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PETITIONER: PRATAP PHARMA (PVT.) LTD. & ANR. ETC. ETC.

       Vs.

RESPONDENT: UNION OF INDIA & ORS.

DATE OF JUDGMENT:       01/04/1997

BENCH: K. RAMASWAMY, D.P. WADHWA

ACT:

HEADNOTE:

JUDGMENT:                             AND            WRIT PETITION (C) Nos.3559 AND 4572/83                          O R D E R      These three  writ petitions,  filed under Article 32 of the constitution  of India,  raise common  question of  law, challenging Section  3(h) of  the Drugs  and cosmetics  Act, 1940, as  amended by  Act 68  of 1982 (for short, the ’Act’) with effect from February 1, 1983 as unconstitutional, being arbitrary and  violative of  Article 14 and 19(1) (9) of the constitution. The grievance of the petitioners is that while the Act  amends the  definition of  "payment and proprietary Medicine" under  Section 3(h) of Act, the definition ’drugs’ under Section  3(b) read  with the  definition of "Ayurvedic drug"  under  section  3(a)  has  not  been  changed;  as  a consequence, there  is  no  prohibition  for  patenting  the Ayurvedic drugs  manufactured  by  the  petitioners  whereas under the  impugned  order  of  the  Drug  controller  dated February 16,  1983 it  is so  construed and  manufacture  of those drugs  is prohibited.  Therefore, the Amendment Act 68 of 1983  and  the  order  passed  by  the  Drug  controller, Government of India, are Ultra Vires the legislative power.      Shri M.N.  Krishnamani, learned senior counsel and Shri Pankaj Kalra, learned counsel appearing for the petitioners, seeks to support their grievance, but we are unable to agree with the  learned  counsel.  It  is  seen  that  patent  and proprietary medicine  was defined  in the  pre-Amendment Act under section 3(h) thus:      "Patent  or  proprietary  Medicine"      Means a  drug which is a remedy for      prescription presented  in  a  form      ready  for   internal  or  external      administration of  human beings  or      animals and  which is  not included      in  the   edition  of   the  Indian      Pharmacopeia  authorised   in  this      behalf by  the  Central  Government      after consultation with the Board."      "Drug"  had   been  defined  under  section  3(b),  and continues under the Amendment Act, to read as under:      "Section 3(b) "drug" includes.

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    (i) All  medicines for  internal or      external  use  of  human  being  or      animals and all substances intended      to  be   used  for   or   (in   the      diagnosis,  treatment),  mitigation      or prevention  of disease  in human      being or animals .....; and      (ii) such  substances  (other  than      food)  intended   to   affect   the      structure or  any function  of  the      human body  or intended  to be used      for the  destruction of (vermin) or      insects  which   cause  disease  in      human being  or animals,  as may be      specified from  time to time by the      Central Government  by notification      in the official Gazette."      "Ayurvedic (including  Siddha) or  Unani Drug" has been defined under section 3(a) of the Act, which reads as under:      "Ayurvedic  (including  Siddha)  or      Unani drug"  includes all medicines      intended for internal use for or in      the      diagnoses,      treatment,      mitigation or prevention of disease      in human  beings mentioned  in, and      processed     and      manufactured      exclusively in  accordance with the      formulae    described    in,    the      authoritative  books  of  Ayurvedic      (including Siddha) and Unani (Tibb)      systems of  medicine, specified  in      the First Schedule."      Under the  Amendment Act  68 of  1983 Section  3(h) has been amended, and reads as under:      "Patent  or  proprietary  medicine"      means-      (i) in relation to Ayurvedic Siddha      or Unani  Tibb systems  of medicine      all  formulation   containing  only      such ingredients  mentioned in  the      formulae    described     in    the      authoritative books  of  Ayurvedic,      siddha or  Unani  Tibb  systems  of      medicine, specified  in  the  First      schedule but  does  not  include  a      medicine, which  is administered by      parental   route    and   also    a      formulation   included    in    the      authoritative books as specified in      clause(a);      (ii)  in   relation  to  any  other      systems of medicine a drug which is      a remedy  or prescription presented      in a  form ready  for  internal  or      external  administration  of  human      beings or  animals and which is not      included  in  the  edition  of  the      Indian pharmacopoeia  authorised in      this   behalf    by   the   central      Government after  consultation with      the Drugs  Technical Advisory Board      constituted under section 5."      A reading of these provisions would indicate that prior to the  amendment "drug" included all medicines for internal or  external   use  of  human  beings  or  animals  and  all

