BMJ 2015;350:h2517 doi: 10.1136/bmj.h2517 (Published 13 May 2015)

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NEWS Many fixed dose drug combinations for sale in India are not approved Ingrid Torjesen London

Large numbers of fixed dose drug combinations—formulations that contain two or more active compounds in a fixed ratio of doses—are being sold to patients in India without having been approved by central regulatory authorities for safety and efficacy, research published this week in PLOS Medicine has found.1 In 2012 an Indian parliamentary committee reported that state authorities had issued manufacturing licenses for “large numbers” of fixed dose drug combinations despite their not having been approved by the Indian central drug licensing agency (the Central Drugs Standard Control Organisation) and warned that this could be putting patients at risk.2

Researchers from Barts and The London School of Medicine and Dentistry and Queen Mary University of London in the UK and the Foundation for Research in Community Health in Mumbai, India, used data from the Central Drugs Standard Control Organization to quantify the sales of non-approved fixed dose drug formulations in four therapeutic areas—those containing a non-steroidal anti-inflammatory drug for pain relief, metformin for diabetes, an antidepressant or a benzodiazepine or both for depression or anxiety, or an anti-psychotic drug. They looked at formulations approved by the agency between 1961 and 2013, and analysed sales data from 2007-12 from PharmaTrac, a database of drug sales in India. They found that in these four therapeutic areas a total of 175 fixed dose drug combinations were marketed in India in 2011-12 but that only 60 of these (34%) had been approved by the central agency. The proportions varied markedly between therapeutic areas—80% of 25 marketed formulations containing metformin were approved but only 27% of 124 formulations containing a non-steroidal anti-inflammatory drug, 19% of 16 anti-depressant or benzodiazepine formulations, and 30% of ten anti-psychotic formulations.

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Almost all sales of fixed dose drug combinations containing metformin (99.6%) were of centrally approved formulations, but non-approved formulations accounted for over two-thirds of the sales of anti-depressant or benzodiazepine combinations (69%), almost half of the sales of anti-psychotic combinations (43%), and more than a quarter of the sales of non-steroidal anti-inflammatory drug combinations (29%). Many of the formulations on the market included drugs that were restricted, banned, or had never been approved in other countries because of associations with serious adverse events. This was the case for 13.6% and 53% of the sales of non-steroidal anti-inflammatory drug and anti-psychotic combinations, respectively.

The researchers called for India to implement “an immediate ban on sales and manufacturing of fixed dose drug combinations not approved by the Central Drugs Standard Control Organization.”

They said, “Withdrawal from the market should be staged, prioritising fixed dose drug combinations that include drugs banned or unapproved internationally and potentially most likely to harm patients.” Prescribers should “review the needs of patients taking these fixed dose drug combinations, taper off the drugs, and substitute appropriate alternatives . . . with monitoring of benefit/need.” 1


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 drugs (NSAIDs), metformin, or psychotropic drugs. PLoS Med 12:e1001826. Mudur G. India signals crackdown on dubious fixed dose drug combinations. BMJ 2013;347:f4588.

Cite this as: BMJ 2015;350:h2517 © BMJ Publishing Group Ltd 2015


Many fixed dose drug combinations for sale in India are not approved.

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