Poisoned Children, Protected Profits: Medicine’s Global Regulatory Scandal, by Fransiscus Nanga Roka

A parent purchases fever-reducing medication for a child. The child develops kidney failure. Somewhere up the supply chain, a supplier has confused some paperwork with evidence of safety. This is the filth of syrup polluted: what appeared to be care became vehicles for wholly preventable poisoning.

By January 2023, more than 300 deaths have been linked to confirmed or suspected contaminated medicines in three countries, mostly children younger than five years old, according to the World Health Organization. The alerts went on to mention The Gambia, Indonesia and Uzbekistan. The contaminants, diethylene glycol and ethylene glycol, both industrial chemicals deadly in sufficient doses. Their inclusion in pediatric medicines reflects a tragic blind spot in pharma oversight.

India’s manufacturers deserve scrutiny. WHO identified Maiden Pharmaceuticals as the producer of four contaminated products in The Gambia, whilst Marion Biotech is stated to be behind the contaminated AMBRONOL and DOK-1 Max syrup products found in Uzbekistan. Conflating all outbreaks into a single Indian story replaces accountability with geographical scapegoating. An inquiry in Indonesia found medicines tainted with the same toxins made by different domestic pharmaceutical firms, as well deficiencies in its raw-material supply chain. Independent evidence, accountability and legal acts on each chain.

The mechanism is brutally simple. Medicinal treatment requires elements corresponding to pharmaceutical-grade propylene glycol, glycerin and sorbitol. Industrial chemicals can enter that supply chain with things like toxic substitution, fake labels and unreliable documentation. The July 2025 report of WHO–UNODC included evidence on criminal exploitation, as well as regulatory gaps such as poor distribution oversight and failure to coordinate actions among enforcement agencies. Low-cost inputs are made viably; the effects arrive in pediatric wards.

Then came another warning. WHO began concerns over contaminated batches of India’s COLDRIF, Respifresh TR and ReLife due to reports of child illnesses and deaths in October 2025. Authorities in India suspended production of affected products and began the recall. India also informed WHO of the products not having been exported to India. The implication could not be clearer: that protecting export markets can not, and does not, protect kids at home.

New Guidelines for Export-Sample Testing After June 2023 India started to lay guidelines across various items and as of today they have introduced testing requirements on a pre-export basis where samples are taken post-production before export. But as of an October 2024 amendment, exemptions have been created associated with foreign regulators’ approvals for manufacturing facilities. These approvals may bolster regulatory cooperation, but they cannot determine the composition of each subsequent batch. Exemptions should be clear and subsequently verifiable.

It is time for governments to create five enforceable obligations.

First, make validated testing of each lot of high-risk excipients (which should be represented in the finished product) a prerequisite. Supplier certificates should always be supported by evidence and never fill in for it.

Second, license and audit chemical intermediaries; validate original manufacturers and keep samples and transaction records. A QR code can track a bottle; it cannot verify that its contents are safe.

Third, timely publish cross-border laboratory findings, inspection failures and recall notices. Challenge exporters’ assurances by funding regional laboratories in importers

Fourth, seek evidence-based prosecutions for willfully substituting supplies and for falsification and culpable negligence. Work to maintain due process in investigating the company executives, intermediaries and compromised officials.

Third, ensure that fund-raising mechanisms are in place and that providing care for surviving victims is financed over the long-term. It should not take years of legal wrangling for families to get help.

India is now a major supplier of medicines, which requires very strict oversight. Importing governments share that duty. The importance of affordable medicine cannot be overstated; but affordability based on uncheckable ingredients is a poison oasis.

Children’s kidneys should never become the world’s last lab for quality control.

Fransiscus Nanga Roka

Faculty of Law University 17 August 1945 Surabaya and Managing Partner Law Firm Victorious Indonesia