Authority: High Court of Himachal Pradesh, Shimla

Order Date: 10 July 2026

Case Overview

  • Petitioners: M/s Crystal Pharmaceuticals (and another) filed two criminal writ petitions (Cr.MMO Nos.1336 and 472 of 2024) under Section 528 of the B.N.S.S/Section 482 Cr.P.C. seeking quash of Complaint Cases registered under the Drugs and Cosmetics Act (CNR No. HPMA 020126592023 and CNR No. HP38010015182023).
  • Respondent: State of Himachal Pradesh, represented by Deputy Advocates General Mr. Ravi Chauhan and Mr. Anish Banshtu.
  • Background of Complaint 1 (Cr.MMO No.1336):
  • On 15‑06‑2017 a Drug Inspector received a letter to sample Propin 40, Batch OP‑812 (Mfg Sept 2016, Exp Aug 2018). Samples drawn on 17‑06‑2017 were sent to Government Analyst, CDL, Kolkata on the same day.
  • Report received on 28‑09‑2017 (Form‑13) declared the drug “Not of Standard Quality” for clarity, particulate matter and sterility.
  • Subsequent correspondence (10‑10‑2017, 16‑11‑2017, 17‑11‑2017, 07‑12‑2017) identified the supplier as Crystal Pharmaceuticals, Gagret (Una) and the manufacturer as Crystal Pharmaceuticals, 365 Model Town, Ambala (Haryana).
  • The manufacturer challenged the report on 09‑01‑2018; the State Drugs Controller directed re‑analysis under Section 25(4) of the Act.
  • Re‑analysis request filed on 05‑05‑2018; multiple court notices (21‑05‑2018, 19‑05‑2018, 22‑06‑2018) directed appearance of the manufacturer and pharmacist.
  • Central Drugs Laboratory, Kolkata dispatched the report to the court on 21‑01‑2019; the court could not produce a certified copy despite applications on 30‑01‑2019 and 23‑03‑2021.
  • On 31‑03‑2022 the laboratory finally supplied Form‑2 and the “Not of Standard Quality” report.
  • State Drugs Controller sanctioned prosecution under Section 18(a)(i) punishable under Section 27(d) on 07‑05‑2022.
  • Notices under Section 22(1)(cca) issued on 26‑04‑2023 to Shri Pawan Kumar (Plant In‑charge) were returned unserved.
  • The complaint was filed on 08‑06‑2023, well beyond the three‑year limitation period (Section 468 Cr.P.C.) and beyond the expiry of the drug batch.
  • Background of Complaint 2 (Cr.MMO No.472):
  • On 22‑07‑2017 a sample of Injection Dexamethasone Sodium Phosphate IP, Batch DX‑436 (Mfg Jan 2017, Exp Dec 2018) was drawn and sent to Government Analyst, RDTL, Chandigarh on 01‑01‑2018.
  • Report received on 26‑04‑2018 (Form‑13) found the drug “Not of Standard Quality” – assay only 50% of claim and particulate matter non‑conforming.
  • Attempts to obtain purchase invoices from PHC Jassur, Block Medical Officer Gangath, and Chief Medical Officer Dharamshala revealed the drug was supplied by Crystal Pharmaceuticals, VPO Gagret (Una) (invoice CP‑837 dated 13‑03‑2017).
  • The wholesaler’s licence had expired on 13‑06‑2018; no response to further notices.
  • Complaint filed on 21‑08‑2023, again beyond limitation and after the sample’s expiry.
  • Petitioners, through counsel Mr. Sanjay Jain, argued:
  • The complaints were barred by limitation (Section 468 Cr.P.C.) as the offences were known on 20‑09‑2017/26‑04‑2018 but complaints were filed in 2023.
  • Violation of Section 25 of the Drugs Act (complaint should be filed immediately) and Rule 45 of the 1945 Rules (analysis within 60 days) – the samples were analysed after more than three/nine months.
  • No specific averment of vicarious liability under Section 34 of the Drugs Act; petitioner No. 2 (proprietor) was not shown to be “in‑charge” of the firm.
  • Lack of natural justice – no opportunity to be heard before summons were issued.
  • Respondent, represented by Deputy Advocate General Mr. Ravi Chauhan, contended that the complaints were valid, the drug was non‑standard, and the proprietor could be held liable under Section 34.
  • The Court examined extensive Supreme Court jurisprudence on the exercise of inherent power under Section 482 Cr.P.C. (cases: Pirthi Chand, Kaptan Singh, Bhajan Lal, Abhishek Singh, etc.) and on vicarious liability under Section 34 of the Drugs Act and Section 141 of the NI Act.
  • The Court found:
  • The complaints were filed after the statutory limitation period and after the expiry of the drug batches.
  • The 60‑day analysis requirement under Rule 45 was breached, depriving the accused of the right to contest the analyst’s report.
  • The complaint lacked specific facts linking petitioner No. 2 to the day‑to‑day conduct of the business, rendering vicarious liability untenable.
  • Continuation of the prosecution would constitute an abuse of process.

Final Outcome

  • The High Court quashed both Complaint Cases (Drugs and Cosmetics Act/0000001/2023 and Drugs and Cosmetics Act/2/2023) and all consequential proceedings pending before the Additional Chief Judicial Magistrates of Mandi and Nurpur.
  • The petitioners were discharged.
  • All pending applications, if any, were ordered disposed of.

Topics: Drugs & Cosmetics Regulation, Criminal Procedure