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How to get CDSCO License in India?

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anand kumar
How to get CDSCO License in India?

The Central Drugs Standard Control Organization (CDSCO) is the National Regulatory Authority for Indian pharmaceuticals and medical devices under the Directorate General of Health Services, Ministry of Health and Family Welfare in India. It is the responsibility of CDSCO to approve new drugs and conduct clinical trials in India under the Drugs and Cosmetics Act, 1940 ("Act") and Drugs and Cosmetics Rules, 1945 ("Rules"). It also lays down standards for drugs and controls the quality of imported medicines and cosmetics, bringing about uniformity in enforcement of Act Rules. All drugs, clinical trials, and cosmetics proposed for use or being used in the country need to comply with Indian regulations and obtain a license from CDSCO before they can be sold and marketed in India.

The CDSCO regulates the matters relating to drugs and cosmetics as per the Drugs and Cosmetics Act and Rules for ensuring public health protection, rights, and well-being. CDSCO (Center Drugs Standard Control Organization) Approval is required for import of APIs, Drug Formulation (e.g., capsules, tablets, injections and ointments), Medical devices, plant and animal products, cosmetics and perfumes, etc. issuing Manufacturing Licenses, Marketing approval, Import License etc. to the manufacturers and importers of the medical products in India. CDSCO registration is compulsory before manufacturing / importing / marketing any drug or cosmetics in India.

The Documents required for CDSCO License:

1.    ID Proof Document.

2.    Undertaking issued by a Government Authority.

3.    Address Proof Document.

4.    Copy of BA/BE Site Registration as approved by CDSCO in case of BA/BE Approved sites Registration.

5.    Manufacturing License or Wholesale Licenses in case of Import or Manufacture of Drugs/Blood Product Registration/Test license Registration.

 

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