Millions of unapproved antibiotics are being sold in India each year, according to a new study published in the British Journal of Clinical Pharmacology. The study also revealed that multinational pharmaceutical companies continue to manufacture dozens of unapproved formulations, despite the global health crisis of rising antimicrobial resistance.
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, researchers 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 (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.
There were 118 different formulations of FDCs 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 Organisation, even though the sale of unapproved new drugs is illegal in India. In contrast to FDCs, 93% 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, 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 lead author Patricia McGettigan, MD, of Queen Mary University of London.
The researchers argue 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 scrutinise the actions of multinational companies,” said senior author Allyson Pollock, MBChB, MSc, of the Institute of Health and Society at Newcastle University.