High Court Quashes Criminal Prosecution in Drugs & Cosmetics Act Case Due to Procedural Violations and Non-Compliance with Statutory Mandates. Prosecution was invalidated because of inordinate delay in sample testing, failure to dispatch sample portion to manufacturer depriving retesting right, and improper cognizance by Special Judge without committal under Section 193 CrPC, under Section 27(d) of Drugs & Cosmetics Act, 1940.

High Court: Bombay High Court Bench: BOMBAY
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Case Note & Summary

The High Court of Judicature at Bombay, in its criminal appellate jurisdiction, adjudicated a writ petition under Article 227 of the Constitution of India filed by a partnership firm and its partners seeking to quash a criminal prosecution initiated against them. The prosecution pertained to Special Case No.32 of 2021 before the Special Judge, Dadra and Nagar Haveli, Silvasa, for an offence punishable under Section 27(d) of the Drugs & Cosmetics Act, 1940. The petitioners, engaged in pharmaceutical manufacturing, were accused of producing drugs not of standard quality, based on a sample drawn on 29 November 2016 from a hospital store, which was tested and reported as substandard on 5 July 2017. The respondent, a Drugs Inspector, obtained sanction for prosecution on 6 November 2019 and filed a complaint on 28 September 2021, leading to the issuance of process against the petitioners. The petitioners raised multiple grounds challenging the prosecution, including inordinate delay in testing the sample in violation of Rule 45 of the Drugs Rules, 1945, non-compliance with Section 23(4)(ii) of the Drugs Act, 1940 due to failure to send a sample portion to the firm, resulting in loss of the right to retest under Sections 23 and 25, alleged non-application of mind by the Special Judge in issuing process, insufficient allegations to rope in the partners under Section 34 of the Drugs Act, 1940, improper cognizance by the Special Judge without committal under Section 193 of the Code of Criminal Procedure, 1973, and jurisdictional limits of the Central Drugs Inspector. The respondent resisted, asserting no procedural infractions and explaining the delay due to unavailability of reference standards. The court, after hearing arguments, focused on the procedural non-compliance as the substratum of the challenge. It analyzed the statutory framework, emphasizing the mandatory nature of procedural safeguards under the Drugs Act, 1940 and Rules, 1945. The court found that the delay in testing was unexplained and violated Rule 45, compromising sample integrity. Non-compliance with Section 23(4)(ii) deprived the petitioners of their statutory right to retest, rendering the prosecution unfair. The complaint's silence on the partners' specific roles made their prosecution under Section 34 unsustainable. The direct cognizance by the Special Judge without committal was held invalid under Section 193 CrPC. Considering these cumulative procedural lapses, the court concluded that the prosecution was vitiated and could not be sustained. Accordingly, the petition was allowed, and the criminal prosecution was quashed, setting aside the impugned order issuing process.

Headnote

A) Criminal Law - Quashing of Prosecution - Article 227 Constitution of India - Constitution of India, 1950, Article 227 - Petitioners sought to quash criminal prosecution under Section 27(d) of Drugs & Cosmetics Act, 1940, citing procedural violations - High Court exercised supervisory jurisdiction under Article 227 to examine legality of prosecution initiation - Held that prosecution was unsustainable due to multiple procedural lapses and non-compliance with statutory mandates (Paras 2, 9-10).

B) Drugs Law - Sample Testing Delay - Rule 45 Drugs Rules, 1945 - Drugs Rules, 1945, Rule 45 - Sample drawn on 29 November 2016, tested on 5 July 2017, causing delay - Rule 45 mandates prompt testing to ensure sample integrity - Delay was inordinate and unexplained, violating procedural safeguards - Held that delay vitiated the prosecution as it compromised the reliability of the analysis (Paras 4, 11-12).

C) Drugs Law - Sample Portion Non-Dispatch - Section 23(4)(ii) Drugs & Cosmetics Act, 1940 - Drugs & Cosmetics Act, 1940, Section 23(4)(ii) - Respondent failed to send one portion of sealed sample to Petitioner No.1 as required - Section 23(4)(ii) mandates dispatch to enable retesting right - Non-compliance deprived Petitioner of statutory right to challenge analysis report - Held that this breach rendered prosecution invalid (Paras 4, 13).

D) Drugs Law - Retesting Right Loss - Sections 23, 25 Drugs & Cosmetics Act, 1940 - Drugs & Cosmetics Act, 1940, Sections 23, 25 - Breach of Sections 23 and 25 led to loss of right to have sample retested - Petitioners argued invaluable right was lost due to procedural infractions - Court found non-compliance undermined fairness and evidentiary value - Held that loss of retesting right was a fatal flaw in prosecution (Paras 4, 13).

E) Criminal Procedure - Issuance of Process - Non-Application of Mind - Code of Criminal Procedure, 1973, Section 204 - Special Judge issued process on 28 September 2021 allegedly without application of mind - Petitioners contended process was mechanical and lacked scrutiny - Court examined complaint and order for adequacy - Held that issuance of process was flawed due to insufficient consideration of facts (Paras 4, 9).

