License in India

CDSCO LICENSE

What is CDSCO License?

The Central Drugs Standard Control Organisation(CDSCO) under Directorate General of Health Services, Ministry of Health & Family Welfare, Government of India is the National Regulatory Authority (NRA) of India. 

The Drugs & Cosmetics Act,1940 and rules 1945 have entrusted various responsibilities to central & state regulators for regulation of drugs & cosmetics. It envisages uniform implementation of the provisions of the Act & Rules made thereunder for ensuring the safety, rights, and well-being of the patients by regulating the drugs and cosmetics.

CDSCO is constantly thriving upon to bring out transparency, accountability and uniformity in its services in order to ensure safety, efficacy and quality of the medical product manufactured, imported and distributed in the country.

Under the Drugs and Cosmetics Act, CDSCO is responsible for approval of New Drugs, Conduct of Clinical Trials, laying down the standards for Drugs, control over the quality of imported drugs in the country, and coordination of the activities of State Drug Control Organizations by providing expert advice with a view of bringing about the uniformity in the enforcement of the Drugs and Cosmetics Act.

Why this License is Required?

 CDSCO is constantly thriving to bring out transparency, accountability, and uniformity in its services in order to ensure the safety, efficacy, and quality of the medical product manufactured, imported, and distributed in the country.

Who can get CDSCO License?

Drug Products

Medical Devices

Cosmetics

Clinical Trials

Document Required for CDSCO License

Role of Shamkris and Process of CDSCO License

Shamkris adopts a results-oriented approach to compliance with mandatory licence requirements in the organization. A simple and guidance methodology help organisation to achieve licence in a timely manner and cost-effective. Shamkris support 100% in advisory, Guidance, Compliance with respect to license requirements to obtain approval.

The License process described below:

Advisory for the document required

Preparation of documents as per application & list of documents.

Application File

Inspection by the department if required

Liason department

License issued

Yearly Compliance if Applicable

Renewal when due

Who can issue the CDSCO License?

FAQ

The Central Drug Standard Control Organisation (CDSCO) is responsible for the so called CDSCO registration, or CDSCO approval, of all drugs and medical devices in India.

The application for Registration and import can be made to the Licensing Authority under the Act i.e. to the Drugs Controller General (I) at CDSCO, FDA Bhawan, Kotla Road, Near Bal Bhawan, New Delhi by the Local Authorized Agent of the foreign manufacturer having either manufacturing or sale License or by the foreign .

An application for an import License shall be made to the licensing authority in Form 8 for drugs excluding Schedule X, and in Form 8-A for Schedule X drugs; either by the Manufacturer or by the Manufacturer’s agent in India who is having the wholesale license for sale or distribution of drugs and shall be accompanied .

Application for registration is submitted to the Drugs Controller General of India. Necessary documents mandatory to acquire license permit: Granting license for manufacturing of medical devices requires filling Form-28 along with prescribed government fees in the form and manner as prescribed by the Act.