INDIA: WHO Hurting Cheap AIDS Drugs Industry – Experts

By Ranjit Devraj Reprint | | Print |

Ranjit Devraj

NEW DELHI, Aug 13 2004 (IPS) - Indian medical experts see the hand of powerful Western drug manufacturers in the World Health Organisation’s withdrawals of its recommendations, this month and earlier in May, for some of India’s cheap and popular combination drugs against HIV/AIDS using generic ‘copycats.’

Generic ‘copycats’ are alternatives to brand name drugs and according to WHO requirements they must show pharmaceutical equivalents – which means that the amount of active ingredient, the dosage form, and the strength are identical to those of a comparable brand.

The generic must also be bio-equivalent, meaning the drug must be absorbed into the blood stream at roughly the same rate and extent as the pharmaceutically equivalent brand.

Amit Sengupta, a medical expert with the Delhi Science Forum , a leading policy watch group told IPS that while WHO’s stated concern for quality was ”unexceptionable” it did have the effect of putting generic combination antiretroviral drugs (ARVs) into disrepute in a highly competitive global market.

”It needs to be asked why WHO decided to open speculation on quality and, going by past record, it is quite possible that the world body has come under pressure from the Western pharmaceutical giants,” said Sengupta.

Antiretroviral drugs are substances used to kill or inhabit the multiplication of retroviruses such as HIV.

With one in four new HIV cases being reported from Asia, the sprawling continent is on the verge of being felled by an AIDS epidemic that would dwarf the devastation wrought by the killer disease in Africa, the Joint United Nations Programme on HIV/ AIDS (UNAIDS) warned.

By the end of 2003, Asia had an estimated 7.4 million people living with HIV out of the 38 million adults and children infected with the human immunodeficiency virus (HIV) world-wide, UNAIDS revealed in its latest report.

On Aug 4, WHO announced it was dropping three generic drugs manufactured by India’s largest pharmaceutical manufacturer, Ranbaxy Laboratories Ltd., from its ‘pre- qualification list’ for failing to prove that their generic drugs that go into the combinations had the same bio-equivalence as the patented originals.

Those three drugs, lamivudine, stavudine and nevirapine are ingredients in a popular, fixed-dose, triple-combination pill called ‘Triviro’ a cheap and convenient first line treatment alternative to expensive patent medicines taken separately and therefore less conducive to compliance.

Sengupta said WHO’s recommendation was not legally binding but could create further confusion over the issue of drug access and result in donor agencies coming under pressure to withdraw support for the drugs in question.

The WHO decision seemed to be in line with repeated claims made by Western drug manufacturers and U.S. government officials that generic drugs do not have the same quality standards as the patented ones.

Late May, WHO withdrew from its pre-qualification list, two drugs that go into another Indian triple-combination, fixed-dose pill ‘Triomune’ manufactured by Cipla Ltd., the Indian pharmaceutical company credited with introducing the ‘dollar-a- day’ treatment that dramatically transformed the ARV drug access scenario.

Cipla was subsequently able to prove that its product met WHO’s bio-equivalence standards but not before funding agencies, including Medecins Sans Frontiers, temporarily suspended support for it in several poor countries in Asia and Africa.

WHO’s pre-qualification list was created to guide procurement by aid agencies that are fighting the HIV/AIDS epidemic and includes more than 60 anti-retroviral drugs made by both patented and generic drug manufacturers.

Some activists said WHO’s policies hurt or delayed its own campaign to reach ARVs to three million people who needed them in the developing countries but has so far managed to get it to fewer than 450,000 sufferers.

But others said, to be fair to WHO, the organisation made clear that its target was not the generic combinations themselves but the contract research organisations (CRO) hired by the Indian manufacturers and their questionable standards.

”While the three Ranbaxy products to be removed from the list meet quality specifications, proof of bio-equivalence is missing in view of non-compliance of good clinical and laboratory practices as well as data handling requirements found in the contracted laboratory,” the WHO statement said.

Sanjay Pujari, director of the HIV unit at the well-known Ruby Hall Clinic in the western city of Mumbai said generic, fixed dose combinations have definite advantages over patented ones which had to be taken separately in a six-pill-a-day regimen.

Pujari, who led a study on generic combinations the results of which are expected to be published this month, said he has had patients on these drugs for more than three years and has reported good response acknowledged by WHO.

”WHO has recommended use of fixed dose combinations for treatment of HIV infection in a meeting in Dec. 2003 where we presented our data on generic anti-retroviral combinations,” Pujari, who is also Assistant Professor of Internal Medicine at the U.S.-based University of South Florida, said in an interview.

Ranbaxy’s Vice President Ramesh Adige claimed that his company’s fixed dose combinations have ”demonstrated their safety and efficacy in the treatment of HIV/AIDS patients in many countries since 2001.”

Adige said Ranbaxy planned to get around its current bio- equivalence problems by approaching a CRO in the United States and file its ARVs for use under the U.S. President’s Emergency Plan for AIDS relief (PEPFAR).

The plan by President George Bush is a 15 billion U.S. dollar initiative over five years designed to turn the tide in combating the global HIV/AIDS pandemic.

Through PEPFAR the US government hopes to help prevent 7 million new infections, treat 2 million HIV-infected people with life-saving drugs, and care for 10 million HIV-infected individuals and AIDS orphans.

”Ranbaxy is committed to supply its range of ARVs at affordable prices to HIV/AIDS patients throughout the world,” Adige declared.

Sengupta at the Delhi Science Forum observed that Cipla and Ranbaxy may actually benefited commercially from the publicity generated by the withdrawals since they have emerged as champions of drugs access cause.

At any rate Cipla, has had no qualms in filing for patents on its ‘inventive’ combination drug Triomune in several countries even if its ingredients are copycat generics.