FDA Approval Rate Shows Indian GMP Sites Are in Good Compliance 
[Posted on: Thursday, July 28, 2016]

Negative audit findings make headlines every time a site in India is found to be in violation of GMP requirements by US FDA. For the last few years, negative news about drug manufacturing facilities in India dominated public discourse so much that it has become a cliché to use findings at sites in India for training in what not to do when it comes to GMP compliance. We wondered several times last year if Indian GMP sites were indeed that bad. A survey by Bloomberg News of the FDA drug approval database found that Indian manufacturers have been successfully getting drugs approvals by FDA at a record rate during the same period negative news about GMP sites in India dominated public perception. Manufacturers based in India consistently secured about a third of all new drug approvals by FDA. Almost all the drugs manufactured in India are generics with less than 1% being NDAs, and even those 1% being 505(b)(2) new drugs. India is home to more than 700 FDA-registered drug manufacturing facilities owned by more than 300 drug companies. As we discussed in our previous posts, 93% of FDA audits in India lead to no or minor findings. Only about 5% of GMP sites in India have been subject to Warning Letters or Import Alerts. Indian manufacturers are known to diligently pursue the audit findings and almost all are able to meet FDA’s requirements during follow-up audits. It seems that FDA audits in India have had the expected results. Reports of FDA’s negative audits created a strong limelight on the violators giving others suggestions about what to avoid. FDA has increased its auditors in India by about 60%; from 12 to 19 India-based auditors. The Chief of the India Office of FDA is a very experienced auditor. These factors may be contributed to more sites in India getting audited, which in turn led to wider awareness of FDA’s expectations. A cynical view could be that may be sites in India have become more proficient in covering up deficiencies but the high numbers of manufacturing sites, and successful approval rate, indicates higher compliance rather than better cover-up. It is expected that drug manufactured in India will continue to dominate the US and Western markets. India may also continue as the destination of choice for contract drug manufacturing.