access to diagnosis and treatment with anti-malarial drugs. However, even a single course of treatment is expensive. However, the private sector pharma
companies are profit oriented. The returns offered by setting up healthcare facilities in these countries coupled with the amount of hard work involved, does not warrant the required investments, which need to be put in. This is precisely the reason why we find most of the healthcare drives undertaken in such countries by World Health Organization (WHO). The onus falls mainly on large pharma companies who can undertake such investments and carry out such activities purely based on social and humanitarian grounds.
Till date, the drug industry and global pharmaceutical companies thrived on developing ‘blockbuster’ drugs that reap huge profits in the markets, and Neglected Tropical Diseases (NTDs) were part of goodwill/charity and part of Corporate Social Responsibility (CSR). But with more than $15 billion worth of drug patents set to expire in 2011, and another $133 billion worth of drugs in the next six years, global pharma companies have started focusing on low-revenue drugs. That is not the only reason for change; shorter developmental periods and relatively lower costs of trials coupled with large population in the world affected by NTDs such as malaria,
dengue, can provide profit and might contribute to the top line and can later turn out to be a blockbuster and earn high profit margin as well. This is an evolving new model for MNC’s and some of the global companies such as Astra Zeneca, Novartis and Pfizer have already made moves and investments towards NTD. It is overall a win-win situation for both consumers and manufacturers.
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Dr A K Sinha Vice President, Formulation, Morepen Laboratories Ltd
Chetan Pathak Country Manager, Tectura India
Modern Pharmaceuticals I March 2011
Roundtable
The global trend in healthcare has moved from infectionbased diseases like malaria, typhoid and cholera, towards lifestyle diseases such as diabetes and osteoporosis. The countries where diseases like malaria is prevalent are primarily poor nations. Little research is done in these countries to find new molecules and remedies for infectious diseases. Besides, the West is aging faster. This is causing greater requirement for R&D in fighting lifestyle diseases, which the west is dominantly affected with. Besides, pharma companies are profit-driven organisations and will only invest in regions where they find good returns. Economically backward countries do not provide any incentive to them to set base there and carry out research. The government in these countries cannot provide incentives to develop proper healthcare facilities and has to fall back on the efforts of organisations like WHO.
India is in a peculiar position. Not only does it have to deal with chronic infection-based diseases, but also lifestyle ones which the current health trend of urbanisation has brought in. Hence, we suffer a double whammy. With such large disparity in the economic status within the country, a lot of research is required to cater to patients from both the fractions. We have witnessed a six-fold increase in cardiac diseases in recent years and on the other hand, malaria is equally widespread. We have the best as well as the worst medical facilities with us. As of now, the global pharma industry does not see any incentive to invest in infectious diseases in economically weaker countries.
Several private pharmaceutical companies are moving towards investing in poorer countries. Indian and Western firms capable of producing high quality drugs are increasing R&D and in turn partnering with African firms to meet the requirements for high quality drugs. Investment by these reputed companies provides assurance of Good Manufacturing Practices (GMP) and drug quality by furnishing the technical expertise that overcomes capacity constraints. These partnerships also provide international firms with incentives, which lead to further investment in poorer countries. Many developing countries lack the technical capacity and regulatory structures to efficiently and consistently produce high quality pharmaceutical drugs. Hence, international supply, whether from India, China or Western countries, is generally easy to obtain and relatively cheap. In Uganda, a partnership between Uganda’s Quality Chemicals and India’s Cipla led to the construction of a new $38 million plant
in Kampala. The plant started in October 2007 and began producing antiretrovirals (ARVs) and antimalarials in January 2008, the first such drugs to be manufactured domestically. The JV builds on the Indian company’s earlier and ongoing partnership with Ugandan company Afro Alpine Pharma, which opened a $4 million factory to produce artemisinin for malaria drugs in Kabale in April. Indian firm Cadila Pharmaceuticals also partnered with Ethiopia’s Almeta Impex to build a facility to produce antibiotics, malarial and tuberculosis treatments, multivitamins, and ARVs domestically. The Indian company invested $11 million and aims to begin exporting drugs to neighbouring markets in Uganda, Djibouti, Kenya and Sudan after it establishes itself in the domestic market.
Traditionally, spending in research is less for diseases like tuberculosis, malaria etc, which affects poor people mostly, and is more prevalent in underdeveloped and developing countries. The policy makers, healthcare activists and consumer organisations have been expressing serious concerns on this issue. The reasons for lack of concerted research efforts on finding new drug for treatment of malaria and other rare diseases are obvious. Patents drive medical research, but the model only works if the companies can recover new drug development cost (approximately 1 billion). The poor cannot afford patented medicines and difficulties in affordability are further compounded by decrease in government spending in healthcare. The March 2011 I Modern Pharmaceuticals
Dr Narottam Puri Advisor, Medical, Fortis Healthcare Ltd, Escorts Heart Institute & Research Centre
Prashant Sehgal Vice President, Marketing, Nestor Pharmaceuticals
recession has also compelled the pharmaceutical industry to cut down expenses on R&D. Perhaps, the solution lies in ‘Open Source Drug Discovery’ – the programme launched globally in September 2008 by the Council of Scientific and Industrial Research (CSIR). The idea of this program is to bring scientists together for new drug discovery at efficient speed and at a fraction of cost. This is a ray of hope and some of the Indian and international leading institutes have already volunteered to contribute. Sudhir Deshpande Director General, All India Drugs Control Officers’ Association 33
Facility Visit
Thermolab Scien fic Equipment Pvt Ltd
Driving quality with zeal Equipped with transparent policies, Thermolab believes in delivering the best results and offering high-quality products that cater to the needs of pharma companies. Despite certain obstacles, the company with its excellent marke ng strategy is on the road to development.
Chandreyee Bhaumik
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t was indeed a proud and exiciting moment for Thermolab Scientific Equipment Pvt Ltd when the US Food and Drug Administration (USFDA) audit for Ranbaxy. Ranbaxy had acquired a stability chamber with a capacity of 2,65,000 ltr from Thermolab. They accepted the challenge not as a threat but as an opportunity for improvement and embarked on the task. 34
Finally, after 8-10 days, to everyone’s contentment, the task was accomplished. The company claims that the result is for everyone to witness. Inevitably, repeated orders soon began pouring from various other pharma companies. Thermolab with its missionary zeal of delivering high-quality products ensures a better performance and superior features. True, the commendable and key attribute of Thermolab has always been to focus on customer-driven core values. Established on the basis of competency and integrity, this facility,
located at Vasai, promises to provide critical equipment required in the development and manufacturing of products by various industries belonging to several sectors. Thermolab is dedicated to facilitating life-saving research operations by providing equipment that would function efficiently all time and without any failures.
Back to the roots Thermolab was established in 1967, with just 10 people manufacturing Modern Pharmaceuticals I March 2011
Facility Visit standard ovens and incubators. In 1985, the company stepped ahead. It witnessed the manufacturing of environmental test chambers that included cold chambers, salt spray chambers, dust and rain chambers and humidity chambers. In 1992, the company’s activities and product lines were expanded, with a wider manufacturing facility having an in-house assembly and testing facility to cater to the growing demands of laboratory equipment. Gradually, over the years, the product range diversified to sophisticated stability test chambers, walk-in type chambers, photo stability chambers, biochemical oxygen demand (BOD) incubators and cooling chambers. Thermolab has been successful in implementing the ISO 9001 Quality System. In 2004, Thermolab Sales and Services Pvt Ltd, a subsidiary of Thermolab, was established to offer calibration, validation, spares and after-sales services. Later, in 2006, the facility took a step forward. It acquired Korten Pharmaceutical Pvt Ltd, a manufacturing unit for injectables. On this, Sandip Mhatre, Managing Director, Thermolab Scientific Equipments Pvt Ltd, elaborates, “By acquiring Korten Pharmaceuticals, Thermolab has entered into the pharma space. It now aims to expand the business four-fold in the international market.” After treading the path of success since its establishment, Thermolab has now acquired 35,000 sq ft manufacturing area along with a trained staff of 150. Thermolab also performs contract manufacturing for various pharma companies like Novartis and Merck. While for the former it caters to the development of Voveran, Calcium Sandoz, etc, with Merck it works on drugs like Polybion and Neurobion.
Spreading wings Thermolab is a known name with regard to manufacturing of stability chambers. Commenting in this regard, Mhatre reiterates, “Without a good stability chamber, products in the pharma industry cannot survive. In this context, tests of long duration, say, a two-hour test, should be conducted. If any feature of the product fails in its operation, then the competitors may assume an advantageous position. Therefore, the stability chamber must be sound enough for it to perform the desired tasks efficiently. With Thermolab products being CE approved, the facility has established a name in most parts of the world. As Mhatre elaborates, “In the coming years, Thermolab will be focussing its efforts on further developing a domestic market for its products, along with securing a foothold in the international market.” March 2011 I Modern Pharmaceuticals
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Facility Visit
he experience of Thermolab group along with the competence and capabili es of Thermolab’s technical team has been the group’s greatest asset. Sandip Mhatre Managing Director, Thermolab Scien fic Equipments Pvt Ltd
Thermolab has a marketshare of 65 per cent in the Indian industry and, with time, hopes to capture more. Keeping in view the growing demand in the pharma industry and the latest developments in products, the target set for annual growth is approximately 70 per cent. Thermolab Group has been in the business of manufacturing, designing and supply of sensitive laboratory equipment for over four decades. For a few of these products, Thermolab has got pioneering credits. The group manufactures and supplies stability chambers for wide-ranging applications in the pharma industry. It also has a policy of using a combination of technologies to deliver the most appropriate solution for the existing condition at the point use. Elaborating on this context, Mhatre affirms, “The experience of Thermolab group along with the competence and capabilities of Thermolab’s technical team has been the group’s greatest asset. As a result, the group has established itself among the most reputed names in the pharma industry.” Discussing expansion plans of the company, Mhatre says, “We are also in the process of establishing Thermolab Analyticals. It will be responsible for stability studies and analytical testing laboratories that will focus on sending the samples.” The survival of any entity mandates a regular investment pattern, which is considered as an essential contributor. Mhatre elaborates, “The total investment till date has been ` 22-25 crore.” Along with investment, 36
it is essential to ascertain the Return on Investment (ROI). “There is approximately 20 per cent ROI,” says Mhatre.
Class apart Mhatre believes that the products manufactured by the company are world class. He avers, “We make the equipment on CMC programmed machinery in order to maintain
Keeping in view the growing demands in the pharma industry and the latest developments in products, the target set for annual growth is approximately 70 per cent.
consistency. For example, if we are making 10 machines, then manufacturing in this manner will ensure that there is no discrepancy. In this case, the aesthetics of the products are also maintained.” Thermolab excels in its walk-in stability chamber that functions much like a refrigerator. It has several models – with different sizes and capacities – where the chambers are manufactured according to customers’ needs. Mhatre explains, “A high production capacity requires chamber with the size of a room. Accordingly, the temperature and humidity of that chamber are adjusted
and controlled. Further, these areas are kept ideal and clean, and airflow is also maintained.” This ensures that there is no difference in the existing conditions when the products are moved to the warehouse or the distributor. Clarifying this aspect, Mhatre elaborates, “In certain cases, when the drugs are moving from Mumbai to Delhi, despite the sealed packaging, sometimes, the drugs get affected by the change in temperature. In this way, the difference in temperatures between warehouses and chemist shops causes the potency of the drug to deteriorate. As a result, when these drugs are consumed, the desired and expected results are not observed. Therefore, following and abiding the International Conference on Harmonisation (ICH) of Technical Requirements for Registration of Pharmaceuticals for Human Use guidelines, we manufacture equipment that maintains temperature and humidity.”
