High Court of Karnataka Quashes Criminal Proceedings Against Pharmaceutical Company and Directors in Drugs and Cosmetics Act Case — Sample Not Drawn in Accordance with Rules. Failure to Follow Sampling Procedure Under Rule 46 of Drugs and Cosmetics Rules, 1945 Renders Prosecution Unsustainable.

High Court: Karnataka High Court Bench: BENGALURU In Favour of Accused
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Case Note & Summary

The petitioners, M/s Emcure Pharmaceuticals Ltd (a drug manufacturing company) and its Managing Director and Director, filed a petition under Section 482 of the Code of Criminal Procedure, 1973 seeking quashing of criminal proceedings in C.C.No.39/2018 pending before the Special Economic Offences Wing, Bangalore, for an offence punishable under Section 27(d) of the Drugs and Cosmetics Act, 1940. The case arose from a sample of a drug taken by the Drugs Inspector on 5-01-2012 from M/s Tulasi Pharma. The sample was sent to the Government Analyst, who reported that the drug was not of standard quality. Consequently, a complaint was filed against the petitioners. The petitioners challenged the proceedings primarily on the ground that the sample was not drawn in accordance with the mandatory procedure prescribed under Rule 46 of the Drugs and Cosmetics Rules, 1945. The trial court had taken cognizance and issued summons, and the revision petition against that order was dismissed by the Sessions Court. The High Court examined the sampling procedure and found that the Drugs Inspector had not complied with Rule 46, which requires the sample to be divided into four portions, sealed, and sent to the Government Analyst in a specific manner. The court noted that the failure to follow the mandatory sampling procedure vitiated the entire prosecution. Relying on the principle that where the sampling is defective, the prosecution cannot sustain, the High Court quashed the entire proceedings in C.C.No.39/2018, including the order dated 20.03.2018 passed by the Special Economic Offences Wing and the order dated 31.03.2022 passed by the Principal City Civil and Sessions Judge, Bangalore. The petition was allowed.

Headnote

A) Criminal Procedure Code, 1973 - Section 482 - Quashing of Criminal Proceedings - Inherent Powers - The High Court can quash proceedings where the complaint does not disclose any offence or where the allegations are absurd or where the legal process is an abuse of process of court. (Para 5)

B) Drugs and Cosmetics Act, 1940 - Section 27(d) - Offence of Manufacture for Sale of Spurious Drugs - The provision penalizes manufacture for sale of drugs that are spurious or misbranded. (Para 1)

C) Drugs and Cosmetics Rules, 1945 - Rule 46 - Sampling Procedure - Mandatory Requirements - The rule prescribes the manner in which samples of drugs must be drawn by the Drugs Inspector, including the requirement of dividing the sample into four portions, sealing, and sending to the Government Analyst. Non-compliance with this mandatory procedure renders the prosecution unsustainable. (Paras 6-10)

D) Drugs and Cosmetics Act, 1940 - Section 27(d) - Quashing of Proceedings - Sampling Defect - Where the sample of the drug was not drawn in accordance with Rule 46 of the Drugs and Cosmetics Rules, 1945, the entire prosecution under Section 27(d) is vitiated. The High Court quashed the proceedings in C.C.No.39/2018 and the orders of the Special Court and Sessions Court. (Paras 11-12)

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Issue of Consideration

Whether the criminal proceedings against the petitioners under Section 27(d) of the Drugs and Cosmetics Act, 1940 are liable to be quashed on the ground that the sample of the drug was not drawn in accordance with the mandatory procedure prescribed under Rule 46 of the Drugs and Cosmetics Rules, 1945?

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Final Decision

The High Court allowed the petition and quashed the entire proceedings in C.C.No.39/2018 pending on the file of the Special Economic Offences Wing, Bangalore, including the order dated 20.03.2018 and the order dated 31.03.2022 passed by the Principal City Civil and Sessions Judge, Bangalore.

