CDSCO Cancels 5 Cosmetic Products of Spectra Medical for High Salicylic Acid Concentration

Do you know CDSCO cancels 5 cosmetic products of spectra medical for high salicylic acid concentration? CDSCO is known as  a national regulatory authority, recently cancelled the import registration of five cosmetic items sold by Spectra Medical India Pvt. Ltd. because of more salycylic acid amount. This case highlight increasing importance regulatory compliance under cosmetic rules 2020, and how authorities are tightening oversight on ingredients safety. This incident also work as a reminder for importers and distributors to carefully check product formulations before placing in the indian market. 

What Led to CDSCO Cancels 5 Cosmetic Products of Spectra Medical for High Salicylic Acid Concentration?

The CDSCO found that several cosmetic products imported by Spectra Medical India Pvt. Ltd. contained salicylic acid levels exceeding the permissible limit. In cosmetic rules 2020, salicylic acid is only authorized to 2% for leave on products. But, the affected cosmetic have between 7% and 30% far beyond the limit. After issuing a show cause notice to the importer, cdsco concluded that the items violated rule 39 of the cosmetic rules, 2020, leading to the cancellation of the import registration certificate (RC/COS-003211) published to the entity. 

Which Cosmetic Products Were Cancelled by CDSCO for Non-Compliance?

S.No.	Product Name	Salicylic Acid	Reason For Cancellation
1.	Mesoestetic Mesopeel Periocula	7%	surpassed authorized limit
2.	Mesoestetic Salicylic (10%)	10%	surpassed authorized limit
3.	Mesoestetic Salicylic (20%)	20%	surpassed authorized limit
4.	Mesoestetic Salicylic (30%)	30%	surpassed authorized limit
5.	Dermamelan Intimate Gel	15%	surpassed authorized limit
6.	Dermamelan Mask	15%	surpassed authorized limit
7.	Mesopeel Modified Jessner	14%	surpassed authorized limit

Legal Provisions Under Which CDSCO Took This Action

Rule 39 of the Cosmetics Rules, 2020, which requires all cosmetic products to adhere to specified safety, quality, and ingredient criteria, served as the basis for the cancelation.

Additionally, depending on the kind of product, Annex B of IS 4707 (Part 4: 2017) restricts the content of salicylic acid to 2%–3%. Both these clauses and Condition No. 3 of the registration certificate, which mandates that importers remove non-compliant goods from the market, were broken by the items.

What Does This Case Teach Cosmetic Importers About Compliance Requirements in India?

The CDSCO cancellation of Spectra Medical’s cosmetics emphasises that importers must ensure ingredient-level compliance before importing any cosmetic product into India.

Even if a formulation is legal in other countries (like the EU or the USA), it may not comply with Indian cosmetic standards.

Hence, importers should:

• Conduct a formulation review as per Indian standards.
• Verify all ingredients through third-party lab testing before registration..

Impacts of CDSCO’s Decision on the Indian Cosmetic Industry

This decision has a ripple effect on importers, brand owners, and distributors. It shows that CDSCO is actively monitoring product formulations and taking strict enforcement actions.

For the industry, it signals:

• Higher regulatory scrutiny for imported cosmetics.
• Potential delays in import and sales due to additional compliance checks.
• Reputation risk for brands failing to meet ingredient standards.
• Increased need for regulatory expertise and local compliance support.

How Can Importers Avoid Similar Legal Issues in the Future?

To avoid registration cancellation, importers should:

• Audit formulations to ensure all ingredients and concentrations meet Indian limits.
• Engage regulatory consultants to handle product dossier preparation and compliance verification.
• Keep transparency with manufacturers abroad about ingredient limits in India.
• Conduct regular testing through NABL-accredited labs.
• Maintain communication with CDSCO and respond promptly to notices or queries.

Why Is Salicylic Acid Regulation Important for Consumer Safety?

Salicylic acid is important for consumer safety because it comes under basic skincare ingredient, which is used for exfoliation and acne control. But high concentration may cause skin irritation, burns, or long-term damage. By enforcing limits, CDCSO assures safe consumer use, saving from adverse reaction and protecting public health. This aligns India cosmetic safety standards with international best practices. 

Conclusion

It emphasizes that each importer must guarantee conformity with the Cosmetics Rules, 2020 and BIS ingredient restrictions prior to market entrance and represents a move towards stricter enforcement of product quality. Maintaining openness, testing, and documentation is essential to avoiding regulatory measures in a developing cosmetics market like India.