Drug-maker Wockhardt’s founder-Chairman Habil Khorakiwala ahs told shareholders that regulatory observations made by the US Food and Drug Administration (FDA) on its Waluj facility came as a “complete surprise.”
The company had 12 plants and overseas; regulators had been visiting them every two years for the past 15 years and found them satisfactory, he said. “So when it happened, it came as a complete surprise,” he later told media persons at an impromptu interaction.
Following the US concern, the Waluj unit came under UK regulatory scanner as well. Even as the company was dealing with these concerns, fresh regulatory observations were made on its Chikalthana plant (Aurangabad), too. But these were not as serious as the quality concerns raised at Waluj, he added.
The company was reviewing the situation, Khorakiwala said. It may consider shifting US-bound products from the troubled Waluj unit to its plant at Shendra, which was set for inspection next month, he said. New product application filings would also be made from there, he added.
The company has taken steps to integrate monitoring of quality across its plants, to be handled directly by the Managing Director. In fact, he said, the MD was seeking a meeting with regulators in the US and UK. Though there was no certainty on when the problem would be resolved, he said, the US continued to be a major market for the company. On pain drug dextropropoxyphene that had been banned in India, Khorakiwala said the company had approached the Madras High Court to stay the ban. Meanwhile, Wockhardt launched a line-extension about a month ago, he told shareholders.
jyothi.datta@thehindu.co.in