On 17 May 2023, the Ministry of Home and Family Welfare (“MoHFW”) issued the draft Cosmetics Amendment Rules, 2021 (“Amendment Rules”) for amending certain provisions of the Cosmetics Rules, 2020 (“Cosmetics Rules”). The Amendment Rules are open for public comments till 1 July 2023. Primarily, the Amendment Rules clarify the regulatory regime on licenses, labelling requirements and expiry date of cosmetic products. This note aims to analyse the substantive changes which have been brought under the Amendment Rules.
Some of the major amendments proposed under the Amendment Rules are as follows:
- The Amendment Rules have introduced a new rule on the cancellation and suspension of licenses under Chapter IV of Cosmetics Rules. The newly inserted rule – Rule 31A grants the state licensing authorities the power to adjudicate on the cancellation of a license and any appeals on it thereafter. A licensee has the right to appeal to the state government against any order of suspension or cancellation of a license within 3 months from the date of the order. The decision arrived at from the appeal shall be final. The Cosmetics Rules did not allocate any such powers to the state licensing authorities.
- The Amendment Rules provide clarity on the labelling of cosmetics that are meant to be exported. The Cosmetics Rules prescribed the requirements for each label of cosmetics being exported. However, the Amendment Rules have removed such mandatory requirements and have now indicated that such cosmetics must only adhere to the labelling requirements prescribed in the country of import.
- The Cosmetic Rules, 2020 bestowed the central government with the power under Rule 11 to establish a Central Cosmetics Laboratory for analysing or testing cosmetic samples. The Amendment Rules have now clarified that the ‘Central Drugs Laboratory’ established under the Drugs and Cosmetics Act, 1940 will carry out the same functions. To that end, the central government has the power to designate any laboratory under its control as a Central Cosmetics Laboratory. Additionally, the definition of ‘laboratory’ has been omitted under the Amendment Rules.
- The Cosmetics Rules mandated licensees to maintain records on cosmetics for a period of 3 years after the expiry of the product. However, the Amendment Rules state that cosmetic records must be maintained for a period of 3 years or 6 months from the date of expiry, whichever is later.
- The definitions of the terms ‘use before’ and ‘date of expiry’ have been clarified under the Amendment Rules to include an explanation that states that:
- When the term ‘use before’ is used – it shall mean, use before first day of month stated on the label.
- When the term ‘date of expiry’ is used – it means the product will expire on the last day of the month’.
- The Cosmetics Rules granted powers to the State Drugs Controller of a licensing authority for the enforcement of rules on stock, sale, exhibit or offer for sale or distribution of all categories of cosmetics. However, to streamline the regulatory process, the Amendment Rules have omitted such powers granted to the State Drugs Controller.
The Amendment Rules provide much-needed clarifications and changes to the newly enacted Cosmetics Rules. For example, adherence to the labelling requirements of the importing country makes it comparatively less burdensome than having dual requirements. Further, clarifications of the terms ‘use before’ and ‘date of expiry’ are essential to avoid any ambiguity. The Amendment Rules also unfold the crucial recourse of appeal to state authorities against any order of suspension and cancellation of license. Hence, in effect, it is a welcome move towards a position of strong certainty for implementation of the Cosmetics Rules.