The National Pharmaceutical Pricing Authority vide its notification dated 1st June 2020 has invited comments and suggestions from the stakeholders on Draft guidelines for dealing cases of discontinuation of scheduled formulations under para 21(2) of Drugs (Prices Control) Order ((DPCO), 2013, to be submitted before 15th June 2020.
In the draft guidelines, paragraph 21(2) provides that any manufacturer of scheduled formulation, intending to discontinue any scheduled formulation from the market shall:
- Issue a public notice;
- Intimate the government in Form-IV of this order in this regard at least six months prior to the intended date of discontinuation;
- The government may, in the 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.
As per the guidelines, permission for discontinuation may be granted by the NPPA wherever the number of market players is 10 or more and the market share of the applicant company is less than 1%. 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 10 or more and the market share of the applicant company is 1%-3%.
Click here to read the Notification.
