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1996 DIGILAW 122 (ALL)

RAMESH GIRI v. STATE OF U P

1996-01-29

R.H.ZAIDI, R.R.K.TRIVEDI, V.N.KHARE

body1996
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. 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. 3. 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. 3. 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. 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. 4. 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. 5. 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. 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 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 licensees 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 ). . . . . . . . (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. 6. 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. 7. With the aforesaid background of the pleadings of the parties and the legal position, now it has to be judged whether there is a real conflict between the view expressed by the two Division Benches. We have gone through the judgments of both the Division Benches. However, in our considered opinion, there appears no conflict in the views expressed by the two Division Benches. We have gone through the judgments of both the Division Benches. However, in our considered opinion, there appears no conflict in the views expressed by the two Division Benches. In fact, the Division Bench while deciding the case of M/s. J. Das Bros, in para 7 explained act of dis pensing drugs by retail dealers in the context of requirement of a qualified person. In explanation to Rule 64 of the Rules it has been explained that dispensing takes place when drug is measured, weighed or made up and then supplied. A perusal of the whole of para 7 of the judgment will show that the Division Bench has nowhere said that the assistance of the qualified person as required by the Rules will not b necessary for selling drugs in retail where it amounts to dispensing. It has only explained legal provisions as they are. For better appreciation para 7 of the judg ment is being reproduced : "we may at once deal with the question as to what do we understand by the expres sion "dispensing" used in the explanation to clause (c ). This expression has not been defined either in the Act or in the Rules. However, if we revert to Rule 64, we will find that in the explanation to sub-rule (i) of Rule 64, while defining the term pharmacy there is a talk of drugs being dispensed. It is provided that a drug is dispensed when it is measured or weighed or made up and supplied. Applying this concept of dispensing to a retail dealer in the context of the requirement of a "qualified persons" as contained in the explanation to clause (c) of sub-rule (15) of Rule 65, four years practical experience in dispensing will mean the measuring or weighing or making up and supplying of drugs. The position is clarified by sub- rule (19) of Rule 65 which says that 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 services 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 name of the drug, the quantity supplied and the name and address of the dealer. This shows that a retail dealer of a drug, who merely supplies or sells a drug as defined in Rule 3 (b) in the same container which the manufac turer has marketed may do so without either being a "qualified person" or employing such a person. It is a matter of common knowledge that certain drugs, as widely understood in the context of the definition are brought by customers from a retail dealer in the same container as marketed by the manufacturer. It is also a matter of common knowledge that retail dealers, more often than not, buy drugs in a bulk which is in the container marketed by the manufacturer and thereafter sell drugs in retail in small quantity in an envelop or other suitable wrapper or container. Such transactions by a retail dealer are enjoined to be under the direct supervision of a "qualified person. " Reading Rules 64 and 65 together it is clear that apart from a drug contained in a container in which the manufacturer has marketed it, no other drug can be supplied or sold by a retail dealer except by or under the supervision of a "qualified person. " We have already indicated that a retail dealer is prohibited from supply any drug on the prescription of a registered medical practitioner unless he is a "qualified person" or he is supplying the drug under the supervision of a "qualified person". Sub-rule (19) of Rule 65 does not exclude the supply in retail of any drug in an envelope or in other suitable wrapper or container etc. by a person who himself is a "qualified person. " There is no conflict between sub-rule (2) and sub-rule (19) of Rule 65. Sub-rule (2) emphasizes that there can be no compounding or the manufacture of any drug or the making of a drug except under direct and personal supervision of a "qualified person". It also emphasizes that in the case of a retail dealer any drug supplied on the prescription of a registered medical practitioner shall be effected only under the direct supervision of a "qualified person" whereas sub-rule (19) does not talk of the supply of a -drug on the prescription of a registered medical practitioner. " 8. It also emphasizes that in the case of a retail dealer any drug supplied on the prescription of a registered medical practitioner shall be effected only under the direct supervision of a "qualified person" whereas sub-rule (19) does not talk of the supply of a -drug on the prescription of a