India sends inferior drugs to Africa – study

Nitai Udan works at a pharmacy in Kolkata on Monday, March 14, 2011. Photographer: Brent Lewin/Bloomberg

Nitai Udan works at a pharmacy in Kolkata on Monday, March 14, 2011. Photographer: Brent Lewin/Bloomberg

Published Sep 19, 2014

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Anna Edney Washington

GENERIC drugs that some Indian firms sent to African countries were lower quality than the same medicines the companies sold at home and outside Africa, according to tests of 1 470 samples, researchers have said.

Two widely used antibiotics and two tuberculosis 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 suggested Indian drugmakers might be sending low-quality drugs to poorer countries, the authors wrote.

US Food and Drug Administration inspections have found quality issues at Indian drug manufacturers, such as faking and manipulating tests meant to ensure the active ingredient works as it should. The administration has banned 36 manufacturing plants in India, including facilities operated by Ranbaxy Laboratories and Sun Pharmaceutical Industries, from sending product to the US. The paper did not say which drug firms made the samples.

“Inferior versions can be both fatal to the patients and promote drug resistance,” 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 and Sun Pharm declined to comment. Krishnan Ramalingam, a Ranbaxy spokesman, did not 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 firms. They took 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 on Wednesday. “This is legal producers working out where they’re going to send low-quality drugs.”

Research found 17.5 percent of samples of the tuberculosis therapy rifampicin sold in Africa tested substandard – 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, the paper said.

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 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 did not contain any active ingredient and were likely to have been counterfeits from China.

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.

The Indian government also did not expect the same quality standards as other health regulators, said Mark Dybul, the executive director of the Global Fund to Fight Aids, Tuberculosis and Malaria.

“India has been a massive problem,” he said. – Bloomberg

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