Non-Compliance with Rule 45 of the Drugs and Cosmetics Rules, 1945, Leads to Quashing of Criminal Proceedings
In a significant ruling, the Nagpur Bench of the Bombay High Court has quashed the criminal prosecution against Mr. Ashwani and others, citing non-compliance with Rule 45 of the Drugs and Cosmetics Rules, 1945. The court highlighted the critical importance of adhering to the 60-day timeline for drug sample analysis, as mandated by the rule.
The case, "Mr. Ashwani v. State of Maharashtra," revolved around the delayed analysis of drug samples taken from a medical shop. The samples, collected in July 2022, were analyzed well beyond the stipulated period without a timely extension request, thereby violating the rights of the accused and potentially endangering public health.
Justice M.M. Nerlikar emphasized that the delay in testing not only jeopardizes the integrity of the prosecution but also undermines the objectives of the Drugs and Cosmetics Act, 1940, which aims to ensure drug safety, efficacy, and quality.
In quashing the proceedings, the court issued several directives to the Food and Drugs Administration of Maharashtra. These include ensuring timely analysis of drug samples, taking strict action against non-compliant officers, and the establishment of more laboratories to handle the workload. The court also called for the development of an efficient online system for real-time monitoring and timely reporting of drug analyses.
The decision underscores the necessity of strict adherence to procedural timelines in drug testing to protect public health and uphold the rights of the accused. The court has set a compliance deadline of three months for the implementation of its directives and scheduled a review for May 2026.
Bottom Line:
Drugs and Cosmetics Rules, 1945 - Non-compliance of Rule 45 vitiates criminal prosecution - Government Analysts must analyze drug samples within 60 days or seek timely extension by giving reasons - Delayed analysis affects the right of accused and public health.
Statutory provision(s): Drugs and Cosmetics Rules, 1945, Rule 45; Drugs and Cosmetics Act, 1940
Mr. Ashwani v. State of Maharashtra, (Bombay)(Nagpur Bench) : Law Finder Doc id # 2843446