Winning over Challenges and roadblocks tend to hinder the road to success for any organisation. But it is the attitude that makes a difference and gives a distinct turn to the journey path. Discussing the obstacles and more importantly the ways to overcome the hindrances, Mhatre says, “This is a field of thorough business. Thus, the products manufactured should be of better accuracy. Maintaining the existing product is not only needed but essential. Thus, in this organisation, we make constant efforts to add more features to the already existing product portfolio.” While elaborating on the future plans of the company, Mhatre reiterates, “Globally, we are looking to reach among the top five companies. Currently, the sales figure is ` 75 crore (revenue wise), and in the next five years, we are expecting it to be ` 500 crore. For this, the expansion is going on.” MPH (chandreyee.bhaumik@infomedia18.in)
Modern Pharmaceuticals I March 2011
Industry Update
Pharma packaging
Countering the counterfeit Assuming some things as it is, customers are not aware generally that they are buying a counterfeit product. With counterfei ng assuming such a significant dimension in the packaging sphere, the need for careful packaging is a must. Thus, packaging op ons available in today’s innova ve world must be explored. that is generally done with the intent of fraud, passing the product as genuine. Therefore, there is a dire need for quality packaging in this critical industry. It is often observed that counterfeiters only attack a successful brand, thereby using the brand for all its worth. This in a way disrupts the presence of the original brand, which in turn loses ground because of lack of consumer confidence. And it is obvious when there is a bad experience with a particular product, the consumer may just stop buying it and the company may see some downward trend in sales.
Why en‘counter’?
Chandreyee Bhaumik
A
dvances are being seen in every sector of the pharmaceutical industry, and packaging is not far behind. In today’s world, the role and significance of quality pharmaceutical packaging does not end with provision of accurate manufacturing and expiry dates. The importance goes much beyond that.
reports state that in the global market of pharma packaging, while developed countries will dominate the demand graph, China, India and Brazil would be among the fastest growing countries. At the same time, it can be said that manufacturers are making constant efforts to reduce the cost of packaging. Indeed, this should not be done at the cost of quality. Further, various market surveys reveal that by 2011, the market is expected to grow by 5.4 per cent annually.
Predic ons for packaging According to reports from Freedonia, an international business research company, worldwide the demand for drug packaging will grow 6.3 per cent annually through 2013. One of these 38
Counterfei ng Over a period of time, counterfeiting has assumed a huge proportion in the pharmaceutical drug market. A counterfeit usually denotes an imitation
A report by World Health Organization (WHO) reveals that the global trade in counterfeit drugs is estimated to be worth £75 billion and will continue to grow at a rate of 13 per cent per year. Further, the report also claims that the Internet is posing a great threat in this context. Almost 50 per cent of the drugs purchased on illegal online pharmacies are considered counterfeits. In this vein, what occurs is an imbalance in the supply chain. The counterfeiters will soon place themselves in an advantageous position. It becomes easier for them to curb the authentic shipment rules, and thereby redirect them to other markets, re-selling them for their own profit. Elaborating in this regard, Alden Zecha, CFO & Strategist, Sproxil, Inc, reiterates, “Pharma companies lose $200 billion annually due to counterfeiting. In fact, strangely enough counterfeiting is growing faster than the overall pharma industry.” Modern Pharmaceuticals I March 2011
Industry Update Thus, counterfeiting has become one of the conspicuous issues in the present pharma space. There is a concern that medicines might be contaminated or contain incorrect or no active ingredients. Commenting on the threats of counterfeiting, Praful Naik, Chief Scientific Officer, Bilcare Ltd, avers, “If a person is taking a packet of soiled biscuits, then he/she can immediately understand from the first bite. However, this is not applicable to medicines. We take the medicine and wait for the miracle to occur. Thus, it is very difficult to discern the truth.” He continues, “Counterfeiting is not an unorganised crime anymore. It is becoming increasingly global, and thereby it is becoming difficult to track and trace the vicious circle.” The US Food & Drug Association (USFDA) has undertaken several initiatives to combat the growing public health problem of counterfeit drugs. It is endeavouring with several other agencies and the private sector for protecting the country’s drug supply from the clutches of counterfeiting. It has implemented rule 21 CFR Part 211, which demarcated present Good Manufacturing Practice (GMP) for finished pharmaceuticals. The rule indicates that tamper-evident packaging be applied for Over-TheCounter (OTC) human drug products. It also shows that a tamper-evident package has one or more indicators, which if breached, can be expected to provide visible evidence of the breach. Elaborating on this issue, Zecha opines that with proper method of countering the counterfeiting act, three pillars consumers, government and pharma industry, will emerge gainers. It is an all win-win scenario. Probably, it is only the counterfeiters who actually lose.
Why not use tech? According to the Packaging World survey, 75 per cent of the respondent’s companies do not plan to use Radio Frequency Identification (RFID). Out of that count, 39 per cent claimed that this attitude was because they were not under March 2011 I Modern Pharmaceuticals
arma companies lose $200 billion annually due to unterfei ng. In fact, strangely enough counterfei ng is wing faster than the overall pharma industry. Alden Zecha CFO & Strategist, Sproxil, Inc
any mandate. Further, of the 25 per cent that plans to use RFID, 69 per cent do so primarily because it is a mandate. Again, 63 per cent purchase tags at a cost of 20 cents or sometimes even less than that. Therefore, it is clear that the entire approach needs questioning. Again, while 70 per cent use it for identification and tracking, 20 per cent use it for automated triggering. Commenting in this vein, Daryll Mascarenhas, General Manager, Supply Chain, GlaxoSmithKline Pharmaceuticals Ltd, elaborates, “Judging the present scenario, the entire system needs considerations. Pharma sector deals with a customer for several products. It is much more than a single product like toothpaste. A person intakes medicine believing that he will receive the benefits. Only after a few days, he can understand whether he has received the benefits. Thus, in this case, the assurance that is needed should be more than the industrial goods.” Again, some of the pharma counterfeits have the same ingredients as the original ones. In this context, Mascarenhas says, “One has to remember that there is nothing as ‘good counterfeiting’. It should be noted and well understood that this act creates adverse effects on both customers as well as the companies.”
However, counterfeiting is not the act of a single company anymore. With time, it has assumed the circumference of a big chain. Several responsible factors are as follows: Lot of monetary power Lack of enforcement Insufficient sanctions Lack of IT: There can be mandate of RFID, but the agency should be able to read and comprehend it Consumer ignorance: A SMS number can be provided, but it requires strong will from the customers’ point of view. They should also be in a position to understand and recognise a counterfeit product
Finding solu ons With time, counterfeiting is becoming an issue of real concern. It is unfortunate that it is occurring in such a significant industry like pharma. Mascarenhas opines, “We are into the business of pharma that aims to resolve health-related concerns. Thus, in this context, counterfeiting is reverse of what the pharma actually intends to achieve. Therefore, there is a definite need to improve the situation.” Today, counterfeiting is much more than a commercial problem. It is beyond that. Commenting in this
It is sad but true that in today’s world a Chinese duplicator can also put a barcode. Therefore, technology needs to be upgraded keeping in mind the viable need. Only then the en re spectrum will be meaningful. Praful Naik Chief Scien fic Officer, Bilcare Ltd
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Industry Update
We are into the business of pharma, which aims to resolve health-related concerns. Thus, in this context, counterfei ng is reverse of what the pharma actually intends to achieve. Daryll Mascarenhas General Manager, Supply Chain, GlaxoSmithKline Pharmaceu cals Ltd
regard, Peter Neve, Vice PresidentGlobal Marketing, Cognex, quotes from an article published in the newspaper, The Washington Post, dated September 11, 2010. He says, “Experts claim that the global fake drug industry, worth about $90 billion, causes deaths of almost 1 million people a year and is contributing to a rise in drug resistance. Estimates vary on the number of these drugs made in India. Further, the Indian government says that 0.4 per cent of the country’s drugs are counterfeit and that substandard drugs account for about eight per cent. But independent estimates range from 12-25 per cent. Indian officials say the clandestine industry has hurt the image of India’s booming pharmaceutical industry and its exports, worth $8.5 billion a year, mostly to African and Latin American countries.” He continues that poor traceability is the root cause of most of the problems. It brings at risk patient safety, supply chain efficiency and also hampers the brand integrity & profits. Like all other companies, Cognex had also made endeavours in providing solutions in this context. Neve says, “We provide systems of packaging in this regard. These systems can read codes, and also carry on the grading & measuring process. We have offered
600 thousand systems. The demand for proper system is similar everywhere. India is not any different from the rest of the world; people everywhere are comprehending this dire need of the hour. Immediate measures are required to be taken before it is too late.” Most companies are trying their best to prove themselves as a worthy solution provider. They plan on being constantly available, without any downtime. With strong partners and presence in the space,
Companies plan on being constantly available, without any down me. With strong partners and pressence in the space, the solu on provider would be ahead of the counterfeiters.
the solution provider would invariably be ahead of its counterfeiters. In this regard, Zecha clarifies, “For consumers, the solution providers help in avoiding the negative health outcomes. Thus, the cost is low or sometimes even free.
E-Pedigree provides electronic record of product origin from manufacturing to dispensing. Further, randomly generated unique iden fier is assigned to saleable items, logis cs units (cases or pallets); item-level traceability requires serialisa on. Peter Neve Vice President-Global Marke ng, Cognex
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It helps the government in locating the fake, and therefore separate it from the rest. Consequently, there would also be a reduction in the health insurance costs and an increase in the tax revenues.” Pharma industry would indeed reap benefits from this. He continues, “There is definitely an increase in the sales, and thus it helps in regaining the market share. It benefits in gaining the market intelligence, and thereby avoids brand damage.” Rigorous brainstorming and thought processes have resulted in innovative solutions from the companies. Sproxil has initiated the establish of a call centre that takes care of the medical concerns. Through this centre, customers can directly connect with the pharma manufacturers. By dialling few numbers the customers can report on counterfeit cases. Further, even from the marketing point of view, it is beneficial. The manufacturers get cautious of this whole act and due steps are taken in that regard. Further, after direct interaction with the consumers, the manufacturers are able to get a view of the consumer demands and expectations.”
Supply as per the demand With time, the need to tackle the increasing counterfeiting has become grave. In this regard, Naik elaborates, “In the present scenario, it is not enough to track and trace. For example, to establish a person’s authenticity, driving license is not enough. The DNA of the person is needed to be established. It is sad but true that in today’s world a Chinese duplicator can also put a barcode. Therefore, technology needs to be upgraded keeping in mind the viable need. Only then the entire spectrum will be meaningful.” While giving solutions, Neve claims that E-Pedigree is one of the many solutions. He says, “It provides electronic record of product origin from manufacturing to dispensing. Further, randomly generated unique identifier is assigned to saleable items, logistics units (cases or pallets); item-level traceability requires serialisation. Serialisation Modern Pharmaceuticals I March 2011
Industry Update
Consumers really need to understand the essence. They buy from Internet and as a result end up consuming fake products. In this regard, there is insufficient awareness. Joseph Ringwood Chief Opera ng Officer, Systech Interna onal
is essential in combatting counterfeiting. To support this strategy, development of web-based labelling and management solutions that aid in delivering secure and compliant printing for mass serialisation & data management to enhance the existing production lines is essential. Again, serialisation also include the ability to track the product movement through the supply chain in order to improve the efficiency. Mascarenhas shares an interesting view regarding the whole scenario. Most of the counterfeit products, which are manufactured in India, are not sold in India. Thus, preventing counterfeiting is one of the biggest challenges in this case. Thus, serialisation will give more value to the supply chain in protecting against counterfeiting. In this regard, he clarifies, “GSK has adopted serialisation. We were few of the first companies adopting RFID. We do it in retail environments not just in the US, but also in Europe.”
