M/S MARION BIOTECH PVT. LTD. & ORS. V. UNION OF INDIA & ANR [2026:AHC:9173]

DATE: 14/01/2025

COURT: High Court of Allahabad

BENCH: Justice Harvir Singh

FACTS:

The present criminal revision arose from a cognizance and summoning order dated 19.01.2024 passed by the Chief Judicial Magistrate, Gautam Budh Nagar, in a complaint filed by the Drugs Inspector against M/s Marion Biotech Pvt. Ltd. and its directors and officials. The complaint alleged multiple violations of the Drugs and Cosmetics Act, 1940, including manufacture and sale of drugs declared “not of standard quality,” adulterated and spurious drugs, procedural non-compliance, and vicarious liability of company officials. The prosecution was founded primarily on government laboratory test reports which revealed the presence of Ethylene Glycol (EG) and Diethylene Glycol (DEG), toxic and prohibited substances in cough syrup manufactured by the company.

The revisionists, who were directors and officers of the company, challenged the summoning order contending that they were mechanically summoned without specific averments regarding their role, responsibility, or active involvement in the alleged offences, as required under Section 34 of the Act. They also alleged procedural irregularities in sampling, testing, sanction under Section 32, and improper invocation of stringent penal provisions relating to adulterated and spurious drugs. The Union of India opposed the revision, asserting that the Drugs Inspector acted within statutory authority and that the Magistrate rightly found a prima facie case at the summoning stage.

ISSUES:

The principal issues before the Court were whether the Magistrate had validly taken cognizance and issued summons with due application of judicial mind; whether the complaint disclosed sufficient prima facie material to attract offences under Sections 16, 17A, 17B, 18, 27 and related provisions of the Drugs and Cosmetics Act, 1940; whether directors and officers of the company could be vicariously liable under Section 34 of the Act at the summoning stage; and whether alleged procedural lapses in sampling, testing, sanction, and analysis warranted interference with the summoning order in revision.

JUDGEMENT WITH REASONING:

The Court dismissed the criminal revisions, holding that the cognizance and summoning order passed by the Magistrate was legal, valid, and based on sufficient prima facie material. It found no illegality, perversity, or jurisdictional error warranting interference. The Court held that all objections raised by the revisionists were matters for trial and that the accused would have adequate opportunity to raise their defence at the stage of framing of charge. Consequently, all connected criminal revisions were dismissed as devoid of merit.

The Court held that at the stage of cognizance and summoning, the Magistrate is only required to ascertain whether a prima facie case exists, and not to conduct a detailed appreciation of evidence or a mini-trial. Upon examining the complaint, laboratory reports, and supporting documents, the Court found that the Drugs Inspector had acted within his statutory mandate. The presence of substantial quantities of EG and DEG, substances prohibited under the applicable Indian and British Pharmacopoeia constituted serious violations capable of rendering the drugs adulterated and injurious to health. The Court noted that the use of industrial-grade propylene glycol, absence of certificates of analysis, and failure to comply with licence conditions under Section 18 and record-keeping obligations under Section 18B were sufficient to establish a prima facie case under the Act.

On the question of vicarious liability, the Court held that directors and senior functionaries fall squarely within the ambit of Section 34 of the Act, which presumes responsibility for the conduct of the company’s business unless due diligence or lack of knowledge is established—an issue to be examined at trial. The Court rejected the argument that mere designation was insufficient at the summoning stage, observing that regulatory offences affecting public health require purposive interpretation. Technical objections relating to sampling location, testing procedure, or sanction were held not to constitute fatal procedural irregularities. Emphasising the grave public health implications of substandard and toxic drugs, including reported child fatalities abroad, the Court concluded that regulatory enforcement cannot be defeated by hyper-technical defences and that the Magistrate’s discretion at the summoning stage was exercised in accordance with law.

ANALYSIS:

This decision reinforces the settled principle that the threshold for judicial scrutiny at the stage of cognizance and summoning is deliberately low, particularly in regulatory offences involving public health. The Court’s refusal to interfere underscores that a Magistrate is not expected to weigh evidence or adjudicate disputed facts at this preliminary stage, but only to assess whether the complaint and accompanying material disclose a prima facie case. By treating objections relating to sampling, testing procedures, sanction, and classification of the offence as matters for trial, the Court affirmed a functional and pragmatic approach that prevents premature stalling of prosecutions through technical challenges. The ruling thus aligns with the broader jurisprudence that discourages the conversion of summoning proceedings into a mini-trial, especially where statutory authorities act on official laboratory reports indicating serious violations.

Equally significant is the Court’s approach to vicarious liability under Section 34 of the Drugs and Cosmetics Act, 1940. By holding that directors and senior officers can be summoned without detailed proof of individual involvement at the threshold stage, the Court emphasized the strict and deterrent nature of public welfare legislation. The presumption of responsibility for those in charge of a company’s affairs reflects a purposive interpretation aimed at safeguarding public health and ensuring corporate accountability. The judgment sends a clear message that allegations of manufacture and distribution of adulterated or toxic drugs, particularly involving substances like EG and DEG cannot be diluted by formalistic defences or reliance on corporate hierarchies. Overall, the decision strengthens regulatory enforcement by prioritising consumer safety and reinforcing the accountability of corporate management in pharmaceutical offences.