The Drugs Controller General of India (DCGI) has cancelled the import registration of several skincare cosmetics imported by Spectra Medical India Pvt. Ltd., citing violations of Rule 39 of the Cosmetics Rules, 2020. The affected products were found to contain salicylic acid concentrations far exceeding permissible limits, prompting regulatory action and a public safety advisory.

Key highlights

Products contained salicylic acid beyond permissible limits

• Concentrations in the banned products ranged from 7% to 30%, significantly above the regulatory limits of:

  1. 3% for rinse-off hair products

  2. 2% for all other cosmetic formulations

• The products were initially registered in September 2023 and were valid until May 31, 2027.

List of products with cancelled registrations

• Mesoestetic Mesopeel Periocula

• Mesoestetic Salicylic (10%, 20%, 30%)

• Dermamelan Intimate Gel

• Dermamelan Mask

• Mesopeel Modified Jessner

Regulatory enforcement under cosmetics rules

• The CDSCO issued a show cause notice in April 2025.

• The importer later agreed to voluntarily surrender the listed products.

• The DCGI then officially cancelled the registration, restricting their import and sale in India.

Rule 39 and public safety implications

• Rule 39 of the Cosmetics Rules, 2020 regulates active ingredient concentration in cosmetics to prevent adverse effects.

• Excess salicylic acid can cause skin irritation, peeling, dryness, and inflammation, especially with prolonged use.

• Regulatory reviews are part of routine safety checks to ensure imported cosmetics meet Indian safety and efficacy standards.

With rising concern over potent skincare ingredients, the DCGI’s cancellation of high-salicylic acid cosmetic imports signals India’s continued commitment to consumer safety. Importers and manufacturers are advised to comply strictly with ingredient limits as defined under national regulations.