Analysis finds bulk of warnings delivered to Indian and Chinese drugmakers

By Ben Hargreaves contact

- Last updated on GMT

(Image: Getty/Malik Evren)
(Image: Getty/Malik Evren)

Related tags: China, India, Sartan, Fda, Ema

The US market is dependent upon API and generic drugs produced in India and China, yet these countries also received the majority of warning letters issued by the US FDA.

The Pharmaceutical Journal published its own analysis​ of the country of origin of the companies that had received warning letters, from the period beginning early 2018 until August 2019.

The findings showed that, for both the US Food and Drug Administration (FDA) and the European Medicines Agency (EMA), Indian and Chinese companies represented approximately half of the recipients of such regulatory action.

In total, the FDA published 75 warning letters to pharmaceutical manufacturers and 37 of these went to either Chinese or Indian companies. For the EMA, it noted 22 compliance notices and 14 for the same countries.

This period of time coincides with the significant problems that emerged over the last year related to ‘sartan’-based medications​, with the active pharmaceutical ingredients (APIs) for such products being predominantly manufactured in India and China.

There remains the question of whether the high proportion of such regulatory action actually reflects the levels of API and medicine produced by India and China for the US market.

It is not known exactly what proportion of APIs and generic drugs make up the US market, but Katherine Eban’s Bottle of Lies​ book on the industry places the figure at 80% of APIs emerging from overseas markets​, which is made up predominantly of Indian and Chinese firms.

Therefore, in terms of numbers, for warning letters to make up around half of all warning letters would be appropriate for the countries’ exports to the US.

When in-PharmaTechnologist spoke to Lee Newton, VP, business unit head of API development & manufacturing at Lonza, about the issue of ‘quality’ in the supply chain, he suggested that it is “more spoken about than real”.

Further than this, Newton suggested that fears over the integrity of APIs produced in ‘pharmerging’ nations, such as China and Indian, had been encouraged, to a certain extent.

“I think ‘quality’ was used as a tool to try and drive price-based negotiations for lower pricing from Western contract development and manufacturing organizations,”​ he concluded.

However, what cannot be argued is the growing dependence that the US has on China and India for its medicine, which has formed a greater priority for discussion​ in the US due to the current ‘trade war’ with China.

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