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Alleging that Ranbaxy’s two factories – located in Dewas and in Paonta Sahib – have made extensive violations of US requirements, the Food and Drug Administration (FDA) issued the ‘import alert’ for generic drugs manufactured at these two factories. This means that the FDA would ‘block’ the import of nearly 30 generic drugs made by this Indian pharmaceutical company owing to its failure in meeting manufacturing standards.

The FDA’s Import Alert is with reference to drugs like - ‘simvastatin’ and ‘pravastatin’ that lower the cholesterol; the antibiotic ‘clarithromycin’; HIV drugs ‘lamivudine’ and ‘zidovudine’; as well as the diabetes drug ‘metformin’.

Warning letters have also been issued to the company by the FDA, highlighting its ‘concern’ that Ranbaxy – a leading supplier of generic drugs in the US market - displayed ‘deficiencies in the company’s drug manufacturing processes’.

The director of the FDA’s Center for Drug Evaluation and Research, Janet Woodstock, said “With this action we are sending a clear signal that drug products intended for use by American consumers must meet our standards of safety and quality.”

However, the FDA does not have any immediate plans of removing Ranbaxy drugs already on the market, primarily because till date there is no substantial evidence that Ranbaxy ‘has shipped defective products’. Moreover, the FDA’s current move would also not affect products from Ranbaxy’s other drug manufacturing plants.

Dr. Douglas Throckmorton, deputy director of FDA’s Center for Drug Evaluation and Research, said during a teleconference that – “To date, we have seen no evidence of harm to consumers from drugs produced at these two facilities and have no reason to believe that drugs already in the United States from these plans pose a safety problem.”