64% of antibiotics sold in India between 2007 and 2012 unapproved, says study
New Delhi: The rampant sale of unapproved antibiotics in India continues, triggering antimicrobial resistance in the country.
A study published in British Journal of Clinical Pharmacology on Monday revealed that out of 118 different formulations of fixed dose combinations (FDCs) being sold in India between 2007 and 2012, over 64% were not approved by the national drugs regulator, the Central Drugs Standard Control Organisation (CDSCO). Only five of these formulations were approved in the UK or US.
The research done by Queen Mary University of London and Newcastle University found that multinational companies continued to manufacture many unapproved formulations between 2007 and 2012, despite pledging to tackle rising antimicrobial resistance.
The researchers examined figures for FDC antibiotics (formulations composed of two or more drugs in a single pill) and single drug formulation (SDF) antibiotics (composed of a single drug) being sold in the Indian market.
“The 118 FDC formulations gave rise to over 3,300 brand-name products made by almost 500 pharmaceutical manufacturers, including multinational companies. By 2011-12, FDCs made up a third of total antibiotic sales in India, yet 34.5% of these sales (comprising 300 million Units) were unapproved formulations. Many of the FDCs combined two antimicrobials, often poorly chosen and likely to exacerbate resistance problems,” the study said.
The study also found that multinational companies manufactured nearly 20% of the FDCs and SDFs sold. Over 20 FDC formulations manufactured by multinational companies had no record of CDSCO approval, and only four of the 53 FDC formulations made in India by multinational companies had UK or US regulatory approval. In contrast, 94% of multinational companies’ single drug formulations were CDSCO-approved, and over 70% had UK or US regulatory approval.
India is one of the countries that has the highest antibiotic consumption rates and sales in the world and has had parliamentary investigations into failures of the country’s drug regulatory system. According to the ministry of health and family welfare, rising antimicrobial resistance is a major challenge in India.
“Selling unapproved, unscrutinised antibiotics undermines measures in India to control antimicrobial resistance. Multinational companies should explain the sale of products in India that did not have the approval of their own national regulators and, in many cases, did not even have the approval of the Indian regulator,” said Patricia McGettigan from Queen Mary, author of the study.
The researchers argue that changes needed to achieve the World Health Organization’s (WHO) vision of good use of antibiotics include banning the sale of unapproved FDC antibiotics and enforcing existing regulations to prevent unapproved and illegal drugs reaching the market.
Improved access to healthcare to reduce non-prescription sales is also needed, along with research to understand why doctors prescribe unapproved antibiotics.
“Limiting antimicrobial resistance is a strategic goal of the WHO and countries worldwide—governments and regulators must take all necessary steps to prevent the production and sale of illegal and unapproved medicines and scrutinise the actions of multinational companies,” said Allyson Pollock, director of the Institute of Health and Society at Newcastle University.