Recently, India has been rocked by a series of tragic incidents involving contaminated cough syrups that have claimed the lives of dozens of children. These heartbreaking cases have exposed critical vulnerabilities in the nation’s pharmaceutical industry, regulatory oversight, and drug safety protocols. The problem goes beyond a single company or product, highlighting systemic challenges in one of the world’s largest drug manufacturing hubs.
The Mystery Illness in Jammu: A Grim Beginning
The story begins in the winter of 2019, in India’s Jammu region, where a mysterious illness began affecting children aged between two months and six years. Initially presenting with common symptoms like cough and cold, many children were prescribed locally available cough syrups by healthcare providers. Instead of improving, these children deteriorated rapidly, vomiting, running high fevers, and suffering kidney failure. By the time authorities uncovered the truth, 11 young lives had been lost.
Investigations revealed that samples of cough syrup manufactured by Digital Vision, an Indian drug company, were contaminated with diethylene glycol (DEG), a toxic industrial solvent commonly used in products such as brake fluids and paint thinners. DEG ingestion is known to cause kidney failure, a fatal condition if untreated.
A Global Alert: The Gambia Tragedy and WHO Warning
The Jammu incident was not isolated. Earlier this year, the World Health Organization (WHO) issued a global warning after the deaths of 66 children in The Gambia were linked to cough syrups made by Maiden Pharmaceuticals Limited, a 32-year-old Indian drug manufacturer.
Laboratory analysis confirmed “unacceptable amounts” of diethylene glycol and ethylene glycol, both poisonous substances, in the cough syrups. These chemicals are industrial solvents and absolutely unsafe for human consumption.
Such events cast a harsh spotlight on India’s sprawling pharmaceutical sector, which is valued at approximately $42 billion annually and supplies a significant portion of the world’s generic and over-the-counter (OTC) medicines.
India: The Pharmacy of the World and the Shadow of Quality Concerns
India’s pharmaceutical industry has grown exponentially over the last decade, with annual growth rates exceeding 9%. It boasts over 3,000 firms operating nearly 10,000 manufacturing facilities, producing generics, vaccines, and various drug ingredients.
India is the primary supplier of affordable generic medicines globally, 40% of OTC and generic drugs sold in the US and a quarter of all medicines dispensed in the UK come from India. It also supplies two-thirds of anti-retroviral drugs used worldwide for HIV treatment.
Prime Minister Narendra Modi has proudly promoted India as the “pharmacy of the world,” underscoring the country’s expertise in generics and cost-effective drug manufacturing. However, this rapid growth has often outpaced regulatory and quality assurance mechanisms, creating dangerous gaps.
Regulatory Challenges and the Problem of Counterfeit Medicines
India’s pharmaceutical industry faces long-standing issues with counterfeit and substandard drugs, especially in rural areas where oversight is weak. Many patients and healthcare workers often confuse substandard drugs, those failing quality checks, with outright fake medicines.
State-run drug testing laboratories are frequently underfunded, inadequately staffed, and poorly equipped. The regulatory framework is stretched thin, with inconsistent enforcement across states. In 2014, India’s top drug regulator openly acknowledged that if the country adopted US-quality standards, most of its drug manufacturing plants would be forced to close.
Rajasthan Health Minister Gajendra Singh also ordered an inquiry and measures to safeguard public interest, an official statement said.
Principal Secretary in the Medical and Health Department, Gayatri Rathore, said the Union government issued an advisory in 2021 against administering Dextromethorphan to children below four years.
The State has reiterated the advisory, while the Drug Controller General of India on Friday advised that the syrup should normally be given only to children above five years, and in no circumstances to those under two years of age.
In Rajasthan, where three children have died, State Health Minister Gajendra Singh Khimsar went even further by blaming the families. “The medicine in question was not prescribed by any government doctor. It was given at the level of the parents, who purchased it themselves. The health department has no role in this. The drug is correct; the report has shown no fault,” he said.
