CDSCO: Regulating India’s Pharmaceuticals

Central Drugs Standard Control Organization

#GS-02 Healthcare, Governance

CDSCO works under Directorate General of Health Services, Ministry of Health & Family Welfare.
It is the National Regulatory Authority (NRA) of India.
The headquarters of CDSCO is in New Delhi and there are six functioning central drug testing laboratories under CDSCO.

Giving approval of New Drugs,
Conducting Clinical Trials,
laying down the standards for Drugs,
maintain control over the quality of imported Drugs in the country and
coordinating the activities of State Drug Control Organizations by providing expert advice with a view to bring about the uniformity in the enforcement of the Drugs and Cosmetics Act.
CDSCO along with state regulators, is given the joint responsibility for granting licenses of certain specialized categories of critical Drugs.
They include blood and blood products, I. V. Fluids, Vaccine and Serum.

The DCGI establishes the standards for the manufacturing, import, sales, and distribution of drugs in India.
DCGI also responsible for regulation of medical and pharmaceutical devices.
The DCGI is the appellate authority in case of disputes with respect to the quality of the drug.
The DCGI is responsible for preparing and maintaining the national reference standard for drugs.
They ensure the uniformity in the implementation of the Drugs and Cosmetics Act.
They are responsible for the training of Drug Analysts of the State Drug Control Laboratories and other Institutions.
They are also in charge of the analysis of cosmetics received from the CDSCO as survey samples.
The DCGI is also the central licensing authority for medical devices which fall under the Medical Device Rules 2017.