The reinstatement of seven generic antiretroviral drugs produced by Ranbaxy Laboratories Ltd in India on WHOâ€™s list of prequalified medicines will reinforce efforts to ensure access to affordable quality AIDS drugs in poor countries, the global health agency stated Friday. WHO also announced that three new medicines produced by the Aurobindo Pharma Ltd laboratories â€” another Indian company that produces generic antiretrovirals (ARVs) â€” were included on the list.
NGOs active in the fight against HIV/AIDS had denounced a campaign by the big pharmaceutical companies to discredit the effectiveness of generic drugs, which are lower-cost copies of the medicines patented by the drug corporations. According to activists and manufacturers of generic ARVs, the campaign was aimed at spreading the idea that the generic drugs produced in India and other developing countries like Brazil may be inferior or even dangerous.
The WTO Agreement on Trade-Related Aspects of Intellectual Property Rights (TRIPS) allows developing countries to issue compulsory licences for the manufacture of generic drugs in cases of public health emergencies like the AIDS epidemic. There are no longer any reasons for taking precautions against the drugs produced by Ranbaxy or the other prequalified generics, said WHO spokeswoman Daniela Bagozzi, who said it was 100 per cent safe to use the drugs.
WHO had removed three of Ranbaxyâ€™s generics from its list of prequalified medicines a year ago, stating that they had not been proven to be equivalent to their patented counterparts. Ranbaxy, Indiaâ€™s leading pharmaceutical company, then decided to withdraw all of its ARVs from the WHO list, in November. ARVs slow down the development of the disease and lengthen the lifespan of those living with HIV/AIDS. They are called antiretroviral drugs because they attack HIV, which is a retrovirus.
The Ranbaxy medicines were taken off the list because â€œWHO 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,â€ said the global agency. WHO set up its prequalification project in 2001 to facilitate access to medicines that meet unified standards of quality, safety and efficacy for HIV/AIDS, malaria and tuberculosis.
Once they are approved, the generic drugs are requalified after three years, or earlier if necessary.
The International Conference of Drug Regulatory Authorities (ICDRA), made up of more than 100 national medicines regulatory authorities, formally recommended in 2001 and 2004 that WHO should continue its prequalification of medicines. AIDS is the leading cause of death in the countries of sub-Saharan Africa, where an average 7.4 per cent of the population is living with HIV. Worldwide, 39 million people were infected with HIV as of late 2004, and 3.1 million people died of AIDS that year, including 510,000 children.
WHO, which estimates that some 6.5 million people in low and medium-income countries are in need of antiretroviral treatment, said the inclusion on the list of the 10 ARVs produced in India â€œwill benefit existing AIDS programmes and procurement schemes.â€ â€” IPS