CDSCO Registration: Essential Document Checklist for Application Pre-Screening

CDSCO, or Central Drugs Standard Control Organisation, is one of the foremost regulatory authorities in India. As India’s national regulatory body, CDSCO oversees the regulation of cosmetics, pharmaceuticals, and medical devices.

Within CDSCO, the Drug Controller General of India (DCGI) oversees the regulation of pharmaceuticals and medical devices in collaboration with the Ministry of Health and Family Welfare. CDSCO is tasked with approving new drugs and issuing licenses in accordance with the Drugs and Cosmetics Rules, 1945.

Roles and Responsibilities of CDSCO

The Central Drugs Standard Control Organisation (CDSCO) serves as India’s National Regulatory Authority (NRA), focusing on enhancing transparency, accountability, and consistency in its operations. CDSCO’s primary mission is to ensure the safety, efficacy, and quality of medical products that are manufactured, imported, and distributed within the country.

Under the Drugs and Cosmetics Act, CDSCO is responsible for:

• Approving New Drugs

• Conducting Clinical Trials

• Establishing Standards for Drugs

• Regulating the Quality of Imported Drugs

• Coordinating with State Drug Control Organizations

• Granting Licenses for critical categories of drugs, such as Blood and Blood Products, I.V. Fluids, Vaccines, and Sera

Licensing Authorities under CDSCO

CDSCO oversees two primary licensing authorities:

• State Licensing Authority (SLA):Issues CDSCO manufacturing or wholesale licenses for In Vitro Diagnostics (IVDs) and Medical Devices classified under Class A and B.

• Central Licensing Authority (CLA):Manages the issuance of CDSCO manufacturing or wholesale licenses for IVDs and Medical Devices classified under Class C and D. The CLA also handles the grant of import licenses for cosmetics in India.

CDSCO Registration Document Checklist for Pre-Screening

To facilitate the CDSCO registration process, provide the following documents:

1. Covering Letter: State the purpose of your CDSCO registration application.

2. Application Form: Complete, stamp, and sign the original application submitted by the manufacturer, importer, or Indian agent. Include product details such as name, variant, manufacturer, and categorization, as well as the authorized agent's information and factory address.

3. TR6 Challan: Provide a TR6 Challan indicating the registration fees. - Power of Attorney (POA):

4. A Power of Attorney (POA):

   • Include the name and address of the Indian agent and manufacturer, along with the manufacturing site.

   • Detail the product name, variants (if any), and the actual manufacturer. Ensure the categorization of products aligns with the cosmetics guidelines.

   • The POA must be jointly signed, stamped, and dated by both the Indian agent and manufacturer, with a clear validity period.

    

Conclusion

CDSCO registration is essential for ensuring the quality and efficiency of pharmaceuticals, medical devices, and cosmetics available to the public. CDSCO's primary goal is to safeguard public health. Ensure that all required documents are submitted for a smooth verification process and timely response.