GG News Bureau
New Delhi, 10th July: The Centre has amended the Drugs Rules, 1945, making licensing mandatory for medicinal formulations containing high levels of ethyl alcohol and requiring their sale only on the prescription of a registered medical practitioner.
The Ministry of Health and Family Welfare said formulations containing more than 12 per cent v/v ethyl alcohol in quantities exceeding 30 mL will no longer be covered under the exemption provided under Schedule K of the Drugs Rules.
These products have now been brought under Schedule H1, making them prescription-only medicines and subjecting their sale to stricter record-keeping requirements.
The amendment follows concerns raised by several state governments regarding the misuse of certain medicinal formulations containing high concentrations of ethyl alcohol, with some products containing as much as 80–90 per cent v/v alcohol, making them susceptible to abuse for intoxication.
Earlier, products such as tinctures of cardamom, ginger and other aromatic medicinal preparations enjoyed exemption from licensing requirements under Schedule K.
With the latest amendment, manufacturers and sellers of such formulations will now be required to obtain the necessary licences under the Drugs and Cosmetics Act, 1940, ensuring that these products are supplied only through the regulated pharmaceutical distribution system.
The Health Ministry said the move is aimed at strengthening regulatory oversight, preventing diversion and misuse of alcohol-containing medicinal products, while ensuring their continued availability for legitimate therapeutic purposes.
According to the ministry, the amendment is part of the government’s broader efforts to strengthen India’s drug regulatory framework, promote the rational use of medicines and safeguard public health.
