Many state licensed drugs in India sold without central regulatory approval

A new study has revealed that many fixed-dose drug combinations (FDCs) are sold in large amount in India, even though they have not received central regulatory approval.

FDCs include two or more active pharmaceutical ingredients combined in a single dosage form. They are used as effective treatments for many conditions, including Parkinson's disease, HIV, malaria and tuberculosis.

In 2012 however, a committee of the Parliament of India reported a very large number of FDCs had been licensed by state drug authorities without approval by CDSCO (the Indian central drug licensing agency) - meaning they haven't been thoroughly examined or tested and could put patients' lives at risk.

Dr Patricia McGettigan, who led the study at Queen Mary University of London, said that India needed to ban the sale and manufacturing of unapproved fixed-dose drug combinations, beginning with those which include drugs banned or unapproved internationally, and therefore most likely to be harmful.

The researchers analysed approval status and sales volumes of FDCs in four therapeutic areas:

Formulations containing a non-steroidal anti-inflammatory drug (NSAIDs, for pain relief)

Formulations containing metformin (for diabetes)

Formulations containing an anti-depressant or a benzodiazepine or both (for depression/anxiety)

Formulations containing an anti-psychotic drug

Array

Among these therapeutic areas, of 175 FDC formulations marketed in India between 2011-2012, the researchers found CDSCO approval for only 60 (34 percent). Whilst 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 percent), almost half of anti-psychotic FDC sales (43 percent), and more than a quarter of NSAID FDC sales (28 percent).

Multiple formulations included drugs which are restricted, banned, or were never approved in other countries because of associations with serious adverse events including death.

Co-author Professor Allyson Pollock added that their research wholly supports the need for a complete overhaul of the new Drugs Bill and they urge the government of India to make this a priority.

The study is published in PLOS Medicine.