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Two-thirds of antibiotic combinations sold illegally in India
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Researchers found that 64% of fixed-dose antibiotic combinations were sold illegally in India over a 5-year period.
Many of these unapproved antibiotics were manufactured by multinational companies that had previously pledged their commitment to combat antimicrobial resistance, according to Patricia McGettigan, MD, of the William Harvey Research Institute at Queen Mary University of London, and colleagues.
“India was recently shown to be the largest consumer of antibiotics per capita among 71 countries and to have increasing levels of consumption,” the researchers wrote in the British Journal of Clinical Pharmacology. “Our study demonstrates for the first time that its high consumption is led by rising sales of fixed-dose combinations (FDC) of antibiotics, the majority unapproved by the national drugs regulator, the Central Drugs Standard Control Organization (CDSCO).”
McGettigan and colleagues examined regulatory records and data from PharmaTrac, a commercial database of pharmaceutical sales in India, to investigate the approval status and volume of antibiotics sold from 2007 to 2012. They found that 118 different antibiotic FDC formulations were marketed in India during this time. In comparison, only five FCD formulations were sold in the United Kingdom or United States, or both. Of the 118 FDC formulations, nearly two-thirds had no record of regulatory approval, according to the researchers. In contrast, 93% of single-dose formulations (SDF) were approved in India and more than two-thirds were also approved in the U.K or U.S., or both.
Nearly half of FDC formulations were dual antimicrobials, many of which were “pharmacologically problematic.” For example, some commonly prescribed FDCs were combinations of broad-spectrum antibiotics with anti-protozoal drugs such as ofloxacin-ornidazole and norfloxacin-metronidazole. These drug combinations, which were used to treat diarrhea, may have affected normal gut flora and exacerbated patients’ symptoms, according to the researchers. They identified other FDCs that were “pharmacologically incompatible” with different half-life durations, as well as FDCs with “potentially serious interactions” that could lead to adverse events such as prolonged cardiac QT-intervals and glycemic disorders.
Further analysis showed that 53 of the 118 FDC formulations were manufactured by multinational companies. Twenty of these FDCs were not approved. Among them, 18 were manufactured by Abbott.
“Selling unapproved, unscrutinized antibiotics undermines measures in India to control antimicrobial resistance,” McGettigan said in a press release. “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.”
The researchers noted that more research is needed to understand why providers continue to prescribe unregulated antibiotic formulations.
“Until definitive action is taken to ban most systemic antibiotic FDCs from manufacture and sale, [antimicrobial resistance] initiatives in India are likely to be undermined,” they concluded. – by Stephanie Viguers
Disclosures: The authors report no relevant financial disclosures.
Perspective
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It is discouraging that the pharmaceutical industry continues to manufacture FDCs that clearly associate with the development of resistance. There is no justification for some of these combinations. It seems like India wants to correct the problem, but the country does not have the wherewithal to do it because so many companies are unregulated and producing both approved and unapproved drugs. In the United States, there are only four or five FDCs that are approved. There are pharmacokinetic and pharmacodynamic reasons for that. There are, however, a lot of empiric combinations. The only way to eliminate that is to have more specific and immediate diagnostics. For example, if we can determine that a severely ill patient is infected with Enterobacter, then we can prescribe appropriate empiric therapy for that one organism.
This study points out the global issue that if all countries do not participate in efforts against antibiotic resistance, then we are not going to reach our goals. We can do all that we want in the U.S. to prevent resistance; however, because of cheaper treatment, Americans and others go to India for medical reasons such knee replacement and transplant surgery. Some of these patients have extensive surgery and are going to get infected with resistant organisms, which they may bring back to the U.S. This has happened already. Many American citizens also try to access cheaper drugs in Canada that are imported from Indian pharmaceutical companies. In addition to having so much unregulated production, I am concerned about the content in these drugs. In the U.S., if you are prescribed 500 mg of an antibiotic, you are going to get close to 500 mg. This has reportedly not always been the case in India, where lower content and over-the-counter availability favors the emergence and persistence of drug resistance. This is a big problem as pointed out in McGettigan and colleagues’ research.
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