Despite high-profile Ranbaxy alerts, US FDA finds India okay
- CBI sought part RTI exemption, Govt gave it full
- Screen Awards: Milkha, Ram-Leela and Madras Cafe dominate
- DGCA seeks fresh public objections after clearing AirAsia for take-off
- Delhi: 51-year-old Danish national alleges gangrape, 15 detained for questioning
- I wonder if I will be able to ever reunite with my husband, my kids. I miss them: Devyani
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.
- Live: Kejriwal does a U turn, urges people to come in largeÂ numbers
- Women competent enough, they need opportunities, saysÂ Rahul
- â€˜Modi has a majoritarian, authoritarian attitudeâ€¦ such a policy and style of govt would be a disaster for thisÂ countryâ€™
- â€˜Narmada water not reaching farmers for want of minor canalsâ€™ | The Indian Express