Despite a double digit rate of growth over the last five years, the Indian biotechnology sector is finding it difficult to launch new products that match global growth trends, the annual biotech report of consultancy Ernst & Young points out.The 26th edition of the report, Beyond Borders: global biotechnology report 2012 released on 10 July, stated that even with a CAGR 19.2 of per cent during 2007–2011, Indian biotech industry has concurrently been facing diverse challenges that have prevented the industry from transcending to the next level.Within the domestic market, companies have not been able to launch new products at a pace that they would have liked. Dealing with multiple regulatory bodies typically results in serious delays, the report says."Companies focused on innovation have not been able to make a sizeable impact on the industry. Many of them are facing funding constraints as the investor community has shied away from investing in early stage ventures. With the lack of funding, many innovative companies will be forced to shut shop or become service providers rather than innovators", it said."India is already facing stiff competition from China, Korea, Singapore, and more recently Malaysia, in terms of attracting investments from MNCs. This has been enabled due to better technological and scientific competence, better infrastructure, tax and duty exemptions, and easier regulatory procedures as compared to India", Ajit Mahadevan, Partner, Ernst & Young said.The report also listed out various government initiatives, including the setting up of biotech parks and fiscal sops that have been initiated to strengthen the industry in the country.According to E&Y estimates, Indian biopharmaceutical industry constitutes 60 per cent of the biotech industry in India and grew at 21 per cent y-o-y to reach $2.3 billion in 2010–11. Vaccines, insulin, erythropoietin and monoclonal antibodies have been the mainstay of the biopharma segment."There is strong call for action for the government to act swiftly to carry out regulatory reforms, develop infrastructure and provide more incentives to the biotech industry to remain competitive and spur growth in the industry. The industry, on its part, needs to come up with a concerted action plan to utilize the available infrastructure and resources more efficiently and focus on nurturing innovation to take the biotech industry to new heights", Mahadevan states.
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The European Parliament on Wednesday rejected the proposal for an Anti-Counterfeiting Trade Agreement (ACTA), which, if passed, could have had an adverse impact on generic medicine exports from countries such as India through European ports.Even in the absence of a law similar to ACTA, there were several instances when genuine Indian medicines in transit got confiscated in European ports on grounds of intellectual property violations. For long, India has been lobbying hard for the smooth passage of Indian generic medicines to developing countries in Africa and Latin America through European ports of transit.Developing nations in Asia, Latin America and Africa had expressed concern over provisions of the proposed ACTA as they feared the movement of genuine low-cost medicines through Europe could get affected. Welcoming the European Parliament decision, International medical humanitarian organisation Médecins Sans Frontières (MSF) said the agreement could have limited access to quality generic medicines."We are relieved that the EU Parliament has struck down ACTA", said Aziz ur Rehman, Intellectual Property Advisor for the MSF Access Campaign. "The way it was written, ACTA would have given an unfair advantage to patented medicines, and restricted access to affordable generic medicines to the detriment of patients and treatment providers alike."ACTA was purported to be a shield against counterfeiting across a number of industries, including medicines, where it was held up as a means of blocking potentially harmful ‘counterfeit' medicines. MSF strongly supports efforts to ensure that generics meet accepted international standards. However, ACTA's overbroad definition of ‘counterfeiting' and its excessive enforcement provisions left too much room for error. Legitimately produced generic medicines could have been seized and detained, hindering access for people who rely on these medicines to survive, an MSF statement said.The stringent provisions in ACTA would also have targeted third parties — including treatment providers like MSF – by exposing them to the risk of punitive action in trademark and patent infringement allegations, it added.Following the rejection of ACTA, the European Commission should review similarly harmful intellectual property provisions being pursued in other agreements, including in free trade negotiations. One such current negotiation is with India, one of the world's biggest exporters of generic medicines, often referred to as ‘the pharmacy of the developing world', the statement said.
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Boehringer Ingelheim (BI), one of the top mid-sized multinational pharmaceutical companies based in Rhein, Germany, has joined the list of global drug firms lining up to tap the potential of the Rs 60,000 crore Indian pharmaceutical market.Unlike most other big pharma companies, the 100 per cent privately held company, with a turnover of 13.2 billion euros in 2011, is looking to achieve organic growth in India by selling its own patented medicines rather than foraying into the turf of generics or copycats of patented drugs with big bang acquisitions."Traditionally our growth is based on innovation led patented products and acquisitions are not in our DNA", says Engelbert C. Tjeenk Willink, member of the board of managing directors at BI.BI set up operations in India with an office in Mumbai in 2003 and has been slowly testing Indian waters, despite its apprehensions on India's patent regime. Now it sells about five products in the country with revenues of Rs 150 crore. These are Actilyse and Aggrenox for prevention of strokes, Mirapex for treatment in Parkinson's disease and cardiovascular drugs Metalyse for acute myocardial infarction and Micardis for hypertension.At present about 400 people are employed in India and most of them were recruited in the recent years, says Sharad Tyagi, managing director of Boehringer Ingelheim India. BI will soon launch Pradaxa, a blockbuster cardiovascular blood thinner drug useful for prevention of strokes in patients suffering from a heart condition called atrial fibrillation. The company is also planning to launch Trajenta, this year in India, indicated for glycaemic control for Type 2 diabetes mellitus patients. This will be marketed through an alliance with another global drug major Eli Lilly, which has a good market share in India in the field of diabetes solutions. Some of BI's old products are currently marketed in India by Zydus Cadila through a licensing agreement, as part of Zydus's German Remedies acquisition in 2002-03 from a clutch of German drug companies."These licensing terms will expire next year and we are evaluating options ", says Willink.Considering the nature of the Indian market, BI will adopt a differential pricing strategy to help its drugs reach more people, he adds. About half the global sales of BI are from the US and the rest are distributed between Europe and Asia Pacific. Their grand entry into India is part of the strategy to tap the BRIC countries. BI entered China a few years ago and currently employs over 3000 people. India will also witness a similar growth plan, says Philipp von Lattorff, vice president, emerging markets at BI."We have a rich pipeline of drugs under development and we will launch them in the Indian market in the coming years", says Willink, who states that sustainable growth is the philosophy of the company. But to sustain and grow big in the Indian market, BI will have to follow an aggressive organic growth strategy, as the Indian market is already flooded with an estimated 70 patented drugs and thousands of generic drugs.
