Extension for MSMEs to Comply with Revised Schedule M

The health ministry is considering extending the compliance deadline for small pharmaceutical companies to upgrade their facilities in accordance with the revised Schedule M of the Drugs and Cosmetics Act, which outlines quality standards for pharmaceutical products.

Current Status and Proposed Extension

• The ministry has sought advice from the legal affairs department on a draft notification regarding this extension.
• The revised Schedule M standards were notified in January last year.
• Current compliance deadlines are: 
  • For companies with an annual turnover over ₹250 crore: July 1, 2023.
  • For micro, small, and medium enterprises (MSMEs) with turnover less than ₹250 crore: January 1 this year.

MSMEs have requested more time to implement necessary changes in manufacturing processes. The government is considering a 12-month extension, following feedback from public comments invited by January 11.

Industry Request and Government Actions

• Pharmaceutical lobby groups are advocating for a two-year extension to adequately improve infrastructure, increase manpower, and provide training.
• The Federation of Pharmaceutical Entrepreneurs (FOPE) has urged the drug controller for an immediate extension.
• The drug regulatory authority has instructed companies to apply online for deadline extensions.

Reports suggest that almost half of the estimated 10,000 drug manufacturing units may fail to meet the current deadline, risking potential closures.