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Inherent Powers Must Be Used Sparingly: Rajasthan HC Refuses to Quash Orison Pharma Drug Misbranding Case

Rajasthan High Court
Jaipur: The Rajasthan High Court has refused to quash a 2018 criminal complaint against a pharmaceutical firm's partner from Himachal Pradesh over a drug allegedly found misbranded in Kota, with Justice Chandra Prakash Shrimali ruling on 25 April 2026 that the accused must face trial before the Chief Judicial Magistrate, Kota.
As per the news reported by PinkCity Post, the Court found sufficient grounds to allow the prosecution to proceed.
The matter traces back to an inspection conducted on 23 April 2015 at the District Drug Warehouse in Kota. During the inspection, Drugs Control Officer Prahlad Kumar Meena collected samples of a medicine produced by M/s Orison Pharma International, based in Kala Amb, Himachal Pradesh. Subsequent analysis by a Government Analyst concluded that the drug was “not of standard quality,” citing discrepancies between the actual contents and what was stated on the label.
In response to a show cause notice, the firm’s partner, Rakesh Goyal, contended that the issue arose from a labeling and packaging mistake rather than any defect in the drug’s formulation. He maintained that the composition complied with prescribed standards and emphasized that the product had not been distributed to consumers, remaining in official custody.
However, the authorities were unconvinced by this explanation and proceeded to file a complaint on 9 May 2018 before the Chief Judicial Magistrate, Kota. The prosecution invoked provisions of the Drugs and Cosmetics Act, 1940 against both the firm and Goyal. Challenging this, Goyal approached the High Court under Section 482 of the Code of Criminal Procedure, seeking to quash the proceedings on the ground that they constituted an abuse of legal process.
The defence argued that the mismatch between label and content was unintentional and lacked any criminal intent. It was also submitted that since the drug was manufactured in Himachal Pradesh, the Kota court lacked jurisdiction. Additionally, the petitioner claimed that the complaint failed to establish his personal liability under Section 34 of the Act, which requires proof that a person was in charge of and responsible for the firm’s operations at the relevant time.
Opposing the petition, the State argued that key events—inspection, sampling, and seizure—had taken place in Kota, thereby establishing jurisdiction. The prosecution further highlighted that the Government Analyst’s findings clearly indicated misbranding. It was also pointed out that Goyal himself had acknowledged the labeling error in his reply to the show cause notice, making the issue one that required examination during trial.
The High Court agreed with the State’s position on jurisdiction, noting that the presence and detection of the drug in Kota constituted a part of the cause of action. Relying on established legal precedents, the Court reiterated that manufacturers can be prosecuted not only at the place of manufacture but also where the product is found or marketed.
Addressing the argument of bona fide error, the Court held that questions regarding intent and the nature of the mistake are factual matters that can only be determined through evidence during trial. Similarly, whether the drug had reached consumers was deemed a matter requiring proof, not presumption at the preliminary stage.
On the issue of vicarious liability, the Court observed that Goyal had actively responded to regulatory notices, indicating his involvement in the firm’s operations. Based on this, it found a prima facie case that he was responsible for the conduct of the business, satisfying the requirements under Section 34 of the Act.
The Court also reiterated that its inherent powers under Section 482 Cr.P.C. must be exercised cautiously and only in exceptional circumstances. Where the complaint discloses an offence on its face, it held, the proceedings should not be terminated prematurely, even if the accused claims to have a valid defence.
Concluding that the material on record established a prima facie case, the High Court dismissed the petition, allowing the trial to proceed. It clarified that its observations were limited to the present stage and would not influence the trial court’s final decision. All pending applications were also disposed of, reports PinkCity Post.
Mpharm (Pharmacology)
Susmita Roy, B pharm, M pharm Pharmacology, graduated from Gurunanak Institute of Pharmaceutical Science and Technology with a bachelor's degree in Pharmacy. She is currently working as an assistant professor at Haldia Institute of Pharmacy in West Bengal. She has been part of Medical Dialogues since March 2021.

