Ban on Fixed-dose Combination Drugs

iasparliament Logo
July 26, 2018

Why in news?

The Drug Technical Advisory Board has recommended banning 343 “irrational” fixed-dose combination (FDC) drugs

What are FDC drugs?

  • An FDC drug is one that contains two or more active ingredients combined in a fixed dose to form a single drug.
  • Several cough syrups, painkillers and dermatological drugs in India are FDCs.
  • Some are marketed with licenses approved only by state regulatory agencies instead of the Drug Controller General of India.
  • These FDCs could be irrational and unsafe for consumption, with potential health risks.  
  • Rampant use of FDCs has allowed antibiotic resistance to assume threatening proportions in India.
  • However, not all FDCs are unsafe as some are crucial to treat chronic illnesses like diabetes and HIV.

How did the issue evolve?

  • Ban - In 2016, the Ministry of Health and Family Welfare had implemented a ban on 349 FDCs.
  • It included popular brands like Saridon, Corex, D Cold Total, and Vicks Action 500 Extra, etc.
  • The government says there are enough single drug alternatives that are safer and effective.
  • Committee - The ban was based on recommendations of the Chandrakant Kokate committee.
  • It said FDCs are "unsafe" and "irrational" for consumption, posing health risks.
  • Court - On pharma companies challenging the ban, the matter was taken to the Supreme Court.
  • Drug makers argued that the statutory bodies on drug regulations were not consulted before the ban.
  • Eventually, the Supreme Court referred the matter to the Drug Technical Advisory Board (DTAB).
  • It directed the DTAB to make a fresh review of the issue with fixed-dose combination drugs.

What are DTAB's findings?

  • Most of the pharma companies had not generated safety and efficacy data of their own for their FDCs.
  • Almost 95% of the appellants failed to prove safety, rationality and compatibility of these FDCs.
  • The indications for which these FDCs were mentioned were too "vague" and not "as per treatment guidelines."
  • For most FDCs, their use would lead to "unnecessary over use".
  • So, patients would be exposed to risk of multiple ingredients, when actually one would suffice.
  • Over the years, India has become a dumping ground for irrational FDCs that are not approved in other countries.
  • Decision - The DTAB in a meeting held recently re-inforced the ban on 343 of the 349 drugs.
  • It, however, felt restricted use could be allowed for six FDCs.
  • The DTAB would forward its report to the health ministry soon.

What are the implications?

  • The market size of the banned drugs is estimated to be around Rs 20-22 billion.
  • The ban, if comes into force, will thus impact the country’s top drug-makers.
  • These FDCs roughly contribute to 1.8% of the overall domestic drug market.
  • The FDC segment is already on a slower growth rate (4.7% in June) compared to the rest of the domestic drug market (8.6%).
  • These 343 FDCs are only a small portion of the FDCs that are sold in the country.
  • The bigger uncertainty would be the additional 944 FDCs that were identified by the Kokate committee as being irrational.
  • The DTAB may look at these products now, and the coverage of the ban is expected to expand.


Source: Economic Times, Business Standard


Quick Fact

Drugs Technical Advisory Board

  • DTAB is the apex body to decide on technical matters related to drugs in the country.
  • It is constituted as per the Drugs and Cosmetics Act, 1940.
  • It functions as part of the Central Drugs Standard Control Organization (CDSCO) in the Ministry of Health and Family Welfare.
Login or Register to Post Comments
There are no reviews yet. Be the first one to review.



Free UPSC Interview Guidance Programme