Despite the global health crisis of rising antimicrobial resistance, millions of unapproved antibiotics are being sold in India and this has posed a threat to the international efforts to control antibiotic resistance.
‘This research finds that the extensive sale and use of unapproved antibiotics in India is a threat to the national and international effort to end drug-resistance and should be banned from sale.’
India has among the highest rates globally of antimicrobial resistance and antibiotic consumption
, and parliamentary investigations have highlighted failures of the country's drug regulatory system.
To examine the availability of antibiotics and their approval status in India, a research team analyzed the regulatory records of antibiotics as well as sales data from 2007 to 2012. The analysis included information on fixed-dose combination (FDC) antibiotics (FDC refers to formulations composed of two or more drugs in a single pill) and single drug formulation (SDF) antibiotics (SDF composed of a single drug) on the market in India.
There were 118 different formulations of FDC's being sold in India between 2007 and 2012, compared with 5 in the United Kingdom and the United States. Of these 118 formulations, 64 percent were not approved by the national drugs regulator, the Central Drugs Standard Control Organization, even though the sale of unapproved new drugs is illegal in India. In contrast to FDCs, 93 percent of 86 SDF antibiotics on the market in India had regulatory approval.
The 118 FDC formulations gave rise to 3307 brand-named products made by 476 pharmaceutical manufacturers, including a dozen multinational companies. Multinational companies manufactured 53 of the 118 FDC formulations. Twenty of these were unapproved in India. Only four were approved in the United Kingdom and the United States.
"Selling unapproved, un-scrutinized 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 lead author Patricia McGettigan, MD, of Queen Mary University of London.
The research team argues that changes are needed to achieve the proper use of antibiotics set by the World Health Organization
(WHO). "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 scrutinize the actions of multinational companies
," said senior author Allyson Pollock, MBChB, MSc, of the Institute of Health and Society at Newcastle University.