Indian Government’s Health Ministry Extends Schedule M Deadline for MSME Pharmaceutical Units

The Union Ministry of Health and Family Welfare recently revised the date of the implementation of the revised Schedule M of the Drugs and Cosmetics Act allowing pharma MSMEs an additional 12 months to comply, extending the date to December 31, 2025. To avail of this extension, pharma companies with a turnover of less than 250 crores must file an application with the Central Licensing Authority with details of their upgradation plan.

The notification by the ministry reads, “Provided that the small and medium manufacturers with turnover of or less than two hundred and fifty crores may seek extension of the timeline for implementation and for that purpose shall make an application to the Central Licence Approving Authority in Form ‘A’ annexed to this notification within a period of three months from the date of publication of this notification along with the plan of upgradation. For such manufacturers, the timeline of implementation shall be extended till 31st December, 2025.”

The Ministry stated that the reason for allowing this extension is to enable pharma MSMEs to arrange the finances for upgradation and time for implementation of the required changes. It also informed that it is as per request by several associations that represent the pharma MSMEs.

According to the ministry, there are around 10,500 manufacturing units in the country, of which around 8,500 are under the MSME category. India is a major exporter of medicines to low and middle-income countries (LMICs), which require WHO GMP certification. Currently, around 2,000 units in the MSME category hold WHO GMP certification.

The pharmaceutical manufacturing and quality domains have developed significantly over the last 15-20 years. “Our understanding of the domain has increased because of developments in pharmaceutical and manufacturing sciences. The linkage between manufacturing and product quality and the interdependence between the two have been established,” the statement said.

“This would bring our GMP recommendations and compliance expectations in line with global standards, especially those of the WHO, ensuring the production of globally acceptable quality drugs,” the statement added.