Shri Krishna Homeo Pharmacy a Partnership Firm, Registered Under the Indian Partnership Act Vs. Union of (Uoi) India Through Secretary, Ministry of Health and Family Welfare (Dept. of Health) and ors. - Court Judgment

Excerpt:
- section 10: [swatanter kumar, c.j., a.p. deshpande & smt. nishita mhatre, jj] admission to professional colleges - technical courses - publication of brochure on basis of which candidates seek admission to various institution keeping in mind their merit and preference of colleges held, for ensuring adherence to proper appreciation of an academic course, it is essential that the method of admission is just, fair and transparent. the first step in this direction would be publication of a brochure on the basis of which the applicants are supposed to aspire for admission to various institution keeping in mind their merit and preference of college. brochure, firstly has to be in conformity with law and the statutory scheme notified by the competent authority. it is a complete and composite document as it deals with the scheme for conducting their entrance examinations, declaration of results, general instructions and method of admission, etc. this brochure is binding on the applicants as well as the authorities. this brochure or admission notification issued by the state or other competent authority cannot be altered at a subsequent stage particularly once the process of admission has begun. there is hardly any exception to this accepted rule of law. section 10: [swatanter kumar, c.j., a.p. deshpande & smt. nishita mhatre,jj] admission to professional colleges - technical courses - approval to additional seats or to start new course - cut off dates held, the settled principle of law is that merit of the applicant is the primary criteria which would determine his rank as well as the college where he would be entitled to admission. this rule should not be frustrated as it will tantamount to entirely upsetting the object of admissions based on merit oriented method and would cast cloud on the fairness and transparency of the method of admission. one of the ways in which merit can be defeated is allowing increase in the intake strength or commencement if new colleges beyond cut-off date and admissions beyond the last date specified in the notification/calendar issued by the concerned authorities. this can be illustrated by giving an example. college a which is running a professional course like engineering or mba etc. has an intake capacity of 60 seats which has duly been notified in the information brochure. however, after the cut-off date, approval is granted by the aicte and thereafter, the process is taken up by the state and the intake capacity of the college is increased by 30 more seats. these seats would obviously, not be notified in the information brochure and the candidate who are meritorious and for whom college a; be the college of reference could not get seats or give preference as the seats were limited. none had the proper knowledge about the increase in intake of seats though at a much subsequent stage and may be even after the last date of admission is over either by themselves or under the order of the court even it is put on the internet or given in the newspaper, the candidates of higher rank or meritorious candidates would not be able to avail of that benefit because they have already submitted the testimonial, have paid their fees and the courses have commenced. in that situation, for variety of reasons, they may not be able to take admission in the institution of their higher preference while the candidates of much lower merit will be admitted to that course. besides defeating the merit, it has been commonly noticed that the late admissions made by the colleges directly effect notified candidates who have questioned it more than often as their admission process is not so just, fair and transparent which has given rise to the litigation. it is also a kind of back door entry method. another serious consequence that result from such admissions is shortening of the academic courses in an undesirable manner. it is expected of other candidate selected to a professional course that he or she would complete the course in its entirety and not by missing more than a month or so in joining the said course. this results in lowering the excellence of education as well as harms the academic standard of professional education. admission to professional colleges: [swatanter kumar, c.j., a.p. deshpande & smt. nishita mhatre, jj] technical courses - held, in process of admission to professional colleges relating to technical courses, primarily three institutional bodies are involved. (i) all india technical council for technical education, (ii) state of maharashtra through director of technical education and (iii) university to which such institution is affiliated the role of all these institutions in distinct and different but for a common object. primary of the rule of all india council for technical education (aicte) is now well settled but that certainly does not mean that role of the state government and for that matter the university is without any purpose or of no importance. the council is the authority constituted under the central act with the responsibility of maintaining education