CHOPRA, J. - (1.) IN this writ petition, the petitioner seeks relief that rule 2 (ee) (iii) of the Drugs and Cosmetics Rules, 1945 and Annx. 1 communication dated 26. 7. 1982, which has admittedly been issued in exercise of these powers by the State Government, be declared void and ultra vires to the Constitution, because, firstly; it is against the provisions of Drugs and Cosmetics Act, 1940 and, secondly; it is against the provisions of INdian Medical Council Act, 1956.
(2.) IN the earlier writ petition, bearing S. B. Civil Writ Petition No. 1533/82, a return was filed by the State Government and State Government admitted therein that Annx. 1 has been issued in exercise of powers conferred on the State Government under rule 2 (ee) (iii) of the Rules of 1945. This letter has been issued by the State Government in pursuance of a letter received by it from the Government of INdia, from the Additional Secretary (Health), Ministry of Health and Family Welfare, dated 11. 6. 1982. Earlier, certain notifications have been issued by the State Government on 14. 05. 1960 and 11. 02. 1966, exercising its powers under the aforesaid rule of the Rules of 1945, as regard the registration of Medical Practitioners and now, this latest notification Annx. l, dated 26. 7. 1982, has been issued in exercise of powers conferred on the State Government under rule 2 (ee) (iii) of the Rules of 1945. The Indian Medical Council Act, 1956 provided certain qualifications for registration as Medical Practitioners. This circular is against those provisions of the Indian Medical Council Act and, sec 15 (2) of the Indian Medical Council Act, 1956 provides that - no person other than a Medical Practitioner, enrolled on a State Medical Register shall practice medicine in any State whereas Sec 15 (1) of the Act of 1956 lays down that the medical qualifications included in the Schedule shall be sufficient for enrolment on any State Medical Register. Now giving a go-bye to all these qualifications, which are mentioned in the Act of 1956, rule 2 (ee) (iii) of the Rules of 1945 authorises the State Government to register in the Medical Register persons, other than Homeopathic Practitioners of a State who although do not fall under clause (i) and (ii) but are declared, by a general or special order made by the State Government in this behalf, as persons practising the modern scientific system of medicine, for the purpose of this Act. It will be better to quote rule 2 (ee) clauses (i), (ii) and (iii) of the Rules of 1945, simultaneously, for a comparative study : - "2. Definitions.- (ee) Registered medical Practitioner means a person - (i) holding a qualification granted by an authority specified or notified under Section 3 of the Indian Medical Degrees Act, 1916 (7 of 1916), or specified in the Schedule to the Indian Medical Council Act, 1956 (102 of 1956); or (ii) registered or eligible for registration in a medical register of a State meant for the registration of persons practising the modern scientific system of medicine (excluding the Homeopathic system of medicine) ;or (iii) registered in a medical register other than a register for the registration of Homeopathic practitioners) of a State who although not falling within sub-clause (i) or sub-clause (ii) is declared by a general or special order made by the State Government in this behalf as person practising the modern scientific system of medicine for the purpose of this Act; or" Annx. 1 authorises the persons who have ten years' practice, even if they are eighth pass to be registered as Medical Practitioners, although they will be de-barred from practising surgery, obstetries and radiation - therapy. It means that persons who will be totally unqualified will be registered as Medical Practitioners, against the spirit of Indian Medical Council Act and against the provisions of the Rules of 1945 in pursuance of the instructions issued vide Annx. 1. Learned Addl. Advocate General who has appeared for the State, has categorically admitted that this Annex. 1 has been issued by the State Government in exercise of powers conferred on it under rule 2 (ee) (iii) of the Rules of 1945. It has been contended in the reply to show cause notice on behalf of the State Government, that the circular is neither ultra vires nor illegal and, therefore, it cannot be struck down, nor the rule can be struck down. Certain objections were raised on behalf of Private Medical Practitioners Association of India, Rajasthan Branch, Jaipur, about the admissibility of the writ petition, but the writ petition has already been admitted and the arguments were heard. Now this has to be seen whether rule 2 (ee) (iii) of the Rules of 1945, which has been framed by the Central Government, is ultra vires of the Drugs and Cosmetics Act 1940. The Drugs and Cosmetics Rules, 1945 have been framed by the Central Government vide notification No. 28/10/45 - H (l) New Delhi, dated 21. 