Presence of Toxic Glycol in Cough Syrup Makes Out Prima Facie Case of Adulterated Drug: Allahabad High Court Upholds Summoning of Marion Biotech Directors in Spurious Drugs Case

“At Cognizance Stage, Magistrate Is Only Required to See Prima Facie Satisfaction—Not Conduct a Mini Trial” – In a major ruling with far-reaching implications for pharmaceutical regulation, the Allahabad High Court dismissed a set of criminal revision petitions filed by M/s Marion Biotech Pvt. Ltd. and its senior officials, including Directors, challenging the cognizance and summoning order passed by the Chief Judicial Magistrate, Gautam Budh Nagar in connection with the manufacture and export of adulterated and spurious cough syrup containing Diethylene Glycol (DEG) and Ethylene Glycol (EG) — chemicals responsible for deaths of over 18 children in Uzbekistan, as per WHO alert.

Justice Harvir Singh, while dismissing the criminal revisions, held:

“The learned Magistrate is not required to conduct a mini trial at the stage of cognizance. Once prima facie material is found to disclose offences under the Drugs and Cosmetics Act, summoning is lawful. There is no glaring illegality or procedural defect in the impugned order.”

The Court found no merit in the plea that the complaint lacked proper sanction or that the Directors were wrongly implicated in absence of specific allegations. Citing public health importance and the toxic nature of the substances detected in the drug, the Court refused to quash the summoning order.

“Use of Industrial Grade Glycol is Violation of Mandatory Standards—DEG and EG Are Toxic and Their Presence in Syrup Is Sufficient to Attract Penal Offence” – Court Declares Invocation of Stringent Penal Sections Justified

The criminal revisions stemmed from Complaint Case No. 2462 of 2024, filed by the Drugs Inspector under Sections 16, 17-A, 17-B, 18(a)(i), 18-B, 27(a)-(d), 28, 28-A, 28-B and 34 of the Drugs and Cosmetics Act, 1940, after laboratory tests showed substantial levels of Ethylene Glycol and Diethylene Glycol in samples of DOK-1 Max Syrup manufactured by the revisionist company.

The High Court observed:

“As per the Indian Pharmacopoeia 2018 and British Pharmacopoeia 2020, DEG and EG must be absent from the formulation. The test reports show presence of these toxic substances in concentrations as high as 34% w/v. This is sufficient at prima facie stage to invoke provisions related to adulterated and spurious drugs.”

Rejecting the argument that the drugs were only “not of standard quality,” the Court clarified:

“The presence of DEG and EG, which are toxic, shifts the drug into the category of adulterated and injurious to health under Section 17-A. The invocation of penal provisions under Section 27 is legally sustainable.”

The test reports from RDTL Chandigarh revealed alarming results:

• Ethylene Glycol 34.28%, Diethylene Glycol 8.36%, among others.

The Court noted:

“The manufacturer is bound to use pharmaceutical grade Propylene Glycol, not industrial grade solvent. The failure to produce certificates of analysis and sourcing from a non-licensed supplier further reinforces the breach of statutory duty.”

“Directors Are Presumed Responsible for Conduct of Company’s Business—Mere Denial of Involvement Cannot Defeat Prosecution” – Court Invokes Section 34 of Drugs and Cosmetics Act

A key plank of the revisionists’ challenge was that no specific role or act was attributed to the Directors or senior officials, and hence they could not be summoned. They argued that vicarious liability under Section 34 of the Act could not be fastened without proof of knowledge or consent.

However, the Court firmly rejected this plea, stating:

“By statutory presumption under Section 34, those responsible for the affairs of the company are deemed guilty unless they establish due diligence or lack of knowledge. At the summoning stage, mere denial of involvement is not sufficient to interfere with the Magistrate’s order.”

It further held:

“The complaint outlines sufficient material to initiate prosecution. The question of whether the Directors exercised due diligence or were unaware is a matter of trial—not revision.”

“Procedural Objections Cannot Override Public Health—Sampling, Testing and Analysis Were Conducted As Per Norms” – Court Declines to Entertain Technicalities Raised by Revisionists

The revisionists also alleged violations of Rule 46 of the Drugs Rules, 1945, improper sampling locations, and absence of requisite sanctions. They argued that samples were drawn from warehouse, not from authorised sale/distribution points, and hence vitiated the prosecution.

Justice Harvir Singh observed:

“The complaint and the record show that the sampling, sealing and analysis were carried out by the Drugs Inspector within the legal framework. These objections are technical in nature and do not go to the root of jurisdiction or legality at this stage.”

He added that “regulatory prosecutions involving public health cannot be defeated by minor procedural irregularities or technical objections.”

The Court also observed that the revisionists had failed to challenge the Government Analyst’s report within 28 days, as permitted under the Act, and hence could not now claim to dispute the lab findings.

“Deaths of 18 Children in Uzbekistan After Consumption of Contaminated Syrup Cannot Be Brushed Aside—Prima Facie Liability Clearly Made Out” – Court Highlights WHO Alert and Global Implications

The Court took serious note of the fact that the World Health Organization issued a Medical Product Alert on 11.01.2023, implicating the revisionist company's product, DOK-1 Max Syrup, in the deaths of children in Uzbekistan due to DEG and EG contamination.

Justice Singh remarked:

“It is not in dispute that the drugs manufactured by the revisionists were found to contain DEG and EG in significant quantities, which are poisonous to human health. This is a matter of international concern, and the company's liability cannot be dismissed at threshold.”

Revisions Dismissed, Summoning Order Upheld—Revisionists to Face Trial

Summing up the legal position, the High Court held:

“Having considered the entire facts and the statutory scheme, the summoning order passed by the learned Magistrate is in accordance with law and does not suffer from any legal infirmity. The revisionists have ample opportunity to defend themselves during the stage of framing of charge and trial.”

Accordingly, Criminal Revisions No. 4884 of 2024, 5442 of 2025, 5443 of 2025 and 5444 of 2025 were dismissed.

Date of Decision: 14 January 2026