Be aware It is not solely about regulations and the enforcement of laws that matter. How many times do we read the contents over the package and then take the medicine? Again, the doctor has faith that the medicine will not be duplicated. This becomes a vicious circle. Lack of awareness at all levels affirms the foothold of the counterfeiters. Joseph Ringwood, Chief Operating Officer, Systech International, says, “Consumers really need to understand the essence. They buy from Internet and as a result end up consuming fake products. In this regard, there is insufficient awareness. In order to improve the situation, everyone needs to be educated on this regard. The entire mass needs to be enlightened. Again, there is an urgent need to comprehend what do the regulations actually mean, and whether they have been enforced in actuality.” Again, there is no lack of will from the companies but the distributors need to show the same interest. Further, he signs off saying, “It is not just about the consumers. Manufacturers are also required to put things in place. Solutions are available and coming up. Using simple technology such as SMS can make the process of understanding easier.” MPh (chandreyee.bhaumik@infomedia18.in)
March 2011 I Modern Pharmaceuticals
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Market Trends
Acquis ons in lab equipment and analy cal instrument market
Following a healthy pa ern? With the need to conduct tests in laboratories on a regular and prompt basis, indeed the future of the lab and ancillary equipment sector is bright. Is acquisi on the right avenue to be traversed? Read on…
Chandreyee Bhaumik
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ab equipment to a researcher is like a pen to a writer. It includes several tools and equipment used by researchers working in lab. A wide plethora of tools ranging from Bunsen burners, microscopes to specialty equipment such as operant conditioning chambers, spectrometers and calorimeters are included in this category. Another important type of lab equipment is glassware used in a range of equipment from beakers to reagent bottles. In general, lab equipment is generally used to perform an experiment and take measurements to arrive at results. 42
Classifica on Today, lab equipment assumes a significant role in the pharma space in its entire value chain from drug discovery to manufacturing. Right from a simple magnetic stirrer to the most expensive Liquid ChromatographyMass Spectrometry (LCMS) system, all equipment that scientists use at any stage of their experiment is referred as lab equipment. Commenting in this regard, Dr Ganapathy Ramakrishnan, President, Chromatographic Society of India, elaborates, “As far as major laboratory equipment are concerned, most of them can be catagorised into separation science products
and spectroscopy products. These instruments are used in every step while separating the individual components of a mixture and further identifying them. Centrifuges, evaporators and storage cabinets also form a considerable portion of the laboratory equipment.” Using a wide range of instruments also requires maintaining a record of the usage, and even calibrating these instruments on a regular basis. Shruti Pande, Clinical Research Associate, International Clinical Research, Wockhardt Ltd, shares important ideas regarding the classification of equipment and the importance of calibration. She elaborates, “The lab equipment that is used for clinical research is either used in central laboratories or the local laboratories. In lab, centrifuges are used for separating blood and plasma. Further, mention can also be made of frozen centrifuges. All these machines should undergo due calibration in order to ensure that they are performing in an optimal manner.” Thus, to maintain transparency in the entire procedure due steps are ensured. Pande clarifies, “The responsibility of checking calibration is outsourced. An expert from outside provides a valid certificate, much like a clean chit, so that the working of the machines can start.” Thus, the lab and the ancillary equipment help in capturing the data from the blood samples. Further, Pande highlights that labs in clinical research also have other equipment like refrigerators (228°C) that maintain the samples and freezer at –20°C for storing the blood samples. Modern Pharmaceuticals I March 2011
Market Trends Defining the market According to the reports by Research and Markets, the UK market for lab equipment, which includes equipment/ instruments, lab consumables, was worth an estimated £2.79 billion in 2007, having increased in value by 31.2 per cent across the review period (2003-07). The reports also show that large companies, many of which are subsidiaries of the US firms, have an increasingly strong grip on the market. Merger and takeover activity is likely to remain an important aspect in this context, considering the drive from the customers in the public sector and industries, such as pharma and chemicals. Again, the report also reveals that in terms of marketing activity, lab equipment is highly specialised market, aimed at fragmented groups of scientific professionals and purchasers in a wide variety of industries and institutions. Again, the report also forecasts that the market will grow more slowly over the 5-year forecast period (20082012) than it was during the previous 5 years. With sales worth an estimated £1.66 billion in 2007, it accounted for 59.5 per cent of the total market’s value. Over the review period, sales increased by 30.3 per cent, with average growth of around 6.9 per cent. The laboratory consumables sector accounted for the remaining 40.5 per cent of the market in 2007, with sales worth an estimated £1.13 billion. Dr Ramakrishnan provides an approximate market scenario of this sector. He reiterates, “The total market for chromatography & mass spectrometry instruments, the accessories and supplies can be estimated to be more than $10 billion worldwide and about 60 per cent is estimated to be catering to the pharma industry.” While drawing the market picture, Pande shares an interesting take. She informs, “Lab equipment in India is not a novel discovery. Most of the equipment is already here. And the product lasts for 4-8 years. Thus, the demand graph of these equipment is more or less consistent. But incase there is a rise in demand for March 2011 I Modern Pharmaceuticals
he Indian market for chromatography and mass pectrometry instruments and the accessories and supplies can be around 350 million of which 60 per cent could be going to pharma industry. Dr Ganapathy Ramakrishnan President, Chromatographic Society of India
a product from overseas, since it is not manufactured there, the national demand for the product also rises. Thus, the demand pattern changes gradually but steadily.”
Acquisi on: The key word With acquisition setting its footprint on every sector, lab and ancillary equipment in pharma space is not far behind. Elaborating in this vein, Dr Ramakrishnan avers, “The
Merger and takeover ac vity is likely to remain an important aspect in this context, considering the drive from the customers in the public sector and industries such as pharma and chemicals.
acquisition and divestment in the global analytical industry is small yet definitely significant. The major one is the acquisition of Varian by Agilent Technologies. Due to anti-trust laws, there were some initial problems.
So Agilent had to divest the GC and GC-MS (Triple Quad) and Inductively Coupled Plasma Mass Spectrometry (ICPMS) business to Bruker. Therefore, Bruker expanded its space into its chromatography mass spectrometry area.” In this context another significant acquisition deserves due mention; Thermo Fisher Scientific acquiring Dionex. Further, another recent one has been Danaher acquiring Beckman Coulter. It is true that there is no local acquisition or merger in this segment, but it is also true that the distribution channels will witness various changes. In this regard, Dr Ramakrishnan adds, “Since there will be changes, the customers will be facing more confusion than before.” While elaborating the trend of acquisitions and merges, Raj K Menon, Owner, Karishma International, was candid enough in his responses. He avers, “It is both sad and unfortunate, but it is true that in India not much of acquisitions is taking place as far as lab and ancillary equipment is concerned. There is no quality manufacturer in India that can attract the global companies.” Explaining the global and the domestic scenario in this context, Menon continues, “Companies from overseas usually prefer coming
he demand graph of these equipment is more or less onsistent. But incase there is a rise in demand for a product from overseas, since it is not manufactured there, the na onal demand for the product also rises. Shru Pande Clinical Research Associate, Interna onal Clinical Research, Wockhardt Ltd
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Market Trends
true that in India not much of acquisi ons is taking ce as far as lab and ancillary equipment is concerned. There is no quality manufacturer in India that can a ract the global companies. Raj K Menon Owner, Karishma Interna onal
here and engage themselves in marketing the equipment.” Again, acquisitions can work in different forms and several levels. It can be either in the form of tie-up or takeover. In India, we primarily see the former trend. Pande says, “The local companies can tie-up with the central lab. This will facilitate the process and help the logistics part of it. However, when the global companies are considered, they are usually interested in takeovers. It is mostly a win-win situation for the companies.”
Then the situation will not be desirable. In this scenario, the smaller companies will find it difficult to survive the nettle of existence rather the prominence.” Further, there are other cons in this context. Ramakrishnan reiterates, “The disadvantage is if a big company has different sales personnel for different products and it has more than one indirect channel for different products, then the customers will face a big problem getting to the right channel for receiving the right products.” Further, he
Quick Picks Giving a balanced view Like every phenomenon, acquisitions in this sector have its own advantages and disadvantages. Dr Ramakrishnan explains, “One advantage will be that the customers will have a single point contact in different companies and they can get more products from one company, thus getting some good price for bulk purchases.” In this regard, Menon comments, “In order to survive in the market that is so inhibited with competition, it is definitely a situation of advantage for the smaller companies. With tie-ups, the smaller companies get opportunistic positions for surviving.” Seconding this opinion, Pande reiterates, “Through acquisitions, companies can expand wide across the landscape.” However, there is a flip side. Elaborating on the disadvantages, Menon discusses, “These acquisitions may sometimes usher in negative aspects also. There are chances that bigger companies may exercise their power in this regard. They may try to establish their monopoly, and thus confirm their supremacy in the industry. 44
With increasing demands of accurate, fast and reliable tests, the requirement for lab instruments having short turnaround times and accurate results is on a rise. This industry of lab and ancillary equipment is definitely poised to see a brighter tomorrow. provides a broader view in this regard. He says, “Global acquisitions will result in lesser number of key players, and this may result in an increase in monopoly situations, which is not advantageous to customers.” Pande shares her opinion in this context also. She discusses, “There can be mismanagement as far as Human Resources (HR) is concerned. With a change in the company policies, the current employees sometimes may have to encounter this challenge.” If that is taken care of, acquisitions can prove to be beneficial.
Investment Investment is the integral part for any enterprise to emerge in its space.
Dr Ramakrishnan is hopeful for this segment. He opines, “There is a lot of scope for Indian companies in this space. In this context, it can be mentioned that Thermo Fisher is the first major instrument company to invest in India by buying the Nashik factory from Chemito. They have used this facility in order to develop new products, and thereby bring in technology from abroad and manufacture it in India. The introduction of Gas ChromatographyMass Spectrometry (GC-MS) system is a good example of this venture. Thus, when the market for lab equipment in India has assumed a significant size and is expanding, there lies a good opportunity for manufacturing in India at least in medium technology products.”
Predic ng the future With increasing demands of accurate, fast and reliable tests, the requirement for lab instruments having short turnaround times and accurate results are on a rise. This industry of lab and ancillary equipment is definitely poised to see a brighter tomorrow. Commenting on the future prospects of this sector, Dr Ramakrishnan avers, “As far as drug discovery, contract manufacturing along with the manufacturing of generics, formulations, bio-equivalent studies, etc. are on the rise, this market will continue to grow. After the dip in business in 2009, the market has bounced back in 2010, and is poised to grow further in the future. Also, the field of instrument support is growing.” Customers are the key growth drivers for the demand of this sector. Dr Ramakrishnan signs off saying, “Customers are looking for service with minimum delay and they are willing to pay for the service unlike yester years.” It will be good to see a parallel growth in this sector with the rise in innovations and technologies. Appropriate marketing, good mergers & acquisitions, and increasing technical experts will all lead to a strong foot forward in this sector. MPh (chandreyee.bhaumik@infomedia18.in)
Modern Pharmaceuticals I March 2011
Marketing
Expiry date
Knowing it be er Pa ents have a habit of storing half used strips of tablets and tubes of ointments for future. Life of a medica on can be determined only if the manufacturing and expiry dates are clearly known. Conven onal prin ng techniques are not user friendly; innova ve approach is necessary to men on these details clearly on the packs.
P
icture this: Last May, a 72-year-old diabetic from Chandigarh had popped the third tablet for his migraine attack and yet found no relief. His college-going grandson shuffled through the medicine drawer to fetch him the fourth one. Reflexively, he turned the
Dr Rajan T D Pharma Consultant & Practising Dermatologist
March 2011 I Modern Pharmaceuticals
strip over to check the expiry date. He was shocked to find that the medicine was well past its expiry. When he checked with his grandfather, the elderly gentleman said that he had checked the date but the print was unclear. The expiry date was Mar 2010. Or was it May 2010? The old man had mistreated himself unknowingly with an expired drug. The pain did not subside, and moreover the unwanted chemical could have been a recipe for disaster! In another case, Mumbai-based Dental Surgeon, Dr D Jagdish was getting ready to leave for his clinic. He was about to leave when his neighbour’s wife came rushing in with a worried look on her face. She explained that her husband had a fall and hurt his knee. Could the doctor
provide some instant pain killer? Dr Jagdish opened his medicine drawer and fished out a sample strip. Instinctively, he flipped it over to check the expiry date. The faint purple print on the gleaming aluminium foil appeared hazy. He wore his spectacles and tried to read it again. It appeared to be 01/2011. Or was it 07/2011? Being uncertain he took his wife’s help but she too was unsure. Finally, in annoyance he chucked the strip into the waste basket and wrote out a prescription to the anxious neighbour. Having a medicine strip with a vague expiry date was not only pointless but outright dangerous! Talk to doctors and patients anywhere in our country and most of them will describe how irritating an experience it is to read the expiry date on most medicine packets. “Having medicines lying at home but not being sure whether it has crossed its period of efficiency makes the drug equivalent to sawdust!” exclaims Dr Jagdish. And there would be many more experts nodding at this.
