DCGI Warns Cosmetic Industry Against Overlapping Claims With Pharma Products

Cosmetics in India are regulated under the Drugs and Cosmetics Act, a stringent framework that imposes rigorous standards on manufacturers and importers. However, stakeholders in the cosmetics industry have expressed concerns about the stringent regulatory protocols for imported products. Many imported cosmetics are being rejected at ports for failing to meet the stringent standards set by the DCGI, leading to significant financial losses for importers.

To address these concerns, the DCGI recently convened a meeting with industry representatives. While acknowledging the need to ensure the safety and quality of cosmetic products, the regulator emphasized the importance of adhering to established norms. The industry, on the other hand, is seeking a relaxation of regulations to facilitate smoother import processes.

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“The meeting was organized to discuss the issues that cosmetic industry is facing. Generally, cosmetics have always been under the Drugs and Cosmetic Act. Importers are having issues related to products approval. The regulatory protocol is much easier in other countries. The importers are demanding regulatory procedures to be eased to prevent their financial losses,” an official aware of the matter told Live Mint, adding that quality and safety of cosmetics products must be ensured.

“The other issue with cosmetics is overlapping some claims. For example, serum and biologicals or stem cell therapy are being used for younger-looking skin or rejuvenation which is overlapping with drugs,” the official added.

Commenting on the issue, Dr Chytra V Anand, a renowned cosmetic dermatologist, highlighted the need for simplification of regulatory processes, clear guidelines, and support for innovation in the cosmetics industry.

“The industry faces challenges due to the complexity of the regulatory environment. The coexistence of multiple laws and authorities can lead to confusion and delays in compliance. Additionally, the absence of clear and consistent regulatory standards creates uncertainty among industry players, complicating adherence to compliance requirements,” Dr Anand, Cosmetic Dermatologist & Founder of Kosmoderma Clinics and SkinQ told Live Mint.

“Simplification of regulatory processes, clear guidelines and standards, support for innovation and enhanced collaboration is required,” he added.

The growing Indian cosmetics market, valued at USD 8.1 billion in 2023 and projected to reach USD 18.4 billion by 2032, offers immense potential. However, the industry faces challenges due to the complex regulatory landscape and the potential for overlapping claims with pharmaceutical products.