Ranbaxy reassures South Africans local drugs are safe

The South African subsidiary of beleaguered drug maker Ranbaxy, has assured the public that drugs manufactured locally are safe, days after the Indian firm paid a fine of $500 million in the US after pleading guilty to charges of making and selling adulterated drugs.

 

Ranbaxy South Africa holds a 68% stake in Sonke Pharmaceuticals, while Community Investment Holdings (CIH) holds the rest. Sonke Pharmaceuticals won a major tender in 2010 to supply antiretroviral (ARV) drugs for the government hospitals in South Africa.

 

"There are no products, ARV or otherwise, on the South African market, or in any other market in any country that were manufactured during this period," Dale Adkisson, executive head of global quality at Ranbaxy, told the weekly 'Sunday Times'.

 

Adkisson was reacting to concerns in South Africa, a major user of ARV drugs, following the fine imposed on Ranbaxy after the company admitted to making sub-standard drugs, falsifying testing data and lying to US authorities from April 2003 to September 2010, according to the weekly.

 

Ranbaxy USA pleaded guilty to three felony counts under Federal Food Drug and Cosmetics Act (FDCA), and four felony counts of knowingly making materially false statements to the Food and Drug Administration (FDA).

 

The generic drugs at issue were manufactured at Ranbaxy's facilities in Paonta Sahib and Dewas in India.

 

As part of the case's resolution, the whistle-blower, a former Ranbaxy executive Dinesh Thakur will receive about $48.6 million from the Federal share of the settlement amount.

 

Ranbaxy USA also acknowledged that drug samples waiting to be tested were stored for unknown periods of time in a refrigerator, which did not meet specified temperature and humidity ranges for an approved stability chamber, and that this was not disclosed to the FDA.

 

Thakur resigned in 2005 after Ranbaxy executives allegedly covered up the activities he had identified as fraudulent.

 

"All Ranbaxy products distributed to the South African public are, and have been, safe, including from the year 2010 and forward," said Adkisson, adding that they were in compliance with the terms and conditions of Ranbaxy's government-approved applications.

 

Anna Mokgokong, chairwoman of CIH also assured that the drugs made by Sonke Pharmaceuticals in South African markets are safe.

 

"The US case has absolutely nothing to do with Sonke Pharmaceuticals or any South African operations. Other than this joint venture (with Sonke Pharmaceuticals), CIH has no other relationship with Ranbaxy," Mokgokong added.