Category: Criminal cases

Court Cites Prescription of Banned Fixed-Dose Combination Medicine and Serious Public Health Consequences

In a significant development in the alleged cough syrup deaths case linked to the deaths of several children in Madhya Pradesh, the Madhya Pradesh High Court has denied bail to a paediatrician accused of prescribing a banned fixed-dose combination (FDC) cough syrup to children below the age of four.

A Single Judge Bench of Justice Pramod Kumar Agrawal dismissed the bail application, observing that the accused doctor had allegedly prescribed a fixed-dose combination medicine that was prohibited for children under four years of age under a government circular issued on December 18, 2023. The Court noted that the alleged conduct had grave consequences, resulting in the deaths of innocent children and causing large-scale harm to public health.

Case Linked to Chhindwara Cough Syrup Tragedy

The case is connected to the alleged Coldrif cough syrup tragedy in Madhya Pradesh’s Chhindwara district, which has been linked to the deaths of more than 26 children. Earlier, the High Court had also rejected the regular bail applications of a government doctor and a pharmacist accused in the same case.

The applicant, a child specialist who had been practising in Parasia, Chhindwara district, for over 45 years, was arrested on March 7, 2026, after an FIR was registered against him under Sections 105, 276 and 238(b) of the Bharatiya Nyaya Sanhita, 2023, along with Section 27(a) of the Drugs and Cosmetics Act, 1940.

Doctor Claims No Knowledge of Contamination

During the hearing, the accused doctor argued that he had no connection with the principal accused or other co-accused persons involved in the case. He maintained that he was unaware of any contamination or adulteration in the cough syrup and had prescribed the medicine in good faith as part of his medical practice.

The doctor further submitted that he neither received any commission from the manufacturer nor from the distributor for prescribing the medicine. He also contended that the deaths were allegedly caused by contamination in the syrup rather than by the fixed-dose combination itself.

Additionally, the applicant pointed out that only two of the four deceased children allegedly treated by him were named in the charge sheet and that his name appeared only in the supplementary charge sheet.

State Cites Laboratory Reports Showing Toxic Contamination

Opposing the bail plea, the State submitted that reports from the Government Laboratory and Drug Department conclusively established that the cough syrup contained diethylene glycol (DEG) at 46.28 per cent W/V, significantly exceeding the permissible pharmacopoeial limit of 0.1 per cent W/V.

According to the prosecution, DEG is a well-known nephrotoxin that can be fatal in children, and the deaths were caused by acute kidney failure and acute tubular necrosis (ATN).

The State further argued that the prescribed cough syrup contained a fixed-dose combination of chlorpheniramine maleate and phenylephrine, which had been prohibited for use in children below four years of age under a circular issued by the Directorate General of Health Services and the Central Drugs Standard Control Organization (CDSCO).

Court Notes Failure to Raise Alarm Despite Cluster of Cases

The prosecution also contended that the accused doctor was aware that several children were developing acute kidney injuries in a cluster pattern indicative of a possible drug-related adverse effect. Despite this, he allegedly failed to alert the Drug Department, hospital authorities, or any competent authority.

The High Court observed that the facts of the case were distinguishable from the Supreme Court’s ruling in Jacob Mathew v. State of Punjab (2005), noting that the complaint in the present matter had been filed by a competent authority, namely the Block Medical Officer.

High Court Refuses Bail

While rejecting the bail application, the Court observed that the accused had allegedly prescribed a banned fixed-dose combination medicine to children below the age of four. The Court further noted that the alleged cough syrup caused widespread harm to public health and that expert opinion from the Head of the Pediatric Department at Government Medical College, Nagpur, also indicated that such fixed-dose combinations should not be administered to children under four years of age.

Considering the seriousness of the allegations, the loss of young lives, and the broader public health implications, the Madhya Pradesh High Court held that the case was not fit for the grant of bail and accordingly dismissed the application.