India’s Poor Quality Drugs End Up in Africa, Study FindsAnna Edney
Generic drugs that some Indian companies send to African countries are lower quality than the same medicines the companies sell at home and outside Africa, according to tests of 1,470 samples, researchers said.
Two widely used antibiotics and two TB treatments, purportedly made in India, are more likely not to have enough of their key active ingredient when sold in Africa, compared with the same pills sold in countries such as Russia and China, according to a paper from the National Bureau of Economic Research. The findings suggest Indian drugmakers may be sending low-quality drugs to poorer countries, the authors wrote.
U.S. Food and Drug Administration inspections have found quality issues at Indian drug manufacturing facilities, such as faking and manipulating tests meant to ensure the active ingredient works as it should. The FDA has banned at least 36 manufacturing plants in India, including facilities operated by Ranbaxy Laboratories Ltd. and Sun Pharmaceutical Industries Ltd., from sending product to the U.S. The paper doesn’t say which drug companies made the tested samples.
“Inferior versions can be both fatal to the patients and promote drug resistance that undermines the future effectiveness of even good quality medicines,” researchers said in the report. “Making poor-quality antibacterials can be a lucrative business because the quality problem is hard to detect by end users.”
The Organisation of Pharmaceutical Producers of India declined to comment. Sun Pharma also declined to comment. Krishnan Ramalingam, a Ranbaxy spokesman, didn’t respond to an e-mail seeking comment.
Researchers led by Roger Bate, an American Enterprise Institute scholar, and funded by the The Legatum Institute and the Humanities Research Council of Canada, collected 1,470 products that claimed to be made by 17 Indian manufacturers. The took the samples from pharmacies in Africa, India and middle-income countries, including China, Russia and Brazil.
“We’re seeing, from the same companies, drug companies sending worse-quality drugs to certain countries,” Bate said at a briefing yesterday in Washington. “This is legal producers working out where they’re going to send low-quality drugs.”
The researchers found 17.5 percent of samples of the tuberculosis therapy rifampicin sold in Africa tested substandard, which means the drug has less than 80 percent of the active ingredient that it should. In India, 7.8 percent of the medicine sampled was substandard, according to the paper.
Almost 9 percent of samples of the widely used antibiotic ciprofloxacin sold in Africa tested substandard, compared with 3.3 percent in India and none in other countries. Of the four drugs tested, the authors collected only ciprofloxacin outside of Africa and India since drug availability varies depending on disease prevalence.
In total, 10.9 percent of the products collected failed an assessment of their active ingredients, 7 percent of which were considered substandard. The rest that failed were falsified, meaning they didn’t contain any active ingredient and were likely counterfeits from China, the researchers said.
The risk of being caught in Africa is low because “countries are typically poorer, have a less educated population and do not function well in regulating drug quality,” the authors wrote.
There is also a distinction between companies that follow the rules and others that don’t. More substandard drugs come from firms in India that haven’t registered in the countries they’re selling in and more falsified drugs claim to be from registered companies, though are likely counterfeit, according to the paper.
The Indian government also doesn’t expect the same quality standards as other health regulators, said Mark Dybul, executive director of the Global Fund to Fight AIDS, Tuberculosis and Malaria.
“India has been a massive problem,” Dybul said at the briefing in Washington. The Indian government, for example, procures the cheapest and lowest quality drugs to combat tuberculosis among its citizens, while treatments bought by aid organizations are of much higher quality, even when purchased from companies in India, Dybul said.
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