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PETITIONER: VINCENT PANIKURLANGARA

       Vs.

RESPONDENT: UNION OF INDIA & ORS.

DATE OF JUDGMENT03/03/1987

BENCH: MISRA RANGNATH BENCH: MISRA RANGNATH DUTT, M.M. (J)

CITATION:  1987 AIR  990            1987 SCR  (2) 468  1987 SCC  (2) 165        JT 1987 (1)   610  1987 SCALE  (1)490  CITATOR INFO :  RF         1987 SC1802  (1)  F          1988 SC 952  (3,6)  RF         1988 SC1737  (73)  RF         1991 SC 363  (9)

ACT:     Constitution  of India,  1950, Article 144--  Civil  and judicial   authorities  to  act  in  aid  of   the   Supreme Court--Public  Interest Litigation relating to  drug  policy filed  in the interest of nation’s health--Statutory  bodies except  State  of Karnataka responding  to  Supreme  Court’s notice--Constitutional obligation stressed.     Public    Interest    Litigation--Health    Care     for citizens--Whether the Supreme Court could interfere with the matter  touching the policy of the Government and  the  duty cast under Article 47 of the Constitution.

HEADNOTE:     The petitioner, an advocate by profession has moved  the Supreme Court in public interest seeking directions  banning import,  manufacture,  sale and distribution of  such  drugs which  have been banned in Western countries or  recommended to  be banned by the Drugs Consultative Committee under  the Drugs  and  Cosmetics  Act, 1940. The  petitioner  has  also sought  directions, (i) for cancellation of licences  autho- rising  import, manufacture, sale and distribution  of  such drugs; (ii) for Constitution of a high powered Authority  to go  into  the hazards suffered by people of the  country  on account  of  such drugs being in  circulation   and  suggest remedial  measures including award of compensation. Disposing of the petition, the Court,     HELD:  1. Statutory bodies when called upon by a  Court, in particular the apex Court of the Country, are  duty-bound to  respond  and join the proceedings before the  Court,  as required  by Article 144 of the Constitution.  These  bodies are not litigants and do not have the choice of keeping away from the Court like private parties in ordinary  litigations opting  to go ex parte. The present matter is certainly  one which is sufficiently important and the stake of the  entire nation is high when the Court suoe moro extended the  oppor- tunity  of  being heard and invited the named  statutory  or

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other  authorities  to  come forward and  place  their  view points on relevant aspects, an attitude of callous indif- 469 ference cannot be appreciated. It is hoped that there  would be no repetition of such a situation. [475G-H; 476A-B] P. Nalla Thampy  v. Union of India, [1983] 4 SCC 598, followed.     2. Having regard to the magnitude, complexity and  tech- nical  nature  of  the enquiry involved in  the  matter  and keeping  in  view of the far reaching  implications  of  the total ban of certain medicines for which the petitioner  has prayed, it is clear that a judicial proceeding of the nature initiated  is  not an appropriate one for  determination  of such matters. [476H; 477A]     2.2  The  issues raised in this petition  are  of  vital importance as they relate to maintenance of approved  stand- ards  of  drugs in general; the writ petition  involves  the claim  for  withdrawal of 7000 fixed dose  combinations  and withdrawal of licences of manufacturers engaged in  manufac- ture of about 30 drugs which have been licensed by the Drugs Control Authorities; the issues that fall for  consideration are  not only relating to technical and specialised  matters relating  to  therapeutic value, justification  and  harmful side  effect  of drugs but also involve examination  of  the ectness  of action taken by the respondents 1 and 2  on  the basis  of advice; the matter also involves the  interest  of manufacturers  and traders of drugs as also the interest  of patients who require drugs for their treatment. The  techni- cal  aspects  which arise for consideration in a  matter  of this type cannot be effectively handled by a Court. Similar- ly the question of policy which is involved in the matter is also  one  for  the Union Government--keeping  the  best  of interests  of  citizens in view to decide. No final  say  in regard to such aspects come under the purview of the  Court. [476D-F; 478F-G]     2.3  This branch namely, Health Care of citizens,  is  a problem  with various facets. It involves and  over-changing challenge.  There  appears  to be, as it  were,  a  constant competition between Nature (which can be said to be  respon- sible  for  new ailments) on the side  and  human  ingenuity engaged in research and finding out curative processes. This being the situation, the problem has an ever-shifting  base. It  is common place that what is considered to be  the  best medicine today for treatment of a particular disease becomes out of date and soon goes out of the market with the discov- ery  or invention of new drugs. Again what is considered  to be incurable at any given point of time becomes subjected to treatment  and  cure with new finds. There  is  yet  another situation  which  must be taken note of as  human  knowledge expands and marches ahead. With the onward march of  science and complexities of the living 470 process  and hitherto unknown diseases are noticed. To  meet new  challenges, new drugs have to be found. In this  field, therefore, change appears to be the rule. [478G-H; 479A-C]     Therefore,  such drugs as are found necessary should  be manufactured in abundance and availability to satisfy  every demand should be ensured. Undue competition in the matter of production of drugs by allowing too many substitutes  should be reduced as it introduces unhealthy practice and ultimate- ly  tends to affect quality. The State’s obligation  to  en- force  production of qualitative’ drugs and  elimination  of the injuries ones from the market must take within its sweep an  obligation to make useful drugs available at  reasonable price so as to be within the common man’s reach. That  would

