Following the instances of de-listing certain antiretroviral (ARV) drugs from its pre-qualification list recently, the World Health Organisation (WHO) has sent a warning letter to all manufacturers of HIV/AIDS drugs participating in the pre-qualification project. The letter urged companies to verify the data they had submitted to WHO and to ensure compliance with good practices at the sites where the studies were conducted.
WHO's warning letter is in the backdrop of its removal of Indian HIV/AIDS drugs from the approved list after inspections at the independent laboratories that conducted bioequivalence studies revealed discrepancies between the original results and those presented to the WHO.
Following the inspection, WHO had noted non-compliance with international guidelines on good clinical and good laboratory practices while conducting the bio-equivalence studies for these products.
With this finding, the ARV drugs of Indian drug majors like Ranbaxy and Cipla had been disqualified from the WHO's pre-qualification list finding that the bioequivalence studies for these products were not conducted in compliance with the international standards.
Subsequently, Ranbaxy had withdrawn all its anti-AIDS drugs from the WHO's approved list after failing to prove that the generic antiretrovirals were equivalent to the branded products.
The WHO de-listing had affected seven ARV drugs of Ranbaxy, which includes Indinavir, Lamivudine and Nevirapine. However, the company is now planning to submit new studies of the seven drugs from March onwards.
After Ranbaxy's voluntary withdrawal of its products from the pre qualification list, WHO had also removed two ARV drugs of another Indian major Cipla and another three of Ranbaxy from the list of approved products earlier this year.