From The New York Times, 16 June 2004
By Lawrence K. Alyman & Donald G. McNeil Jr.
The World Health Organization has pulled two generic antiretroviral drugs from its list of approved H.I.V. drugs that are most often used in poor countries, saying a routine check found the manufacturer had not proved that they were biologically equivalent to patented drugs.
It is the first time that W.H.O. has removed any H.I.V. drug from its list, Lembit Rago, an official of the Geneva-based agency, said yesterday. drugs it finds acceptable for procurement by United Nations agencies. But, he said, the problem was not expected to interfere with W.H.O.'s initiative to treat three million H.I.V.-infected people, mostly in Africa , by next year.
Cipla, an Indian company that has been in the forefront of getting generic drugs approved for use in poor countries, made the two generic drugs, lamivudine, which is also known as 3TC, and zidovudine, which is also known as AZT. The action follows the Bush administration's recent announcement of a significant shift in its AIDS policy to allow the purchase of cheaper generic drugs for Africa and the Caribbean . Cipla said the situation was "on the mend" and that it expected its drugs to be put back on the list within a matter of weeks. The problem was detected during an inspection of an independent laboratory that Cipla had hired to conduct bioequivalence studies among volunteers whose blood had been tested after they took the generic drugs.
The tests were devised to determine whether the concentration of the generic drug in the blood was the same as in its patented counterpart. Dr. Rago did not provide the name of the company that did the testing. A review found that the company's documents did not meet the standards known as good clinical and laboratory practice, Dr. Rago said in a telephone interview from Washington , where he was attending a meeting. Despite the inspection's findings, the generic drugs may be bioequivalent to the patented drugs. But W.H.O. had to remove them because the documentation was lacking, Dr. Rago said. Inspections have found similar problems with the bioequivalency of many drugs in countries in Europe and the United States , Dr. Rago said. He also said many developing countries do not require bioequivalency testing. Cipla's chairman, Dr. Yusuf K. Hamied, said the problem was due to inadequate record keeping in the testing laboratory in Bombay . Dr. Hamied, reached by telephone in London, said that Cipla's lamivudine has been tested for bioequivalency in a laboratory in the United States and approved by the Food and Drug Administration and that he would submit that data to the health agency. Dr. Hamied said the testing was done for the American drug agency because Cipla hopes to sell generic lamivudine when an American patent expires in 2006.
W.H.O. did not issue a news release about the problem after it was detected in May. Dr. Rago said such an announcement was not necessary because his agency had informed other United Nations agencies about the problem and had posted the delisting on its Web site, http://www.who.int. GlaxoSmithKline of Britain holds the American patents on lamivudine (3TC) and zidovudine (AZT).