The Union Health Ministry has also called for comments from the legal affairs department for its final draft notification on delaying the deadline of compliance by small pharmaceutical firms for adopting the revised Schedule M of the Drugs and Cosmetics Act.

Key Highlights:
Extended Timeline for MSMEs:

• MSME manufacturers with turnover less than ₹250 crore can be accorded another 12 months of time to upgrade the facility to standards set by modified Schedule M.

• Large units (turnover of more than ₹250 crore) were mandated to comply by July 1, 2023, whereas the initial date for MSMEs was January 1, 2025.

Feedback and Public Comments:
The pre-legislative notification, released last week, called for public inputs by January 11, which have been collated and submitted to the legal affairs department for final clearance.

Industry Issues:

• MSMEs and drug lobby associations, such as FOPE, have also sought a two-year delay on the grounds of making significant infrastructural, manpower, and training improvements.

• FOPE recently penned a letter to the drug controller, highlighting the urgency of the extension in order to prevent disruptions in operations.

Compliance Issues:
Industry officials believe that as many as 10,000 of India's 10,000 drug manufacturing facilities will not be able to comply with the revised Schedule M requirements, which could lead to their closure.

Applications for Extension Online
The drug regulator instructed pharmaceutical firms to file online requests for an extension of the compliance date.

Statements of Stakeholders:
Health Ministry Spokesperson (anonymous):
The feedback has been collated, and the final draft has been submitted to the legal affairs department for clearance. A decision is imminent.The draft notification's legal screening will decide if MSMEs in the drug industry get an important extension in complying with Schedule M. The ruling has serious repercussions for small producers dealing with infrastructure development in order to sustain quality requirements.