India’s central cosmetics regulator, The Central Drug Standard Control Organization (“CDSCO”), has recently passed an order cancelling the registration of an importer of a cosmetic product after it discovered inconsistency between the claims made on label of the product and claims made on the product website. The order is relevant because it evidences a new trend that the Indian regulator is scrutinizing not just claims made on product label at the time of grant of registration but is also scrutinizing claims made on the product marketing materials and product website after grant of import registration certificate.
In this article, we have summarized the reasons for cancellation of the order and contextualized the cancellation in background of sensitivity of the regulator to cosmetic products that make drug-type claims.
Legal Background
In order to import cosmetics into India, a registration is required to be taken by the importer under The Cosmetics Rules, 2020 (“Cosmetics Rules”). The registration entitles the importer to import cosmetics mentioned in the registration certificate for the term of certificate. However, during the term, the importer has to ensure compliance with conditions of the registration as well as the Cosmetics Rules in order to maintain the registration.
Under Indian law, there is a separate regulatory pathway for import of drugs, and a separate license is required under The Drugs Rules, 1945 (“Drug Rules”) to import drugs in India. The definition of “drug” is very broad, and any substance which makes any claim that it may diagnose, treat, mitigate or prevent any disease or disorder is regulated as a drug.
In other words, a cosmetic product will be regulated as a drug and would require license under Drugs Rules (separate than the registration certificate under Cosmetics Rules), if the importer of cosmetic product makes a claim which qualifies the product to be a drug under Indian laws.
The CDSCO cancelled the registration certificate of M/s. Esthetic Centers lnternational Pvt. Ltd. for the following reasons:
a) Inconsistency between the claims made on the label which was submitted to CDSCO at the time of application of registration certificate and the claims made on the website of the product.
| Claims on the approved label | Claims on the website |
|---|---|
| Anti-hair loss solution | Treatment for Post-Chemotherapy hair loss, Androgenetic alopecia, Seborrhoeic dermatitis of scalp etc. |
b) Nature of the claims being ‘drug’ claim owing to the use of the word “treatment” and reference to human diseases and conditions.
- Key takeaways
a) It is now evident that CDSCO is scrutinising marketing claims of a cosmetic product including claims made on the product website. The CDSCO appears to be especially sensitive to products which are registered as cosmetics but are found to be making drug claims after receiving registration to import.
b) CDSCO is taking serious action against registration holders despite the registration holder undertaking to comply with directions and undertaking to remove all inconsistent and drug-type claims from the product website. In this case, the importer had removed all the references to disease conditions from the website, but the CDSCO still cancelled the registration certificate.
In fact, the CDSCO does not have powers under Cosmetic Rules to cancel registration if the importer of cosmetic product makes a misleading claim in violation of Rule 36 of Cosmetic Rules. Such power is only available against domestic manufacturers of cosmetics due a lacunae in the existing law. However, CDSCO has overlooked the shortcoming and still chosen to cancel the registration, which shows the seriousness with which CDSCO views such violations.
- Conclusion
It is important for importers, marketers and manufacturers of cosmetics product to ensure that the claims made by them on the label of cosmetics at the time of receipt of registration or license are consistent with the marketing claims made by them after import or manufacture of cosmetic product into India. Any inconsistency, especially with reference to overlap with drug-type claims, can invite serious action including cancellation of import registration are manufacturing license, as the case maybe.
