CENTRAL DRUGS STANDARD CONTROL ORGANISATION (Syllabus: GS Paper 2 – Health)

Context:Central Drug Regulatory Authority (CDSCO) has advised post-marketing surveillance to generate safety and efficacy data  on a third FDC that belongs to a class of painkillers called non-steroidal anti-inflammatory drugs

Central Drugs Standard Control Organization (CDSCO)

• About: CDSCO establishes standards and measures to ensure the safety, effectiveness, and quality of drugs, cosmetics, diagnostics, and medical devices within the country.
• Headquarters: New Delhi.
• 6 Zonal Offices of CDSCO: Mumbai, Kolkata, Chennai, Ghaziabad, Hyderabad, and Ahmedabad.
• Ministry: Ministry of Health & Family Welfare.
• Under the Drugs and Cosmetics Act:

oCDSCO is tasked with the approval of drugs, conduct of clinical trials, and establishment of standards for drugs.

oThis coordination aims to ensure uniform enforcement of the Drugs and Cosmetics Act, contributing to a standardized and regulated pharmaceutical landscape in the country.

• Export Regulation:

oCDSCO plays a role in regulating the export of drugs from India.

oManufacturers with CDSCO certification can export drugs to other countries, expanding India's pharmaceutical presence internationally.

• Function:

oApproval of new drugs and clinical trials.

oImport Registration and licensing.

oBanning of drugs and cosmetics.

oTesting of new drugs.