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involve regulating the price. It may be that there may be an improved  quality of a particular medicine which on  account of  its  cost of production will have to sell  at  a  higher price but for every illness which can be cured by treatment, the patient must be in a position to get its medicine.  This is  an  obligation  under Article 47  of  the  Constitution. [479G-H; 480A-B]     Bandhua  Mukti  Morcha v. Union of India, [1984]  3  SCC 161, referred to.

JUDGMENT: ORIGINAL JURISDICTION: Writ Petition No. 3492 of 1983. Under Article 32 of the Constitution of India. Petitioner-in-person.     A.K.  Ganguli, M.S. Rao, S.N. Kacker, A.B.  Divan,  G.V. Iyer,  C.V.S.  Rao, G. Chandra, P. Parmeswaran,  H.K.  Puri, Vimal Dave, Swaraj Kaushal, R.K. Mehta and M.K.D. Namboodiri for the Respondents. The Judgment of the Court was delivered by     RANGANATH  MISRA,  J.  The petitioner,  an  advocate  by profession  is the General Secretary of Public Interest  Law Service  Society, Cochin. In his application as  amended  on 7th  February, 1983, under Article 32 of the Costitution  he has  asked for directions, in public interest,  banning  im- port, manufacture, sale and distribution of such drugs which have been recommended for banning by the Drugs  Consultative Committee  and  has also asked for cancellation of  all  li- cences  authorising import, manufacture, sale and  distribu- tion in respect of 471 such drugs. He has also asked for a direction to the Central Government to constitute a high-powered Authority to go into the hazards suffered by people of the country on account  of such  drugs being in circulation and suggest remedial  meas- ures including award of compensation. He has further  prayed that directions should be given for framing of strict  regu- lations to ensure the quality and standard of approved drugs and to ensure weeding out of same, harmful as also injurious drugs  from the market. The petitioner has alleged that  the drug industry in India is dominated by multi-national Corpo- rations originally based in U.S.A.U.K., Federal Republic  of Germany,  Swedon, Japan, France and the like.  According  to the  petitioner these Corporations have large resources  and make  huge profits. The control exercised by the  Government in  this country on such Corporations is minimal and  inade- quate.  The  disease-prone sub-continent of India  has  been used  as  pasture ground by these  Corporations.  The  Hathi Committee, appointed by the Central Government in its Report submitted  in  1974, highlighted the havoc played  by  these Corporations in the Indian scene and pleaded for nationalis- ing  the  drug industry in the best interest of  the  Indian people.  The  recommendation has not been  accepted  by  the Government. According to the petitioner several drugs banned in  the advanced west after appropriate analytical  research are routed into India and on account on lack of control  and sluggish enforcement of the law conveniently find their  way into  the  market. What is poison to the human body  in  the west  is equally poison to people in India but  not  knowing the  repercussion  thereof on the human system,  such  drugs freely circulate and are even prescribed for patients.     The Central Government announced its drug policy in 1979 and set out a guideline covering the relevant aspects of the trade. According to the petitioner no attempt has been  made

