Considering the facts, circumstances, and seriousness of the offence, Additional Sessions Judge Gautam Kumar Gujre observed, "On perusal of the available evidence, the court noted that substantial material indicates a serious offence. According to the FIR and supporting documents, other persons, including distributors and company representatives, were aware that the medicine Coldrif—which could cause a child’s death—was being manufactured and sold, yet it was still distributed and prescribed.
"Even after receiving knowledge of the deaths, the prescription of the same formulation continued. The investigation was found incomplete, and the alleged offence is grave in nature. If bail were granted, there existed a possibility of obstruction of justice," the court stated in its order.
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- Not doctor's negligence, but regulatory failure: IAP President-Elect on cough syrup deaths
After his arrest, the doctor reportedly 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 stated that 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.
The arrest of Dr Praveen Soni sparked strong reactions within the medical community, with the Indian Medical Association (IMA) questioning whether he is being made a scapegoat in the case. The association argued that Dr Soni had followed standard treatment protocols and is being singled out for responsibility. The association said that it was unfair to place the entire blame on him when the pharmaceutical company responsible for manufacturing the cough syrup was given a clean chit by the government.
Following the tragedy, the World Health Organisation (WHO) expressed “deep concern” over gaps in India’s drug safety regulations.
Live law reports that Dr Soni was charged with knowingly selling a drug as a different one (Section 276 of IPC) and for illegally manufacturing, selling or distributing cosmetics (Section 27 of the Drugs and Cosmetics Act, 1940). According to the FIR, a total of 15 children died after being administered the syrup by Dr Praveen Soni
However, Dr Soni's defence counsel argued that he was unaware of the substandard batch of medicine and claimed he had been falsely implicated.
"He is a government pediatrician, and his only role was prescribing the medicine. It was contended that the contamination in the medicine was due to the pharmaceutical company’s negligence, and the doctor had no prior knowledge about the toxic composition. He has been practising medicine for years, with no prior criminal record. The responsibility to inspect and test the medicine lies with the Drug Controller Department, not with the treating doctor. Therefore, the First Information Report was registered without proper basis, even though the doctor had no direct role in the manufacturing or sale of the syrup," stated the counsel.
On the other hand, the police reports stated that despite government guidelines issued in December 2023 advising against giving certain fixed-dose combination medicines to children under four years old, the doctor had been accused of continuing to prescribe the syrup.
It has been reported that the Directorate General of Health Services issued guidelines to all state and union territories on December 18, 2023, directing that children under the age of 4 should not be given fixed-dose combinations (FDC).
The police further claimed that the applicant doctor received a commission of 10 per cent for prescribing this coldrif syrup as medicine. It was also claimed that his relatives, located next to his private clinic, operated a medical shop that had a dangerous stock of coldrif syrup.
The prosecution claimed that, even after the medicine caused convulsions, severe illness, and kidney failure in children, resulting in several deaths, Dr Soni allegedly persisted in prescribing the syrup. It further argued that granting bail to the accused could allow him to influence witnesses or tamper with evidence.
After hearing arguments from both sides, the Court ultimately refused to grant bail to Dr Soni.
Also read- Toxic Cough Syrups: Tamil Nadu doctors criticise Govt's delay in alert
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