Regulator Approves Norms For Discontinuation Of Scheduled Drugs

New Delhi: To ensure availability of essential drugs in the market, the National Pharmaceutical Pricing Authority (NPPA) is putting in place a framework for alternative arrangements in case of discontinuation of scheduled formulations by private pharmaceutical 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, drug pricing regulator 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.

The regulator may also consider an upwards price revision if the drug is being discontinued because of non remunerative pricing, it 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 will follow the ceiling price fixed by NPPA and should also issue a notice in at least 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 to continue to manufacture/import and to sell the drug for a period of 12 months from the intended date of discontinuation, wherever Moving Annual Turnover (MAT, in units) of the company is more than 25 per cent, if no other issues are involved, the regulator said.

No objection for gradual discontinuation will be granted and the company will be advised within 60 days from the receipt of Form-IV to continue to manufacture/import and sell the drug for a period of minimum nine months from the intended date of discontinuation, wherever MAT of the applicant company is more then 10 per cent but less than 25 per cent, it added.

Here again the company should not reduce the level of production by more than 40 per cent after getting permission from NPPA. During this period, the company shall follow the ceiling price fixed by NPPA and will also issue a notice in at least two national papers one in English and one in Hindi, the guidelines said.

No objection will be granted by the regulator without referring the cases to the Authority for gradual discontinuation. The applicant company will be advised within a period of 60 days from the receipt of the Form-IV to discontinue to manufacture or import and sell the drug for a period of minimum six months from the intended date of discontinuation, wherever MAT of the the applicant company is up to 10 per cent, NPPA said.

The company will not reduce the level of production by more than 40 per cent of the production (of last year's production in each quarter) after getting permission from NPPA.