Many fixed-dose drug combos in India lack approval: study

India needs to ban the sale of many fixed-dose drug combinations - used to treat diseases such as HIV and TB - which have not received regulatory approval but are sold in huge numbers in the country, scientists say, citing concerns over their safety and efficacy.
Many fixed-dose drug combinations (FDCs), which include two or more active pharmaceutical ingredients combined in a single dosage form, have not received central regulatory approval but are sold in substantial numbers in India, researchers said.
FDCs are used as effective treatments for many conditions, including Parkinson's disease, HIV, malaria and tuberculosis.
The new study provides specific evidence in support of a 2012 report by a committee of the Parliament of India which found that a very large number of FDCs had been licensed by state drug authorities without approval by Central Drugs Standard Control Organisation (CDSCO), the central drug licensing agency, researchers said.

The drugs haven't been thoroughly examined or tested and could put patients' lives at risk, they said.
"In the interests of its patients, 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," Dr Patricia McGettigan, who led the study at Queen Mary University of London, said.

"The wellbeing of patients is paramount. People taking these FDCs need to be reviewed and carefully switched to safe and appropriate alternatives," said McGettigan.
Using information from CDSCO on FDC formulations approved between 1961 and 2013, and FDC sales data between 2007 and 2012 from PharmaTrac (a database of drug sales in India), the researchers analysed approval status and sales volumes of FDCs in four therapeutic areas.

Among these therapeutic areas, of 175 FDC formulations marketed in India between 2011 and 2012, the researchers found CDSCO approval for only 60 (34 per cent).
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 per cent), almost half of anti-psychotic FDC sales (43 per cent), and more than a quarter of non-steroidal anti-inflammatory drug (NSAID) FDC sales (28 per cent).
Multiple formulations included drugs which are restricted, banned, or were never approved in other countries because of associations with serious adverse events including death, researchers said.

"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," Professor Allyson Pollock, Global Health expert and co-author at Queen Mary University of London, added.
The study was published in the journal PLOS Medicine.