S. K. Dhaon, J. - (1.) IN this bunch the controversy is the same. All these petitions were heard together with a view to dispose them of finally. Accordingly, we are doing so.
(2.) WE are taking necessary facts from writ petition no. 9687 of 1981. Initially, in this petition there were IS petitioners However, learned counsel for the petitioners scored off 7 petitioners and, therefore, this petition is confined to M/s. J. Das and B. Dasi Brothers. The material facts in this petition are these. The petitioner in a Chemist and Drugist engaged in retail business of selling manufactured drugs in the form of tablets, powders, liquids and ointments. It is not maintaining any pharmacy for compounding of drugs against the prescriptions of the medical practitioners. It deals in allopathic drugs It is covered by the Drugs and Cosmetic Act, 1940 (hereinafter referred to as the Act). Rules have been framed under the said Act Rule 65 together with the provisions as contained in section 42 of the Pharmacy Act, 1948 (hereinafter referred to as the Pharmacy Act) are being enforced as against the petitioner. On the basis of the said Rules, the respondents insist that the petitioner cannot carry on the business of a chemist and drugist without employing a "qualified person " On the basis of section 42 of the Pharmacy Act, the respondents insist that the petitioner must employ a registered pharmacist if it wants to carry on its business. Failure to comply either with the rules or with section 42 of the Pharmacy Act will subject it to a penal action. The prayers to the petition are these. The respondents may be prohibited from enforcing section 42 of the Pharmacy Act with effect from 1st September, 1981, a writ in the nature of mandamus may be issued commanding the respondents and their subordinates to refrain from prosecuting and punishing the: petitioner for violating rule 65 (15) (c) of the Drugs and Cosmetic Rules, 1945 and section 42 of the Pharmacy Act. The further prayer is that Rule 65 (c) of the Drugs and Cosmetic Rules as amended and section 42 of the Pharmacy Act may be declared ultra vires as the same contravene Article 19 (1) (g) of the constitution, The respondents may be commanded to register the persons as "qualified persons" as they were doing before 31st December 1969. A counter affidavit has be:en filed by Sri J. N. Dutta, Assistant Drugs controller (India) Directorate General of Health services, Ministry of Health, Government of India, New Delhi. The material averments are these. The Act and the rules framed thereunder have been in force for over 35 years in this country. The Act regulates, the import, manufacture, distribution and sale of drugs and cosmetic with a view to ensuring that the consumer gets drugs of standard quality which are labelled properly. The Act has been amended by the Parliament on six occasions to keep in abrest with the changes that took place in the areas of pharmacy and medicines. The Commissioner, Food and Drugs Administration, Maharashtra had written to the Drugs controller (India) drawing his attention to the recommendation made by the study group constituted by the Central Council of Health and suggesting that Rule 65 (15) (c) of the Drugs and cosmetics rules be amended to provide that such persons who have not less than four years experience and who in the opinion of the licensing authority have adequate knowledge of dispensing of drugs should once again be accepted as 'qualified person." The Drugs technical advisory Board considered the proposal and recommended that it would not be desirable to amend Rule 65 (15; (c) as recommended by the Central Council of Health. In April, 1979, the Central Family Welfare Council and central council of Health recommended that no amendment be made in Rule 65 (15) The council felt that it was unlikely that the country's requirements of Pharmacists would be adequately met by September, 1981 and it would be necessary to extend the date of enforcement of section 42 of the Pharmacy Act by a period of three years to enable the States to train an adequate number of pharmacists during this period and recommended that the Pharamacy Act be amended so that section 42 of the said Act would come into force from 1st September, 1984, instead of Ist September 1981. Accordingly, a Bill was introduced in Parliament so as to extend the date of enforcement of section 42 from 1st September, 1981 to 1st September, 1984. Four categories of Pharmacists in service of retail pharmacy have been contemplated. They are (1) those registered under the Pharmacy Act prior to 1962 (2) qualified persons (3) recognised as qualified under Rule 65 (15) (c) upto 31st December, 1969, and (iv) persons not recognised as qualified but have experience in dispensing. There are two categories of Pharmacists, namely "diploma holder" and "degree pharmacists". While the diploma pharmacists are generally employed in chemist shops degree pharmacists are generally employed in factories. There is a provision in the Education Regulations that a matriculate having two years experience in dispensing could quality for regular diploma course in Pharmacy in one year after undergoing the course. The course could also be undergone by attending day or evening classes by taking part time tuition. In this State this provision was originally followed for a period of five years and it ended on 14th December 1964. However, after the amendment of the Pharmacy Act, 1976 and after taking a stock of the situation arising out of the mandatory enforcement of section 42 w.e.f. 1st September 1981, this provision of short term course was extended upto 31st August 1981. Thus, an additional facility was afforded to the unregistered persons to qualify themselves for registration in the State of Uttar Pradesh. There are over one lakh registered pharmacists in the: country at present and fresh diploma holders in pharmacy are being turned out every year. The preamble to the Act is, an Act to regulate the import, manufacture, distribution and sale of drugs and consmetics. Therefore, it is apparent that the