The National Pharmaceutical Pricing Authority (NPPA) has issued the final guidelines for discontinuation of manufacturing medicines, which are under price control regime. The issued guidelines are also applicable to scheduled medical devices which have been notified as a drug.
The NPPA website will be updated, based on the application filed by pharma companies and approved by the competent authority for discontinuation of scheduled formulations from the market on a monthly basis.
According to the final guidelines, any manufacturer who is intending to discontinue any scheduled formulation from the market, needs to issue a public notice in the newspaper, which varies based on the company’s moving annual turnover (MAT) value. If the MAT of the company is one per cent or less than one per cent then it has to be one newspaper, whereas, in the case of more than one per cent, the public notice has to be put in at least two national newspapers, one in English and one in Hindi. Besides this, the manufacturer also needs to intimate the government through form-IV at least six months prior to the intended date of discontinuation.
The final guidelines also inform that wherever the MAT of the company is more than one per cent or less than one per cent of total MAT value, it has to inform at least six months prior to the proposed/intended date of discontinuation and in such cases, it will be noted that without issuing any direction to the company, the case will be deemed approved. Whereas, in the case of more than one per cent of the total MAT value, the company will be directed with the approval of Chairman NPPA within a period of 60 days from the receipt of Form IV, intimating the request has been noted.
Besides this, the company will be directed to continue production/import and sale of the formulation for a period of up to 12 months from the date of issue of public notice.
In the final guidelines, the authority has mentioned that to ensure that there is no shortage of the formulation in the market, the government may direct the manufacturer of the scheduled formation to continue with the required level of production or import for a period not exceeding one year, from the intended date of discontinuation within a period of 60 days of receipt of such intimation.
It has directed that after getting the permission of discontinuation from the NPPA, the intending company should not reduce the level of production by more than 25 per cent of last year in each quarter.
It has also mentioned that wherever concerns regarding shortage are apprehended or a formulation is found to be critical for public health; based on the circumstances and also in cases where it is established that the company is intending to discontinue production/import and sale of a scheduled formulation and has already launched or intends to launch ‘a’ new drug to evade a price control; cases requiring continuance of production/ import and sale beyond 12 months or any other case related to this will be referred to the standing committee after the approval of NPPA’s Chairman.
Stakeholder reactions
The NPPA had received several applications from pharma companies to discontinue their brands from the market.
Following this, in June, the NPPA issued draft guidelines for discontinuation of scheduled formulations and invited the industry’s comments on it. Based on industry stakeholders’ comments and suggestions, NPPA has released the final guidelines.
The industry has appreciated the authority for considering and incorporating their suggestions while drafting the final guidelines.
Vivek Padgaonkar, Independent Healthcare Consultant, Ex-Director OPPI, Ex GSK commented, “The NPPA has always been uniform, consistent and transparent in its approach to make the essential medicines available to needy patients. The revised guidelines for discontinuation of scheduled formulations under Para 21(2) is a very good approach by NPPA.”
While giving the background to this development, he informed, “In fact, in the last few years, many companies have approached the NPPA for the same reason and a few companies, with the fear of losing brand identity, continue to sell those brands though not financially viab...
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