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Deshpande P, Rodrigues C, Shetty A, Kapadia F, Hedge A, Soman R. New Delhi metallo-βlactamase (NDM-1) in Enterobacteriaceae: treatment options with carbapenems compromised. J Assoc Physicians India 2010; 58: 147–49. Shetty, P. Medical Tourism booms in India, but at what cost? Lancet 2010; 376: 671–72. Deshpande LM, Mendes, RE, Castanheira M, Mathai D, Bell J, Jones RN. Dissemination of NDM-1 producing Enterobacteriaceae in India. Interscience Conference of Antimicrobial Agents and Chemotherapy. Boston; Sept 11– 15, 2010. C2-701. Centers for Disease Control and Prevention. Detection of Enterobacteriaceae isolates carrying metallo-β-lactamase–United States, 2010. MMWR Morb Mortal Wkly Rep …ver más…

These workhorse agents underpin recommended prescribing guidance for most infections in primary care and for many indications in hospital practice. These antibiotics are disproportionately cheap in comparison to proprietary compounds and are preferred by a cash-conscious health service; in the USA they have even been marketed free of cost.2 Because of their widespread use, generic antibiotics have become increasingly resistant to many common pathogens. For example, about 70% and more than 20% of Escherichia coli isolates causing community or hospitalassociated infections are resistant to amoxicillin and trimethoprim, respectively.3,4 These concerns raise several issues relating to antibiotic licensing and regulation. To be granted a license, a manufacturer of a generic agent has simply to show satisfactory pharmaceutical quality

and bioequivalence to the original agent. There is currently no regulatory requirement to show efficacy of approved indications or to target pathogens, despite major changes in prevailing rates of resistance. There is also no requirement to monitor antibiotic resistance trends and no yardstick by which resistance triggers a review of prescribing indications. Prescribers deserve reassurance that licensed agents remain fit for purpose. The regulatory situation remains unsatisfactory and provides a false sense of security. Furthermore, generic agents dominating prescribing