The government has tightened rules to prevent misuse of medicines containing high alcohol. Now a license will be required for medicines containing more than 12% alcohol and they will be available only on doctor’s prescription, so that they cannot be misused.
New Delhi [भारत]July 10 (ANI): In an important step towards strengthening regulatory oversight and preventing misuse of medicinal products containing 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.
Why was this decision taken?
Under Schedule K of the Drugs Rules, 1945, certain medicinal products, including tinctures of cardamom, ginger and other aromatic preparations, were exempted from licensing requirements. Some of these formulations contain high concentrations of ethyl alcohol, in some cases up to 80–90% v/v, increasing their potential for abuse for intoxication. References were also received from some state governments in this regard.
Included in Schedule H1, doctor’s prescription required
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 fall within the scope of the exemption provided to them under Schedule K. As a result, such products will need to obtain the requisite license under the Drugs and Cosmetics Act, 1940. The amendment also moves these products to Schedule H1 of the Drugs Rules, 1945, which mandates sale on the prescription of a registered medical practitioner and strict record-keeping.
This amendment is expected to strengthen the regulatory oversight on medicinal products containing alcohol, thereby ensuring their supply only through the regulated pharmaceutical supply chain. This will significantly reduce the potential for diversion and abuse, while ensuring their continued availability for legitimate therapeutic use. This initiative is in line with the Government’s continued efforts to strengthen the regulatory framework for medicines, promote rational and responsible use of medicinal products and protect public health.
Another proposal related to import of medicines
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 had proposed amendments to the Drugs Rules, 1945, to simplify the process of obtaining permission to import drugs for investigation, testing or analysis. It is commonly known as Form 11. (ANI)
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