Centre tightens rules for medicinal products containing high levels of Ethyl Alcohol: Here's what changes
India, July 10 -- The Ministry of Health and Family Welfare has withdrawn the existing exemption under Schedule K of the Drugs Rules, 1945, from licensing requirements for medicinal formulations containing ethyl alcohol, tightening regulatory oversight to curb their misuse.
Under the earlier provisions of Schedule K, certain medicinal preparations-including tinctures of cardamom, ginger and other aromatic formulations-were exempt from licensing requirements.
"Some of these formulations contain high concentrations of ethyl alcohol, in certain cases up to 80-90% v/v, making them susceptible to misuse for intoxication. References were also received from certain State Governments in this regard," the ministry said in a statement.
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