AIDS
Three AIDS medicines have been removed from a pre-qualification list after a laboratory conducting research into the medicines failed to comply with international health and safety standards.
According to a recent report from the World Health Organization (WHO), three antiretrovirals were withdrawn from the list following an inspection of the laboratory, which concluded it did not meet with international standards of good clinical and laboratory practices.
Two different strengths of the triple fixed-dose combination pill containing lamivudine, stavudine and nevirapine as well as a lamivudine plus zidovudine tablet have all been withdrawn from the list until further notice.
WHO said the medicines, which are manufactured by Ranbaxy, will remain excluded until data of new studies become available.
A pre-qualification assessment does not usually include an inspection of the laboratories where the studies are done. However, WHO has said it is extra vigilant when it comes to medicines it prequalifies for use in developing countries, as it wants to ensure they are of the highest standard.
