Thai FDA certifies quality of Indian-made heart drug

Bangkok - Thailand's Food and Drug Administration (FDA) has certified the quality of the Indian-made generic heart drug Clopidogrel which is 23 times cheaper than its patented alternative Plavix, media reports said Saturday.

"We confirm that every lot of Clopidogrel imported from India has been tested, with its quality and efficacy approved by the Department of Medical Science before being distributed to hospitals," FDA deputy secretary Veerawan Tangkaew said in an interview with The Nation newspaper.

The certification was deemed necessary after hospitals, pharmaceutical companies and individuals questioned the efficacy of the copycat drug which costs only 3 baht (0.08 cents) per pill compares with 70 baht (2.03 dollars) for its patented rival Plavix.

Thailand has already imported 6 million Clopidogrel pills from India under its Compulsory Licensing scheme, that allows the government to import generic pharmaceuticals to treat major diseases prevalent in the country.

The generic pharmaceuticals are only used for patients under the Universal Health Scheme and the Social Security Fund, both of which are heavily subsidized by the government. In theory, private hospitals and their patients must use patented pharmaceuticals.

Thailand's use of Compulsory Licensing, a tactic which is recognized by the World Trade Organization (WTO), has been highly controversial, pitting several multinational pharmaceutical giants against the kingdom. (dpa)