NEW DELHI, July 10 -- The Centre has withdrawn the licensing exemption for medicinal formulations containing more than 12 per cent of ethyl alcohol and brought them under stricter regulatory oversight,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, officials said. 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, the ministry said.
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, it said.
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