High High Court
Case Details
IN THE HIGH HIGH COURT OF ORISSA AT CUTTAC TTACK CRLMC No. 3280 of 2017 Naveen Bhatia & tia & Others …. Petitioners Mr. M.K. Mishra, Sr. Sr. Advocate -versus- State of Odisha a ha and another. …. Opp. Parties Op Mrs. S. Moh . Mohanty, ASC CORAM: THE HON’BLE BLE MR. JUSTICE CHITTARANJAN D JAN DASH Date of Judgment: 30.07.2025 Chittaranjan Dash, 1. By means ash, J. eans of this application, the Petitioners see rs seek to invoke the inherent powe t powers of this Court for quashing the p the proceedings initiated against th inst them in connection with 2(C) CC Cas C Case No.55 of 2012 pending befo g before the learned S.D.J.M., Sonepur, for r, for the alleged commission of of of offences under Section 27(d) of the f the Drugs and ct, 1940. Cosmetics Act, 19 2. The backg background facts of the case are that that the Drugs Inspector, Subarn ubarnapur Range, Subarnapur, lodged a ged a complaint alleging that on 22 t on 22.08.2007, he collected a statutory sam ory sample of the drug “Vigizyme L yme Liquid,” Batch No. VVZ/01, M/D: 0 /D: 06/07, E/D: 08/2008, manufac anufactured by M/s Three B Health Care Care Ltd., Opp. Dental College, R ege, Rampur Road, Paonta Sahib (H.P.) from .) from the sales premises of M/s N M/s New Life Medical Store, At/Po-Ullun Ullunda, District Subarnapur, throug
Legal Reasoning
through Sri Lalit Kumar Sahu, the then Drug n Drug Inspector, CRLMC No. 3280 of 0 of 2017 Page 1 of 8 Bolangir Range, v nge, vide Form-17, for the purpose of test an test and analysis. One sealed portion portion of the drug sample (1 × 200 ml) was l) was sent to the Government Analy t Analyst, State Drug Testing and Research earch Laboratory (SDTRI), Bhuban hubaneswar, vide Form-18 of the Drug Drug Inspector, Bolangir, against gainst memorandum No.1586 dated 23.08 23.08.2007. The Government Ana t Analyst declared the above drug as as “NOT OF STANDARD QUA 3. As per No D QUALITY” vide Form-13 of the test repor t report. er Notification No.19110 dated 29.07.2009 7.2009 issued by the Government of ent of Orissa, Health and Family Welfare D lfare Department, the Inspector took r took charge of the newly created Office of fice of the Drugs Inspector, Subarn ubarnapur Range, on 01.10.2009 along w ong with related documents. The p The portion of the drug sample as requ s required under Section 23(4)(iii) 4)(iii) and a copy of the test report in F t in Form-13 as required under Sec er Section 25(2) of the Drugs and Cosmetics smetics Act, 1940 were sent to the m the manufacturer, M/s Three B Health C alth Care, Paonta Sahib, Himachal P chal Pradesh, by registered post with A.D., A.D., vide Drugs Inspector, Bolangi olangir Letter No.933 dated 26.07.2008. In 008. In response, the manufacturer f 4. During inv turer furnished a reply vide its letter dated 22 ted 22.08.2008. ng investigation, M/s New Life Medical Stor al Store, Ullunda, was directed, vide , vide Drugs Inspector, Bolangir Letter No ter No.935 dated 26.07.2008, to disc to disclose the source of acquisition of the sa f the said drug. In response, the firm e firm produced a self-certified copy o opy of purchase Invoice No.364 d .364 dated 25.06.2007 of M/s Archana E hana Enterprises, Rugudipada, Distr , District Bolangir. Subsequently, vide Drugs Drugs Inspector, Bolangir Letter etter No.1062 dated 14.08.2008, M/s , M/s Archana Enterprises was als was also directed to disclose the source of ac of acquisition of the said drug. In re . In response, the firm furnished a self-certif certified copy of purchase Invoice N oice No.797 dated 03.07.2007 of M/s Vision Vision Medilink, CRLMC No. 3280 of 0 of 2017 Page 2 of 8 Ahmedabad. On f . On further inquiry, vide Drugs Inspecto spector, Bolangir Letter No.509 date 9 dated 22.04.2009, M/s Vision Medilink, A link, Ahmedabad, was also asked to d ed to disclose the source of acquisition of the of the said drug. In response, the fir the firm furnished a reply dated 08.05.2009, .2009, along with a self-attested cop d copy of its drug license and the purchase rchase invoice of M/s Three B Healt Health Care, Paonta Sahib. The Drugs Drugs Controller, Orissa, vide Letter No.3 r No.3255 dated 07.04.2009, instru tructed to establish the supply link b link between the manufacturer and r and the wholesaler and accordingly sub ly submit a draft prosecution repor report for approval. For further investi nvestigation and effective drug rec ug recall, the Drugs Inspector, Cuttack-1 R 1 Range, was directed to assist st vide Letter No.809 dated 24.07.20 .07.2009, and in response, a report report was furnished vide her letter dated 2 ated 28.08.2009. Vide Office Letter Letter No.954 dated 05.10.2010, M/s Thre s Three B Health Care, Himachal P chal Pradesh, was directed to furnish the h the Articles of Association and Memorandum of its Board of Direc Directors under intimation to the D o the Drugs Controller, Himachal Pradesh, v desh, vide Memo No.956 dated 05 ed 05.10.2010. In response, the Drugs Drugs Licensing Authority, Himach imachal Pradesh, furnished the said docu documents vide Letter No.HFW-H 1.2011. H(Drugs) 231/06-3405 dated 07.01.2011 On comple ompletion of the investigation, it was revea revealed that the manufacturer, M/s r, M/s Three B Health Care, represented by i ed by its