Labelling difficul es A lot of thought goes into the generation of a new drug and it is put through a series of tests and trials. The making of a brand also involves a great deal of brainstorming to identify a catchy brand name and using an appropriate packaging. Availability of modern packaging materials and advanced techniques of making containers have led to the generation of a variety of drug packs. Syrups are available in plastic and glass bottles, capsules/tablets are packed 45
Marketing maximum retail price, manufacturing and expiry dates. Although packing and printing technology has improved a lot in the Tablet past decade, the pharma industry has not intensely used these techniques to the fullest for information printed on its packs. Using the tactic of fine B.No. SRD 653/11 Exp 08/13. Exp 08/13. Exp printing is a bad manufacturing Figure 1: Format on tablet strip practice as it attempts to deceive the in aluminium foils, blister packs, information seeker. Alu-Alu packs. Injections are dispensed in multidose glass vials and glass Problems faced ampoules. Ointments and creams are Aluminium strips containing tablets sold in collapsible aluminium tubes, and capsules usually have the expiry lamitubes or jars made of plastic or glass. date stamped on the side opposite the Again, lotions are also available in brand name. Sometimes the print itself is plastic bottles. blurred. In other cases, the printed matter Each of these packaging pose their is of high quality but the matt finish of the respective challenges when it comes aluminium foil makes the matter illegible. to labelling the contents of the drug Tablets in blister packs pose a different as well as printing the batch number, kind of problem. The print on the reverse manufacturing and expiry dates. While of the pack looks neat only till the patient the tablets are packed between two foils punctures the first blister. Once a couple of of aluminium, the intervening spaces are tablets are consumed, the expiry date itself secured by heat compression giving it a ‘expires!’ Imagine the person’s discomfiture matt finish. Consequently, any matter when he reaches for the pack after a few printed on the roughened surface is months and finds holes in the print. difficult to read. Syrup bottles usually are well labelled Nowadays, tablets are also packed in unless the dripping of the medicine blurs different formats, some of which are the printed data. done keeping the aesthetic feel in mind. Injection vials stored by doctors in their Creams and ointments are packed in shelves or refrigerators pose new challenges aluminium tubes, lamitubes, plastic jars, to the already distressed physician. There glass jars, plastic bottles, sachets, etc. are instances of the adhesive behind the pasted drug label coming off within weeks of purchase of the vial. One can visualise Legal binding As required under the law, manufacturers the physician’s state of mind when he finds print the generic name, the brand three labels of different vials lying peeled name, the ingredients of the drug, the off in the refrigerator tray. Solving the drug manufacturer or marketer’s name jigsaw of matching the right label to the and address, their licence number, right vial could be a matter of life and death the Schedule group, batch number, for his patient. Skin creams and eye ointments come in neat B.No. packs these days. Companies Skin / eye ointment SRD 653/11 spend a sizeable amount on Exp 08/13 the packs to make them look tantalizing in chemist’s Leave extra shelves. While large glass or Crimp here part of tube plastic jars have their details beyond crimp neatly printed on them, the for prin ng companies find it difficult Figure 2: Format on ointment tube to fit their matter on the 46
tiny tubes. A large amount of data can be printed onlt in small fonts on 5 g and 10 g collapsible-tube containers. The fine print is unreadable to the average patient. In some cases, the carton of the cream does not mention the manufacturing or expiry dates but plainly states: ‘refer the tube for details.’ The lower end of the tube usually is machine sealed, called the crimp, by compressing and folding the edge. This 3-4 mm crimp bears an imprint of the batch number, the manufacture date and/or the expiry date. As a matter of explanation an arrow on the tube clarifies, ‘Expiry date: 24 months from the date of manufacture.’ The alpha-numeric groove of the imprint is not always clearly readable. So a tube of corticosteroid ointment which the dermatologist prescribed recently for an allergic rash becomes useless after sometime, simply because nobody in the house is able to unquestionably interpret the expiry date.
Innova ons needed Ask any doctor working in the public health sector and he will relate numerous instances of blunders committed by poorly educated people with regard to medicines and dosages. Even educated people can tend to misread these dates and take improper medications. Instances of expired drugs being unknowingly consumed are not uncommon in our country. A better system of printing and labelling of manufacturing and expiry dates is necessary to prevent medication errors. A deeper thought into difficulties faced by the elderly or patients with poor eyesight will provide sufficient clues to design a more patient-friendly packaging. Tablet strips should have a strip of white background (Figure 1) along one of its edges. Red coloured print against this background will make any written matter legible. These strips of white can be on both sides of the strip for better safety. The expiry date should be repeated all along the strip to make it easy for the patient to cut off a part of the strip after some tablets are consumed. Tubes containing creams and ointments need to be made a little Modern Pharmaceuticals I March 2011
Marketing Similarly, the label on injection vials (Figure 3) should be left longer than the circumference of the bottle. The extra portion can be used to print these essential B.No. details in large font and can SRD be rolled over. 653/11 All these prints should Exp 08/13. be of a minimum font size 10 Arial, in red colour against a white background. Wherever possible, the expiry date should Injec on Extension of label to be be repeated to make it easy rolled over the vial itself for the patient to decipher the same even if the packaging Figure 3: Format on injection vial is somewhat damaged in longer than the present size. A portion rain, during transport or in the patient’s of the tube beyond the crimp should shelves. Where possible expiry date and be left behind. This portion (Figure 2) batch numbers should be printed on both should be used exclusively for the batch sides of tablet strips. number and expiry date. Such a space In any field involving human activity, will allow printing to be done in larger a great deal of attention is given to the print, which is easily readable especially initial development of an idea. When the for the elderly. idea turns out to be a success, everyone
Injec on
March 2011 I Modern Pharmaceuticals
copies it and finally it becomes a pattern or a norm. Industrialists are happy to continue with any existing pattern as long as the moolah is raking in! It takes a courageous effort to change the routine pattern and go one step further, even if it involves some hardship. Would not an improvement in such fine matters be a positive marketing tool? In the case of medical science and its allied fields, our efforts must be constantly aimed at improving the life of the people around us. A paradigm shift is necessary to improve the standard of labelling of essential information on drug packs. With a majority of the population in the third world countries not having access to affordable health care, it is important for us to remember that we cannot throw away half used strips of paracetamol simply because we are unsure whether it has expired. Until the printing system improves, our patients may read the blurred expiry date as “Exit per Day!� MPh (rajan.td@gmail.com)
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Clinical Research
Clinical trial feasibility
Analysis and evalua on A delay in study startup and pa ent enrollment are major problems for cost overruns in clinical trials. A well-designed and executed feasibility study would help in ways more than one. Details provided through a feasibility study
T
he cost of a clinical trial is influenced by several factors including startup and recruitment timelines. Appropriate selection of countries and investigational sites is the key to conducting a successful trial. Literally, feasibility survey means a process of evaluating scientific as well as operational do-ability of a clinical study in the given geography.
Nandita S Dingankar Senior Manager – Medical Services, SIRO Clinpharm
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Feasibility study helps in the identification of appropriate countries and investigational sites for a new clinical trial. It also provides an estimate for the per site recruitment rate and the overall enrollment period to complete the recruitment. Additionally, it aids in identifying the challenges one may face during the execution of a study and in planning strategies for risk management. All these would eventually facilitate project completion in terms of optimum timelines, patient recruitment targets and cost. It is a general observation that companies that undertake robust feasibility survey process experience ‘on target’ completion and lesser delays than those who do not undertake such a thorough feasibility assessment.
Clinical trial feasibility study should be designed and planned after thoroughly reviewing and understanding the planned trial protocol. A robust feasibility study should check the overall acceptability of the study from the scientific, regulatory and ethical perspectives. It should also note the investigator’s interest in the trial, available standard of care and compatibility of the clinical trial treatments and assessments with currently available patterns of care. It should also assess the availability of target patient population, patient database and recruitment capability of the site. Accessibility to specific equipments/tests/facilities that may be required for the given study, experienced study team and ethics committee are some other important aspects that should be evaluated in a feasibility study. Last but not the least, feasibility study should also check the competing trial scenario in the given geography and at the considered sites.
Different types of feasibili es Various types of feasibilities include: Study feasibility: In this study, it is assessed whether a given study can be conducted in a given geography. All factors that influence the do-ability of a trial such as regulatory challenges, ethicality of the study design, availability of patient population and required expertise are evaluated in detail. The operational challenges are also taken into consideration while evaluating the study feasibility. Site or investigator level feasibility: This assesses the suitability of a given site to participate in the proposed study. Modern Pharmaceuticals I March 2011
Clinical Research All factors at site level are taken into consideration in this feasibility assessment, such as qualification and experience of the investigator, presence of experienced study staff, availability of good infrastructure, availability of target patient pool, suitable ethics committee profile etc. It is also important to assess the attitude of the investigator during the discussion. In case there is any poor or bad experience with the given investigator, it would play a vital role in decision making for the final site selection.
Stake holders for feasibility at the CRO end Some Clinical Research Organisations (CROs) have dedicated team for conducting clinical trial feasibilities, while it may be the responsibility of clinical operations team in some others. Irrespective of which department handles feasibilities, it is important that the concerned teams collaborate and work close to deliver on a feasibility request. Operations team would be able to gather the operational challenges. Medical services team would be able to check if the proposed study is rational, scientifically as well as ethically. Regulatory team is responsible for identifying the regulatory challenges. Involvement of all these teams will go a long way in running a successful feasibility. Apart from this, understanding expectations from client and regular communication with the client are also necessary.
Available tools A well-designed feasibility questionnaire is a standard tool for undertaking clinical trial feasibility. Feasibility questionnaire should provide sufficient information about the target population to get realistic data about the site capabilities. At least the following information should be provided: eligibility criteria, study design, treatment provided to the subjects, schedule of assessment and any other specific details (eg need for hospitalisation, need for repeated blood sampling etc). 52
Site selec on for feasibility Selection of investigators for obtaining inputs is a vital step to a good feasibility. Optimum number of sites/ investigators should be contacted to obtain realistic information for the planned clinical trial. For study feasibility, 3-4 good experienced investigators, with good performance in the past trials, may suffice. For site feasibility, the number of sites to be approached for feasibility would depend on the planned study (disease under consideration, client’s plan regarding country selection, sample size required etc).
Companies that undertake robust feasibility survey process experience ‘on target’ comple on and lesser delays than those who do not undertake such assessments.
Deriving the realis c recruitment es mates As much data should be collected as possible before giving the final projections for the proposed clinical trial. The data should be compiled and analysed site wise and also across the sites. Sites that seem suitable for the planned study should be short listed; the final projection for the study should be based on the inputs received from these short listed sites rather than all the sites that responded. It is important to keep in mind the client’s expectation in terms of the number of patients for the given study and the planned country spread. It is said that the investigators are sometimes very optimistic while proposing recruitment numbers; it is the responsibility of the CRO to apply adequate filters and propose realistic estimates. Certain features of a study
can cause additional road blocks (eg repeated blood sampling, frequent visit schedule etc), which may have a significant impact on the study. The projection is complete only when we include the screen failure and dropout rate obtained in consultation with the investigators. Further, for chronic diseases (eg: rheumatoid arthritis) the patients flow in largely from the database; hence, simple mathematical extrapolation is not advisable in such cases. Eg, if a site quotes 2 patients per site per month – it may not be correct to assume 12 patients over 6 months of recruitment period. It is desirable to ask the sites the total number of patients that the site can recruit over 6 months. More often than not, the site proposes lesser number of patients (say 8-10 patients) over 6 months. Numbers are stated only as an example.
