TMI Blog2011 (7) TMI 1083X X X X Extracts X X X X X X X X Extracts X X X X ..... y Welfare, Government of India] is unconstitutional and invalid. The grievance is primarily in regard to Rule 44-I inserted in the Prevention of Food Adulteration Rules 1955 by the said Amendment Rules. The said Rule reads as follows : 44 I. Restriction on sale of common salt No person shall sell or offer to expose for sale or have in his premises for the purpose of sale, the common salt, for direct human consumption unless the same is iodized : Provided that common salt may be sold or exposed for sale or stores for sale for iodization, iron fortification, animal use, preservation, manufacturing medicines, and industrial use, under proper label declarations, as specified under clause (22) of subrule (zzz) of rule 42. The incidental challenge is to consequential amendments to the Rules by insertion of Rule 43(zzz)(22) which reads as under : Rule 43(zzz)(22). Every container or package of common salt shall bear the following label, namely : 2. The Government of India has been promoting the use of iodised salt in place of common salt, for human consumption, since 1962 by launching a centrally assisted programme for supplying iodised salt in place of common sal ..... X X X X Extracts X X X X X X X X Extracts X X X X ..... overnment omitted Rule 44H from the Rules with effect from 30.9.2000, by the Prevention of Food Adulteration (Fifth Amendment) Rules 2000 (vide notification dated 13.9.2000), so that more informed decisions could be taken by the respective State Governments on the question whether a provision should be made for sale of only iodised salt for direction human consumption. It was felt that by providing such option to the state governments, there would be no unnecessary compulsion to use iodised salt in areas where iodine deficiency disorders were not prevalent. The Central Government also proposed to play a greater role in enhancing the awareness about the benefits of iodised salt and monitor the impact of the salt iodisation programme in the country. 4. The said omission of Rule 44-H was challenged by Common Cause , an NGO, in Writ Petition (C) No.525 of 2000 in this Court. During the pendency of W.P. (C) No.525 of 2000, a Core Advisory Group on Public Health Human Rights, National Human Rights Commission, was required to critically apprise the evidence available on the public health consequences arising from consumption of non-iodized salt by the populace. The said Core Advisor ..... X X X X Extracts X X X X X X X X Extracts X X X X ..... en people who do not suffer from iodine deficiency are forced to take iodised salt regularly, there is risk of many of them developing complications induced by higher intake of iodine and increase in iodine levels. According to the petitioners, constant use of iodised salt on account of compulsory iodisation, would lead to iodine-induced hyper-thyroidism with increased chances of death. It is contended that while iodised salt would help to make up the iodine deficiency in about 10% of the populace, it would adversely affect the health of remaining 90% of the populace who have no deficiency in iodine levels. 5.1) The petitioners submit that when the entire populace do not need iodised salt, it is unfair and unjust to deny them the right to choose between iodised salt and non-iodised salt. It is submitted that Rule 44-I violates Articles 14 and 21 of the Constitution, which entitle every person to have free choice in regard to consumption of food. 5.2) The petitioners submit that the cost of iodised salt being several times more than the cost of non-iodised salt, the majority of the populace were adversely affected by the rule requiring compulsory iodisation. It is contended th ..... X X X X Extracts X X X X X X X X Extracts X X X X ..... re licensed and more than 500 units have started production of iodised salt. Respondent contends that Rule 44-I is neither inconsistent with the provisions of the Act nor beyond its rule making power. The power to make such a rule is traced to section 7(iv), and section 23(1) and 23(1A)(f) of the Act. 7. Therefore, the following two questions arise for our consideration: (i) Whether Rule 44-I is unconstitutional? (ii) Whether Rule 44-I is inconsistent with the Act and beyond the rule making power of the Central Government? Re : Question (i) 8. The question whether iodised salt is beneficial to the public or whether it causes harm to the majority of the populace, is a highly disputed and debated issue, on which there is strong divergence of opinion in the scientific community and among the experts on medicine, nutrition and public health. The petitioners have produced some medical and scientific literature which according to them demonstrates that Universal Salt Iodisation (for short USI ) is not completely effective in attaining its object of elimination of Iodine Deficiency Disorders and at the same time injurious to the majority of populace who do not suffer from ..... X X X X Extracts X X X X X X X X Extracts X X X X ..... and control of Iodine Deficiency Disorders by Basil Hetzel, United Nations Publication, March 1988 Page 76-77 and N. Kouchupillai M.M.Godbole, N.F.I. bulletin October 1986 page 343). 