Health Ministry Proposes Amendments to Drugs and Cosmetics Rules

The Union Health Ministry has issued a draft notification proposing amendments to the Drugs and Cosmetics Rules, 1945. Key changes include adding bacterial endotoxin testing for all parenteral products regardless of volume, prohibiting antimicrobials in non-pharmaceutical food industries without licenses, and exempting certain chemical contraceptives like centchroman and ethinyl estradiol from Schedule H.

The draft aligns with recommendations from the Drugs Consultative Committee and Technical Advisory Board. It also proposes stricter qualifications and supervision requirements for wholesale drug licenses and removes exemptions allowing sale of antimicrobials to manufacturers of non-medicinal products without proper licenses.

These amendments aim to resolve regulatory contradictions, improve drug safety, and tighten controls on antimicrobial sales. The government will consider objections received within 30 days of the draft’s publication in the Official Gazette before finalizing the rules.

04-06-2025