In a devastating turn of events, India faced a major public health crisis in 2025 when contaminated cough syrups led to the deaths of at least 24 children. The tragedy has raised serious concerns about the safety of pharmaceutical products and the effectiveness of regulatory oversight in the country.
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The crisis began in late September 2025 when reports emerged from Chhindwara in Madhya Pradesh about several children falling critically ill after consuming cough syrup. Within weeks, the number of fatalities rose, prompting urgent investigations. By early October, health authorities identified that the deaths were linked to three specific cough syrups: Coldrif, Respifresh TR, and ReLife.
These syrups were manufactured by Sresan Pharmaceutical, Rednex Pharmaceuticals, and Shape Pharma, respectively. The affected regions included Madhya Pradesh and Rajasthan, where health officials reported a surge in acute kidney injuries and other severe symptoms among children under five years old.
The Syrups Involved: Coldrif, Respifresh TR & ReLife
Coldrif by Sresan Pharmaceutical
Coldrif, produced by Sresan Pharmaceutical, was the most implicated syrup in the tragedy. It was found to contain diethylene glycol (DEG) levels nearly 500 times the permissible limit. This toxic substance is an industrial-grade solvent and is not approved for use in medicines. The presence of DEG in Coldrif led to acute kidney failure and other life-threatening conditions in children.
Respifresh TR by Rednex Pharmaceuticals
Respifresh TR, manufactured by Rednex Pharmaceuticals, was another syrup found to be contaminated with DEG. Although the exact concentration was not disclosed, health authorities issued warnings about its potential risks, especially to young children.
ReLife by Shape Pharma
ReLife, produced by Shape Pharma, also contained toxic levels of DEG. The syrup was widely distributed in various states, and its contamination raised alarms about the oversight of pharmaceutical products in the domestic market.
The Toxic Ingredient: Diethylene Glycol Explained
Diethylene glycol (DEG) is a chemical compound used as a solvent in industrial applications. This chemical is strictly industrial and extremely poisonous, making it completely unsafe for ingestion by humans. When ingested, DEG can cause severe health issues, including acute kidney failure, neurological damage, and even death. Tests revealed that the level of diethylene glycol (DEG) in the contaminated cough syrups exceeded safe limits by nearly 500-fold, posing a severe and immediate risk to children’s health.
Regulatory Gaps & Investigations in India
The scandal has highlighted significant regulatory failures within India’s pharmaceutical industry. The Central Drugs Standard Control Organization (CDSCO), responsible for drug regulation, failed to detect the contamination before the syrups reached the market. Additionally, the affected syrups were not subjected to the rigorous testing required for export, leading to their widespread distribution domestically.
In response to the crisis, Indian authorities conducted raids on manufacturing facilities, including seven locations linked to Sresan Pharmaceutical. The company’s manufacturing licenses were revoked, and a money-laundering investigation was initiated. Similar actions were taken against Rednex Pharmaceuticals and Shape Pharma.
How Parents Can Protect Their Children
In light of the tragedy, it is crucial for parents to take proactive steps to ensure the safety of their children regarding cough syrup use:
Verify Product Information: Always check the label for the manufacturer’s details and approval numbers.
Consult Healthcare Professionals: Before administering any medication, consult a pediatrician to confirm its safety and appropriateness.
Report Adverse Effects: If your child experiences any unusual symptoms after taking a medication, report it to local health authorities immediately.
Stay Informed: Keep abreast of health advisories and product recalls issued by health authorities.
What the WHO and Indian Authorities Recommend
The World Health Organization (WHO) has issued a Medical Product Alert, urging national regulatory authorities to increase surveillance of oral liquid medicines, especially those manufactured in India. The WHO emphasized the need for stringent testing and monitoring to prevent the circulation of contaminated products.
In India, the CDSCO has taken several measures, including suspending the licenses of the implicated companies, initiating product recalls, and conducting nationwide audits of pharmaceutical manufacturers. However, experts argue that these actions are reactive rather than proactive and that systemic reforms are needed to strengthen drug safety oversight.
Lessons for the Pharmaceutical Industry
The 2025 cough syrup tragedy serves as a stark reminder of the importance of stringent quality control and regulatory compliance in the pharmaceutical industry. Manufacturers must ensure that their products undergo rigorous testing for contaminants and adhere to safety standards. Additionally, there is a pressing need for greater transparency and accountability within the industry to restore public trust.
Conclusion
The 2025 cough syrup scandal in India has underscored critical lapses in drug safety and regulatory oversight. While authorities have taken steps to address the immediate crisis, long-term reforms are essential to prevent such tragedies in the future. Parents must remain vigilant and informed to safeguard their children’s health. Collective efforts from regulatory bodies, healthcare professionals, and the pharmaceutical industry are necessary to ensure that such a crisis does not repeat.
As the investigation continues, it is hoped that this incident will lead to meaningful changes in India’s pharmaceutical regulations, ultimately ensuring that children’s health is protected from such preventable harm.
FAQs: India’s Deadly Cough Syrup Scandal 2025
As of October 2025, at least 24 children under the age of five have died after consuming contaminated cough syrups, mainly in Madhya Pradesh and Rajasthan.
The three syrups implicated are:
Coldrif (Sresan Pharmaceutical)
Respifresh TR (Rednex Pharmaceuticals)
ReLife (Shape Pharma)
All three syrups contained diethylene glycol (DEG), an industrial solvent that is highly toxic and not intended for human consumption.
DEG is an industrial chemical used in antifreeze and solvents. Ingesting even small amounts can lead to acute kidney failure, nerve damage, and death, especially in children.
Investigations revealed regulatory gaps in Indian pharmaceutical oversight. The syrups bypassed rigorous safety testing, and manufacturers allegedly used cheap, industrial-grade ingredients instead of pharmaceutical-grade solvents.
The hardest-hit regions were Madhya Pradesh (Chhindwara, Seoni) and Rajasthan (Jaipur and surrounding districts). Other states reported suspicious cases, but the majority were in these areas.
Common symptoms included:
Severe vomiting
Acute kidney failure
Reduced urine output
Lethargy and weakness
Neurological symptoms such as seizures in extreme cases
The government:
Suspended licenses of Sresan, Rednex, and Shape Pharma
Initiated nationwide product recalls of all three syrups
Conducted raids on manufacturing facilities
Launched investigations and criminal proceedings against company officials
The World Health Organization (WHO) issued a Medical Product Alert, warning countries to:
Avoid the implicated syrups
Increase surveillance of all oral liquid medicines
Test pharmaceutical-grade ingredients for contamination
While most Indian cough syrups are safe, parents must verify manufacturer details, batch numbers, and approvals before administration, as the 2025 scandal exposed systemic weaknesses.