registered medical practitioner. " 8. Learned Judges of the Division Bench whole deciding the case of Amod Kumar Agarwal V. Union of India sent for the record of Writ Petition No. 13197 of 1981 (wrongly mentioned as 1991) which was one of the petitions decided along with the case of J. Das & Bros, and perused and have found that there are no such observations which may help the petitioners before them in any way. The relevant para. 25 of the judgment in Amod Kumar Agarwal"s case is being reproduced below: "25. We have sent for record of Writ Petition No. 13197 of 1981 and having gone through the judgment minutely, we do not find anywhere in the said judgment that with reference to Rules 61, 64 and 65 of the Rules under which licences are issued to sell, stock, exhibit for sale or distribute drugs, any Rule to this effect has been construed in the man ner as argued by the learned Counsel giving reference to the order in Sanjay Agrawals case (supra ). Thus in our opinion, the observation made in Sanjay Agrawal case (supra), is of no help to the petitioner. " It appears that a confusion took place in view of the last paragraph of the judgment in M/s J. Das Bros, case where the learned Judges concluded the judgment by these words: "in view of the foregoing discussion these petitions succeed in part but without any order as to costs. " However, after perusal of whole of the judgment, there is nothing on which basis this may be inferred that the petitions really succeeeded in part. All the conten tions raised on behalf of petitioners were rejected by the Bench. The Division Bench while parting with the case in para. 15 observed : "however, we hope and trust that if there are any practical difficulties in the way of the petitioner in complying with the provisions of the Act, the Rules framed thereunder and the Pharmacy Act, the relevant authority shall look into the same even now and give then the necessary redress. 15 observed : "however, we hope and trust that if there are any practical difficulties in the way of the petitioner in complying with the provisions of the Act, the Rules framed thereunder and the Pharmacy Act, the relevant authority shall look into the same even now and give then the necessary redress. The expression relevant authority includes the Parliament and the Rule making authority also. " 9. It appears that the Division Bench instead of dismissing the writ petition stated that the petitions succeed in part to keep the contentions raised on behalf of the petitioner alive to be raised before the relevant authority as mentioned above and to avoid attaching finality by the rejection of the contentions by Courts judg ment. The subsequent Division Bench while deciding the case of Amod Kumar Agrawal in our opinion, rightly inferred that the judgment of the Division Bench in J. Das Brothers case does not help the petitioner in any way. 10. In view of the aforesaid discussion, in our opinion, as there was no con flict, it was not necessary to refer the matter to the Full Bench. However, as learned Counsel for petitioners argued before us again the entire controversy, we thought it proper to examine ourselves as to whether the contentions raised on behalf of the petitioners can be accepted or not. On behalf of petitioners Shri Shah O. P. Agarwal addressed us in Writ Petition No. 981 of 1984. Shri Sudama Ji Shandilya argued in Writ Petition No. 980 of 1984 and Shri Mahesh Gautam, advocate, argued in Writ Petition No. 36581 of 1984. The other Counsel for petitioners adopted the argu ments advanced by the aforesaid Counsel. On behalf of respondents, Shri U. N. Sharma, learned Senior Standing Counsel for Union of India, gave the reply. 11. Shri Shah O. P. Agrawal after placing various provisions contained in the Act and the Rules, has submitted that though a retail dealer having obtained the licence in Forms 20 and 20-A is not required to employ the services of a qualified person, but he is subject to general conditions contained in Rule 65 as the licence in Form 20-A is included in Rule 65. Contrary to it, a retail dealer with licence in Form 21-A also does not engage services of a qualified person but is not subject to general conditions contained in Rule 65 as the licence in Form 21-A is not included in Rule 65. Thus, there is ambuguity and the provisions are discriminatory. It has been further submitted that under sub-rule (19) of Rule 65 though a retail dealer is entitled to sell any drug in container, envelop or Wrapper, in which the drug has been marketed by the manufacturer for sale and the services of a qualified person are required only when the drug is sold in container, envelop or wrapper other than one in which the drug was originally marketed by the manufacturer. However, even this relaxation is taken away if the drug or medicine is supplied on the prescription of a registered medical practitioner and in such a case the drug or the medicine can be sold in retail only under the supervision of a qualified person even though it is sold in the same container, envelop or wrapper. It is submitted that petitioners are dealing with patent or proprietary drugs as defined in Section 3 (h) of the Act and the seller has nothing to do with these readymade medicines. They are to be sold as they are marketed for sale by the manufacturer. Learned Counsel has further ar gued that there is a scarcity of qualified persons in the State and registered phar macists are not now available for employment and this is causing great hardship to retail dealers. 