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Guidelines issued prohibiting drug-makers from sudden discontinuation of essential medicines

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

Authority The National Pharmaceutical Pricing has developed a detailed set of categorization rules commonly used drugs based on their sales. It is intended to ensure that even if a manufacturer wants to interrupt any essential drug production, the drug remains in the supply to consumers to find an alternative.

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

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

“NPPA will also explore the possibility of alternative arrangements to complement the output gap may be caused by such withdrawal by referring the matter to the director of photography (Department of Pharmacy) to request the power supplies of the government to produce these drugs” the guidelines said.

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The regulator has also asked companies to follow the price cap imposed on essential drugs to the time allowed a complete disruption and an alternative that is available in the market.

The guidelines follow reports of disruption of many essential drugs after strict government measures to keep prices down. While pricing policy does not allow pharmaceutical companies to discontinue production of medications six months notice, companies often report to the government and then raise prices. The regulator said that in such cases will be fined companies for overcharges.

However, the guidelines also have a provision to allow businesses a rise in prices after a detailed investigation if that is the reason for the suspension.

Courtesy: TOI

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