{"id":122858,"date":"2006-12-13T00:00:00","date_gmt":"2006-12-12T18:30:00","guid":{"rendered":"https:\/\/www.legalindia.com\/judgments\/german-remedies-ltd-vs-state-of-kerala-on-13-december-2006"},"modified":"2015-04-28T23:50:31","modified_gmt":"2015-04-28T18:20:31","slug":"german-remedies-ltd-vs-state-of-kerala-on-13-december-2006","status":"publish","type":"post","link":"https:\/\/www.legalindia.com\/judgments\/german-remedies-ltd-vs-state-of-kerala-on-13-december-2006","title":{"rendered":"German Remedies Ltd vs State Of Kerala on 13 December, 2006"},"content":{"rendered":"
Kerala High Court<\/div>\n
German Remedies Ltd vs State Of Kerala on 13 December, 2006<\/div>\n
       \n\n  \n\n  \n\n \n \n  IN THE HIGH COURT OF KERALA AT ERNAKULAM\n\nOP No. 14979 of 2001(G)\n\n\n\n1. GERMAN REMEDIES LTD.\n                      ...  Petitioner\n\n                        Vs\n\n1. STATE OF KERALA\n                       ...       Respondent\n\n                For Petitioner  :SRI.B.S.KRISHNAN (SR.)\n\n                For Respondent  :GOVERNMENT PLEADER\n\nThe Hon'ble MR. Justice K.A.ABDUL GAFOOR\n\n Dated :13\/12\/2006\n\n O R D E R\n                K.A.ABDUL GAFOOR, J.\n\n            -------------------------\n\n                     O.P.No.14979 of 2001\n\n            -------------------------\n\n            Dated this the 13th day of December, 2006.\n\n\n\n                            JUDGMENT\n<\/pre>\n
Abdul Gafoor, J.\n<\/p>\n<\/p>\n
          The   petitioner   is   a   drug   manufacturer.     In<\/p>\n
relation   to   the   drug   manufactured   by   the   petitioner<\/p>\n
viz.   Syntocinon,   which   contains   Oxytocin,   the   Drug<\/p>\n
Inspector detected that labelling was not in conformity<\/p>\n
with   Rule   96(vii)   of   the   Drugs   and   Cosmetics   Rules,<\/p>\n
1945 and entry No.8 under the heading ‘Miscellaneous<\/p>\n
Drugs’   in   Schedule   P   to   the   said   Rules.   Accordingly,<\/p>\n
prosecution   was   initiated   alleging   violation   of   the<\/p>\n
relevant   provisions,   lodging   Ext.P7   F.I.R.     This   is<\/p>\n
sought to be quashed in this writ petition.<\/p>\n
          2.     It   is   submitted   that   the   said   medicine   is<\/p>\n
included   as   item   No.8   under   the   heading<\/p>\n
‘Miscellaneous   Drugs’   in   Schedule   P   to   the   Rules<\/p>\n
whereby   the   storage   condition   is   mentioned   as   “cold<\/p>\n
place”,   which   is   further   described   in   the   foot   note   of<\/p>\n
O.P.No.14979 of 2001<\/p>\n
                                                       :: 2 ::\n<\/p>\n
the   said   schedule   as   “at   a   temperature   between   2<\/p>\n
degree   centigrade   and   8   degree   centigrade”   which<\/p>\n
shall   be   available   in   Kerala,   only   inside   a<\/p>\n
‘refrigerator’ other than a ‘freezer’.  But the labelling<\/p>\n
contained   in   the   item   of   medicine   manufactured   by<\/p>\n
the   petitioner   indicated   the   storage   condition   as<\/p>\n
“store  in  a  cool   place  and  should  not  be  allowed  to<\/p>\n
freeze”.\n<\/p>\n<\/p>\n
                 3.  ‘Cool place’, according to the schedule to<\/p>\n
the   Rules,   is   a   place   where   the   temperature   is<\/p>\n
between   10   degree   and   25   degree.     This   was<\/p>\n
adopted, according to the petitioner, because of the<\/p>\n
storage   conditions   in   the   Indian   Pharmacopocia,<\/p>\n
1996,   Ext.P10   as   amended   by   Ext.P4.     It   is   also<\/p>\n
submitted   that,   a   learned   single   Judge   has<\/p>\n
considered   this   aspect   in   respect   of   the   very   same<\/p>\n
medicine manufactured by another manufacturer and<\/p>\n
O.P.No.14979 of 2001<\/p>\n
                                                       :: 3 ::\n<\/p>\n
had   found   that   because   of   this   confusion   arising<\/p>\n
because of the condition  contained in the Rules and<\/p>\n
the   description   in   Indian   Pharmacopocia,   1996,   the<\/p>\n
prosecution ought not to have been launched.  Thus,<\/p>\n
it is submitted that the said view shall be adopted in<\/p>\n
this case.  Therefore, Ext.P7 shall be quashed.<\/p>\n
                 3.   It   is   submitted   by   the   Government<\/p>\n
Pleader,   justifying   the   launching   of   the   prosecution<\/p>\n
as   per  Ext.P7,   that   the   medicine   in   question   is   one<\/p>\n
mentioned   under   the   heading   ‘miscellaneous   drugs’<\/p>\n
in   Schedule  P  covered  by  Rule   96(vii)   of   the   Rules.<\/p>\n
