Allahabad High Court Refuses to Quash Proceedings Against Pharma Firm in Toxic Cough Syrup Case Linked to Uzbekistan Child Deaths

Introduction

In a ruling that underscores the paramount importance of public health in pharmaceutical manufacturing, the Allahabad High Court has declined to interfere with criminal proceedings against M/s Marion Biotech Pvt Ltd and its five directors/officials. The case stems from allegations of producing sub-standard cough syrup, DOK-1 Max, contaminated with toxic substances like ethylene glycol and diethylene glycol, which was linked to the tragic deaths of over 18 children in Uzbekistan in 2023. Delivered by Justice Harvir Singh on January 14, 2026, the decision upholds a summoning order issued by the Chief Judicial Magistrate, Gautam Budh Nagar, under various sections of the Drugs and Cosmetics Act, 1940. This verdict reinforces strict regulatory compliance for drug manufacturers, emphasizing that mere possession of a license is insufficient without adherence to its conditions. The proceedings, initiated based on lab reports and a World Health Organization (WHO) alert, highlight ongoing global concerns over contaminated medicines exported from India.

Case Background

The controversy traces back to September 2021, when Marion Biotech Pvt Ltd, a Noida-based pharmaceutical company, manufactured batches of DOK-1 Max cough syrup. Intended for export, the product was distributed internationally, including to Uzbekistan. In early 2023, Uzbekistan authorities reported a cluster of acute kidney injuries and fatalities among children who had consumed the syrup, attributing the incidents to high levels of toxic glycols—ethylene glycol (EG) and diethylene glycol (DEG)—used as contaminants in the formulation.

A WHO medical product alert issued on January 11, 2023 (Ref. RPQ/REG/ISF/Alert No.1/2023), flagged DOK-1 Max and another Marion product, Ambronol Syrup, as contaminated due to the use of industrial-grade, non-pharmaceutical propylene glycol and glycerin. These substances are explicitly prohibited in drug manufacturing under standards like the Indian Pharmacopoeia 2018 (IP 2018), which mandates "no peaks corresponding to ethylene glycol and diethylene glycol" in propylene glycol tests.

In India, the Central Drugs Standard Control Organisation (CDSCO) and Uttar Pradesh State Drugs Control conducted a joint investigation. Samples collected from the company's warehouse and control room by a Drug Inspector tested positive for EG and DEG in alarming concentrations: up to 34.28% w/v EG in one batch, as per reports from the Regional Drugs Testing Laboratory (RDTL), Chandigarh, dated January 14, 2023. The company allegedly sourced the propylene glycol from M/s Maya Chemtech India Pvt Ltd, an unlicensed supplier for pharmaceutical purposes, and failed to produce required Certificates of Analysis (CoA) under Section 18B of the Act.

This led to Complaint Case No. 2462 of 2024 filed by the Drug Inspector against the company and its directors under Sections 18(a)(i) (prohibition on manufacturing/selling sub-standard drugs), 16 (standards of quality), 17A (adulterated drugs), 17B (spurious drugs), 18A (disclosure of manufacturer), 18B (maintenance of records), punishable under Sections 27(a), 27(b)(i), 27(b)(ii), 27(c), 27(d), 28, 28A, and 28B of the Drugs and Cosmetics Act, 1940. The Chief Judicial Magistrate took cognizance on January 19, 2024, issuing summons. The company and directors challenged this via four connected criminal revisions (Nos. 4884/2024, 5442/2025, 5443/2025, 5444/2025) under Section 482 CrPC, seeking quashing on grounds of procedural lapses and lack of individual liability.

The legal questions at the core include: Whether the summoning order was issued without judicial application of mind? Does the complaint establish prima facie liability of company officials under Section 34? And, are technical procedural issues fatal to the prosecution at the pre-trial stage?

