{"id":204425,"date":"1995-11-08T00:00:00","date_gmt":"1995-11-07T18:30:00","guid":{"rendered":"https:\/\/www.legalindia.com\/judgments\/dr-miss-aletta-grace-bell-vs-dr-miss-s-tirkey-and-anr-on-8-november-1995"},"modified":"2015-03-12T07:26:01","modified_gmt":"2015-03-12T01:56:01","slug":"dr-miss-aletta-grace-bell-vs-dr-miss-s-tirkey-and-anr-on-8-november-1995","status":"publish","type":"post","link":"https:\/\/www.legalindia.com\/judgments\/dr-miss-aletta-grace-bell-vs-dr-miss-s-tirkey-and-anr-on-8-november-1995","title":{"rendered":"Dr. (Miss) Aletta Grace Bell vs Dr. (Miss) S. Tirkey And Anr on 8 November, 1995"},"content":{"rendered":"<div class=\"docsource_main\">Supreme Court of India<\/div>\n<div class=\"doc_title\">Dr. (Miss) Aletta Grace Bell vs Dr. (Miss) S. Tirkey And Anr on 8 November, 1995<\/div>\n<div class=\"doc_citations\">Equivalent citations: 1996 AIR  538, \t\t  1996 SCC  (1) 285<\/div>\n<div class=\"doc_author\">Author: M Punchhi<\/div>\n<div class=\"doc_bench\">Bench: Punchhi, M.M.<\/div>\n<pre>           PETITIONER:\nDR. (MISS) ALETTA GRACE BELL\n\n\tVs.\n\nRESPONDENT:\nDR. (MISS) S. TIRKEY AND ANR.\n\nDATE OF JUDGMENT08\/11\/1995\n\nBENCH:\nPUNCHHI, M.M.\nBENCH:\n<a href=\"\/doc\/1457401\/\">PUNCHHI, M.M.\nMANOHAR SUJATA V. (J)\n\nCITATION<\/a>:\n 1996 AIR  538\t\t  1996 SCC  (1) 285\n JT 1995 (8)   203\t  1995 SCALE  (6)445\n\n\nACT:\n\n\n\nHEADNOTE:\n\n\n\nJUDGMENT:\n<\/pre>\n<p>\t\t\t O R D E R<br \/>\n     This is  an appeal\t against the judgment and order of a<br \/>\nDivision Bench\tof the Patna High Court passed in Civil Writ<br \/>\nJurisdiction Case No.3326 of 1979, on 17-7-1980.\n<\/p>\n<p>     The appellant  &#8211;  Dr.  (Miss)  Alette  Grace  Bell,  as<br \/>\nMedical\t Superintendent-cum-Administrative  Officer  of\t the<br \/>\nDuncan Hospital\t at Raxaul in the State of Bihar, was served<br \/>\nwith a\tletter from  the Drug Controller Bihar to the affect<br \/>\nthat the  hospital being in the manufacture and distribution<br \/>\nof a  drug referred to a I.V. Solution, was required to take<br \/>\na licence  under the  provisions of  The Drugs and Cosmetics<br \/>\nAct, 1940,  for the  default  of  which\t it  has  to  suffer<br \/>\nprosecution. Challenging  the same  before  the\t Patna\tHigh<br \/>\nCourt, the  appellant contended that since its product was a<br \/>\npreparation  by\t  compounding  of  glucose  or\tsodium\twith<br \/>\ndistilled  water   and\tadministered   to  patients  in\t the<br \/>\nhospital, this\tsolution was  manufactured not\tfor sale but<br \/>\nfor  distribution,   and  the\tact   of   manufacture\t for<br \/>\ndistribution  required\t no  licence.\tThe  High  Court  on<br \/>\nexamining the  various provisions  of the  Act, came to hold<br \/>\nthat the appellant&#8217;s hospital was required to obtain licence<br \/>\nunder clause  (c) of  Section 18  of The Drugs and Cosmetics<br \/>\nAct, 1940.  This view  of the  High Court  had led  to\tthis<br \/>\nappeal.\n<\/p>\n<p>     When leave\t was granted,  interim\torder  of  stay\t was<br \/>\nvacated. We  are therefore not aware whether any prosecution<br \/>\nof the appellant followed or not. Be that as it may, we must<br \/>\nstate the  legal position. The offence was committed on 2-5-<br \/>\n1979 when the Drugs Inspector on his usual visit, discovered<br \/>\nthe appellant  engaged in  the manufacture  of I.V. Solution<br \/>\nfor  administration   to  patients   in\t the  hospital.\t The<br \/>\nprovision requiring  licence, being Section 18(c) of the Act<br \/>\nthen read as follows:\n<\/p>\n<blockquote><p>     &#8220;From such\t date as  may be fixed by the<br \/>\n     State Government  by notification in the<br \/>\n     official  gazette\tin  this  behalf,  no<br \/>\n     person shall  himself or  by  any\tother<br \/>\n     person on\this  behalf  manufacture  for<br \/>\n     sale, or  sell, or\t stock or exhibit for<br \/>\n     sale,  or\t distribute   any   drug   or<br \/>\n     cosmetic,\t except\t   under,   and\t   in<br \/>\n     accordance with  the  conditions  of,  a<br \/>\n     licence issued  for such  purpose\tunder<br \/>\n     this Chapter.&#8221;\n<\/p><\/blockquote>\n<p>With effect from 1-2-1983, the provision reads:\n<\/p>\n<blockquote><p>     &#8220;&#8230;&#8230;&#8230;.manufacture for\t sale or  for<br \/>\n     distribution,  or\t sell,\tor  stock  or<br \/>\n     exhibit or offer for sale, or distribute<br \/>\n     any drug  or cosmetic, except under, and<br \/>\n     in accordance  with the conditions of, a<br \/>\n     licence issued  for such  purpose\tunder<br \/>\n     this chapter.