Writ Petition No. 1043 of 2022 · Bombaybench High Court · 2025
Case Details
( 1 ) 42-WP-1043-2022IN THE HIGH COURT OF JUDICATURE AT BOMBAYBENCH AT AURANGABAD42 CRIMINAL WRIT PETITION NO. 1043 OF 2022Vijay Kumar Uppal S/o. Shri Dhram Chand And OthersVERSUSThe State Of Maharashtra, Through, Drug Inspector, R. M. Bajaj...Ms. Rashmi Kulkarni a/w Ms. Namita Thole h/f Mr. Sanket S. Kulkarni,Advocate for the Petitioners.Mr. S. B. Jadhav, APP for Respondent-State.CORAM:KISHORE C. SANT, J.DATE:10th JULY 2025.PC :-1.Heard the parties.2.The petitioners have approached this Court with a prayer to quashand set aside the criminal prosecution initiated against them, bearingRCC No.494/2007 pending before the learned Judicial Magistrate FirstClass, Parbhani. 3.The original accused No.3, 5 and 6 in the said complaint haveapproached this Court. The complaint is filed under Section 18(a)(i) r/w16(1)(a) and Section 34 punishable under Section 27(d) and SectionEthape ( 2 ) 42-WP-1043-202218B r/w 22(cca) punishable under Section 28-A of the Drugs andCosmetics Act, 1940 (hereinafter referred to as “the said Act”.)4.The complaint is filed on 23rd August 2007. Material, events anddates are as follows:- the Inspector appointed under the said Act seized a drugs samplenamely, “GENTOSON” Gentamicin Eye/Ear Drops, on 2nd January 2006.The expiry date of the said medicine was October 2007. After theseizure, sample was sent for analysis on 4th January 2006, and the reportwas received from the lab on 16th June 2006. On receiving the report,the sanction was sought from the Commissioner. The Commissionergranted sanctioned on 7th July 2006. It is thereafter the complaint cameto be lodged on 23rd August 2007 by complainant i.e. Inspectorappointed under Section 21 of the Drugs and Cosmetics Act. 5.The learned JMFC, by order dated 4th February 2015, directlyissued a proclamation. By order dated 5th November 2019, he also issuedNon-bailable Warrant to the accused Nos. 1 and 2. He observed thataccused No.3 to 6 were also absent and proceeded further. Ethape
Facts
( 3 ) 42-WP-1043-20226.The petitioners have, therefor, approached this Court mainly ontwo grounds: firstly, that the expiry of the drugs was October 2007 andthey could not get an opportunity under Rule 45 of the said Act andRules, which mandatorily requires that the accused be given anopportunity to re-analyze the sample. Section 25(3) read with Rule 45requires the analysis to be done within 60 days from the date of reportfrom Government analyst. In the present case, the report was receivedlong before the date of filing of complaint itself i.e. on 16th June 2006.By the time, the complaint was presented, the period of 60 days hadalready over. The second ground is that the complaint was lodged by oneR. M. Bajaj. From the document annexed to the complaint showingauthorization, it is seen that Mr. R. M. Bajaj was appointed as anauthorized person for District of Osmanabad, whereas the complaint waslodged in the Court at Parbhani. For Parbhani district, another Inspectorwas authorized to lodge a complaint. The ground is thus raised that theperson who filed a complaint was not duly authorized by theGovernment. Ethape ( 4 ) 42-WP-1043-20227.The learned Advocate for the petitioner strenuously submits thatcontinuation of the proceeding on the above ground would be totally indefiance of the principles of natural justice and fair play. It would also beagainst the mandatory requirement under Rule 45 and Section 25(3) ofthe said Act and Rule. He, therefore, prays that petition be allowed byquashing and setting aside the proceeding. 8.The learned APP, on the basis of affidavit-in-reply filed by theState, submits that in the present case, there is a legal presumptioncreated under Section 25 of the Drugs and Cosmetics Act. The reportreceived under Section 25(1) is conclusive evidence. There is nostatutory intimation by the accused of intention showing disagreementwith the report of Government analyst. By relying on Sections 18 and16, he submits that, the drug was found not to be conforming to thestandard quality. No drug can be manufactured which is not of standardquality or is misbranded, adulterated, or spurious. In the present case,drug was found not to be of standard quality. The report of the testshows that the tests for sterility of droppers and the sample do notEthape ( 5 ) 42-WP-1043-2022comply with IP 96 requirement for “Tests for sterility of droppers”. Theobservation in the report shows that there is evidence of growth in thetubes inoculated for sterility test as per IP 96 method when tested on tendroppers. Microscopic examination shows presence of gram positivebacilli in both the media tubes. There is clear report showing that thesample does not comply with IP 96 requirements for “PH” and thus itwas concluded that sample was not of standard quality. 