Ranbaxy drugs are safe, says SA regulator

PTIJohannesburg Last Updated:June 5, 2013 |20:36 IST

Generic drugs distributed in South Africa by pharmaceutical giant Ranbaxy are "safe" and "efficacious", the country's regulator body said on Wednesday, days after the beleaguered drug maker paid a fine of $500 million in the US for selling adulterated drugs there.

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.

"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 Ranbaxys manufacturing sites and were satisfied standards had improved.

The assurance comes in the wake of the drug maker paid a fine of $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).

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

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.

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Ranbaxy drugs are safe, says SA regulator