WHO adds Cipla's two HIV drugs in prequalified list
Geneva: The World Health Organisation today said it will again add two HIV drugs from India`s Cipla in its prequalified list after they were delisted in May for non-compliance of standards.
"The World Health Organisation (WHO) is reinstating two antiretrovirals manufactured by Cipla Ltd, India, in its list of prequalified medicines," WHO said in its website.
The two medicines were 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 bioequivalence tests on the products, it 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.
According to WHO, the firm carried out new bioequivalence 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," it said.
The two medicines Lamivudine 150 mg tablet and Lamivudine 150 mg, plus Zidovudine 300 mg tablets are widely used by patients in developing countries.
WHO`s prequalification programme aims to make quality medicines available for the benefit of those in need. This is achieved through its evaluation and inspection activities and by building national capacity for sustainable manufacturing and monitoring of quality medicines.
The list of prequalified medicinal products used for HIV/AIDS, malaria, tuberculosis and for reproductive health produced by the programme is used principally by United
Nations agencies, including UNAIDS and UNICEF to guide their procurement decisions.
Reacting to the development, Cipla shares today moved up nearly 2 per cent and finally settled at 321.65 on Bombay Stock Exchange, up 1.48 per cent from its previous close.