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Banning the drug Valdecoxib In India

The National Pharmaco Vigilance Advisory Committee has prohibited the sale and manufacture of the drug// Valdecoxib, indicated for arthritis and acute pain in India under the Drugs and Cosmetics Act.

Studies done abroad have indicated that the drug Valdecoxib is found to double the risk of heart attacks and strokes and also result in severe skin reactions.

Although some of the leading pharmaceutical companies have stopped manufacturing it and have withdrawn the drug from the Indian market, a few leading companies differ in opinion and have adopted a “wait and watch” approach as a result of which they have still not withdrawn the drug from the market.

Some of the leading drugs manufacturing companies in India also have a major market-share in the product, with sales amounting to Rs.25 crore another reason for their reluctance to withdraw the drug from the market.

According to US officials, the request for withdrawal of the drug was made by the FDA after seeking approval from a committee they had constituted for advice on the issue. Higher authorities in the Indian Drug Manufacturers Association however feel that based on US models, the drug should not be banned in India as each countries requirement are different and withdrawal and approval of drugs should be made accordingly.


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