- There are only 1,500 qualified inspectors for 10,000 Indian pharma manufacturing facilities, according to a sectoral study conducted by Assocham and research firm RNCOS.
- Numerous Indian pharma manufacturing facilities, including those owned by Sun Pharma and Polydrug, have faced censure over quality control.
- There has been nearly 50 import alert bans imposed on Indian plants over the last five years.
The Indian pharmaceutical market will reach a value between $32 billion and $55 billion by 2020 according to various estimates. The predicted growth would be a marked increase from the current roughly $15 billion valuation and would effectively make the India the sixth largest market in the world by absolute size.
In the U.S. alone, 40% of generics are supplied by Indian manufacturers. The rising cost of drugs coupled with a growing demand for generics underscores the global need for India's drug manufacturing capacity.
But, according to the report, there simply aren't enough qualified inspectors to oversee the sector, even as the FDA attempts to ramp up its presence. There is a serious need to deploy more resources towards inspections, while also creating a set of uniform policies among domestic inspectors.