Introduction: A Tragedy that Shocked the Nation
India has been jolted by the deaths of at least 12 children in Madhya Pradesh and Rajasthan, linked to the consumption of contaminated cough syrup. Laboratory investigations revealed the presence of diethylene glycol (DEG), a toxic chemical used in antifreeze, in concentrations as high as 48.6%—far beyond safety limits. States responded by banning the implicated product, ordering nationwide inspections, and issuing urgent advisories. The episode reignited questions about drug safety, manufacturing practices, and regulatory failures that have long plagued the sector.
Anatomy of a Disaster
Case Details and Timeline
In early September 2025, Chhindwara district in Madhya Pradesh began to report cases of acute kidney failure in children following administration of Coldrif syrup, manufactured by Sresan Pharma. The tragedy unfolded as follows:
Multiple children developed complications within days, with the first death occurring on September 2.
A spike in fatalities forced hospitals and authorities into action.
Laboratory analysis conclusively linked the deaths to extreme DEG contamination.
State and central governments banned Coldrif, seized stocks, and extended the prohibition to other medicines from the same manufacturer.
National Alarm and Response
Central Drug Standards Control Organisation (CDSCO) began risk-based inspections in six states, recognizing systemic risk.
The Union Health Ministry issued an advisory against cough and cold syrup prescriptions for children below two.
Compensation and medical reimbursement for affected families were announced, but outrage grew as investigations pointed to deeper failures.
How Spurious and Adulterated Drugs Proliferate
Regulatory Gaps and Fragmentation
India’s pharmaceutical sector operates under layered, often fragmented oversight: central bodies (CDSCO), state drug controllers, and district health authorities. Key weaknesses:
Insufficiently resourced state authorities, limited lab capacity, and few trained inspectors.
Disjointed record-keeping and lack of unified databases.
Delays and gaps in post-market surveillance and recall protocols.
Economic Pressures and Ethical Lapses
Fierce competition and price controls drive manufacturers toward cost-cutting—sometimes substituting toxic chemicals for safer ingredients (DEG for propylene glycol).
Weak supply chain traceability lets counterfeit and substandard drugs slip through.
Training gaps among staff—especially in small and mid-scale plants—mean SOPs aren’t always followed.
Supply Chain Weakness and Poor Pharmacovigilance
Medicines pass through tens of thousands of distributors with minimal batch tracing.
India’s pharmacovigilance programme remains poorly understood, with adverse event reporting rare and enforcement patchy.
Outdated Manufacturing Infrastructure
_____________________________________________________________________________________Many small and medium enterprises operate in decades-old facilities, lacking modern equipment, interlocks, and robust safety mechanisms—making cross-contamination and process failures common.
The Regulatory Framework—Shortfalls and Loopholes
Drugs and Cosmetics Act and Its Limits
The Drugs and Cosmetics Act, 1940—amended many times—remains the sector’s legal backbone, mandating product approval, batch testing, and penalties.
Penalties for first-time or minor violations are often tiny compared to profits, making compliance a low priority.
Lack of harmonization across states means some regions are “soft targets” for unscrupulous manufacturers.
Recalls, Testing, and Post-Market Surveillance Failures
Testing is often slow and limited; recalls even slower, allowing contaminated products to remain on shelves for months.
Inspections are infrequent, often announced in advance, and affected by staff shortages.
International Fallout
_____________________________________________________________________________________India’s status as a major medicine exporter means global reputation is also at stake. Recent cough syrup incidents abroad have triggered bans and lawsuits, hurting the credibility of “Made in India” medicines.
Accountability Across the Production Chain
The Role of Analysts
Drug analysts serve as gatekeepers: chemically, physically, and micro-biologically testing every batch before approval.
If analysts neglect, falsify, or ignore problems, dangerous medication enters the market.
Production Chemists and Quality Staff
Production chemists maintain batch integrity, check weighing and mixing, follow SOPs, and validate final release. Their documentation and sign-off are essential.
Quality assurance staff ensure compliance, document deviations, and trigger corrective actions.
Supervisors and Regulatory Inspectors
Supervisors enforce day-to-day GMP compliance, inspect documentation, and train staff.
Regulatory agencies must audit facilities, enforce standards, and order recalls/scans as needed.
Shared Responsibility
_____________________________________________________________________________________Accountability must extend to every link. Negligence, omission, or willful non-compliance at any stage can directly cause harm. Historically, legal action focuses on management, but there is an urgent need to prosecute every complicit party—from analyst to inspector.
Penalties and Enforcement
Current Provisions
Drugs and Cosmetics Act: Up to life imprisonment and multi-lakh fines for manufacturing or selling adulterated drugs causing death.
IPC Sections 274/275: Six months imprisonment or fines for adulteration/sale; but actual deterrence is weak.
The Reality of Enforcement
Rare prosecution of non-management staff despite clear evidence of chain accountability and negligence.
Most regulatory actions are limited to bans, recalls, or license cancellations.
Experts call for stronger enforcement targeting individuals across all roles.
Schedule M—The Imperative Reform
What is Revised Schedule M?
Revised Schedule M upgrades India’s GMP standards to global levels by mandating:
Modern facilities (clean rooms, validated equipment, proper personnel/material flow)
Strict process documentation and training
Enhanced inspection protocols
The Harm of Extensions
Despite its importance, Schedule M compliance deadlines have been routinely postponed for small and medium manufacturers, now extended to December 2025.
Every extension leaves patients exposed to substandard manufacturing processes.
Delays undercut not only domestic safety but global reputation.
No More Excuses
_____________________________________________________________________________________India must enforce Revised Schedule M across all facilities, with immediate closure or penalties for non-compliance. The new law cannot remain negotiable or optional.
Pathways to True Accountability
Immediate Action Steps
Unconditional, universal Schedule M enforcement—No further extensions. Facilities must shut down if non-compliant.
Criminal liability across all roles—prosecution, blacklisting, and license cancellation for every complicit staff member.
Transparent compliance reporting—publicly track audit results, recalls, and enforcement actions.
Robust pharmacovigilance—train health workers and educate the public to report adverse events; ensure timely regulatory follow-up.
Mandatory re-training—every staff member must undergo periodic GMP and compliance updates.
Long-Term Reforms
Investment in inspector training, testing labs, and digital batch tracing.
Collaboration with global regulatory bodies for harmonized best practices.
Incentivize ethical practices by linking compliance to market access and export privileges.
Conclusion: Lives at Stake, Reform Cannot Wait
India stands at a crossroads. The cough syrup deaths are not isolated; they are a symptom of endemic regulatory and ethical failures. Full accountability—analyst to owner, inspector to regulator—must be enforced. The Revised Schedule M offers a clear path, but only if implemented without delay, compromise, or further extensions.
India’s children deserve safe medicine—nothing less will do.
Disclaimer:
This blog expresses the author’s personal analysis, opinions, and interpretation of the recent cough syrup tragedy and pharmaceutical regulatory issues in India. The content is intended for educational and informational purposes only, and does not constitute professional medical, legal, or regulatory advice. Readers are encouraged to consult qualified professionals for specific guidance. The author and publisher disclaim any liability arising from the use or interpretation of this material. Opinions shared here reflect the author's viewpoint based on currently available information and should not be taken as official or legally binding statements.
References:
A comprehensive list of regulatory updates, news articles, expert commentaries, and official advisories from October 2025 forms the basis of this analysis.
