Law Updates

Subject

Summary: The Central Government has issued draft rules to amend the Drugs Rules, 1945, under the authority of the Drugs and Cosmetics Act, 1940. The proposal has been released after consultation with the Drugs Technical Advisory Board and is currently open for public comments. According to the draft notification published by the Ministry of Health and Family Welfare, the amendment targets Schedule F, Part XII-C, Para G of the Drugs Rules, 1945. The government has proposed to remove the provision that requires final pharmaceutical products to be tested for HIV-I antibodies, HIV-II antibodies, Hepatitis B surface antigen, and Hepatitis C virus antibodies. The draft rule specifically states that the sentence mandating these viral testing requirements will be omitted from the regulation. This proposed change forms part of the government’s ongoing efforts to update and streamline pharmaceutical regulatory provisions. Stakeholders, pharmaceutical companies, and industry experts may submit objections or suggestions within 30 days from the date the Gazette of India notification is made available to the public. After reviewing the feedback, the government will finalize the amendment and announce the effective date through the Official Gazette.

Subject

Summary: The Ministry of Health and Family Welfare has notified the Cosmetics (Amendment) Rules, 2025, under the Drugs and Cosmetics Act, 1940. These rules amend several provisions of the Cosmetics Rules, 2020. Key changes include definitions for "use before" and "date of expiry," clarifying that products should be used before the first day of the month mentioned, and expire on the last day. The term "controlling officer" is replaced with "Controlling Authority" throughout the rules. Rule 7 now designates the Government Analyst under the Act as the analyst for cosmetics. The Central Drugs Laboratory will function as the Central Cosmetics Laboratory for testing, appeals, and other duties. Records for batches and raw materials must be kept for 3 years or 6 months after expiry, except for soap manufacturers, who follow Licensing Authority-approved procedures. Rule 31A introduces cancellation or suspension of licenses for violations, with appeal provisions to the State Government. Labelling norms for export have been updated to meet destination country laws. "Licence" is replaced by "approval" in several rules, with changes reflecting regulatory clarity and alignment. Courier provisions have been removed. These amendments aim to strengthen compliance, transparency, and governance in the cosmetic manufacturing sector.