Schedule M outlines tighter quality norms for manufacturing.
The drug rules will subsequently be amended to provide the extension of time for another year i.e till December 31’2025, they said.
Once the final notification is published–which is likely today-the micro, small and medium enterprises (MSMEs) will be asked to fill an application with ten drug regulatory authorities detailing the strategy on how they will comply within the prescribed timeline.
The revised Schedule M standards were notified in January last year. While units with annual turnover of more than Rs 250 crore had to comply from July 1, 2023, the implementation date for MSMEs was January 1 this year. However, the MSMEs had sought more time to make the necessary changes in their 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 was sent to the legal affairs department for vetting. It has now been finalised and will be notification will be out soon,” one of the people cited earlier told ET.The country’s 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.
The lobby group FOPE had also 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 the estimated 10,000 drug manufacturing units in the country may not be able to meet the deadline for upgrading their facilities as per the revised Schedule M, making them vulnerable to potential closure.
Industry leaders had earlier met the health minister and sought an extension, citing problems like delay in procurement of machinery and update of infrastructure.
The revised Schedule M requires the industry to comply with the newly notified norms for manufacturing practices and requirements of premises, plants and equipment for pharmaceutical products, with provisions for annual product quality review (PQR), quality risk management (QRM), and pharmaceutical quality system (PQM).
