When the FDA issued an import alert against Sun Pharma's plant in Gujarat in March, the drugmaker reassured investors the facility accounted for just 1% of U.S. sales. But with the allegations of failings at the plant becoming more and more damning, the FDA is reportedly following its now-familiar strategy of going after other facilities in the network.
|Sun Pharma headquarters in Mumbai, India--Courtesy of Hemant Mishra/Mint|
Last week's warning letter hinted at the impending actions, with the FDA calling on Sun to take a close look at all of its production plants. Livemint reports that the FDA has already begun broadening its investigation, with an unnamed source telling the newspaper regulatory inspectors have visited a couple of Sun sites recently. Detailed inspections are expected in the next few weeks. The outcomes of the inspections have big implications for overseas sales.
The FDA is reportedly focusing on two export-oriented ingredient plants, plus two formulation units. And Sun only has to look to the company it is trying to buy, Ranbaxy, to see how the FDA can throttle exports. The import ban placed on Ranbaxy covered plants that generated almost half of its U.S. sales. In the worst-case scenario, Sun could have to fix several of its sites to meet FDA standards at the same time as remediating the facilities it is set to buy from Ranbaxy.
As well as being a drain on Sun, more revelations would further tarnish India's reputation. "This is not related to training or understanding a particular technical or quality concept, but mainly related to honesty and ethical issues. What is more disturbing is that senior management and company owners appear to either support such practices covertly or overtly and in many instances encourage them," Uday Shetty, a consultant who has worked for companies including GlaxoSmithKline ($GSK), told Livemint.
- read Livemint's article