&#8221;<\/p><\/blockquote>\n<p>     As is  evident, prior to the amendment, manufacture for<br \/>\nsale of\t any drug  or  cosmetic,  as  a\t composite  activity<br \/>\nrequired a  separate licence.  Likewise, distribution of nay<br \/>\ndrug  or   cosmetic  required\ta  separate   licence.\t The<br \/>\nsignificant  change   effected\tby  the\t amendment  is\tthat<br \/>\n&#8220;manufacture for  sale\tor  for\t distribution&#8221;\tis  now\t one<br \/>\ncomposite  activity   and  would   require  a\tlicence.  If<br \/>\ndistribution of\t any drug or cosmetic is a separate activity<br \/>\nunconnected with manufacture, then as of before, it requires<br \/>\na separate  licence.  In  all  situations  licence  must  be<br \/>\nobtained to carry out activity on the conditions given under<br \/>\nChapter IV  of the  said Act  of which Section 33 is a part,<br \/>\nempowering the\tCentral Government to make rules. Section 33<br \/>\nis laid\t in the\t usual format.\tClause (e)  of Section 33(2)<br \/>\nsays that Rules to be framed by the Government may prescribe<br \/>\nthe forms  of licences\tfor the\t manufacture for sale or for<br \/>\ndistribution (the  relevant words added after the amendment)<br \/>\nand inter  alia for  the distribution  of drugs etc. as also<br \/>\nthe form  of objection\twhich such lliecneesmayabd authority<br \/>\nempowered to issue the same etc. etc. Significantly, no form<br \/>\nof licence  for manufacture  for distribution  of  drugs  or<br \/>\ncosmetics has  been provided.  No conditions  has been\tlaid<br \/>\nsubject to  which such licence may be issued. Only two forms<br \/>\nstood prescribed  prior to  the amendment.  Those  were\t for<br \/>\nobtaining licence  (i) for the manufacture for sale and (ii)<br \/>\nfor sale of drugs and cosmetics. Now after the amendment the<br \/>\nform is\t for the manufacture for sale or for distribution of<br \/>\ndrugs or  cosmetics. In the absence of the requisite form of<br \/>\nlicence being  part of\tthe rules  as  per  requirements  of<br \/>\nSection 18(c),\tit is  difficult to  conceive as  to how the<br \/>\nappellant was obligated to apply for obtaining the requisite<br \/>\nlicence, and  before which  authority and  in which form and<br \/>\nsubject to  which conditions.  It thus\tappears clear  to us<br \/>\nthat the  requirement in  that regard  leaves a vacuum which<br \/>\nfor reasons best known to the Executive has remain unfilled.<br \/>\nThe obligation\tof the\tappellant and her sequel prosecution<br \/>\nbeing founded  on the  supposed requirement of Section 18(c)<br \/>\nof the\tAct, not  only the  provision, but  the rules  which<br \/>\ncarry out its purpose have to be viewed strictly. When there<br \/>\nis a  vacuum, as  spelled out before, its benefit must go to<br \/>\nthe appellant.\tShe thus has been able to successfully plead<br \/>\nand prove that in the absence of the requisites laid down in<br \/>\nSections 18(c) and 33 of the Act, she and hence the hospital<br \/>\ncould not  be required\tto obtain  a licence for manufacture<br \/>\nand distribution  of the  drug on  the date when the offence<br \/>\nwas allegedly committed.\n<\/p>\n<p>     Thus, for\tthe aforesaid  reasons, we  differ from\t the<br \/>\nview taken  by the  High Court,\t and upset  its judgment and<br \/>\norder granting\tthe writ  to the appellant, as prayed. There<br \/>\nshall be no orders as to costs.<\/p>\n","protected":false},"excerpt":{"rendered":"<p>Supreme Court of India Dr. (Miss) Aletta Grace Bell vs Dr. (Miss) S. Tirkey And Anr on 8 November, 1995 Equivalent citations: 1996 AIR 538, 1996 SCC (1) 285 Author: M Punchhi Bench: Punchhi, M.M. PETITIONER: DR. (MISS) ALETTA GRACE BELL Vs. RESPONDENT: DR. (MISS) S. TIRKEY AND ANR. DATE OF JUDGMENT08\/11\/1995 BENCH: PUNCHHI, M.M. [&hellip;]<\/p>\n","protected":false},"author":1,"featured_media":0,"comment_status":"open","ping_status":"open","sticky":false,"template":"","format":"standard","meta":{"_lmt_disableupdate":"","_lmt_disable":"","_jetpack_memberships_contains_paid_content":false,"footnotes":""},"categories":[30],"tags":[],"class_list":["post-204425","post","type-post","status-publish","format-standard","hentry","category-supreme-court-of-india"],"yoast_head":"<!-- This site is optimized with the Yoast SEO plugin v27.3 - https:\/\/yoast.com\/product\/yoast-seo-wordpress\/ -->\n<title>Dr. (Miss) Aletta Grace Bell vs Dr. (Miss) S. 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