New Delhi, May 20 (KNN) The Drugs Controller General of India (DCGI) has received hundreds of applications from micro, small and medium enterprise (MSME) pharmaceutical manufacturers detailing their plans to comply with good manufacturing practices (GMPs), according to officials familiar with the matter.

MSME manufacturers rushed to submit applications before the May 11 deadline, as failure to meet compliance criteria could result in significant regulatory actions, including show-cause notices, production-halt orders, suspension, or even licence cancellation.

In 2023, the government amended Schedule M of the Drugs and Cosmetics Act, 1945, to align Indian GMPs with World Health Organisation standards.

The implementation follows a phased approach, with larger pharmaceutical companies (those with annual turnover exceeding Rs 250 crore) required to comply within six months, while smaller firms were granted a one-year timeline.

Although MSME manufacturers have until December 31 to fully implement the GMPs, they were required to submit their upgrade proposals to the Central Licensing Authority by May 11.

The health ministry has not responded to queries regarding this matter.

This regulatory tightening comes in response to quality concerns surrounding Indian-manufactured medicines in international markets.

Recent incidents where domestically produced cough syrups were allegedly linked to child fatalities in Gambia and Uzbekistan in 2022 and 2023 have intensified scrutiny of Indian pharmaceutical manufacturing processes.

The GMP compliance measures are designed to ensure that drugs manufactured in domestic facilities meet rigorous standards for safety, quality, and efficacy.

(KNN Bureau)