Not doctor's negligence, but regulatory failure: IAP President-Elect on cough syrup deaths

Speaking to Medical Dialogues, Dr Mohan emphasised that the high levels of diethylene glycol (DEG) found in the syrup samples indicate severe adulteration at the manufacturing level, not a prescribing error by the arrested paediatrician, Dr Praveen Soni. 

Medical Dialogues had earlier reported that at least 11 children have died from kidney failure after consuming contaminated Coldrif cough syrup in Madhya Pradesh's Chhindwara district in the past 30 days. Following these deaths, police arrested Dr Pradeep Soni, a paediatrician posted at the Community Health Centre (CHC) in the town, who had prescribed the syrup, and registered him as an accused in the case. Apart from Dr Soni, the police have named the directors of a Tamil Nadu-based pharmaceutical company (M/s Sresan Pharmaceuticals, Kanchipuram, Tamil Nadu) as the second accused in the case.

Also read- MP Cough Syrup Case: Doctors' associations demand central probe, case withdrawal for arrested paediatrician

After his arrest, the doctor confessed he had been prescribing the same cough syrup for the past 15 years to children suffering from cough and fever, completely unaware that it was contaminated. He said he could never have imagined that the syrup could be unsafe. Following this, several medical associations demanded the immediate withdrawal of the case against the bona fide medical practitioner, stating that he is a victim of the systematic failure. 

The Coldrif cough syrup in question was manufactured by Sresun Pharmaceuticals. During a government quality check, it was found to contain Diethylene Glycol (DEG) far beyond the permissible limit, which is - 48.6%. DEG is an industrial chemical known to cause kidney failure and death.

"Diethylene glycol is not an approved solvent in drug preparations. It is a toxic industrial solvent that should never be used in medications," Dr Mohan explained. "In pharmaceutical-grade excipients like glycerine or propylene glycol, the maximum allowable contamination by DEG or related glycols is extremely small — typically less than 0.1 %. The presence of 45–50 % DEG in tested samples indicates gross adulteration or substitution, not a minor quality deviation," she added. 

Dr Mohan further stated that this is not the first such tragedy. Referring to previous such incidents in Gambia in October 2022 and in Uzbekistan in January 2023, she said that similar contamination of pediatric syrups with DEG and ethylene glycol had caused fatal kidney injuries in many children.

"These incidents underline a recurring pattern: manufacturing-level contamination and systemic regulatory failure, rather than individual prescribing error," she said, pointing out that both previous cases involved Indian companies.

When asked whether the paediatrician was at fault, Dr Mohan stated that Dr Soni — or any prescribing physician — could not have reasonably known about such contamination. "No clinician would knowingly prescribe a toxic formulation. In situations where manufacturing integrity and regulatory vigilance have failed, accountability cannot rest solely on the treating doctor," she added.

"In short, the evidence points to a systemic breakdown in manufacturing and regulatory safeguards, not medical negligence," said Dr Neelam.

According to her, the Coldrif case highlights multiple lapses, including the use of industrial solvents during manufacturing, poor quality control and raw material checks, inadequate regulatory oversight, and random batch testing, as well as delayed or absent pharmacovigilance action despite early warning signs.

Following the incident, the Union Health Ministry issued an advisory warning against the use of cough and cold syrups in children below two years, as reported by Medical Dialogues. Dr Mohan said that while the advisory is important, it is not new to most qualified paediatricians.

“Well, most qualified pediatricians in India are already careful about this. We generally avoid prescribing cough and cold syrups in children under two years of age unless there’s a very specific indication. So this advisory from the government is actually not new to paediatricians,” she said.

However, she noted that the advisory is a very important public health reminder, especially since in India, many non-pediatric practitioners treat children, and the over-the-counter purchase of such medicines is widespread. “This advisory will help reduce that misuse,” she added.

“The concern with these combination syrups is that they can cause sedation or breathing difficulty in very young infants, and sometimes mask serious illness. For parents, I would emphasise that a cough is often a protective reflex — it helps clear mucus and infection. In most viral infections, treatment is supportive: keep the child well-hydrated, use saline nasal drops, maintain a humid environment, and treat fever symptomatically. If a child develops breathing difficulty, poor feeding, or a persistent cough, parents should see a paediatrician immediately. Between two and five years, even then, we usually avoid these medicines unless the cough significantly interferes with sleep or feeding — and then, it’s strictly on a case-by-case basis,” she explained.

Offering guidance to parents, Dr Mohan urged them to stay alert and always consult a paediatrician before giving any medication to their children and asked them not to purchase over-the-counter medicines without medical advice. 

She further provided five measures that can prevent recurrence of such tragedies and help restore public confidence in the safety of children’s medicines:

1. Do not use old prescriptions or those meant for adults. Every child’s weight, age, and illness are different, and medicines must be tailored accordingly.

2. Purchase medicines only from trusted and verified pharmacies, and always check the manufacturer’s details and expiry date. 

3. Avoid substitutes or alternative brands suggested by pharmacists if the prescribed medicine is unavailable, unless your paediatrician approves it.

4. Report any unusual reaction or side effect immediately to your doctor or the nearest hospital. 

5. For policymakers and drug manufacturers, there is a need to strengthen transparency and accountability in the system, with strict random batch testing and public reporting of results.

Also read- Kerala Paediatricians criticise Centre's cough syrup ban for children under 2