regulation of distribution and sale of drugs is one of the objects of the enactment. Chapter IV of the Act deals with the manufacture, sale and distribution of drugs and cosmetics and the said chapter was enforced in this State on 1st October, 1947. Section 3 (b) contains an inclusive definition of "drug". It appears to be a comprehensive definition as it, inter alia, includes all medicines for internal or external use of human beings or animals and all substances intended to be used for or in the diagnosis, treatment, mitigation or prevention of any disease or disorder in human beings or animals, including preparations applied on human body of the purpose of repelling insects like mosquitoes. It also includes all such substances intended for use as components of a drug including empty gelatin capsules. It also includes all such devices intended for internal or external use in diagnosis, treatment, mitigation or prevention of disease or disorder in human beings or animals. In section 3 (f) "manufacture" too has been given an inclusive definition. According to it, in relation to any drug "manufacture" includes any process or part of a process for making, altering, ornaments finishing, packing, labelling, breaking up or otherwise treating or adopting any drug with a view to its sale or distribution but does not include the compounding or dispensing of any drug of the packing of any drug in the ordinary course of retail businesses. In section 3 (h) "patent or proprietary medicine" is defined to mean in relation to Ayurvedic, Sidha or Unani Bibb System and in relation to the Allopathic system of medicine a drug which is a remedy or prescription presented in a form ready for internal or external administration of human beings or animals and which is not included in the edition of the Indian Pharmacopoeia or any other pharmacopoeia authorised in this behalf by the Central Government after consultation with the Drugs Technical Advisory board. In section 3 (i) prescribed means prescribed by rules made under the Act.
(3.) SECTION 33, which falls within chapter IV, inter alia, provides that 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 the Chapter ("Chapter IV) Rule 64 of the Drugs and cosmetics rules. 1945 (hereinafter referred to as the Rules prescribes certain conditions which have to be satisfied before a licence is granted in forms 20, 20-B, 20-F, 20-G, 21 or 21-B. The proviso to rule 64 lays down that in the case of a pharmacy a licence in Form 20 or 21 shall not be granted unless the licensing authority is satisfied that the requirements prescribed for a pharmacy in Schedule N have been complied with. In schedule N a list of minimum equipment for the efficient running of a pharmacy is given. The explanation to this rules says that for the purpose of the rule the term ''pharmacy" shall be held to mean and include every store or shop or other place (1) where drugs are dispensed, that is, measured or weighed or made up and supplied or (2) where prescriptions are compounded, or (3) where drugs are prepared or (4) which has upon it or displayed within it, or affixed to or used in connection with it, a sign bearing the word or words "pharmacy" Pharmacist, Dispensing Chemist" or Pharmaceutical chemistry or (5) which, by sign, symbol or indication within or upon it gives the impression that the operations mentioned in (1), (2) and (3) are carried out in the premises or (6) which is advertised in terms referred to in (4) above. Rule 65 provides that licences in certain forms shall be subject to the conditions stated therein and to the following general conditions. We may note that it is the petitioner's own case that it has obtained one of the licences in either of the forms mentioned in rule 65. sub-rule (1) of rule 65 provides that any drug shall, if compounded or made on the licensee's premises be compounded or made by or under the direct and personal supervision of a qualified person Sub-rule (2) states that the supply, otherwise than by way of wholesale dealing of any drug supplied on the prescription of a Registered Medical practitioner shall be effected only by or under the personal supervision of a qualified person. It is thus clear that sub- rule 2 emphasises that a retail dealer, who supplies any drug on the prescription of a registered Medical Practitioner, shall do so only by or under the supervision of a qualified person. Sub-rule (3) also emphasises that the supply of any drug, other than those specified in Schedule X on a prescription of a registered medical practitioner shall be recorded etc. and in clause (g) it is enjoined that the signature of the qualified person by or under whose supervision the medicine was made up or supplied should also be entered in the register. It is thus clear that the Rule mandates that for the supply of any drug by a retail dealer on the prescription of a registered medical practitioner the presence of a qualified person is imperative. Sub-rule (15) of rule 65 (c) states that the description "Pharmacy" "Pharmacist" "Dispensing chemist or Pharmacutical Chemist" shall be displayed by such licensees who employ the services of a "qualified person" and maintain a "Pharmacy" for compounding against prescriptions. The explanation is important. It says that for the purposes of Rule 65 "Qualified person" means a person who :- (a) holds a diploma or degree in pharmacy or pharmaceutical chemistry of an institute approved by the licensing authority ; or (b) is a registered pharmacist as defined in the Pharmacy Act, 1948 ; Provided that in those states (including Union territories) where the first register of Pharmacist under section 29 of the said Act has not been prepared, a person possessing qualifications to have his name entered in that register shall be deemed to be qualified person till such time as that register is prepared ; or (c) has not less than four years' practical experience of dispensing which is in the opinion of the licensing authority adequate and has been approved by that authority as a "qualified person" on or before the 31st December 1969." ;