Arguments Presented

The revisionists, represented by counsel Sri Saroj Kumar Yadav (held by Sri Niraj Kumar Singh), mounted a multi-pronged defense challenging the summoning order's validity. They argued that the Magistrate failed to apply judicial mind, issuing summons mechanically without scrutinizing the complaint. Key contentions included the absence of specific averments under Section 34, holding directors liable only if they were "in charge and responsible" for the business—mere designation as directors was insufficient without evidence of direct involvement, consent, connivance, or neglect. They claimed the complaint was "bald and fleeting," lacking details of overt acts by individuals.

Procedurally, the revisionists highlighted non-compliance with Section 32 (prior sanction for prosecution), rendering proceedings vitiated. The test report from RDTL allegedly violated Rule 46 of the Drugs and Cosmetics Rules, 1945, by omitting detailed protocols and methods; tests for EG/DEG were not routine but conducted only on special request, questioning their relevance. Sampling from the warehouse (not sales points under Section 22) was termed a "glaring irregularity" prejudicing the accused. Substantively, they asserted the drug was only "not of standard quality" under Section 16, not "adulterated" (Section 17A) or "spurious" (Section 17B), barring invocation of harsher Sections 27(a) and 27(b). They relied on precedents like Pepsi Foods Ltd. v. Special Judicial Magistrate (1998) 5 SCC 749 for quashing on technical grounds and State of Haryana v. Bhajan Lal (1992) AIR SC 604 to argue the case fell within quashable categories due to insufficient allegations.

In contrast, the Union of India, represented by Sri R.P.S. Chauhan (Assistant Solicitor General), defended the proceedings as statutorily sound and essential for public health. They emphasized the Drug Inspector's adherence to mandate in sampling and prosecution based on objective lab evidence, including the RDTL report showing toxic levels (e.g., 15.87% to 34.28% EG/DEG across batches). The complaint provided prima facie evidence, with adequacy to be tested at trial, not summoning stage—citing State of Orissa v. Debendra Nath Padhi (2005) 1 SCC 568 against mini-trials here.

On liability, they invoked Section 34, arguing directors as "closely associated" with operations are vicariously liable absent proof of due diligence; the company's failure to produce CoA violated Section 18B, and sourcing from an unlicensed supplier breached license conditions under Section 78. EG/DEG use contravened IP 2018 and British Pharmacopoeia 2020 (applicable for exports), rendering the drug adulterated/spurious. The Uzbekistan deaths and WHO alert underscored real-world harm, justifying Sections 17A/17B and 27(a) (life imprisonment for death-causing adulterated drugs). Technical objections on sampling location or report details were "mere technicalities" not fatal, as per Amit Kapoor v. Ramesh Chander (2012) 9 SCC 460. They urged against narrow interpretations defeating the Act's public purpose, noting the syrup's poison classification abroad and US-FDA/BIS guidelines prohibiting EG/DEG (>0.10% limit).

Legal Analysis

Justice Harvir Singh's reasoning centered on the Drugs and Cosmetics Act, 1940's regulatory framework, prioritizing public health over technical defenses. The court dissected key provisions: Section 16 defines "standard quality" per the Second Schedule (IP standards); Section 17A deems drugs adulterated if containing "harmful or toxic substance[s]" like EG/DEG, which cause renal failure and death; Section 17B covers spurious drugs via substitution (industrial glycols for pharmaceutical ones); Section 18 prohibits manufacturing/selling such drugs without license compliance; and Section 34 imposes deemed guilt on company officials "in charge" unless due diligence is proven.

The court found prima facie evidence in the RDTL reports and investigation findings—e.g., no CoA for propylene glycol from unlicensed M/s Maya Chemtech, violating Section 18B—and rejected quashing, as summoning requires only legal/factual plausibility, not guilt proof ( Gulam Mustafa v. State of Karnataka , 2023 SCC OnLine SC 603). License possession under Section 78 is "not sufficient and absolute"; violations (e.g., prohibited glycols per IP 2018/BP 2020) justify prosecution. Procedural claims (no sanction under Section 32, Rule 46 non-compliance, sampling site) were dismissed as non-fatal at this stage, especially in regulatory cases where public safety governs ( CBI v. Aryan Singh , 2023 SCC OnLine SC 379).

