South Africa withdraws TB drugs because of quality concernsBMJ 2008; 337 doi: https://doi.org/10.1136/bmj.a1385 (Published 20 August 2008) Cite this as: BMJ 2008;337:a1385
South African health authorities have withdrawn two generic drugs widely used in the country to treat tuberculosis, amid concerns about their quality.
When the health minister, Manto Tshabalala-Msimang, announced the withdrawal earlier this month she said that her department had received information suggesting that the ingredients in the two combination drugs, called Antib-4 and Ebsar, “were not at the level stated in the label after storage.”
Antib-4 combines pyrazinamide, ethambutol, isoniazid, and rifampicin. Ebsar is a combination of isoniazid and rifampicin.
Both drugs are manufactured in India by Rusan Pharma and imported into South Africa, where they are registered to another company, MDI.
The health minister said that a laboratory accredited by the World Health Organization had found that at least two of the four ingredients in Antib-4 and both ingredients in the other drug were below the required level.
Further tests are being undertaken before the Medicines Control Council takes any action, Mrs Tshabalala-Msimang said. Meanwhile as a precautionary measure she had decided to “withdraw from circulation” all the stocks of drugs that had been manufactured four or more months earlier.
The minister said that Pharmascript, the South African company that distributes the drugs in the public healthcare sector, had offered to provide replacements of the same drugs of more recent manufacture.
In a statement Pharmascript said that it is “extremely concerned about the allegations, and we have undertaken to maintain communications and cooperation with the department to establish the truth about the two products in question.”
Graham Somerville, an executive of Pharmascript, said that there were no clinical indications that anything was wrong with the drugs. His company had been told that a whistleblower, believed to be from a rival company, had contacted the health department to say that the quality of the drugs was “wanting.”
Both his company and the Indian company had tested the drugs and had not found any problems, he said. “We test each batch, and the drugs were as they were supposed to be.”
The prevalence of tuberculosis in South Africa is among the highest in the world, and multiple drug resistant and extensively drug resistant tuberculosis is a fast growing problem.
Drugs for the public healthcare sector in South Africa are purchased through a tender system, and companies supplying cheaper generic drugs fill much of the demand. But concerns have recently been raised that in poorer countries too much emphasis is put on low cost at the expense of quality (Journal of Tropical Medicine and International Health www3.interscience.wiley.com/journal/120747094/abstract).
The health minister’s announcement came less than a week after the government was forced to withdraw two generic versions of antiretrovirals. The manufacturer, Adcock Ingram, said that one of its employees had swapped the contents of batches of nevirapine and zidovudine. The company was recently fined by competition authorities for its part in rigging tender bids in the public hospital system (BMJ 2008;336:413, doi: 10.1136/bmj.39497.390069.DB).
Cite this as: BMJ 2008;337:a1385