The High Court · 2025

Petition under section 528 of BNSS praying that in the circumstances stated in the Memorandum of Grounds of criminal Petition, the High court may be pleased to stay all further proceedings including appearance of the petitioner in c.c. No.04 0f 2023 0n the file of the court of I Additional District and sessions Judge at Khammam pending the criminal Petition before this court in the interest of justice. This Petition coming on for hearing, upon perusing the Memorandum of Grounds of criminal Petition and upon hearing the arguments of sri Banala Suresh, Advocate for the Petitioner and the'Sri E.Ganesh, Assistant Public Prosecutor on behalf of the Respondent. The Court made the following: ORDER THE HONOURABLE SRI JUSTICE E.V.VENUGOPAL CRIMINAL PETITION No.5126 of 2025 ORDER: The present criminal petition is hled under Sectton 528 of BNSS, seeking to quash the proceedings in C.C.No.4 of 2023 on the fi1e of the learned I Additional District and Sessions Judge at Khammam (for short, 'the trial Court).

2. The petitioners herein are the accused Nos.1 and 3 arrd the respondent herein is the complainant before the trial Court. For the sake of convenience hereinafter parties are referred to as accused Nos.l and 3 and the complainant.

3. The brief facts of the case are that on 25.09.20 13. LW. t visited the shop of LW.2 by name M/s. Sharada Medicals, trpon verification LW- I identilied Doxyla-86 tablets, B.No.DBM- i 206 manufactured by M/s. Maneesh Healthcare, are not of standard quality, hence, LW. I picked up said batch tablets for the pr,trpose of analysis. On the same day, he sent it to the Government Analyst, Drugs Control Laboratory, Vengalrao Nagar, Ilyderabad along with Memorandum in Form-18, as per the provision and procedure lard under Drugs and Cosmetics Acr, 1940. On

11.10.2013, LW.1 received the report. The Government Analyst ) declared Doxyla-B6 tablets B.No.DBM- 12O6 are of not standard \ quality. Immediately, LW. 1 served copy of the report to M/s. Sharada Medicals, with instruction to drsclose the source of supply and produce the registers and records of said drug. M/s. Sharada Medicals replied to the report stating that they have pruchased the said drug from M/s. Lakshmi Sai Balaji Medicals, Vijayawada LW.1 served notice to M/s. Lakshmi Sai Balaji Medicals. M/s. Lakshmi Sai Balaji Medicals replied that they have purchased the said drug lrom M / s. Marnatha Medicalas Agencies, Vrjayawada. . Medicals to disclose the supply of the said clrug. On 18.10.2013 LW.1 served notice to M/s. Mamatha LW.1 received reply from M/s. Mamatha Medical stating that the said drug was purchased from M/s. Vasu Pharma Distributors, Gandhi Nagar, Hyderabad. LW.1 issued notice to M/s. Vasu Pharma Distributors to disclose the source of supply of the said drug and further instructed not to sell the said drug since it is declared as "Not of Standard Quality". M / s. Vasu Pharma Distributors sent a reply to LW.1 stating that the said drug was purchased from M/s. Maneesh Pharmaceuticals, Mumbai. LW.1 sent notice to M/s. Maneesh Pharmaceuticals to disclose the source of supply of the said drug. M/s. Maneesh Pharmaceuticals replied to the notice sent by LW. 1 stating that the said drug was manufactured by their plant at Himachal Pradesh. LW. 1 serrred notice to M/s. Maneesh Pharmaceuticals, Himachal Praclesh with an instruction to confirm the manufacture of the sard drug and produce information regarding the manufacturing records and distribution particulars, and also instructed to produce the attested copies of Drug Licenses, name and address of the responsible person of the firm. But no reply has been received Thereafter, LW. I addressed a letter to the Public Information Officer-cum-State Drugs Controller, Baddi-1732O5, Solan District, Himachal Pradesh with additional required fee thror-rgh IPO zrnd requested to provide information. On 02.O4.2014, LW. I received reply from Public Information Officer-cum-State Drugs Controller provided attested copies of Drugs manufacturing licenses ol M/s. Maneesh Pharmaceuticals and memorandum and a rticles of association. M / s. Maneesh Pharmaceuticals are manufactuing drugs of not standard quality and also not replied to the notice issued to it. Hence the complaint.