9.The learned APP thus submits that the report of the lab itselfassumes character of a conclusive evidence. The prosecution must get anopportunity to prove the offence. He thus prays for rejection of the writpetition.10.During the course of argument, the learned Advocate for thepetitioner relied upon the judgment in the case of Lalankumar Singhand Ors. Vs. State of Maharashtra1. Paragraph No.36 of the saidjudgment reads as under:“36. Perusal of the order passed by the learned Single Judge of the HighCourt would itself reveal that the learned CJM has not even cared to passa formal order of issuance of process. It will be relevant to refer to the12022 SCC OnLIne SC 1383Ethape ( 6 ) 42-WP-1043-2022following part of the judgment and order of the learned Single Judge ofthe High Court: “….Though, it is true that on the certified copy produced by thepetitioners there is no such formal order but copy of Roznama (dailynotings of the proceeding) shows that such order was made on30.03.2009. The Roznama dated 30.03.2009 reads as follows : (i) Complaint filed by Vilas Vishwanath Dusane. (ii) Copy of list of documents containing 44 document. Order was made on Exhibit 1 (of issue process). Take entry in registerof criminal cases and issue summons against accused. List the matter forappearance of accused on 18.06.2009. This record is sufficient to infer that the order of issue process wasmade and after that summons were issued against accused to ask themto appear in the Court.” 11.Learned Advocate for the petitioners further relied on thejudgment of this Court in the case of M/s. Quixotic Healthcare and Ors.Vs. The State of Maharashtra and Anr.2. Paragraph Nos. 9 and 10 of thesaid judgment reads as under:“9.Turning towards the main point that has been agitated on behalf ofthe petitioners, it is to be noted that the complainant had visited MahaveerStores to draw samples on 17-11-2019. He sent the sample for analysis on18-11-2009. The report was received on 02-02-2010 after the laboratoryhad conducted the test on 27-01-2020. This testing of the sample is beyondthe statutory period prescribed under Rule 45 (supra). When the samplewas tested after the expiry period, the the result is bond to be 'not ofstandard quality'. There is no explanation by the Laboratory about thedelayed testing. Such report can not be considered at all. Benefit of suchlapse on the part of the Laboratory should go to accused. Further, as per the22020 ALL MR (Cri.) 1880Ethape
Legal Reasoning
( 7 ) 42-WP-1043-2022complainant himself, he had made various communications on 02-02-2010including the letter sent to the present petitioners. It is not in dispute thatthe accused No.1 gave letter dated 15-02-2010, in which, it has beenspecifically stated that they are not agreeing with the report and would liketo have rechecking. They might have not given it in the form prescribed oralong with the fees that was required to be paid, but that cannot be theground to refuse. There was no question of limitation as the said right andintention to get the sample rechecked was exercised within limitation i.e.within 28 days from the knowledge of the report. Therefore, the ratio laiddown in GlaxoSmithKline Pharmaceuticals Ltd. [2011 ALL MR (Cri) 2889(SC)] cannot be made applicable as the facts differ. Another point to benoted is that when the complainant had knowledge that the accused wantto dispute the report and the wordings given in paragraph No.6 in theaffidavit-in-reply filed on behalf of respondent No.3 were very much clearabout the said intention, then the complainant ought to have taken steps.Surprisingly, since he says that when he had visited the factory of accusedNo.1 personally, he had handed over one sealed counter part of the sample.He has not produced any acknowledgment regarding handing over of thesample to accused No.1 and under which provisions of law, he had donethat act has also not been explained by him. Surprising part to be noted isthat even before the accused had received notice dated 02-02-2010; thesanction to prosecution was granted by the competent authority on 15-02-2010. In fact, on that day, the petitioner had received the notice dated 02-02-2010. 