GUYANA'S GENERIC ARV MANUFACTURING CALLED INTO QUESTION
Guyana is facing the possibility of no longer manufacturing its own antiretroviral (ARV) drugs because of mounting pressure from the international donor community for the drugs to come from an approved source or to undergo a bioequivalence test, according to local reports. The country manufactures generic ARV drugs, which should contain the same active substances as original brand-name ARV drugs. A key element for a generic drug is establishing bioequivalency -- meaning that the drug must produce the same biological availability of the active substance in the body when given in the same quantity as the original.
Guyana's ARVs are procured from the New Guyana Pharmaceutical Corporation (NGPC), which is not a U.S. FDA-approved supplier. The Global Fund to fight AIDS and Malaria, based in Switzerland, has set such approval as a condition for its financing of the purchase of ARVs.
Guyana should source its ARVs, says the Global Fund, from other countries that produce generic FDA-approved drugs. However, Guyanan Health Minister Leslie Ramsammy has noted that the country's government is not prepared to adhere to this condition as it would be too costly -- approximately $4 million per drug.
Nonetheless, international aid agencies like the Global Fund have been trying to ensure that generic drugs produced in various parts of the world adhere strictly to the manufacturing process, and have requested bioequivalence tests for Guyana's ARVs.
Approximately 1,500 people are receiving ARV treatment under the government's current program.