Thousands of unapproved antibiotics being sold in India, says UK study

Thousands of unapproved antibiotics are being sold in India by the multinational pharmaceutical companies in violation of the regulatory rules, British researchers have reported.

Analysing Indian regulatory records, they found that out of 118 fixed dose combinations (FDC) being sold in India, 64% were not approved by the Central Drugs Standard Control Organisation. Only five of the formulations were approved in the UK or US.

The 118 FDC formulations gave rise to over 3,300 branded products made by almost 500 pharmaceutical manufacturers, including multinational companies.

By 2011-12, the FDC made up a third of total antibiotic sales in India, yet 34.5% of these sales were unapproved medicines. Many of the FDC combined two antimicrobials, often poorly chosen and likely to exacerbate resistance problems.

"Selling unapproved, unscrutinised antibiotics undermines measures in India to control antimicrobial resistance. The companies should explain the sale of products that didn't have the approval of their own national regulators and, in many cases, did not even have the approval of the Indian regulator," said Patrician Gigantic, lead author of the study at Queen Mary University of London.

The study comes a month after the Supreme Court asked the Centre to examine 349 FDC medicines - banned by the government, but the order was stayed by the court - to find out if there is any "therapeutic justification" to make these DCMS in the first place.

The researchers examined figures for the FDC antibiotics (formulations composed of two or more drugs in a single pill) and single drug formulation (SDF) antibiotics (composed of a single drug) on the market in India.

They reported that multinational drug companies manufactured nearly 20% of the FDCs and SDFs. As many as 28 FDC manufactured by then had no record of the CDSCO approval, and only 4 of the 53 FDC made in India by these firms had UK or US regulatory approval.

In contrast, 94% multinational companies' single drug formulations were CDSCO-approved, and over 70% had the UK or US regulatory approval.

Each year, irrational FDCs worth Rs 40,000-50,000 crore is sold in India as against nearly Rs 10,000 crore worth of scientific combinations, according to estimates by pharmaceutical industry watchers.

The study carried out jointly by the researchers at Queen Mary and Newcastle universities have been published in the British Journal of Clinical Pharmacology.