NEW DELHI
The central government tightened regulations on medicinal formulations containing high levels of ethyl alcohol. These products will now require proper manufacturing licenses and can only be sold with a medical prescription. The move aims to prevent widespread misuse while ensuring genuine patients retain access for therapeutic purposes.
Previously, several medicinal preparations, including tinctures of cardamom, ginger, and other aromatic liquids, were completely exempt from licensing requirements under Schedule K. However, authorities discovered that some of these products contained ethyl alcohol concentrations as high as 80 to 90 percent. This high alcohol content made them highly vulnerable to being used as cheap intoxicants, sparking serious safety concerns from various state governments.
To curb this loophole, the Ministry of Health and Family Welfare mandated that all medicinal formulations containing over 12 percent alcohol and packaged in quantities exceeding 30 milliliters will lose their exemption status. Consequently, all manufacturers and sellers must secure necessary licenses under the Drugs and Cosmetics Act of 1940.
Furthermore, these formulations have been moved to Schedule H1. This critical shift means pharmacies can sell them only against a registered doctor’s prescription. Shopkeepers must also maintain strict sales records.
Officials stated this revised framework will greatly strengthen oversight of alcohol-heavy medicines by keeping them strictly within regulated pharmaceutical distribution chains. Published via an official Gazette notification, this timely amendment is part of a broader national effort to promote responsible drug use and protect public health.