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to  give effect to the policy and there has really  been  no enforcement.  The objectives outlined therein have  remained on  paper. Though the policy indicated that  Government  in- tended to develop indigenous drug technology so as to become self-sufficient, no effective steps have been taken in  this direction.  The  poor illiterate people of India  are  often misled  and  misguided  as they are not aware  of  the  evil effects  of certain drugs available in the market and  often become  a  tool  in the hands of  quacks  and  inexperienced doctors. Often they fall a victim to publicity and not known how dangerous the result of taking the particular drug could be they take it. According to the petitioner, almost half of the  drugs used in India are still being imported  into  the country,  notwithstanding  indigenous  manufacture  both  by local as also the multi-national Corporations. The petition- er has contended that modern drugs reach 472 only  one-fifth of the Indian population. According to  him, the drug industry is totally profit-oriented and no care  or attention  is bestowed upon good health of the  citizens  of India.     In 1980, the Drug Consulative Committee set up a subCom- mittee  of experts for screening the formulations  of  drugs prevalent in the Indian market from the point of therapeutic rationale in order that irrational and harmful  combinations of  drugs  could be banned. The said  Committee  of  experts recommended  banning  of twenty fixed dose  combinations  of drugs.  According  to  the petitioner,  400-500  drugs  with different  trade names belong to the group of  these  twenty fixed dose combinations. The sub-Committee’s report was duly approved by the Committee as also the Ministry of Health  in 1981. The Central Drugs Controller issued directions to  the State  authorities  to  strictly enforce the  ban  of  drugs pertaining to these combinations. On account of slackness in the enforcement machinery these drugs are still prevalent in the market.     The Legislation in the field is the Drugs and  Cosmetics Act, 1940 (hereinafter referred to as the Act). The act  was amended in 1982 and the definition of ’drug’ was amended and sections 10-A and 26-A were inserted into the Act conferring power on the Central Government to prohibit import of  drugs and  cosmetics in public interest as also to prohibit  manu- facture, sale or distribution thereof. The amended Act  came into  force  with  effect from 1st February,  1983,  but  on account  of  proceedings  taken in  Court  by  manufacturers challenging the vires of Section 26-A of the Act and interim directions given by the Courts, the benefit of the new power conferred  on the Central Government is not  yet  available. According to the petitioner, Article 21 of the  Constitution guarantees fight to life and this Court has interpreted  the guarantee  to  cover a life with normal  amenities  ensuring good living which include medical attention, life free  from diseases and longavity upto normal expections. On account of both  want  of appropriate enforcement of the  law  as  also strict  measures necessary to eradicate the existing  evils. the fundamental right to life is not available to the  citi- zens of the country.     In his writ petition the petitioner originally impleaded the Union of India, the Central Drugs Controller as also the Drugs Controller of Kerala as Respondents 1, 2 and 3 respec- tively.     The Assistant Drugs Controller of India filed an affida- vit by way of joint return to the Rule Nisi on behalf of the Union of India and the 473

