Centre amends rules to strengthen regulation of high alcohol-containing drug formulations

• The Ministry of Health and Family Welfare has withdrawn the licensing exemption for medicinal formulations containing more than 12 per cent of ethyl alcohol and brought them under stricter regulatory oversight, including mandatory licensing and prescription-only sale, to curb misuse and prevent diversion for intoxication.

• 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.

• Some of these formulations contain high concentrations of ethyl alcohol, in certain cases up to 80-90 per cent volume per volume (v/v), making them susceptible to misuse for intoxication.

• To address this concern, the government has mandated that all formulations containing more than 12 per cent v/v ethyl alcohol, in quantities exceeding 30 ml, shall no longer be covered under the exemption provided under Schedule K.

• Such products will be required to obtain the requisite licences under the Drugs and Cosmetics Act, 1940.

• 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.

• The amendment is expected to strengthen regulatory oversight over those medicinal products containing alcohol, ensuring their supply only through the regulated pharmaceutical supply chain.

• It will significantly reduce the possibility of diversion and misuse while ensuring their continued availability for legitimate therapeutic use.