AEGiS-Bangkok Post: Alarm bells sound over Aids drugs Bangkok PostImportant note: Information in this article was accurate in 2004. The state of the art may have changed since the publication date.
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Alarm bells sound over Aids drugs

Bangkok Post - June 24, 2004
Apiradee Treerutkuarkul


Health authorities are keeping a close watch on two generic Aids drugs made in India after the World Health Organisation (WHO) removed them from a list of pre-qualified products.

Suboonya Hutangkabodi, deputy secretary-general of the Food and Drug Administration, said health authorities were checking whether any lamivudine and zidovudine tablets had been smuggled into the country.

The move follows WHO reports that the two anti-retroviral drugs, produced by Indian company Cipla Ltd, failed to prove bioequivalence of good clinical practices, good laboratory practices and raw data, despite having received certification for production.

Ms Suboonya said lamivudine was once imported for registration in Thailand, but its registration was revoked after authorities found the drug was similar to the GPOVIR formulation, a cocktail of anti-Aids drugs produced by the Government Pharmaceutical Organisation (GPO).

GPO director Thongchai Tawichachart said the removal of the two drugs from the list would not affect the country's effort to curb the Aids virus because the GPO could produce similar generic drugs with proof of bioequivalence for anti-retroviral treatment.


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