see also: WHO Media Centre: http://www.who.int/entity/mediacentre/news/notes/2005/np19/en/index.html
WHO, Geneva.
In recent days, the World Health Organization (WHO) has reinstated seven antiretroviral (ARV) medicines manufactured by Ranbaxy Laboratories Ltd which had previously been removed from the WHO list of prequalified medicines. At the same time, three new products produced by Aurobindo Pharma Ltd. have been added to the list.
The addition of ten medicines will benefit existing AIDS programmes and procurement schemes. It will reinforce efforts to scale up access to ARVs in high-burden countries by increasing the choice of quality products in countries which may have only limited capacity to control and monitor medicines. Currently, approximately 6.5 million people in low- and middle-income countries need ARV therapy.
Four of the medicines relisted were withdrawn by the manufacturer in November, 2004; the other three were delisted by WHO in August, 2004. The medicines were taken off the list because WHO inspections of independent laboratories used by the manufacturer to run bioequivalence studies had revealed practices which did not conform with the international standards required by WHO.
Ranbaxy commissioned different laboratories to do new tests on the products' bioequivalence with the originator medicines. Subsequently, WHO ran the full range of quality, safety and efficacy checks on the medicines as well as thorough inspections of the new laboratories. The products and laboratories were all found to be satisfactory. The ten antiretroviral products recently added to the list are:
Ranbaxy products:
- lamivudine 150 mg tablet, bottle (60), blister (10);
- lamivudine/Stavudine 150 mg/40 mg tablet, bottle (60), blister (10);
- lamivudine/Stavudine 150 mg/30 mg tablet, bottle (60), blister (10);
- zidovudine 300 mg tablet, bottle (60), blister (10) ;
- lamivudine/stavudine/nevirapine 150mg/40mg/200mg tablets, bottle (60) ;
- lamivudine/stavudine/nevirapine 150mg/30mg/200mg tablets, bottle (60) ;
- lamivudine/zidovudine 150mg/300mg tablets, bottle (60)
Aurobindo products:
- lamivudine 150mg tablets, bottle (60) ;
- lamivudine 300mg tablets, bottle (60) ;
- zidovudine 300mg tablets, bottle (60)
Ms Daniela Bagozzi, telephone: +41 22 791 4544; mobile phone: +41 79 475 5490, email: bagozzid@who.int