The USFDA’s warning to Wockhardt over deficiencies in its manufacturing facilities in Waluj, , is the latest in a series of setbacks for the Indian pharmaceuticals industry in the US and Europe over the past few years.
In May, Ranbaxy pleaded guilty to criminal charges of fraud and adulteration and agreed to pay a $500-million fine. “This has resulted in Indian companies coming under the USFDA scanner,” a source in a multinational drug company told Hindustan Times.
Over the last two decades, Indian generics drug companies, such as Ranbaxy, Dr Reddy’s Laboratories, Cipla and others have taken on western multinationals by manufacturing and selling off-patent drugs at a fraction of the price charged by western Big Pharma.
However, most analysts said greater FDA scrutiny should not be considered a witch-hunt. “FDA reviews companies across the world and its alerts are not unique to India. Fundamentally, India has the second largest number of USFDA-approved plants and manufacturing units. So, the auditing process becomes obvious,” said Hitesh Sharma, partner, life sciences, Ernst & Young.
Indian companies have been at the receiving end of stricter vigil. Several export consignments Cipla and Dr Reddy’s were seized in 2009 at European ports on charges of patent infringements.
Besides the import ban imposed on Ranbaxy’s manufacturing plants in Himachal Pradesh and Madhya Pradesh, other key instances include a 2009 ban on one of the sterile plants of Hyderabad-based Aurobindo Pharma, an import ban on Claris Lifesciences’ plant in 2008 and a four-year ban on the manufacturing plant of Sun Pharma's US subsidiary Caraco Pharma.