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
| 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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