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
- Name of the company or firm or any other entity importing/Manufacturing the medical device, specification and standards of the particular medical device.
- Details of medical device/IVD Medical Devices.
- Certificate of compliance with respect to ISO 13485 standard accredited by the National Accreditation Board for Certification. Bodies or International Accreditation Board for Certification Bodies or International Accreditation Forum in respect of such medical device.
- Free Sale Certificate (FSC) from Country of Origin in case Imported Medical Devices.
- Undertaking signed by the importer/Manufacturer stating the information provided by the applicant is true.
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:
- Advertising for the document required
- Preparation of documents as per application & list of documents.
- Application File
- Inspection by the department if required
- Liaison department
- License issued
- Yearly compliance if applicable
- Renewal when due
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.
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.