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Central Drugs Controller. He pointed out that 19  categories of  fixed dose combinations were recommended for  withdrawal from the market and named them in Annexure-I to the  counter affidavit.  According to him, the provisions of the Act  and the  rules  made thereunder  confer  sufficient  legislative authority  and power on the Central Government as  also  the Central  Drugs  Controller  to effectively  operate  in  the field.  In paragraph 8 of the counter-affidavit it has  been stated  that the report of the sub-Committee was  considered by  the  Drugs Consultative Committee as also by  the  Drugs Technical  Advisory  Board and the  recommendations  of  the Board had been accepted by the Ministry of Health in 1982. A circular letter was issued to all the State Drug Controllers on  22nd of April, 1982 asking them to ban  manufacture  and sale of the named categories of fixed dose combinations  and the cut-off date being 30th September, 1982 for stopping for manufacture of these combinations and 3 1st March, 1983  for sale of these combinations was stipulated. On June 26, 1982, a  further circular letter was issued by the  Central  Drugs Controller  to  the State Drugs Control Authorities  in  the matter of banning of Oestrogens and Progestins. That  circu- lar  letter  has  clearly indicated the  cut-off  dates  for stopping   the  manufacture  and  sale  of  these-drugs   as 31.12.1982 and 30.6. 1983 respectively.     These  respondents  have taken the  further  stand  that reports regarding prevalence of standard drugs as stated  in the  Writ Petition have come to light as a result of  action taken  by  the State Drugs Control Authorities.  As  regards combinations of Oestrogens and Progestins, in February  1975 the  World Health Organisation informed all the member  Gov- ernments about the action taken by the Australian Department of  Health  for withdrawal from the market of  a  number  of hormonal  pregnancy  testing preparations. On the  basis  of such information supplied by the World Health  Organisation, the Indian Drugs Controller held consultations with a number of  gynaecologists  within the country who opined  that  al- though  in  advanced  countries  hormonal  preparations  for pregnancy testing had been discontinued on account on better methods  for  detection of pregnancy  being  available,  the prevailing  situation  in  India did  not  require  complete withdrawal from the market of the preparations and it recom- mended that a warning to the effect that there was possibil- ity of congental malformation in case the preparations  were administered  in  the earlier stage of pregnancy  should  be indicated.  Accordingly, a decision was taken that  combina- tions  of  Oestrogens and Progestins may  be  continued  for pregnancy test but a warning to the following effect was 474 asked  to be put on the package as also in any other  promo- tional literature regarding the drugs:-               "Warning:- There is some evidence to show that               hormonal  preparations when used during  preg-               nancy may lead to foetal abnormalities and  as               such these should not be used during pregnancy               or for pregnancy diagnosis." The  Director-General of India Council of  Medical  Research communicated the following recommendations:-               "Fixed  dose  combinations of  oestrogens  and               progesterone  may  be totally  banned  in  the               country  even for the treatment  of  secondary               amenorrhoea  as other, substitutes are  avail-               able in the market for management of secondary               amenorrhoea. ’ ’ On the basis of same the Ministry of Health took a  decision to  ban  fixed dose combinations of these medicines  in  the

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country  and  cut-off dates for manufacture  and  sale  were fixed  as 31st December 1982 and 30th of June 1983,  respec- tively.     From time to time the Drugs Controller of India has been advising the State Drugs Controller for stopping of manufac- ture  of  combinations which have been found to  be  bad  or injurious to health and instances thereof have been given in the  counter  affidavit. With the amendment of  the  Act  in 1982,  the Central Government has now been armed with  power to  prohibit, in public interest, the  import,  manufacture, sale  and  distribution  of any drug or  cosmetic  which  is likely  to involve any risk to human beings or it would  not have the theapeutic value claimed in respect of such  prepa- ration.  The counter affidavit points out that M/s  Nicholas Laboratories of India Ltd. of Bombay and M/s Unichem Labora- tories Ltd., respondent No. 9 before us filed writ petitions before the High Court at Bombay and obtained interim  orders of  stay; similarly in M/s Organon (India) Ltd.,  respondent No.  8 before us moved the Calcutta High Court and  obtained an  interim order of stay in regard to  their  preparations. Challenge  in these writ petitions is to the vires  of  Sec- tions  10-A and 26-A of the Act. The counter affidavit  fur- ther points that some of the medicines which are alleged  to have been banned in some developed countries are allowed  to continue in the market of the other developed countries  and there is no uniformity. 475     The  second counter-affidavit of these  respondents  has been  filed  after the writ petition was  amended.  On  this occasion, the Assistant Drugs Controller of India has stated that  it is a fact that the Hathi Committee recommended  116 drugs to be sufficient to treat more than 90 per cent of the diseases  prevalent in the country. It was,  however,  found out that this position was not correct and many other  drugs were  required  to meet the situation. It pointed  out  that though  the Hathi Committee identified 116 essential  drugs, it  did  not  recommend banning of the  remaining.  The  WHO Expert Committee in its report (serial No. 722 of 1985)  has indicated  that  285 basic drugs and 358  single  ingredient formulations  should be considered to be most important  for the  health and care of the human race. It is asserted  that all these companies manufacture medicines within the  frame- work of the list published by the World Health Organisation. It  is.  pointed out that there are about 8000  small  scale manufacturers  and  214 big manufacturers in  the  organised sector  for manufacture of medicines. When for  some  reason one particular brand of drug is not available in the market, a substitute thereof has got to be looked for. According  to them, all appropriate steps have been taken by the Union  of India and the Central Drugs Controller and the petitioner is not entitled to any relief in this writ petition.     The  respondent  No. 4 is the Association  of  the  Drug manufacturers  and respondent No. 5 is the  organisation  of pharmaceutical  producers  the  remaining  respondents   are manufacturers  of  specified  drug  preparations.  In  their respective affidavits, respondents No. 4 and 5 have  pleaded against maintainability of the writ petition.     This  court  as  early as 11.4.1983  directed  issue  of notice  to the Medical Council of India, the Indian  Medical Association  and  the Drugs Medical Council  of  India,  the Indian medical Association and the Drugs Control authorities of the States except that of Kerala as it was already made a respondent  to the writ petition. Obviously such notice  was given as in the opinion of the Court, the matter was one  of great  importance and the Court looked for participation  of

