 "US FDA scolds Cadila Pharma over manufacturing practice in Gujrat plant")
According to FDA, on multiple occasions, the plant has had manufacturing issues, sometimes for having more than the allowable number of impurities that it did not adequately investigate. The warning clearly points out that if necessary requirements are not addressed by Rajiv Modi led company then it could result into import alert from the drug regulator and it may also withhold approval for any new drugs using materials manufactured at the Gujrat facility.
The American drug regulator further pointed out, in a letter dated October 15 , that this was not the first time such poor practices were exercised in the Gujrat plant. "This is a repeat deficiency from our 2012 inspection which also identified a large stability sample backlog. Your 2012 investigation failed to address the impact of the delayed sample testing on your known typical impurity profile,." The letter added.
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Cadila Pharma has been given 15 days to respond to the regulator' query.
Later in the day, Rajiv Modi, CMD of Cadila Pharma said, “"The USFDA is one of the world's leading regulatory agencies and we work closely with them. As for this particular case, our scientists and regulatory compliance officials are already working on it and we hope to resolve it soon.”
Cadila Pharna supplies drugs to over 85 countries which consist of US, Japan and Kenya.
It also has got a foothold in the African continent with a formulation manufacturing facility in Ethopia.
US market is the biggest market for generic drug makers and Indian companies, despite a huge exposure to the market, have been facing tight scrutiny from FDA. Of late, Indian drug makers have been facing stringent enforcements in the US. Several manufacturing plants of leading domestic companies, apart from Ranbaxy, including Sun Pharma, Wockhardt and Strides Arcolab have come under the US FDA scanner for compliance related issues. The frequency of regulatory inspections in Indian plants has also increased significantly in past few years.
Recently, in a first of its kind, the US Congress has also launched a probe against two major Indian generic drug makers over price rise in the US market. The FDA also stripped off the key exclusivity period from Ranbaxy over Nexium and Valcyte drug, adding to the misery of the Gurgaon based company.
A tussle between India and America is also underway over issues such as intellectual property and increasing regulatory enforcements by the US regulator on Indian companies. In fact, issues entailing IPR, especially with reference to pharmaceutical and information technology, were top on the list of PM Modi’s agenda during his recent visit to the US. On April 30, the US had brought out the Special 301 report, an annual review of the global state of IPR protection and enforcement, in which it has classified India as a ‘priority watch list country’.