Roger Bate
8 October 2008
opinion
Kampala — The US Food and Drug Administration (FDA) has just banned 30 drugs from India's giant Ranbaxy Laboratories because of quality fears but Ranbaxy continues to supply the developing world with other drugs that are not checked for quality.
The US President's Emergency Plan for AIDS Relief (PEPFAR) later suspended purchases of Ranbaxy drugs too, after buying $9m last year, mainly for Africa, but this has not been matched by the other agencies and countries that supply low-quality drugs to poor countries supplied in line with World Health Organisation recommendations.
Deficiencies in HIV anti-retrovirals (ARVs) or in malaria drugs can increase patient resistance to drugs and help the disease mutate into new and virulent forms. Rising resistance in sub-Saharan Africa, Thailand and Cambodia is a time-bomb that will increase deaths from AIDS and will multiply the cost of treatment many times over.
The FDA says its action against Ranbaxy Paonto Sahib and Dewas plants is "preventive." It has known about problems at Ranbaxy plants for several years but it recommends that consumers continue taking their medications manufactured by Ranbaxy, so the ban seems to be a punishment for Ranbaxy refusing to allow an audit rather than any immediate fear about drugs sold in the US: none of those has failed quality tests.
But back in 2005 a whistleblower from Ranbaxy contacted me with evidence of safety-data manipulation, including data on HIV drugs for Africa. We forwarded this to US authorities and the WHO. In June 2006, the FDA warned Ranbaxy that it would recommend withholding approval of Paonto Sahib products until deficiencies were corrected. A year later, the company counsel admitted that it had not yet addressed all of the FDA concerns. Early this year, the FDA inspected both suspect plants and found serious violations.
Then in July this year, the US Department of Justice said allegations from reliable sources and supporting documents indicate a pattern of systemic fraudulent conduct. It said Ranbaxy uses active pharmaceutical ingredients (API) from unapproved sources, blends unapproved API with approved API, and uses less API in its drug than had been approved by the FDA.
But since its investigation began in early 2007, the FDA has approved 18 Ranbaxy drugs for the US, PEPFAR has bought $9m of its HIV drugs (not certified in the US) and distributed more than 1.8 million packages to 15 countries, mainly in Africa.
Ranbaxy says except for issues that have already been fully aired with the US government, it knows of no evidence to support the Justice Department case and no charges have been laid.
The Indian government has called for a swift resolution and the Commerce Department has hinted it will complain, perhaps through the World Trade Organisation. But speed is not as important as establishing good precedent. The FDA is right to insist on upholding standards: badly made life-saving drugs can create life-threatening resistance.
It throws down the gauntlet to the Global Fund, the European Union, the Clinton Foundation and all the agencies and countries using the WHO pre-qualification list of medicines which are approved for developing countries but which have not passed the tests demanded in rich countries: the list is designed to encourage local production rather than to save lives.
These donors and governments know about the FDA allegations against Ranbaxy and the long-standing deficiencies of other suppliers but have not yet altered procurement. The WHO did suspend Ranbaxy anti-retrovirals from its pre-qualification list in 2004 but re-instated them in 2006.
As the contaminated milk horror grows in China, quality control in food and drug manufacturing in the rapidly-developing world is a matter of life and death. India already supplies 75% of the world's counterfeit and sub-standard drugs.
US patients have the FDA, the Justice Department and Congress on their side but no-one is protecting the interests of the poor in developing countries: this scandal must be seized by governments, charities and pressure groups to impose quality control on the WHO pre-qualification list and save patients in Africa and Asia.
The writer is a resident fellow of the American Enterprise Institute think-tank
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