Prosecution under the Drugs and Cosmetics Act was quashed due to procedural delays, lack of evidence, and misapplication of statutory provisions.

ORDER :

FARJAND ALI, J.

1. By way of filing this instant Criminal Petition under Section482 CrPC (now Section 528 of BNSS, 2023), the petitioners seek quashing of Case No. 17/2023 pending before the Hon'ble Chief Judicial Magistrate, Jalore. The said case has been instituted against the petitioners for the alleged contravention of Sections 16(1)(c), 17, 17B, 18(a)(i), and 18(a)(vi) of the Drugs and Cosmetics Act, and is punishable under Sections 27(c), 27(d), and 36 of the said Act. The allegations pertain to the manufacture, sale, and distribution of the drug "Ipra Tropium Bromide Respirator Solution,"which is claimed to be spurious and substandard.

2. The present case arises from the legal sampling of "Ipra Tropium Bromide Respirator (Nebulizing Solution)," Batch No. 708076, drawn on 22.09.2017 by Shri Pankaj Gehlot, Drugs Control Officer, from the District Drug Warehouse, Jalore, for testing and analysis. The sample was forwarded to the Government Analyst, DTL Jaipur, under Form-18 on 04.10.2017, and the analyst's report dated 14.06.2019 declared the sample as Not of Standard Quality (NSQ), finding the active ingredient at 33.49% of the label claim.

3. Upon receipt of the report, a copy was furnished to the petitioner company by Smt. Saira Banu, Drugs Control Officer, on 21.06.2019. Within the statutory period, accused No.2, Kirti J Shah, on behalf of the company, contested the report and requested retesting at the Central Drugs Laboratory (CDL), Kolkata. Pursuant to an application dated 28.06.2019, the sample was sent to CDL Kolkata, which, vide report dated 11.05.2020, reaffirmed the NSQ status, citing non-conformity in identification and assay tests. Notably, the CDL's analysis occurred after the expiry of the sample in June 2019.

4. Subsequently, based on the investigation and requisite sanction, the Drugs Control Officer, Jalore, lodged a complaint before the Court of Chief Judicial Magistrate, Jalore, on 04.06.2023, against M/s Ciron Drugs & Pharmaceuticals (P) Ltd. and its directors, alleging violations under Sections 16(1)(c), 17, 17B, 18(a)(i), and 18(a)(vi), punishable under Sections 27(c), 27(d), and 36 of the Drugs and Cosmetics Act, culminating in the registration of Case No. 17/2023.

5. Heard learned counsels present for the parties and gone through the materials available on record.

6. The liability of company directors under the Drugs and Cosmetics Act, 1940, is governed by Section 34, which mandates that only those directors who are responsible for the conduct of business can be held liable. The record indicates that an inspection was conducted on 11.05.2023 by Drugs Inspectors Shri Tara Chand (Sikar) and Shri Pol (Palghar FDA, Maharashtra), wherein it was found that only Shri Ratanshi T. Shah was responsible for the day-to-day affairs of the company. Despite this, all directors have been indiscriminately prosecuted without any evidence demonstrating their involvement in the alleged offence.

7. Notably, Shri Ratanshi Shah passed away on 16.02.2022, rendering the prosecution against him abated by operation of law. Consequently, there remains no substantive legal basis to implicate the other directors, as they were neither responsible for the conduct of the company’s business nor were involved in the alleged contravention.

8. The prosecution is vitiated by inordinate delays and multiple non-compliances with mandatory statutory provisions. The chronology of events establishes a clear violation of procedural safeguards:

Delay in Sending Sample for Testing: The legal sample of “Ipra Tropium Bromide Respirator (Nebulizing Solution)” was drawn on 22.09.2017, but was forwarded for testing only on 04.10.2017. Section 23(4)(i) of the Drugs and Cosmetics Act mandates that the sample be sent to the Government Analyst “forthwith,” meaning on the same day or the next working day. The delay of 12 days in this case is a gross violation.

Delay in Issuance of Analyst’s Report: The Government Analyst issued its report on 14.06.2019, alm