- (1.) V. N. Khare, Actg. C. J. and R. R. K. Trivedi, J. A Division Bench of this Court noticed conflict between the decisions given by the Division Benches in the case of M/s J. Das Bros. V. Union of India and others, reported in 1992 (1) EFR 606, and following this judgment, judgments given by several other Division Benches and the view expressed by another Division Bench in case of Amod Kumar Agarwal v. Union of India and others, 1994 (1) EFR 219 and consequently referred the matter to Full Bench. Thus, this matter has come up before us. Before we deal with the judgments of the two Division Benches mentioned above, it will be appropriate to mention the dispute which gave rise to the present petitions.
(2.) THE questions of law and fact almost in all the writ petitions are identical. We are mentioning the facts of Writ Petition No. 981 of 1994 - Ramesh Giri, Proprietor, M/s. Goswami Medical Stores v. State of U. P. and others. Petitioner is a chemist and druggist dealing in retail business of selling manufactured drugs in forms of tablets, powder, liquids and ointments. Petitioner does not have any licence for pharmacy. He also does not maintain any pharmacy nor compound, made up or dispense drugs. Most of the medicines sold by petitioner are patent and proprietary medicines. Case of the petitioner is that he sells drugs and medicines in the same wrapper or container in which the manufacturer has marketed them. THE petitioner has obtained licence from the District Licensing Authority in Forms 20 and 21 of the Drugs and Cosmetics Rules, 1945 (hereinafter referred to as the Rules ). Case of the petitioner is that the problem started with the amendment of Rule 65 (15) (ii) (c) by Notification dated 26-7-1969 published in the Gazette of Government of India, dated 17-8-1969. Prior to this amendment, the Chief Medical Officer/district Licensing Authority was empowered to issue certificate of qualified person on the basis of four years' experience at the retail shop of dispensing. This source of availability of pharmacists was totally stopped. After the amendment qualified persons were not available as registered pharmacists who possessed diploma or degree in pharmacy and are registered under Section 31 of the Phar macy Act, 1948. This amendment created shortage of qualified persons. It is stated that in the State of Uttar Pradesh about 25,000 pharmacists are required while there are only three colleges in the State. THE outlet of diploma holders of these colleges is 300 only. Besides this, the State Government is contemplating to have retail shops in villages. THE result is that in every city, town and village, chemist and druggist shops are facing great hardship. Petitioners can only arrange finances to employ the services of the qualified persons/pharmacists but they have no say in the matter so far as preparing pharmacists by giving better education is concerned. It is the job of the State. However, for non- availability of the pharmacists, petitioners right to trade in retail pharmacy cannot by taken away or jeopardised and such restrictions are violative of Article 19 (1) (g) of the Constitution of India. For non availability of the retail phamacists, petitioners cannot be compelled to suffer. THE sale of protected drugs packed in bottles or other containers through pharmacist is highly an idealistic approach. In retail sale it is wholly uncalled for unless the Government has means and method to cater to the needs of 86 crores population of the country. If the provisions of Section 42 of the Pharmacy Act, 1948 are en forced that shall be harassment to the petitioners who are engaged in the retail business of medicines for long time. It has been prayed that a writ, order or direc tion in the nature of mandamus directing the respondents and their subordinate officers be issued not to prosecute and punish petitioners for violating Rule 65 (15) (ii) (c) of the Drugs and Cosmetics Rules, 1945. It has also been prayed that the amendment to the aforesaid Rule and Section 42 of the Pharmacy Act, 1948 be declared to be ultra vires of Article 19 (1) (g) of the Constitution of India. A counter affidavit has been filed on behalf of the respondents 1, 2 and 3 wherein it has been stated that the Drugs and Cosmetics Act, 1940 has been legis lated in order to regulate the import, manufacture, distribution and sale of drugs. The aim and object of the Act is to prevent distribution of sub-standard drugs and further the distribution of drugs by specialists in order to ensure proper dispensing of the drugs as prescribed by medical practitioner and this way ensure and protect the health of the people. Then various provisions of the Act and Rules have been explained. Majority of the drugs fall under the classification of Schedule C, C (1) and H drugs which according to the Act and the Rules are to be dispensed with only on the prescription of registered medical practitioner and it is