Indian-Manufactured Chemotherapy Drugs Fail Quality Checks: What Does The Study Say?

A recent investigation by the Bureau of Investigative Journalism has revealed that tainted cancer drugs have been shipped to more than 100 countries around the world exposing patients to the risk of ineffective treatments and unwarranted side effects. Vital chemotherapy drugs undergo a tedious journey full of checks and regulatory approvals before they land in the patient’s hands. This vetting ensures that the drugs meet the necessary efficacy standards and achieve their intended purpose. 

What did the Investigation Reveal?

The study published on June 26 highlighted that about a fifth of the cancer drugs failed the quality tests with 16 of the 17 implicated manufacturers being India-based. The study examined the quantity of an active ingredient in seven common types of cancer drugs: cisplatin, cyclophosphamide, doxorubicin, ifosfamide, leucovorin, methotrexate and oxaliplatin. The World Health Organisation (WHO) regards all these drugs as essential medicines for cancer treatment. The researchers at the University of Notre Dame, Indiana analysed samples from four countries comprising Cameroon, Ethiopia, Kenya and Malawi. 

189 samples of generic drugs from 17 manufacturers were employed for testing; of which a fifth of them failed the test. The required quantity of the active ingredient should amount to 88 percent, as per the norm. Most of these drugs contained way less than this stipulated amount, whereas others contained the compound in excess. In some cases, the ingredient quantity exceeded over 112 percent. 

According to the report, these drugs have been shipped to over 100 countries in the past six years including the United Kingdom, the United States, Saudi Arabia, Nepal, Ethiopia and North Korea. The study reported that the worst performing drug from the lot was made by Venus Remedies. Eight samples of cyclophosphamide, a drug used to treat cancers including lymphoma and breast cancer failed to meet the required standards. Six of the eight drugs contained less than half the amount of the active ingredient claimed by the manufacturer. 

Who are the Most Affected?

The report highlights that 10 percent of medical products in developing countries are substandard or falsified. 

Multiple low and middle income countries face the brunt of this issue. Countries like Nepal and Bangladesh lack the resources and the expertise to verify drug quality. This handicap paired with corruption and porous borders leads to counterfeit drugs plaguing the system in large quantities. 

India is the largest exporter of generic medicines in the world producing approximately 20 percent of the world’s share. In a competitive market such as this, curbing the quantity of the active ingredient or using outdated machinery aids the manufacturers into lower production costs and hence, more profits. This issue of substandard drugs can usually be traced back to manufacturing, quality control, packaging or storage.

Other Instances of Tainted Indian Drugs 

A study published in the journal, Production and Operations Management, in March 2025 found that generic drugs manufactured in India are related to 54 per cent more severe adverse effects, including hospitalisation, disability and death, compared to the equivalent generic drugs made in the US. 

In December 2022, the WHO linked Indian-made cough syrups to acute kidney failure and deaths of 66 children in the West African country, The Gambia. According to the WHO report, the cough syrups contained unacceptable amounts of diethylene glycol and ethylene glycol, chemicals often meant for industrial use.