What is CDSCO and How can I get a CDSCO license in India?
The Drugs and Cosmetics Act 1940 and Rules 1945 established the Central Drugs Standard Control Organization, or CDSCO, as a regulating agency for the Indian medical device industry. The Central Drugs Standard Control Organization (CDSCO) is India’s national medical device and pharmaceutical regulating authority. It is a licensing authority that approves the import of any new chemical entity (drug) into India. Every country has its own dedicated governing body. The ministry of health regulates all areas of pharmaceutical and medical device development through CDSCO online Registration Portal. CDSCO is controlled and regulated by the Directorate General of Health Services, which is part of India’s Ministry of Health and Family Welfare. The Central Drugs Standard Control Organization (CDSCO) has its headquarters in New Delhi, India. Six zonal offices, four sub-zonal offices, thirteen port offices, and seven laboratories are located around the nation.
CDSCO’s Activities
- New medication approval and clinical trials
- CDSCO registration and license can be imported.
- Blood banks, vaccinations, and some medical gadgets licensing.
- Amendment to Drugs & Cosmetics Act and rules. if necessary
- Participation in GMP certification processes run by the World Health Organization.
- Grants for test licenses, personal licenses, and export NOCs
- Central labs drug testing.
In June 2018, CDSCO updated its list of notified medical devices and IVD devices. All medical devices and IVD items are included in this list. CDSCO’s new notification provides a list of additional medical devices that was regulated by May 1, 2020.
What is the procedure for importing medical equipment into India?
According to the regulations of the Drugs & Cosmetic Act & Rules, a Registration Certificate in Form 41 and an Import License in Form 10 are necessary for the import of medical equipment into India. The manufacturing site and products (medical devices) must be registered with the Indian drug regulatory body in order to import medical devices (i.e. Central Drugs Standards Control Organization).
Who is eligible to register with the CDSCO?
On the CDSCO web portal, the following applicants can register:
- Importers are companies that import goods.
- Agents from India
- Foreign Companies with Indian Subsidiaries
- Enterprises
What is the procedure for obtaining a Certificate of Registration?
Form 40 is used to apply to the Licensing Authority for a CDSCO Registration Certificate. This can be done by either a manufacturer with a valid wholesale license for the sale or distribution of medications or an authorized agent in India with a valid wholesale license, according to the laws. It must be submitted with the fees listed in sub-rule (3) of Rule 24 A of the Drugs and Cosmetics Rules 1945, as well as the information and undertakings listed in Schedules D-I and D-II, all of which must be signed by or on behalf of the manufacturer. Through the SUGAM Online Portal, the applicant files an application in accordance with the checklist provided at https: cdscoonline.gov.in.
CDSCO Online Registration can be obtained for a variety of reasons.
The CDSCO has the authority to approve registration for a variety of reasons. The following are the various purposes for which an applicant can register on the CDSCO portal:
- Registration of Cosmetics
- Registration of Blood Bank
- Registration of Blood Products
- NOC with Dual Purpose (Trader)
- Import or Manufacture of drugs
- NOC for export (Zone)
- BA/BE Approved Sites
- Sponsors (BA/BE and CT)
- Licence to Test
- Registration with the Ethics Committee
- R&D Organization for Formulation
Documents Required for CDSCO Online Registration
The following documents must attach to the registration application on the CDSCO portal:
- Document that proves your identity
- An undertaking issued by a government department.
- Proof of Address Document
- In the case of BA/BE Approved Sites Registration, a copy of the BA/BE Site Registration as approved by CDSCO.
- In the case of import or export, a manufacturing license or wholesale license is required.
