Pharma Companies May Get Time Till December To Comply With Schedule M Norms

New Delhi:  The government is likely to give an extension till December this year to the drug manufacturers to implement revised Schedule M, people aware of the matter told ET.

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.

SOURCE : Economic Times

  • Related Posts

    • Pharma
    • February 17, 2025
    • 70 views
    GSK Pharma shares gain 20% following strong Q3FY25 results

    GSK Pharma shares gained by 20 percent on Monday, February 17, as brokerages like ICICI Securities and Motilal Oswal continue to maintain positive rating of the stock. GlaxoSmithKline Pharmaceuticals Ltd…

    • Pharma
    • February 17, 2025
    • 66 views
    Glenmark Pharma shares rise 4% on Q3 results, FY26 guidance

    Shares of Glenmark Pharmaceuticals Ltd rose 4% on February 17 after the firm gave a strong guidance for FY26 and it returned to black in the December quarter. The drugmaker…

    Leave a Reply

    Your email address will not be published. Required fields are marked *

    You Missed

    Wow! What a Change of Heart in Practitioners of Allopathy!

    Wow! What a Change of Heart in Practitioners of Allopathy!

    GSK Pharma shares gain 20% following strong Q3FY25 results

    GSK Pharma shares gain 20% following strong Q3FY25 results

    Glenmark Pharma shares rise 4% on Q3 results, FY26 guidance

    Glenmark Pharma shares rise 4% on Q3 results, FY26 guidance

    US Tariffs on pharma: What are the potential impact on Indian drugmakers

    US Tariffs on pharma: What are the potential impact on Indian drugmakers

    Twin Health bats a1000 before enters Digital Health NY 100

    Twin Health bats a1000 before enters Digital Health NY 100

    US tariff jitters rock pharma stocks; Sun Pharma, Lupin, Dr Reddy’s slump 2-4%

    US tariff jitters rock pharma stocks; Sun Pharma, Lupin, Dr Reddy’s slump 2-4%