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.
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Full citation: "Threats to global antimicrobial resistance control: Centrally approved and unapproved antibiotic formulations sold in India." Patricia McGettigan, Peter Roderick, Abhay Kadam, and Allyson Pollock. British Journal of Clinical Pharmacology. Published Online: February 5, 2018, DOI: 10.1111/bcp.13503.
URL Upon Publication: http://doi.wiley.com/10.1111/bcp.13503
Author Contact: To arrange an interview with the author, please contact Joel Winston, Public Relations Manager - Medicine and Dentistry, Queen Mary University of London, at j.winston@qmul.ac.uk or 0207 882 7943.
About the Journal: The British Journal of Clinical Pharmacology has the primary goal of publishing high quality research papers on all aspects of drug action in humans. The journal has a wide readership, bridging the medical profession, clinical research and the pharmaceutical industry, and is published monthly. It is owned by the British Pharmacological Society and published by Wiley. The journal's current Impact Factor is 3.83 (Thomson Reuters Science Citation Index).
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The British Pharmacological Society is a charity with a mission to promote and advance the whole spectrum of pharmacology. Founded in 1931, it is now a global community at the heart of pharmacology, with over 3,500 members from more than 60 countries worldwide. The Society leads the way in the research and application of pharmacology around the world through its scientific meetings, educational resources and peer-reviewed journals: the British Journal of Clinical Pharmacology, Pharmacology Research & Perspectives, and the British Journal of Pharmacology, which includes the Concise Guide to PHARMACOLOGY, featuring open access overviews of the key properties of over 1,700 human therapeutic targets and their drugs, and links to http://www.guidetopharmacology.org.
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