10. In an open letter dated 9.9.2005 addressed to the Minister for Health Family Welfare, Government of India, 235 eminent doctors and medical experts pointed out that adverse side-affects to a large number would outweigh benefits to a few and raised the following issues for the consideration of the Ministry : The studies available in the public domain provide only weak evidence in support of the universal ban. The prevalence and seriousness of the problem both appear to have been overestimated, especially given that some qualified analysts have pointed out methodological flaws. For instance, goiter is known to be difficult to assess, and it can exist as a physiological (normal) condition as well as a disease condition, but the studies do not account for this. The studies assessing impact of salt iodisation programmes appear to have assumed effectiveness of the programme approach, even though findings of several studies demonstrate varying impact. Some studies show little impact ..... X X X X Extracts X X X X X X X X Extracts X X X X ..... y addition of potassium iodate which may be harmful to some, iodised salt is the adulterated salt. (d) Iodised salt is known to cause hyperthyroidism and also severe allergic reactions to some and its universal consumption leads to health hazards. (e) Without correcting iron and protein deficiencies, advising people to consume iodised salt amounts to putting cart before the horse. (f) People who are deficient in iodine, are deficient in all nutrients. For them total nutrition correction and not iodised salt is the answer. Material in support of the compulsory use of iodised salt 12. On the other hand the respondent submitted that the decision to ban non-iodised salt for human consumption was taken on detailed studies and on the advice of the Core Advisory Group on Public Health and Human Rights (NHRC). Reliance is placed on the following passages from the report dated 6.2.2004 of the Core Advisory Group : The Core Advisory Group reviewed the documents which were sent to it by the NHRC and the members also drew upon their expertise and several scientific publications, to critically appraise the evidence available on the public health consequences arising from ..... X X X X Extracts X X X X X X X X Extracts X X X X ..... ements in Human Nutrition [2004 Edition, p.314] states: Excess iodine intake in healthy adults in iodine replete areas is difficult to define. Many people are regularly exposed to huge amounts of iodine- in the range of 10-200 mg/daily without apparent adverse effects This tolerance to huge doses of iodine in healthy iodinereplete adults is the reason why WHO stated in 1994 that, Daily iodine intake of upto 1 mg i.e. 1000 ug appears to be entirely safe . In conclusion, it appears clearly that the benefits of correcting iodine deficiency far outweigh the risks of iodine supplementation. Report of a WHO Expert Consultation: Salt as a Vehicle for Fortification , (2007), at p. 7 states: Salt is the most widely used food vehicle for iodine fortification. USI, that is iodization of all salt for human (food industry and household) and livestock consumption, is the strategy recommended by WHO for the control of iodine deficiency (WHO, 1999). Salt iodization programmes are currently implemented in over 70 countries around the world where IDD is a public health problem (Delange F, et al, 1999). Lewis E Braverman in his article Adequate iodine intake the good far outwei ..... X X X X Extracts X X X X X X X X Extracts X X X X ..... is supplied) 14. There is thus some material to support the contention of the petitioners that around 90% of the populace do not need iodised salt and that consumption of excess iodine may have some adverse effects. On the other hand there is also considerable material for the view that compulsory iodisation is also necessary to prevent IDDs in about 10% (or more) of the populace and the consumption of iodised salt by the remaining 90% who do not require it, may not be injurious to their health as excess iodine is easily excreted. The question whether there should be universal salt iodisation is a much debated technical issue relating to medical science. An informed decision in such matters can only be taken by experts after carrying out exhaustive surveys, trials, tests, scientific investigations and research. Courts are neither equipped, nor can be expected to decide about the need or absence of need for such universal salt iodisation on the basis of some articles and reports placed before it. This Court in a series of decisions has reiterated that courts should not rush in where even scientists and medical experts are careful to tread. The rule of prudence is that courts will ..... X X X X Extracts X X X X X X X X Extracts