CDSCO: Regulating India’s Pharmaceuticals

CDSCO: Regulating India's Pharmaceuticals

Central Drugs Standard Control Organization

#GS-02 Healthcare, Governance

For Prelims

Central Drugs Standard Control Organisation (CDSCO):

  • 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.

Functions of CDSCO:

CDSCO is granted a multitude of responsibilities under Drugs and Cosmetics Act, these include;
  • 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.

Drug Controller General of India

  • The Drug Controller General of India (DCGI) is the head of CDSCO.

Functions of DCGI:

  • 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.