NHRC Issues Notices to Three States Over Cough Syrup Deaths: A Wake-Up Call on India’s Drug Safety System

— by vishal Sambyal

The NHRC has issued notices to Madhya Pradesh, Rajasthan, and Uttar Pradesh after the deaths of children linked to contaminated cough syrup. Here’s what’s being done to ensure drug safety in India.

A Tragic Alarm: When Medicine Turns Deadly

What should have brought relief turned into tragedy. The deaths of at least 14 children in Chhindwara, Madhya Pradesh — allegedly due to contaminated cough syrup — have sparked a nationwide outcry and a deeper look into India’s pharmaceutical oversight. The National Human Rights Commission (NHRC) has now intervened, issuing notices to three state governments — Madhya Pradesh, Rajasthan, and Uttar Pradesh — demanding a thorough probe into the matter.

This isn’t just about one batch of medicine gone wrong; it’s a chilling reminder of how lapses in manufacturing standards can cost innocent lives.

Background: The Cough Syrup Behind the Crisis

The syrup in question, Coldrif, was manufactured by Sresan Pharmaceutical, a company based in Kancheepuram, Tamil Nadu. The product is now under intense scrutiny after initial reports revealed that it contained diethylene glycol (DEG) — a toxic industrial solvent known to cause acute kidney failure when ingested.

Authorities in Madhya Pradesh immediately banned the sale of Coldrif after the deaths were reported. Officials confirmed that laboratory tests detected the presence of toxic substances far beyond permissible limits.

The incident drew parallels with previous cases where DEG-contaminated cough syrups caused fatalities in Gambia and Uzbekistan, raising uncomfortable questions about India’s pharmaceutical regulation and export standards.

NHRC Steps In: Demanding Accountability

In a strong move, the NHRC has issued notices to the governments of Madhya Pradesh, Rajasthan, and Uttar Pradesh, directing them to investigate the deaths and take swift action to remove spurious medicines from circulation.

The Commission has also written to the Ministry of Health and Family Welfare, the Drugs Controller General of India (DCGI), the Central Drugs Standard Control Organisation (CDSCO), and the Directorate General of Health Services (DGHS), urging them to:

  • Conduct a nationwide probe into the supply of spurious drugs.
  • Direct all regional drug labs to collect and test samples of cough syrups.
  • Submit comprehensive test reports on drug quality.

This level of national coordination underscores the gravity of the issue — and the urgent need to restore public confidence in the safety of India’s drug supply chain.

Government’s Response: Action on Multiple Fronts

Following the NHRC’s intervention, the Madhya Pradesh government sent several clinical, environmental, and pharmaceutical samples to NIV Pune, CDL Mumbai, and NEERI Nagpur for testing.

Preliminary reports ruled out infectious diseases as the cause of death in most cases, confirming suspicions of chemical toxicity. Out of 10 medicine samples analyzed so far, nine met quality standards, but the Coldrif syrup sample showed DEG levels beyond permissible limits.

As a result:

  • The Tamil Nadu Food and Drugs Administration (FDA) initiated regulatory action against Sresan Pharmaceutical.
  • The CDSCO has recommended cancellation of the company’s manufacturing license.
  • Criminal proceedings have been launched against the manufacturer.

The Larger Problem: Cost-Cutting and Oversight Failures

Experts warn that this tragedy exposes a recurring flaw in India’s pharmaceutical manufacturing ecosystem — the temptation to substitute expensive pharmaceutical-grade ingredients with cheaper industrial-grade alternatives.

According to the Indian Medical Association (IMA), pharmaceutical-grade glycerin and propylene glycol, key components in cough syrups, are significantly more costly. Some manufacturers, cutting corners, use industrial-grade substitutes like diethylene glycol (DEG) and ethylene glycol (EG) — which are cheaper, visually indistinguishable, but highly toxic.

If quality checks fail at both the manufacturing and regulatory levels, such toxic substances can slip into the market, posing life-threatening risks, especially for children.

Union Health Ministry’s Nationwide Review

In response, the Ministry of Health and Family Welfare held a high-level meeting chaired by Union Health Secretary Punya Salila Srivastava, bringing together officials from all states and Union Territories.

The meeting emphasized:

  • Strict adherence to Good Manufacturing Practices (GMP) under Revised Schedule M of the Drugs Rules, 1945.
  • Immediate compliance checks for all drug manufacturers.
  • Ensuring rational use of cough syrups, particularly among children.

The revised Schedule M, notified in December 2023, now extends beyond traditional GMP to include equipment and facility standards for pharmaceutical products. The goal: to prevent contamination, strengthen accountability, and align India’s pharmaceutical practices with global norms.

Expert Insight: A Wake-Up Call for India’s Pharma Reputation

Public health experts say the NHRC’s notice signals a turning point. “India is known as the pharmacy of the world,” said a Delhi-based pharmaceutical analyst. “But incidents like this threaten that reputation. We need consistent regulatory vigilance and transparent testing mechanisms to ensure that no unsafe product reaches patients.”

The deaths in Chhindwara have reignited debates over India’s fragmented drug regulation system — where state-level authorities often lack the resources or manpower to monitor thousands of manufacturing units.

What’s Next: Toward a Safer Pharmaceutical Future

As investigations continue, the case could reshape how India approaches drug manufacturing oversight. Regulatory tightening, stricter testing protocols, and nationwide compliance audits are expected to follow.

For grieving families, however, these measures come too late. Their tragedy serves as a painful reminder of the cost of negligence — and the moral duty of a system entrusted with safeguarding lives.

Conclusion: From Reaction to Reform

The NHRC’s notice may mark the beginning of a long-overdue reform in India’s drug quality control. But real change will require more than administrative action — it demands transparency, accountability, and moral responsibility across the pharmaceutical ecosystem.

Until every batch of medicine is guaranteed safe, the promise of healing remains incomplete.

Disclaimer: This article is based on publicly available official statements and verified government updates. It is intended for informational purposes and not as medical or legal advice.