X X X X ..... th common salt and iodised salt are available in the market and only those 10% who are deficient in iodine can opt for iodised salt. The Government of India has taken note of scientific and medical inputs, research results and survey data to conclude that compulsory iodisation is the most effective and accepted method for elimination of iodine deficiency disorders and that consumption of iodised salt by persons not suffering from iodine deficiency will not adversely affect them. Rule 44-I is stated to be in implementation of a policy decision regarding public health. The material placed by the petitioners is not sufficient to hold that the reason for the ban is erroneous and that Rule 44-I is unreasonable and arbitrary. We therefore reject the contention that the provision placing a ban on sale of non-iodised salt for human consumption resulting in compulsory intake of iodised salt, is arbitrary and violative of Article 14 or injurious to the health of general populace and therefore violative of Article 21. The use of common salt (non-iodised salt) for industrial and commercial use has not prohibited. The ban operates only in regard to use of common salt for human consumption. Ther ..... X X X X Extracts X X X X X X X X Extracts X X X X ..... other article which the Central Government may, having regard to its use, nature, substance or quality, declare, by notification in the Official Gazette, as food for the purposes of this Act; Food (Health) Authority is defined in section 2(vi) as under : Food (Health) Authority means the Director of Medical and Health Services or the Chief Officer in-charge of Health administration in a State, by whatever designation he is known, and includes any officer empowered by the Central Government or the State Government, by notification in the Official Gazette, to exercise the powers and perform the duties of the Food (Health) Authority under this Act with respect to such local area as may be specified in the notification; Section 23 of the Act relates to the power of the central government to make rules, relevant portions of which are extracted below : 23. Power of the Central Government to make rules. (1) The Central Government may, after consultation with the Committee and after previous publication by notification in the Official Gazette, make rules to carry out the provisions of this Act: x x x (1A) In particular and without prejudice to the generality of the f ..... X X X X Extracts X X X X X X X X Extracts X X X X ..... erpretation of statutes that the conferment of rule-making power by an Act does not enable the rule making authority to make a rule which travels beyond the scope of the enabling Act or which is inconsistent therewith or repugnant thereto. (emphasis supplied) In Indian Express Newspapers (Bombay) Pvt. Ltd vs. Union of India 1985 (1) SCC 641, this Court held : A piece of subordinate legislation does not carry the same degree of immunity which is enjoyed by a statute passed by a competent legislature. Subordinate legislation may be questioned on any of the grounds on which plenary legislation is questioned. In addition, it may also be questioned on the ground that it does not conform to the statute under which it is made. It may further be question on the ground that it is contrary to some other statute. That is because sub-ordinate legislation must yield to plenary legislation. (emphasis supplied) In General Officer Commanding-in-Chief vs. Dr. Subhash Chandra Yadav 1988 (2) SCC 351, this Court held : Rules have statutory force. But before a rule can have the effect of a statutory provision, two conditions must be fulfilled, namely, (1) it must conform to th ..... X X X X Extracts X X X X X X X X Extracts X X X X ..... ancillary. It will authorise the provision of subsidiary means of carrying into effect what is enacted in the statute itself and will cover what is incidental to the execution of its specific provision. But such a power will not support attempts to widen the purposes of the Act, to add new and different means of carrying them out or to depart from or vary its ends. (See Section 59 in chaper Delegated Legislation in Francis Bennion s Statutory Interpretation, 3rd Edn.) (emphasis supplied) In J. K. Industries vs. Union of India 2007 (13) SCC 673, this Court reiterated the grounds on which a sub-ordinate legislation can be challenged as follows : That, any inquiry into its vires must be confined to the grounds on which plenary legislation may be questioned, to the grounds that it is contrary to the statute under which it is made, to the grounds that it is contrary to other statutory provisions or on the ground that it is so patently arbitrary that it cannot be said to be in conformity with the statute. It can also be challenged on the ground that it violates Article 14 of the Constitution. 