Moreover, these six warnings from the US Food and Drug Administration’s Centre for Drug Evaluation and Research (CDER) account for almost two-thirds of all the letters it has sent out globally over that period.
They seem excessively high when taken in the context of just 10 India-bound warning letters sent by the CDER between 2010 and 2012 - out of a global total of 130.
Targeting India
Given that many of these communications refer to established companies that operate under consistent practices, these numbers might indicate that the FDA has set out to target Indian companies.
Moreover, the US regulator is planning to grow the number of staff in its Indian bureaux to 19 from less than five in 2009, giving further evidence that the FDA plans to monitor Indian activities more closely.
Its two Indian offices, in Delhi and Mumbai, monitor the quality of foods and drugs made in India, the second largest drug exporter and the seventh largest food exporter to the US. Nearly one quarter of the spices, oils and food colourings used in the US comes from India, the largest producer, consumer and exporter of spices globally.
In the most recent development, the CDER issued warning letters to Promed Exports and Posh Chemicals, accusing both companies of manufacturing violations. And, echoing the prominent cases of pharmaceutical majors Ranbaxy and Wokhardt earlier this year, the centre also suggested that Posh, which is headquartered in Hyderabad, had manipulated its data - a much more serious charge.
Lead times
Indian newspaper Economic Times has reported that not only is the US regulator increasing manpower in India, “in most cases companies no longer get the luxury of two to three months' notice before an inspection, a common practice till a few years ago.”
Until recently, companies would typically use this lead time to spruce up their facilities and get ready it for their inspections, the paper alleged. This in turn brings mounting challenges for pharmaceuticals.
Speaking to Economic Times, Vinita Gupta, CEO of Lupin Pharma, said she didn’t believe the recent regulatory actions by USFDA had been directed solely against Indian pharma companies.
“I have seen the warning letters issued to the US, Indian and other companies globally, and all the FDA is trying to do is differentiate the good manufacturers from the not-so-good ones. Indian manufacturers are not being targeted against and play a big role in the US, accounting for over 25% of the overall prescription market."
But there is no doubt that the FDA’s increasing strength in India is beginning to uncover alleged shortfalls and cover-ups that would previously have gone unnoticed by the regulator.