Board of Directors, had m ad manufactured and sold the substanda standard drug in violation of Sectio Section 18(a)(i) of the Drugs and Cosmetic smetics Act. M/s Vision Medilink, dilink, represented by its proprietor S tor Sri Subash Shivkumar Lohia, Lohia, had stocked and sold the said dru id drug, also in violation of Secti Section 18(a)(i) of the Act, making them them liable for punishment under under Section 27 thereof. Similarly, the distr e distributor, M/s CRLMC No. 3280 of 0 of 2017 Page 3 of 8 Archana Enterpris terprises, represented by its partners Sri Pram ri Pramod Kumar Mishra and Sri An Sri Anil Kumar Nanda, and the retailer, M/ er, M/s New Life Medical Store, re ore, represented by its proprietor Smt. Smt. Chandrama Bastia, were foun e found to have violated Section 18(a)(i) o (a)(i) of the Act, punishable under S nder Section 27(d). Accordingly, the prosecu rosecution report was approved by ed by the Drugs Controller, Orissa, Bhuban hubaneswar, and the complaint was nt was filed, which was registered as 2(C s 2(C) CC Case No.55 of 2012 on 0 12 on 02.04.2012. 5. The learned Court, having learn taken cognizan gnizance, issued summons to the the accused persons vide order dated 0 ated 02.04.2012, directing their a eir appearance on 19.06.2012. Aggrieve ggrieved by the issuance of the sai the said summons, the Petitioners have appr e approached this Court seeking quas g quashing of the aforesaid proceedings. 6. Mr. Manoj Manoj Mishra, learned Senior Advocate ap ate appearing on behalf of the Pet he Petitioners, submitted that the entire p ntire prosecution lodged against the nst the Petitioners for the alleged violation lation of Section 18(a)(i) of the Dr he Drugs and Cosmetics Act, making them them liable for punishment under under Section 27(d), is not maintainable, in ble, inasmuch as the prosecution rep ion report submitted by the Drug Inspector s ector suffers from inherent infirmitie irmities. It is contended that the statutory r tory right of the Petitioners to exer o exercise their defence in accordance with l with law has not been afforded, th ed, thereby rendering the entire prosecutio secution void ab initio. Elaborating rating on his submissions, Mr. Mishra con ra contended that the complaint its int itself reveals that the sample was was drawn on 22.08.2007. In ter In terms of the provisions under Sections ctions 25(3) and 25(4) of the Drug Drugs and Cosmetics Act, it is incumben umbent upon the authority to afford afford the Petitioners an opportunity to ex to exercise their CRLMC No. 3280 of 0 of 2017 Page 4 of 8 right to challenge llenge the report of the State Laboratory by tory by seeking a reference of the sa the sample to the Central Drugs Laboratory f atory for testing. 7. In the pre he present case, although the sample was e was drawn on 22.08.2007 and t and tested by the State Laboratory, the , the result was communicated to ed to the Petitioners’ company only vide l vide letter dated 26.07.2008, receiv received on 05.08.2008. The Petitioners, w ners, without any delay, replied to t d to the authority on 22.08.2008, challengi llenging the said report within the st the statutory period of twenty-eight days. 8. The statut statutory right to challenge the report of ort of the State Laboratory is em is embodied under Section 25(3) of the f the Drugs and Cosmetics Act, 19 ct, 1940, which provides: 25(3) Any by a Gove evidence o shall be co sample wa and other p 18A] has, copy of the the Court b the sample evidence in Any document purporting to be a report Government Analyst under this Chapter sh ence of the facts stated therein, and such ev be conclusive unless the person from who le was taken [or the person whose name, a other particulars have been disclosed under S ] has, within twenty-eight days of the receip of the report, notified in writing the Inspec ourt before which any proceedings in resp sample are pending that he intends to a ence in controversion of the report.” eport signed pter shall be ch evidence whom the me, address nder Section receipt of a Inspector or in respect of s to adduce Section 25(4) furth ) further mandates: in controversion 25(4) Unle analysed i person has of adduc Governmen own motio the compla drug [or c under sub or analysis the test or Unless the sample has already been tes ysed in the Central Drugs Laboratory, wh on has under sub-section (3) notified his int adducing evidence ernment Analyst’s report, the Court may, motion or in its discretion at the request eit omplainant or the accused, cause the sample [or cosmetic] produced before the Mag r sub-section (4) of Section 23 to be sent f nalysis to the said Laboratory, which shall est or analysis and report in writing signed en tested or ry, where a his intention sion of a may, of its est either of ample of the Magistrate sent for test shall make igned by, or CRLMC No. 3280 of 0 of 2017 Page 5 of 8 under the Drugs Lab evidence o r the authority of, the Director of the C s Laboratory, and such report shall be conc ence of the facts stated therein. the Central e conclusive 9. Furthermo hermore, although the Petitioners invoked invo their statutory right with ht within twenty-eight days, the shelf life of life of the sample expired on 31.08.2 1.08.2008, rendering it impossible