Govt. amends rules to regulate drugs containing alcohol, Pg12

Key Highlights:

• The Union Health Ministry has amended drug rules to tighten regulation on medicinal products with high alcohol content.
• Formulations containing over 12% v/v ethyl alcohol, in quantities exceeding 30 ml, are no longer exempt from licensing requirements.
• These products now require licenses under the Drugs and Cosmetics Act, 1940.
• The amendment shifts these formulations from Schedule K to Schedule H1 of the Drugs Rules, 1945.
• The move aims to prevent misuse for intoxication, as some formulations contain up to 80-90% v/v ethyl alcohol.

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Detailed Insights:

• The regulatory change strengthens oversight over medicinal products that were previously susceptible to misuse due to their high alcohol content.
• Previously, certain products like tinctures of cardamom, ginger, and other aromatic preparations were exempted from licensing under Schedule K.
• Placing these products under Schedule H1 mandates their sale only against a prescription from a registered medical practitioner.
• The amendment also requires stricter record-keeping for the sale of such alcohol-containing medicinal products by pharmacies.
• This initiative ensures that these products are available only through the regulated pharmaceutical supply chain, reducing diversion and misuse.

Key Concepts Involved:

• Drugs and Cosmetics Act, 1940: The primary legislation in India regulating the import, manufacture, distribution, and sale of drugs and cosmetics.
• Drugs Rules, 1945: Rules framed under the Drugs and Cosmetics Act, 1940, providing detailed provisions for its implementation and classification of drugs.
• Schedule K: A schedule under the Drugs Rules, 1945, listing drugs or classes of drugs exempted from certain provisions of the rules to facilitate their availability.
• Schedule H1: A schedule under the Drugs Rules, 1945, introduced in 2013, listing drugs that require a prescription for sale and mandate stricter record-keeping by pharmacists.