The Centre has implemented stricter regulations on medicinal formulations with high levels of ethyl alcohol, requiring licensing and prescription-only sale. Previously exempt under Schedule K, products like tinctures of cardamom and ginger, containing up to 80–90% v/v ethyl alcohol, are now under scrutiny due to misuse concerns. To combat this issue, formulations with over 12% v/v ethyl alcohol and packaged in quantities exceeding 30 mL must now obtain licenses under the Drugs and Cosmetics Act, 1940.
These formulations are now categorized under Schedule H1 of the Drugs Rules, 1945, subjecting them to more stringent regulatory control. Sales of products under Schedule H1 require a registered medical practitioner’s prescription and entail enhanced record-keeping. The revised framework aims to ensure alcohol-containing medicinal products are distributed solely through regulated channels, reducing the risk of diversion and misuse while maintaining access for legitimate therapeutic needs.
This amendment aligns with the government’s broader agenda to fortify the drug regulatory framework, encourage responsible medication use, and safeguard public health. The Ministry of Health and Family Welfare has issued a Gazette notification detailing the amendments.
