New Delhi, July 10: The Central government has tightened regulations for medicinal formulations containing high levels of ethyl alcohol, making them subject to licensing requirements and prescription only sales to prevent misuse while ensuring access for genuine medical needs.
The Ministry of Health and Family Welfare said several medicinal formulations, including tinctures of cardamom, ginger and other aromatic preparations, were earlier exempt from licensing under Schedule K. However, some of these products contain ethyl alcohol in concentrations of up to 80 to 90 percent, raising concerns over misuse for intoxication.
Following concerns raised by several state governments, the Centre has amended the rules. Medicinal formulations containing more than 12 percent v/v ethyl alcohol and sold in packs larger than 30 mL will no longer qualify for exemption under Schedule K.
Manufacturers and sellers of these products must now obtain licences under the Drugs and Cosmetics Act, 1940. In addition, these formulations have been brought under Schedule H1 of the Drugs Rules, 1945.
Under Schedule H1, these medicines can only be sold with a prescription from a registered medical practitioner. Pharmacies must also maintain stricter records of their sale and distribution.
The Health Ministry said the revised rules will strengthen oversight of alcohol containing medicinal products by ensuring they are supplied only through the regulated pharmaceutical distribution system. The move is expected to reduce the risk of diversion and misuse while ensuring continued availability for patients who require these medicines for legitimate therapeutic purposes.
The amendment has been notified through a Gazette notification issued by the Ministry of Health and Family Welfare as part of the government’s efforts to strengthen India’s drug regulatory framework and promote the responsible use of medicines.
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