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NPPA has approved norms for discontinuation of scheduled drugs

The drug pricing regulator NPPA, for the purpose of ensuring availability of essential drugs in the market, has been putting in place a framework for alternative arrangements in case of discontinuation of scheduled formulations by private pharma firms, among other measures.

The National Pharmaceutical Pricing Authority (NPPA) has said in a guidelines regarding discontinuation of scheduled formulations under DPCO, 2013 that in case where the manufacturer has over 50 percent of the market share, the regulator will take up the issue with Department of Pharmaceuticals (DoP) to request public sector drug firms to produce the drug.

It further said that “In exceptional circumstances where manufacturer under consideration has more than 50 percent of the share and other, the cases will be examined on case to case basis and decided on merits, subject to approval of the authority.”

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