Precedents reinforced this: Revisionists' citations like Medicamen Biotech Ltd. v. Rubina Bose (2008) 7 SCC 196 (requiring specific averments for Section 34) were distinguished, as the complaint here implicated directors in operations. Union's reliance on Sanofi India Ltd. v. Union of India (2021) 3 HCC (Del) 691 upheld broad liability for health violations. The court clarified distinctions: "Not of standard quality" escalates to adulterated/spurious if toxic, invoking harsher penalties under Section 27(a) for death-risk drugs (minimum 10 years' imprisonment, fine ≥10 lakh or 3x drug value, compensable to victims/relatives).

Technicalities like warehouse sampling (vs. Section 22 sales points) were not irregularities vitiating process, as collection/sealing followed norms. The Uzbekistan context—18+ child deaths from "poisonous" syrup—illustrated Section 27(a)'s gravity, aligning with WHO/US-FDA alerts on DEG/EG toxicity (CNS effects, acidosis, renal failure). Narrow corporate defenses were rebuffed: Directors' day-to-day association implies responsibility, preventing evasion for "pecuniary gain."

This analysis integrates other sources' details, like the WHO alert and lab specifics, to show the court's evidence-based approach, avoiding speculation while highlighting global export risks.

Key Observations

The judgment features several pivotal excerpts emphasizing regulatory rigor:

• "The Drugs Inspector operated well within his statutory mandate, collecting samples and initiating prosecution based on objective lab analysis. 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."

• "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 use of Ethylene Glycol in manufacturing the cough syrup was completely prohibited under the applicable British pharmacopoeia. At the time of manufacturing the drugs in question in September 2021, the British pharmacopoeia 2020 was applicable."

• "The DOK-I Max syrup manufactured by the revisionists, was found poisonous in Uzbekistan, which resulted in death of more than 18 children... Enforcement of public health laws cannot be thwarted by technical objections relating to mere technicalities."

• "By statutory provisions, those responsible for the company’s affairs i.e. Directors, senior functionaries are within the sweep of Section 34 for offences committed under the Act, and they are wholly and fully responsible for conduct of the business of the company."

These quotes, drawn directly from paragraphs 23-28 of the judgment, encapsulate the court's focus on evidence, compliance, and societal harm.

Court's Decision

The Allahabad High Court dismissed all four connected criminal revisions as "devoid of merit," finding "no glaring mistake or gross irregularity" in the summoning order. Justice Harvir Singh ruled: "The cognizance/summoning order passed by the learned Magistrate is in accordance with law and calls for no interference by this Court... the revisionist will have ample opportunity to redress themselves at the time of framing of the charge and the stage of charge is yet to come."

Practically, this allows the trial to proceed in the Noida court, where the company and directors must defend against charges carrying severe penalties: up to life imprisonment and substantial fines under Section 27(a) for adulterated drugs causing death/grievous hurt, with fines compensable to victims' relatives (as defined in the Explanation). The decision mandates record maintenance and potential appeals on the government analyst report (untimely here, per Section provisions).

Implications are far-reaching. It signals zero tolerance for sub-standard drug exports, bolstering CDSCO enforcement amid global scrutiny (e.g., post-2023 Uzbekistan/Gambia incidents). For pharma firms, it mandates rigorous supply-chain verification, CoA production, and pharmacopoeia adherence, curbing "industrial-grade" substitutions. Corporate officials face heightened vicarious liability under Section 34, requiring proactive compliance to invoke due diligence defenses.

Future cases may cite this for rejecting early quashing in regulatory prosecutions, prioritizing public health over technicalities. It could spur stricter BIS/US-FDA-aligned standards in India, reducing export recalls and fatalities. However, it raises questions on resource strains for small firms, potentially influencing policy on sanctions (Section 32) and testing protocols. Overall, the ruling fortifies the Act's protective intent, ensuring accountability in an industry vital to global health.