12. 1945 in exercise of powers conferred on the Central Government by Sections 6 (2), 12 and 33 of the Drugs and Cosmetics Act, 1940 that is, Act No. 23 of 1945. Thus, the Central Government has framed these Rules in exercise of powers conferred on it by aforesaid three Sections, which read as under : - "6. The Central Drugs Laboratory. (2) The Central Government may after consultation with the Board make rules prescribing - (a) the functions of Central Drugs Laboratory; (b) & (c) (omitted) (d) the procedure for submission to the said Laboratory (under Chapter IV or Chapter IV A of samples of drugs or cosmetics) for analysis or test, the forms of the Laboratory's reports thereon and fees payable in respect of such reports; (e) such other matters as may be necessary or expedient to enable the said Laboratory to carry out its functions; (f) the matters necessary to be prescribed for the purposes of the proviso to sub-section (1 ). " "12. Power of Central Government to make rules.- (l) The Central Government may, after consultation with (or on the recommendation of) the Board and after previous publication by notification in the Official Gazette make rules for the purpose of giving effect to the provisions of this Chapter: Provided that the consultation with the Board may be dispensed with if the Central Government is of opinion that circumstances have arisen which render it necessary to make rules without such consultation, but in such a case the Board shall be consulted within six months of the making of the rules and the Central Government shall take into consideration any suggestions which the Board may make in relation to the amendment of the said rules. (2) Without prejudice to the generality of the foregoing power, such rules may - (a) specify the drugs or class of drugs (or cosmetics or class of cosmetics) for the import of which a licence is required and prescribe the form and conditions of such licences, the authority empowered to issue the same, the fees payable therefore (and provide for the cancellation or suspension of such licence in any case where any provision of this Chapter or the rules made there under is contravened or any of the conditions subject to which the licence is issued is not complied with); (b) prescribe the method of test or analysis to be employed in determining whether a drug (or cosmetic) is of standard quality; (c) prescribe, in respect of biological and organometallic compounds, the units or methods or standardisation; (cc) prescribe under clause (d) of Section 9-A the colour or colours which a drug may bear or contain for purposes of colouring : (d) specify the diseases or ailments which an imported drug purport or claim to prevent cure or mitigate and such other effects which such drug may not purport or claim to have; (e) prescribe the conditions subject to which small quantities of drugs, the import of which is otherwise prohibited under this Chapter may be imported for the purpose of examination, test or analysis for personal use; (f) prescribe the places at which drugs or cosmetics may be imported and prohibit their import at any other place; (g) require the date of manufacture and the date of expiry of potency to be clearly and truly stated on the label or container of any specified imported drug or class of such drugs and prohibit the import of the said drug or class or drug after the expiry of a specified period from the date of manufacture; (h) regulate the submission by importers and the securing, of samples of drugs (or cosmetics) for examination, test or analysis by the Central Drugs Laboratory, and prescribe the fees, if any, payable for such examination, test or analysis; (i) prescribe the evidence to be supplied, whether by accompanying documents or otherwise of the quality of drugs (or cosmetics) sought to be imported, the procedure of officers of Customs in dealing with such evidence and the manner of storage at places of import of drugs (or cosmetics) detained pending admission; (j) provide for exemption, conditionally or otherwise from all or any of the provisions of this Chapter and the rules made thereunder of drugs (or cosmetics) imported for the purpose only of transport through, and export from India; (k) prescribe the conditions to be observed in the packing of bottles, packages or other containers of imported drugs (or cosmetics) (including the use of packing material which comes into direct contact with the drugs); (l) regulate the mode of labelling the drugs (or cosmetics) imported for sale in packages, and prescribe the matters which shall or shall not be included in such labels; (m) prescribe the maximum proportion of any poisonous substance which may be added to or contained in any imported drug, prohibit the import of any drug in which that proportion is exceeded, and