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September, 2006 Pragati Maidan, New Delhi, India |
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Ranbaxy Withdraws AIDS Drugs From South Africa
Concerns over quality raised by clinical company
Ranbaxy Laboratories has withdrawn its entire AIDS drug portfolio from South Africa after concerns on quality were raised. This effectively ends Ranbaxy`s bid to participate in the multimillion-rand AIDS drugs tender of the South African government. Ranbaxy has just withdrawn the antiretroviral (ARV) range of drugs used for the treatment of AIDS from South Africa.
Ranbaxy recalled the ARVs citizen problems with the clinical trial company, which conducted studies to determine whether the drugs offered the same therapeutic benefits as the originals. The development comes at a time when the company is planning to go for fresh listing of ARVs with the WHO by the year-end. In fact, the WHO de-listing of Ranbaxy`s three generic ARVs in early August 2004 had little impact on the South African markets, which follows its own regulatory system – Medicines Control Council. Moreover, only one of the drugs in question, a combination of lamivudine and zidovudine, was registered in South Africa.
However, Ranbaxy has now accepted that subsequent clinical studies by the company have identified similar problems with the entire ARV range that was marketed in South Africa – Lamaid, Nevran, Zidaid and Avocomb. The company has also written to healthcare professionals in South Africa to return all batches of these formulations to their wholeseller or to the company.
Ranbaxy has big plans in South Africa and has partnered a South African pharmaceutical company, Adcock Ingram, in form of a joint venture, Thembalami Pharmaceuticals which is focused on marketing generic AIDS drugs. Thembalami currently imports its AIDS drugs from India, but plans to start local manufacture once its production site is approved by MCC.
After Ranbaxy`s withdrawal, the government will have to choose between Aspen Pharmacare of South Africa and Cipla, the only other Indian Company short listed in the tender process. The other bidders for the tender are Aboot, Boehringer Ingelheim, Bristol Meyers Squibb, GSK and Merck Sharpe Dohme.
Date: 28-Oct-2004
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