CDSCO Registration
The Central Drugs Standard Control Organisation (CDSCO) serves as the regulatory authority for the Indian medical devices industry. It operates under the framework established by the Drugs & Cosmetics Rules, ensuring the safety, efficacy, and quality of medical devices in India.
An Overview of CDSCO Registration
The Central Drugs Standard Control Organisation (CDSCO) functions as the National Regulatory Authority (NRA) under the Directorate General of Health Services, Government of India, and the Ministry of Health and Family Welfare. Established under the Drugs & Cosmetics Act, 1940, and the Drugs & Cosmetics Rules, 1945, CDSCO oversees the regulation and approval of new drugs and clinical trials in India. It sets standards for drug quality, monitors the quality of imported drugs, coordinates with State Drug Control Organisations (SDCO), and provides expert advice to ensure consistent enforcement of drug regulations.
Purpose of CDSCO Registration
Organisations engaged in the manufacture, import, export, or research and development of drugs and cosmetics, as well as those conducting bioavailability (BA) and bioequivalence (BE) studies for export purposes, must obtain CDSCO registration. The CDSCO registration can be obtained for various purposes, including:
- Test License
- Dual Use NOC (Trader)
- Blood Bank Registration
- Cosmetics Registration
- BA or BE Approved Sites
- Import or Manufacture of Drugs
- Ethics Committee Registration
- Research and Development Organisation Formulation
- Sponsors (BA, BE, and Clinical Trials)
- Export NOC (Zone)
- Blood Product Registration
Who Can Apply for CDSCO Registration in India?
The following entities are eligible to apply for CDSCO registration through the online portal:
- Indian Agents
- Corporates
- Importers
- Foreign Enterprises with an Indian Subsidiary
Note: Manufacturing units cannot register directly on the CDSCO portal. Instead, a corporate entity must create login credentials for the manufacturing unit, allowing them to access the portal.
The Central Drugs Standard Control Organization (CDSCO) in India has several divisions, each focusing on different aspects of drug regulation and control:
- Cosmetics Division: Regulates the manufacturing and import of cosmetics in India under the Drugs & Cosmetics Act. It ensures that cosmetics are safe for human use and comply with relevant standards.
- Drugs Consultative Committee (DCC) and Drugs Technical Advisory Board (DTAB): Provide advice on matters related to the administration of the Drugs & Cosmetics Act and Rules. They also convene meetings to review and monitor the implementation of rules.
- Bioavailability/Bioequivalence (BA/BE) Division: Deals with the assessment of the bioavailability and bioequivalence of drug products. This is essential for ensuring the effectiveness and safety of generic drugs.
- Import and Registration of Drugs Division: Oversees the import of drugs into India and processes applications for the registration and import license of drugs as per the Drugs & Cosmetics Rules.
- New Drugs Division: Reviews applications for the approval of new drugs in India. New drugs must demonstrate safety and efficacy before they can be manufactured, imported, or marketed in the country.
- Medical Devices and Diagnostics Division: Regulates notified medical devices in India. This includes devices used for artificial insemination, surgical dressings, prophylactic purposes, etc.
- Biological Division: Regulates biological products used for medical purposes. This includes vaccines, human organs/tissues, gene and cellular therapies, etc.
RegAlliance offers assistance with CDSCO registration for medical equipment, providing expert guidance, a smooth process, and timely responses to ensure compliance with regulations.