India Pharma Outlook Team | Friday, 09 May 2025
According to Health Ministry officials, there are about 10,000 medium and small manufacturing businesses and only 100 of them submitted applications. Only the minimum number of pharmaceutical companies submitted plans for the upgrade of facilities and the implementation of the Schedule M revised deadline ends on Monday.
Schedule M, quality, stands for pharmaceutical products under the Drugs and Cosmetics Act. The ministry published a notification regarding the extent of the deadline for implementing revised Schedule M, by the month of February. This helps manufacturers with less than Rs. 250 crore revenue are required to submit applications to the Central License Approving Authority within three months, along with their upgrade plans.
Over the quality of following allegations of made-in-India drugs by multiple countries, in 2023, the central government with the World Health Organization (WHO) updated the Good Manufacturing Practices (GMP) under Schedule M, 1945 of the Drug rules.
Punya Salila Srivastava, the Health Secretary, has written to state health secretaries, to issue essential directions to state drug regulators to discuss the matter with drugmakers in their own places.
As per the available data, only a very small number of firms have submitted their application requesting to extend the timeline for implementation of the revised Schedule M, stated by the health secretary in her letters. She mentioned, by taking the necessary together, it can ensure the safety, quality and efficacy of drugs. To this effect, compliance with the necessary provisions of the revised Good Manufacturing Practices under Schedule-M is critical.