PATENTED DRUG LAUNCHES MAY BE DELAYED IN INDIA

Launch of patented drugs in India could be delayed due to the government's "thought process on linking patented drug prices to the country's per-capita income", according to a report by consultancy firm Deloitte. "The recent government thought process on linking patented drug prices to the country's per-capita income in relation to certain developed markets could result in delayed patented drug entry into India," the report said. As per the 2013 Global life sciences outlook by Deloitte, the debate over compulsory licensing remains a contentious issue in India, while innovator pharmaceutical firms will also face several challenges such as margin pressure from pharma generics and complex regulatory policies. In the recent past, India has witnessed some major developments related to patented drugs. In a major landmark judgement in April this year, the Supreme Court had rejected Swiss pharma giant Novartis's plea for patent protection on cancer drug Glivec and to restrain Indian firms from making generic copies of the drug. Earlier in March this year, Intellectual Property Appellate Board (IPAB) had upheld compulsory license granted to domestic firm Natco Pharma allowing it to produce cheaper generic versions of Nexavar, a patented drug of multinational Bayer Corporation, used for treating the liver and kidney cancers. Last year, Natco was allowed to manufacture and sell generic Nexavar at a price not exceeding Rs 8,880 for a pack of 120 tablets required for a month's treatment as compared to a huge Rs 2.80 lakh per month charged by Bayer. Spelling other challenges in the India pharmaceuticals market, Deloitte said low insurance penetration was resulting in a self-pay market with considerable affordability and access barriers, apart from a lack of consumer awareness and education and heavy market fragmentation. Despite challenges, the outlook for 2013 is promising, Deloitte said. "There is an inherent demand for health care products and services due to India's large patient base and increasing awareness of wellness by its growing population," it said. Second, both the government and private sectors are increasing their initiatives to improve health/well-being and enhance population coverage (including access to rural and low-tier cities), it added.