F) Drugs Law - Vicarious Liability - Section 34 Drugs & Cosmetics Act, 1940 - Drugs & Cosmetics Act, 1940, Section 34 - Complaint was silent on specific role of Petitioner Nos.2 to 5, partners of firm - Section 34 allows roping in persons for offences by firm - Petitioners argued bald assertions insufficient for liability - Court found complaint lacked particulars to invoke Section 34 - Held that prosecution against partners was unsustainable without specific allegations (Paras 4, 9).

G) Criminal Procedure - Cognizance by Special Judge - Section 193 Code of Criminal Procedure, 1973 - Code of Criminal Procedure, 1973, Section 193 - Special Judge took cognizance directly without case being committed - Section 193 restricts cognizance by Court of Session to committal - Petitioners argued this was impermissible - Court found cognizance was taken in violation of procedural mandate - Held that direct cognizance without committal was invalid (Paras 4, 9).

H) Drugs Law - Jurisdictional Limits - Central Drugs Inspector Authority - Drugs & Cosmetics Act, 1940, Drugs Rules, 1945 - Respondent, a Central Drugs Inspector, initiated action allegedly beyond jurisdictional limits - Petitioners contended Inspector had no authority in the area - Court examined appointment and jurisdictional rules under Act and Rules - Held that jurisdictional transgression, if proven, would affect prosecution validity (Paras 4, 5).

Issue of Consideration: Whether the criminal prosecution initiated under Section 27(d) of the Drugs & Cosmetics Act, 1940, is liable to be quashed due to alleged procedural infractions, non-compliance with statutory provisions, and infirmities in the prosecution process

Final Decision

The High Court allowed the writ petition, quashed and set aside the criminal prosecution initiated against the Petitioners in Special Case No.32 of 2021, and set aside the order dated 28 September 2021 issuing process against the Petitioners.

2026 LawText (BOM) (03) 125

WRIT PETITION NO.2777 OF 2024

2026-03-24

N.J. Jamadar J.

2026:BHC-AS:14013

Mr. Nitin Bhasin with Mr. Vishal N. Nevshe, for Petitioners; Mr. Anilkumar Singh i/by Mr. D.P.Singh, for Respondent – Union of India; Mr. K.C.Shinde, APP for State

M/s. C.B.Healthcare and Ors.

Union of India

Nature of Litigation: Writ Petition under Article 227 of the Constitution of India seeking to quash criminal prosecution

Remedy Sought

Petitioners seek to quash and set aside criminal prosecution initiated against them in Special Case No.32 of 2021

Filing Reason

Alleged procedural infractions and non-compliance with statutory provisions under the Drugs & Cosmetics Act, 1940 and Drugs Rules, 1945 in the prosecution

Previous Decisions

Special Judge, Dadra and Nagar Haveli, Silvasa, issued process against the Petitioners for an offence under Section 27(d) of the Drugs Act, 1940 by order dated 28 September 2021

Issues

Whether the prosecution is liable to be quashed due to delay in testing the sample violating Rule 45 of Drugs Rules, 1945 Whether non-compliance with Section 23(4)(ii) of Drugs & Cosmetics Act, 1940 deprives the right to retest and vitiates prosecution Whether the complaint lacks specific allegations to rope in partners under Section 34 of Drugs & Cosmetics Act, 1940 Whether the Special Judge's cognizance without committal under Section 193 CrPC is valid Whether the issuance of process by the Special Judge suffered from non-application of mind Whether the Central Drugs Inspector had jurisdictional authority to initiate action

Submissions/Arguments

Petitioners argued inordinate delay in testing sample violates Rule 45 of Drugs Rules, 1945 Petitioners contended failure to send sample portion under Section 23(4)(ii) of Drugs Act, 1940 lost retesting right Petitioners asserted complaint is silent on specific role of partners, making prosecution under Section 34 unsustainable Petitioners claimed Special Judge took cognizance directly without committal, violating Section 193 CrPC Petitioners alleged issuance of process was mechanical and without application of mind Petitioners argued Central Drugs Inspector had no jurisdictional authority Respondent resisted, asserting no procedural infractions and explaining delay due to unavailability of reference standards

Ratio Decidendi

Procedural compliance under the Drugs & Cosmetics Act, 1940 and Drugs Rules, 1945 is mandatory; inordinate delay in testing samples violates Rule 45 and compromises reliability; non-compliance with Section 23(4)(ii) deprives the right to retest, rendering prosecution unfair; prosecution against partners requires specific allegations under Section 34; cognizance by Special Judge without committal under Section 193 CrPC is invalid; cumulative procedural lapses vitiate the prosecution.

Judgment Excerpts

By this Petition under Article 227 of the Constitution of India, the Petitioners seek to quash and set aside criminal prosecution initiated against the Petitioners The sample was purportedly drawn for the purpose of test and analysis by issuing Form No.17 Government Analyst, CDTL, issued a report of analysis in Form No.13 on 5 July 2017, opining that the sample was ‘not of standard quality’ Rule 45 mandates prompt testing to ensure sample integrity Section 23(4)(ii) mandates dispatch to enable retesting right

Procedural History

Sample drawn on 29 November 2016; sent to CDTL, Mumbai on 30 November 2016; report issued on 5 July 2017; show cause notice issued; joint investigation report dated 4 September 2017; sanction obtained on 6 November 2019; complaint filed on 28 September 2021; process issued on 28 September 2021; writ petition filed in 2024; reserved on 11 December 2025; pronounced on 24 March 2026.

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