NPPA Releases Draft Guidelines For Discontinuation Of Scheduled Formulations

Mumbai, 3 June 2020:

The National Pharmaceutical Pricing Authority (NPPA) has released draft guidelines for dealing with cases of discontinuation of scheduled formulations under paragraph 21(2) of Drugs Prices Control Order (DPCO)- 2013 for stakeholders suggestions and comments. The national drug pricing regulator has directed stakeholders or drug manufacturers to send suggestions or comments on draft guidelines by June 15, 2020 to the NPPA office or email at monitoring-nppa@gov.in.

Paragraph 21(2) of the DPCO-2013 provides that any manufacturer of scheduled formulation, intending to discontinue any scheduled formulation from the market shall issue a public notice and also intimate the government in Form-IV of this order in this regard at least six months prior to the intended date of discontinuation.

As per the draft guidelines, the government may in public interest direct the manufacturer of the scheduled formulation to continue with the required level of production or import for a period not exceeding one year from the intended date of such discontinuation within a period of 60 days of receipt of such intimation.

Paragraph 21 of the DPCO 2013 provides for monitoring the availability of scheduled formulations. In this regard, manufacturers of scheduled formulations and the APIs contained in the scheduled formulations are required to furnish the information in respect of production and sales data of such drugs in Form-III of Schedule II as stipulated in paragraph 21(1) of DPCO 2013 on quarterly basis. The provisions of these guidelines are applicable to scheduled formulations only. All Form-IV intimations for discontinuation of medical devices which are part of National List of Essential Medicines (NLEM) and Schedule I of DPCO 2013 shall be put up before NPPA on a case to case basis.

National Pharmaceutical Pricing Authority was constituted through a Government of India resolution dated August 29, 1997 as an attached office of the Department of Pharmaceuticals (DoP) under the Union ministry of chemicals and fertilizers as an independent regulator for pricing of drugs and to ensure availability of medicines at affordable prices. Pharmabiz