The government has removed the licensing exemption for medicinal formulations containing more than 12 per cent of ethyl alcohol, a move aimed at tighter regulatory oversight to curb misuse of medical products (with high alcohol content) for intoxication, officials said.
Notified on Wednesday (8 July), the amended drug rules will come into effect six months after their publication in the official gazette and include mandatory licensing and prescription-only sale for drug formulations containing more than 12 per cent ethanol.
The ministry said that certain medicinal products, including tinctures of cardamom, ginger and other aromatic preparations, have been exempted from licensing requirements under Schedule K of the Drugs Rules, 1945.
Ethyl alcohol content in some of these formulations may go up to 80-90 per cent volume per volume (v/v), posing a likely risk of their misuse for intoxication, it said, a concern raised by certain state governments.
To address the issue, the Centre has mandated licensing requirements for all formulations containing more than 12 per cent v/v ethyl alcohol, in quantities exceeding 30 ml, and they shall no longer be covered under the exemption provided under Schedule K.
Such products will be required to obtain the required licences under the Drugs and Cosmetics Act, 1940, the ministry said.
The amendment also shifts these products to Schedule H1 of the Drugs Rules, 1945, which mandates sale against the prescription of a registered medical practitioner and stricter record-keeping.
By ensuring supply only through the regulated pharmaceutical supply chain, the new rule is expected to strengthen regulatory oversight over those medicinal products containing alcohol, reducing the possibility of diversion and misuse while ensuring their continued availability for legitimate therapeutic use, the ministry said.