governed by Rule 65 (1) and (2) of the Rules. The supply of medicines against a prescription essentially requires certain skill with correct interpretation of generally illegible routine prescription, checking the doses prescribed, proper detailing of the same to the patient. Frequently certain Latin terms are also used in the prescription detail ing about the drugs and food items which is only possible to understand through a qualified person. Such kind of job cannot be left open to be performed by an un qualified person. Strict enforcement of the provisions of the Act and the Rules is necessary to protect the public health. The petitioner is engaged in sale of drugs by way of retail by taking licence under the Drugs and Cosmetics Act, 1940. It is not admitted that petitioner is only selling drugs, powder, liquid and ointment. The provisions of the Act and the Rules are not in any way violative of Article 19 (1) (g) of the Constitution of India which does not permit uncontrolled and unrealistic right to trade. Reasonable restrictions can be imposed in public interest. Since the dispensing of drugs involves hazard to the public health as the large Indian popula tion is illiterate, therefore, the dispensing of drugs should be through qualified per sons. It has been stated that in State of U. P. there are about 16,000 retail outlets and as against it there are 19636 registered pharmacists. Approximately, 500 phar macists are being registered every year in the State Pharmacy Council. Every year about 120 pharmacists who are trained from outside the State are also being registered. There are 18 colleges giving training and diploma in Uttar Pradesh. There is no shortage of pharmacists in the State. In fact, there are number of un employed diploma pharmacists waiting for engagement. Petition has been filed on incorrect allegations only to avoid employment of the pharmacists as required under law. Rejoinder has also been filed by petitioner reiterating the facts already stated in the writ petition. From the pleadings of the parties narrated above, it is clear that the con troversy is with regard to the employment of qualified persons/pharmacists in the retail shops of the" Chemists and Druggists. The provisions contained in the Act and the Rules requiring the compulsory engagement of such qualified persons/phar macists for selling drugs and medicines-flave been questioned both on legal and factual plain.
(3.) THE controversy was identical before the two Division Benches. Now it shall be appropriate to have a quick look at the relevant provisions contained in the Act and the Rules. THE Drugs and Cosmetics Act, 1940 (hereinafter referred to as the Act) came in force on 10-4-1940. It has been subjected to various amendments from time to time according to the needs. THE main object of the Act is to regulate the import, manufacture, distribution and sale of drugs and cosmetics. THE statement of objects and reasons as stated in the Amending Act No. 68 of 1982 are that the problems of a dulteration of drugs and also of production of spurious and sub-standard drugs are posing serious threats to the health of the community. It is, therefore, considered necessary to amend the Drugs and Cosmetics Act, so as to impose more stringent penalties on the antisocial elements indulging in the manufacture or sale of adulterated or spurious drugs of drugs not of standard quality which are likely to cause death or grievous hurt to the user. This opportunity is also being availed of to incorporate certain other provisions or the other aspects of effective control on the manufacture, distribution, sale of drugs and cosmetics on the basis of experience gained in the working of the Act. THE provisions of the Act which are relevant with regard to the controversy in hand are the definition of the word 'drug' provided in Section 3 (b) and "patent or proprietary medicine" mentioned in Section 3 (h) of the Act. Chapter IV of the Act contains provisions regarding manufacture, sale and distribution of drugs. Section 18 (iii) provides prohibitiqn of sale of drugs except under and in accordance with the conditions of the licence issued for such purpose. Section 33 confers power on the Central Government to make rules in consultation with or on the recommendation of the Drugs Technical Advisory Board to make rules for the purpose of giving effect to the provisions of this Chapter. Clause (e) of sub-section (2) of Section 33 provides that the Rules may be made to prescribe forms of licences for the manufacture for sale or distribution of the drugs or any specified drug or class of drugs, etc. Under these Rules the Central Government made Drugs and Cosmetics Rules, 1945 which have also been amended from time to time, Chapter VI of the Rules contains provision with regard to sale of drugs other than homoeopathic medicines. Rule 59 provides that the State Government shall appoint licensing authorities for the purpose