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Review indicates a significant amount of marketed, unapproved fixed-dose combination drugs in India

Results from a time-trend analysis and cross-sectional examination indicate a significant amount of unapproved fixed-dose combinations of nonsteroidal anti-inflammatory drugs, anti-depressants and anti-psychotics were marketed in India.

In 2012, an Indian government committee reported state authorities had issued manufacturing licenses for a significant amount of fixed-dose combination drugs without prior approval from the Central Drugs Standard Control Organization (CDSCO).

“Drug regulators internationally have expressed concerns about the quality of medicines manufactured in India,” study researcher Patricia McGettigan, MD, FRCPI, FRACP, of the Barts and the London School of Medicine and Dentistry, and colleagues wrote. “Particular concerns have been approvals for and the proliferation of fixed-dose combination products.”

Patricia McGettigan

Researchers conducted a time-trend analysis of fixed-dose combination drug sales from 2007 and 2012 and a cross-sectional examination of data from 2011 to 2012 to determine drug formulations on the market with or without record of CDSCO approval.

Before May 2002, there were 124 formulations of nonsteroidal anti-inflammatory drugs (NSAIDs) marketed, of which 27% were centrally approved and 73% were unapproved.

There were 25 marketed formulations of metformin, of which 80% were approved and 20% were unapproved. Of the 16 marketed formulations of anti-depressants/benzodiazepines, 19% were approved and 81% were unapproved. Three of the ten marketed formulations of anti-psychotics were approved and 70% were unapproved.

After May 2002, approved fixed-dose combinations increased from 26% to 28% for NSAIDs and from 0% to 38% for anti-psychotics. Approved formulations decreased for metformin (from 100% to 75%) and antidepressants/benzodiazepines (20% to 18%).

Unapproved formulations of NSAIDs accounted for 28% of fixed-dose combination drug sales, unapproved metformin accounted for 0.4%, anti-depressants/benzodiazepines accounted for 69% and anti-psychotics accounted for 43%.

More than 12% of fixed-dose combination drug sales came from internationally restricted or banned formulations of NSAIDs and 53% of sales came from banned anti-psychotics.

“The development of fixed dose combination drugs is becoming increasingly important from a public health perspective and they are commonly used to manage some of the world’s most infectious diseases,” study researcher Allyson Pollock, MBChB, of the Queen Mary University of London, said in a press release. “Benefits such as cost-effectiveness, simple distribution logistics and improved patient adherence all add to their importance. However, these benefits are completed negated when potentially dangerous and unregulated drug combinations are used and given to patients. India needs to build a rigorous foundation for putting safety, effectiveness, rationality and need at the heart of the country’s drug regulatory system.” – by Amanda Oldt

Disclosures: The researchers report no relevant financial disclosures.