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2026 Supreme(HP) 311

IN THE HIGH COURT OF HIMACHAL PRADESH, SHIMLA
SANDEEP SHARMA, J.
Umang Vohra - Petitioner
Versus
Union of India - Respondents
CrMMO No. 733 of 2025
Decided On : 25-03-2026
 

Advocates Appeared:
For the Petitioner:Mr. Gagan Anand, Mr. Ramanjit Singh and Mr. Pranjal Munjal, Advocates.
For the Respondents: Mr. Balram Sharma, Deputy Solicitor General of India.

Vicarious liability under Section 34 of Drugs and Cosmetics Act requires specific complaint averments that director/MD in charge and responsible for company business conduct; mere designation insufficient if authorized rep handles day-to-day and manufacturer contractually liable. (38 words)

Headnote:(A) Drugs and Cosmetics Act, 1940 - Sections 18(a)(i) & (vi) read with Section 16(1)(a) punishable under Section 27(d), Section 34 - Bharatiya Nagrik Suraksha Sanhita, 2023 (BNSS) - Section 528 (CrPC Section 482) - Complaint for manufacturing, marketing substandard drug failing assay tests by two government labs - Petition by Managing Director of marketing company (accused No.5) for quashing complaint and summoning order - No specific averment in complaint that petitioner in charge of and responsible for day-to-day conduct of business of company - Manufacturer separately licensed with expert staff, entered quality and purchase agreements warrantying compliance and indemnifying marketing company - Authorized representative (accused No.6) responsible for day-to-day operations - Vicarious liability under Section 34 requires specific averments of role; mere MD designation insufficient - Proceedings quashed qua petitioner as abuse of process, preventing protracted trial bound to fail. (Paras 9-13, 28-41)

(B) CrPC Section 482 (BNSS Section 528) - Quashing criminal proceedings - High Court may quash if continuation abuse of process or secures ends of justice - Material by accused must be sound, rule out assertions, unrefuted, leading to conclusion defence based on indubitable facts - Steps: sterling quality material, rejects accusations, cannot be refuted, trial abuse - No mini-trial but consider unimpeachable evidence. (Paras 19-26)

(C) Drugs and Cosmetics Act, 1940 - Section 34 - Offences by companies - Vicarious liability on person in charge and responsible for business conduct at time of offence - Not mere director/MD unless specific averment of role in day-to-day affairs - Strict construction; complainant must aver how accused responsible - Proviso allows escape if no knowledge or due diligence - Applies to marketer where manufacturer contractually responsible. (Paras 28-35)

Facts of the case:
Sample of drug manufactured by one company, marketed by another, drawn from manufacturer, failed quality tests by two labs (assay Ofloxacin low, Metronidazole high) - Show cause, retest, investigation, sanction - Complaint against manufacturer, its MD/QA manager, marketing company, its MD (petitioner), authorized representative - Summoning order issued - Petitioner filed petition claiming no day-to-day role, agreements place responsibility on manufacturer.

Findings of Court:
Complaint silent on petitioner's specific role; authorized representative handles day-to-day; manufacturer warranted quality, compliance - No basis for vicarious liability without averments - Quashing warranted under inherent powers.

Issues: Whether complaint/summoning order qua MD of marketing company sustainable absent specific averments of being in charge/responsible for business conduct; applicability of Section 34 vicarious liability to non-manufacturer.

Ratio Decidendi: Complaint must contain specific averments that accused was in charge of and responsible to company for conduct of business under Section 34; bald MD statement insufficient - Material (agreements, licenses, authorized rep) rules out liability, unrefutable, trial abuse.

Result: Petition allowed. Complaint and proceedings quashed/set aside qua petitioner (accused No.5); petitioner discharged.

Table of Content
1. substandard drug sample failed dual lab tests. (Para 1 , 2 , 3 , 4 , 5 , 6 , 7 , 8)
2. marketer md not responsible for manufacturing quality. (Para 9 , 10 , 11 , 12 , 13)
3. md vicariously liable as company in-charge. (Para 14 , 15)
4. s.482 crpc quashes abuse of process. (Para 16 , 17 , 18 , 19 , 20 , 21 , 22 , 23 , 24 , 25 , 26 , 27)
5. s.34 requires specific averments for vicarious liability. (Para 28 , 29 , 30 , 31 , 32 , 33 , 34)
6. no averments equals no md liability. (Para 35 , 36 , 37)
7. quash proceedings qua petitioner md. (Para 38 , 39 , 40 , 41)

JUDGMENT :

Sandeep Sharma, J.

