Registration of Cosmetic Products in India – New Rule
The cosmetic industry in India has noted a significant growth in recent years. With the increasing demands of cosmetic products, it has become essential to ensure that these products are safe for use and comply with the required quality standards. India has recently implemented a new rule for the registration of cosmetics, aiming to enhance the safety and quality of cosmetic products available in the market, to protect consumers from potential harm caused by unsafe or substandard cosmetic products.
In India, cosmetic registration is done in compliance with the provisions of Drugs and Cosmetic Act, 1940, and the Cosmetic Rules, 2020. It is administered by the Central Drugs Standard Control Organization (CDSCO), which falls under the Ministry of Health and Family Welfare. CDSCO oversees the registration process, monitoring, and enforcement of quality standards for cosmetic products.
As of 2020, the registration process for cosmetic products in India has been streamlined through the new rules introduced by the CDSCO. All manufacturers and importers who plan to market cosmetic products in India are required to get cosmetic registration. Here is an overview of registering cosmetic products in India under the new rule:
CREATION OF SUGAM ACCOUNT
- The registration of cosmetic products in India has been digitized, and all the applications are submitted through the CDSCO’s online portal called “SUGAM”. Applicants need to create an account and provide the necessary information and documents as per prescribed format to the concerned authority (CDSCO) for approval.
- Once after approval, the authority will send the approval of registration to the concerned email ID. After which the portal can be accessed for online form submission by entering the verified login credentials.
ONLINE FORM SUBMISSION (APPLICATION)
- The application for registration is made in Form COS-1 for import and COS-12 for manufacture.
- The registration application form must be filled with accurate information and all the necessary documents required for the registration process must be attached. This includes the product formulation, manufacturing process, safety data, labelling details, proof of compliance and any relevant details regarding the product.
- Non-Indian manufacturers must appoint an authorized Indian agent who will act as a liaison between the manufacturer and the CDSCO. The agent should have a power of attorney from the manufacturer.
- The applicable fees for the registration process must be paid and vary based on the type of cosmetic product and its category.
- The completed application form, supporting documents, and fees are uploaded to the SUGAM portal for approval.
REVIEW AND APPROVAL OF THE APPLICATION
- The CDSCO will review the application and the provided documents, to ensure compliance with the rules and regulations, which includes evaluating the safety, efficacy, and quality of the cosmetic product.
- The CDSCO may request for more information or may conduct inspections if necessary.
- If the CDSCO is satisfied with the compliance of the cosmetic product, it grants the approval for registration.
- If the application is unsatisfactory, any discrepancies are communicated to the applicant via the SUGAM portal. Once the discrepancies are addressed, the application is compiled and processed for approval.
GRANT OF REGISTRATION
- If the submitted application is thorough and accurate in all respects, then it is forwarded to the licensing authority for approval. After approval, the approval letter will be available on the applicant’s SUGAM dashboard.
- Once the application is approved, the CDSCO will issue a registration certificate for the cosmetic product, which confirms that the product has met the necessary regulatory requirements, for import or manufacture.
POST REGISTRATION COMPLIANCE
- After the registration, the manufacturers and importers should continue to comply with the rules and regulations established by the CDSCO.
- This includes product quality, safety, labelling, updates, or changes in the product formulation, maintaining proper records, reporting the adverse events and timely renewal of registration.
- It is essential to note that the registration is mandatory for imported cosmetics as well as those manufactured in India, and the exact requirements and procedures may vary depending on the specific rules and regulations.
In India, registering cosmetics is a vital process for ensuring consumer safety and fostering the growth of the cosmetic industry. It plays an important role in keeping the interests of the consumers and maintaining the integrity of the market. The process of registration may be time consuming and complex, but it is essential for the manufacturers to adhere to the regulations to obtain market access. Seeking professional assistance can help companies navigate through the registration process smoothly by complying with all necessary requirements.
The full cosmetic rules 2020 can be accessed by clicking on the link below: