Manufacturing compliance deadline to be extended for small drug firms

The Centre plans to extend the deadline for complying with good manufacturing practice (GMP), on par with the World Health Organization (WHO) standards for small pharmaceutical companies with a revenue of ₹250 crore or less by one year till 31 December 2025.

- Priyanka Sharma

The regulation will come into force from 1 January 2026. The earlier deadline expired on 1 January 2025.

This comes against the backdrop of several representations submitted to the government by various associations requesting extension of the timeline to enable micro, small, and medium pharma companies to comply with the provisions of the revised Schedule M.

Good Manufacturing Practices (GMP) are being implemented in the country to bring quality into products by way of control on materials, methods, machines, processes, personnel, and facility or environment.