U.S. inspectors visiting a factory in India owned by drugmaker Wockhardt Ltd in March found torn data records in a waste heap and urinals that emptied into an open drain in a bathroom six meters from the entrance to a sterile manufacturing area.
And when an inspector asked about the contents of unlabelled vials in the laboratory glassware washing area, a plant worker dumped them down a sink and said the contents could not be determined, according to a July 18 letter from the U.S. Food and Drug Administration to Wockhardt, which makes sterile injectable drugs and various forms of insulin.
Habil Khorakiwala, chairman of Wockhardt, last week told shareholders that the problem at its Waluj plant “is an inexcusable lapse, but we have taken swift and definitive action, both corrective and pre-emptive,” including appointment of a new quality chief and hiring of outside consultants.
It’s not our intention to single out Wockhardt or any other Indian manufacturer.
In fact, problems at pharmaceutical manufacturing plants exist everywhere, including the US. Consider:
Imports of pharmaceuticals from India into the US exceeded $4 billion last year.
When you consider that many of those imports are generics, the actual volume imported must be staggering.
That volume will likely continue to grow, as public and private payers continue to look for cost-efficient ways to provide drugs to its patients.
The FDA has a real challenge on its hands. With over 150 FDA-approved plants in India (and growing), the FDA will hopefully continue to rapidly increase the number of inspections, as well as the pace of these inspections.
It is likely that some of the 150 plants will continue to have issues, perhaps leading to some closures. This actually bodes well for companies with FDA-approved facilities who can maintain their quality standards.
If anything, companies in India who can produce pharmaceutical products that meet or exceed FDA cGMP standards might command a slight premium over products from facilities who are barely meeting these standards.