FDCs & CDSCO (Syllabus: GS Paper 3 – SCI & TECH)

Context: The Central Drugs Standard Control Organization (CDSCO) has allowed companies to manufacture and market five fixed dose combinations (FDCs) that were banned last year.

Fixed Dose Combinations

• About: FDC refer to products containing one or more active ingredients used for a particular indication(s). 
• FDCs can be divided into the two groups

oFirst group of FDCs: Includes those in which one or more of the active ingredients is a new drug.

oSecond group FDCs: Includes those in which active ingredients already approved/marketed individually are combined for the first time, for a particular claim and where the ingredients are likely to have significant interaction of a pharmacodynamic or pharmacokinetic nature.

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: CDSCO 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: CDSCO 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.