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Drug firm Elder Pharmaceuticals has announced plans to foray deeply into the growing personal and lifestyle healthcare sector by focusing on creating products for hypertension, diabetes, cardiac care, pain management, nicotine replacement therapy and other pharmaceuticals.With its recently added manufacturing plant in Navi Mumbai, the company has acquired a strong presence in women's healthcare, nutraceuticals, anti-infectives, lifestyle diseases and pain management. The company derives 95 per cent of its revenue from the domestic market and is presently ranked 27th by IMS ORG.The firm's main strength lies in marketing the women's healthcare product, Shelcal, a calcium supplement to prevent osteoporosis, and its extensions. In fact a major part of their products are oriented towards taking care of women's healthcare needs, including infections and the requirements of post-menopausal women. "Elder's focus is on creating a product in a therapeutic category and establishing brand leadership in that segment, apart from developing our own portfolio," says Alok Saxena, Director, International, Elder Pharmaceuticals, who informs that the company has the highest number of in-licence agreements in the domestic market. "Products are chosen based on research and licensed from companies that discovered the original molecules. We stay away from patent infringement, hence the need to acquire so many licences from companies abroad," Saxena clarifies. Elder also has an in-licence with Diawa of Japan for Imbran, an immunomodulator that enhances the body's immune response and is particularly valuable for patients with cancer, AIDS and swine flu. Carnisure, a cardiovascular product, is on a high growth trajectory and will be a major brand in its category. Other key brands include Somazina (for brain stroke), Hibor (low molecular weight heparin) and the recently launched own brand nicotine replacement therapy. Saxena explains that "we are now enhancing our presence in the field of pain management, where we have identified chronic diseases such as arthritis and cartilage disease and have a specific arrangement with two foreign companies to market the products." The company plans to stay in the chronic diseases segment, which requires knowledge and understanding; the products have to be extensively explained to the medical profession for their application. Two drugs, Sampure and Artodar, are specific to this disease. "We have extended our portfolio beyond oral medication to market rubefacients." says Saxena.Nutraceuticals is another area where the company is expanding its operations, catering to cardiac, diabetic and kidney disease patients. Phytomega, which was introduced in arrangement with Enzymotec of Israel, reduces the dose of statins over a period of time and is extremely effective in bringing down levels of triglycerides, the cause of various coronary blockages. It has been clinically proved to be effective and can be deemed as an essential product with statin intake. Ecozyme is a recent introduction. CoQ10 is a vital product for promoting cardiovascular health. The company has created six manufacturing facilities in Uttaranchal, Himachal and Maharashtra for different products. It also has a 61 per cent stake in Biomeda of Bulgaria, which has a manufacturing facility for tablets and is backed by a strong distribution network in that country. This move will fuel the company's growth in the European Union and CIS markets.
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The Supreme Court on Thursday ordered Delhi's private hospitals, built on subsidised government land, to provide free treatment to the poor, saying they cannot "wriggle out" of their responsibility.A bench of justices R V Raveendrana and A K Patnaik asked the city hospitals to reserve 25 per cent of their out-patient department capacity and 10 per cent of beds at the indoor level for free treatment of the poor.The hospitals cannot "wriggle out" of their responsibility to treat the poor free of cost, the court said."The bottom line is that the poor patients are not to be charged," said the bench, dismissing the plea of some private hospitals against providing free treatment to the poor.The court passed the order on a batch of petitions filed by ten private hospitals challenging a Delhi High Court order to provide free treatment to the poor patients as per the land lease agreements between the government and them.There are 37 hospitals which were granted land by the government at concessional rates out of which 27 have been providing free treatment to poor patients."Why did you (hospitals) take the land? You hand over the land to the government and purchase it somewhere else," the bench remarked when the counsel appearing for the hospitals pleaded that it was not practical to provide free treatment to the poor in all the cases."You want to wriggle out after signing the contract with the government while taking the land (at concessional rate)," the bench said.The hospitals contended that the treatment of diseases like cancer, neuro surgery and plastic surgery are costly and cannot be provided free of cost.The bench upheld the Delhi High Court's order, which, in 2007, had ruled that all private hospitals which were given public land at highly subsidised costs would provide free treatment to the poor, earmarking 25 per cent of their out-patient department (OPD) capacity and 10 per cent of their in-patient department capacity for them."They (poor patients) will be provided free admission, bed, medication, treatment, surgery facility, nursing facility and consumables and non-consumables. The hospitals charging any money from such patients shall be liable to be proceeded against in accordance with the law. Besides that, this would be treated as violation of the orders of the court," the high court had said.The high court had pronounced the judgement on a PIL seeking implementation of the land lease agreement between the government and the hospitals for providing, among other things, free treatment to certain percentage of the poor patients out of their total treatment capacities.(PTI)
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