/ 11 November 2004

Tests lead to recall of cheap Aids drugs

The campaign to get cheap Aids drugs to millions of Africans was dealt a blow on Wednesday when a manufacturer in India admitted it could not prove the quality of its medicines and withdrew them from the list approved by the World Health Organisation.

Ranbaxy’s action will strengthen the arguments of those in the United States who have insisted that the cheap copies, known as generics, are unproven and potentially unsafe.

Those running the $15-billion emergency plan for Aids relief, launched by President George Bush, back the use of the expensive brand-name drugs from the big multinational pharmaceutical companies which invented them — and which stand to make considerable profits if they are bought in large quantities for developing countries.

But campaigners say poor countries can only afford generics. Buying cheap copies will allow the limited money for Aids relief to go further and save many more lives, they say.

Generics companies, considered pirates by the multinationals that have patents on Aids drugs in Europe and North America, have undercut the price of originals in poor countries where patents do not apply. A year’s treatment that once cost $10 000 can now cost less than $200.

Ranbaxy, one of the leading generics manufacturers in India, has played a part in India’s economic gains. It not only supplies Aids drugs to developing countries but also many generic versions of off-patent medicines to Europe.

According to the WHO, the company has withdrawn all 10 of its Aids drugs because of ”discrepancies in the documentation” which was submitted to the organisation to prove that they were ”bio-equivalent” to the original drugs.

This year, under pressure from the US, the WHO sent in its inspectors to laboratories contracted by Ranbaxy and the other big Indian generics producer, Cipla.

The inspectors were checking studies which appeared to show that the drugs worked as well as the originals had been properly carried out. They discovered flaws in the process and removed three Ranbaxy Aids medicines and two produced by Cipla from its list of approved drugs. It asked the manufacturers to run their own checks on the contract labs.

Now Ranbaxy, having done that, has taken all its Aids drugs off the list.

It appears that the raw data from the small trials in humans carried out by the contract labs — to show, for instance, that the concentration of the generic drug in the bloodstream is the same as with the original — is not consistent with the results given to the WHO.

Ranbaxy’s Aids drugs are used in at least nine developing countries, according to the Global Fund for Aids, TB and Malaria, which gives financial support to developing countries to buy medicines. At least $2-million of Global Fund money has been spent by developing countries on Ranbaxy drugs.

Those countries — Benin, Central African Republic, Côte d’Ivoire, Honduras, India, Malawi, Moldova, Mongolia and Swaziland — should now in principle switch to other Aids drugs, but in practice, the WHO acknowledges, it may be difficult to find alternatives. Ranbaxy is already planning to commission new studies of its drugs in the hope of getting them back on the approved list.

Médecins sans Frontières, whose volunteer doctors use Ranbaxy’s Aids drugs, says it will switch to others where it can. But although it supports the WHO approval process, known as pre-qualification, it is a new development, according to Daniel Berman of MSF.

”Brazil had 100 000 people on [generic] treatment and didn’t have the requirement,” he said. ”We feel like these removals are growing pains of pre-qualification.”

Generics are essential to reaching the target of 3-million people on Aids treatment by 2005, set by the WHO.

Ranbaxy’s problems may affect its sales in the lucrative markets of the developed world, which include the NHS. It is understood regulators are now asking for more information. Nobody at Ranbaxy was available for comment on Wednesday. – Guardian Unlimited Â