Unsafe and Unapproved Drugs Sold on Large Scale in India, Study Finds

The majority of fixed-dose combination analgesics and antipsychotics on the Indian market have never been approved, leading to the sale of millions of doses of unsafe drugs, a new study concludes.

Researchers in the UK and India found that 73 percent of 124 FDC nonsteroidal anti-inflammatory drugs, 81 percent of 16 antidepressants/benzodiazepines and 70 percent of 10 antipsychotics had not been approved by the Central Drugs Standard Control Organization, according to the study in PLOS Medicine.

Many of the drugs were restricted, banned or never approved in other countries due to their association with serious adverse events, including death, the study says.

The unapproved formulations in turn gave rise to numerous branded products — 43 percent of NSAIDs, 76 percent antidepressant/benzodiazepines and 78 percent antipsychotic, the study says.

The researchers call for an immediate ban on sales and manufacturing of unapproved products and improvements in CDSCO’s transparency and accountability around regulatory decisions.

In 2012, a parliamentary committee issued a scathing report alleging that manufacturing licenses for large numbers of FDC drugs had been issued by state authorities without prior approval. In a January 2013 letter, India’s drugs controller general said that FDC drugs whose safety and efficacy hasn’t been vetted in clinical trials can’t be sold in the country.

The researchers conducted a time-trend analysis of FDC sales volumes from 2007 to 2012 and a cross-sectional examination of 2011 to 2012 data to determine how many approved and unapproved formulations and branded products were on the market.

Patricia McGettison of the William Harvey Research Institute in London, UK, led the study team, which also included researchers from Queen Mary University of London in the UK and the Foundation for Research in Community Health in Mumbai, India. — Jonathon Shacat