Protec on of confiden ality Minimum information, which is mandatory to obtain enough facts about the site capabilities, should be shared with the site. Maintaining the confidentiality of the client’s proprietary information is very critical. Clients’ confidential information should not be shared with investigators without a valid Non-Disclosure Agreement (NDA). NDA may be a general NDA between the operating CRO or it may be a studyspecific NDA. It is also important that the NDA used by the CRO is reviewed by the client and is acceptable to them. Some clients feel more comfortable to use their own NDA template. This process of signing an NDA with the sites needs to be customized per feasibility in consultation with the client.
Why do the homework? Good and effective feasibility is the back bone of any clinical study. In clinical research, the recruitment of the right patient population within the planned timelines is the most important factor in ensuring success. MPh (Nandita.Dingankar@siroclinpharm.com)
Modern Pharmaceuticals I March 2011
Legal Edge
Bolar provision and the pharma industry
Striking the right balance The generic form of a drug can be used a er drug patent expiry, but it must be tested before it is introduced in the market. Thus, experiments on generics must be done before patent expiry, to make them available soon a er patent expiry, so that pa ents are not affected. Here are few cases of dispute in different countries surrounding patent expiry of drugs and manufacturing of their generic forms. policy conflicts can only be decided by the legislature, not by the courts.
The United States
T
he term ‘Bolar’ provision draws its origin from the case of Roche Products versus Bolar Pharmaceutical. Roche Products held a patent for active ingredient of Valium, a drug it manufactured and sold. Bolar, a generic drug manufacturer, used Valium before expiration of the patent to experimentally determine its bioequivalence with its generic product to obtain data for seeking US Food and
Anuradha Salhotra Managing Partner, Lall Lahiri & Salhotra
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Drug Administration (USFDA) approval for the generic product. Bolar argued before the court that its experimental use of Roche’s patented product did not constitute infringement under the patent law. The Court of Appeals for the Federal Circuit (CAFC) held that the exception for experimental use was not applicable, as Bolar was seeking USFDA approval only to sell its generic version of drug after expiry of the patent, ie, for business purpose. Bolar further argued that in the interest of the public, policy generic drugs should be available soon after expiration of patent. This required the experimental use of the patented product for regulatory data generation. Otherwise, the patentee would continue to enjoy patent monopoly even after its expiration. The court ruled that such
In order to remedy the situation, the US congress passed the statute 35 U.S.C. § 271(e)(1) of the Drug Price Competition and Patent Term Restoration Act allowing experimental use of the patented product for generating data for the purpose of obtaining regulatory approval. This is also known as the Hatch-Waxman Act. This provision relating to exemption for experimental use or ‘safe harbor’ reads: “It shall not be an act of infringement to make, use, offer to sell, or sell within the United States or Import into the United States a patented invention other than a new animal drug or veterinary biological product which is primarily manufactured using recombinant DNA, recombinant RNA, hybridoma technology, or other processes involving site specific genetic manipulation techniques solely for uses reasonably related to the development and submission of information under a Federal law which regulates the manufacture, use, or sale of drugs or veterinary biological products.” The provision in the statute opened the doors to generic manufacturers for generating the necessary data required during the term of patents about to expire shortly, and thereby be ready to make available the generic drugs immediately after the patent expiry. Later in the case of Merck versus Integra, the Supreme Court held that Modern Pharmaceuticals I March 2011
Legal Edge the use of patented invention, including pre-clinical studies of patented drugs for the purpose of submission of information to the government for obtaining regulatory approvals, is exempted under the law, and that such exemption is not merely restricted to pre-clinical data pertaining to safety of drug in humans and that the exemption does not specifically exclude any kind of experimentation on patented drugs or their use in any experiment even if these are not meant for submission to the federal regulatory authority. In order to create a balance between originator pharmaceuticals and generic manufacturers, the US also provides extensions of the terms of patents to enable the pharma industry to compensate for the time taken to obtain FDA approval before they could be marketed. It also provides a five-year period of data exclusivity, which ensures additional protection to the originator drug company, as generic manufacturers can apply for marketing approval of their version only after expiry of the data exclusivity period. In the case of Eli Lilly & Co. versus Medtronic, Inc, US Supreme Court interpreted the scope of the ‘safe harbor’ provision under § 271(e)(1). In this matter, Eli Lilly brought out a suit against Medtronic for infringing its cardiac defibrillators patent. Medtronic asserted that its experimental activities were for obtaining approval from the regulatory authority for their version of cardiac defibrillators and such activities were allowed under the safe harbor provisions of the statute. The district court held that the safe harbor provisions did not include medical devices. The Federal Circuit reversed the district court decision stating that exemptions under Hatch-Waxman covered experimental use of a patented invention for all kinds of products listed in the provision for the purpose of obtaining approval for its substitute. Affirming the Federal Circuit’s decision, the Supreme Court stated that all of the products eligible for a patent term extension are subject to the exemption under § 271(e)(1), March 2011 I Modern Pharmaceuticals
since all these – medical devices, food additives, color additives, new drugs, antibiotic drugs and human biological products – are subject to premarket approval under various provisions of the Food Drug and Cosmetics Act.
Hatch-Waxman Act The Hatch-Waxman Act provides an excellent way to strike a balance between the interests of pioneer pharma companies, competing generic manufacturers and consumers. The intention for creating the Act was to maintain incentives necessary for the Patent holders keeping them motivated for further research and innovation and to enable lower cost generic products to reach the market, thereby benefiting the consumer. Under the provisions of this Act, a generic manufacturer can file Abbreviated New Drug Application (ANDA). The applicant is required to prove that his product is bioequivalent to the NDA. The ANDA must reference the NDA of the patented drug listed in the Approved Drug Products with Therapeutic Equivalence Evaluations, known as the ‘Orange Book’. The Orange Book provides a list of the patents applicable to the approved drugs. In order to reference an NDA, the generic manufacturer must file one of four alternative certifications provided for under Hatch-Waxman Act: I. The required patent information of branded drug has not been filed II. The patent has already expired III. The patent has not yet expired, but will do so prior to FDA approval of the ANDA IV. The patent is invalid or will not be infringed by the ANDA These certifications are termed as Para I, II, III and IV certifications, respectively.
ANDA cer fica on An ANDA certified under paragraphs I or II is approved immediately after meeting all applicable regulatory and scientific (efficacy, safety and bioequivalence) requirements. Therefore, the generic drug manufacturer gets immediate
approval for non-patented drugs notified in the Orange Book, or for drugs for which the patent has expired. An ANDA certified under Para III filing is made when the ANDA applicant does not plan to sell the generic drug until the original drug is off patent. In case of Para III, the application is processed for approval; however, its approval status depends on the product’s patent expiry. ANDA approval under Para III certification is made effective from the date of patent expiration. In such circumstances, though the generic can enter the market soon after the expiry of the patent, without delay. The most crucial of all is an ANDA certified under Para IV. The ANDA applicant filing a Para IV certification must notify the proprietor of the patent. The patent holder may bring a patent infringement suit within 45 days of receiving such notification. Therefore, this leads to litigation proceedings. The first generic company that files an ANDA obtains a 180-day exclusivity period, during which the approved generic manufacturer can exclude any other prospective generic manufacturer from entry into market with the same generic product. The 180-day exclusivity commenced upon a generic manufacturer’s first sale of the generic after receiving the FDA approval for its ANDA.
TRIPS Agreement Article 30 of the Trade-Related Aspects of Intellectual Property Rights (TRIPS) Agreement permits the member states to provide such exceptions to the exclusive rights conferred by a patent that do not unreasonably prejudice the legitimate interests of the patent owner, keeping in view the legitimate interests of the third parties. Bolar provisions or experimental exceptions fall in the scope of such exceptions. The World Trade Organisation (WTO) has upheld the Bolar provision as conforming to the TRIPS Agreement in a dispute case titled ‘Canada — Patent Protection for Pharmaceutical Products’. In its report adopted on April 7, 2000, a WTO dispute 55
Legal Edge settlement panel ruled that the Bolar provision in Canadian law conforms to the TRIPS Agreement.
European Union In Europe, Directive 2004/27/EC was issued directing the European nations to amend respective national laws by October 30, 2005, to enable that conducting of necessary studies, trials and related activities for obtaining regulatory approval for medicinal products for human use will not be considered as violator of patent rights or supplementary protection certificates for those products. Another directive 2004/28/EC was issued relating to veterinary medicinal products. These directives have resulted in harmonising Bolar provision in various European nations. The United Kingdom amended Section 60(5) of the Patents Act, 1977, accordingly. The amendment made through the Medicines (Marketing Authorisations, etc) Amendment Regulations 2006 provides that any studies, tests or trials conducted for obtaining regulatory approval for medicinal products will not be considered as infringement. These amendments came into force with effect from October 30, 2005. The UK Medicines and Healthcare Products Regulatory Authority has brought out a list of exempted activities defining the limitations for the exemption. The term of a granted European patent may be extended under national law if national law provides term extension to compensate for pre-marketing regulatory approval. According to European Commission, ‘data exclusivity’ refers to the eightyear protection period during which generic applicant may not refer to the information of the original marketing authorisation holder and ‘marketing exclusivity’ refers to the 10-year period after which generic products can be placed on the market. However, in relation to marketing authorisation applications submitted before the above-mentioned dates, the wording 56
‘data exclusivity’ refers to the six or 10-year protection period granted to the original marketing authorisation holder before generic applicants can file their applications for marketing authorisation.
China China introduced a new ‘Bolar’ provision through the third amendment to its Patent Law in the later part of 2008. Before this amendment, the Chinese Patent Law had no provisions related to exemption of experimental use of invention. However, even before the enactment of these provisions, Chinese courts held in a few cases that it was not infringement to make patented drugs for the purpose of regulatory approval. In the case of Sangong & Shanghai Sangong Pharmaceutical, Ltd, versus Beijing Wansheng Pharmaceutical, Ltd, Wansheng used Sangong’s patented invention to make a drug for generating data for regulatory approval of a new drug. Beijing No. 2 Intermediate People’s Court held that the use of patented invention by Wansheng for making the drug for the purpose of generating data for regulatory approval did not constitute an infringement, as Wansheng did not use the patented invention for making the drug for selling. The court held that such actions did amount to exploitation of the patent for production or for business purposes, but are not infringing activities under Article 11 of the Chinese patent law.
Japan Article 69(1) of the Japanese Patents Act stipulates that “the effects of the patent right shall not extend to the working of the patent right for the purposes of experiment or research.” Interestingly, this provision is not limited to patents for drugs only. Supreme Court of Japan has held in a case of Ono Pharmaceutical Co Ltd versus Kyoto Pharmaceutical Co Ltd, that any testing of a patented new chemical entity or a medicine by a third party, to obtain regulatory approval for marketing a drug or medicine using
the same active agent after expiry of the patent, does not constitute infringement of the patent for the chemical entity or the medicine. The court said that the stipulation in the Act regarding exemption for working of the patent right for the purpose of experiment or research read this exception should not be construed narrowly to prevent experimental use by third parties to generate data for obtaining marketing approval for a patented medicine till the expiry of the date when the patent ceases to have effect would result in extending the life of the patent. Supreme Court further said that exemption applied only to any experimental use for generating data for the purpose of seeking marketing approval of the drug. However, bulk manufacture and stocking of patented drug prior to the expiry of patent to facilitate commercial sales immediately after the expiry of the patent would constitute infringing activity.
Australia Australia amended the Patents Act 1990, through Intellectual Property Laws Amendment Act 2006 to introduce a new Bolar provision applicable to all granted pharmaceutical patents. The amendment introduced a new section 119A stipulating that a pharmaceutical patent will not be infringed if used only for the purpose of inclusion of the pharmaceutical product in Australian register of therapeutic goods or for generating data for obtaining regulatory approval in a foreign country. However, the provisions debar export of any pharmaceutical product unless the term of the relevant patent has been extended.