standards and judging upon the infra-structure and facilities available for imparting such professional education. its opinion is of utmost importance and shall take precedence over views of the state as well as that of the university. the concerned department of the state and the affiliating university has a role to pay but it is limited in its application. they cannot lay down any guidelines or policies which would be in conflict with the central statute or the students laid down a by the central body. state can frame its policy for admission to such professional courses but such policy again has to be in conformity with the directives issued by the central body. while the state grants its approval and university its affiliation for increased intake of seats or commencement for a new course/college, its directions should not offend and be repugnant to what has been laid down in the condition of approval granted by the central authority or council. what is most important is that all these authorities have to work ad idem as they all have a common object to achieve i.e. of proper imparting of education an ensuring maintenance of proper standards of education, examination and ensuring proper infrastructure for betterment of educational system. only if all these authorities work in a co-ordinated manner and with co-operation they would be able to achieve the very object for which all these entities exist admission to professional courses: [swatanter kumar, c.j.,a.p. deshpande & smt. nishita mhatre, jj] admission schedule - interference by courts held, all the expert bodies viz. aicte as well as directorate of education in consultation with the departments of the state regulating the process of admission and maintenance of standards of education had notified a legal binding document specifying dates and schedule for various matters in relation to admission of students and commencement of courses. there has to be so compelling circumstances and grounds before the court to interfere with the prescribed schedule. it is neither so arbitrary nor so perverse, keeping in view the essential features relating to imparting education to professional courses that it should invite judicial chastisement to the extent of laying down entirely new schedule. merely because there has been some delay on the part of either of these authorities to timely grant of either of these authorities to timely grant or decline approval and permission to commence a course per se would not be sufficient ground for disturbing the notified schedule and timely commencement of courses. - the object of the restriction is clearly to prevent a misuse of the quantities of alcohol that are used in the manufacture of homoeopathic preparations. even on the assumption that a similar diversion of alcohol may conceivably take place in the manufacture of ayurvedic medicines, the argument of the petitioner at the highest would be that the classification is under inclusive, but it is well settled that it is not necessary for the legislature to regulate every conceivable activity in order to regulate something. that is for the parliament to best determine.d.y. chandrachud, j1. the petitioner is a partnership firm registered under the partnership act, 1932, and carries on the business of manufacturing and selling homoeopathic medicines at a factory situated at chinchwad. the homoeopathic medicines manufactured by the firm are broadly categorised into: i) homoeopathic potential dilutions; ii) mother tinctures;iii) bio-chemic tablets;iv) specialities and tonics; andv) sundries including globules, diskets and ointments. 2. the challenge in these proceedings is to a notification issued by the central government on 22nd february, 1994 by which the provisions of rule 106-b of the drugs and cosmetics rules, 1945 were inserted in exercise of the rule making power under the drugs and cosmetics act, 1940. rule 106-b provides as follows : '106-b. prohibition of quality and percentageno homoeopathic medicine containing more than 12% alcohol v/v (ethyl alcohol) shall be packed and sold in the packing or bottles of more than 30 milliliters, except that it may be sold to hospitals/ dispensaries in packings or bottles of not more than 100 milliliters.' the prohibition in rule 106-b is hence on the packing and selling of homoeopathic medicines with an alcohol content of more than 12% in containers of more than 30 milliliters. an exception has been made in the case of sale to hospitals and dispensaries where the dimensions of the container are not to exceed 100 milliliters. 3. on behalf of the petitioner, it has been submitted that (i) rule 106-b violates the fundamental rights of the petitioner under articles 14 and 19(1)(g) of the constitution; (ii) rule 106-b makes an unreasonable discrimination between homoeopathic and ayurvedic manufacturers, since there is no such prohibition in the case of ayurvedic medicines; (iii) rule 106-b is ultra vires the provisions of the drugs and cosmetics act, 1940 and that the requisite procedure was not followed while enacting the rule; (iv) the drugs technical advisory board was not competent to advice the government in respect of homoeopathic medicines since the board did not have any representative with expert knowledge in the field of homoeopathy. 