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these authorities in the debate with a view to assisting the Court  in the disposal of the matter. We are surprised  that the notice from the Court has not evoked response  excepting the  State of Karnataka. (Statutory bodies when called  upon by a Court, in particular the apex Court of the Country, are duty-bound  to respond and join the proceedings  before  the Court. as required by Article 144 of the constitution. These bodies  are  not  litigants and do not have  the  choice  of keeping away from the Court like private parties in ordinary litigations opting to go 476 ex-parte.  The  present  matter is certainly  one  which  is sufficiently important and the stake of the entire nation is high  when  the Court suo moto extended the  opportunity  of being heard and invited the named statutory or other author- ities  to come forward and place their view points on  rele- vant aspects, an attitude of callous indifference cannot  be appreciated. We hope and trust that there would be no  repe- tition of such a situation.     It must be remembered that this is not a normal  litiga- tion with adversaries pitted against one another. What  this Court  said in P. Nalla Thampy v. Union of India,  [1983]  4 SCC 598 has full application. There it said:-               "The lis before us is not of the ordinary type               where  there  are two  contending  parties,  a               claim  is  raised  by one and  denied  by  the               other, issues are struck, evidence is led  and               the findings follow  ......  The writ petition               is essentially in the nature of public  inter-               est litigation and the petitioner has attempt-               ed to voice the grievances of the community."     The  issues in this petition are of vital importance  as they relate to maintenance of approved standards of drugs in general; the writ petition involves the claim for withdrawal of  7000 fixed dose combinations and withdrawal of  licences of  manufacturers engaged in manufacture of about  30  drugs which  have been licensed by the Drugs Control  Authorities; the issues that fall for consideration are not only relating to technical and specialised matters relating to therapeutic value,  justification and harmful side effect of  drugs  but also  involve examination of the ectness of action taken  by the  respondents 1 and 2 on the basis of advice; the  matter also  involves the interest of manufacturers and traders  of drugs as also the interest of patients who require drugs for their treatment.     The  respondent No. 5 has made references to the  recom- mendations  of  the  Drugs Consultative  Committee  and  the ultimate  consideration of DTAE to plead against the  prayer of banning of preparations. As already. stated the remaining respondents  are manufacturers of specific preparations  and have supported in their respective counter-affidavits  their claim that drugs manufactured or handled by them should  not be banned.     Having regard to the magnitude, complexity and technical nature of the enquiry involved in the matter and keeping  in view the far 477 reaching implications of the total ban of certain  medicines for  which the petitioner has prayed, we must at the  outset clearly  indicate that a judicial proceeding of  the  nature initiated  is  not an appropriate one for  determination  of such  matters. There is perhaps force in the  contention  of the  petitioner  that the Hathi Committee too  was  not  one which could be considered as an authoritative body competent to  reach  definite  conclusions. No  adverse  opinion  can,

