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After price control, several key drugs in short supply

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52 new drugs come under price control

NEW DELHI: Launches of new medicines in India have come down by over 87% during the last four-five years and drug manufacturers blame price regulations and policy uncertainty for making India an unattractive destination for both domestic as well as multinational pharmaceutical companies.In 2008, 270 new drugs were approved for sale in India, whereas it dropped to 44 and 35 in 2012 and 2013, respectively. In 2014, only 56 new medicines were approved till November, government data shows.“Most of the big pharmaceutical companies have knocked out India from their list of key markets. The reason is stricter policy measures cutting down on margins, making it less attractive as a business proposition for future growth,” a senior executive in a leading domestic pharmaceutical company said.A stricter regulatory regime, which not only brings down drug MRPs but also continuously expands span of price control, is cited as the main reason why drug manufacturers are losing their India focus. Industry officials also blame looming uncertainty in policy as another reason for companies to delay product launches. Apart from pricing, the pharma industry has been facing hiccups in foreign investment, new drug approvals, as well as clinical trials.Government and regulators, however, brush aside such concerns. According to a senior official in the National Pharmaceutical Pricing Authority (NPPA), the price regulations are as per the policy and MRPs are fixed based on average price of medicines in that segment. “There is no reason for a particular company to find it unviable when others are making the same drug at a lower price,” the official said, adding that market surveys show a huge disparity in prices of similar medicines sold under different brands.The number of drug approvals peaked in 2008, when as many as 270 new drugs were granted approval, followed by 217 in 2009, 224 in 2010, and 140 in 2011, the data shows.However, since 2012, when the government released the National Pharmaceutical Pricing Policy bringing in 348 medicine formulations under price control, the new drug launches started reducing drastically.“The role of NPPA is to implement the policy in letter and spirit and not create confusion leading to instability in the drug industry,” another senior industry official said.Recently, many medicines were also found missing from the market following stringent regulatory measures.Experts say the government needs to find a middle path for balancing regulation with viability. “While making healthcare affordable and accessible is a key responsibility for the government, it cannot do so at the cost of the industry. The government needs other policy measures such as insurance and public private partnerships to strike a balance,” an industry analyst said.