New Licensing and Prescription Rules for High-Alcohol Medicines
The Ministry of Health and Family Welfare has amended the Drugs Rules, 1945, removing the exemption available for medical formulations containing high concentrations of ethyl alcohol. This move tightens regulatory oversight to prevent misuse of these products.
Certain medicinal products, including tinctures of cardamom, ginger, and other aromatic preparations, were previously exempted from licensing under Schedule K. Some of these formulations contain 80–90% v/v ethyl alcohol, making them vulnerable to misuse for intoxication.
Government Response to State Concerns
“References were also received from certain State Governments in this regard. To address this concern, the Government has mandated that all formulations containing more than 12% v/v ethyl alcohol in quantities exceeding 30 mL will no longer qualify for the Schedule K exemption. Consequently, such products will be required to obtain licenses under the Drugs and Cosmetics Act, 1940,” the ministry said.
The amendment also shifts these products under Schedule H1 of the Drugs Rules, 1945, which mandates sale against the prescription of a registered medical practitioner and stricter record-keeping.
Impact on Pharmaceutical Supply Chain
The amendment is expected to strengthen regulatory oversight over medicinal products containing alcohol, ensuring their supply only through the regulated pharmaceutical supply chain. The ministry said the revised norms would help reduce the possibility of diversion and misuse while ensuring that the medicines remain available for legitimate therapeutic use.
