NPPA approves norms for discontinuation of scheduled drugs

To ensure availability of essential drugs in the market, the drug pricing regulator NPPA is putting in place a framework for alternative arrangements in case of discontinuation of scheduled formulations by private pharma firms, among other measures.

In cases where the manufacturer has over 50 per cent 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, National Pharmaceutical Pricing Authority (NPPA) said in guidelines regarding discontinuation of scheduled formulations under DPCO, 2013.“In exceptional circumstances where manufacturer under consideration has more than 50 per cent 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,” it added.

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 to request PSUs to produce such drugs, it added.NPPA may also consider an upwards price revision if the drug is being discontinued because of non remunerative pricing, the regulator said.

The company in any case should not reduce the level of production by more than 40 per cent of last year’s production in each quarter, after getting permission from NPPA, it added.During this period, the company shall follow the ceiling price fixed by NPPA and should also issue a notice in atleast two national papers, one in English and one in Hindi, the guidelines said.

‘No objection’ will be granted by NPPA for gradual discontinuation and the applicant company may be advised within 60 days from the receipt of Form-IV.