Allahabad High Court Declines To Quash Case Against Pharma Company Over Cough Syrup Linked To Child Deaths In Uzbekistan
The DOK-I Max syrup manufactured by the revisionists, was found poisonous in Uzbekistan, which resulted in death of more than 18 children.
The Allahabad High Court has refused to quash criminal proceedings initiated under the Drugs and Cosmetics Act, 1940 against a pharmaceutical company and its directors accused of manufacturing sub-standard cough syrup that allegedly caused multiple child deaths in Uzbekistan.
A World Health Organization (WHO) alert was issued in 2023 concerning two cough syrups manufactured by Marion Biotech. According to the Government of India, consumption of one of these syrups was linked to the deaths of over 18 children in Uzbekistan.
In 2024, Marion Biotech, along with five of its directors and senior officials, approached the Allahabad High Court seeking quashing of a summoning order passed by the Chief Judicial Magistrate, Gautam Budh Nagar (Noida). The summoning order had been issued on the basis of a complaint filed by the Drug Inspector, Uttar Pradesh, alleging violations of the Drugs and Cosmetics Act.
A Bench of Justice Harvir Singh held that the Drug Inspector had acted strictly in accordance with his statutory duties. The Court observed that the inspector had lawfully collected samples and initiated prosecution based on scientific and objective laboratory analysis, which constituted sufficient prima facie material to allow the trial to proceed.
The Court noted, “The complaint lays out the basis for prosecution, and the analytical report constitutes adequate prima facie evidence for the case to proceed in accordance with law. It is further noted that, having a license to manufacture the certain drugs is not sufficient and absolute. However, the company has to comply with the conditions of license, is equally important and, if there is any violation in respect of the conditions, given in the license itself, an appropriate case can be made out against the revisionists, as such the revisionists have violated the conditions of license, as enumerated in Section 78 of the Act.”
The company’s counsel argued that the complaint failed to establish any direct role or active involvement of the directors or senior officials in the alleged offences. It was also contended that testing for diethylene glycol and ethylene glycol was not a mandatory requirement and was conducted only at the special request of the Drug Inspector.
Rejecting these submissions, the Court observed that the use of ethylene glycol in the manufacture of cough syrup was completely prohibited under the British Pharmacopoeia, which governed drug standards at the relevant time in 2021, when the medicines were manufactured.
The Court further took note of findings by the Central Drugs Standard Control Organisation (CDSCO) and the Uttar Pradesh State Drugs Control Department, which revealed that the company had failed to produce a manufacturer’s or supplier’s certificate of analysis for propylene glycol, in violation of Section 18-B of the Act. It was also found that the propylene glycol used in manufacturing the syrup had been procured from an entity that did not possess a valid drug licence for its sale or distribution.
The Court observed, “The DOK-I Max syrup manufactured by the revisionists, was found poisonous in Uzbekistan, which resulted in death of more than 18 children.”
The Court underscored that enforcement of public health legislation cannot be diluted or obstructed by technical objections. The Court remarked that the manufacture and circulation of sub-standard drugs poses a serious threat to public health and, therefore, any deviation from statutory standards must be dealt with firmly.
The Court held, “The technicalities raised about sampling location or manner as characterized, are not having any procedural fatal irregularity, especially in criminal regulatory prosecutions governed by public safety standards and at this stage is not to establish guilt, but to put the process in motion, when the complaint and annexed evidence, shows legal and factual plausibility of the alleged offences to be tried upon relevant sections under the Drugs and Cosmetics Act, 1940.”
Finding no error or serious irregularity in the summoning order passed by the trial court, the High Court concluded that interference was unwarranted. Accordingly, it declined to quash the proceedings pending before the Noida court.
Cause Title: M/s Marion Biotech Pvt. Ltd. & Ors. v. Union of India & Anr., [2026:AHC:9173]
Appearance:
Petitioners: Advocates Niraj Kumar Singh, Saroj Kumar Yadav
Respondents: Advocate R.P.S. Chauhan