Law Points

  • Quashing of criminal proceedings
  • Sampling procedure under Drugs and Cosmetics Rules
  • 1945
  • Rule 46
  • Section 27(d) of Drugs and Cosmetics Act
  • 1940
  • Inherent powers under Section 482 CrPC
  • Non-compliance with mandatory sampling rules
  • Defect in sampling vitiates prosecution
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Case Details

2022 LawText (KAR) (09) 71

Criminal Petition No. 6919 of 2022

2022-09-22

M. Nagaprasanna

Sri. Pramod Nair (Senior Advocate), Sri Anand Muttalli, Sri Gaurav Ganapathy C.G. (Advocates) for petitioners; Smt. K.P. Yashodha (HCGP) for respondent

M/s Emcure Pharmaceuticals Ltd, Sri Satish Ramanlal Mehta, Sri Mahesh Nathalal Shah

State of Karnataka

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Nature of Litigation

Criminal petition under Section 482 CrPC seeking quashing of proceedings for offence under Section 27(d) of Drugs and Cosmetics Act, 1940.

Remedy Sought

Petitioners sought quashing of the order dated 20.03.2018 passed in Crl.Misc.No.1/2018 (later C.C.No.39/2018) by the Special Economic Offences Wing, Bangalore, and the order dated 31.03.2022 passed in Crl.RP.No.323/2018 by the Principal City Civil and Sessions Judge, Bangalore.

Filing Reason

The sample of the drug was not drawn in accordance with the mandatory procedure under Rule 46 of the Drugs and Cosmetics Rules, 1945, rendering the prosecution unsustainable.

Previous Decisions

The trial court took cognizance and issued summons; the revision petition against that order was dismissed by the Sessions Court.

Issues

Whether the criminal proceedings under Section 27(d) of the Drugs and Cosmetics Act, 1940 are liable to be quashed due to non-compliance with the sampling procedure under Rule 46 of the Drugs and Cosmetics Rules, 1945?

Submissions/Arguments

Petitioners argued that the sample was not drawn in accordance with Rule 46 of the Drugs and Cosmetics Rules, 1945, which is mandatory, and therefore the prosecution is vitiated. Respondent State opposed the petition, but the court found merit in the petitioners' contention.

Ratio Decidendi

The sampling procedure under Rule 46 of the Drugs and Cosmetics Rules, 1945 is mandatory. Non-compliance with the mandatory procedure for drawing and handling of samples vitiates the prosecution under Section 27(d) of the Drugs and Cosmetics Act, 1940. The High Court, in exercise of its inherent powers under Section 482 CrPC, can quash such proceedings to prevent abuse of process of court.

Judgment Excerpts

The petitioners are before this Court calling in question entire proceedings in Criminal Miscellaneous No.01 of 2018 which later become C.C.No.39 of 2018 registered for an offence punishable under Section 27(d) of the Drugs and Cosmetics Act, 1940. The facts that led to the registration of crime are that on 5-01-2012, the Drugs Inspector, Bangalore visits M/s Tulasi Pharma and takes a legal sample of the drug. The sampling procedure under Rule 46 of the Drugs and Cosmetics Rules, 1945 is mandatory. Non-compliance with the mandatory procedure for drawing and handling of samples vitiates the prosecution.

Procedural History

On 5-01-2012, the Drugs Inspector took a sample of a drug from M/s Tulasi Pharma. The sample was sent to the Government Analyst, who reported it as not of standard quality. A complaint was filed against the petitioners under Section 27(d) of the Drugs and Cosmetics Act, 1940. The trial court took cognizance and issued summons. The petitioners filed a revision petition (Crl.RP.No.323/2018) which was dismissed by the Principal City Civil and Sessions Judge, Bangalore on 31.03.2022. Thereafter, the petitioners filed the present petition under Section 482 CrPC before the High Court.

Acts & Sections

  • Code of Criminal Procedure, 1973 (CrPC): 482
  • Drugs and Cosmetics Act, 1940: 27(d)
  • Drugs and Cosmetics Rules, 1945: 46
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