Bombay High Court Quashes Criminal Complaint in Drugs and Cosmetics Act Case Due to Violation of Statutory Right Under Section 25(4) — Delay in Filing Complaint After Expiry of Shelf Life Deprives Accused of Right to Get Sample Tested from Central Drugs Laboratory.

High Court: Bombay High Court Bench: NAGPUR In Favour of Accused
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Case Note & Summary

The petitioners, a pharmaceutical company and its directors/employees, were accused in a criminal complaint filed by the Drug Inspector under the Drugs and Cosmetics Act, 1940, for alleged manufacture and sale of substandard Atrovastatin-10 tablets. The complaint was filed on 09.01.2023, after the expiry of the shelf life of the drug (which expired in August 2022). The petitioners filed a writ petition under Article 226 of the Constitution read with Section 482 CrPC seeking quashing of the complaint and the order issuing process. The main legal issue was whether the statutory right of the accused under Section 25(4) of the Act to apply to the court for sending the sample to the Central Drugs Laboratory (CDL) for testing was violated, as the complaint was filed after the shelf life had expired, making it impossible to exercise that right. The petitioners argued that the order issuing process was a stamp order showing non-application of mind, and that the delay in filing the complaint after receipt of the Government Analyst's report (received on 25.07.2022) violated their right to defend. The court held that the right under Section 25(4) is a valuable statutory right, and if the complaint is filed after the expiry of the shelf life, the accused is deprived of that right, rendering the proceedings an abuse of process. The court also noted that the order issuing process was cryptic and did not reflect application of mind. Consequently, the court quashed the complaint and the order issuing process, allowing the petition.

Headnote

A) Criminal Procedure Code - Quashing of Complaint - Section 482 CrPC - Abuse of Process - Complaint quashed where statutory right under Section 25(4) of Drugs and Cosmetics Act was violated due to delay in filing complaint after expiry of shelf life of drug, depriving accused of right to get sample tested from Central Drugs Laboratory (Paras 5-7).

B) Drugs and Cosmetics Act - Statutory Right - Section 25(4) - Right to Get Sample Tested - Accused's right to apply to the court for sending sample to Central Drugs Laboratory is a valuable right; if complaint is filed after expiry of shelf life, the right is rendered illusory and proceedings are liable to be quashed (Paras 5-7).

C) Criminal Procedure Code - Issuance of Process - Section 204 CrPC - Non-Application of Mind - Order issuing process must reflect application of mind; a stamp order without reasons is not sustainable (Para 3).

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Issue of Consideration

Whether the criminal complaint and proceedings under the Drugs and Cosmetics Act, 1940 are liable to be quashed on the ground that the statutory right of the accused under Section 25(4) to get the sample tested from the Central Drugs Laboratory was violated due to the complaint being filed after the expiry of the shelf life of the drug.

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Final Decision

The court allowed the petition and quashed the Criminal Complaint R.C.C. No.53 of 2023 and the order issuing process dated 13.02.2023 passed by the learned Chief Judicial Magistrate, Amravati.

Law Points

  • Statutory right under Section 25(4) of Drugs and Cosmetics Act
  • 1940
  • Non-application of mind in issuance of process
  • Quashing of criminal proceedings
  • Summons case procedure
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Case Details

2025:BHC-NAG:14548

Criminal Writ Petition No. 749/2025

2025-12-15

M. M. Nerlikar, J.

2025:BHC-NAG:14548

Ms. Rashmi S. Kulkarn (for petitioners), Mr. Bhagwan M. Lonare (APP for respondents)

M/s. Agron Remedies Pvt. Ltd., Mudit Agrawal, Narendra Panchal, Narendra Kumar Jatau

State of Maharashtra, Commissioner, Food & Drug Administration

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Nature of Litigation

Criminal writ petition under Article 226 of the Constitution read with Section 482 CrPC seeking quashing of criminal complaint and order issuing process under the Drugs and Cosmetics Act, 1940.

Remedy Sought

Petitioners sought quashing of Criminal Complaint R.C.C. No.53 of 2023 and order issuing process dated 13.02.2023 passed by the Chief Judicial Magistrate, Amravati.

Filing Reason

Petitioners alleged that the complaint was filed after expiry of shelf life of the drug, violating their statutory right under Section 25(4) of the Drugs and Cosmetics Act to get the sample tested from the Central Drugs Laboratory, and that the order issuing process was a stamp order without application of mind.

Issues

Whether the criminal complaint and proceedings are liable to be quashed due to violation of statutory right under Section 25(4) of the Drugs and Cosmetics Act, 1940? Whether the order issuing process dated 13.02.2023 suffers from non-application of mind?

Submissions/Arguments

Petitioners argued that the order issuing process was a stamp order showing non-application of mind; the Magistrate failed to give brief reasons. Petitioners argued that the statutory right under Section 25(4) of the Drugs and Cosmetics Act was violated as the complaint was filed on 09.01.2023 after the expiry of the shelf life of the drug (Atrovastatin-10 Tablets), depriving them of the right to get the sample tested from the Central Drugs Laboratory. Petitioners submitted that the Government Analyst's report was received by the Drug Inspector on 25.07.2022, and the application for referring the sample to CDL was made on 02.09.2022, after the shelf life had expired.

Ratio Decidendi

The statutory right of the accused under Section 25(4) of the Drugs and Cosmetics Act, 1940 to apply to the court for sending the sample to the Central Drugs Laboratory for testing is a valuable right. If the complaint is filed after the expiry of the shelf life of the drug, the accused is deprived of that right, rendering the proceedings an abuse of process of law. The order issuing process must reflect application of mind; a cryptic stamp order is not sustainable.

Judgment Excerpts

At the outset, the learned counsel for the petitioners submits that the discharge application filed by the petitioners is pursuing the wrong remedy. In-fact, the said remedy is not available in summons case, therefore she does not press prayer clause (B) of the petition. The learned counsel for the petitioners submit that the order of issuance of process is a stamp order which shows non-application of mind. She submits that the statutory right provided under Section 25(4) of the Drugs and Cosmetics Act has been violated, therefore she seeks quashing of the entire complaint and the proceedings.

Procedural History

The Drug Inspector filed a criminal complaint (R.C.C. No.53 of 2023) before the Chief Judicial Magistrate, Amravati on 09.01.2023. The Magistrate issued process on 13.02.2023. The petitioners filed a discharge application, but later realized the remedy was not available in a summons case. They then filed the present writ petition under Article 226 read with Section 482 CrPC seeking quashing of the complaint and the order issuing process.

Acts & Sections

  • Drugs and Cosmetics Act, 1940: 25(2), 25(4)
  • Code of Criminal Procedure, 1973: 482
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