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therefore, be framed against the Central Government for  not acting upon its recommendations.     A  healthy  body is the very foundation  for  all  human activities. That is why the adage "Sariramadyam  Khaludharma Sadhanara". In a welfare State, therefore, it is the obliga- tion of the State to ensure the creation and the  sustaining of conditions congenial to good health. This Court in  Band- hua  Mukti Morcha v. Union of India, [1984] 3 SCC 161  aptly observed:-               "It  is the fundamental right of  everyone  in               this country, assured under the interpretation               given  to Article 21 by this Court in  Francis               Mullin’s case--[1981] 1 SCC 608--to live  with               human  dignity, free from  exploitation.  This               right to live with human dignity enshrined  in               Article  21 derives its life breath  from  the               Directive  Principles  of  State  Policy   and               particularly clauses (e) and (f) of Article 39               and  Articles  41  and 42 and  at  the  least,               therefore,  it must include protection of  the               health  and strength of the workers,  men  and               women,  and  of  the tender  age  of  children               against  abuse, opportunities  and  facilities               for  children to develop in a  healthy  manner               and  in  conditions of  freedom  and  dignity,               educational facilities, just as humane  condi-               tions of work and maternity relief. These  are               the  minimum requirements which must exist  in               order  to enable a person to live  with  human               dignity,  and  no  State--neither the  Central               Government---has the right to take any  action               which  will deprive a person of the  enjoyment               of these basic essentials". While endorsing what has been said above, we would refer  to Article  47  in Part IV of the  Constitution.  That  Article provides:--               "The  State  shall regard the raising  of  the               level of nutrition and the standard of  living               of  its people and the improvement  of  public               health  as  among its primary duties  and,  in               particular, the State shall endeavour to bring               about prohi-               478               bition of the consumption except for medicinal               purposes  of intoxicating drinks and of  drugs               which are injurious to health." This Article has laid stress on improvement of public health and  prohibition of drugs injurious to health as one of  the primary  duties  of  the State. In  Akhil  Bharatiya  Soshit Karmachari  Sangh v. Union of India, [1981] 1 SCC  246  this Court  has  pointed out that, "the  Fundamental  Rights  are intended to foster the ideal of a political democracy and to prevent the establishment of authoritarian rule but they are of no value unless they can be enforced by resort to courts. So  they are made justifiable. However, it is  also  evident that  notwithstanding their great importance, the  Directive Principles  cannot in the very nature of things be  enforced in  a  Court  of Law, but it does not  mean  that  Directive Principles  are  less important than Fundamental  Rights  or that  they  are  not binding on the various  organs  of  the State."  In  a series of pronouncements  during  the  recent years this Court has culled out from the provisions of  Part IV  of  the Constitution these several  obligations  of  the State  and called upon it to effectuate them in  order  that the  resultant  pictured  by the  Constitution  Fathers  may

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become  a  reality. As pointed out by  us,  maintenance  and improvement of public health have to rank high as these  are indispensable to the very physical existence of the communi- ty  and on the betterment of these depends the  building  of the  society  of which the  Constitution  makers  envisaged. Attending to public health, in our opinion, therefore, is of high priority--perhaps the one at the top.     None  of  the  parties before us  claimed,  and  perhaps tightly, that the prevailing state of affairs in this regard is a commendable one. The technical aspects which arise  for consideration in a matter of this type cannot be affectively handled  by a court. Similarly the question of policy  which is involved in the matter is also one for the Union  Govern- ment--keeping  the best of interests of citizens in view  to decide.  No final say in regard to such aspects  come  under the purview of the court. Yet there are certain  contentions raised by the petitioner which deserve serious consideration and we would now proceed to deal with them.     The branch with which we are now dealing, namely, health care  of  citizens,  is a problem with  various  facets.  It involves an everchanging challenge. There appears to be,  as it were, a constant competition between Nature (which can be said  to  be responsible for new ailments) on one  side  and human ingenuity engaged in research and 479 finding  out curative processes. This being  the  situation, the  problem has an ever-shifting base. It is  common  place that  what is considered to be the best medicine  today  for treatment  of a particular disease becomes out of  date  and soon goes out of the market with the discovery or  invention of  new drugs. Again what is considered to be  incurable  at any  given point of time becomes subjected to treatment  and cure  with new finds. There is yet another  situation  which must be taken note of as human knowledge expands and marches ahead. With the onward march of science and complexities  of the  living  process and hitherto unknown diseases  are  no- ticed.  To meet new challenges, new drugs have to be  found. In this field, therefore, change appears to be the rule.     We  have  already taken note of the  position  that  the Hathi  Committee  was  of the view that a  fixed  number  of formulations were enough to meet the demand. From the  coun- ter-affidavit of respondents 1 and 2, we have gathered  that this  conclusion of the Hathi Committee was not accepted  as on  analysis it was not found to be a correct  statement  of the  position. The World Health Organisation in its  report, on  the  basis of expert advice, is of the view  that  human ailments can be treated effectively with 285 basic drugs. We assume  and it is not disputed that the expertise  available to  the World Health Organisation was of a higher order  and perhaps  more accurate than what was at the disposal of  the Hathi Committee. While we are cognizant of the position that the  problem is a shifting one and one cannot have  a  fixed process  to deal with the situations that would  arise  from time  to  time, the Central Government on the basis  of  the expert  advice can indeed adopt an approved national  policy and prescribe an adequate number of formulations which would on  the whole meet the requirement of the people  at  large. Obviously,  instant  attention has to be  bestowed  to  keep abreast  of  the  changing situations and  make  proper  and timely  amends. While laying the guidelines on  this  score, injurious  drugs should be totally eliminated from the  mar- ket. Great care in this regard has to be taken.     Such drugs as are found necessary should be manufactured in abundance and availability to satisfy every demand should be ensured. Undue competition in the matter of production of

