Daijiworld Media Network - New Delhi
New Delhi, Jul 10: The Central government on Friday introduced tighter regulations for medicinal formulations containing high concentrations of ethyl alcohol, making their manufacture and sale subject to licensing requirements and restricting their purchase to prescription-only access in an effort to curb misuse.
The Ministry of Health and Family Welfare said several medicinal products, including tinctures made from cardamom, ginger and other aromatic ingredients, had earlier been exempt from licensing under Schedule K of the Drugs Rules. However, many of these formulations contain ethyl alcohol levels of up to 80–90 per cent by volume, making them susceptible to misuse as intoxicants.
The ministry noted that several state governments had raised concerns over the growing misuse of such alcohol-rich medicinal products, prompting the Centre to review the existing regulatory framework.
Under the revised rules, medicinal formulations containing more than 12 per cent v/v ethyl alcohol and sold in pack sizes exceeding 30 millilitres will no longer qualify for exemption under Schedule K. Manufacturers, distributors and retailers dealing with these products will now have to obtain licences in accordance with the provisions of the Drugs and Cosmetics Act, 1940.
The government has also brought these formulations under Schedule H1 of the Drugs Rules, 1945, placing them under enhanced regulatory supervision. Medicines listed under Schedule H1 can be dispensed only on the prescription of a registered medical practitioner and require pharmacists to maintain detailed sales records.
According to the ministry, the revised regulations are intended to ensure that such products are distributed exclusively through authorised pharmaceutical channels, thereby reducing the possibility of diversion for non-medicinal use while preserving access for patients who require them for legitimate treatment.
The ministry said the changes form part of the government's ongoing efforts to strengthen India's drug regulatory system, encourage the responsible use of medicines and enhance safeguards for public health.
The amendments have been formally notified through a Gazette notification issued by the Ministry of Health and Family Welfare.