Page 3 - Guidance document for import of Drugs & Pharmaceuticals from India

INDIAN DRUG REGULATORY MECHANISM

Public health is one of the major objectives of Govt. of India and to achieve this

it is important that drugs/vaccines are available to the public are Quality,

Safety and affordable. Manufacture, sale, distribution, export, import of drugs

in India are governed by both Centre and State Governments under the Drugs

& Cosmetics Act, 1940 and Rules 1945 thereunder. At Central level, CDSCO

(Central Drugs Standard Control Organization) is the organization headed by

Drugs Control General (India). CDSCO is a separate division that comes under

Ministry of Health. At State level, each State has its own FDAs/Drugs Control

Administrations.

Functions of CDSCO

At Central level, CDSCO performs the following important functions:

 Approvals of new drugs and clinical trials

 Import Registration and Licensing

 License approving of blood banks, LVPs, Vaccines, r-DNA products and

some Medical Devices

 Amendments to Drugs& Cosmetics Act and Rules

 Grant of Test License

 No Objection Certificates (NOCs) for Export, Testing of New Drugs

 Clearance of import/export of Drugs & Pharmaceuticals