Schedule M of the Drugs and Cosmetics Act outlines quality standards for pharmaceutical products. A decision is expected soon, they said, adding that manufacturers with annual turnover of less than ₹250 crore-the micro, small and medium enterprises (MSMEs)-could get another 12 months’ time to comply.
Government officials could not be reached for a comment. The revised Scheduled M standards were notified in January last year. While units with annual turnover of over ₹250 crore had to comply from July 1, 2023, the implementation date for MSMEs was January 1 this year. MSMEs had sought more time to make the changes in manufacturing processes.
The ministry then issued a draft notification proposing to extend the deadline for the MSMEs. In this regard, it had invited public comments by January 11.“The feedback was compiled and the final draft has been sent to the legal affairs department for vetting,” one of the people cited earlier told ET. Pharma lobby groups have been seeking a two-year extension to the deadline, saying that much time is needed for improving infrastructure, increasing manpower and training.
On Tuesday, lobby group FOPE had written to the drug controller, calling for an extension of the notification implementation. “Your immediate mediation in the matter shall go a long way,” it said.
The drug regulatory authority has also directed the pharma companies to submit online applications seeking extension of the deadline to comply with the revised Schedule M.
ET had earlier reported, citing industry executives, that nearly half of estimated 10,000 drug manufacturing units may not be able to meet the deadline for upgrading their facilities as per the revised Schedule M, making them vulnerable to potential closure.
