Quashing of Prosecution Against Directors: High Court Rules on Vicarious Liability for Substandard Drugs
In the judgment of Paramjit Arora and Another v. State of Himachal Pradesh, the High Court of Himachal Pradesh quashed a criminal complaint and summoning order against two directors of a pharmaceutical company. The Court ruled that directors cannot be held vicariously liable for the manufacture of substandard drugs under the Drugs and Cosmetics Act, 1940, unless there are specific allegations that they were in charge of the company’s day-to-day operations.
Case Background: The Substandard Anaesthesia
The case originated from a 2021 inspection where a Drugs Inspector drew a sample of “Lignocaine and Adrenaline Injection I.P.” manufactured by M/s Health Biotech Limited.
- The Report: The Government Analyst declared the sample “Not of Standard Quality” because it failed to conform to the required assay of Adrenaline Bitartrate.
- The Prosecution: Following a series of inquiries tracing the drug from distributors back to the manufacturer, the State instituted a criminal complaint against the company and its directors under Sections 18(a)(i) and 27(d) of the Drugs and Cosmetics Act.
The Dispute: Mere Designation vs. Active Management
The petitioners, who were directors of the manufacturing firm, challenged the proceedings on the ground that they had no active role in the manufacturing process.
- Lack of Specific Averments: The petitioners argued that the complaint was silent regarding their involvement in day-to-day functions and failed to establish their vicarious liability under Section 34 of the Act.
- Technical Director Defense: The company had officially appointed a Technical Director (Mr. Rohini Raman Pathak) who was notified to the Registrar of Companies and the Licensing Authority as the person specifically responsible for the manufacturing affairs of the drugs.
- Role Limitation: The petitioners contended that as directors, their roles were restricted to financial management rather than pharmaceutical production.
Legal Principles: Vicarious Liability under Section 34
Justice Sandeep Sharma relied on extensive Supreme Court precedents (including Bhajan Lal and S.M.S. Pharmaceuticals) to define the limits of corporate criminal liability:
- The Two-Fold Requirement: Under Section 34, for a person to be deemed guilty of an offense committed by a company, the prosecution must prove they were (a) in charge of and (b) responsible to the company for the conduct of its business at the material time.
- No Automatic Liability: The Court emphasized that there is no “magic” in the word “Director”. Simply holding a title does not create a presumption that the individual is aware of or responsible for everyday affairs.
- Mandatory Specificity: A complaint must contain clear and unambiguous allegations as to how and in what manner the director was responsible for the conduct of the business. Bald statements or merely reproducing the text of the statute are insufficient.
The Court’s Findings and Quashing of Complaint
The High Court found that the prosecution’s case against the petitioners was fatally flawed:
- Absence of Evidence: The complaint was completely silent regarding the petitioners’ specific roles in manufacturing.
- Authorized Representative: Because the department had already recognized a specific Technical Director as the person responsible for manufacturing, there was no legal basis to prosecute other directors for quality failures.
- Abuse of Process: The Court concluded that allowing the trial to continue against the petitioners would be a “futile trial” and a “weapon of harassment,” as the prosecution was bound to fail.
Final Ruling
The High Court allowed the petition and quashed the criminal complaint and summoning orders insofar as they related to the two petitioner-directors. They were discharged from the case.
STPL (Web) 2026 HP 149
Paramjit Arora And Another V. State of Himachal Pradesh (D.O. J. 02-04-2026)
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