India: Deadline Extension for Implementation of Schedule M
At the end of December 2023, the Indian Ministry of Health revised the provisions of Schedule M of the Drugs and Cosmetics Act. Schedule M describes good manufacturing practices (GMP) for pharmaceutical products (we reported).
The timing of implementation of the new rules is to be based on the turnover of the companies, with different deadlines for medium/small and large manufacturers (12 and 6 months respectively).
In February 2025, small and medium-sized manufacturers were given a further extension: they have until 11 May 2025 to submit a plan for implementing the new regulations to the licensing authority. The implementation period will then be extended to 31 December 2025.
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