Cipla's AIDS drugs back on WHO list

Wednesday, 01 December 2004, 20:30 IST
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NEW DELHI: Two AIDS drugs of Indian pharma major Cipla Ltd have been reinstated in the approved list of the World Health Organisation (WHO), after being withdrawn earlier. "The WHO is reinstating two anti-retrovirals manufactured by Cipla Ltd., India, in its list of prequalified medicines," WHO said Wednesday. The two medicines, used in the treatment of AIDS, had been delisted by WHO in May this year "due to non-compliance with international standards at the contract research organisations (CROs) hired by Cipla to conduct bio-equivalence tests on the products", the UN organisation said. As a consequence of WHO's delisting, the manufacturer carried out new bio-equivalence studies to confirm that the two medicines are as effective as their respective brand-name counterparts. "Further WHO scientific assessment and inspections have validated the compliance of these new studies, including the CROs involved, with all international requirements," the WHO statement said. "This is good news for patients and another important step forward in our progress towards the 3 by 5 target," WHO Director General Lee Jong-wook said. The two medicines - Lamivudine 150mg tablet blister pack of 10 and Lamivudine 150mg plus Zidovudine 300mg tablet, in blister pack of 10 - are widely used by patients in developing countries.
Source: IANS
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