New Zealand According to Section 68B of New Zealand Patents Act, it is not an infringement of a patent for a person to make, use, exercise, or vend the invention concerned solely for uses reasonably related to the development and submission of information required under New Zealand law or the law of Modern Pharmaceuticals I March 2011
Legal Edge any other country that regulates the manufacture, construction, use, or sale of any product.
India Indian Patents Act, 1970, has a provision since inception related to experimental use exception, which reads, ‘The grant of patent will be subject to condition that any machine, apparatus or other article made by the use of process in respect of which the patent is granted may be used, and any process in respect of which the patent is granted may be used, by any person, for the purpose merely of experiment or research...’ This exception has helped Indian Industry to develop and hone skills for incremental innovations over last three decades and even developed skills for drug discovery and new chemical entities. Incremental innovations generally involve development of new processes, improved compounds, polymorphic forms, isomers, salts, metabolites, pro-drugs and drug delivery systems. Patent legislation in India has come a long way from its early days and now it meets global standards. In 2008-09, a total of 3,672 patent applications were filed in the field of drugs.
The game changer In May 2003, a new Section 107A was introduced in Indian Patents Act. This section, which introduced the Bolar provisions in the Act reads, “Any act of making, constructing, using, selling or importing a patented invention solely for uses reasonably related to development and submission of information required under any law for the time being in force, in India, or in a country other than India, that regulates the manufacture, construction, use, sale or import of any product.” This provided for a research exemption as an exception to the general rules of patent infringement. Commonly known as a Bolar provision, this research exemption enables a manufacturer of generic drugs to use a patented invention to obtain marketing approval without the patent owner’s permission March 2011 I Modern Pharmaceuticals
before the patent expires. The generic drug maker can then market their own version of the patented drug as soon as the patent expires. Indian parliamentary Joint Committee on the Patents (Second Amendment) Bill, 1999, recommended insertion of the section 107A in the principal Act, ‘relating to certain acts which are not to be considered as infringement. This provision has been made to ensure prompt availability of products, particularly generic drugs, immediately after expiry of the term of the patent. The amendment in this clause has been made to make a provision in consonance with the Bolar provisions at the global level. According to the press communiqué issued by the Parliamentary Committee, the amendment is ‘to make a provision for enabling persons other than patent holder to obtain marketing approval from the appropriate regulatory authorities within three years before the expiration of the term of the patent’.
Pharmacy of the world Global prescription sales growth of generic drugs climbed by 7.7 per cent, up from 3.6 per cent in 2008, in the 12 months ended September 2009, according to the US-based health care information and consulting company IMS Health. Another study states that India and China now account for roughly 25 per cent of the global generic market and demand in these countries is expected to remain strong for the foreseeable future as the middle class continues to emerge. To that end, China is projected to have the highest average annual growth rate at 18.4 per cent and India’s market will grow by 14 per cent through 2013. According to a study by the Journal of International AIDS Society, Indian firms supplied over 80 per cent of total AIDS medicines between 2002 and 2008. As of 2008, Indian companies accounted for 65 per cent of the total value ($ 463 million) of AIDS medicine purchases. This was possible only due to the production of generics by Indian
drug manufacturers. Thus, Indian generic industry plays a crucial role on providing life-saving drugs to underdeveloped countries at lower costs.
TRIPS plus agenda The European Union (EU) is currently negotiating a Free Trade Agreement (FTA) with India, which according to Non-Governmental Organisations (NGOs) includes provisions harmful for generic manufacturers. Some of the TRIPS plus provisions, which EU is pushing, would impact Indian generic industry in the following manner: Introduction of data exclusivity Stopping the flow of generic medicines through border measures Strict enforcement of Intellectual Property (IP) laws Data exclusivity will not allow generic manufacturers to enter the market soon after the expiry of the patent. The generic industry will have to undergo long clinical trials, which are expensive, thereby increasing the cost of production of the generic drug. It is feared that Indian generic drugs may become costlier or unavailable, which would seriously affect HIV and cancer patients around the world, more specifically in the poorest countries.
Finding a way forward Indian pharmaceutical industry has a competitive edge in that it has access to highly educated and skilled scientific manpower at a fraction of cost available to the western world. Already most of the transnational corporations have set up R&D centres and are using Indian facilities for conducting research and clinical trials to avail the cost advantage. Indian drug industry must now refocus on and make heavy investments in R&D. Indian pharmaceutical industry’s strength will be determined by how well it exploits it core competencies, growth of its R&D capabilities, its growth in various markets through licensing agreements, mergers & acquisitions and co-marketing agreements. MPh (Email: salhotra@lls.in)
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Events Calendar
National CHENNAI Tamil Nadu Mar 11-13, 2011 Chennai Trade Centre
PUNE Maharastra Oct 14-17, 2011 Auto Cluster Exhibition Centre
AHMEDABAD Gujarat Nov 2011 Gujarat University Exhibition Hall
INDORE Madhya Pradesh Jan 2012 Poddar Plaza, Nr Gandhi Hall
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
PharmaTech Expo 2011 Jointly organised by PharmaTechnology Index.com and IDMA, this event aims to be the largest pharma expo in Indore. The objective of this event is to project the latest technological trends in the pharma industry, facilities & services available, quality control and government regulations. This event will showcase latest products, machinery, equipment developments in the industry for generating business and upgradation, and to show the brand value of organisations, joint venture with firms, project collaborations, etc; April 22-24, 2011, Lal Baugh Palace Grounds, Indore For details contact: IDMA Tel: + 91 22 2497 4308 Fax: + 91 22 2495 0723 Email: prach17@gmail.com Website: www.idma-assn.org
11th Bangalore Bio Bangalore Bio will offer unrivalled opportunity in the Asia Pacific region to meet the leaders in the biotech world. The exhibitors profile includes bio-nations and states, R&D organisations, bio-pharma companies, bio-suppliers, bioinformatics, engineering & equipment, biotech parks, diagnostics & instrumentation, clinical research, consulting and allied services. The event will witness industry and corporates, trade commissions, international business representatives, conference delegates, regulators and policy makers; May 4-6, 2011, TBA, Bengaluru
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For more details contact: M M Activ Bangalore Tel: + 91 80 4113 1912 Fax: + 91 80 4113 1914 Email: redmanjunath@gmail.com Website: www.bangaloreindiabio.in
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 and equipment. The event will have exhibitors such as contract manufacturers, liaison agents, sourcing companies, generic and OTC manufacturers & wholesalers, government suppliers, etc; September 17-19, 2011; Gujarat University Exhibition Hall, Ahmedabad, Gujarat For more details contact: Orbitz Exhibitions Pvt Ltd Tel: + 91 22 2410 2801 Fax: + 91 22 2410 2805 Email: info@pharmacindia.com Website: www.pharmacindia.com
Analytica Anacon 2011 Analytica Anacon 2011 is the 6th international trade fair and conference for analytical instrumentation, biotechnology, laboratory technology and services, which aims to bring together the international exhibitors and market leaders. This event will provide an excellent opportunity to showcase innovative products and solutions in the industry; October 12-14, 2011; Bombay Exhibition Centre, Mumbai
For more details contact: Munich International Trade Fairs, New York, USA Tel: + 1 646 437 1013 Fax: + 1 212 262 6519 Email: jliehn@munich-tradefairs.com Website: www.munichtradefairs.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. Major suppliers of pharmaceutical ingredients, outsourcing, equipment and bio-solutions are also expected to exhibit. The CPhI conference will include updates on latest innovations, technologies, trends and developments in the pharmaceutical industry in India; November 30 to 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 PharmaTek 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. The exhibitor list includes plant and machinery for pharma production, bulk drugs, intermediates and formulations, raw materials and excipients, research and development, and instruments and materials, etc; February 23-25 2012, Bombay Exhibition Centre, Mumbai For more 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 March 2011
Events Calendar
International BIOTECH WORLD 2011 The exhibition will show processes & devices for biotechnological productions and laboratory researches, biological preparations for pharmaceutical, food, agricultural sector and also biological agents, bioactive additives, testsystems, alternative energy sources, nano-molecular energy converters, laboratory safety, etc; March 21 - 24, 2011; The House of Moscow Government, Russia For details contact: JSC Expo-Biochim-Technologies Tel: +7 495 933 9051 Fax: +7 495 933 9054 Email: atv@biomos.ru Website: www.mosbiotechworld.ru/eng
DUPHAT 2011 Dubai International Pharmaceuticals and Technologies Conference and Exhibition (DUPHAT) is an annual pharma event. It serves as a convergence point for pharmacists, scientists, researchers, manufacturers, distributors; March 22-24, 2011; Dubai International Exhibition Centre, UAE For details contact: Index (Conferences and Exhibitions Organisation Est) Tel: +971 4 362 4717 Fax: +971 4 362 4718 Email: index@emirates.net.ae Website: www.duphat.ae
International China Pharmaceutical R&D Summit The 6th International China Research and Development (R&D) Summit 2011 will bring together over 80 speakers from international and domestic pharma & biotech companies to share expert opinions & experiences on transformation and innovation in clinical challenges, regulatory updates, NCE discovery efforts, pre-clinical partnerships, biosimilars development, etc; April 11-13, 2011; Grand Hyatt Hotel, Shanghai, China
For details contact: IBC Life Sciences and BayHelix Group Tel: +65 6508 2401 Fax: +65 6508 2407 Email: register@ibcasia.com.sg Website: www.ibclifeSciences.com/china
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
International Pharmaceutical Exhibition The International Pharmaceutical Exhibition will bring together manufacturers and suppliers of process plant & equipment. This exhibition will provide a platform for service providers to showcase their products and services to decision makers from leading pharmaceutical manufacturers; May 10-12, 2011; Charlotte Convention Centre, Charlotte, USA For details contact: Arosa Exhibitions Limited Tel: + 1 980 219 8449 Email: gviniconis@arosa-group.com Website: www.charlotteconventionctr.com
CPhI China 2011 CPhl China is a platform where pharmaceutical manufacturers, biopharm aceutical companies, biotechnology companies & API manufacturers will display a variety of products & services. The event will enable business partnerships, launch new products and showcase innovations; June 21-23, 2011; Shanghai New International Expo Centre (SNIEC), Shanghai, China For details contact: Cphl China 2011 UBM International Media Tel: +31 0 204 099 593 Email: haohao.chen@ubm.com Website: www.cphi-china.com
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
For more details contact: IBC Life Sciences Tel: + 65 6508 2401 Fax: + 65 6508 2407 Email: register@ibcasia.com.sg Website: www.ibclifesciences.com
ICSE Europe The ICSE Europe aims at targeting the top leaders of the pharmaceutical industry. The event will organise an exhibition alongwith concurrent conferences. The exhibitors profile includes biotrails, pharmacology, pre-clinical, biotechnology, pharma equipments and machinery, production equipments, clinical research, patient safety monitoring, etc; October 25-27, 2011, Messe Frankfurt, Frankfurt, Germany For more details contact: UBM Live Tel: + 31 20 409 9544 Fax: + 31 20 363 2616 Email: icse@ubm.com Website: www.icseexpo.com
Bio-Europe Spring 2010 Bio Europe Spring 2011 is a forum to promote business development between pharmaceutical, financial and biotechnology companies in Italy; November 14-16, 2011; Milano Convention Centre, Milano, Italy For details contact: BIO (Biotechnology Industry Organization) Tel: +1 202 962 9200; Fax: +1 202 488 6301 Email: cbeckman@bio.org Website: www.bio.org/events
The information published in this section is as per the details furnished by the respective organiser. In any case, it does not represent the views of Modern Pharmaceuticals
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Modern Pharmaceuticals I March 2011
Report
BioAsia 2011
Going clean with green technology BioAsia 2011 once again lived up to the expecta ons derived from yesteryears. This year, in collabora on with Pharmexcil, BioAsia also had a Buyer Seller Meet (BSM) that added more value to this annual interna onal biotech event.