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drugs by allowing too many substitutes should be reduced  as it  introduces  unhealthy practice and ultimately  tends  to affect quality. The State’s obligation to enforce production of  qualitative drugs and elimination of the injurious  ones from the market must take within its sweep an obligation  to make useful drugs available at reasonable price so as to  be within 480 the  common man’s reach. That would involve  regulating  the price. It may be that there may be an improved quality of  a particular medicine which on account of its cost of  produc- tion  will  have  to sell at a higher price  but  for  every illness which can be cured by treatment, the patient must be in a position to get its medicine. This, in our view, is  an obligation which the Court has already found in the relevant articles of Part IV of the Constitution.     The prescribed preparations must maintain their quality, and  for  ensuring  it, strict  regulations  are  necessary. Provision  in  statutes or rules or instructions  issued  by executive  authorities  do not meet the demands  of  today’s situation. The process of regulation has to be strengthened. Law must be provided with sufficient biting teeth and  there must  be  genuine apprehension in the mind of  every  person engaged  in the trade that any infraction would  be  visited with  exemplary punishment. In the prevailing  situation  in the  country, unless the law is properly enforced, it  would be difficult to regulate the quality of the drugs.  Standar- disation  of the preparations will also introduce a  healthy atmosphere  in the market. The practising doctor  should  be acquainted  with the drug policy, availability of drugs  and take care to prescribe available medicine to his patient.     There  must be due emphasis on indigenous production  so that in due course, what the Government contemplated in 1979 in its then drug policy may be effectuated by India. We have made  large  strides  in our advancement  in  the  field  of science  as  also manufacture of drugs  since  independence. Drugs  prepared in India today have an international  market in  a  limited way. There does not seem to be  any  lack  of ability  to  manufacture drugs. We  commend  to  Government, therefore,  that  the drug policy of the  Government  should emphasise  upon a time-bound switch over to indigenous  pro- duction.     Research in this field is of vital importance.  Constant attention  has to be devoted to get the best of  results  at the  laboratories  and put to use all useful  findings.  The traditional indigenous system of treatment in India had once upon a time made a lot of advancement. There is,  therefore, sufficient scope for research on the basis of our own knowl- edge. Herbal preparations, as far as practicable, should  be encouraged  and appropriate laboratories should be  set  up, both  in the public and the private sector to  continue  the system of research into every branch in this field  relevant to gathering of knowledge and proper utilisation thereof  in the field of treatment and manufacture of drugs. We  reiter- ate that it is not for the Court to lay down the drug policy of 481 the  Government. We are aware of the fact that the State  is concerned  and anxious to improve the general condition  and is  willing to exercise adequate control; Parliament has  in several legislations in recent years enhanced the penalities with  a  view to ensure elimination of injurious  drugs  and maintenance  of  the quality and standard of  drug  prepara- tions.  There is, however, no scope for complacency in  this field and constant and regular attention has to be  bestowed

