Many combination drugs not approved by regulator
11, Dec 2018
Prelims level : GS2: Issues relating to development and management of Social Sector/Services relating to health Mains level : Health
- of the 110 anti-TB (tuberculosis) Fixed Dose Combinations (FDCs) available in India, only 32 (less than 30%) have been approved by the Central Drugs Standard Control Organisation (CDSCO), the country’s drug regulator. In the case of malaria FDCs, only eight out of 20 (40%), have been approved.
Reasons for low status of approval:
- Lack of transparent regulatory framework
- Ambiguity over licensing powers
- Institutional problems such as understaffing, lack of skills, and inadequate infrastructure
- Issuance of manufacturing licenses by the State Licensing Authority without the prior clearance of the Drug Controller General of India DCG(I)
- It is unfortunate that a majority of approved FDCs in the Indian market are irrational and lack scientific justification.
- The scientific rigour of the CDSCO in approving these FDCs has been questioned time and again in Parliamentary and academic reports.
- The rationality of unapproved FDCs should be reviewed and irrational formulations should be banned
About Fixed Dose Combination drugs:
- A fixed dose combination( FDC) drug is one which contains combination of 2 or more APIs (Active pharmaceutical ingredients) in a single form, which is manufactured and distributed in fixed doses. FDCs were earlier produced to treat single diseases but now can also treat multiple diseases if diseases are related.
About Central Drugs Standard Control Organisation:
- The Central Drugs Standard Control Organization (CDSCO) is the national regulatory body for Indian pharmaceuticals and medical devices, and serves parallel function to the European Medicines Agency of the European Union, the PMDA of Japan, the Food and Drug Administration of the United States and the Medicines and Healthcare products Regulatory Agency of the United Kingdom.
About Drug Controller General of India:
- DCGI under gamut of Central Drugs Standard Control Organization (CDSCO) is responsible for approval of licenses of specified categories of drugs such as blood and blood products, vaccines, IV fluids and sera in India.
- DCGI lays down standards and quality of manufacturing, selling, import and distribution of drugs in India.
- It acts as appellate authority in case of any dispute regarding quality of drugs.
- It prepares and maintains national reference standard.
- It brings about uniformity in enforcement of Drugs and Cosmetics Act.
- It trains Drug Analysts deputed by State Drug Control Laboratories and other Institutions.
- The DCGI is advised by the Drug Technical Advisory Board (DTAB) and the Drug Consultative Committee (DCC)