Cosmetic Regulatory Services in India

Overview

India, recognized as the world’s second-most populous country, is fast emerging as a thriving beauty and personal care product market. For global Cosmetic brands looking to enter this dynamic space, adhering to India Cosmetic regulations compliance is vital.

Understanding India’s Regulatory Landscape:

The Central Drugs Standard Control Organization (CDSCO), under the purview of the Drugs and Cosmetics Act, 1940 Rules, 1945, and Cosmetics Rules 2020 regulates Cosmetic products in India through a structured registration and licensing process.

What Does Cosmetic Product Registration in India Involve?

To initiate imported Cosmetic product registration in India, importers, Indian subsidiaries, or Authorized agents must apply through the government’s SUGAM portal. All applications are submitted using Form COS–1, and upon successful review, a Cosmetics Registration Certificate is issued in Form COS–2.

The process for CDSCO Cosmetic registration includes submitting comprehensive documentation, including product formulation, label compliance, with acceptable claims, a Free Sale Certificate, and a Letter of Authorization, among other documents. CDSCO mandates a separate registration process for novel Cosmetic products using Form COS–12, with the final approval granted via Form COS–3. The growing focus on innovation in personal care has also pushed for more robust Cosmetic safety assessments in India, especially for unique product types or new combinations.

As Regulatory pathways evolve, companies must comply with the Legal Metrology Act. Accurate representation of claims and ingredients is essential to staying compliant.

The registration process also requires appointing an Authorized Indian Representative (AIR) to communicate with Regulatory authorities. Ensuring all documents are complete and compliant with CDSCO guidelines is critical to avoid delays or rejection.