CDSCO Registration or Licenses
The Central Drugs Standard Control Organization (CDSCO) is the regulatory authority in India responsible for the regulation and approval of pharmaceuticals, medical devices, and cosmetics. It operates under the Central Drugs and Standard Control Organization Act, 1940, and the Drugs and Cosmetics Act, 1940. CDSCO ensures that drugs and healthcare products available in the Indian market are safe, effective, and of good quality.
For companies involved in the manufacturing, import, distribution, and sale of drugs and medical devices in India, obtaining CDSCO registration or licenses is a crucial step to comply with regulatory requirements. Here are some key registrations and licenses issued by CDSCO:
Manufacturing License: Any company planning to manufacture drugs or medical devices in India needs to obtain a manufacturing license from the State Licensing Authority or the Central Licensing Authority (depending on the category of drugs or medical devices).
Import License: Companies planning to import drugs or medical devices into India need to apply for an import license from the Central Licensing Authority.
Wholesale License: Wholesale distribution of drugs requires a wholesale license issued by the State Licensing Authority.
Retail License: Retail pharmacies selling drugs to the public need to obtain a retail license from the State Licensing Authority.
Import Registration Certificate (IRC): Importers of drugs and medical devices need to obtain an Import Registration Certificate from the CDSCO for each specific product they intend to import.
Clinical Trial Registration: Companies conducting clinical trials of drugs and medical devices in India must register the trial with the CDSCO's Clinical Trials Registry India (CTRI).
Form 44: This is a registration certificate issued by the CDSCO for the premises where drugs are stored or exhibited for sale.
The specific requirements, documentation, and procedures for obtaining these registrations and licenses may vary based on the type of product and its classification. It's essential for companies to adhere to the guidelines and regulations provided by the CDSCO.