British researchers have found that many fixed-dose drug combinations (FDCs) in India lack central regulatory approval despite concerns over the safety and efficacy of such combinations. A study led by Queen Mary University of London, revealed that these FDCs are being sold in substantial numbers in India.

In 2012, the Parliamentary Standing Committee on Health & Family Welfare reported that a very large number of FDCs had been licensed by state drug authorities without approval by the Central Drugs Standard Control Organisation (CDSCO).

Patricia McGettigan who led the study at Queen Mary University of London, is of the opinion,

“India needs to ban the sale and manufacturing of fixed-dose drug combinations not approved by the CDSCO — beginning with those which include drugs banned or unapproved internationally and, therefore, most likely to be harmful.”


  • Among 175 FDC formulations marketed in India between 2011 and 2012, the researchers found CDSCO approval for only 60 (34 percent).
  • While almost all Metformin FDC sales were from CDSCO-approved formulations, products with no record of CDSCO approval accounted for
    • Over two-thirds of anti-depressant/benzodiazepine FDC sales (69%),
    • Almost half of anti-psychotic FDC sales (43%)
    • More than a quarter of NSAID FDC sales (28%)
  • Multiple formulations included drugs which are restricted, banned or were never approved in other countries because of associations with serious adverse events including death.

The authors believe, “The well-being of patients is paramount. People taking these FDCs need to be reviewed and carefully switched to safe and appropriate alternatives.”

Allyson Pollock, professor, global health expert and study co-author, says,

“Our research wholly supports the need for a complete overhaul of the new Drugs Bill and we urge the government of India to make this a priority.”

Source: McGettigan P, Roderick P, Mahajan R, Kadam A, Pollock AM. Use of Fixed Dose Combination (FDC) Drugs in India: Central Regulatory Approval and Sales of FDCs Containing Non-Steroidal Anti-Inflammatory Drug(NSAIDs), Metformin, or Psychotropic Drugs. PLoS Med. 2015 May 12;12(5):e1001826

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