12. In the facts and circumstances narrated above, the requirement of engaging services of a qualified person is in fact an unreasonable restriction which is not in any way in public interest and is violative of Article 19 (1) (g) of the Constitution of India. It has been further submitted that the sale of patent or proprietary medicines or manufactured drugs and in retail sale of such drug no pharmacy is required to be done as understood in the explanation attached to Rule 64. The sale of such drugs and patent and proprietary medicines should have been given a separate treatment from those drugs where dispensing is required. The sale of such drugs and patent and proprietary medicines should have been given a separate treatment from those drugs where dispensing is required. The learned Counsel has submitted that under Sections 10, 11 and 12 of the Pharmacy Act, 1948, it is for the State to make education regulations and to provide as any registered pharmacists as required in the State and the State Government may be directed to enforce Section 10. Learned Counsel has relied on the case of Rs. Chemists Federations Agreement reported in (1953) 3 All England Reports 448, AIR 1951 SC 118 , Chintamani Rao and another v. State of Madhya Pradesh, AIR 1954 SC 224 ; M/s. Dwarika Prasad Laxmi Narain v. State of U. P. and others, AIR 1960 SC 430 ; Narendra Kumar and others v. Union of India and others, AIR 1979 SC 193 ; Chief Justice, A. P. v. L. B. A. Dikshitulu, AIR 1986 SC 205; Municipal Corporation of the City of Ahmedabad and others v. Jan Mohammad Usman Bhai. 13. Shri Sudama Ji Shandilya, learned Counsel appearing for petitioners in Writ Petition No. 980 of 1984 submitted that the petitioner holds a licence in Form 21. It has been further submitted that under sub- rule (15) of Rule 65 of the Rules three categories of the retail sellers have been contemplated. The sellers who do not require services of qualified person have been put under description drug stores whereas under Clauses (b) and (c) where the services of qualified person are required, they are to be described as chemist and druggist or pharmacists etc. as the case may be. Learned Counsel has submitted that under sub-rule (19) of Rule 65, petitioner may deal in retail sale of the patent or proprietary medicines and if the petitioner does not want to employ the service of a qualified person, he may apply for a licence in Form 21-A. The petition may be disposed of finally with the similar observations as were made in the judgment dated 6-10-1993 in case of Amod Kumar Agrawal. 14. Shri Mahesh Gautam, learned Counsel for petitioner in Writ Petition No. 36581 of 1994 submitted that the petitioners applied for licence in Forms 20 and 21. However, the application was rejected in arbitrary manner vide order dated 8-11-1994 which has been challenged in the writ petition. 14. Shri Mahesh Gautam, learned Counsel for petitioner in Writ Petition No. 36581 of 1994 submitted that the petitioners applied for licence in Forms 20 and 21. However, the application was rejected in arbitrary manner vide order dated 8-11-1994 which has been challenged in the writ petition. Learned Counsel has submitted that the Rules are arbitrary and they do not in any manner serve the public interest. 15. Shri U. N. Sharma, learned Counsel appearing for the respondents, on the other hand, has submitted that there is no anomaly or ambiguity in the provisions contained in the Act or the Rules. The Rules contain minute details and categorisation of the drugs under the different schedules considering their nature and effect on the human body. Restrictions have been imposed considering the importance of the public health. 16. Shri Ashwini Kumar, Deputy Drug Controller of India, also appeared before us and explained in detail the various provisions of the Act and the Rules. It has been submitted that most of the drugs are covered under Schedules C, C-l and H and they cannot be left to be handled by an unqualified person as in that case there is likelihood of hazard to the public health. The Rules have been framed after seeing the working of the Act and the Rules for more than four decades and they are based on experience. The regulation of the sale of such drugs is necessary and in public interest. Learned Counsel for Union of India placed reliance on the judg ment of Lucknow Bench of this Court in case of Lakshmi Medical Stores and others v. Union of India and others delivered on 21-2-1994 wherein identical controversies have been considered and rejected. 17. We have considered the rival submissions made by the learned Counsel for parties. The challenge on behalf of the petitioners centres round the requirement under the Rules for taking assistance of qualified persons (now registered phar macists since 6-9-1994) for sale of patent and proprietary medicines on prescription of a registered medical practitioner. The contention is that though patent or proprietary medicine may be sold in retail on demand made by any customer without assistance of a qualified person but if the same medicine is prescribed by a registered medical practitioner, it cannot be sold without assistance of a qualified person. The contention is that though patent or proprietary medicine may be sold in retail on demand made by any customer without assistance of a qualified person but if the same medicine is prescribed by a registered medical practitioner, it cannot be sold without assistance of a qualified person. It is alleged that the Rules which make it obligatory to employ registered pharmacists for selling patent and proprietary medicines are unreasonable, ar bitrary and violative of Article 19 (1) (g) of the Constitution. It has also been sub mitted that no dispensing is involved in selling such medicines and the assistance of qualified person (registered pharmacist) are wholly uncalled for and against public interest. 