Substandard manufacturing investigated: Ranbaxy under the microscope

Indian manufacturer Ranbaxy is in the news yet again. And, in a trend that seems not too surprising, it’s in the news for all the wrong reasons. Currently, Ranbaxy is under contract with the American Government to provide antiretroviral drugs (for HIV/AIDS) at a lower cost. However, these very drugs are now under the microscope, with investigations last month instituted to examine whether the same are substandard, impotent or unstable. ProPublica (an independent, non-profit newsroom that hopes to bring to light stories of public interest through investigative journalism) has unearthed a U.S. investigation into whether Indian giant Ranbaxy has violated standards set by the Food and Drug Administration (FDA) in its manufacturing process and by concealing the same, engaged in a “pattern of systemic fraudulent conduct” for drugs including those used as a part of the PEPFAR (the American programme ‘President’s Emergency Plan for AIDS Relief’).

Additionally, in what seems like very incriminating evidence, documents filed in Court suggest an effort to cover up the manufacture of these substandard drugs. [Read more about this here].

As of now, despite ongoing investigations, there have been no formal charges pressed against Ranbaxy, nor have some of the drugs been removed from FDA’s approved list of generic antiretrovirals for PEPFAR. While organisations such as ProPublica question the decision to retain these drugs on the Pepfar list and whether US Embassies have been informed of this investigation, the FDA has already passed the buck on to other agencies by claiming that they are not involved in either the purchase or distribution of antiretrovirals through PEPFAR, but only help in accelerating the approval process.

Considering the fact that President Bush in 2007 signed a 5 year extension on the programme PEPFAR programme and that reportedly $131 million is spent on the funding of generic manufacturers under the PEPFAR alone, may be it is time to sit up and take notice of the activities by companies such as Ranbaxy. Despite a reputation as a leading generic manufacturer, regular features in the news in the recent past are an indication of their quick fall. And with the aim to provide some relief through programmes such as PEPFAR still a burning objective, situations such as this : with misuse of funds received to manufacture generic drugs, followed by the effort to keep the same under wraps and the continued manufacture of such substandard drugs, is a step backward, and must be dealt with severely.

Read the full report here and other related reports here and here.


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