Fixed dose combinations (FDCs) misuses in India

According to a study by the Queen Mary University in London and the Newcastle University, published in the British Journal of Clinical Pharmacology, Indians are consuming  dangerous Fixed Dose Combinations (FDCs) antibiotics that are not approved by the country’s drug regulator Central Drugs Standard Control Organisation (CDSCO).

What the study says?

  • The study, titled, ‘Threats to global antimicrobial resistance control: centrally approved and unapproved antibiotic formulations sold in India‘, says that of the 118 FDCs sold in India, 64%  did not have approval from the drug-quality regulator, the Central Drugs Standard Control Organisation. Selling of unapproved drugs is illegal, and yet, Indian companies and MNCs continued to be in flagrant violation the policy.
  • Out of 118 FDCs—available under 3,307 brand-names made by 476 companies, including MNCs— Only 43 were approved by the CDSCO, while five were approved by the U.S. and the U.K. drug regulators. 
  •  Seven of the FDCs that were not approved by the CDSCO were among the top 20 bestselling FDCs in 2011-12 in India. Surprisingly, 16 of these 20 bestselling FDCs were not approved in the U.S. and the U.K. either.
  • The study gives the example of  a combination of ofloxacin and cloxacillin  FDC, which is not approved by the CDSCO, is the second-most popular Indian FDC.
  • Even some approved drugs were also irrational, For example, ofloxacin and the anti-protozoa drug ornidazole were mixed even though they had different dosing schedules and it could worsen diarrhoea.
  • The study says that around 42% of the Fixed Dose Combinations sold in India in 2011-12 included at least one ‘highest priority critically important antimicrobials’ as  designated by the WHO. These are last resort antibiotics for human life. 
  •  In March 2016, the Central Government had banned 344 FDCs.  All India Drugs Action Network  approached the Supreme Court against this arbitrary order. The Supreme Court, while upholding the ban after appeals from pharma companies, has referred the issueto the Drugs Technical Advisory Board to examine the cases afresh.  

What are FDCs

  • Fixed Dose Combinations (FDCs)  are a blend of two or more drugs to maximise drug efficacy and can promote antibiotic resistance if they are not designed rationally.

Threat  to life

  • Indians are one of the highest antibiotics consumers of the world. It also means increased threat to life due to danger posed by resistance to antibiotics. 
  • According to a study,  antibiotics resistance kills around 700,000 globally, by 2050, the figure could reach 10 million, of which 2 million will be Indians.  



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