18. The contentions raised, however, are not tenable if the provisions of the Act and the. Rules are examined and considered in depth. Section 2 (b) of the Drugs and Cosmetics Act, 1940 defines patent or proprietary medicines. The patent and proprietary medicines may be Ayurvedic, Siddha or Yunani Tibb or any other sys tem of medicine. Its sale and supply by retail is authorised without employing ser vices of qualified persons/registered pharmacists if it is sold in the same packet or container or wrapper. However, if the container is changed, services of pharmacists are required. This requirement is mentioned in sub-rule (19) of Rule 65 of the Drugs and- Cosmetics Rules, 1945. Sub-rule (2) of Rule 65 of the rules further re-quries that supply, otherwise than by a wholesale dealer, or any drug supplied on the prescription of a registered medical practitioner, shall be efffected only by or under the personal supervision of a qualified person. The attack of the petitioners is directed against these two provisions. It cannot be denied that the provisions of the Act and the rules framed thereunder are directly connected-with the problems of health of the members of the society and these provisions have been amended after considering the working of the Act, and the Rule for more than four decades. A particular drug or medicine may ordinarily be sold to a consumer for purpose of consumption and for relief against a particular trouble but if the same drug or medicine is prescribed by a medical practitioner along with other medicines, it may need some precautions which may be known to or understood only by a registered pharmacist. A particular drug or medicine may ordinarily be sold to a consumer for purpose of consumption and for relief against a particular trouble but if the same drug or medicine is prescribed by a medical practitioner along with other medicines, it may need some precautions which may be known to or understood only by a registered pharmacist. Sometimes the pharmacist who knows the composition of the medicine may even refuse to sell the drug or advise the patient to consult medical prac titioner again if the composition of the drug may not suit the patient along with other medicines. Thus the problem should not be considered in isolation. There are various factors involved in the case of sale of even patent and proprietary drugs. 19. Much has been said about the inclusion of licence in Form No. 20-A in Rule 65 which prescribes general conditions for licence and exclusion of licence in Form No. 21-A in the aforesaid Rule. However, different treatment to the two licences may be understood from the difference with regard to the medicines and drugs in respect of which the licence is given. In Form 20-A a restriction on licence to sell, stock or exhibit or offer for sale or distribute a drug by retail is given in-respect of drugs other than those specified in Schedules C, C (1) and X whereas in Form 21-A licence is given for sale of retail drugs specified in Schedule C (1) and only excluding those specified in Schedule X. Thus, it cannot be said that under the two licences, retail sale is with regard to the same drugs. In our opinion, different treatment has been given in view of the difference in the drugs in which under the licence retail sale or supply may be made. From the medicines mentioned in Schedule C (1) and other schedules, this difference can be easily understood. In our opinion, there is no ambiguity or arbitrariness. The contentions raised on behalf of the petitioners based on Article 19 (1) (g) of the Constitution have been repelled by the three Division Bench decisions of this Court for very good and cogent reasons. We are in respectful agreement with the reasons mentioned therein. The petitioners have a fundamental right under Article 19 (1) (g) to enter into business of retail sale of medicines and drugs. We are in respectful agreement with the reasons mentioned therein. The petitioners have a fundamental right under Article 19 (1) (g) to enter into business of retail sale of medicines and drugs. However, once they chose to enter into such a business, the right is not absolute. It is subject to regulations prescribed by the Act and the Rules. In series of judgments of Honble Supreme Court and this Court, this controversy has been dealt with and it has been said that right to do business is subject to reasonable restriction and, in our opinion, as the drugs or medicines are directly connected with the health of the society, therefore, the restrictions under the Act and the Rules cannot be said to be unreasonable. They are in public inter est. The cases relied on by the learned Counsel for petitioners are clearly distin guishable and do not help petitioners in any manner. 