The Bombay High Court has delivered a significant ruling affirming that inordinate delay in testing drug samples and failure to transmit a portion of the sample to the manufacturer vitiates criminal prosecution under the Drugs and Cosmetics Act, 1940. The judgment underscores that procedural compliance is not a mere formality but a substantive safeguard for the accused, and its breach renders the prosecution an abuse of process.
Background & Facts
The Dispute
The petitioners, M/s. C.B.Healthcare and its partners, face criminal prosecution under Section 27(d) of the Drugs and Cosmetics Act, 1940 for manufacturing a drug, FEXINOL-12, alleged to be "not of standard quality." The prosecution stems from a sample drawn on 29 November 2016 from a hospital’s medical store in Silvasa, Dadra and Nagar Haveli. The sample was traced back to the petitioners, who are the manufacturer based in Baddi, Himachal Pradesh.
Key Facts
- The drug batch, FEXINOL-12, Batch No. CBT-400/16, was manufactured in September 2016.
- The sample was drawn by a Drugs Inspector on 29 November 2016.
- One portion of the sample was sent to the Central Drugs Testing Laboratory (CDTL), Mumbai, on 30 November 2016.
- The Government Analyst issued the report of analysis (Form No.13) on 5 July 2017 - over seven months after receipt of the sample.
- The expiry date of the drug batch was August 2018.
- The complainant, a Drugs Inspector appointed by the Central Government, issued a notice under Section 18A on 26 December 2017 to M/s. Knoll Healthcare Pvt. Ltd., the distributor, and copied it to the petitioners.
- On 15 January 2018, the petitioners formally requested the Inspector to send them a portion of the sealed sample, which was denied.
- Sanction for prosecution was granted by the Drugs Controller General of India on 6 November 2019.
- The complaint was filed on 28 September 2021 - over three years after the drug’s expiry date.
- The Special Judge issued process against the petitioners on 28 September 2021.
Procedural History
- 29 November 2016: Sample drawn from Vinoba Bhave Civil Hospital, Silvasa.
- 30 November 2016: Sample portion sent to CDTL, Mumbai.
- 5 July 2017: Government Analyst’s report issued, declaring drug "not of standard quality."
- 26 December 2017: Notice under Section 18A served on distributor, copied to petitioner.
- 15 January 2018: Petitioner requests sample portion; request denied.
- 4 September 2017: Joint investigation report prepared.
- 6 November 2019: Sanction for prosecution granted by DCGI.
- 28 September 2021: Complaint filed before Special Judge, Dadra and Nagar Haveli.
- 28 September 2021: Special Judge issued process against petitioners.
- 27 March 2024: Writ Petition filed before Bombay High Court.
- 24 March 2026: Judgment pronounced.
The Parties' Positions
Petitioners contend that the prosecution is legally unsustainable due to: (1) violation of Rule 45 of the Drugs Rules, 1945 by delayed testing; (2) failure to transmit a portion of the sample to the manufacturer under Section 23(4)(iii); (3) loss of right to retest due to expiry of the drug; (4) mechanical issuance of process without application of mind; (5) lack of specific averments against partners under Section 34; and (6) improper cognizance by the Special Judge without prior commitment by a Magistrate.
Respondent argues that: (1) delay in testing was due to unavailability of reference standards; (2) service of notice under Section 18A on the distributor and copying it to the petitioner satisfies Section 23(4)(iii); (3) petitioners failed to notify intent to controvert the report within 28 days; and (4) the Notification under Section 36AB(1) empowers the Special Judge to take cognizance directly.
Relief Sought
The petitioners seek quashing of the complaint (Special Case No.32 of 2021) and the order dated 28 September 2021 issuing process, on grounds of procedural illegality and abuse of process.
The Legal Issue
The central question is whether a criminal prosecution under Section 27(d) of the Drugs and Cosmetics Act, 1940 can proceed when there is inordinate delay in sample testing beyond the 60-day mandate under Rule 45 of the Drugs Rules, 1945, and when a portion of the sealed sample is not transmitted to the manufacturer, thereby extinguishing the accused’s statutory right to retest the sample.
Arguments Presented
For the Petitioner
Counsel for the petitioners relied on M/s. Quixotic Healthcare v. State of Maharashtra, Swapnil v. State of Maharashtra, Laborate Pharmaceuticals India Ltd. v. State of Tamil Nadu, and Medipol Pharmaceutical India Pvt. Ltd. v. PGIMER to argue that delay beyond the statutory period renders the analysis suspect and violates the right to retest. He emphasized that Rule 45 is mandatory, not directory, and that the Government Analyst’s failure to seek extension under the proviso cannot be excused by post-hoc affidavits. He further cited Amery Pharmaceuticals v. State of Rajasthan and Brij Lal Mittal v. State of Haryana to show that transmission of sample portion to the manufacturer is non-negotiable, and that mere copying of notice under Section 18A does not discharge the obligation under Section 23(4)(iii). He also contended that the complaint lacks specific averments against the partners under Section 34, and that the Special Judge lacked jurisdiction to take cognizance directly under Section 193 CrPC.