By way of instant petition filed under S.528 Bharatiya Nagrik Suraksha Sanhita, 2023 (hereinafter, ‘BNSS’), prayer has been made on behalf of the petitioner/accused No.5, for quashing of Complaint No. 15 of 2024 titled Union of India through Inspector of Drugs, Kamla, Central Drugs Standard Control Organisation (C.D.S.C.O.) Sub Zone Baddi-HP v. M/s Crest Lifesciences Pvt. Ltd. and others as well as consequent proceedings, emanating therefrom, pending before learned Additional Chief Judicial Magistrate, Nalagarh, Himachal Pradesh. Besides above, prayer has been made on behalf of the petitioner for quashing of summoning order dated 18.1.2024 (Annexure P-26), whereby Additional Chief Judicial Magistrate, while taking cognizance of offence punishable under S.18(a)(i) & (vi) read with S.16(1)(a) punishable under S.27(d) of the Drugs and Cosmetics Act, 1940 (hereinafter, ‘Act’) issued process against the petitioner, alleging therein that M/s Crest Lifesciences Pvt. Ltd., Plot N. 127-128, EPIP, Phase-I, Jharmajri, Tehsil Baddi, District Solan (HP) is holding a licence to manufacture drugs and has manufactured drug “Oflox OZ Suspension 30 ML, Ofloxacin & Metronidazole Suspension, B. No. CLOF14014, M/D-09/21: E/D-08/23” and said drug was marketed by M/s Cipla Ltd., Cipla House, Peninsula Business Park, Ganpatrao Kadam Marg, Lower Parel, Mumbai-400013.

2. Complainant further averred that the then Drugs Inspector, Shri Arun Prashar drew sample of drug “OFLOX OZ SUSPENSION 30 ML, Ofloxacin & Metronidazole Suspension, B. No. CLOF14014, M/D-09/21: E/D-08/23” manufactured by M/s Crest Lifesciences Pvt. Ltd. and marketed by M/s Cipla Limited from finished goods store of the manufacturer during visit of manufacturing firm. As per complainant, one portion of sealed sample was sent to the Government Analyst, Regional Drugs Testing Laboratory (RDTL), Chandigarh alongwith Form-18 bearing No. NZ/BD-SZO/AP18/2021-22/2846 dated 22.9.2021, as per the Act and Rules for test and analysis. As per averments made in the complaint, Government Analyst, RDTL, Chandigarh after test and analysis, declared the sample as “Not of Standard Quality” vide test report No. LSD/RDTL/0595/21-22, dated 21.11.2021 with the remarks that the sample does not conform to the claim as per Patent & Proprietary in respect to the Assay of Ofloxacin, Metronidazole Benzoate calculated as Metronidazole. Ofloxacin was found 81.92% against the limit of 90%-110% and Metronidazole Benzoate calculated as Metronidazole was found 182.66% against the limit of 90%-110%.

3. After receipt of repot from RDTL, a notice under S.18B, 22(1) (CCA) and 25(3) of the Act was served vide letter No. NZ/BD- SZO/NSQD-AP/15/2020-21/4207 dated 1.12.2021 to furnish certified copies of documents pertaining to drug under S. 18-B and 22(1)(CCA) of the Act to M/s Crest Lifesciences Pvt. Ltd. alongwith a copy of test report. Vide afore Show Cause Notice, M/s Crest Lifesciences Pvt. Ltd. and M/s Cipla Ltd. were called upon to furnish certified copies of documents pertaining to drug, under aforesaid provision of law.

4. In response to letter dated 1.12.2021, the manufacturer i.e. M/s Crest Lifesciences Pvt. Ltd. submitted its reply that it did not agree with the results of Government Analyst and it wants re-analysis /retesting from Central Durgs Laboratory, Kolkata. Accordingly, a portion of sample was sent to Central Durgs Lab



























































































































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