Get Form 12a Cdsco

At first glance, it's abbreviation soup – EMA, FDA, NIHR, OHRP, IRB – but this collection of organizations is responsible for making sure clinical trials are run properly, to protect patients and develop medicines that are safe and effective.

Documents required to Import Registered Drugs in India Covering Letter. Power of Attorney (original) Application Form. Copy of Import permission. Copy of wholesale/manufacturing license of the Indian Agent. Authorization letter.

Checklist for Import: Covering Letter. Original Power of Attorney. Copy of Import permission for new drug (s) in Form-45 (formulation) or in Form-45A (new bulk drug substances) Copy of Whole sale Licence(20B/21C) or Manufacturing Licence of the Indian agent/Corporate office address. Authorization letter.

At the central level, the Drugs and Cosmetics Act, 1940, has created the Central Drugs Standard Control Organisation (CDSCO), within which the Drugs Controller General of India (DCGI) is the key regulatory authority, acting under the advice of the Drug Technical Advisory Board (DTAB) and the Drug Consultative Committee ...

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.

Major functions of CDSCO: Regulatory control over the import of drugs, approval of new drugs and clinical trials, meetings of Drugs Consultative Committee (DCC) and Drugs Technical Advisory Board (DTAB), approval of certain licenses as Central License Approving Authority is exercised by the CDSCO headquarters.

The CDSCO is the national regulatory and licensing authority for approving drugs in India. The implementing authorities are the central government, through the CDSCO, and state governments, through the state drug licensing authorities.