2026 Supreme(Online)(Bom) 3709

HIGH COURT OF BOMBAY
N. J. Jamadar, J
C. B. Healthcare – Appellant
Versus
Union of India – Respondent
WRIT PETITION NO.2777 OF 2024

Prosecution for sale of sub-standard products is unsustainable when procedural lapses, specifically excessive testing delays and failure to provide samples, result in the loss of the accused's valuable statutory right to independent re-analysis of the evidence.

Headnote:(A) Drugs and Cosmetics Act, 1940 - Sections 23, 25, 32 and 34 - Drugs Rules, 1945 - Rule 45 - Criminal Procedure Code, 1973 - Section 193 - Prosecution against manufacturer for sub-standard drugs - Inordinate delay in testing samples beyond mandated period and failure of regulatory authorities to deliver part of sample to manufacturer violates valuable right to re-testing - Prosecution is impermissible when the substance has lost its shelf life, rendering re-analysis impossible. (Paras 14, 15, 21, 38)

(B) Cognizance of offences - Trial court designated as special court - Cannot take cognizance directly unless case is committed by judicial magistrate - Special statute does not contain a non-obstante clause to bypass committal proceedings - Absence of such provision necessitates compliance with general procedural code for committal. (Paras 41, 42, 46)

(C) Vicarious liability - Must be specifically pleaded - Mere status as partner or director is insufficient to infer liability in daily business conduct - Requirement for specific allegations regarding responsibility for daily affairs of the firm. (Paras 48, 49, 50, 52)

Facts of the case:
A regulatory inspection of a manufacturing facility led to samples being drawn for analysis. A government report declared the samples to be not of standard quality. The manufacturer was not provided with one portion of the sample, and significant delays occurred in finalizing testing and filing the subsequent criminal complaint. By the time legal proceedings were initiated, the product had long passed its shelf life, depriving the accused of the statutory right to seek independent re-testing. Arguments were raised regarding procedural non-compliance, the authority of the court to take direct cognizance, and the sufficiency of allegations regarding vicarious liability.

Findings of Court:
The failure to comply with the mandated time frames for analysis and the failure to provide the manufacturer with a sample portion created an irreversible loss of a valuable defense right. The court held that the delay was predominantly attributable to the regulatory authority. Furthermore, the court emphasized that a specialized criminal court cannot take direct cognizance of an offence without a committal order, as the governing statute lacks specific enabling provisions to bypass the procedure laid down in the general procedural code.

Issues: Whether the delay in testing and non-compliance with sample distribution mandates vitiates prosecution; whether a trial court can take direct cognizance in the absence of a specific enabling provision; and whether bald allegations are sufficient to invoke vicarious liability.

Ratio Decidendi: A prosecution based on delayed test results, where the opportunity for re-analysis is lost owing to the product's expiration, constitutes an abuse of judicial process. Procedural safeguards designed to protect an accused's right to challenge laboratory findings must be strictly followed to prevent prejudiced outcomes.

Result: Petition allowed; proceedings quashed.