4. an affidavit in reply has been filed in these proceedings by deputy drugs controller (india), central drugs standard control organization, west zone, mumbai, on behalf of the first, second and third respondents. the attention of the court has been drawn to the fact that similar writ petitions challenging the vires of rule 106-b were dismissed by the madras high court on 16th december, 1995 and by the patna high court on 5th january, 1998. it has been stated that the prohibition in question was brought into effect with the object of placing a ban on large size packaging of homoeopathic medicines containing more than 12% of alcohol. the prohibition, it has been stated, has been brought into effect in public interest in order to prevent the misuse of alcohol used in homoeopathic medicines and to provide quality medicines to beneficiaries of the homoeopathic system of medicine. it has been stated that the rule was introduced pursuant to the recommendations of a committee which enquired into the sura tragedy that occurred in delhi and that the findings of the committee established that there was a rampant misuse of alcohol, for purposes other than medicinal preparations. rule 106-b, it is urged, is a preventive measure against the misuse of alcohol which is made available to manufacturers at concessional rates for being used in the preparation of medicines. very often such alcohol is found to be diverted for other purposes. prior to the issuance of the notification by which rule 106-b was brought into force, homoeopathic medicines were available in the market in large packings of 450 milliliters and instances involving the wrongful use of alcohol used in the manufacture of these medicinal preparations were brought to light. hence, it was proposed to ban or prohibit the packaging and sale of homoeopathic medicines in containers exceeding 30 milliliters. the government of india is stated to have invited comments of manufacturers, retailers and traders of homoeopathic medicines on the draft notification which was widely circulated. the comments that were received were duly considered before the final notification was issued. the notification, it has been submitted, was issued by government in the interests of consumers and of the society at large. the manufacture and sale of medicines, it is urged, can be controlled and regulated both with reference to the standards to be observed and the manner or method of packing. 5. the drugs and cosmetics act, 1940 regulates the import, manufacture, distribution and sale of drugs and cosmetics. section 5 of the act provides for the constitution of a drugs technical advisory board to advise the central and state governments on technical matters arising out of the administration of the act and to carry out the other functions assigned to it by the act. the constitution of the board is provided by sub-section (2) of section 5, which is as follows : '(2) the board shall consist of the following members, namely, (i)the director general of health services, ex officio, who shall be chairman; (ii) the drugs controller, india, ex officio: (iii) the director of the central drugs laboratory, calcutta, ex officio; (iv) the director of the central research institute, kasauli, ex officio; (v) the director of the indian veterinary research institute, izatnagar, ex officio: (vi) the president of the medical council of india, ex officio; (vii) the president of the pharmacy council of india, ex officio; (viii) the director of the central drug research institute, lucknow, ex officio; (ix) two persons to be nominated by the central government from among persons who are in charge of drugs control in the states; (x) one person, to be elected by the executive committee of the pharmacy council of india, from among teachers in pharmacy or pharmaceutical chemistry or pharmacognosy on the staff of an indian university or a college affiliated thereto; (xi) one person, to be elected by the executive committee of the medical council of india, from among teachers in medicine or therapeutics on the staff of an indian university or a college affiliated thereto; (xii) one person to be nominated by the central government from the pharmaceutical industry; (xiii) one pharmacologist to be elected by the governing body of the indian council of medical research; (xiv) one person to be elected by the central council of the indian medical association; (xv) one person to be elected by the council of the indian pharmaceutical association; (xvi) two persons holding the appointment of government analyst under this act, to be nominated by the central government.' 