India’s Drug Safety Crisis: When Children’s Medicine Becomes a Threat

The latest contamination alert from Telangana has sent shockwaves through India’s healthcare community. Almont-Kid Syrup, a common children’s allergy medication, has been found contaminated with ethylene glycol, a toxic industrial chemical. But this isn’t an isolated incident. It’s the latest chapter in a troubling pattern that’s exposing dangerous cracks in India’s drug regulatory system.

A Pattern of Failures

The Gambian Tragedy and Indian Cough Syrups (2022)

The alarm bells rang loudest when the World Health Organization linked four Indian-manufactured cough syrups to the deaths of 70 children in The Gambia. Laboratory tests revealed catastrophic levels of diethylene glycol and ethylene glycol, industrial solvents that cause acute kidney injury. The implicated syrups, manufactured by Maiden Pharmaceuticals, had been exported despite India’s regulatory oversight.

The Uzbekistan Deaths (2022)

Shortly after, 19 children died in Uzbekistan after consuming Doc-1 Max syrup, manufactured by Marion Biotech. Again, ethylene glycol contamination was the culprit. The pattern was becoming undeniable: children’s medicines were being poisoned with industrial chemicals, and the regulatory net was failing to catch them.

Fake ORS Scandal (2024)

In a different but equally alarming case, authorities uncovered a massive counterfeit operation producing fake Oral Rehydration Solution (ORS) packets. These spurious products, lacking proper electrolyte composition, were being sold across multiple states, putting children suffering from dehydration at grave risk during a period when diarrhoea diseases claim thousands of young lives annually.

The Abhayrab Incident (2024)

Most recently, health authorities flagged Abhayrab anti-rabies vaccine batches for quality concerns. Rabies is nearly 100% fatal once symptoms appear, making vaccine efficacy literally a matter of life and death. The fact that such a critical, life-saving medication raised red flags demonstrates how widespread quality control failures have become.

Why Is This Happening?

Manufacturing Shortcuts
Ethylene glycol and diethylene glycol are cheaper substitutes for pharmaceutical-grade glycerin and propylene glycol. Some manufacturers appear to be cutting costs by using industrial-grade solvents, either through negligence or deliberate fraud.

Regulatory Gaps
India’s Central Drugs Standard Control Organisation (CDSCO) oversees thousands of manufacturing units, but enforcement remains inconsistent. Batch testing before market release isn’t universal, and post-market surveillance is limited. State drug controllers often lack resources for rigorous oversight.

Counterfeit Networks
The fake ORS case exposed sophisticated counterfeit operations that exploit distribution gaps, particularly in rural areas where verification systems are weakest.

Export vs. Domestic Standards
Critics point out that drugs meant for export often face stricter quality checks than those for domestic consumption, a disturbing double standard.

The Current Alert: What Parents Must Know

The Telangana DCA has issued a stop-use notice for Almont-Kid Syrup (Batch No. AL-24002) containing Levocetirizine and Montelukast. If you have this medication:

∙ Stop using it immediately
∙ Do not discard it, report it to authorities for investigation
∙ Contact the nearest Drugs Control Authority or use the official toll-free helpline
∙ Consult your paediatrician for alternative medications

What Needs to Change

India’s pharmaceutical industry is the world’s third-largest by volume, supplying affordable medicines globally. But recent scandals threaten this reputation and, more importantly, children’s lives. Urgent reforms needed include:
∙ Mandatory batch testing before market release
∙ Stricter penalties for manufacturers using substandard ingredients
∙ Stronger surveillance systems for post-market monitoring
∙ Transparent recall mechanisms with public notifications
∙ Better coordination between central and state drug authorities
∙ Whistleblower protection for industry insiders reporting violations

Stay Vigilant

For parents and caregivers, these incidents underscore the importance of:
∙ Buying medicines only from licensed pharmacies
∙ Checking batch numbers and expiry dates
∙ Reporting suspicious products to authorities
∙ Staying informed about drug alerts through official channels

The healthcare system’s credibility rests on a fundamental promise: first, do no harm. When children’s medicine becomes a source of poisoning rather than healing, that trust is shattered. India’s drug regulatory bodies must urgently transform from reactive crisis managers to proactive guardians of public health, before more families pay the ultimate price.

MBH/AB

2 Likes

Yes, it’s true that Drugs Control Administration of Telangana has advised to stopped the use for Almont-Kid Syrup,a pediatric anti-allergy medication,due to contamination with Ethylene Glycol,a highly toxic substance.

Your review shows good awareness of drug safety and public health risks. It is clear, responsible, and meaningful for healthcare and pharmacy students.

This is a very important topic - it clearly shows how drug safety failures can put children’s lives at risk, especially with contaminated syrups and low-quality medicines slipping through oversight. It’s great that the article highlights real cases and why stronger regulation, testing, and vigilance are urgently needed. What do you think should be the first step to improve drug safety in India?

This is deeply disturbing and heartbreaking. When medicines meant to heal children become a source of harm, it reflects a systemic failure that cannot be ignored

This is deeply alarming. Repeated contamination incidents show systemic regulatory failure. Strong enforcement, transparent recalls, and zero tolerance for shortcuts are essential to protect public trust and children’s lives.