Generic drugs distributed in South Africa by Ranbaxy Laboratories 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 U.S. for selling adulterated drugs there.
“We are confident that drugs now 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.
Ms. Hela said representatives from the regulator and those from the World Health Organization, the U.K. Medicines and Healthcare Products Regulatory Agency and the Australian Therapeutic Goods Authority, had inspected Ranbaxy’s manufacturing sites and were satisfied.
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 in the U.S. for falsifying data and selling sub-standard drugs manufactured at two of its plants in India.
Ms. Hela told the daily that the MCC had inspected a clinical research organisation in India called Vimta Laboratories that did work for Ranbaxy and rival generic manufacturer Cipla.