High-alcohol medicinal formulations to require licence, prescription
Centre brings all formulations containing over 12 per cent ethyl alcohol and sold in bottles exceeding 30 mL under Schedule HI
The government has tightened regulations to prevent the misuse of medicinal products with high levels of alcohol by withdrawing their exemption from licensing requirements and bringing them under stricter prescription norms.
The Ministry of Health and Family Welfare has amended the Drugs Rules, 1945, removing the exemption available under Schedule K for medical formulations containing high concentrations of ethyl alcohol.
Certain medicinal products, including tinctures of cardamom, ginger and other aromatic preparations, have been exempted from licensing requirements under Schedule K. Some of these formulations contain 80–90 per cent v/v ethyl alcohol, making them vulnerable to misuse for intoxication.
“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 per cent 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.
The amendment is expected to strengthen regulatory oversight over those 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.