21. We will now examine whether the rule is valid in the light of the aforesa ..... X X X X Extracts X X X X X X X X Extracts X X X X ..... hat no person shall manufacture for sale, store, sell or distribute any article of food, the sale of which is for the time being prohibited by the Food (Health) Authority in the interest of public health. Rule 44-I is not a prohibition by the Food (Health) Authority in the interest of public health. The Food (Health) Authority refers to the Director of Medical and Health Services or the Chief Officer in-charge of the health administration in a state as also any officer empowered by the central government or the state government by notification in the official gazette to exercise the power and perform the duties of the Food (Health) Authority with respect to such local area as may be specified in such notification. We are not concerned with either any notification by the central government constituting the Food (Health) Authority nor the exercise of power by any Food (Health) Authority in the interest of public health. Therefore, section 7(iv) is of no assistance to decide upon the validity of rule 44-I, nor can it be a source of power to make rule 44-I, nor can it be a source of power to make rule 44-I. 24. If the Act vests the power of prohibiting the manufacture for sale, stor ..... X X X X Extracts X X X X X X X X Extracts X X X X ..... 6, the respondent specifically admits as follows : ...the respondent has never stated that the use of any non-iodised salt is injurious to health. the restriction on sale of noniodised salt have been issued in view of the fact that regular consumption of iodised salt ensures prevention and control of Iodine Deficiency Disorder. (emphasis supplied) In the additional counter affidavit filed by the respondent on 30.3.2009, the respondent has again reiterated as follows : That the respondent has never stated that the use of noniodised salt is injurious to health That there is no blanket ban on sale of common salt. The ban on sale of common salt has been imposed (by Rule 44-I)only for direct human consumption. Thus the ban on sale of direct salt for human consumption has been imposed in the interest of public health. (emphasis supplied) Section 23(1A)(f) empowers making a rule to prohibit sale only if the substance is injurious to health when used as food. If use of common salt is not injurious to health, the question of making a rule prohibiting the sale of such a substance would not arise under clause (f) of section 23(1A) of the Act. 26. We will next con ..... X X X X Extracts X X X X X X X X Extracts X X X X ..... ing of food adulteration or to suppress any social or economic mischief. What Relief? 27. We have already noticed that as at present there is no material to show that universal salt iodisation will be injurious to public health (that is to the majority of populace who do not suffer from iodine deficiency). But we are constrained to hold that rule 44-I is ultra vires the Act and therefore, not valid. The result would be that the ban on sale of non-iodised salt for human consumption will be raised, which may not be in the interest of public health. We are therefore, of the view that the central government should have at least six months time to thoroughly review the compulsory iodisation policy (universal salt iodisation for human consumption) with reference to latest inputs and research data and if after such review, is of the view that universal iodisation scheme requires to be continued, bring appropriate legislation or other measures in accordance with law to continue the compulsory iodisation programme. 28. The question is having held that Rule 44-I to be invalid, whether we can permit the continuation of the ban on sale of non-iodised salt for human consumption for any ..... X X X X Extracts X X X X X X X X Extracts X X X X ..... to do complete justice between the parties...and are in the nature of supplementary powers...[and] may be put on a different and perhaps even wider footing than ordinary inherent powers of a court to prevent injustice. The advantage that is derived from a constitutional provision couched in such a wide compass is that it prevents 'clogging or obstruction of the stream of justice. [See : Supreme Court Bar Association (supra)] 29. In view of the above and to do complete justice between the parties in the interest of public health, in exercise of our jurisdiction under Article 142 of the Constitution, we direct the continuation of the ban contained in Rule 44-I for a period of six months. The central government may within that period review the compulsory iodisation programme and if it decides to continue, may introduce appropriate legislative or other measures. It is needless to say that if it fails to take any action within the expiry of six months from today, Rule 44-I shall cease to operate. 30. We therefore allow this writ petition in part and declare that Rule 44-I of the Prevention of Food Adulteration Rules, 1955 (inserted by Prevention of Food Adulteration (Eighth ..... X X X X Extracts X X X X X X X X Extracts X X X X
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