Historical Pattern of DEG Poisoning in India
Tragically, incidents of mass poisoning due to DEG-contaminated medicines are not new in India. Since 1972, over 70 people, mostly children, have died in at least five separate events involving cough syrups or other medicines laced with DEG.
In 2013, a major scandal involved Ranbaxy Laboratories, India’s then-largest drug manufacturer. After a prolonged investigation, the company was fined $500 million by US authorities for manufacturing and distributing substandard drugs. This was the largest fine ever imposed on a generic drug maker for violations involving drug safety.
Recent Incidents and Government Actions
The recent cases of child fatalities linked to cough syrups have prompted swift government action in several states.
In Rajasthan, the Drug Controller Rajaram Sharma was suspended amid allegations of interference in medicine quality standards. The government halted distribution of 19 medicines supplied by Kayson Pharma after children fell ill or died due to substandard cough syrups under the state’s free medicine scheme.
The Rajasthan Medical Services Corporation Limited (RMSCL) revealed that out of over 10,000 samples of Kayson Pharma’s medicines tested since 2012, 42 were found substandard.
In response, Rajasthan’s Chief Minister Bhajan Lal Sharma ordered a detailed probe into how these medicines passed quality assurance checks. Committees were formed to investigate and recommend further actions.
Tamil Nadu Bans ‘Coldrif’: Production Halted Amid Toxicity Concerns
Following reports linking the cough syrup ‘Coldrif’ to child deaths in Madhya Pradesh and Rajasthan, Tamil Nadu’s government banned its sale and ordered the immediate removal of the product from the market.
The syrup, manufactured by a company based in Chennai, was suspected of contamination with diethylene glycol. Inspections at the manufacturing facility in Kancheepuram district led to the collection of samples for lab testing. Production was halted pending results.
Union Health Ministry Advisory: Caution on Cough Syrups for Children
In light of these tragedies, the Union Health Ministry issued an advisory to all states and Union Territories, warning against the use of cough and cold medications for children under two years old.
“These are generally not recommended for ages below five years, and for those above that, any use should follow careful clinical evaluation with close supervision and strict adherence to appropriate dosing, the shortest effective duration, and avoiding multiple drug combinations.”
The advisory emphasized that such medications are generally not recommended for children below five years and should only be used after careful clinical evaluation, close monitoring, and strict adherence to dosing guidelines.
The ministry also highlighted that most acute cough illnesses in children are self-limiting and typically resolve without pharmacological intervention. It urged healthcare providers and public health institutions to promote rational drug use and disseminate this guidance widely.
Conflicting Lab Results and Continued Uncertainty
Despite the Tamil Nadu ban and production halt of Coldrif, test results from government labs in Madhya Pradesh and Rajasthan revealed no presence of diethylene glycol or ethylene glycol in the cough syrups linked to recent child deaths.
This discrepancy has caused confusion and further scrutiny of pharmaceutical quality control practices. The Tamil Nadu Drugs Control Department maintained its stop production order after finding one batch “not of standard quality” and adulterated with diethylene glycol.
Meanwhile, the Union Health Ministry reiterated that the syrup linked to Rajasthan deaths did not contain propylene glycol, another potential contaminant source.
Sub-Divisional Magistrate of Parasia, Shubham Yadav, said, “The biopsy confirmed a kidney infection. Common causes include dirty water, rats, and mosquitoes. We are in preventive mode. Sales of the drug have been stopped, and samples have been sent for testing. Action will be taken only if responsibility is proven.”
The Road Ahead: Strengthening Drug Safety in India
The cough syrup tragedies have exposed deep fissures in India’s drug manufacturing and regulatory systems. As the country continues to be a vital global supplier of affordable medicines, ensuring stringent quality control and regulatory enforcement is imperative.
Key priorities
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Upgrading drug testing laboratories with better funding, staffing, and technology.
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Harmonizing regulatory standards with international best practices without stifling domestic production.
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Increasing transparency and accountability for drug manufacturers.
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Educating healthcare providers and the public on the risks of irrational medicine use, especially in children.
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Strengthening post-market surveillance to quickly detect and respond to adverse drug events.