Last week an Indian generics company delivered a body-blow to millions of Africans. Hetero withdrew six of its anti-AIDS drugs, compounds which were supposed to be generic copies of those which are used to treat the disease in the developed world. The company was following another Indian manufacturer, Ranbaxy Laboratories. As a result, out of the 28 generics AIDS drugs produced by Indian companies pre-qualified by the World Health Organization in May, 18 have now been withdrawn.

Pro-generics pressure groups have downplayed this alarming development. Medecins Sans Frontieres responded: "We are not worried for the safety of our patients. We are confident in the drugs we are using. We can't make an equation that if a drug is removed that it's not a good drug."

Yet this decision betrays thousands of desperately poor and sick Africans who were told by the WHO, generics manufacturers, pressure groups and "experts" ranging from nearly all EU politicians to U.S. Senators Kennedy and McCain, that Indian copycat drugs would save them. Now nobody knows whether the drugs work.

The WHO "pre-qualification" process is in tatters. It had claimed it could treat three million Africans by the end of next year (the "3 by 5" campaign), but it has had to resort to using drugs that had not been properly tested for bio-equivalence to brand name medicines (produced by the likes of GSK and Merck). Indian drug companies provided most of these drugs and now three-quarters of them have been withdrawn.

In August the WHO rejected three anti-retrovirals that it had been buying from Ranbaxy, as well as two drugs made by Cipla, another Indian generics manufacturer, on the grounds that they were sub-standard. Although the two Cipla drugs have now been reinstated, after the WHO received fresh information on bio-equivalence, since then seven more Ranbaxy drugs have been withdrawn, effectively meaning that all that company's AIDS drugs have now been pulled.

Nobody from the WHO nor the companies involved have offered any substantial assistance in managing the recall of these drugs or even providing briefings to African doctors as to the state of their clinical management.

These drug recalls may have calamitous effects, a fact which is well-recognized by health professionals. Resistance is already a problem in many African countries, such as Zimbabwe and South Africa, because drugs are not consistently available, and clinical practice is not always good. If, as seems likely, the recalled drugs were less effective than the branded originals, resistance will have developed even faster, in the same way that failing to complete a course of antibiotics helps the bacteria to develop resistance.

Clinical trials using the withdrawn drugs are now worthless because it cannot be known with any certainty whether a patient who fails to respond to treatment has suffered from some clinical or procedural mistake, or because he was given a bad batch of drugs.

The effect of the recalls leaves patients with an invidious choice: use a possibly sub-standard product; use a brand original drug, which will work, but may cost much more; or use nothing. Take the case of Lucy, a young mother of two children, living in extreme poverty in Zimbabwe. She was very frail, moving slowly to shake my hand, which she did with the support of her left arm. She is on a triple drug therapy, as part of a trial by the Mpilo Hospital in Bulawayo. She was able to walk for the first time in months, and although I didn't realize it at the time, I was seeing her at her best.

A few weeks earlier, she had been put on the children's dose of a branded drug because the doctors thought failure might have been the result of undernourishment. Previously she had been on the adult dose of a different drug and it overpowered her, actually making it harder for her to eat, creating a vicious circle. But now it seems the original drug may not have worked since it was a Ranbaxy cocktail.

Will Ranbaxy offer Lucy compensation, or even an apology? And what of the doctors trying to treat her, hoping that changes of diet and drugs might help? They were making decisions based on false information about the efficacy of the drug.

Lucy told me she couldn't afford the drugs so she felt lucky to be part of the trial. Nevertheless, she was having to buy drugs for asthma and other opportunistic infections. Meanwhile she is raising two children in two rooms of a small house. Lucy only found out her husband had HIV from his death certificate, which is when she was tested and found out she too, was infected. Still, Lucy may yet turn out to be lucky if she is switched to a reliable drug and given a guaranteed supply.

For all the Lucys of Africa it is essential that the US administration sticks to its guns and only buys drugs that are proven to work. And Britain must follow its lead. The WHO drive to treat three million Africans by the end of next year is now sure to fail. WHO should accept defeat, acknowledge blame for its policy of approving untested drugs and apologize to the patients. Then it must work with, rather than against, the US administration to deliver useful drugs in a controlled and responsible way to ensure that patients really do get better.

Roger Bate is a visiting fellow at AEI.