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• W2016397968 abstract "Byline: G. Swaminath True Lies In a blow to the revenues of India's largest pharmaceutical manufacturer and one of the world's leading generic companies, the United States Food and Drug Administration (FDA) has blacklisted about 30 generic drugs being manufactured by the company at two of their manufacturing sites, citing failure to adhere to current Good Manufacturing Practices requirements. US has not sought a ban nor sought withdrawal of the products manufactured from the blacklisted sites, as the FDA's repeated testing and review led the agency to conclude that there is no reason to question the safety or effectiveness of blacklisted drugs.[sup] [1] There are many who feel that this action by the FDA is unduly harsh and probably protectionist. However, the FDA wants to send a clear signal that drug products intended for use by American consumers must meet their standards of safety and quality.[sup] [1] To those around the world who were cursing India for its poor drug regulatory record, the present FDA sanction seems like divine retribution. It is nevertheless unfortunate that the axe has fallen on a company with a reputation for the affordability and safety of its generic drugs. India has the notoriety of being a major producer of the world's counterfeit drugs. Counterfeit drugs form 10% of the world's drug trade according to the World Health Organisation (WHO). Globally, this trade in fake medicines is one of the fastest growing grey economies - after prostitution, narcotics, terrorism, and arms trade.[sup] [2] Mashelkar Committee,[sup] [3] which studied the various aspects of the growing threat from spurious drugs, quoted figures which varied from 0.5% (from state authority figures) to a widely quoted 35%, taken from a report in the Lancet in 2001[sup] [4] ostensibly based on WHO figures. average figure over studies is 15-20%, with the annual rate of growth at 25%, and manufacturing concentrated in northern states of India. WHO, however, clarified it had not conducted any study that had said that 35 per cent of world's spurious drugs are produced in India. It added, The majority of the Indian pharmaceuticals are produced by large manufacturers according to WHO Good Manufacturing Practices (GMP)![sup] [5] This kudos from the WHO is gratifying as India also is a leading source of high quality drugs sold by legitimate drug manufacturers, at affordable prices, sometimes at as low as a tenth of the cost in other countries, as is seen with psychiatric medication. According to the WHO,[sup] [2] counterfeit in relation to medicinal products means the deliberate and fraudulent mislabelling with respect to the identity, authenticity, effectiveness, composition and/or source of a finished medicinal product, or ingredient for the preparation of a medicinal product. Counterfeiting can be applicable to both generic and branded products as well as traditional remedies. Imitation : Best Form of Chicanery? Counterfeit products may include i) products with correct ingredients, but containing insufficient or erroneous quantities of active ingredients, or expired active ingredients either to save cost or owing to poor quality control factors; ii) wrong ingredients with possibly toxic elements and impurities and therefore directly harmful to patients; iii) without active ingredients or using similar class of cheaper ingredients to escape detection; iv) produced by unhygienic manufacture, or lack of rigorous cleaning between production batches; or v) products with false or misleading packaging.[sup] [2],[6] situation is complicated by the fact that counterfeit drugs often contain active pharmaceutical ingredients, if only because the producers are keen to both avoid detection and generate repeat business. drugs may be ineffective and dangerous as well as difficult to spot because they use active ingredients which are from similar class, for e. …" @default.
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• W2016397968 date "2008-01-01" @default.
• W2016397968 modified "2023-09-27" @default.
• W2016397968 title "Faking it - I <i>The Menace of Counterfeit Drugs</i>" @default.
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• W2016397968 doi "https://doi.org/10.4103/0019-5545.44743" @default.
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