Paris - In a move that delighted activists campaigning for cheaper AIDS drugs, the World Health Organization on Wednesday made public its first list of drug companies that meet its quality standards, and it included a large Indian generic manufacturer and three smaller European ones.
The decision represented a setback for major multinational pharmaceutical companies, who want only patent-holders to be allowed to sell drugs and decide what discounts to offer. It means that there will be price competition among manufacturers of important anti-retroviral drugs.
Of the 41 drug formulations on the list, which included 11 anti-retroviral drugs and five drugs for the opportunistic infections, funguses and cancers that attack AIDS patients, 26 were no surprise; they come from the major international pharmaceutical manufacturers GlaxoSmithKline, Bristol Myers Squibb, Roche and Abbott Laboratories. But 10 were from Cipla Ltd., the generic drug maker based in Bombay that was the first to try breaking the patent monopolies of large Western companies a year ago by offering AIDS triple-therapy for $350 a year to charities and African governments.
"I am delighted," said Yusuf Hamied, chairman of Cipla. "This proves that we adhere to good manufacturing practices on a par with other companies. It says Cipla is kosher, so now the multinationals can't throw at us what they have said: 'They're Indian, they're Third World, the quality might be iffy.'"
Cipla products whose quality the WHO accepted include the anti-retrovirals nevirapine; zidovudine, better known as AZT, and lamivudine, better known as 3TC. Those three make up one common AIDS cocktail. The WHO also accepted Cipla's acyclovir for shingles infections, ciprofloxacin for bacterial infections and vinblastine and vincristine sulfate for cancers. Companies were asked a year ago to apply for WHO approval, and teams of inspectors from the WHO and Unicef spent up to two weeks at each factory.
Hamied said his factories around India have passed 22 U.S. Food and Drug Administration inspections for various generic products they make for the American market, so he was not surprised he passed. He said he has several other drugs, including the anti-retroviral stavudine, or D4T, that he said he hoped would make the WHO's next list, which is expected in a few weeks. An Indian competitor, Ranbaxy, which makes a three-anti-retroviral combination that it offers for as little $295 a year to customers with 5,000 or more AIDS patients, did not make the list.
A company spokesman, Paresh Chaudhary, said the company was not yet ready to export but hopes its factory in Dewas will pass WHO muster in April. Its antibiotic-production-lines have already passed U.S. inspections, he said.
Dr. Bernard Pecoul, director of a campaign by Medecins Sans Frontieres to force drug prices lower, said he was "totally supportive" of the WHO's inspection and approval plans and said of the first list, "Theoretically, it's excellent because it creates competition." But he expressed frustration that some important drugs were missing. There was not a single approved supplier for fluconazole, the anti-fungal that suppresses cryptococcal meningitis, which gives some AIDS patients agonizing headaches before killing them.