The drug rules will subsequently be amended to provide the extension of time, they said. Once the final notification is published-which is expected this week-the manufacturers will be asked to fill an application with ten drug regulatory authorities detailing the strategy on how they will comply within the prescribed timeline.
As per ET, the health ministry had sought the legal affairs department’s view on its final draft notification on allowing small pharmaceutical companies more time for upgrading their facilities to comply with the revised Schedule M.
Schedule M of the Drugs and Cosmetics Act outlines quality standards for pharmaceutical products. The revised Scheduled 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 has been sent to the legal affairs department for vetting,” 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.
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