Central Drugs Standard Control Organisation (CDSCO)

Category: Health & Regulatory Governance | GS Paper II and III

SEO Title: CDSCO: Functions, DCGI, Drug Regulation and Medical Device Rules in India

UPSC Notes

The Central Drugs Standard Control Organisation is India's central regulatory authority for drugs, clinical trials and specified health products.

  • Administrative authority: Directorate General of Health Services, Ministry of Health and Family Welfare.

  • Head: Drugs Controller General of India (DCGI).

  • Principal legislation: Drugs and Cosmetics Act, 1940, and associated rules.

  • New Drugs and Clinical Trials Rules: 2019.

  • Medical Devices Rules: 2017.

  • Major functions: Approval of new drugs and clinical trials, import registration, oversight of vaccines and blood products, and coordination with state drug regulators.

  • State regulators: Responsible for much of the licensing and enforcement relating to drug manufacturing and distribution within their jurisdictions.

  • Quality assurance: Drug contamination incidents, including those involving diethylene glycol and ethylene glycol, have highlighted the importance of manufacturing quality standards.

  • Schedule M: Relates to Good Manufacturing Practices (GMP) requirements.

  • SUGAM: Online portal associated with regulatory services.

Key Pointers for Prelims

  • CDSCO is the central drug regulatory organisation.

  • DCGI heads the organisation.

  • State drug controllers have important licensing and enforcement functions.

  • Schedule M is associated with Good Manufacturing Practices.