4. Basing on the above contents, case has been registered against the M/s. Maneesh Pharmaceuticals/ accusecl No.1 nnd its directors, under Sections 18(a)(i), r/w Section t6 zrnd l8-8, \'- 4 22(l)(ccal Drugs and Cosmetics Act, 1940 punishable under \ Section 27 (dl, 28(al and 22(31 of Drugs and Cosmetics Act, 1940.

5. Heard learned counsel appearing for petitioners / acc used Nos.l and 3 and learned Assistant Public Prosecutor appearing for the respondent- S tate. Perused the record

6. Learned counsel appearing for the petitioners would submit that the drug Doxyla 86 tablet is popular drug and of a standard quality, the respondent collected the drug; and before scnding it for test, decided that it is not of standard quaiity. G.O-Ms-No.98, dated O6.09.201 1 is for constitution of Special Court lor Lrial of offences related to adulterated drugs or spurious drugs. The said drug is not an adulterated drug or spurious drug, and is not liable for the punishment under the Act. He further submitted that the testing lab issued a vague test report without proper reason as to why the drug is not of standard quality as the Drugs and Cosmetics Act, 194O without any mention of the standard parameter.

7. Learned counsel further submitted that accused No.2 who is the father of petitioner No.2 herein was managing the affairs of 7 ) the company, during the penclency of the case, accused No.2 died, and the same was informecl to the trial Court, and the case against him was abated.

8. To support his case, learned counsel relied upon the judgment of High Court of Maharasthra, in the czrse of State of Maharashtra us. Ja usaharto't Sha,mlal ltja uanet. The relevant portion of the jtrdgment reads as under: "5. Rule 46 prouides, in so far as is mateial for this judgment, that on rbcelpt of a package from an Inspector containincl a sample for test or analysis, the Goternment Analgst shall forthuith supply to the Inspector a report ol the resutt of the test or analysis, together tuith full protocols of the te-sls or analg-si.s applied. It ucts the gieuance of Mr. Manohar that the prouisjons o_,f Rules 57 and 46 haue been breached in lhis case, ulith the resuLt that the order of conuiction and sentence passecl by the tearneri Magistrate, should be set aside ancl the respondent shouLd be acquittecl.

7. Coming to the requirements of Rule 46, on 26th Mag 1971, the Gouernment Analgst gaue his certif.cate, stating th..t the sample uas not of standctrd qualitg as defined in the Act, that the sample utcts not "Santontne", and that the sample gaue I.p. Qualitatiue tests for the presence of magnesium and. sulphate. The report of the Couernment Analyst reads as uncler.. "Details of the results of Test or Analysis tuith protocols of Tests applied. Proper Name Santonine Obse r uatio n of labellinq I 1t,;zoy utr.l. I \- 6 Outer label Santonine India (Hond wntten) container label Santonine, Indn Descnption lclenttJication W hite Cry sta lline p oude r The sample does not complA utith 1.P. identtlicational tests for Santonine. The sample giues qualitotiue tests for Magnesium and Sulphate. "NoLu, tt is not in dispute thot it is not knolDn what the "protocols of tests applied" utere. The report is silent on this point, and so is the record. In uiew of the prouisions of rule 46 ultich are mandatory, the Gouernitent Analgst u..t,'s bound to furnish to the Inspector the full protocols of the tests opplied. Admittedla, this has not been done: This tacuna, in our opinion u,tas a fatol hurdle in the path of the prosecution.

8. The Analgst hos not giuen euidence, nor is there anything on record to indicote uhat test uas applied to reueal the alleged presence of Maglnesium and Sulphate. If the prosecution hod led the euiclence of the Anatyst, he could haue been cross examined and the prosecution case could houe been tested on this point also. This utas a lacuna which must militate against the prosecution.

