Allahabad HC Upholds Criminal Proceedings Against Marion Biotech, Directors In Cough Syrup Case

The case arises from a complaint filed by the Drugs Inspector against Marion Biotech Pvt Ltd and six company officials, alleging violations under Sections 18, 16, 17A, 17B, 18A and 18B, punishable under Sections 27, 28, 28A and 28B of the Drugs and Cosmetics Act.

The prosecution is founded on government laboratory test reports from the Regional Drugs Testing Laboratory (RDTL), Chandigarh, which declared multiple samples of DOK-1 Max cough syrup as containing dangerously high levels of DEG and EG—toxic industrial chemicals prohibited in pharmaceutical formulations.

The matter gained international attention after the World Health Organization (WHO) issued a Medical Product Alert in January 2023, linking the Marion Biotech-manufactured syrup to the deaths of over 18 children in Uzbekistan, allegedly due to contamination with DEG and EG

Marion Biotech Pvt Ltd and its directors and officials, argued that the summoning order had been passed in a mechanical manner without proper application of judicial mind. They contended that the complaint failed to make specific averments establishing that the directors were in charge of, or responsible for, the day-to-day conduct of the company’s business at the relevant time, as mandated under Section 34 of the Drugs and Cosmetics Act, 1940.

Mere designation as directors or officers, they submitted, could not automatically attract criminal liability in the absence of allegations showing consent, connivance, or negligence. The petitioners further maintained that the test analysis report only declared the drug to be “not of standard quality” and did not categorize it as “adulterated” or “spurious,” making the invocation of harsher penal provisions legally unsustainable.

They also challenged the validity of the laboratory report, alleging non-compliance with Rule 46 of the Drugs Rules, 1945, and questioned the manner and location of sampling, claiming it was done from a warehouse or control room in violation of statutory safeguards.

Additionally, the petitioners argued that the prosecution was vitiated due to the absence of a valid sanction under Section 32 of the Act and that these cumulative procedural lapses rendered the criminal proceedings an abuse of the process of law.

Opposing the revisions, the Union of India submitted that government laboratory tests had detected alarmingly high concentrations of Ethylene Glycol (up to 34.28% w/v) and Diethylene Glycol (up to 8.36% w/v) in the cough syrup samples, far beyond permissible limits and posing a grave threat to human life. It was argued that the use of industrial-grade propylene glycol, procured from an unlicensed supplier, was strictly prohibited under both the Indian Pharmacopoeia 2018 and the British Pharmacopoeia 2020, which were applicable at the time of manufacture.

The prosecution further contended that the company failed to produce mandatory Certificates of Analysis, constituting a clear violation of Section 18B of the Drugs and Cosmetics Act. It was also pointed out that the accused did not avail themselves of the statutory remedy to challenge the government analyst’s report within the prescribed 28-day period, thereby allowing the report to attain finality.

Emphasizing the limited scope of judicial scrutiny at the summoning stage, the Union government argued that the court is only required to ascertain the existence of a prima facie case, not to conduct a mini trial. The prosecution strongly stressed that public health legislation cannot be weakened by technical objections, particularly in cases involving toxic substances and alleged child fatalities, where strict enforcement is essential to protect public safety.

The High Court observed that a licence to manufacture drugs is not absolute and must be strictly complied with in accordance with statutory conditions.

It held that the presence of toxic and prohibited substances such as DEG and EG squarely falls within the definition of “adulterated drugs” under Section 17A(e) of the Drugs and Cosmetics Act. The court further noted that directors and senior company officials are covered by the principle of vicarious liability under Section 34, unless they are able to demonstrate that the offence was committed without their knowledge or despite the exercise of due diligence.

It found that the sampling, sealing, and testing procedures had been conducted in accordance with prescribed statutory norms and that a narrow or overly technical interpretation of regulatory provisions would defeat the public health objective of the legislation.

Concluding the judgment, the High Court dismissed all the connected revision petitions, observing:

“All Criminal Revisions No. 4884 of 2024, 5442 of 2025, 5443 of 2025 and 5444 of 2025 are devoid of merit and are liable to be dismissed. Hence, dismissed.”

To view the official order, click the link below: