Now, new guidelines to prohibit drug-makers from sudden discontinuation of essential medicines

NEW DELHI: In a move to ensure availability of essential medicines, including life-saving drugs, the drug pricing authority has come up with new guidelines prohibiting drug-makers from sudden discontinuation of such medicines to circumvent price control regulations.

The National Pharmaceutical Pricing Authority has drawn a detailed set of norms categorising commonly used medicines based on their sales. It is aimed at ensuring that even if a manufacturer of any essential medicine wants to discontinue production, the drug remains in supply till consumers find an alternative.

For instance, the guidelines say if a drug has a market share of more than 10% and less than 20% and its manufacturer wants to stop selling it in India, the regulator will allow gradual discontinuation but the company will have to continue selling the medicine for at least nine months and not reduce production by more than 40%.

For more commonly used medicines, NPPA has asked companies to continue selling such drugs for at least a year. In case of medicines with more than 50% of market share, the regulator will examine on a case-to-case basis and decide on merit.

“NPPA will also explore the possibility of alternative arrangements to supplement the production gap likely to be caused by such withdrawal by referring the matter to DoP (Department of Pharmaceuticals) to request the government PSUs to produce such drugs,” the guidelines said.

The regulator has also asked companies to follow the price cap imposed on essential medicines till the time they are allowed a complete discontinuation and an alternative is available in the market.

The guidelines follow reports on discontinuation of many essential drugs after the government’s stringent measures to keep prices low. While the pharmaceutical pricing policy does not allow companies to discontinue production of medicines without a six-month prior notice, companies often inform the government and then increase prices. The regulator said that in such cases companies will be fined for overcharging consumers.

However, the guidelines also have a provision to allow companies a price hike after detailed investigation if that is the reason for discontinuation.