Good Manufacturing Practices (GMP) - A Boost for Indian Healthcare
Author: Healthcare Practice Team
DCGI to push GMP compliance; revised Schedule M aligns India with global standards — large firms must comply immediately, smaller firms have extension until Dec 31, 2025.
The Drug Controller General of India (“DCGI”) is set to instruct state and Union Territory authorities to identify and take action against drug manufacturers who have failed to adopt Good Manufacturing Practices (“GMP”). This step targets pharmaceutical companies and firms that have not even applied for GMP compliance assessments. GMP ensures consistent product quality and safety, protecting both patients and the integrity of drug manufacturing, guarding against substandard and counterfeit drugs. The revised Schedule M of GMP rules aims to bring Indian pharmaceutical standards in line with global benchmarks, improving the country’s reputation as a reliable drug supplier. As per the revisions, companies with revenue above ₹250 crore are required to implement GMP without delay. Smaller firms have been granted an extension until December 31, 2025, to upgrade their facilities and comply.
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