Cancer drugs fail quality tests

This is the second of a two-part series by The Bureau of Investigative Journalism on how poor quality chemotherapy drugs have been sent to more than 100 countries

- Paul Eccles, Andjela Milivojevic & Ramu Sapkota

At the end of 2022, a surprise inspection by the United States' drug regulator found a "cascade of failure" at an Intas factory in India, where staff members were seen shredding and pouring acid on quality records.

The shutdown that ensued sent shockwaves across the US, with nearly every major cancer centre reporting shortfalls in chemotherapy drugs during 2023, according to The New York Times.

Accord Healthcare said the batch of cisplatin that failed The Bureau of Investigative Journalism's (TBIJ's) tests had met all established quality standards, and shared data from internal and external studies indicating its quality. It said it has not received any market concerns related to this batch.

In India, the world's largest producer of generic drugs, questions have been raised over whether manufacturers are properly punished for producing drugs that aren't fit for purpose — and whether foreign regulators have proper oversight.

"The Indian government's interest is in trying to protect the industry," said public health activist and former Big Pharma whistleblower Dinesh Thakur.

Sixteen of the 17 manufacturers identified in this investigation are based in India and five have been previously flagged by a regulator for producing substandard batches of drugs.

One of them, Zee Laboratories, has been flagged 46 times since 2018.

India's drug regulator told the TBIJ that Zee Laboratories has been audited and given a “stop production order”, which was lifted after the company resolved the problems in question. It did not give details about when this was, which issues it pertained to or whether the company faced any consequences.