Safeguarding Our Children: How India Is Tightening the Screws on Toxic Cough Syrups

In a deeply troubling turn of events, India’s drug regulator has moved swiftly in response to a spate of child fatalities linked to contaminated cough syrups. What these incidents revealed is a glaring vulnerability in the pharmaceutical supply chain — particularly in how “high-risk” solvents like propylene glycol are handled, and how unlicensed pharmacies in remote villages continue to distribute potentially dangerous medicines.

A Crisis That Could Have Been Prevented

It all started when investigations revealed that certain pediatric cough syrups contained toxic contaminants such as diethylene glycol (DEG) and ethylene glycol — industrial solvents that have no place in medicines intended for children. In some batches, DEG levels were found to exceed permissible limits by a staggering margin. Faulty testing procedures and poor sourcing of excipients (inactive ingredients) have been identified as major culprits.

Tightening the Noose: Stricter Monitoring & Digital Traceability

In order to prevent any recurrence, the Central Drugs Standard Control Organization (CDSCO) has introduced a digital tracking mechanism for “high-risk” solvents via the ONDLS (Online National Drugs Licensing System) portal. This tool will enable real-time monitoring of the production, batch-wise quantity, certificate of analysis (CoA), and sales data of solvents such as propylene glycol, glycerin, and others.

Moreover, solvent manufacturers are now required to upload these details onto the portal, helping regulators trace the entire supply chain. Authorities also plan to enforce stricter testing of every batch of raw materials — a long-overlooked step that has contributed to this crisis.

Re-thinking Propylene Glycol

Propylene glycol is commonly used as a solvent, stabiliser, and preservative in liquid medicines. But experts have flagged its potential to carry dangerous impurities. In response, the regulator has asked scientific experts from the Drugs Consultative Committee (DCC) to deliberate on whether propylene glycol can be swapped out for safer alternatives.

Village Pharmacies Under the Scanner

One of the more striking reforms targets unlicensed village pharmacies — tiny, informal shops that were previously allowed to sell cough syrups in very small habitations. Under the existing Drugs and Cosmetics Act, these shops were granted an exemption in Schedule K, permitting them to stock certain over-the-counter remedies. But now, after the tragedy, regulators are proposing to delete the exemption that lets these unlicensed vendors sell cough syrups.

Risk-Based Inspections Are Already Underway

In parallel, CDSCO has launched risk-based inspections across six states, targeting manufacturing plants that produce syrups and other liquid oral formulations. The aim is to identify quality-control gaps, ensure regulatory compliance, and re-evaluate just how safe — or unsafe — existing production practices are.

What This Means for Public Safety & Trust

These measures, though reactive, represent a crucial turning point in India’s pharmaceutical regulation. The digital monitoring system brings traceability to a previously opaque supply chain. Likewise, removing the blanket exemption for unlicensed village pharmacies could curb the unchecked sale of unsafe medicines in underserved areas.

By reviewing whether propylene glycol can be replaced, regulators are not just playing defense — they’re rethinking the building blocks of pediatric formulations. For families, healthcare providers, and manufacturers alike, these reforms send a powerful message: when it comes to children’s health, there’s no room for lax standards.

Conclusion

The tragedy of children dying from contaminated cough syrup has prompted serious reforms — reforms that were long overdue. Through digital systems, stricter testing, and oversight on even the most remote pharmacies, India is taking meaningful steps to restore trust and ensure that medicines are safe — especially for its most vulnerable citizens. But change will only be meaningful if enforcement follows legislation, and if regulators stay vigilant about every link in the drug supply chain.