Indian Drug Quality - the case of Ipca

By Roger Bate

By now readers of this site, and my writing in particular, will know that criticism of Indian pharmaceuticals and their makers is a regular occurrence. And this post is no different – well sort of. Ipca is a large Indian company that makes a wide variety of products. I know the company best for the antimalarial product it makes, a version of a fixed dose artemisinin combination therapy (ACT), the best antimalarial on the market. It is one of fewer than ten producers approved by WHO and stringent regulatory agencies. Over one hundred million treatments of this medicine are used every year, saving many tens of thousands of children’s lives and shortening the suffering of millions from this age old scourge.

But earlier this month Christopher Game of the Global Fund for AIDS TB and malaria, announced it would no longer buy Ipca’s ACT. The Global Fund is the largest purchaser of these medicines, and so the decision probably has significant short run costs for Ipca.

What is interesting is that the main reason Mr Game gave for not buying their product was the recent warning given to Ipca by US Food and Drug Administration about entirely different products sold into USA. Mr Game said the Fund would only procure from buyers with “no outstanding issues with regulators”.

It does appear that Ipca misled FDA about data integrity issues, and lying to regulatory agencies throws into question the trustworthiness of the company, and for this Mr Game’s response is both timely and fair. But this policy opens the Fund up to potential problems. After all many companies often have disputes with regulators. At any moment there are dozens of companies in dispute with FDA, will the Fund act so aggressively against other companies?

The other interesting thing to note is that Ipca’s ACT never failed any quality control tests as far as I know. The several dozen samples we tested in our routine assessments over the past few years all passed basic quality tests. And some of those that are still approved by Global Fund failed our tests - the sample sizes for some of these products was small. It is interesting conundrum; a valuable product that is often in short supply that has not failed any tests is withdrawn when perhaps inferior products remain.

As more information arises I will revisit this subject in later posts.

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