Drugs (Draft Amendment) Rules, 2021

The Ministry of Health and Family Welfare vide its notification dated 13th September 2021 has published the Drugs (Draft Amendment) Rules, 2021 to further amend the Drugs Rules, 1945. Through this amendment, a new class of drug has been notified under schedule K which shall be exempted from the provisions of Chapter IV of the Act and the Rules thereunder, which require them to be covered with a sale license in Form 20 or Form 20A: The retail sale of the Liquid Antiseptics may be exempted from the requirement of sale license, subjected to the following conditions: The drugs are to be manufactured by licensed manufacturers and should not contain any substance specified in Schedule G, H, H1 or X. The drugs shall be sold in the original unopened containers of the licensed manufacturer and shall be purchased from a licensed wholesaler or a licensed manufacturer.

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