Cosmetics (Amendment) Rules, 2025 Notified

To strengthen oversight of the booming Indian cosmetics market and ensure consumer safety, the Ministry of Health and Family Welfare has issued the Cosmetics (Amendment) Rules, 2025, through G.S.R. 513(E) dated the 29th of July 2025, bringing important amendments to the Cosmetics Rules, 2020, under the Drugs and Cosmetics Act, 1940. The rules introduce some clarifications and align regulatory mechanisms as highlighted below:

• An explanation has been added to rule 3(w) clarifying that “use before” means before the first day of a mentioned month and “date of expiry” means the cosmetic expires on the last day of the month.
• Instead of a separate “Central Cosmetics Laboratory,” the Central Drugs Laboratory established under the Drugs and Cosmetics Act, 1940, has been formally designated as such to centralise testing.
• Licensees have now been given an option to maintain the specified records of each batch of cosmetics manufactured, the raw materials used, the testing done, etc. in either hard copy or electronic mode, for a period of three years or six months after expiry of the batch, whichever is later. This shall not be applicable to soap manufacturers.
• An enabling provision has been added giving powers to the State Licensing Authority to cancel or suspend a license after granting due opportunity of being heard. Aggrieved licensees may appeal to the state government within 90 days.
• Cosmetics meant for export are required to comply with the law of the destination country. However, if a cosmetic is required by the consignee to not be labeled with the name and address of the manufacturer, the label on the package or container shall bear a code number as approved by the State Licensing Authority.
• The option of sending samples for testing by courier has been done away with. Samples can only be shared by registered post or delivered in person for test or analysis by order of court.
• “Spurious Cosmetics,” defined under Section 17D of the Drugs and Cosmetics Act, 1940, which was missing under the rule pertaining to confiscation, has now been added.

The plans to amend the Cosmetics Rule 2020 have been floating since May 2023, when the government announced its intention to strengthen the regulatory mechanism for cosmetics following the incidence of substandard cosmetic products found to be sold in the market with the potential to cause face allergies and skin infections. In June this year, an expert panel, the Drugs Consultative Committee (DCC), also reviewed a proposal to discourage mercury use in the formulation of cosmetics and concluded that India’s current regulations under the Cosmetics Rules, 2020, are already in line with the Minamata Convention and do not require any amendment.

The debate around the safety of anti-aging and skin-whitening products also gained momentum with the untimely death of television personality Shefali Jariwala, speculated to be linked to cosmetic procedures. A series of global product recalls impacting the health and beauty sector have also raised concerns over safety and regulatory compliance. According to industry data, the cosmetic market in India was valued at $8.1 billion in 2023 and is expected to reach $18.4 billion by 2032.

The Drugs Controller General of India (DCGI) had recently issued a strict warning to the cosmetics industry to adhere to the regulatory protocols and refrain from making unusual claims. The government had also notified Schedule M in June last year, which proposed a blanket ban on the manufacture of any other article or product apart from drugs in the units licensed for drug production. The Karnataka High Court provided temporary relief in December last year to pharmaceutical companies by directing the government not to act against firms producing nutraceuticals in drug-licensed units until the next hearing.

The recent changes reflect a broader government push toward consumer safety, transparency, and industry accountability, while also catering to the growth of exports and legitimate domestic innovation.