A chilling crisis has once again gripped India, with reports of children dying from acute kidney injury after consuming contaminated cough syrup. This isn't an isolated incident, but a tragic, recurring pattern that exposes systemic failures in India's drug regulatory framework, threatening not only the lives of its citizens but also the reputation of the country's vast pharmaceutical industry.
The New Outbreaks: A Deadly Chemical Confirmed
Recent tragedies in states like Madhya Pradesh and Rajasthan have sounded a grave alarm. Multiple child deaths were linked to the consumption of cough syrups such as 'Coldrif' and 'Nextro-DS'. Initial investigations in Madhya Pradesh, specifically in the Chhindwara district, focused on a specific batch of Coldrif syrup, which was eventually confirmed by a test in Tamil Nadu to contain dangerously high levels as much as 48.6% of Diethylene Glycol (DEG).
DEG and its industrial cousin, Ethylene Glycol (EG), are toxic industrial solvents used in products like antifreeze. They are sometimes fraudulently or mistakenly substituted for the safer pharmaceutical-grade solvent, Propylene Glycol, often to cut costs. Even small amounts are lethal, causing severe poisoning that leads to acute kidney and liver failure.
Following the confirmation of DEG, state governments immediately banned the sale and distribution of the contaminated products and launched urgent investigations. This latest contamination echoes similar, devastating episodes that have plagued India's pharmaceutical sector for decades.
A History of Poison: India's DEG Epidemics
The use of toxic contaminants in Indian-made medicines is not a new scourge. Cases of mass DEG poisoning stretch back years:
- 1986 Mumbai: 14 patients died after receiving glycerin contaminated with DEG.
- 1998 Gurgaon (Haryana): At least 33 children died after ingesting a DEG-contaminated cough expectorant.
- 2020 Jammu: 12 children died after consuming a contaminated cough syrup.
This recurring nature highlights a lack of systemic overhaul and the failure to enforce stringent quality control measures at the manufacturing level.
The Global Fallout and Regulatory Response
The domestic crisis is compounded by the international scandal that erupted in 2022. That year, cough syrups manufactured by Indian companies like Haryana-based Maiden Pharmaceuticals and Delhi-based Marion Biotech were linked to the deaths of hundreds of children in The Gambia and Uzbekistan. The World Health Organization (WHO) issued alerts, severely damaging the "Pharmacy of the World" brand India had meticulously built.
In the wake of the global outcry, the Indian government took some steps:
Mandatory GMP: The Central Drugs Standard Control Organization (CDSCO) mandated that all pharmaceutical companies implement Good Manufacturing Practices (GMP) standards within a set timeframe, depending on their size.
Export Testing: Additional quality tests were made mandatory for all cough syrups intended for export to ensure they meet international standards before shipment.
Advisories: The Directorate General of Health Services (DGHS) issued advisories for the rational use of cough syrups in children, cautioning against prescribing or dispensing them, especially to children under two years of age.
Despite these steps, the reality on the ground remains problematic. While some companies faced temporary production halts or license suspensions, the lack of punitive measures such as criminal prosecution or permanent blacklisting for key executives and companies reflects a profound systemic failure. As one investigation found, a company linked to the 2022 Gambia deaths continued to manufacture and export other pharmaceutical products shortly thereafter.
The Core Problem: A Fragmented System and Weak Enforcement
The root of the crisis lies in a fragmented regulatory ecosystem and chronic understaffing. Drug regulation in India is split between the national CDSCO and numerous state-level drug authorities.
- Decentralized Control: This dual structure leads to uneven enforcement, with export violations and domestic quality issues often slipping through the cracks. Calls for a centralized system under CDSCO to ensure a 'one quality, one standard' approach are yet to be fully realized.
- Resource Deficit: Regulatory bodies are severely understaffed. The low number of drug inspectors and the underutilization of drug-testing labs mean that routine checks, which are essential for catching raw material contamination like DEG substitution, are inadequate.
- Lack of Recall Law: Crucially, India still lacks a mandatory drug recall mechanism. This means substandard drugs remain on the market for too long, directly jeopardizing public safety.
The recent discovery of DEG in the 'Coldrif' syrup, despite initial government claims that the samples were clean, underscores the inconsistency in testing and investigation. While a nationwide crackdown and inspections have been initiated, only a comprehensive, centralized overhaul of the regulatory system coupled with strict enforcement and severe penalties for negligence will break this deadly cycle and truly protect the nation's children.
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