Ranbaxy withdraws all its AIDS drugs from WHO list
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《英国医生杂志》
Ranbaxy, an Indian generic drug company, has withdrawn all of its AIDS medicines from the World Health Organization抯 list of recommended drugs, not because they are unsafe or of poor quality, but because they may not be as effective as they should be, a spokeswoman for the WHO said.
The WHO announced Ranbaxy抯 move on 9 November, six months after the health agency removed these and certain other AIDS medicines from its so called prequalification list of essential medicines. The WHO had told its member countries that patients should stop using these delisted medicines unless they were unable to get any of the other recommended products.
Ranbaxy, however, has not commented or explained why it took the step of withdrawing the drugs. A spokeswoman for the WHO, Daniela Bagozzi, said that Ranbaxy had found discrepancies in data intended to prove that the generic or copied AIDS medicines were bioequivalent (had the same effect as the patented originals).
Ms Bagozzi denied suggestions that the move came under direct pressure from the United States, which supports the big drug companies that develop and produce patented products. She said it was a voluntary move by Ranbaxy.
Ms Bagozzi said that the WHO dropped three generic AIDS drugs made by Ranbaxy and two made by Indian company Cipla from the list after inspections at independent contract research organisations that study bioequivalence found discrepancies in data.
She said that the WHO then sent a letter to all manufacturers of AIDS medicines, whose drugs were on the WHO抯 recommended list, asking them to check the data that they had submitted to the WHO on those drugs.
The WHO said that patients should stop using the delisted medicines and switch to alternative products, but if this was not possible—as might be the case in many developing countries that used the drugs—patients should continue using the delisted drugs.
"If it turns out that these drugs are not bioequivalent, they are still safe to use," Ms Bagozzi said, adding that it was riskier for patients to switch to products that were not WHO recommended than to continue with the delisted products which fulfilled all other criteria, including safety and quality.
The WHO said that after Ranbaxy抯 products were delisted, the WHO prequalified list of recommended medicines still included 89 products, of which 54 were antiretrovirals for treating HIV/AIDS.(Geneva Fiona Fleck)
The WHO announced Ranbaxy抯 move on 9 November, six months after the health agency removed these and certain other AIDS medicines from its so called prequalification list of essential medicines. The WHO had told its member countries that patients should stop using these delisted medicines unless they were unable to get any of the other recommended products.
Ranbaxy, however, has not commented or explained why it took the step of withdrawing the drugs. A spokeswoman for the WHO, Daniela Bagozzi, said that Ranbaxy had found discrepancies in data intended to prove that the generic or copied AIDS medicines were bioequivalent (had the same effect as the patented originals).
Ms Bagozzi denied suggestions that the move came under direct pressure from the United States, which supports the big drug companies that develop and produce patented products. She said it was a voluntary move by Ranbaxy.
Ms Bagozzi said that the WHO dropped three generic AIDS drugs made by Ranbaxy and two made by Indian company Cipla from the list after inspections at independent contract research organisations that study bioequivalence found discrepancies in data.
She said that the WHO then sent a letter to all manufacturers of AIDS medicines, whose drugs were on the WHO抯 recommended list, asking them to check the data that they had submitted to the WHO on those drugs.
The WHO said that patients should stop using the delisted medicines and switch to alternative products, but if this was not possible—as might be the case in many developing countries that used the drugs—patients should continue using the delisted drugs.
"If it turns out that these drugs are not bioequivalent, they are still safe to use," Ms Bagozzi said, adding that it was riskier for patients to switch to products that were not WHO recommended than to continue with the delisted products which fulfilled all other criteria, including safety and quality.
The WHO said that after Ranbaxy抯 products were delisted, the WHO prequalified list of recommended medicines still included 89 products, of which 54 were antiretrovirals for treating HIV/AIDS.(Geneva Fiona Fleck)