India with world’s second largest population stands a great market for Cosmetics wherein the Central Drug Standard Control Organization (CDSCO) regulates beauty products under the overarching regulations governed by Drug and Cosmetic Act 1940 & Rules 1945 vide Gazette Notification G.S.R 426(E). The manufacturers, their authorized agents and subsidiaries in India, and any other importers can apply for issuing a registration certificate for the import of cosmetics in India by uploading necessary documents through SUGAM portal. The application for registration i.e. Form 42 with required documents are submitted to CDSCO, followed by obtaining Registration certificate i.e. Form 43 within 3-6 months and has three-year validity of the registration. While the Regulatory process is moderate in approach, the key difficulty lies in making appropriate product and placement choice in sub-urban and rural areas of the sub-continental country where the major portion of population resides. Lack of evolved supply and distribution channels is another key setback to navigate through the region.
With a global operational center in India, Freyr provides Regulatory Intelligence services to understand cosmetics regulations, identify the right channels and products to retain optimum market potential. Freyr also provides authorized agent services and help in procuring SUGAM portal membership and uploading form 42 alongside all the necessary documents.
- Formulation Review
- Cosmetics Claims and Substantiation Services
- Labeling Review as per Drugs & Cosmetics Rules Act
- Dossier Compilation
- Registration with the CDSCO
- SUGAM Portal Membership
- Authorized Agent Services
- Strategic local Health Authority contacts
- Expert Regulatory team with proven global RA expertise
- Quick turnarounds and faster time-to-market