In recent months, India has faced a sobering reminder of the critical gaps in its pharmaceutical oversight. The deaths of children linked to contaminated cough syrups have shaken public trust and forced the country’s drug regulators to re-examine long-standing loopholes in manufacturing and distribution. Now, in a decisive move, India’s drug regulator is working to tighten rules around high-risk solvents such as propylene glycol, while also taking aim at unlicensed village pharmacies that continue to operate with little oversight.
These reforms come not just as a reaction to tragedy, but as a long-overdue realignment of priorities in an industry that supplies medicines to millions at home and across the world.
The Hidden Danger Inside a Common Ingredient
At the centre of this crisis is propylene glycol — a commonly used solvent that helps dissolve ingredients in syrups and other liquid medicines. While the compound itself can be safe when manufactured to pharmaceutical grade, it can carry deadly impurities if sourced from unreliable suppliers or tested inadequately.
In past incidents, diethylene glycol (DEG) and ethylene glycol — toxic industrial chemicals — were found in place of, or mixed with, propylene glycol. Even in tiny concentrations, these contaminants can cause organ failure, especially in children whose bodies cannot process the toxins efficiently.
Recognising the risk, the regulator is now consulting experts to determine whether propylene glycol should be replaced entirely in pediatric formulations. If approved, this could mark one of the biggest formulation shifts in India’s over-the-counter medication landscape.
Quality Checks: From Optional to Mandatory
For years, quality testing of these solvents has relied largely on documentation provided by manufacturers — a system that assumes honesty and competence. Unfortunately, the tragic outcomes have shown that documentation alone is not enough.
In response, the regulator is now working on stricter, mandatory quality checks for every batch of high-risk solvent entering the pharmaceutical supply chain. This includes verifying the purity of ingredients before they are used in production. The goal is simple: no batch of medicine should reach a patient without thorough validation of its raw materials.
Unlicensed Pharmacies Under the Spotlight
Another major change under consideration concerns unlicensed village pharmacies. These shops, often the only source of medicines in small rural habitations, were previously allowed to sell certain products — including cough syrups — despite not being regulated under India’s pharmaceutical laws.
The new proposal aims to remove this exemption entirely. If implemented, only licensed pharmacies run by trained personnel would be allowed to sell cough syrups, closing a loophole that has allowed unregulated medicines easy access to vulnerable communities.
A Turning Point for Public Health
These reforms represent a pivotal moment for India’s healthcare system. The regulatory tightening is more than a reaction to crisis — it’s a step toward rebuilding public confidence in everyday medicines. Better raw-material testing, real accountability for manufacturers, and oversight of small-scale sellers together form a stronger safety net for consumers.
When children’s lives are at stake, there is no room for complacency. India’s renewed focus on pharmaceutical safety may well mark the beginning of a safer, more transparent era for medicine in the country.
