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TMI Blog1987 (3) TMI 519X X X X Extracts X X X X X X X X Extracts X X X X ..... 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 these Corporations in the Indian scene and pleaded for nationalising 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 d ..... X X X X Extracts X X X X X X X X Extracts X X X X ..... s 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 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 str ..... X X X X Extracts X X X X X X X X Extracts X X X X ..... e 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 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 recommended that a warning to the effect that there was possibility of congental malformation in case the preparations were administered in the earlier stage of pregnancy should be indicated. Accordingly, a decision was taken that combinations 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 promotional literature regarding the drugs:- "Warning:- There is some evidence to show that hormonal preparations when used during pregnancy 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 recommendat ..... X X X X Extracts X X X X X X X X Extracts X X X X ..... ee 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 framework 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 M ..... X X X X Extracts X X X X X X X X Extracts X X X X ..... g 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 recommendations 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 for ..... X X X X Extracts X X X X X X X X Extracts X X X X ..... armachari 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 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 community and on the betterment of these depends the building of the society of which the Constitu ..... X X X X Extracts X X X X X X X X Extracts X X X X ..... 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 market. 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 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 ..... X X X X Extracts X X X X X X X X Extracts X X X X ..... icient scope for research on the basis of our own knowledge. 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 reiterate 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 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 o ..... X X X X Extracts X X X X X X X X Extracts X X X X ..... e 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 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 Governmen ..... X X X X Extracts X X X X X X X X Extracts X X X X
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