M/s Ciron Drugs Pharmaceuticals Pvt. Ltd. v. State of Rajasthan, Through Pp
2025-03-20
FARJAND ALI
body2025
DigiLaw.ai
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.
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, almost 20 months after receiving the sample. Rule 45 of the Drugs and Cosmetics Rules, 1945, stipulates that the analyst’s report must be furnished within 60 days. The delay in the issuance of the report renders it legally untenable. Retesting Conducted Post-Expiry of Sample: The company, exercising its right under Section 25(3) of the Act, contested the Government Analyst’s report and sought a retest at the Central Drugs Laboratory (CDL), Kolkata. The sample was sent on 27.06.2019, just three days prior to its expiry in June 2019. The CDL Kolkata received the sample after its expiry and issued a report dated 11.05.2020. A sample that has already expired cannot be a valid subject of chemical testing, as its stability and potency degrade over time.
The sample was sent on 27.06.2019, just three days prior to its expiry in June 2019. The CDL Kolkata received the sample after its expiry and issued a report dated 11.05.2020. A sample that has already expired cannot be a valid subject of chemical testing, as its stability and potency degrade over time. Delay in Filing Complaint: Despite being aware of the procedural lapses, the Drugs Control Officer, Jalore, proceeded to file a complaint before the Chief Judicial Magistrate only on 04.06.2023, almost four years after the analyst’s report and six years after the initial sample collection. Such unexplained and inordinate delay violates the right to a fair trial and amounts to an abuse of the legal process. These procedural defects render the prosecution arbitrary, malafide, and contrary to the principles of natural justice. 9. The petitioners have been charged under Section 17B of the Act, which pertains to spurious drugs. However, a careful examination of the allegations and test reports reveals that the drug in question does not meet any of the statutory definitions of “spurious” under Section 17B: • It was not manufactured under the name of another drug (Section 17B(a)). • It was not an imitation or deceptive substitute for another drug (Section 17B(b)). • There is no evidence that the active ingredient was wholly or partly substituted with another substance (Section17B(c)). 10. The complaint itself acknowledges that the drug “lost its potency due to improper methods and lack of precautions,” which contradicts the charge under Section 17B(d). Thus, the charge of manufacturing and selling a spurious drug is legally unsustainable, and consequently, Section 27(c), which prescribes punishment for spurious drugs, is inapplicable to the petitioners. 11. The Drugs Inspector failed to record the storage conditions at the time of sample collection. The stability of a pharmaceutical product is highly dependent on proper storage, and temperature variations can cause a drug to degrade. Given that neither the complainant nor the investigating officer verified the storage conditions at the District Drug Warehouse, the entire basis of prosecution is fundamentally flawed, as the deterioration of the sample could be attributed to external factors rather than manufacturing defects. 12. For the foregoing reasons, this Court finds that the entire prosecution is vitiated by procedural irregularities, unexplained delays, misapplication of statutory provisions, and lack of material evidence against the petitioners.
12. For the foregoing reasons, this Court finds that the entire prosecution is vitiated by procedural irregularities, unexplained delays, misapplication of statutory provisions, and lack of material evidence against the petitioners. The learned Magistrate failed to apply judicial mind while taking cognizance of the complaint. 13. Accordingly, the instant petition is allowed, and Case No.17/2023 pending before the Hon’ble Chief Judicial Magistrate, Jalore, is hereby quashed against the petitioners. 14. The stay petition is disposed of.