Dr Asma Mohd Yousuf
“H
yderabad is the hub for Research and Development (R&D). It is the pharma and bulk drug capital of the country. It is the FDA approved second DNA production city in the world. And Genome Valley and BioAsia are the successful stories of Hyderabad.” Well said by Prof Dr Seyed E Hasnain, Chairman, AP Biotech Advisory Council and Vice Chancellor, University of Hyderabad, in his opening speech at BioAsia 2011, which was indeed a success once again. Organised by the Federation of Asian Biotech Association (FABA), Genome Valley - Government of Andhra Pradesh, University of Hyderabad (UOH), All
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India Biotech Association (AIBA) and Pharmaxecil, the eighth edition of BioAsia 2011 was held at Hyderabad International Convention Centre (HICC) from February 21-24, 2011. For the first time, the event was attended by contingents from Malaysia, Iran, China, Europe and other parts of the world.
Global bio-business forum The eighth edition of the annual biotechnology conference, BioAsia 2011 was inaugurated by Dr J Geetha Reddy, Honorable Minister for Major Industries, Sugar, Commerce and Export Promotion of Andhra Pradesh, on February 22, 2011. The minister in her address mentioned that BioAsia 2011 has received record participation of delegates from 190 companies belonging to 24 countries registering for the event. The minister also
unveiled the plaque to mark the launch of projects such as Lonza Knowledge Centre, located in Genome Valley; Sri Bio Integrated Discovery Centre, a unit for stem cell banking and research from Pacific Hospitals & Tran-Scell Biologics and Lepakshi Knowledge Hub, coming up in Anantapur district. This was followed by the inauguration of the exhibition by the minister. Some of the prominent people present at the inauguration were Prof Dr Hasnain; Dr Halimah Ali, Minister for Higher Education and Research, Selangor, Government, Malaysia; Dr Abbas S Lofti, Director General, NIGEB, Republic of Iran; Dr Anji Reddy, Chairman, Dr Reddy’s Laboratories; Dr Jun Yu, Professor and Associate Director, Beijing Institute of Genomics, China and Dr Roger Williams, CEO, United States Pharmacopeia, USA. In the course of his address, Dr Williams said, “10-30 per cent of generic medicines in the US come from India. This is an achievement to the Indian manufacturers as they provide quality medicines for everyday diseases. Many chemical and medical products all over the world are imported from Hyderabad. India is in a position to leap ahead of rest of the world in the field of biotechnology and biosimilars.” The Genome Valley Excellence Awards was presented to Dr Anji Reddy for his contribution to the life sciences industry and the Beijing Institute of Genomics, Chinese Academy of Sciences, China for its exemplary work and contributions in the field of genomics. Dr Anji Reddy confidently admitted, “India has 150 US FDA-approved plants. It is just a matter of time that in the future, Indian companies will produce drugs that will Modern Pharmaceuticals I March 2011
Report serve not just the Indian population but the entire world.” The first day concluded with a CEO conclave on the theme ‘Looking Back, Looking Forward’. The panel comprised eminent industry dignitaries like Dr Anji Reddy; Utkarsh Palnitkar, Executive Director, Centrum Captial Ltd; Dr Bobba Venkatadri, General Partner, Venture East; and Dr D S Brar, Chairman, GVK Bio. In the conclave, the requirements for the biotech industry to progress further and the strengths & weaknesses that affect its growth were discussed.
The show goes on... On February 23, 2011 the event saw with release of whitepaper, ‘The Asian Promise’ prepared by Grant Thornton, the knowledge partner for the event. The report was released by Dr B S Bajaj, Convener of BioAsia 2011. This was followed by country presentations by the eminent people in the industry chaired by Dr Srinivas K Rao, MD, Indian Institute of Biotechnology. The country presentation was started with Indian representative Mahadeven Narayanamoni, Partner & Health Care Leader, Grant Thornton, who informed that the Indian Biotech Industry in 2010 touched $3 billion, of which 53 per cent was exports. India has witnessed 19 M&As and Private Equity (PE) deals in 2010 worth $230 million. Further, Yang Weigang, Deputy Director General of Beijing Municipal Science and Technology Commission spoke about the current status and development potential of Bio Pharmaceutical Industry in China. Information on the biotechnology advancements in Iran was provided by Prof Abbas S Lotfi, Director General, National Institute of Genetic Engineering and Biotechnology, Tehran. Prof Dr Abdul Manan Mut Jais, Neurophysiology, University Putra Malaysia, Selangor, Malaysia, spoke on the Malaysian biotechnology directions and approaches and said that Malaysia is focussing on food- and agricultural-based biotechnology. The session was concluded by the speakers discussing on the lack of funding in the Asian countries for grooming their biotech industries compared with Western March 2011 I Modern Pharmaceuticals
nations, which is the major reason for Asian backwardness. Besides, the inability to utilise the huge untapped opportunities in Asia despite of having two-thirds of the global population is yet another hindrance. They also said that the Asian biotech industry should become another revolution by offering solutions to the global problems. The technical sessions on February 22-23, 2011 were divided into three track conferences - MediAsia, HealthAsia and AgriAsia. These were conducted by various eminent personalities and focussed on many topics amongst which one important subject of discussion was green chemistry and green biotechnology.
Awards and accolades The event concluded on February 24, 2011. The valedictory ceremony was attended by prominent people like Zurab Katchkatchishvili, Ambassador of Georgia; Sam Bob, Principal Secretary, Government of Andhra Pradesh; D Balasubramanian, Director of Research, L V Prasad Eye Institute; Dr P V Appaji, Executive Director, Pharmaceuticals Export Promotion Council of India (Pharmexcil). To acknowledge some of the advancements in Biotechnology, E S L Narasimhan, the Governor of Andhra Pradesh, awarded YSR Innovation award to Chaitanya Reddy of Vishnu Dental College, West Godavari district for the project ‘Manually Operated Mobile Air Compressor’ in dentistry. The award comprised ` 1 lakh cash along with a memento and citation. The BioAsia Young Minds award of ` 50,000 cash prize, a memento and citation was bagged by Vignesh Sridharan from Chennai. Iranian Biotech of Republic of Iran received the best trade show award, while the first runner-up was Sri Biotech Ltd, Hyderabad and second runner-up was awarded to Lablinks Biotech, Bengaluru. The Governor of Andhra Pradesh in his speech emphasised on the importance of agri biotechnology to increase productivity to face the challenges from land shrinkage and support the burgeoning population in the country. He further said that companies should come to Andhra Pradesh as the Government is fully committed to support them. Also, the
Governor announced that BioAsia 2012 will be held from February 09 to February 11, 2012 at HICC, Hyderabad.
Business interac ons For the first time in BioAsia 2011, Pharmaxecil organised a focussed BSM exclusively oriented for export promotion of the biopharma and biotech products. Expressing his views on this, Dr Appaji said, “The BSM arranged by Pharmaxecil is an added advantage to BioAsia 2011. Pharmexcil has been partnered with FABA by Government of Andhra Pradesh for the next three years. This year, we have visitors from various nations like the US, Ukraine, Vietnam, South Africa, Zimbabwe, Namibia, Tanzania and many more.” He further said, “BSM always gives an opportunity to the large as well as small and medium manufacturers to meet and interact with international visitors that will help in making business. Moreover, if such sessions are organised in events like BioAsia then they offer a bigger platform for B2B interactions and at the same time helps in creating awareness about such facilities. This year BSM has been successful, and next year we expect more participation, and therefore a bigger success.”
A glabal event BioAsia has successfully created market for Andhra Pradesh and India. It is a platform that helps in exploring the possibilities of business-to-business discussions. Dr B S Bajaj, Convener BioAsia, said, “More than 400 business-to-business meetings were conducted during the course of the three-day event. The event attracted more than 900 registrations from delegates and exhibitors, while more than 1,500 visitors thronged the exhibition at BioAsia 2011.” “With the record number of participation from across the world, this mega event should be called ‘Global Asia’ instead of ‘BioAsia’,” remarked Dr Geeta Reddy in the inaugural address, a statement which received a huge applause from the audience. Perhaps, with the name and fame earned, it appears that in the near future these words will be a successful reality. MPh (asma.yousuf@infomedia18.in)
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Product Update Hot-ink roller Process Instrumentation & Controls manufactures and offers hot-ink rollers that keep workers, products and environment clean & safe, by using this innovative and environmentally friendly technology. These hot-ink rollers are outstanding products and do not require adding or charging of conventional inks. They are solid at room temperature and do not smudge. The hot-ink rollers are non-toxic and give sharp impressions and contain solvent-free ink. Therefore there are no hazards possible as in the case of conventional inks (claims the company). The hot-ink rollers find application in various industries, such as food, pharmaceuticals, cosmetics, dairy, frozen food, etc. They are available in various sizes and colours. Along with the hot-ink rollers, various other contact coding consumables are also available. Process Instrumenta on & Controls - Vadodara - Gujarat Tel: 0265-235 7228, Fax: 0265-235 5429, Mob: 09825139846 Email: batchprinting@yahoo.com
Cap welder Weiler Engineering, Inc manufactures both fully automated and manual load cap welding systems to mate with the ASEPTECH® blow/fill/seal machines to produce a multi-entry insert format for LVPs. The unit can be supplied as an integrated package along with a new machine, or provided as stand-alone unit for an existing machine. The cap welder is designed with an accumulation station and an independent control system that can be linked to the BFS machine. Production output is paired with the BFS machine output for maximum productivity. A variety of injection moulded after-market caps can be used with this system. Weiler Engineering Inc - Illinois - USA Tel: +1-847-6974900, Fax: +1-847-6974915 Email: creed@weilengineering.com
PTFE lined valve Supremo line & Control manufactures fluoropolymer FEP, PFA, PTFE, lined SGI/ WCB/SS/MS pipes, valves and fittings using Dupont’s technical know-how and raw materials for appropriate application of the resin for successful results with international quality for chemical industry. Salient 64 64
features of these products include: 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: 09724505282 Email: supremoproduct@gmail.com
Humidity & temperature indicator Katlax Enterprises Controller and Instrumentation Group (CIG) offer humidity (RH) and temperature indicator (ceiling hanging). This latest industrial automation instruments can be positioned right where they are required, indicator feature dual LCD displays, RH and temperature readings one by one at the same time. Humidity and Temperature (Ceiling Hanging) indicator’s features consists of: supply voltage- 230VAC ± 10 per cent @ 50 Hz; display type- seven segment Red 4.0”; display- three digits scrolling (every 5 sec); and display range consists of -50°C to + 150°C temperature & 0 to 100 per cent humidity. Its application are in automotive, HVAC, consumer goods, weather stations, humidifiers, de-humidifiers, food & agro, textile, test & measurement, space electronic assembly, ICU, air handling unit, multiplex, data logging and automation. Katlax Enterprises Pvt Ltd - Gandhinagar - Gujarat Tel: 02764-286784, Fax: 02764–286793, Mob: 09724506614 Email: info@katlax.com
Vacuum suc on cup 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. Schmalz India Pvt Ltd - Pune - Maharashtra Tel: 020-4072 5500, Fax: 020-4072 5588 Email: schmalz@pn3.vsnl.net.in Modern Pharmaceuticals I March 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. ACG Worldwide - Mumbai - Maharashtra Tel: 022-2287 2557-59, Fax: 022-2287 2560 Email: rajendra.khimsaria@acg-world.com
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Product Update FORM IV Statement about ownership and other particulars about Modern Pharmaceuticals, as required to be published in the first issue every year after the last day of February. 1. Place of Publication: Ruby House, ‘A’ Wing, JK Sawant Marg, Dadar (W), Mumbai-400 028 2. Periodicity of Publication: Monthly 3. Printer’s Name: Mr Mohan Gajria Nationality: Indian Address: Infomedia 18 Ltd, Ruby House, ‘A’ Wing, JK Sawant Marg, Dadar (W), Mumbai-400 028 4. Publisher’s Name: Mr Lakshmi Narasimhan Nationality: Indian Address: Infomedia 18 Ltd, Ruby House, ‘A’ Wing, JK Sawant Marg, Dadar (W), Mumbai-400 028 5. Editor’s Name: Mr Manas Bastia Nationality: Indian Address: Infomedia 18 Ltd, Ruby House, ‘A’ Wing, JK Sawant Marg, Dadar (W), Mumbai-400 028 Address: Ruby House, ‘A’ Wing, JK Sawant Marg, Dadar (W), Mumbai- 400 028 6. Names and addresses of Individuals who own Modern Pharmaceuticals & partners or shareholder holding more than 1% of total capital of Infomedia 18 Limited (formerly known as Infomedia India Limited), Ruby House, ‘A’ Wing, JK Sawant Marg, Dadar (W), Mumbai-400 028. Details of the shareholders of Infomedia 18 Limited who are holding more than 1% of the paid up equity share capital of the company as on 11-02-2011: a. Television Eighteen India Limited, 601, 6th Floor, Hotel Le-Meridian, Raisina Road, New Delhi-110 001. b. Soumen Bose, (acting in capacity of trustee of Infomedia 18 Merger Trust for the benefit of India Advantage Fund II) Flat - 11, Neelam, 2nd Floor, Road 14 B, Off Linking Road, Khar(W), Mumbai -400 052 c. ACACIA Partners, LP, Citibank N.A., Custody Services, 77, Ramnord House, Dr. A.B. Road, Worli, Mumbai- 400 018 d. Sanjiv Dhireshbhai Shah, 702, Silicon Towers, Behind Samar theshwar Mahadeo, Law Garden, Ahmedabad - 380 006 e. ACACIA Conservation Fund LP, Citibank N.A., Custody Services, 77, Ramnord House, Dr. A.B. Road, Worli, Mumbai- 400 018 f. The Oriental Insurance Company Ltd, Oriental house, P. B. 7037, A-25/27, Asaf Ali Road, New Delhi-110 002 g. ACACIA Institutional Partners, LP, Citibank N.A., Custody Services, 77, Ramnord House, Dr. A.B.Road, Worli, Mumbai-400 018 h. Optimum Securities Private Limited, 3, Amba Bhuvan, 29, Sion Circle, Sion (W), Mumbai-400 022. I, Lakshmi Narasimhan, hereby declare that all particulars given above are true to the best of my knowledge and belief.
