High Court · 2025

Petition under Section 482 af UP'C praying that in the circumstances stated in the Memorandum of Grounds of Criminal Petition' the High Court may be pleased to CC. No' 46 ot 2023 ' on the file of 'l sr Addl Junior Civil Judge cuM rx Addl. Metroporitan Magistrate, Ranga Reddy District at Kukatpally' registered under Section 1B (a) (iv) R/w. Sl No 42 of Schedule 3 R/w Rule '106 which is punishabre under Section 27 (d) of the Drugs and cosmetics Act' 1940 and Rures 1g45 and quash the same as misconceived, iflegar, arbitrary, uniust by the Criminal Petition as prayed for ,:,. NO: 2 0F 202it Petition I nc,:- Section 4g2 of Cr.p.C praying that in th: circumstances stated in the r errnc randum of Grounds of criminar petition, the High court may be pleased to sta,z irlr further proceedings in cc. No. 46 of 2t)23,on the fire of 1st Addl. Junior (;i\ it JL dge CUM lX Addl. Metropolitan [r/lagistratr,,, Ranga Reddy District at Kukatpzrll,r pending disposal of this Criminal petitr.n. This pe1:itror (roming on for hearing, upon perusrng the l,/emorandum of Grounds of Crir,rirrirl petition and upon hearing the argurrentr; of Sri Bhanu Murthy Bara, rrdv,1631s for the petitioner and sri E. Ganer;h, r:rssistant pubric Prosecutor (T(i) orr beharf of the Respondent No.2 and none arpeared for the Respondent Nc.1 . The Court made thr: following: ORDER THE HONOURABLE SRI JUSTICE E.V.VENUGOPAL CRIMINAL PETITION No.10558 0F 2023 ORDER: This Criminal Petition is filed seeking to quash the proceedings in C.C.No.46 of 2023 on the frle of the leamed I Additional Junior Civil Judge-cum-IX Additionat Metropolitan Magistrate, Ranga Reddy District, at Kukatpally' registered under Section 18(a)(iv) r/w. Sl.No.42 of Schedule U' R/w' Rule 1O6 which is punishable under Section 27 (dl of the Drugs and Cosmetics Act, 194O (for short, "the Act") and Rules 1945'

2. Heard Mr.Bhanu Murthy Bala, learned counsel for the petitioners and Mr.E.Ganesh, learned Assistant Public Prosecutor appearing for respondent No'2-State' The brief facts of the case are that petitioner No' 1 Company 3. is the business of manufacturing of drugs and pharmaceutical products, which has WHO-GMP certification' It is stated that petitioner No.l Company is the manufacturer and supplier of the subject drug "PILE SEAL" ointment under valid License' PILE SEAL ointment is used for the treatment of the internal and external piles. Whileso, respondent No' 1 had liled a complaint 2 against the Jretitioners which was numbered as C.C.No.362g of 20 18 o n r .r e file of the learned XIX Metropolita n Magistrate, cyberabad. at Miyapur, Ranga Reddy Distrir:t. on i,tdministrative grounds, the case was transferred and re_numbered as C.C.No.46 of 2023 ,)n 1.he file of the learned IX Additional Metropolitan Magistrrrtr:, Ranga Reddy District, at Kukatpr,rlly. In the complaint. :t \^ras alleged that on Og. 10,20 15, respondent No. 1 along rvitt tvz,: rns4i.1..s went to M/s.Lakshmi pharma situated at D.Nc,.li- ,11, Shop No.5, Maljeera Roacl C:handanagar, Sheriling;arrLpally Mandal which holds the drug license in Form 2OB, 211f bea.ring License No.137/RR/ Ap/2OO4,t\tt valid upto 3 1-05-2Cr I 9 , r hat during the inspection, in the presence of mediatbrs, it "r,as found that the stock of dru51 b,v the name "pILE SEAL" Ointr-,:nt, Batch No.14O1, Manufacttrring c'rte Oa/2( 14 and expiq Czted 0Z/2016, manufactured by petrtioner No. 1 company v'ras labered as *for the treatment of ext,3rn.r & interna-r piles" in r,,{ri:h the claim "piles,, is objectionzrble claim and contravener; tlLr: Section lg(a)(vi) r/w Sl.No.42 of Scher,lule ,J, r /w. Rule 106 vr l:<:h is punishable under Sectio n 2T (,f) ol the Drugs and Cosmerir:s Act, l94O and Rules 1945.

4. Learnr:<i :cunsel for the petitioners submits that neither the test reports ,tf government analyst nor any phot,t ol the seized 3 product "Pile Seal" has been attached with the complaint whereas Section 20 of the Act clearly envisages that the appointment of Government analyst should be notified in the official gazntte of Government. He submits that, in similar circumstances, this Court vide order dated 29.ll.2OI8 in Criminat Petition No'1128 of 2018 and order dated 07.06. 2022 inCriminal Petition No. t ts+ of 2o2o quashed the proceedings against the petitioners therein. Relying on the aforesaid decisions, Iearned counsel seeks to allow :)71 the Criminal Petition.

