Centre amends drugs rules to strengthen regulation of high alcohol-containing drug formulations
New Delhi, July 10 -- In a significant step towards strengthening regulatory oversight and preventing misuse of medicinal products with high alcohol content, the Ministry of Health and Family Welfare has removed the existing exemption (under Schedule K) from licensing requirements for formulations containing ethyl alcohol.
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% v/v, making them susceptible to misuse for intoxication. References were also received from certain State Governments in this re...
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