Centre Extends GMP Compliance Deadline for Small Pharma Firms

The Centre intends to extend the deadline for complying with good manufacturing practice (GMP), aligned with World Health Organization (WHO) standards, for small pharmaceutical firms earning ?250 crore or below by one year to 31 December 2025.

The regulation will be effective starting 1 January 2026. The previous deadline lapsed on 1 January 2025. This occurs against the backdrop of numerous representations made to the government by different associations asking for a timeline extension to help micro, small, and medium pharma companies adhere to the requirements of the updated Schedule M.

Good Manufacturing Practices (GMP) are being enforced in the nation to enhance product quality through regulation of materials, methods, machinery, processes, staff, and the surrounding environment.

The government announced that the new Schedule M was released in December 2023. To ensure a seamless transition from the current Schedule M to the updated Schedule M, a transition period of 6 months for large manufacturers (with revenue exceeding Rs.250 crore) and 12 months for MSMEs (with revenue below Rs.250 crore) was determined.

India is a significant supplier of pharmaceuticals to developing nations, necessitating WHO GMP certification. Currently, there are approximately 2,000 units in the MSME category in the nation that have WHO GMP certification. India has approximately 10,500 drug manufacturing units, with about 8,500 classified as MSMEs.