As of the end of October, the US FDA had conducted 97 inspections of the more than 600 pharmaceutical plants in India registered with the US. It found that at many facilities producing medicines for export to the US, samples of drugs failing to meet quality standards for purity were retested rather than discarded. Failed records were deleted, and batches passing subsequent tests were sent for export. The FDA requires manufacturers to test their US-bound pharmaceuticals and report their results, itself testing them only if receiving numerous complaints about them. India has had good-manufacturing practices for drug production but has only since last year required compliance with guidelines for testing labs. According to the India Drugs Controller General, adoption of the standards takes a few years. Indian factories are the second-largest suppliers of drugs to the US, producing mostly generics and active ingredients for pharmaceuticals. Annual sales of the top 10 Indian drug companies are about $15 billion.

Source: Bloomberg