In a significant move to strengthen the regulation of certain medicinal products, the Ministry of Health and Family Welfare has notified the Drugs (Tenth Amendment) Rules, 2026, bringing specific high-alcohol oral formulations under the stricter provisions of Schedule H1 of the Drugs Rules, 1945.
The notification, issued as G.S.R. 607(E) on 8 July 2026, introduces tighter controls on the sale of oral medicines containing more than 12% alcohol (v/v) when packed and sold in containers larger than 30 mL. The amendment was finalized after the draft notification published in October 2025 received no objections or suggestions from stakeholders during the public consultation period.
Under the amended rules, these formulations will no longer enjoy the exemption available under Schedule K and have been specifically added as Entry No. 52 in Schedule H1. Schedule H1 medicines are prescription-only drugs that require pharmacists to maintain detailed records of their sale, helping authorities monitor their distribution and reduce the risk of misuse.
The government has stated that the amendment was made after consultation with the Drugs Technical Advisory Board (DTAB) under the provisions of the Drugs and Cosmetics Act, 1940.
The notification also provides a six-month transition period, meaning the new requirements will become effective six months after publication in the Official Gazette. During this period, pharmaceutical manufacturers, distributors, healthcare providers, and pharmacies are expected to align their labeling, distribution, and dispensing practices with the revised regulations.
The amendment is expected to enhance regulatory oversight of alcohol-containing medicinal formulations while promoting responsible prescribing and dispensing practices across the country.
