- The FDA has banned imports from a Mumbai-based plant in Ambernath, owned by Polydrug Laboratories Pvt Ltd.
- This is the tenth site in India to face an "import alert" ban this year.The ban is due to quality-related issues, including data integrity issues, as well as failure to record customer complaints.
- Polydrug manufactures drugs for the treament of hypertension and fungal disease, as well as muscle relaxants.
Disappearing data, made-up data, customer complaints ignored, mixed-up drugs, product recalls, sanitation issues—the list goes on. These are some of the quality-control issues faced by Indian drug manufacturers.
Since 2011, there have been a total of 44 import bans on Indian drug manufacturers. These problems are real, ongoing, and frequently reported. However, on the other side, the cost of manufacturing drugs is significantly cheaper in India than in the U.S. and Europe-—and there are many experienced pharmaceutical professionals in India.
According to various estimates, the size of the Indian pharmaceutical market will be $45 billion to $55 billion by 2020, up from roughly $15 billion currently. That would effectively make the Indian pharma market the sixth largest in absolute size in the world. In the U.S. alone, 40% of generics are supplied by Indian manufacturers. Add to that the rising cost of and growing demand for generic drugs, and one thing is clear: The world absolutely needs India's drug manufacturing capcity and prowess.
Unfortunately, quality-control issues continue to shut down production and imports. The FDA has increased its presence in India in order to conduct inspections of plants, which has made it possible to conduct more inspections. There are now 19 FDA inspectors dedicated to Indian manufacturing facilities, as well as a number of meetings and new guidelines, all of which are being deployed to improve overall quality-control issues.