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HEALTH: WHO Reinstates Generic HIV Drugs from India

Gustavo Capdevila

GENEVA, Aug 19 2005 (IPS) - The reinstatement of seven generic antiretroviral drugs produced by Ranbaxy Laboratories Ltd in India on WHO’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 (World Health Organisation) also announced that three new medicines produced by the Aurobindo Pharma Ltd laboratories – another Indian company that produces generic antiretrovirals (ARVs) – were included on the list.

Non-governmental organisations 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 World Trade Organisation (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 underlined that these products are 100 percent safe.

Bagozzi underlined that WHO does not believe that only people living in rich countries have a right to quality affordable anti-HIV drugs.

WHO had removed three of Ranbaxy’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, India’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 “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,” said the global agency.

These studies guarantee the generic copy drug’s “bioequivalence” to the patented product.

But WHO said Friday that after Ranbaxy commissioned different laboratories to do new bioequivalence tests, “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.”

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 percent 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 “will benefit existing AIDS programmes and procurement schemes.”

The decision will also “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,” said Bagozzi.

The Ranbaxy drugs reinstated on the list are seven different combinations of Lamivudine, Lamivudine/Stavudine, Zidovudine and Lamivudine/Stavudine/Nevirapine. The Aurobindo products are tablets of Lamivudine and Zidovudine.

Ranbaxy commented at its headquarters in Gurgaon, near New Delhi, that “This significant development should unlock ARV supplies and make it easier for developing countries to access affordable generic ARVs, and scale up treatment rapidly.”

Ranbaxy CEO Brian Tempest said the relisting of the company’s products by WHO and the earlier approval by the U.S. Food and Drug Administration (USFDA) “will ensure that HIV patients have access to quality generic ARVs, irrespective of the funding programme in their country.”