Amendment to Drugs Rules, 1945: Stricter Controls for High Alcohol Content Medicines

Exam-focused facts from the 13 July 2026 current affairs briefing.

Key facts

The Ministry of Health and Family Welfare (MoHFW) amended the Drugs Rules, 1945, on July 10, 2026.
Medicinal formulations containing more than 12% v/v ethyl alcohol in quantities exceeding 30 mL now require manufacturing and sale licences.
Such formulations can only be dispensed on the prescription of a Registered Medical Practitioner (RMP).
These products have been moved from Schedule K to Schedule H1 under the Drugs and Cosmetics Act, 1940.
The Schedule H1 classification mandates the maintenance of detailed sales records to monitor distribution and prevent misuse.
The amendment addresses the misuse of formulations such as tinctures of cardamom, ginger, and other aromatic medicinal preparations.