MR. ASHWANI S/O RAM PYARA LAMBA AND 5 OTHERS v. THE STATE OF MAH. AT THE INSTANCE OF NALANDA B URKUDE, WORKING AS A DRUGS INSPECTOR, AT THE OFFICE
Non-Compliance with Rule 45 of Drugs and Cosmetics Rules, 1945: Prosecution Quashed Due to Delayed Analyst Report and Extension Request.
Court: Bombay High Court
Citation: 2026:BHC-NAG:945
Decision Date: 17-01-2026
List of Laws
The Drugs and Cosmetics Act, 1940; The Drugs and Cosmetics Rules, 1945
- Facts: The petitioners, directors of M/s Oscar Remedies Pvt. Ltd., faced criminal prosecution after a Drug Inspector found samples of their drug RTZOL-DSR to be of non-standard quality. The petitioners argued that Rule 45 of the Drugs and Cosmetics Rules, 1945, was not complied with because the Government Analyst's report was not sent within 60 days of receiving the sample, and the extension sought was after the expiry of the 60-day period.
- Procedural Posture: The petitioners filed a Criminal Writ Petition in the High Court of Bombay, Nagpur Bench, seeking to quash the criminal prosecution pending before the C.J.M. Gadchiroli.
- Issue: Whether the non-compliance with Rule 45 of the Drugs and Cosmetics Rules, 1945, vitiates the entire proceedings and warrants quashing of the criminal prosecution against the petitioners.
- Holding: Yes, the High Court held that non-compliance with Rule 45 vitiates the proceedings, and the petition was allowed, quashing the criminal prosecution.
- Reasoning: The Court emphasized that Rule 45 mandates the Government Analyst to analyze drug samples and furnish reports within 60 days of receipt. While an extension of time is permissible, it must be sought with specific reasons before the initial 60-day period expires. In this case, the extension was sought after the 60-day period, and it was unclear whether the Government granted the extension. The court also noted the delay in delivering the Chemical Analyst's report to the manufacturer. Citing a previous judgment, the court reiterated that timely analysis is crucial to ensure the quality and accuracy of the report and to protect the accused's right to have the sample rechecked. The court also issued directions to the Commissioner of Food and Drugs Administration to ensure timely receipt of sample reports and to take action against officers failing to comply with the Drugs and Cosmetics Act and Rules.
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