10.The most important point to be noted is that since beginning, thecomplainant had the knowledge that the shelf life of the drug, of which thesample has been taken, would expire on 31-08-2010. When he had receivedthe report on 02-02-2010 and got the knowledge that the accused want toget the sample rechecked as expressed in their letter dated 02-03-2010, soalso, the sanction for prosecution was taken on 15-02-2010 itself, then whyhe was required to wait till 30-08-2010 to lodge the report is a question andthe entire contents of the complaint are silent on this point. The learnedMagistrate totally erred in passing the order of issuance of process as he didnot consider that on the next day of the presentation of complaint, the drugwas to expire. Even after the order of issuance of process has been passedon the same day of the presentation of complaint i.e. 30-08-2010, thesummons would not have been served immediately. Learned Magistratefailed to consider that testing of the sample was not done with themandatory period by the Laboratory. There is total non application of mindby the learned Magistrate while passing the impugned order. Therefore,definitely, the observations by this Court in Parenteral Drugs (India) Ltd.(Supra) are applicable here. Further the ratio in M. Sea Pharmaceutical Pvt.Ltd. (Supra) and M.S. Medicamen Biotech Ltd. (Supra) are also applicable.Ethape ( 8 ) 42-WP-1043-2022When the vital right of the accused to get the sample rechecked underSection 25(3) and 25(4) of the Drugs and Cosmetics Act, 1940 have beenviolated because of belated filing of the complaint, then this is a fit casewhere the constitutional powers of this Court under Article 27 of theConstitution of India should be exercised. 12.This Court has heard the arguments and gone through the recordavailable with the petition and the judgments cited. In the present case,it is seen that no formal order of issuance of process was passed. Only asummons was issued on 14th August 2013, and prior to that NBW wasissued against accused No.1 as he was absent on 21st April 2012.Subsequently, the proclamation was directed to be issued on 4th February2015. This Court finds that the Hon'ble Apex Court in the case ofLalankumar Singh Vs. State of Maharashtra (supra) has dealt with thisaspect and that appeal was allowed. The order of issuance of processwas quashed and set aside. In the case of M/s. Quixotic Healthcare(supra), this Court considered Rule 45 of the Drugs and Cosmetics Rule,and it was observed that testing of the sample has to be done within 60days. In that case, the testing was found to be beyond statutory periodprescribed under Rule 45. The sample was tested after 60 days, whichnaturally showed it to be not of standard quality. In that view, this CourtEthape
Decision
( 9 ) 42-WP-1043-2022quashed and set aside the proceeding. The Court noted the dates andobserved that when the complainant had knowledge about the standardsof the drugs, he still filed the complaint. Looking to the dates, it wasobserved that the accused could not get an opportunity to get the samplere-tested or re-analysed. In the present case also, this Court is convincedthat when the report was received on 16th June 2006, the complaint wasfiled on 23rd August 2007, which is clearly after 60 days, and no timecould be given to the accused to get the sample re-tested or re-analysed.Even the order of proclamation itself was issued without a proper orderof issuance of process in the year 2015. 13.Considering all above, this Court is convinced that the proceedingof the complaint would clearly be an abuse of process of law. Writpetition is, therefore, allowed in terms of prayer clause (A). Petitionstands disposed off. [KISHORE C. SANT, J.]Ethape