"We have issued a statement of non-compliance against Wockhardt’s site in Chikalthana, India and Wockhardt’s contract manufacturer Nestor Ltd in the UK after recent inspections identified a number of manufacturing issues that breach Good Manufacturing Practice (GMP) guidelines,” an MHRA spokesman told In-Pharmatechnologist.com.
“We are unable to disclose the GMP violations while our investigation remains ongoing,” the MHRA spokesman said. “We are in correspondence with Wockhardt about the inspection findings and we will take the time we need to ensure that any action we take is in the best interests patients in the UK.”
But the spokesman did not seem to think the issue of cGMP violations for Indian manufacturers was growing or widespread.
“The majority of inspections of Indian manufacturing sites result in a satisfactory outcome and the MHRA and its European regulatory partners operate a routine inspection programme to assess GMP compliance of manufacturers and importers,” he added.
In 2012, the MHRA conducted about 400 inspections in theUKand 116 in countries outside of the EU. Of the inspections outside the EU, 47 were performed inIndia, and by comparison, 52 were performed in the US.
Shifting cGMP Landscape?
Although the MHRA may not believe these latest violations cited by Wockhardt are part of a growing trend among Indian manufacturers, some within the industry think they are being increasingly targeted by regulators as exports from the country increase.
In-Pharmatechnologist.com spoke with executives at eight API (active pharmaceutical ingredient) and generics manufacturers last week in Hyderabad, Delhi and Mumbai, India. More than half of the executives said the recent US FDA inspections have been more harsh and demanding than in years past.
Dr. BPS Reddy, CEO of Hetero Pharma, told us that every six months it seems as though the FDA has “a new program” in terms of how it inspects facilities. He said the industry is learning and adapting but the FDA needs to discuss the changes on an ongoing basis.
Satish Reddy, vice chairman and managing director of Dr. Reddy’s Laboratories, noted that it’s inevitable that the FDA is increasing its inspections as the number of facilities in India and filings grow.
But Dr. Harri Babu, CEO of Mylan Laboratories in Hyderabad, told us he doesn’t think the issuance of warning letters is unique to Indian companies as warning letters are common for all companies. “It’s not a big constraint or stopping future growth,” he added.
But the increase in inspections may not slow as India is now looking to increase its generic exports to almost $25B in 2016, which would be an increase of almost $12B from this year, according to the India Brand Equity Foundation and Pharmexcil.