Centre amends drugs rules to strengthen regulation of high alcohol-containing drug formulations

Certain medicinal products, including tinctures of cardamom, ginger and other aromatic preparations, have been exempted from licensing requirements under Schedule K of the Drugs Rules, 1945.

In a significant step towards strengthening regulatory oversight and preventing misuse of medicinal products with high alcohol content, the Ministry of Health and Family Welfare has removed the existing exemption (under Schedule K) from licensing requirements for formulations containing ethyl alcohol. Certain medicinal products, including tinctures of cardamom, ginger and other aromatic preparations, have been exempted from licensing requirements under Schedule K of the Drugs Rules, 1945. Some of these formulations contain high concentrations of ethyl alcohol, in certain cases up to 80-90% v/v, making them susceptible 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% v/v ethyl alcohol, in quantities exceeding 30 mL, shall no longer be covered under the exemption provided to them under Schedule K. Consequently, such products will be required to obtain the requisite licenses under the Drugs and Cosmetics Act, 1940. The amendment also shifts these products to 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. It will significantly reduce the possibility of diversion and misuse while ensuring their continued availability for legitimate therapeutic use. The initiative is in line with the Government's continued efforts to strengthen the regulatory framework for drugs, promote the rational and responsible use of medicinal products and safeguard public health.

Earlier, on June 26, in a significant step towards promoting research and innovation and enhancing ease of doing business in the pharmaceutical sector, the Union Ministry of Health and Family Welfare proposed amendments to the Drugs Rules, 1945, to simplify the procedure for obtaining permission for import of drugs for examination, test or analysis. This is commonly known as Form 11. (ANI)