6. the board is an expert body consisting of persons with wide experience in medicine, public health and pharmacy. section 33 of the act empowers the central government to frame rules after consultation with or on the recommendation of the board for the purpose of giving effect to the provisions of chapter iv which regulates the manufacture, sale and distribution of drugs and cosmetics.7. the production, manufacture, distribution and sale of drugs has serious ramifications on public health as it does impinge upon the welfare of the community. the drugs and cosmetics act 1940 and the rules which have been framed thereunder, therefore, regulate the conditions under which the manufacture, sale and distribution of drugs can take place. in the affidavit in reply that has been filed in these proceedings, the circumstances in which the provisions of rule 106-b came to be inserted have been adverted to. the central government was seized of complaints relating to the misuse of alcohol used in medicinal preparations and more particularly those in relation to misuse of alcohol in the manufacture of homoeopathic drugs. the imposition of a restriction on the size and packaging of the containers in which homoeopathic drugs incorporating more than 12% alcohol are sold is a reasonable restriction in the interest of the general public. the object of the restriction is clearly to prevent a misuse of the quantities of alcohol that are used in the manufacture of homoeopathic preparations. there is hence absolutely no merit in the submission that the rule is unconstitutional on the ground that there is a violation of the fundamental right under article 19(1)(g) of the constitution of india. the madras high court has repelled a similar challenge to the constitutional validity of rule 106-b and on this ground that it violates article 19(1)(g). in bhola laboratories v. union of india, in writ petitions 13679 and 26487 of 1995 decided on 6th december, 1995, mr. justice d. raju (as the learned judge then was) held thus : 'the manufacture and sale of medicine can be regulated and controlled both with reference to the standards and the manner and method of packing and the wisdom or expediency of the requirement in this regard are not matters which should concern the court unless it is demonstrated before this court that grave injustice or prejudice is caused by such prescription and that any of the legally protected rights are violated. in this case, though it is claimed that it is easy and convenient both for the manufacturer and the dealer to pack it in the quantity of 450 ml. as has hither to been, as to how the said stipulation really affect the petitioner manufacturer or the dealers or impedes his/their business is not demonstrated with any precision or clarity and that, therefore i do not see any legal grievance whatsoever substantiated in the submission made in this regard. as the rule stands, it appears even on a cursory reading that the object of the rule making authority is to prevent abuse of the drug concerned containing alcohol of more and above than a prescribed percentage for other than genuine and medicinal purposes by imposing a restriction in the manner of its package and that, in my view, no exception could be taken to the reasonableness of the measure. the plea based on articles 14 and 19(1)(g) of the constitution, therefore, fails and shall stand rejected.'the manufacture of drugs must be pursued in a manner which is consistent with the protection of public interest and rule 106-b is intended to ensure that there is no diversion or misuse of alcohol which is used in the preparation of homoeopathic medicines.8. there is absolutely no merit in the submission that there is a discrimination between manufacturers of homoeopathic and ayurvedic medicines. even on the assumption that a similar diversion of alcohol may conceivably take place in the manufacture of ayurvedic medicines, the argument of the petitioner at the highest would be that the classification is under inclusive, but it is well settled that it is not necessary for the legislature to regulate every conceivable activity in order to regulate something. the legislature can recognize and distinguish between degrees of evil and regulate those areas where its intervention is most required. such a classification cannot be regarded as arbitrary or unconstitutional.9. the submission that rule 106-b has been brought into force without complying with mandatory procedural requirements is based on the allegation that the drugs technical advisory board did not have any representative with an expert knowledge in the field of homoeopathy. the constitution of the board is provided for in section 5(2) of the act. hence, it would not be for the court to mandate any change in the statutory provision relating to the constitution of the board. that is for the parliament to best determine. moreover, in the affidavit in reply that has been filed in these proceedings, it has been pointed out that as homoeopathy is a full fledged and specialised branch of medicine, the drugs technical advisory board has constituted a sub-committee exclusively for homoeopathic science. homoeopathic drugs fall within the meaning of the expression 'drug' in section 2(b) of the act. part vii a of the drugs and cosmetics rules 1945 makes special provisions for the manufacture for sale or for distribution of homoeopathic medicines. part ix a similarly embodies provision for the labelling and packing of homoeopathic medicines. we are of the view that there is no merit in the submission that has been urged on behalf of the petitioner. the act has provided for a specific constitution of the drugs technical advisory board. the board, it has been stated before the court, duly considered the objections which were received from manufacturers before the rules were brought into force. 10. in the circumstances, we find that there is no merit in the petition. the petition is accordingly dismissed.