The Central Government has published draft rules to amend the Drugs Rules, 1945 under the Drugs and Cosmetics Act, 1940. These rules, proposed after consultation with the Drugs Technical Advisory Board, will be considered 30 days after publication in the Gazette of India. Suggestions or objections can be sent to the Ministry of Health and Family Welfare. The draft amendment adds “Pregabalin” to Schedule H1. Final rules will come into force three months after their publication in the Official Gazette.
The Central Government has issued draft rules to amend the Drugs Rules, 1945 under the Drugs and Cosmetics Act, 1940. These draft rules have been prepared after consultation with the Drugs Technical Advisory Board and are published in the Gazette of India for public information.
Any person likely to be affected can send objections or suggestions within thirty days of publication. Such feedback will be considered by the Government before finalizing the rules. Comments may be addressed to the Under Secretary (Drugs), Ministry of Health and Family Welfare, at Kartavya Bhawan, New Delhi, or sent by email.
The draft rules are titled the Drugs (Amendment) Rules, 2025. Once finalized, they will come into force three months after publication in the Official Gazette.
A key change proposed is the addition of “Pregabalin” to Schedule H1 of the Drugs Rules, 1945.
Schedule H1 lists drugs that require stricter regulation, prescription control, and monitoring due to their potential risks.
By including Pregabalin, the Government aims to strengthen oversight and ensure safer use of medicines. This amendment reflects the growing emphasis on stricter compliance in drug regulation.