Which brands of asparaginase are substandard?

An investigation by the Bureau of Investigative Journalism has revealed serious concerns about poor-quality brands of a particular cancer drug spreading around the world. The drug, called asparaginase, is a crucial treatment for patients with acute lymphoblastic leukaemia (ALL), the most common kind of childhood cancer.

The Bureau found that at least a dozen brands of asparaginase have been proven to be poor quality, with ten still on the market. In some cases brands fell well below the standard needed to treat cancer. Many have also been found to contain contaminants such as bacteria that could be harmful to patients.

In the past five years these brands have been shipped to more than 90 countries. Experts estimate 70,000 children around the world are at risk. We are publishing the names of these brands and their manufacturers/suppliers in the table. You can read the Bureau’s full investigation here.

There is more detail of the research into substandard asparaginase in the scientific papers listed below the table.

* No longer manufactured

Sun Pharmaceuticals told the Bureau that it does not currently manufacture or market Asginase, and the product was discontinued in 2019.

Beijing SL Pharmaceutical told the Bureau that it has produced asparaginase for a dozen countries over the past decade, and had never received reports of quality concerns bar those from Brazil. The company said its asparaginase is tested by Chinese drug regulators and in-house, where — they claimed — results have stayed within statutory limits over the past decade.

Hetero Healthcare, Zydus, Celon Laboratories, Miracalus, Naprod Life Sciences, Getwell Oncology, Cadila, VHB Medi Sciences, Chandra Bhagat Pharma, United Biotech and Virchow Biotech did not respond to requests for comment.