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Over half of all US/EU regulator warnings issued to Indian and Chinese manufacturers, report finds

Published on 28/08/19 at 10:55am

Concerns have been raised concerning the integrity of the global supply chain after a report from The Pharmaceutical Journal revealed that over half of the total formal warnings issued by US and European regulatory bodies are directed at facilities based in India or China.

The data noted by the report show that, of the 75 warning letters published to manufacturers by the FDA’s Office of Manufacturing Quality between early 2018 and August 2019, 37 in total were sent to these two countries – 18 to China and 19 to India.

Across the Atlantic, the European Medicines Agency issued 22 compliance notices, with 14 going to either India or China.

This has particular implications for the UK, where India and China are among the top five suppliers outside the EU of its generic drugs for the NHS, 80-90% of which are imported.   

“There does seem to have been a spate of inspectors going in [to Chinese and Indian pharmaceutical manufacturers] and finding problems and that is a good thing because it shows the system is working,” argued Gino Martini, Chief Scientist at the Royal Pharmaceutical Society. “But we do need to make sure there are regular inspections to the same standard that manufacturers in the UK would get.”

Warwick Smith, Director General of the British Generic Manufacturers Association, added: “Where I am concerned is the concentration in production of APIs – that is what should keep people awake at night. If you only have one or two manufacturers for APIs for a critical product, that is a real weakness in the supply chain.”

MHRA data show that around 5% of Indian manufacturer inspections identified “critical deficiencies” in 2017 and 2018 compared to 4% of UK manufacturers. However, statements of non-compliance, which are the only tool the MHRA has to manage manufacturers outside the UK, were issued in 6% of Indian inspections, compared to 0.8% of UK inspections.

Matt Fellows

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