TaxTMI 
TaxTMI 
1987 (3) TMI 519
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.... 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 measures including award of compensation. He has further prayed that directions should be given for framing of strict regulations 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 Corporations 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 inadequate. 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 ....
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....l 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 manufacture, sale or distribution thereof. The amended Act came into force with effect from 1st February, 1983, but....
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....s issued by the Central Drugs Controller to the State Drugs Control Authorities in the matter of banning of Oestrogens and Progestins. That circular 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 Governments 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 although in advanced countries hormonal preparations for pregnancy testing had been disconti....
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....nbsp; 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 Sections 10-A and 26-A of the Act. The counter affidavit further 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....
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....s 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 exparte. 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 authorities to come forward and place their view points on relevant aspects, an attitude of callous indifference cannot be appreciated. We hope and trust that there would be no repetition of such a situation. It must be remembered that this is not a normal litigation 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 interest&n....
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....therefore, it is the obligation of the State to ensure the creation and the sustaining of conditions congenial to good health. This Court in Bandhua 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 conditions of work and maternity relief. These are the minimum requirements which must exist in ....
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....ore, 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 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. 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 bein....
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....sp; 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 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 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, 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 i....
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....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 preparations. There is, however, no scope for complacency in this field and constant and regular attention has to be bestowed in order that the flow into the market may be only of acceptable drugs. Every indigenous drug manufacturer must have an obligation 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 ....
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....tion 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 Committee. The Central Government should set up regional Drug Laboratories in addition to the Central Laboratory as provided 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 constitute another high powered authority, as prayed for by the 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 ....