Bangkok Post - February 7, 2009
Apiradee Treerutkuarkul

Since the introduction of the compulsory licensing (CL) policy on certain drugs to help cut treatment costs in the country, many queries have been received over the quality of Indian-made medicines compared to the more expensive patented versions.

Weerawan Taengkaew, FDA deputy secretary-general, said the latest bioequivalence study found the medicine being imported for use in the country from India following the imposition of compulsory licensing had shown the effectiveness of the much cheaper generic version was not inferior to the original being marketed under the name Plavix.

The study was based on an international guideline that demands no less than 30 volunteers be recruited to test the side-effects and efficacy of a generic drug, she said.

"Clopidogrel is being imported for distribution to Thai patients under the universal health care scheme and is of a reliable quality and just as safe for use as Plavix," the FDA deputy chief said. She added the main reason why doctors and hospitals were doubting its quality was that they found it hard to believe the two could be as good because of the wide price gap between them.

The original version, or Plavix, costs 70 baht per tablet whereas the generic one imported from India is priced at less than three baht each.

Since August 2007, the Government Pharmaceutical Organisation (GPO) has imported six million Clopidogrel tablets from the India-based manufacturer Cadilla Healthcare for distribution to state hospitals throughout the kingdom. It has been prescribed to heart patients under both the universal health care and Social Security Fund schemes to employees of private companies and civil servants and their family members.

Previously, the Plavix patent holder had threatened to take legal action against the generic manufacturer and the Thai agency distributing the copycat version.

Moreover, some pharmaceutical companies and individuals have also questioned the quality of the cheaper versions of patented Aids and cancer drugs imported for local use after the announcement of the CL policy in 2006 and 2007.

However, the FDA deputy chief has shrugged off these claims, saying they were just business tricks to discourage the government from introducing the compulsory licensing system.

Pisamorn Klinsuwan, GPO deputy director, said the agency would test the effectiveness of each batch of medicines prior to their import.

So far, there have been no reports on severe side-effects from the generics, be they Aids or cancer regimens imported for use under the CL policy, she said.

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