India Issues Nationwide Advisory on Cough Syrup Use in Children After Deaths in Madhya Pradesh and Rajasthan

Health Ministry Warns Against Use of Cough Syrups for Children Below 5; DEG Contamination and Improper Prescriptions Under Investigation

The Union Health Ministry has issued a nationwide advisory to all States and Union Territories (UTs) on the rational and judicious use of cough syrups in the paediatric population, following alarming reports of child deaths linked to their consumption in Madhya Pradesh and Rajasthan.

The advisory, issued through the Directorate General of Health Services (DGHS), comes in response to investigations into the tragic deaths of children allegedly after consuming cough syrup products such as Coldrif Syrup and Dextromethorphan Hydrobromide Syrup.

Key Advisory Highlights

The advisory clearly states that:

• Cough and cold medications should not be prescribed or dispensed to children under 2 years of age.

• These medications are generally not recommended for children under 5 years, and in older children, they must only be used after clinical evaluation, under strict supervision, and with precise dosing.

• Combination drugs (i.e., multiple active ingredients) should be avoided.

• Most acute cough illnesses in children are self-limiting, resolving without pharmacological intervention.

• Non-pharmacological measures such as adequate hydration, rest, and supportive care should be the first line of management for cough in children.

The Ministry directed State and UT Health Departments, District Health Authorities, and all clinical establishments to disseminate this advisory widely across government dispensaries, Primary Health Centres (PHCs), Community Health Centres (CHCs), district hospitals, and medical institutions.

Child Deaths and Subsequent Investigations

The advisory comes after nine child deaths were reported in Madhya Pradesh and two in Rajasthan, allegedly following the consumption of cough syrups. These incidents sparked nationwide concern over the safety and regulation of paediatric cough syrups in India.

In Madhya Pradesh, the deaths were linked to Coldrif Syrup, a formulation containing paracetamol, phenylephrine hydrochloride, and chlorpheniramine maleate.

Following the incident, a joint investigation team comprising representatives from the:

• National Centre for Disease Control (NCDC)

• National Institute of Virology (NIV)

• Central Drugs Standard Control Organisation (CDSCO)

• And other scientific bodies

...was dispatched to the site to collect samples for detailed testing. Samples of cough syrups, blood, and cerebrospinal fluid (CSF) were analysed by laboratories.

The Ministry confirmed that none of the samples tested positive for Diethylene Glycol (DEG) or Ethylene Glycol (EG) — toxic chemical contaminants known to cause acute kidney injury and have been linked to fatal poisoning in children in previous global cases.

Additionally, one of the children tested positive for leptospirosis, a bacterial infection spread through water contaminated with animal urine. Investigations into water samples, respiratory specimens, and entomological vectors (organisms that transmit diseases) are still underway by labs including NIV Pune and NEERI.

The Madhya Pradesh State Food and Drug Administration (SFDA) also tested three samples of Coldrif Syrup and confirmed the absence of DEG or EG contaminants.

Contaminated Batch Detected in Tamil Nadu

In a twist to the story, on October 3, 2025, the Tamil Nadu Drugs Control Department ordered an immediate stop to the production of Coldrif Syrup after the Government Drugs Testing Laboratory found Batch No. SR-13 to be “not of standard quality” and “adulterated with Diethylene Glycol (DEG)”.

This batch was manufactured in May 2025 by Sresan Pharmaceutical Manufacturer in Kancheepuram district, with an expiry of April 2027.

A show-cause notice has been served to the manufacturer for possible licence cancellation. S. Gurubharathi, Deputy Director of Drugs Control and Licensing Authority of Tamil Nadu, confirmed that regulatory action was taken promptly after linking the batch to the deaths in Madhya Pradesh.

Rajasthan Deaths Linked to Dextromethorphan-Based Syrup

Meanwhile, in Rajasthan, two children — Samrat Jatav (2) from Bharatpur and Nityansh Sharma (5) from Sikar — died after allegedly consuming Dextromethorphan Hydrobromide Syrup IP 13.5 mg/5 ml. This syrup was manufactured by Kayson Pharma, a Jaipur-based company supplying drugs under the Chief Minister’s Free Medicine Scheme.

Dextromethorphan (DXM) is a common cough suppressant found in over-the-counter medications. While it is widely used, DXM can cause serious side effects in children including drowsiness, vomiting, agitation, and in extreme cases, neurological complications. It is not recommended for children, especially those under 5.

The Rajasthan Health Department clarified that the DXM-based syrup is not part of state-prescribed medications, and that the deceased children had been given the syrup at home without a doctor’s consultation. Disciplinary action, including suspension of a doctor and pharmacist, has been taken in one case for violating medical protocol by prescribing the drug inappropriately.

Tests conducted on the syrup in Rajasthan confirmed it did not contain Propylene Glycol, a substance sometimes used in pharmaceuticals which can degrade into DEG/EG under poor manufacturing conditions.

Background on Toxic Contaminants

Diethylene Glycol (DEG) and Ethylene Glycol (EG) are industrial solvents that should never be present in medicinal syrups. They are known to cause renal failure, metabolic acidosis, and death, particularly in children. India has previously faced international scrutiny due to such contaminants:

• In 2020, 12 children in Jammu died after drinking DEG-contaminated cough syrup.

• In 2022, at least 70 children in The Gambia lost their lives due to Indian-manufactured syrups laced with these chemicals.

These tragic precedents underscore the critical need for strict quality control, routine inspections, and good manufacturing practices (GMP) in the pharmaceutical industry.

Nationwide Action and Public Advisory

The Health Ministry reiterated its call for responsible prescribing and dispensing of cough syrups. It urged both public and private healthcare providers to:

• Avoid over-prescription of paediatric cough and cold medications.

• Adhere to clinical evaluation protocols before prescribing such syrups.

• Educate parents to avoid self-medication and consult qualified physicians.

• Strengthen capacity-building measures to improve awareness among prescribers and dispensers.

Citizens have been advised to refrain from administering any medication to children without a valid prescription, particularly over-the-counter cough syrups.

As investigations continue, the government has taken a multi-pronged approach, involving regulatory action, clinical investigation, and public health advisories. The incidents in Madhya Pradesh and Rajasthan are a stark reminder of the dangers of unregulated paediatric medication and underscore the urgent need for safeguards in drug manufacturing, distribution, and use.