Poor Regulation of Antibiotics in India Creates Global Nightmare
​​[Posted on: Thursday, February 8, 2018]

Drug companies openly sell unapproved antibiotic combinations in India creating a terrifying scenario of prevalence of multidrug resistant bacteria creating incurable infections. There have been several reported cases of the multidrug resistant bacteria infecting travelers bringing the infections to other countries worldwide. According to research study published this week in the British Journal of Clinical Pharmacology, 118 multi-antibiotic combination formulations are sold in India, of which 75 had no record of regulatory approval and only 5 formulations were approved in the UK and/or US. The multi-drug combinations could contain one or more antibiotics combined with other agents such as beta-lactamase inhibitors, lactobacilus, mucolytics, and secretolytics. Most of the manufacturers of these products are India-based companies; 464 out of 476 manufacturers; but 12 multinational drug companies (MNCs) are also included in the list of offenders. These are: Abbott, Astra Zeneca, Baxter, Bayer, Eli Lilly, GlaxoSmithKline (GSK), Merck/MSD, Novartis, Pfizer, Sanofi-Aventis, and Wyeth. The MNCs produce a much higher proportion of the unapproved antibiotic combination formulations; 53 of the 118 formulations, and account for about 1 in 5 of the unapproved products sold annually. Among the twenty top-selling antibiotic formulations, 90% of multidrug combinations and 100% of the single antibiotic formulations are MNC-manufactured. Antibiotics are over-prescribed to dangerous levels, with several formulations containing antibiotics on the WHO list of highest-priority critically important drugs, which should be used sparingly due to high risk of developing resistance. And all this is done openly, without any regulatory oversight. Regarding the spread of global infections, flu and other viral infections generally dominate the news due to the rapid spread across boundaries and quick symptoms. Multidrug resistant bacteria are generally associated with hospital acquired infections and usually spread through injury or surgery. There are about 2 million bacterial infections and 23,000 deaths each year in the US compared to about 10-35 million infections, up to 710,000 hospitalizations, and up to 56,000 deaths linked to flu infections. However, multidrug resistant bacteria are increasingly a concern for travelers. To control global spread of diseases, it is important to harmonize enforcement of regulations across national boundaries. Right now it is primarily a problem in India but it could quickly spiral out of control into a global concern.