Has the US Food and Drug Administration (FDA) become fastidious in its scrutiny of Indian pharmaceutical plants registered with it? Information received by FE from the USFDA making use of that country’s Freedom of Information Act (the US equivalent of India’s Right to Information Act) shows that although the FDA has been rigorous and frequent with its inspections of Indian units over the last few years, only a tiny fraction of these inspections has escalated into serious adverse actions like issuance of warning letters to the Indian firm concerned or the more damaging import alerts.
The FDA told FE that it had given as many as 403 intimations of violations of its manufacturing norms to Indian plants in the period from 2011 to November 2013. That these were indeed minor violations, customarily to mention in the inspection report (formerly called Form 483) is evident from the fact that in the six financial years to FY14, only 21 warning letters were issued to Indian plants.
It is not obvious, therefore, that Indian companies should be subjected to such stiff and fractious scrutiny. What could give further credence to the notion that the FDA may be a bit more suspicious of Indian plants than those elsewhere is
that close to a fourth of USFDA inspections for Good Manufacturing Practices (GMP) outside the US are conducted in India. Of course, India has 526 US-FDA units, (second only to China, which has 960 such units), but even China attracts only 10% of the FDA inspections outside the US.
Most top-notch Indian drug companies have the larger chunk of their revenue coming from the US and the rest of North America. According to a JPMorgan report, Indian companies produce approximately 40% of generic drugs and over-the-counter products and 10% of finished dosages in the US.
When it comes to FDA’s serious crackdown (such as bans/import alerts), at the receiving end has mostly been plants in Mexico, Canada and the UK, showing that GMP negligence is found more in those countries than in India or China. While 74% of Mexican drug-making sites registered with FDA