The US Food and Drug Administration (FDA) has prohibited Indian drug major Ranbaxy Laboratories Ltd from producing and selling active pharmaceutical ingredients for American markets from its Toansa facility in Punjab, citing manufacturing violations.
The move follows an FDA inspection of the facility which identified significant violations of good manufacturing practices. Following this, the pharmaceutical firm voluntarily suspended API shipments from the facility to the US.
With this, all Indian plants of the company have been banned from shipping products for sale in the US, the world’s largest drug market and key revenue generator for Indian generic pharma companies.
Previously, US FDA had banned Ranbaxy from selling products made at its factories in Paonta Sahib, (Himachal Pradesh), Dewas (Madhya Pradesh) and Mohali (Punjab) over irregularities.
“The Toansa facility is now subject to certain terms of a consent decree of permanent injunction entered against Ranbaxy in January 2012,” Ranbaxy Laboratories said in a filing to the BSE on Friday.
Ranbaxy Labs’ CEO and MD Arun Sawhney said, “This development is clearly unacceptable and an appropriate management action will be taken upon completion of internal investigation.”
Due to the increasing healthcare cost in developed countries and major drug companies going off-patent in the US market, the demand for cheap drug imports in the country has risen. This has led to closer inspection and scrutiny of the drugs by the US drug regulator.
Ranbaxy, majority owned by Japan’s Daiichi Sankyo, saw its share price crash over the news and was down over 18 per cent in mid-day trades on the BSE in a weak Mumbai market on Friday.
(Edited by Joby Puthuparampil Johnson)