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substances  intended   to  be  used  for  or  in  diagnoses, treatment, mitigation  or preservation  of disease  in human beings  or   animals  etc.  "Ayurvedic  Drug"  includes  all medicines intended  for internal  or external  use for or in the  diagnosis,   treatment,  mitigation  or  prevention  of disease in  human beings,  mentioned in,  and processed  and manufactures exclusively  in accordance  with  the  formulae described  in,   the  authoritative   books   of   Ayurvedic (including Siddha)  and Unani  (Tibb)  system  of  medicine, specified in  the First  schedule. While continuing the same system of  drugs without  any change  in the  Amendment Act, what has been excluded is the medicine which is administered by  parental   route;  and   a  formula   included  in   the authoritative books  as specified in clause (a) of section 3 is excluded.  As a consequence, the necessary result is that any Ayurvedic  or Siddha or Unani drug which is administered by parental  route and also giving a formula included in the authoritative  books  specified  in  the  schedule  attached thereto stand  excluded. Simultaneously,  one of  the  items i.e. 164A  relating to  Indian medicines  is  included  with which we  are  not  concerned.  It  is  contended  that  the Ayurvedic, Siddha  and Unani systems of medicine are ancient systems and  are part  of our ancient heritage which provide more lasting  and permanent  cure to all types of disease or ailments than  the  transient  and  instant  relief  through allopathic medicines.  The former  are time taking while the latter is  instant. However,  our systems  of medicine  must also keep  pace  with  scientific  development  with  modern technology and  face cooperative  spirit of development. The process  and   manufacture  must   go  along  the  developed scientific system.  So the  drug manufactured  by Ayurvedic, Siddha and Unani system of pharmacopoeia for cure of disease must, of necessity, be of standard quality prescribed by the relevant provision  of the  Act  or  system  of  preparation should be  certified to  be fit  for use, sale, storage etc. The administration equally must note that the foreign multi- national pharmaceutical  companies are  getting  our  herbal medicine patented  and are  getting worldwide  market  which benefit must not be denied to Indians and Indian companies.      The primary  question, therefore,  is whether  such  an amendment is ultra vires the provisions of the constitution. Under Entry  19 of  list III read with Entry 49 of List I of the seventh  schedule, the  parliament is competent to enact and to  amend the Act. Therefore, the legislative competence is  beyond  pate  of  question.    The  arbitrariness  of  a legislation violating  Article 14  cannot be  adjudged to be arbitrary when  the Parliament  is of the view that it is to ensure safety  of the  life of  human beings or animals. The regulation  of   manufacture  of   drug  and  patenting  are necessary and  are in  public interest as the evil is sought to be  remedied  by  legislative  measure.  When  drugs  are administered to human being/animals, they are required to be regulated as  adumbrated under  the Act.  As a  consequence, thought by  implication the right to practice of medicine or manufacture of  the drugs  has been guaranteed under Article 19(1) (g) , it is a regulation within the meaning of Article 19(6) of  the  constitution.  As  a  consequence,  it  is  a reasonable restriction on the right to carry on the trade or business of  manufacture  of  the  ayurvedic  drugs  by  the petitioners.      Shri Pankaj  Kalra contends  that unless  there  is  an express prohibition  under the  provisions of  the Act,  the authority cannot  infer that  there is a prohibition. We are unable to  agree with  the counsel. If the drug manufactured by the  petitioners is  found to  be in  conformity with the

