Draft Drugs (Amendment) Rules, 2022


The Department of Health and Family Welfare vide notification dated the 23rd May, 2022 has issued the draft Drugs (Amendment) Rules, 2022. The Rules provides revised procedure for grant of permission to manufacture new drug for sale or distribution under rule 80 of the New Drugs and Clinical Trials Rules, 2019.

Where an application is made for the manufacture of drug formulation falling under the purview of New Drug as per the New Drugs and Clinical Trials Rules, 2019 or Drugs Rules, 1945, as the case may be, the license to manufacture for sale or distribution of the drugs shall be granted after approval of the drug as new drug.

Objections and suggestions, if any, may be addressed via email to drugsdiv-mohfw@gov.in within sixty days of publication of the draft amendment.

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