MSME Pharma Companies Get Another Yr To Upgrade Facilities

New Delhi: The Health Ministry gave small and medium pharma companies with a turnover of less than Rs250 crore an additional 12 months to implement the revised good manufacturing practices under Schedule M of the Drugs and Cosmetics Act.

They should now comply with improved manufacturing practices by December 31, 2025. The extension comes following requests by manufacturing units to upgrade their facilities, the ministry said in a statement. Good Manufacturing Practices (GMP) are being implemented in the country to build and bring quality into products by way of control on materials, methods, machines, processes, personnel and facility/environment etc, the ministry said.

There are around 10,500 manufacturing units in the country out of which around 8,500 fall under the MSME category. India is a major exporter of medicines to low and middle-income countries (LMIC) that require WHO GMP certification. Currently, there are around 2000 units in the MSME category in the country having WHO GMP certification.

The pharmaceutical manufacturing and quality domain has developed and progressed significantly in the last 15-20 years, the statement said. “Our understanding of the domain has increased because of development in pharmaceutical and manufacturing sciences.

Linkage between manufacturing and product quality and interdependence between the two has been established,” the statement said. To keep pace with the fast-changing pharmaceutical manufacturing and quality domain, the government revised the GMP mentioned in the current Schedule ‘M’ of Drugs and Cosmetics Act.

“This would bring our GMP recommendations and compliance expectation at par with global standards, specially to those of WHO, and ensure production of globally acceptable quality of drug,” the statement said. The new Schedule M was notified in December 2023. In order to have a smooth transition from the present Schedule M to the revised Schedule M, it was decided to provide a transition period of 6 months and 12 months for large manufacturers (more than Rs250 crore turnover) and MSMEs (less than Rs250 crore turnover) respectively and the notification was published on 5th January 2024.

Accordingly, the Central Drugs Standard Control Organization (CDSCO), in collaboration with states and UTs, chalked out an aggressive nationwide plan for stakeholders to make them aware about the new Schedule M including its requirements, importance and technical justification, resource availability etc, the statement said.