Introduction
India updated its cosmetic and drug rules in 2025 to strengthen compliance, improve accountability, and ensure consumer safety. The amendments focus on clear labeling, strict licensing enforcement, faster resolution of offences, and greater flexibility for international trade. These reforms also modernize terminology and strengthen regulatory procedures.
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What Are The Cosmetics (Amendment) Rules, 2025
The 2025 changes bring precision to cosmetic labeling. “Use before” now means the first day of the month shown on the label, while “expiry date” refers to the last day of that month. Manufacturers must maintain detailed batch-wise records of raw materials and final products, testing each batch and keeping records for three years or six months after expiry, whichever is later. Soap makers receive an approved exemption from this rule.
Licensing now carries stricter conditions. State Licensing Authorities can suspend or cancel a license after a formal hearing, and license holders have ninety days to appeal. The State Government’s decision is final. The Central Drugs Laboratory has been officially designated as the Central Cosmetics Laboratory for all testing, analysis, and appellate duties.
For exports, labels may follow the importing country’s requirements. In certain cases, the manufacturer’s name and address can be replaced by a State-approved code if requested by the consignee. Terminology is updated to replace “controlling officer” with “Controlling Authority,” “licence” with “approval,” and “licensed premises” with “approved premises” for better consistency. The amendments also remove courier dispatch provisions for official samples, encouraging more secure and traceable transport. Only a Government Analyst appointed under Section 20 of the Act is now recognized for testing purposes.
What Are The Drugs & Cosmetics (Compounding of Offences) Rules, 2025
The Ministry of Health introduced the Drugs and Cosmetics (Compounding of Offences) Rules, 2025 on 24 April 2025 through G.S.R. 259(E). These rules set out how certain offences can be settled by paying penalties instead of facing prosecution. Both Central and State authorities are empowered to act as Compounding Authorities. They may receive applications either before or after prosecution has begun and can request reports from the reporting authority, generally within one month.
If approved, the authority decides the penalty and grants immunity. The applicant must pay within thirty days. If immunity is refused by a court, the amount paid is not refundable. Immunity can also be withdrawn if the applicant hides facts, provides false evidence, or fails to meet agreed conditions. This framework supports the Jan Vishwas Act by decriminalizing minor infractions such as unintentional labeling errors or packaging misprints, replacing imprisonment with financial penalties.
Conclusion
The 2025 amendments to the Drugs and Cosmetics Act modernize India’s regulatory system. They deliver clear labeling rules, stronger licensing controls, and faster resolution of regulatory disputes. By updating procedures, adopting flexible export standards, and aligning with global trade practices, these changes enhance both industry efficiency and consumer safety.