of this part for such areas as may oe spcified and makes further provisions as to how applications for grant or renewal of the licences shall be made. Rule 61 provides forms of licences to sell drugs. Rule 62-A provides for restricted licences in Forms 20-A and 21-A. It would be appropriate to reproduce Rule 62-A (a) hereunder : " (a) Restricted licences in Form 20-A shall be issued, subject to the discretion of the licensing authority, to dealers or persons in respect of drugs whose sale does not require the supervision of a qualified person. " Rule 64 contains conditions to be specified before a licence in Form 20, 20-B, 20-F, 20-G, 21 to 21-B be granted or renewed. Rules 64 and 65 prescribe conditions or licences. Both the Rules are very material for the present controversy, hence the relevant provisions of Rules 64 and 65 are "being reproduced below: "64 (1) A licence in Form 20, 20-B, 20-F, 20-G, 21 or 21-B to sell, stock, exhibit or offer for sale or distribute drugs shall not be granted or renewed to any person unless the authority empowered to grant the licence is satisfied that the premises in respect of which the licence is to be granted or renewed are adequate, equipped with proper storage accom modation for preserving the properties of the drugs to which the licence applies and are in charge of a person competent in the opinion of the licensing authority to supervise and control the sale, distribution and preservation of drugs:" Provided that in the case of a pharmacy a licence in Form 20 or 21 shall not be granted or renewed unless the licensing authority is satisifed that the requirements prescribed for a pharmacy in Schedule N have been complied with : Provided further that licence in Form 20-F shall be granted or renewed only to a pharmacy and in areas where a pharmacy is not operating, such licence may be granted or renewed to a chemist and druggist. Explanation.- For the purpose of this 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 sup plied; 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', "phamarcist", "dispensing Chemist", or "pharmaceutical Chemist", or (5) which, by sign, symbol or indication within or upon it gives the impression that the operations mentioned at (1), (2) and (3) are carried out in the premsies; or (6) which is advertised in terms referred to in (4) above. " * * * "65. Condition of licences.- Licences in Forms 20, 20-A, 20-B, 20-F, 20-G, 21 and 21-B shall be subject to the conditions stated therein and to the following general condi tions : (1) 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. (2) 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. * * * 9 (a) Substances specified in Schedule H or Schedule X shall not be sold by retail except on and in accordance with the prescription of a Registered Medical Practitioner and in the case of Substances specified in Schedule X, the prescriptions shall be in duplicate, one copy of which shall be retained by the licensee for a period of two years. * * * * (15) (a) THE prescription "drug store" shall be displayed by such licensees who do not require the services of a qualified person. (b) THE description "chemists and Druggists" shall be displayed by such licensees who employ the services of a "qualified person" "but who do not maintain a "pharmacy" for compounding against prescriptions. (c) THE description "pharmacy", "pharmacists", "dispensing Chemist" or "phar maceutical Chemist" shall be displayed by such licensees who employ the services of a "qualified persons" and maintain a "pharmacy" for compounding against prescriptions. Explanation.- For the purpose of this rule - (i ). . . . . . . . (ii) 'qualified person' means a person who - (a) holds a diploma or degree in pharmacy or pharmaceutical chemistry of an in stitute 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 pharmacists 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 a qualified person till such time as that register is prepared; or (c) has not less than four years' practical experience or dispensing with 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. (19) THE supply by retail of any drug in a container other than the one in which the manufacturer has marketed the drug, shall be made only by dealers who employ the ser vices of a "qualified person" and such supply shall be made under the direct supervision of the 'qualified person' in an envelope or other suitable wrapper or container showing the following particulars on the label- (a) name of the drug, (b) the quantity supplied, (c) the name and address of the dealer. Several Schedules have been appended to the Rules. Schedule A contains various statutory forms including those in which licences are to be granted to sell, stock or exhibit or offer for sale or distribute drugs by retail. Schedules C, C (l), E (l), G, H and X contain different categories of drugs which have been grouped together for purpose of granting licence.;