Knock, Knock! Who's There? In India, It's A Surprise Visit From FDA Posted Tue, 10/08/2013 - 10:36am by Ed Silverman

The next time a drugmaker in India hears an unexpected knock at the door, there may be an FDA inspector standing on the other side. Why? The agency is planning to follow the same system of facility inspections in India that is followed in the US and other developed countries, including aggressive surveillance and surprise visits, according to LiveMint.

“India has become a priority location for the FDA as it houses the largest number of FDA-approved drug manufacturing plants outside the US and it is also emerging as the largest exporter of generic drugs to that country,” an unnamed source, who is familiar with agency plans, tells the news site. The surprise visits are being considered because of instances where documents have been fabricated as well as growing concerns about human error in Indian manufacturing units.

Indeed, the FDA recently issued an Import Alert on products made at a Ranbaxy Laboratories facility in Mohali, India, just four months after the drugmaker agreed to pay $500 million to the US Department of Justice to settle criminal and civil charges associated with a long-running manufacturing scandal that involved two other plants in India. The violations included fabricating in-house test data and concealing these activities from FDA inspectors by falsifying records. A consent decree remains in force (back story).

Then there was the July warning letter issued to Wockhardt, which was recently banned from making medicines for Europe. An FDA inspector encountered a recalcitrant employee who played hide-and-seek with documents, which was considered a deliberate attempt to stall the inspection. There were also two sets of books for batch records and some problems with sterility, such as urinals located near a storage facility that lacked drain pipes, causing urine to pool on the floor (see this).  

Over the past couple of years, in fact, the FDA has issued a veritable stream of warning letters to Indian drugmakers, including Lupin, Cadila Healthcare and Aurobindo. Another letter was recently sent to Strides Arcolab, or more specifically, the Agila Specialties unit that makes vaccines and injectable drugs, which Mylan Laboratories (MYL) is buying for $1.6 billion in order to expand its product portfolio and geographic reach (read here).

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