Are GMP Sites in China Better Than Those in India?
[Posted on: Thursday, 04 February, 2016]

India and China have similar number of FDA-registered GMP manufacturing sites, 662 and 694, respectively. India and China manufacture similar kind of regulated products, primarily API and finished drug products, and very few biologics and medical devices. The two countries are culturally and economically quite similar as well. However, manufacturing sites in China have received a lot fewer Warning Letters for non-compliance than those in India; 24 Warning Letters to sites in China compared to 33 letters to sites located in India. In the year 2015 alone, manufacturing sites in India received 12 Warning Letters while those in China received 3. It raises an obvious question, are manufacturing sites in China inherently more compliant that those located in India? In a recent publication, FDA said that it wants to add more inspectors at its China Office to increase the GMP inspections in China. FDA also said that it has increased audits of Chinese API and OTC drug manufacturers. However, there is no publicly available statistical data to support the quality of manufacturing sites in China. Per FDA’s inspections database, it appears that about 60% of FDA-registered manufacturing sites in China have been inspected at least once in the last 5 years, about 90% of which lead to either no or minor findings. A review of the Warning Letters issued to manufacturers in China indicates common violations of data integrity, training, documentation and hygienic practices. In the absence of public data, one can speculate if there are any systemic differences between India and China in terms of GMP compliance per FDA. FDA has been trying to increase the number of its inspectors in China from 8 to 26, but had been facing visa difficulties. Comments have been made about logistical challenges due to language and access to inspection for FDA inspectors. Such issues have not been raised for FDA inspections in India. FDA has not publicly announced any staffing challenges in India, the likes it faces in China. Language is not an issue in India, where English is the primary language of recording GMP documents. There also have been no reports of sites in India obstructing FDA audits in any way. Still it is hard to say if these practical differences could account for the fewer Warning Letters to sites in China. Last year the Chinese government announced strict enforcement of cGMP rules for all manufactures. These new rules are identical to the European and US GMP rules. According to reports, this enforcement led to more than 2000 facilities shutting down. This certainly indicates a strong desire by the Chinese regulators to wean out the non-compliant manufacturing facilities. That coupled to increased FDA audits in China should soon show results. Perhaps, it is not fair comparison but prevailing data does indicate that pharmaceutical manufacturing in China may be getting an upper hand to manufacturing sites located in India.