Necessarily, the manufacturer has, with reference to<\/p>\n
the labelling, to conform to the standards mentioned<\/p>\n
in   Schedule   P   in   relation   to   the   said   drug.     If   the<\/p>\n
labelling of the medicine will affect its potency.   This<\/p>\n
is   an   important   medicine   to   be   administered   at   the<\/p>\n
time of child birth.   The administration  of  the  drug,<\/p>\n
O.P.No.14979 of 2001<\/p>\n
                                                       :: 4 ::\n<\/p>\n
the   potency   of   which   has   been   reduced   because   of<\/p>\n
the   change   in   the   storage   condition,   may  turn   fatal<\/p>\n
and   therefore,   the   prosecution   shall   be   allowed   to<\/p>\n
continue the proceedings.\n<\/p>\n<\/p>\n
                 4.   It   is   submitted   that   the   Indian<\/p>\n
Pharmacopocia   is   having   statutory   recognition     as<\/p>\n
mentioned in the rules.  Therefore, the specifications<\/p>\n
in Inidan Pharmacopocia, is also to be followed.  The<\/p>\n
specification   regarding   the   storage   of   the   medicine<\/p>\n
concerned mentioned in the India Pharmacopocia, as<\/p>\n
amended by Ext.P4 is, ‘store in cool place and should<\/p>\n
not be allowed to freeze’.  This will necessarily mean<\/p>\n
that the said ‘cool place’ is a place where there is a<\/p>\n
chance   of   freezing.     Therefore,   it   cannot   be   room<\/p>\n
temperature. When this phraseology is used in India<\/p>\n
Pharmacopocia,   it   is   not   opposed   to   the     storage<\/p>\n
conditions mentioned in Schedule P.  So, it cannot be<\/p>\n
O.P.No.14979 of 2001<\/p>\n
                                                       :: 5 ::\n<\/p>\n
stated that there was commission  of  any offence to<\/p>\n
launch the prosecution.\n<\/p>\n<\/p>\n
                 5.   Anyhow,   by   now,   the   petitioner   is<\/p>\n
following strictly the storage conditions mentioned in<\/p>\n
Schedule   P   for   the   purpose   of   labelling   the   drug   in<\/p>\n
question.   Another single Judge has already taken a<\/p>\n
view that it was because of the confusion regarding<\/p>\n
the   storage   place   as   mentioned   in   Schedule   P   and<\/p>\n
the India   Pharmacopocia,   this   situation  had arisen.<\/p>\n
In such circumstances, following the said view, which<\/p>\n
has   not   been  appealed   against   with   respect  to   that<\/p>\n
aspect, Ext.P7 is quashed.\n<\/p>\n<\/p>\n
                 Writ petition is allowed as above.<\/p>\n
                                                                  Sd\/-\n<\/p>\n
                                               (K.A.ABDUL GAFOOR)<\/p>\n
                                                                   JUDGE<\/p>\n
sk\/<\/p>\n
                                  \/\/true copy\/\/<\/p>\n
                                                K.A.ABDUL GAFOOR, J.\n<\/p>\n
                                     ———————————————-<\/p>\n
                                          O.P.No.14979 of 2001<\/p>\n
                                                      JUDGMENT<\/p>\n
                                             13th    December, 2006.\n<\/p><\/blockquote>\n
                                  ————————————————<\/p>\n","protected":false},"excerpt":{"rendered":"
Kerala High Court German Remedies Ltd vs State Of Kerala on 13 December, 2006 IN THE HIGH COURT OF KERALA AT ERNAKULAM OP No. 14979 of 2001(G) 1. GERMAN REMEDIES LTD. … Petitioner Vs 1. STATE OF KERALA … Respondent For Petitioner :SRI.B.S.KRISHNAN (SR.) For Respondent :GOVERNMENT PLEADER The Hon’ble MR. Justice K.A.ABDUL GAFOOR Dated […]<\/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":[8,21],"tags":[],"class_list":["post-122858","post","type-post","status-publish","format-standard","hentry","category-high-court","category-kerala-high-court"],"yoast_head":"\nGerman Remedies Ltd vs State Of Kerala on 13 December, 2006 - Free Judgements of Supreme Court & High Court | Legal India<\/title>\n<meta name=\"robots\" content=\"index, follow, max-snippet:-1, max-image-preview:large, max-video-preview:-1\" \/>\n<link rel=\"canonical\" href=\"https:\/\/www.legalindia.com\/judgments\/german-remedies-ltd-vs-state-of-kerala-on-13-december-2006\" \/>\n<meta property=\"og:locale\" content=\"en_US\" \/>\n<meta property=\"og:type\" content=\"article\" \/>\n<meta property=\"og:title\" content=\"German Remedies Ltd vs State Of Kerala on 13 December, 2006 - 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