January 6, 2023

Government of India vide gazette notification no. GSR 922 (E) dated 28.12.2023 has notified new set of rules and regulations for implementation of Good Manufacturing Practices for manufacturing of pharmaceutical products. The new rules are covered under Schedule M which is a part of Drug and Cosmetics Act. New rules are named as Good Manufacturing Practices and Requirements of Premises, Plant and Equipment for Pharmaceutical Products.

Schedule M prescribes requirements to the manufacturing plants of pharma companies for maintenance, manufacturing, control and safety testing, storage and transport material, written procedures and records, and traceability etc. The revised GMP guidelines have come at a relevant time when India is reinforcing itself as the global pharma manufacturing hub.

A draft notification was issued in 2018 to upgrade and synchronize old Schedule M (published in the year 2005) comparable to international standards. Now, considering the importance of upgraded and revised GMP in ensuring quality of drugs, the Government has notified the draft rules.

Larger companies with a turnover of over Rs 250 crores have been asked to implement the changes within six-months, while medium and small-scale enterprises with turnover of less than Rs 250 crores have been asked to do so within one-year. The time that is provided to the industry is for their smooth transition from the present Schedule M to revised Schedule M. The new version of Schedule-M is designed to ensure compliance to standards of drugs, promote exports, promote innovation and also to build trust and confidence on quality of drugs manufactured and sold.

To create awareness amongst drug manufacturers about good manufacturing practices (GMP) requirements to ensure quality of medicines, workshops on Revision of Schedule-M were organized across India in September 2023 by CDSCO in partnership with IDMA.

Click Schedule M Revised for downloading revised Schedule M specifying New GMP requirements in India