specify substances which shall be deemed to be poisonous for the purpose of this Chapter and the rules made there under; (n) require that the accepted scientific name of any specified drug shall be displayed in the prescribed manner on the label or wrapper of any imported, patent or proprietary madicine' containing such drug ; (o) provided for the exemption, conditionally or otherwise, from all or any of the provisions of this Chapter or the rules made there under, of any specified drug or class of drugs (or cosmetics or class of cosmetics)". "33. Power of Central Government to make rules. (1) The Central Government may after consultation with, or on the recommendation of the Board and after previous publication by notification in the Official Gazette, make rules for the purpose of giving effect to the provisions of this Chapter; Provided that consultation with the Board may be dispensed with if the Central Government is of opinion that circumstances have arisen which render it necessary to make rules without such consultation but in such a case the Board shall be consulted within six months of the making of the rules and the Central Government shall take into consideration any suggestions which the Board may make in relation to the amendment of the said rules. (2) Without prejudice to the generality of the foregoing power, such rules may - (a) provide for establishment of laboratories for testing and analysing drugs (or cosmetics); (b) prescribe the qualifications and duties or Government Analyst and the qualification of Inspectors; (c) prescribe the methods of test or analysis to be employed in determining whether a drug or cosmetic is of standard quality; (d) prescribe, in respect of biological and organometallic compounds, the units or methods of standardisation; (dd) prescribe under clause (d) of Section 17-A the colour or colours which. a drug may bear or contain for purpose of colouring; (e) prescribe the forms of licences for the manufacture for sale or for distribution, for the sale and for the distribution of drugs or any specified drug or class of drugs or cosmetics or any specified cosmetic or class of cosmetics the form of application for such licences, the conditions subject to which such licences may be issued, the authority empowered to issue the same the qualification of such authority and the fees payable therefor and provide for cancellation or suspension of such licences in any case where any provision of this Chapter or the rules made thereunder is contravened or any of the conditions subject to which they are issued is not complied with; (ee) prescribe the records, registers or other documents to be kept and maintained under Section 18 B; (eea) prescribe the fees for the inspection (for the purposes of grant or renewal of licences) of premises, wherein any drug or cosmetic is being or is proposed to be manufactured; (eeb) prescribe the manner in which copies are to be certified under sub-section (2-A) of Section 22; (f) specify the diseases or ailments which a drug may not purport or claim to prevent cure or mitigate and such other effects which a drug may not purport or claim to have; (g) prescribe the conditions subject to which small quantities or drugs may be manufactured for the purpose of examination, test or analysis; (h) require the date of manufacture and date of expiry or potency to be clearly and truly stated on the label or container of any specified drug or class of drugs, and prohibit the sale, stocking or exhibition for sale, or distribution of the said drug or class of drugs after the expiry of a specified period from the date of manufacture or after the expiry of the date or potency; (i) prescribe the conditions to be observed in the packing in bottles, packages and other containers of drugs or cosmetics including the use of packing material which comes into direct contact with the drugs, and prohibit the sale stocking and exhibition for sale, or distribution of drugs or cosmetics packed in contravention of such conditions; (j) regulate the mode of labeling packed drugs or cosmetics and prescribe the matter which shall or shall not be included in such labels; (k) prescribe the maximum proportion of any poisonous substance which may be added to or contained in any drug, prohibit the manufacture, sale or stocking or exhibition for sale or distribution of any drug in which that proportion is exceeded, and specify substances which shall be deemed to be poisonous for the purposes of this Chapter and the rules made thereunder; (1) require that the accepted scientific name of any specified drug shall be displayed in the prescribed manner on the label or wrapper of any patent or proprietary medicine containing such drug; (m) omitted (n) prescribe the powers and duties of Inspectors and the qualifications of the authority to which such Inspectors shall be subordinate