In the foreign generic drug market declining margins are expected but, in recent findings, a lack of adequate regulation and outright negligence led to a more daunting outcome in the case of methotrexate, an anti-rheumatic drug for the treatment of Leukemia and other cancers. In this case, the adversely-affected were children.

The company in question is Naprod Life Sciences. A manufacturing plant in Mubai, where, according to Bloomberg, quality control was severely lacking. This lackluster oversight is noted to have been caused more by malfaescence than incompetence. European inspectors found “severe violations” of basic manufacturing guidelines at a sister company, Mac-Chem Products India Pvt Ltd, up to an including the discovery of Pseudominas aeruginosa in a shipment sent to Columbia in 2019. P. aeruginosa is a deadly, antibiotic-resistant bacteria found in a multitude of environments.

In January of 2020 the medication was administered to 100 Columbian children and out of that group, four children, already suffering from cancer, died. These reactions were linked to the bacteria-contaminated medicine by doctors who tested sealed vials from three batches the following month.

Naprod plays a crucial and even vital role in the world’s supply chain. Although not approved for sale in the U.S., where regulations are more austere, they are able to sell elsewhere. It was reported by Businessweek that inspection reports in three different continents reflected discrepancies in drug formulation like shorted values of active ingredients to cut costs, in the case of cisplatin, as well as other quality control concerns. Indian companies supply one-fifth of the world’s generic drugs; the industry is worth about $50 Bn annually.

None of this has led to serious consequences from regulators or public warnings from the World Health Organization, which is supposed to coordinate efforts among all the government authorities policing medicine quality.

INVIMA, the drug administration of Columbia, stated “The market for chemotherapy products is increasing, and it’s increasing in locations where often the regulatory agencies are under-resourced. It’s a very risky situation right now.”