Are Indian Drug Manufacturers Really That Bad in GMP Compliance?
[Posted on: Thursday, October 29, 2015]

In recent years, any event of an FDA Warning Letter or other actions towards drug manufacturers located in India is headline news for most media sources. Warning Letters to Indian manufacturers are projected as evidence of an industry wide culture of non-compliance and there seems to be a strong perception that Indian drug manufacturer may be the worst GMP offenders in the entire industry. However, a careful review of FDA’s audit findings paints a different picture. There are about 662 FDA-registered sites in India. That’s similar to the 694 sites registered in China. India and China each have about three times as many FDA-registered sites as Canada (243), Germany (226), France (184), South Korea (179), and Japan (173). In the last 5 years for which data was available, FDA has audited about 88% of Indian sites or about 580 out of 662, and 93% of the times, FDA audits led to no findings or minor findings that could be addressed voluntarily by the site (called VAI or “Voluntary Action Indicated”). In the 40 audits when major findings were found, 33 led to Warning Letters, and 29 companies were subjected to import alerts. In China, by comparison, FDA audited 58% of the sites or 400 out of 694, in which 94% of led to no or minor findings. Of the 24 times major findings were found, all of them led to Warning Letters and most of the 24 companies involved were subjected to import alerts. Two other Asian countries, Japan and South Korea, had varying experiences. All sites in Japan were audited more than once in the last 5 years with 97% success rate, and about 6 out 192 audits led to major findings, 4 companies received Warning Letters and 2 companies were subjected to import alerts. On the other hand, only 22% of sites in South Korea were audited, where 2 out of 41 audits led to major findings but no Warning Letters were issued. Canadian companies were audited 291 times with 96% success rate, 12 major findings, 15 Warning Letters and 6 import alerts. Manufacturers in Germany, United Kingdom, France and Italy, had similar experiences with about 98% success rate. All sites in Canada, Germany, United Kingdom, France and Italy were audited at least once in the last 5 years, compared to about 88% sites in India and 58% in China probably because India and China had far more sites than all the other countries on this list, and logistical issues with FDA audits. The detailed findings of our analysis are available by sending email to [email protected]. Overall, it seems obvious that Indian manufacturers have similar experience with GMP compliance as any other country. This is very surprising in the light of the highly negative perception in the media. Ever since the Indian company Ranbaxy was found to have major GMP violations in 2011-2013, Indian companies have been subjected to harsher than normal scrutiny by the western media. This was exacerbated by other episodes as the blotched testing of generic drugs by GVK Bio that led to more than 700 drugs being banned in Europe which although had nothing to do with GMP compliance, feeds to the general perception of bad compliance by Indian companies. It seems that the fable has taken over the facts. The ratio of compliance to non-compliance in Indian companies is no different than companies in rest of the World. This wrong perception hurts rather than help the consumers by creating unfounded fear and anxiety for consuming drugs manufactured in India. No doubts the violators should be penalized and everyone should be held accountable, but it’s about time we give the Indian manufacturers their fair share of credit as well.

Expert Opinion: Mukesh Kumar
VP, RA, Amarex Clinical Research