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prescribed standard,  and is  likely to  cause injurious  to health or  to endanger the life of a patient, and therefore, there is  no need  for an express prohibition under the Act. It is  now  well  settled  legal  position  that  regulation includes total prohibition, if it sis found necessary in the public interest.  Manufacture of drugs for administration to human beings/animals  is regulated by the act and therefore, it attracts  Article 19(6).  We hold  that the  Act is intra vires the  constitution and does not violate the fundamental rights guaranteed  under Articles  14 and  19(1) (g)  of the constitution.      The   question   then   arises:   whether   the   drugs manufactured by  the petitioners  can be  prohibited for the purpose of  administration to  the human  beings or  animals within the  exclusionary clause  under section  3(h) of  the Act. The question is primarily one of fact, to be decided on the basis  of material available. The Drug Controller in the impugned  letter   has  merely   opined  on   the  basis  of definitions contained,  they are prohibitable and therefore, directed that  they cannot be manufactured thereafter. There must be  evidence on  record before the authority to reach a conclusion that  the drugs  manufactured by  the petitioners are prohibitable items under the Act. Unless expert body has gone into  and tested  these  items  and  decided  that  the standards adopted by them under the respective pharmacopoeia formula are  not  consistent  with  or  conformable  to  the requested established  standards and  unless it is certified that they  are unfit  for use of human  beings/animals, they are not  prohibitable per  se. Therefore,  the  expert  body should go  into that  question and decide which of the items manufactured by  the  petitioners  are  conformable  to  the established standards  of pharmacopoeia  formula and satisfy the required  tests as admissible in that behalf. We are not experts in this field. We cannot hazard to reach a  decision on the  issue. Though  Shri Pankaj  Kalra has brought to our notice some  of  the  articles  written  by  persons  having knowledge in  this branch of science, we do not want to take risk to  reach any  conclusion on  the basis  of  the  above articles. The appropriate course would be that the competent expert body  should go  into that  question and  decide  the same.      Section 33-C  of the  Act contemplates  constitution of the Expert Body by a committee constituted thereunder by the Government of  India. Therefore  the Government  of India is directed constitute  an expert body consisting of experts in the Ayurvedic    system  of  medicine  and  also  some  from Allopathy as  contemplated under  section 33-c.  The  expert body should  go into  the question  and decide  whether  the items of  drugs  manufactured  by  the  petitioners  are  in conformity  with   the  provisions   of  the   Act  and  the established formulae  in the  Ayurvedic  Pharmacopoeia.  The Government of  India or Drug controller, as the case may be, would  then   take  a   decision  on   the  basis   of   its recommendation. In  case they  find any of these drugs to be injurious to  the health  of human beings/animals; necessary opportunity would  be given  to the manufacturers to rectify it; in  case they  do not  rectify the injurious element and the drugs  are still  found to  be so defective as cannot be administered,  then   necessary  orders   would  be   passed prohibition them  from manufacturing  the same. In the event of such  a decision  being taken,  an opportunity  would  be given to  the persons  concerned so that they can also place their material  before the committee and thereafter the Drug controller/Board or Government of India, as the case may be, would take  a decision  on the  basis of  the expert  body’s

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opinion and  the material  placed by the petitioners in that behalf.      Since experts in Ayurvedic system of medicine are to be members of the committee to be constituted by the Government of India  under section 33-c of the Act, it would be open to the petitioners  to suggest  to the central Government names of the  experts known  to them  and it  is for  the  central Government to consider whether such person may be drafted as a member of the committee so constituted.      It appears  that there is an inter se dispute as to who is entitled  to be  the proprietor of the petitioner in W.P. No.  4572/83.   It  appears  that  the  dispute  is  pending adjudication in  the civil court and impleading some of them in this  writ petition as representing the petitioner is for the purpose of disposal of the matter pending in this court, It would be subject to the decision by the civil court.      In view of the stay orders granted by this court and as we are  remitting the matter to the Government of India, the interim stay  would continue  till the  decision is taken by the Drug controller  on the basis of the report submitted by the expert  body and  the decision to be taken by Government of India/Drug  controller. It  is needless  to mention  that since  the   matters  are  pending  for  a  long  time,  the Government of  India   would  constitute  the  committee  as expeditiously as  possible and  the report  may be submitted with in  six months from the date of the constitution of the committee.      The writ  petitions are  disposed  of  accordingly.  No costs.