5. karned Assistant Public Prosecutor submits that the matter requires to be tried and seeks to dismiss this Criminal Petition.

6. Undisputedly the ointment 'Pile Seal' is mentioned on the label and on the cover as 'for the treatment of external and internal piles'. Schedule U' as per RuIe 106 of the Rules in the Act, item 42 speaks of piles and fistulae' Rule 106(1) reads that no drug may purport or claim to prevent or cure or may convey to the intending user thereof any idea that it may prevent or cure' one or more of the diseases or ailments specilied in Schedule U'' Sub-rule (2) speaks that no drug may purport or claim to procure or assist to procure, or may convey to the intending user thergof 4 any idbe. lta[ it may procure or assist to procule, rniscarriage in 7 . The r o -rl issue is whether the use of th e v.,ords for the treatmerrt cl external and internal piles is covered b,,, Rule lo6(l) of the Fluk:s in the statutory violation define,l irr Section 1g clause (a)(rv). For more clarity, the relevant portion. .f the section reads ttLat iiom such date as may be fixe,l L,y the State Governmen' ry notification in the officiar Gazette irr this behalf, (notified *, e.f ,\pril, 1947) no person shall himselt or by any other person cn tr:sr behalf give any drug which b1- m,:ans of any statement cl:sign or device accompanying it or b.i, any other means, pu-l)( r1s or claims to prevent, cure or mitigirte any such disease cr ailotent, or to have any such other e,ffec L as may be prescribe I B. Clarrs,e (i,,,) of sub-section (a) of lg anc cl:tusr, (1) of Rule 106 no u'a.; used the word treatm€nt rlsnspjs -rously and undisput.dlr' I'lo*' coming to the definition of drug u;rder Section 3 clause (b) il is an inclusive dehnition, which says d:-ug includes all medic. ne s Ior internal or externa_l use ol httm an beings or animals and ir:l substances intended to be used fr:r or in the diagnosis, tr':€ tment, mitigation or preventiorL of an.. disease or 5 disorder in human beings or alimals, including preparations applied on human body for the purpose of repelling insects like mosquitoes... g. The definition of drug supra provides as an inclusive one for use of human being or animal and all substances used for or in the either diagnosis or treatment or mitigation or prevention of any disease or disorder. It, itself clarifies though not by any specific words difference between mitigation and treatment, which are different and not one and the same' From this what Section 18(a) clause (iv) r/w Rule 1O6(1) speaks is prohibition of any statement design or device accompanying it or by any other means, purports or claims either to prevent or to cure or to mitigate any such disease. Thus, once prevention, cure' mitigation and treatment are different, though the very definition of drug includes treatment, what is prohibited in the advertisement is not any statement of treatment but statement of cure or mitigation. A treatment may mitigate, may not rnitigate' may cure, may prevent some other disease being caused in future. Thereby, it is having a wider meaning arrd not confined to either cure or mitigation or prevention' In this context' if one refers to page No.4762 of P.Ramanatha Aiyar's Advanced Law kxicon, 3'a Edition, the definition of treatment, in relation to. -t"4 ) \ 6 disease, irrclrrCes anything dbne or provided fcrr a lleviating the effects oi' 'tr: disease, whether it is done or providr:d by way of cure or ro- ( io. Ha'rinl< :'egard to the submissions ol b,tth the learned counsel irrcl rr view of the above discussion, the pr.oceedings in so far as th<: ltetitioners/ accused Nos. I and 2 erre r:oncerned in C.C.No.4ri cl.2:t.O23 on the file of the learned I Addir ional Junior Civil Juclge :um-lX Additional Metropolitan M:rgis r.rate, Ranga I To, Reddy Dirstrlr)r , at Kukatpally are hereby quashecl

11. AccrrdirLl5l1,, Crimina,l Petition is allowed. Mis:e,lla-reous Petitions, pending if any, sharl strrnd closed. //TRUE COPY// SiD/- V. KAVITHA DEPU ry REGISTRAR SE(;:TION OFFICER 1 2 3 4 The lst Adrll Junior civir Judge cum rx Addr. Metroporitan M,,rgistrate, Ranga Reddy Dist.ir;t at Kukatpally One CC to Sri thanu Murthy Bala, Advocate tOpUCl Two ccs t: the Pubric prosecutor, High court for the srate ,:f rerangana at Hyderab?rd (,-rli I) (t Two CD r;ocie rs HIGH COUFIT .IATED:021t)412025 -1"--' ', - ' .; ,.'.t/ - \ l\ii //, '' i4I ORDER CRLP.No 10558 of 2023 i,'j- 't .'' \*l 2I ,lU! 2m ,.. j,r .l- ]! s( o .a' Allowing the,sriminal petition p--- (. L)' V 6