IN THE HIGH COURT OF JUDICATURE FOR RAJASTHAN AT JODHPUR
FARJAND ALI, J.
Ganesh Narayan Nayak S/o Narayan Vaikunth Nayak - Appellant
Versus
State Of Rajasthan, Through Pp - Respondent
S.B. Criminal Misc(Pet.) No. 6621/2023
Decided on : 21-03-2025
(A) Drugs and Cosmetics Act, 1940 - Sections 18(a)(i), 18(a)(vi), 27(b)(i), 25(3), 19(3) - Code of Criminal Procedure, 1973 - Section 482 - Quashing of complaint - Complaint filed against petitioners for alleged drug quality issues - Procedural lapses identified, including failure to send samples for reanalysis and non-compliance with statutory requirements - Vicarious liability not established for non-executive directors - Limitation period exceeded for filing complaint - Prosecution deemed an abuse of process of law. (Paras 8, 10, 11, 12, 18, 22)
(B) Legal principles - Vicarious liability under Section 34 of the Drugs and Cosmetics Act - Non-executive directors cannot be held liable without specific allegations - Statutory protections for distributors and marketers - Importance of compliance with procedural safeguards in criminal proceedings. (Paras 8, 9, 12, 18)
Facts of the case:
The petitions challenge Complaint No. 158/2017 filed against various directors and companies for alleged drug quality violations, stemming from a 2012 inspection that revealed a drug sample failed quality tests. The complaint was filed four years later, beyond the statutory limitation period.
Findings of Court:
The court found multiple legal infirmities in the prosecution, including lack of vicarious liability, procedural lapses, and expiration of the limitation period, leading to the conclusion that the complaint was an abuse of the process of law.
Issues: The main issues included the legality of the complaint, the applicability of vicarious liability to non-executive directors, and the impact of procedural lapses on the prosecution.
Ratio Decidendi: The court ruled that the complaint was legally untenable due to procedural irregularities, lack of substantive allegations against the petitioners, and the expiration of the limitation period, emphasizing the need for compliance with statutory requirements.
Result: The petitions are allowed, and all proceedings arising from Complaint No. 158/2017 are quashed.
ORDER :
FARJAND ALI, J.
1. These criminal miscellaneous petitions under Section 482 read with Section 483 of the Code of Criminal Procedure, 1973 (Cr.P.C.), have been filed by the respective petitioners seeking quashing of Complaint No. 158/2017 dated 06.02.2017, titled State of Rajasthan through Drug Control Officer vs. M/s Life Line Fluid and Drug Store, Rajsamand and Others, along with all subsequent proceedings arising therefrom, pending before the learned Chief Judicial Magistrate, Rajsamand, Rajasthan, on the ground that the same is illegal and amounts to an abuse of the process of law.
2. Given the similar nature of allegations, legal issues, and prayers involved in all the petitions, they are being decided together through this consolidated order.
3. The origin of the dispute dates back to an inspection conducted on 30.11.2012 by the Drugs Control Officer (respondent No. 2) at the premises of M/s Life Line Fluid and Drug Store, Rajsamand. During the said inspection, a sample of the drug “Tab. Glimp-2” (Batch No. BD-11374), manufactured by M/s Skymap Pharmaceuticals, was collected for analysis. The Government Analyst, Jaipur, vide report dated 15.01.2013, declared the sample as not of standard quality due to non-conformity with the dissolution test.
4. The distribution chain of the subject drug was traced back through intermediary distributors, eventually leading to M/s Biochem Pharmaceuticals Industries Limited (now amalgamated with M/s Zydus Healthcare Limited), which marketed the product, and M/s MKS Pharma Limited, a wholesale license holder. Despite this tracing, the Drugs Control Officer did not follow the statutory requirement of sending the sample to the manufacturer for reanalysis under Section 25(3) of the Drugs and Cosmetics Act, 1940 (hereinafter “the 1940 Act”).
5. The prosecution proceeded to file Complaint No. 158/2017 on 09.01.2017 before the learned Chief Judicial Magistrate, Rajsamand, under Sections 18(a)(i), 18(a)(vi) read with Sections 16(i)(a) and 17A, punishable under Section 27(b)(i) of the 1940 Act. Cognizance was taken vide order dated06.02.2017.
6. The petitioners before this Court include the following:
CRLMP No. 6621/2023: M/s Biochem Pharmaceuticals Industries Limited - Additional Directors (Non-Executive), and others.
CRLMP No. 6626/2023: M/s Biochem Pharmaceuticals Industries Limited, its Directors, competent persons, M/s MKS Pharma Limited, and its Directors. CRLMP No. 108/2024: M/s Skymap Pharmaceuticals, its partners, manufacturing chemists, and analytical chemists.
7. This Court has heard the learned counsels present for the parties, meticulously perused the records and given its thoughtful consideration to the facts of the case, the legal provisions involved, and the judgments cited. The fundamental issue at hand pertains to the legality of the complaint and the subsequent proceedings, keeping in view the statutory provisions under the Drugs and Cosmetics Act, 1940, and the Code of Criminal Procedure, 1973.
8. A comprehensive review of the complaint and the attendant circumstances reveals a glaring procedural lapse, which vitiates the very foundation of the prosecution. The principle of vicarious liability, as embodied under Section 34 of the Drugs and Cosmetics Act, 1940, fastens liability only upon those individuals who were in charge of and responsible for the conduct of the business at the time of the alleged offence. In the present case, the petitioners, who were appointed as Additional Directors (Non-Executive) much after the relevant period, cannot be saddled with criminal liability merely by virtue of their designation. The Hon’ble Supreme Court, in Gunmala Sales (P) Ltd. v. Anu Mehta, (2015) 1 SCC 103, has enunciated the principle that unimpeachable documents, such as Form-32 and board resolutions, can be relied upon for quashing criminal proceedings under Section 482 Cr.P.C. The present case falls squarely within the ambit of this settled legal proposition, as the documents on record
The prosecution was quashed due to procedural lapses, lack of vicarious liability for non-executive directors, and exceeding the statutory limitation period, constituting an abuse of the process of l....
The court established that former directors cannot be held vicariously liable for offences committed after their tenure, and highlighted multiple procedural lapses that rendered the prosecution unsus....
Prosecution under the Drugs and Cosmetics Act was quashed due to procedural delays, lack of evidence, and misapplication of statutory provisions.
Distributors of drugs are not liable for quality issues if they prove acquisition from a licensed manufacturer and proper storage, as per Section 19(3) of the Drugs and Cosmetics Act.
The court ruled that mandatory compliance with the statutory provisions in drug testing processes is essential; failure to do so invalidates prosecution.
Proceedings under the Drugs and Cosmetics Act can be quashed if the company involved is not named as an accused and procedural compliance is not met.
Criminal liability for partners requires specific allegations of responsibility; mere designation is insufficient, and complaints may be barred by limitation.
The judgment establishes that a valuable right to re-test a drug sample, as provided under Section 25(4) of the Drugs and Cosmetics Act, cannot be denied without due process, and failure to comply wi....
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