The National Pharmaceutical Pricing Authority (NPPA) has issued draft Guidelines for disposal of Form IV application under para 21(2) of DPCO, 2013 for discontinuation of scheduled formulations from the market by the pharmaceutical companies. Paragraph 21 of the DPCO, 2013 provides for monitoring the availability of scheduled formulations in the market.

As per the guidelines, manufacturers of the scheduled formulations and the active pharmaceutical ingredients contained in the scheduled formulation are required to furnish the information in respect of production and sale of such drugs in Form-III as stipulated in para 21(1) of the order quarterly.

Para 21(2) of the DPCO 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 month prior to the intended date of discontinuation and 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 a 60 days of receipt of such intimation, the guidelines say.

As per the guidelines, permission for discontinuation may be granted by the NPPA wherever number of market players are ten or more and the market share of the applicant company is below one percent. Permission may also be granted by the NPPA for gradual discontinuation and the applicant company may be advised within a period of 60 days from the receipt of Form-IV to continue to manufacture/import and sale the drug during the next six months, wherever number of market players are ten or more and the market share of the applicant company is one per cent to three per cent.

The guidelines further say that permission may be granted by the NPPA for gradual discontinuation and the applicant company may be advised within a period of 60 days from the receipt of Form-IV to continue manufacture/import and sale the drug during the next 12 months, wherever the number of market players are more than five and less than 10 and the market share of the applicant company is above three per cent but less than five per cent. The company intending to discontinue the scheduled formulation from the market shall also issue a public notice.

Permission for discontinuation may be granted by the NPPA only after approval of the Authority where number of market players are less than five and the applicant company holds five percent or more of market share. In this regard, an agenda note should be put up of consideration of the Authority within one month of the receipt of Form-IV application.

The NPPA has invited comments from stakeholders and industry associations within a period of three weeks on the draft Guidelines.