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in  order that the flow into the market may be only  of  ac- ceptable drugs.     Every indigenous drug manufacturer must have an  obliga- tion by law to disclose the formula of preparation and other statutory information in the national language and at  least one  or  two other languages, keeping in view the  place  of manufacture of the drug and the area of its circulation. Any statutory warning to be administered should also follow  the same  course. We would like to indicate that it is  for  the Government  on the basis of expert advice to decide  whether use  of  poisonous medicine may not be  reduced;  after  all administering  the  warning is not a  sufficient  excuse  to circulate poison by way of medicine. We hope and trust  that the Union of India would come forward with a declaration  of its drug policy at a very early date.     It  appears to us that there is an immediate need for  a central  enforcement machinery in the interest of  community at  large.  We hope and expect that every  State  Government would  cooperate with the Central Government in this  regard and  the Central Government would take a lead  to  establish such an authority which would have jurisdiction all over the country with a view to regulating manufacture and  punishing defaults and lapses. Licencing of manufacture should also be centralised so that uniformity can be maintained. These  are matters  of  common  concern and we hope  that  the  Central Government, without loss of time, would take care to  evolve a  system which would effectively operate. Leave is  granted to the Central Government to apply to the Court, if there be any  difficulty  experienced  in implementation  of  such  a scheme.     Section  5 of the Act authorises constitution of a  Cen- tral  Drugs Technical Advisory Board as also a  State  Board for  each State. The object of setting up of such Boards  is to  advise the respective Governments on  technical  matters arising  out of the administration of the Act and  to  carry out  such other functions as are assigned to the  Boards  by the  Act.  Sub-section (2) provides for the manning  of  the Central Board. We are of the view that adequate  representa- tion  should  be,  provided to consumers and  at  least  two capable representatives from 482 out  of  their category should be nominated by  the  Central Government. The manning of this Board should be such that in its  functioning  it would be in a position  to  effectively advise the Central Government on all technical matters.     Section  7  provides  for the setting up  of  the  Drugs Consultative  Committee  and  its statutory  purpose  is  to advise the Central Government, the State Governments and the Drugs  Technical  Advisory Board on any  matter  tending  to secure uniformity throughout India in the administration  of the Act. We are of the view that on this Committee too there should be adequate representation on behalf of the consuming public.  If  necessary, prompt steps may be taken  to  bring about  suitable amendments to authorise such  representation both on the Technical Board as also the Consultative Commit- tee.     The  Central  Government  should set  up  regional  Drug Laboratories  in addition to the Central Laboratory as  pro- vided  by  section 6 of the Act to  facilitate  and  promote research and coordinate activity in that regard.     We  have  no doubt that the existing  Drug  Consultative Committee is a useful body but the Central Government should consider whether it requires to be broad-based and  confined with larger scope of operation or it is necessary to consti- tute  another high powered authority, as prayed for  by  the

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petitioner  so that such a vital matter like  public  health does not go without adequate attention.     Before we part with the case, we must point out that the amending provisions of 1982 which were brought into force in 1983  have remained mostly inoperative on account of  orders of injunction granted by High Court. The Central  Government may  get  impleaded in the pending  proceedings  before  the different  High Courts and request the said High Courts  for expeditious  disposal of the matters. At one point of  time, we  were thinking of making an order dissolving the  interim directions but that would have necessitated impleading these parties  in this case and hearing them. We have,  therefore, thought it proper to suggest that the Central Government may get  impleaded in the pending proceedings, if they  are  al- ready not parties and apply to the High Courts. We sincerely hope that when any such application is moved before the High Court  where  a dispute of this type is  pending,  the  High Court would make every endeavour to expedite the disposal of the  proceedings and have the same disposed of as  early  as possible  and preferably within a period of two months  from the date when it is 483 approached  so  that the dispute may end. If  there  be  any difficulty  in giving effect to this part of  the  judgment, the  Central Government has leave of this Court to  make  an appropriate application for directions.     The objection raised by the petitioner with reference to specific  medicines has not been examined by us  mainly  for the reason that we have found this proceeding not an  appro- priate  one  for such purpose. We, however,  hope  that  the Central Government shall take into consideration the  objec- tions raised by the petitioner and have the same referred to the  Consulative Committee or to such other body as it  con- siders expedient for immediate examination and a decision in that regard shall be taken, not later than six months.     The  petitioner  has indeed done a  commendable  job  in bringing the matter before the Court. We appreciate his move and are inclined to think that he should be suitably compen- sated  with a view to reimbursing him for the  expenses.  We direct  the Ministry of Health of the Central Government  to deposit a sum of Rs.5000 (Rupees Five Thousand only) in this Court  within two months hence which the petitioner will  be at liberty to withdraw. Petition disposed of. 484