India has officially declared three widely used cough syrups—Coldrif, Respifresh TR, and ReLife—as toxic after laboratory analysis confirmed the presence of diethylene glycol (DEG), a highly poisonous chemical that caused the deaths of at least 17 children in Madhya Pradesh. The tragedy, which has sent shockwaves across the country, exposed critical lapses in drug safety standards and reignited questions about the oversight of India’s massive pharmaceutical industry.
The incident came to light when children in Madhya Pradesh’s Ujjain and Khandwa districts began showing alarming symptoms—vomiting, abdominal pain, decreased urine output, and eventual kidney failure—after being treated with Coldrif syrup for mild cough and cold. Laboratory tests conducted at the state drug control laboratory revealed that the syrup contained 48.6% diethylene glycol, an industrial solvent used in antifreeze and brake fluids, which is lethal even in small quantities. For comparison, the permissible limit for DEG in pharmaceutical formulations is 0.1%. Health authorities immediately alerted the Central Drugs Standard Control Organisation (CDSCO), prompting a nationwide probe.
Following Coldrif’s confirmation as toxic, two other syrups—Respifresh TR (manufactured by Rednex Pharmaceuticals) and ReLife (produced by Shape Pharma)—were tested and also found contaminated with DEG, though at lower levels (1.34% and 0.61% respectively). Both manufacturers are based in Gujarat and have been directed to cease production and recall all distributed batches. Coldrif’s maker, Sresan Pharmaceutical from Tamil Nadu, has had its production license suspended, and its owner has been arrested for gross negligence and violation of the Drugs and Cosmetics Act. Authorities are also probing whether the contamination was due to adulterated excipients—especially glycerin or propylene glycol—that may have entered the supply chain through unregulated chemical dealers.
In response, the Union Health Ministry ordered a blanket ban on the three syrups, while state governments across India moved quickly to enforce recalls. Tamil Nadu, Telangana, Haryana, and Rajasthan have banned the sale and use of the products, with drug inspectors seizing stock from pharmacies, hospitals, and wholesalers. The National Human Rights Commission (NHRC) issued notices to the governments of Madhya Pradesh, Rajasthan, and Uttar Pradesh, calling the deaths a violation of the right to safe medical care and demanding detailed reports within two weeks.
The Central Drugs Standard Control Organisation (CDSCO) has launched an all-India inspection campaign, focusing on manufacturers of liquid oral formulations—especially pediatric syrups. The regulator has instructed all state drug controllers to conduct batch-wise testing of raw materials, particularly solvents like glycerin and polyethylene glycol, which are prone to contamination if purchased from unverified chemical suppliers. The Health Ministry is also preparing a proposal to make it mandatory for drug manufacturers to source ingredients only from certified suppliers with validated testing records.
This is not the first time that DEG contamination in Indian-made syrups has caused deaths. In 2022, over 60 children in The Gambia and 18 in Uzbekistan died after consuming cough syrups exported from India, leading to global outrage and an international investigation. The World Health Organization (WHO) later confirmed that those syrups—also containing DEG and ethylene glycol—were of Indian origin. Despite promises of reform and tighter regulation after the Gambian incident, the current domestic tragedy highlights that many systemic issues remain unresolved.
Experts have identified multiple factors behind these recurring lapses:
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Weak testing capacity: Most state drug testing labs are under-equipped, making it difficult to test every batch of drugs before market release.
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Fragmented oversight: Drug regulation in India is divided between central and state authorities, leading to inconsistent enforcement.
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Supply chain opacity: Many small manufacturers procure solvents from uncertified vendors to cut costs, often bypassing quality verification.
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Lenient penalties: Violations of the Drugs and Cosmetics Act often result in minor fines or short suspensions, offering little deterrence to offenders.
In Telangana, officials have revealed that ReLife syrup had previously been flagged as “Not of Standard Quality” earlier this year for labeling issues—though no chemical contamination was detected at that time. This revelation has intensified criticism that routine monitoring was either ignored or inadequately enforced.
Health experts warn that DEG poisoning can cause irreversible renal failure, neurological damage, blindness, and death, especially in children, whose metabolic systems cannot process such toxins. The symptoms—vomiting, confusion, drowsiness, and decreased urine output—often appear several hours after ingestion, making early detection difficult. The Madhya Pradesh Health Department has confirmed that all 17 deceased children had consumed Coldrif syrup within 48 hours of hospitalization.
The government has since issued a public advisory urging parents to immediately stop using Coldrif, Respifresh TR, or ReLife, and to report any suspected adverse effects to the nearest hospital or drug control office. Pharmacies have been told to withdraw the syrups from shelves, maintain inventory records, and assist with the recall process.
Amid growing outrage, the Ministry of Health is reportedly drafting amendments to the Drugs and Cosmetics Act to strengthen penalties and increase jail terms for manufacturers found guilty of producing substandard or toxic drugs. The ministry is also exploring the establishment of a centralized database for ingredient traceability, allowing regulators to track every component from raw material sourcing to final packaging.
Public health advocates and industry experts agree that India’s reputation as the “pharmacy of the world” now faces a credibility crisis. While Indian pharmaceutical exports supply affordable medicine to more than 150 countries, repeated cases of contamination—both domestic and international—risk undermining global trust. Experts argue that India must move from a reactive to a preventive regulatory model, emphasizing proactive testing, transparent audits, and corporate accountability rather than post-crisis crackdowns.
The current tragedy serves as a sobering reminder that quality lapses in pharmaceuticals can have devastating consequences. The loss of young lives in Madhya Pradesh underscores the human cost of regulatory complacency. As the investigation continues, families of the victims are demanding justice, compensation, and assurances that such negligence will never recur. The government’s next steps—strengthening oversight, enforcing compliance, and rebuilding public trust—will determine whether India can truly uphold its promise of safe, affordable medicine for all.