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 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
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.
Dated: 16th February 2011 Sd/Lakshmi Narasimhan Signature of the publisher
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Cole-Parmer India - Mumbai - Maharashtra Tel: 022-6716 2222; Fax: 022-6716 2211 Email: response@coleparmer.in Modern Pharmaceuticals I March 2011
Product Update Medical refrigerator 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 & antiepidemic stations and clinics. This medical refrigerator is provided with microprocessorbased 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. Sigmatech Scien fic Products - Hyderabad - Andhra Pradesh Tel: 040 - 6453 4491, Mob: 098496 32904, Fax: 040-4003 1896 Email: s_tech07@yahoo.com
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Product Update Vibratory finishing system
PFA lined valve
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, preplate finish, etc of delicate or heavy parts and for precision deburring/finishing. Vibratory finishing is also safer for threaded parts.
Dip-Flon Engineering & Co offers perfluoroalkoxy (PFA) lined valves. For many chemical plants, linings made of PFA have been used as an alternative to exotic alloy, expensive metal for valves, pumps, control valves, etc. PFA is an injectable type of thermoplastic, which is processed in pressure sintering process. PFA’s success is due to several higher permeation resistances combined with high chemical resistance for most of the chemicals used in industry and also temperature resistance from –60 to 200oC (-75 to 400oF). PFA has generally much lower permeation rates than PTFE with the same wall thickness but it has the same chemical and thermal resistance properties.
Niraj Op cal Machinery - Ahmedabad - Gujarat Tel: 079-2929 5747, Fax: 079-2583 3659 Mob: 9825554860, 9909904148 Email: badrakia@rediffmail.com
Dip-Flon Engineering & Co - Ahmedabad - Gujarat Tel: 079-2562 4003, Fax: 079-2562 5665 Email: dipflon@satyam.net.in
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
An invite that rewards as well... Dear Reader, ‘Modern Pharmaceuticals’ solicits original, well-written, application-oriented, unpublished articles that reflect your valuable experience and expertise in the pharmaceutical industry. You can send us Technical Articles, Case Studies and Product Write-ups. The length of the article should not exceed 3000 words, while that of a product write-up should not exceed 200 words. The articles should preferably reach us in soft copy (either E-mail or a CD). The text should be in MS Word format and images in 300 DPI resolution & JPG format. The final decision regarding the selection and publication of the articles shall rest solely with ‘Modern Pharmaceuticals’. Authors whose articles are published will receive a complimentary copy of that particular issue and an honorarium cheque. Published by Infomedia 18 Limited, ‘Modern Pharmaceuticals’ is the leading monthly magazine exclusively meant for producers and user fraternities of the pharmaceutical industry. Well supported by a national readership of over 80, 000 and our strong network of 26 branch offices across India, this magazine reaches out to key decision makers among the Indian manufacturers of pharma products, machinery and allied sectors. Brought out in association with Hong Kong-based Ringier Trade Media Ltd (one of the world’s largest trade publishing houses with more than 200 special interest So get going and rush your articles, write-ups, etc… Thanking you, Yours sincerely,
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Modern Pharmaceuticals I March 2011
Product Index Sl No Product
Pg No
Sl No Product
Pg No Sl No Product
Pg No
1
Accelerated ageing test......................................... 41
50 Financial services.................................................... 35
97 Pharmaceutical grinding & dispersion................ 49
2
Access control system............................................. 67
51 Fire alarm ................................................................ 67
98 Photoelectric sensor ...................Front Inside Cover
3
Air filter ............................................................. 51, 53
52 Flameproof pH indicator/controller.................... 21
99 Plastic pallet ............................................................ 61
4
Air shower controller ............................................. 67
53 Fuel........................................................................... 41
100 Polymer characterisation....................................... 41
5
Analytical instrument ............................................ 74
54 Gases ...................................................................... 41
101 Potentiometer.......................................................... 21
6
Analytical instrumentation ................................... 37
55 Gear oil .................................................................... 41
102 Pre-engineered & pre-fabricated modular
7
Auto tube filling sealing......................................... 69
56 GMP heat exchanger................................................ 7
panel ................................................................ 51, 53
8
Banking services................................................... 35
57 GMP reactor ............................................................. 7
103 Process heat exchanger ............................................ 7
9
Biodiesel................................................................... 41
58 Heart valve frame................................................. 73
104 Process reactor .......................................................... 7
10 Biological safety cabinet .................................. 51, 53
59 HEPA filter terminal housing ......................... 51, 53
105 Programmable logic controller......Front Inside Cover
11 Blister packaging machine..................................... 69
60 Hot-ink roller.......................................................... 64
106 Programmable terminal ............Front Inside Cover
12 Blistrip...................................................................... 69
61 HPLC ................................................................. 37, 74
107 Proximity sensor.........................Front Inside Cover
13 Blow/fill/seal machine............................................ 12
62 Humidity & temperature indicator...................... 64
108 PTFE lined valve..................................................... 64
14 Calibration source................................................ 21
63 Hydrogenator/autoclave........................................... 7
109 Quality control equipment & apparatus .......... 69
15 Cap welder............................................................... 64
64 Indicator ................................................................ 21
110 Quick-change terminal house......................... 51, 53
16 Capping machine ................................................... 11
65 Industrial control & sensing
111 Rapid endotoxin detection system..................... 67
17 Capsule section machine....................................... 69
device .........................................Front Inside Cover
112 Return air riser.................................................. 51, 53
18 Chiller ........................................................................ 8
66 Informatic................................................................ 37
113 RFID.............................................Front Inside Cover
19 Chromatography .................................................... 74
67 Injectable manufacturing line......................... 51, 53
114 Rotary vacuum dryer............................................... 7
20 Clean room door.............................................. 51, 53
68 Injectable powder filling machine........................ 11
115 Rotocone dryer ......................................................... 7
21 Coating pan............................................................. 68
69 Inspection system ................................................... 17
116 Safe change housing....................................... 51, 53
22 Coloumn ................................................................. 74
70 Invertor/variable frequency
117 Safety light curtain .....................Front Inside Cover
23 Coloumns & chemistries....................................... 37
drive ...........................................Front Inside Cover
118 Sampling booth ................................................ 51, 53
24 Complete tablet bottle packing line..................... 11
71 Lab conductivity................................................... 21
119 SEZ developer ..................................Front Gate Fold
25 Compositional & trace metal analysis ................. 41
72 Lab portable online pH meter.............................. 21
120 Silicone carbide heat exchanger.............................. 7
26 Conductivity ........................................................... 21
73 Laminar airflow workstation .......................... 51, 53
121 SME finance ............................................................ 35
27 Conical screw dryer.................................................. 7
74 Level controller ...........................Front Inside Cover
122 Spherical paddle chopper dryer ............................. 7
28 Controller ................................................................ 21
75 Liquid filling machine............................................ 11
123 Sterilising/depyrogenating tunnel .................. 51, 53
29 Conveyers belt......................................................... 69
76 Logger ...................................................................... 59
124 Sticker labelling machine....................................... 11
30 Cooling tower ........................................................... 9
77 Lubes-engine oil ..................................................... 41
125 Switching relay............................Front Inside Cover
31 Counters & power supplies.......Front Inside Cover
78 Mass spectroscopy................................................ 74
126 Tablet section machine ........................................ 69
32 Data logger............................................................ 59
79 Material identificaton............................................. 41
127 TDS conductivity indicator/controller ................ 21
33 Diesel fuel ............................................................... 41
80 Measuring & monitoring relay......Front Inside Cover
128 Tempurature controller .............Front Inside Cover
34 Digital microcontroller pH meter........................ 21
81 Medical refrigerator................................................ 69
129 Testing system ......................................................... 41
35 Digital USB microscope ........................................ 68
82 Metallography ......................................................... 41
130 Three parameter display........................................ 67
36 Dispensing booth ............................................. 51, 53
83 Molecular spectroscopy ......................................... 74
131 Timer............................................Front Inside Cover
37 Door interlock system............................................ 67
84 Motion control ...........................Front Inside Cover
132 Transmeter............................................................... 21
38 Drives ........................................................Back Cover
85 Motion horizontal cartoner .................................. 67
133 Transmission fluid.................................................. 41
39 Dry syrup powder filling line ............................... 11
86 Ointment/cream/paste section machine........... 69
134 Turnkey project......................................................... 7
40 Electrical turnkey project.................................... 67
87 Online B2B marketplace................................... 31,71
135 Twin-screw co-rotating extruder.......................... 73
41 Elemental analysis .................................................. 74
88 Online TDS digital indicator ................................ 21
136 Twin-screw element ............................................... 73
42 Empower ................................................................. 37
89 ORP indicator/controller....................................... 21
137 Twin-screw extruder .............................................. 73
43 Encoder........................................Front Inside Cover
90 Packaging machine ........................................ 11, 69
138 UHPLC .................................................................. 74
44 Ensule automatic capsule filling........................... 69
91 Pass box ............................................................. 51, 53
139 UPLC........................................................................ 37
45 Factory automation ......................Cover on Cover
92 Pass box interlock system...................................... 67
140 Vacuum suction cup ............................................ 64
46 Failure analysis........................................................ 41
93 Petrol & fuel oil ...................................................... 41
141 Vibratory finishing system .................................... 70
47 Fan filter unit ..................................................... 51,53
94 PFA lined valve ....................................................... 70
142 Vision sensor...............................Front Inside Cover
48 Fill tube.................................................................... 69
95 pH electrodes .......................................................... 21
143 Washing & airjet cleaning machine................... 11
49 Filler compositional analysis................................. 41
96 pH meter ................................................................. 21
144 Wet glue labelling machine................................... 11
March 2011 I Modern Pharmaceuticals
71
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