and specify the drug or classes of drugs or cosmetics or classes or cosmetics in relation to which and the conditions, limitations or restrictions subject to which, such powers and duties may be exercises or performed; (o) prescribe the forms of report to be given by the Government Analyst and the manner of application for test or analysis under Section 56 and the fees payable therefore; (p) specify of offences against this Chapter or any rule made there under in relation to which an order of confiscation may be made under Section 31; and (q) provide for the exemption conditionally or otherwise, from all or any of the provisions of this Chapter or the rules made thereunder, of any specified drug or class of drugs or cosmetic or class of cosmetics; omitted. " All of these three Sections no where provide that the Central Government has power to frame rules for the registration of Medical Practitioners. Thus, the rule which contain provision 2 (ee) (iii) could not have been framed in exercise of powers conferred on the Central Government under these three Sections. It is not the case of the respondents that they have been framed under any other law, for the time being in force. A bare reading of these three Sections clearly indicates that they authorise the Central Government to frame rules for the Central Drugs Laboratory and for giving effect to the provisions contained in Chapter III as regard import of drugs and cosmetics vide Section 12 of the aforesaid Act and Section 33 authorises the Central Government to frame rules in consultation with or on the recommendations of the Board after PBO publication for the purposes of Chapter IV of the Act, which deals with the manufacture, sale and distribution of drugs and cosmetics. These Chapters do not make any provision for registration of Medical Practitioners.
(3.) UNDER these circumstances, rule 2 (ee) (iii) of the Rules of 1945 is against the legislative competence of the Central Government because, these Rules have been framed in exercise of powers conferred on the Central Government under Sections 6 (2), 12 and 33 of the Drugs and Cosmetics Act, 1940 and when those provisions of the Act do not entitle it to frame rules for registration of Medical Practitioners the powers conferred on the State Government by rule 2 (ee) clause (iii), are ultra vires of the Act of 1940 and, therefore, this rule (rule 2 (ee) (iii)) is to be declared as ultra vires of the Drugs and Cosmetics Act, 1940 and, any circular which has been issued by the State Government in exercise of powers under aforesaid rule, is also to be quashed. It is argued by Mr. Bhandari, orally as also by ,a written argument slip submitted before us after closure of arguments, that the Act of 1940 is a pre constitutional law and subject matter of the Act of 1940 now falls, under Entry 19 of List III of Schedule VII of the Constitution and, therefore, it confers concurrent jurisdiction on the Central Government and the State Government to frame the rules. It is not the competence of the State Government to frame the rules which is challenged before us. What is under challenge is validity of rule 2 (ee) (iii) of the Rules of 1945, which has been framed by the Central Government, rather against its legislative competence because Sections of the Act of 1940 under which these Rules of 1945 have been framed, i. e. rule 2 (ee) (iii) of these Rules is ultra vires of those provisions of the Act. Those provisions of the Act nowhere authorise the Central Government to frame rules about who will be registered as Medical Practitioner and who will be entitled to practise medicine. Actually, this rule is against Section 15 of the Indian Medical Council Act 1956 which confers right on the persons possessing qualifications prescribed in the Schedule to that Act, to be authorised to be enrolled as Medical Practitioners on any State Medical Register. As this rule is against the provisions of Sec. 15 of the Act of 1956, this is another ground on which the rule is to be struck down and, if rule is to be struck down the impugned Annx. 1 which has been issued in exercise of powers under this rule is also to be quashed. Shri Saluja has placed reliance in this connection on a decision of their Lordships of Supreme Court rendered in Dr. A. K. Sabapathy v. State of Kerala and ors. (1) wherein the provisions of the Travancore-Cochin Medical Practitioners' Act (9 of 1953), Section 38 first proviso and the notifications issued by the State Government in exercise of those powers dated 13. 4. 1981 were under challenge. Their Lordships felt that if any provision of the Act or the Circular is against the recognised Medical qualification for enrolment as Medical Practitioner under the allopathic system of medicine, as prescribed by the Indian Medical Council Act, 1956 then that Section or the notification is to be held void. ;