to send t send the drug for re-analysis to the C o the Central Laboratory as contemplated un ted under Section 25(4). It is eviden evident from the record that the intimation ation of the test result was withhe withheld almost till the expiry of the dru he drug, thereby frustrating the v the valuable statutory right of the Pet e Petitioners to challenge the State e State Analyst’s report. It is further signific ignificant that the complaint itself w self was lodged nearly five years after the er the test result. Had the complaint plaint been filed promptly, the Court could h could have, either suo motu or at the at the instance of the Petitioners, exercised ercised its power under Section 25(4 n 25(4) to send the sample for re-testing. Th ng. The failure of the Drug Inspector Inspe th to act diligently, both in promptly in communicating th ing the test result and in initiating procee proceedings, has caused serious pre us prejudice to the Petitioners’ right of defen defence. 10. For compl completeness, Section 34 of the Drugs and s and Cosmetics Act, dealing with with offences by companies, provides that s that only those persons who were were in charge of and responsible for the or the conduct of the company’s bu y’s business at the time of commission of on of the offence shall be deemed g med guilty, unless they establish that the o t the offence was committed withou without their knowledge or despite due e due diligence exercised by them y them. In essence, the delay in communi mmunication and initiation of prose prosecution, coupled with the expiry of ry of the sample before the Petitio Petitioners could exercise their statutory r tory right of re- analysis, vitiates th iates the very foundation of the prosecution a ution and renders the proceeding ab ng ab initio unsustainable. CRLMC No. 3280 of 0 of 2017 Page 6 of 8 11. Keeping in ping in view the legal position as discusse scussed above, it was incumbent up ent upon the authority under the Drugs and gs and Cosmetics Act to afford suff d sufficient opportunity to the Petitioners t s to have the drug tested by the by the Central Laboratory upon their challe challenge to the report of the State State Laboratory, as mandated under law. C law. Compliance with this statutory atutory safeguard is a pre-condition before before attributing any liability to the to the Petitioners regarding the standard o dard of the drug. The absence of s e of such re-testing through the Central ntral Laboratory renders the compl complaint itself incomplete and the very i very initiation of prosecution unsust unsustainable. 12. The record record reveals that, though the sample was le was drawn on 22.08.2007, the the test result of the State Labor Laboratory was communicated to ed to the Petitioners only vide letter dated 2 dated 26.07.2008, received on 05.08 05.08.2008. The Petitioners promptly exer y exercised their statutory right and ht and challenged the said result within tw thin twenty-eight days, as required uired by law. However, the drug sample, hav le, having expired on 31.08.2008, co 08, could not be referred for re-testing/anal g/analysis by the Central Laboratory oratory under Section 25(4) of the Act. Co ct. Consequently, the authority fai ty failed to comply with a mandatory datory statutory requirement befo before launching the prosecution. 13. This Court Court cannot blink aside from the irregular regularities in the functioning of th of the authorities, who, despite handling andling a matter directly affecting cting public health and safety, failed to d to ensure due compliance with s with statutory provisions. Such inaction refle n reflects serious lapses in the disch discharge of official duties. This matter des ter deserves to be brought to the not he notice of the authorities at the helm for m for appropriate departmental actio onsible. l action against any officer found responsible CRLMC No. 3280 of 0 of 2017 Page 7 of 8 14. Coming to ing to the case at hand, as the authority thority failed to comply with the th the mandatory provisions before inst e instituting the prosecution, no cri no criminal liability can be ascribed to the to the Petitioners, and continuation o ation of the proceedings would amount to a nt to an abuse of of law. the process of law. 15. In view of iew of the discussions made hereinabove, th ove, this Court is of the considered dered opinion that the prosecution initiated itiated against the Petitioners suffers suffers from inherent infirmities and non non-compliance with the mandato ndatory provisions of the Drugs and Cosm Cosmetics Act, 1940. The belated elated communication of the test report and rt and consequent denial of the Petit e Petitioners’ statutory right to seek re-testi testing through the Central Labora aboratory vitiate the entire proceedings. 16. According ordingly, the CRLMC is allowed. The pro he proceeding in 2(C) CC Case No. se No.55 of 2012 pending before the learne learned S.D.J.M., Sonepur, as agains against the present Petitioners, is hereby qua y quashed. Bijay (Chittaranjan Da n Dash) Judge Signature Not Verified Digitally Signed Signed by: BIJAY KETAN SAHOO Reason: Authentication Location: HIGH COURT OF ORISSA Date: 31-Jul-2025 17:18:35 CRLMC No. 3280 of 0 of 2017 Page 8 of 8