For the Respondent
The Respondent argued that the delay was due to unavailability of reference standards, and that the petitioners were aware of the report through the Section 18A notice and failed to invoke their right to controvert under Section 25(3). He relied on State of Haryana v. Brij Lal Mittal to argue that non-transmission to the manufacturer is cured if the distributor is notified. He further contended that the Notification under Section 36AB(1) of the Drugs Act, read with Section 32(2), constitutes an express exception to Section 193 CrPC, permitting direct cognizance by the Special Judge.
The Court's Analysis
The Court undertook a rigorous analysis of the statutory framework under the Drugs Act, 1940 and the Drugs Rules, 1945. It held that Rule 45 imposes a mandatory duty on the Government Analyst to complete testing and furnish the report within 60 days of receipt of the sample. The use of the word "shall" and the explicit proviso requiring a formal application for extension indicate a legislative intent to treat the timeline as peremptory.
"The explanation for the delay, if at all there was any, should have come from the Government Analyst and that too in the manner envisaged by the proviso to Rule 45(1) and not by way of an affidavit of the Respondent. Any other interpretation would render the peremptory nature of sub-Rule (1) and the proviso thereto otiose."
The Court rejected the Respondent’s justification based on unavailability of reference standards, noting that such a reason must be formally communicated to the Government by the Analyst, not asserted in a reply affidavit.
Regarding Section 23(4)(iii), the Court held that the obligation to transmit a portion of the sample to the person whose name and address were disclosed under Section 18A is absolute. The Court distinguished Amery Pharmaceuticals, clarifying that when the manufacturer is identified as the source, the sample portion must be sent to the manufacturer, not merely copied to them via notice to a distributor. The Court emphasized:
"The requirement of the provision would stand complied with when the Inspector gives one portion of the sample to the person from whom he took the sample, and forward the second portion to the Government Analyst and the third portion to the Court... and fourth portion to the person whose name and address, etc, were disclosed by the vendor."
The Court further held that the right to retest under Section 25(4) is rendered illusory when the sample is no longer viable. The drug expired in August 2018; the complaint was filed in September 2021 - over three years later. The Court cited Laborate Pharmaceuticals and Medipol Pharmaceutical to affirm that when the sample’s shelf life has expired and the accused is denied the opportunity to retest, the prosecution becomes a "lame prosecution" and an abuse of process.
On the issue of cognizance, the Court held that Section 32(2) does not override Section 193 CrPC. The absence of an express provision in the Drugs Act permitting direct cognizance by the Court of Session, coupled with the lack of language such as "notwithstanding anything contained in the CrPC," means the procedural safeguards under Chapters XV and XVI of the CrPC must be followed. The Notification under Section 36AB(1) designates a Special Court for trial, not for taking cognizance without commitment.
Finally, while the Court noted deficiencies in the complaint’s averments against the partners under Section 34, it declined to decide the issue definitively, holding that the prosecution against the manufacturer alone was already unsustainable.
The Verdict
The petition was allowed. The Bombay High Court quashed and set aside: (i) the order dated 28 September 2021 issuing process against the petitioners; and (ii) the entire criminal prosecution in Special Case No.32 of 2021. The Court held that the prosecution, in light of the inordinate delay in testing, failure to transmit the sample portion, and expiry of the drug, constitutes an abuse of the process of the Court.
What This Means For Similar Cases
Procedural Compliance Is Non-Negotiable
- Practitioners must challenge prosecutions where sample testing exceeds 60 days without a formal extension request from the Government Analyst.
- Affidavits explaining delay by investigating officers are legally insufficient; only the Analyst’s application under Rule 45 proviso is valid.
- Any prosecution relying on delayed analysis must be resisted on grounds of evidentiary unreliability and violation of Article 21.
Transmission of Sample Portion Is Mandatory to Manufacturer
- If the manufacturer is identified as the source of the drug, the sample portion must be transmitted directly to them under Section 23(4)(iii).
- Service of notice on a distributor or retailer, even if copied to the manufacturer, does not satisfy this obligation.
- Failure to transmit the sample portion extinguishes the right to retest and renders the prosecution voidable.
Shelf Life Expiry Vitiates Prosecution
- When the drug’s shelf life has expired before the complaint is filed, the right to retest under Section 25(4) is rendered impossible.
- Courts must consider the physical viability of the sample when assessing the fairness of prosecution.
- Delayed prosecution after expiry of shelf life, especially when attributable to the State, will be quashed as an abuse of process.
Cognizance Requires Magistrate’s Commitment
- Special Courts under Section 36AB(1) are empowered for trial, not for direct cognizance.
- Section 193 CrPC remains applicable unless the special law expressly overrides it.
- Prosecutors must ensure complaints are filed before a Magistrate, who then commits the case to the Special Court.
Vicarious Liability Requires Specific Averments
- Mere assertion that a person is a director or partner is insufficient under Section 34.
- The complaint must specify how the individual was "in charge of and responsible for the conduct of the business" at the time of the offence.
- Absent such particulars, courts must quash proceedings against individuals.