9. Rules 57(1) and (2) and 46, tuith uthich ute are concerned, are mandatorg. It is, therefore, imperatiue that theg must be stictlg obserued. It must also be manifest from the record thot theg haue been so obserued to the letter and not onlg in substance or spiit. These rules are framed os a measure of secuitA and safeguard not onlA to an accused but also to the officers oJ the deportment. Their obseruance must not, in the interest of justtce, be left to conjeciure or inference. A stict obseruance of these ntLes can also enable the prosecution to proue its case, uhich in this cose, on the aspect of the dntg not being of standard qualitg, it has failecl to do begond reasonable doubt, the benefit u.thereof must go to the respond,ent. l lO. In the result, tue uphold Mr. Manohar,s first contention and held that the conuiction of the respondent accused unrler section 18 la) (i), nomelU stocking of a drug t,ttich is not of standard Enlity, cannot be .sustained.

9. I{igh Court of Andhra pradesh in Chekka Venkata Chenna Kesaua Sudheer Vs. Drugs Inspector (Agurueda), Andhra Region, Indian Med.icines and. Homeopathg Department, Secunderabad. and another2, wherein it was held that in the absence of any averment in the complaint to the effect that the accused person was in charge of and responsible for the conduct of busrness of company, the proceedings initiated against him are liable to be quashed. He further relied upon the decisions passed by the Apex Court in Suntta palita & Others Vs. M/s poLnchami Stone Quarry3, Dagle De, Souza Vs. Gouernment of Ind.ia through Deputg Chief l,abour Commissioner (C) and olnothert, Sibg Thomas Vs. M/s. Somang Ceramics Limited s and_ Ashok Sheutqkramoni and Others Vs. State of Andhra pradesh and. another6 and sought to allow the criminal petition. 2 2oo8 rt rnLo 1crl.) l7 (A?) ' Arising our of Sl.p {( r l ) N,, lolr)h ol l0lq ' Arising our of Sper ral I (c\ e l,etrtion (Crl. ) No lq I I nf l0 j0 '@Special Leave Pcritioll (Crl.) N,,.ll of] l0 " (2023) tl Suprenrc (',,un Ca:(\ JrJ \- \ 8

10. Per contra, the learned Assistant public prosecutor vehemently contended that petitioner No.2 being the director of petitioner No.1-Company, is equally responsible for the business of the company. All the grounds as have been raised by the petitioners in this petition can very well be raised by them before the trial Court itself but they have approached this Court in exercise of power under 528 of BNSS. The allegations against the petitioner No. 1-Company and petitioner No.2-Director of preparing sub standard medicines are serious in nature and it is dangerous for human consumption, hence they cannot be absolved of their criminal liability under the provision of the Drugs and Cosmetics Act, i940. It is hence submitted that the petition deserves to be dismissed. I 1. In vrew of the aforesaid submissions, and on careful perusal of the judgments placed on record, there are no specific allegations as against the petitioners, except stating that petitoner No.l is the company and petitioner No.2 is the Director of the company. The averments as alleged in the complaint do not disclose that the report has not been sent to the manufacturer, but to M/s. Sharada Medicals, where the sample has been collected. The said M/s. Sharada Medicals has been arrayed as () one of the witnesses to speak against the petitioners. It is impermissible, that itserf is sufficient to infer that the prosecution failed to trial the offences under Sections lg(a)(i), r/rv Section i6 and 1B-8, 22(I)(ccal Drugs and Cosmetics Act, 1940 punishable under Section 27 (d), 28(a) and 22131 of Drugs and Cosmetics Act, 1940. Except being the company and the director, no other cogent or corroborative evidence is available on record to show that the petitioners have involved in the manufacture of sub- standard quality of alleged drug. Therefore, this Court is inclined to quash the proceedings against the petltioners in C.C.No.4 of 2023

12. Accordingly, the Criminal petition is allowed Pending miscellaneous applications, if an1,, shall stand closed. //TRUE COPYII Sd/. V. KAVITHA DEPUTY REGISTRAR To, '1. The First Additional Judiciat First Class Magistrate at Khammam. 2. Two CCs to the pubtic prosecutor, H,gh a;"r;fii"tn" Strt" of Tetangana at 9. 9n" CC to Sri Banala Suresh, Advocate tOpUCl 4. Two CD Copies Hyderabad [OUTI J. _ <:J- .>.\ SECTION OFFICER ry- NVB/kam HIGH COURT DATED:2610612025 o( \ -+ H1 feS 1B JUr 206 a * r.,F-L-. ORDER GRLP.No.5126 ot 2025 ALLOWING THE CRIMINAL PETTTION { t( r {