To download the draft guidelines, click here
It has also invited comments and suggestions from stakeholders on the draft guidelines before June 15, 2020. The suggestions can be sent to NPPA’s office in New Delhi or emailed at [email protected]
As per the draft guidelines, any manufacturer intending discontinuation of any scheduled formulation from the market needs to issue a public notice in at least two national newspapers (one in English and one in Hindi). It also needs to intimate the government through form-IV informing at least six months prior to the intended date of discontinuation.
The government may, in the public interest, direct the manufacturers of the scheduled formulations 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 sixty days of receipt of such intimation.
Also read: FDA refers 202 cases of DPCO to NPPA
Moreover, to ensure that there is no shortage of the formulation during this period, based on the company’s moving annual turnover (MAT) in the unit, wherever it is less than 10 per cent to 12 per cent, manufacturers will be directed to continue production/import and sale of the formulation for the period of six and nine months respectively.
The draft has also defined the timelines for wherever MAT in units formulations are in the market for less than 25 per cent, more than 25 per cent and more than 40 per cent. As per the draft guidelines, the date of discontinuation will be considered from the date of issued public notice.
The notification stated, “With a view to achieve adequate availability of medicines in the market and to regulate the distribution of drugs, in case of emergency or in circumstances of urgency or in case of non-commercial use in the public interest, the government may direct any manufacturers of any active pharma ingredients (APIs), bulk or formulation to increase the production and to sell such API, bulk drug or formation to such other manufacturer(s) of formulations and to direct to formulators to sell the formulations to institutions, hospitals or any other agency as the case may be.”
Commenting on this move, Viranchi Shah, National Vice President, IDMA-GSB said, “We have received draft guidelines and will be brainstorming with our member companies and based on the discussion we will revert to NPPA within a stipulated time frame.”
An industry observer said, “Due to the nationwide lockdown, the industry faced several challenges at all fronts which had led to the assumption that there is a shortage of medicines in the market. To ensure availability of medicines in the market, in-detail discussions amongst industry, policy and decision-makers is necessary. The authorities should finalise policy post these discussions and after understanding the issue completely.”