Johannesburg: Generic drugs distributed in South Africa by Indian pharmaceutical giant Ranbaxy are "safe" and "efficacious", the country's regulator body said today, days after the beleaguered drug maker paid a fine of USD 500 million in the US for selling adulterated drugs there.
"We are confident that drugs currently on the market are safe, efficacious and of quality," Mandisa Hela, Registrar of the South African Medicines Control Council (MCC), told the daily Business Day here.
Hela said representatives from the regulator and those from the World Health Organisation, the UK Medicines and Healthcare Products Regulatory Agency and the Australian Therapeutic Goods Authority, had inspected Ranbaxy's manufacturing sites and were satisfied standards had improved.
The South African subsidiary of India's largest pharmaceutical company has also issued a similar statement, assuring the public that drugs manufactured locally are safe.
This assurance came after the drug maker paid a fine of USD 500 million in the US for falsifying data and selling sub-standard drugs manufactured at two of its plants in India.
Ranbaxy USA had 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).
In 2004, Ranbaxy, which was then in a partnership with South African manufacturer Adcock Ingram, said it was voluntarily withdrawing several AIDS drugs from the South African market, but it subsequently emerged that this had been an order from the MCC which was concerned about the potential risk of the drugs to the public.
Hela told the daily that the MCC had inspected a clinical research organisation in India called Vimta Laboratories that did work for both Ranbaxy and rival generic manufacturer Cipla.
"There were areas that needed improvement and Ranbaxy was informed of them," she said, adding that the MCC had been told records of data that it requested from Vimta had been destroyed in a fire.
Hela said the MCC subsequently re-evaluated Ranbaxy's local applications to register the drugs, and found "there were missing data, changes to dates in documentation and comparative data were not credible".
After the WHO struck several Ranbaxy generic AIDS drugs from its list of pre-approved medicines, the MCC cancelled the local registration of the drugs in October 2004 and ordered the company to recall the medicines.
Hela said that in 2006, after the US FDA suspended imports from Ranbaxy's manufacturing site in Paonta Sahib in India, the MCC conducted its own random tests of Ranbaxy drugs sold in South Africa and found no critical deficiencies.
The generic drugs at issue were manufactured at Ranbaxy's facilities in Paonta Sahib and Dewas in India.
A series of inspections by other regulators in 2007 and 2008 found no further problems either.
Comments
0 comment