Health Ministry tightens drug approval norms, introduces debarment for fake data submissions

August 7, 2026 12:27 AM

Health Ministry tightens drug approval norms, introduces debarment for fake data submissions

In a major move to strengthen the integrity and transparency of India's drug regulatory system, the Union Ministry of Health and Family Welfare (MoHFW) has notified stricter provisions under the Drugs Rules, 1945, empowering licensing authorities to debar applicants who submit fake or fabricated data in support of drug-related applications. The amendments, notified through G.S.R. No. 756(E), are aimed at ensuring that regulatory approvals are based on authentic scientific evidence while discour...

Health Ministry brings Pregabalin under stricter schedule H1 rules to curb misuse

May 22, 2026 12:34 PM

Health Ministry brings Pregabalin under stricter schedule H1 rules to curb misuse

The Union Ministry of Health and Family Welfare (MoHFW) has brought the drug Pregabalin under the stricter Schedule H1 category of the Drugs Rules, 1945, in a move aimed at preventing misuse, illegal sale and unauthorised access to the medicine. The MoHFW issued the notification through Gazette Notification G.S.R. 377(E) dated May 13, 2026, which was published in the Gazette of India on May 20. The ministry said that the decision was taken following reports from several states regarding the mi...