Introduction
The Central Drugs Standard Control Organization (CDSCO) headed by the Drugs Controller General (India) is the Central Authority for regulating the quality of drugs marketed in the country under the Drugs and Cosmetics Act, 1940 and Rules thereunder.
The import, manufacture, distribution and sale of Drugs, Cosmetics and Medical Devices in the country are regulated under the provisions of the Drugs and Cosmetics Act, 1940 & Rules made thereunder i.e. Drugs Rules, 1945, Medical Devices Rules, 2017, New Drugs & Clinical Trials Rules, 2019 and Cosmetics Rules, 2020.
The CDSCO with its Headquarters in New Delhi has 08 Zonal offices, 06 Sub-Zonal offices, 08 Central Drugs Testing Laboratories and 16 port Offices.
The functions of CDSCO is as under:
- Approval of new drugs and clinical trials
- Import Registration and Licensing
- Licensing of Blood Banks, LVPs, Vaccines, r-DNA Products, issuance of WC
- Import of all Medical Devices and Manufacture of Medical Devices (Class C & D)
- Amendment to D &C Act and Rules
- Banning of drugs and cosmetics
- Grant of Test License, Personal License
- Pharmacovigilance
- Capacity Building, Workshops and symposia
The objective of the drug regulatory system is to ensure availability of safe, effective and quality drugs, cosmetics and medical devices based on scientific excellence and best possible regulatory practices.
The mission is to safeguard and enhance the public health by assuring the safety, efficacy and quality of drugs, cosmetics and medical devices.
Website link of the institute
https://cdsco.gov.in/opencms/opencms/en/Home/Last Updated On 05/11/2024