20. Now taking into consideration the second contention regarding change of container, package or wrapper, it may be said that ordinarily an unqualified seller and a layman-purchaser may not know the atmospheric reactions on the medicine if exposed to light, air or moisture by opening or changing the container and the requirement by law to employ services of a qualified person for selling medicines in cases where the container, package or wrapper is changed, cannot be said to be unreasonable or arbitrary. It cannot be denied that the health of the members of the society is of vital importance. With the industrial and technological development, health hazards have gained new and serious dimensions. To save citizens from these hazards, very efficient and suitable medical facilities are required which include the selling of medicines with appropriate knowledge about medicines and in cautious manner. The age old long practice of selling and consuming medicines without much care cannot now be followed and has rightly been given up. Services of qualified persons are not only for the retail sale of the medicines in proper and just manner but it will also work as ,a check against unauthorised sale of medicines of purposes other than treatment. It is well known to every body that a large number of medicines are now being used for purposes of intoxication. Services of qualified persons are not only for the retail sale of the medicines in proper and just manner but it will also work as ,a check against unauthorised sale of medicines of purposes other than treatment. It is well known to every body that a large number of medicines are now being used for purposes of intoxication. If a qualified person is present in the shop at the time of sale, it may provide a check against such improper use of the medicines. Further, as contended on behalf of respondents, the supply of medicines against a prescription essentially requires certain skill for correct interpretation of generally illegible routine prescriptions, checking the doses prescribed and detailing the same properly to the patient. It is also correct that frequently certain Latin terms are also used in the prescriptions detailing about drugs and food items which is only possible to follow through a qualified person. Such kind of job cannot be left open to be performed by an unqualified person. The framers of law are experts or the subject and they known better what steps are required for maintaining health of members of the society and to prevent any kind of health hazards by sale of spurious and sub-standard drugs. It is difficult to accept the contention raised that the restrictions are in any way against public interest. 21. Most of the medicines have been categoriesed and shown in various schedules provided under the Rules. For example, schedule c consists of drugs which are biological and are special products. Similarly Schedule C (l) consists of the various special products. Schedules E and E (l) contain list of poisonous sub stances. Schedule H contains the list of drugs which may be sold only on prescrip tion of a registered medical practitioner. Schedule X again contains list of the drugs mentioned in Rules 23, 61, 75, 97 and 105-A. The nature of drugs mentioned above are such about which it cannot be said that requirement of employing services of qualified persons is unreasonable. The drugs mentioned in these Schedules are of such nature that they can be consumed only on the advise given by a medical prac titioner. The drugs mentioned in these Schedules are of such nature that they can be consumed only on the advise given by a medical prac titioner. The nature of the business of trade dealing in medicines is such that any kind of relaxation may not be advisable or proper as it is connected with the health of the society and a little lapse at the stage of supply of medicines may cause ir reparable loss or injury to the patients. 22. The argument on the strength of sub-rule (15) of Rule 65 of the Rules that there is no requirement of employing qualified persons by dealers while supplying drugs in containers marketed by the manufacturers may be tested by employing rule of interpretations laid down by the Courts. Such rule of interpretation have been found to be considerable assistance as they are based on human experience. Prece dents show that by taking assistance of rule of interpretations, the Courts have solved the problem at hand. 23. Maxwell in his "interpretation of Statutes" states "there is no doubt that the office of the Judge is, to make such construction as will suppress the mischief, and advance the remedy, and to suppress all evasions for the continuance of the mischief. To carry out effectually the object of the Statute, it must be so construed as to defeat all attempts to do or avoid doing, in an indirect or circuitous manner that which it has prohibited or injoined. " 24. As noticed earlier the object of the Act is to regulate the import, manufac ture, distribution and sale of drugs in the country. We cannot loose sight of the fact that there is a considerable amount of adulteration of drugs and also production of spurious and sub-standard drugs which have been posing serious threat to the health of the community. Drug, if rightly used, reduces the pain and suffering of people and if abused, affects the health of the community. Of late the notoriety of abuse of drugs has assumed alarming proportion in our country. Drug, if rightly used, reduces the pain and suffering of people and if abused, affects the health of the community. Of late the notoriety of abuse of drugs has assumed alarming proportion in our country. We should not fail to realise that adverse effect of drugs is tremendous and is concerned with the life and death situation of people and in that set of circumstances, the Court must give effect to the will of the Parliament as Statute is the will of Legislature and the fundamental rule of, to which all rules are subordinate, is that Statute is expounded according to the intent of those who made it, otherwise the object and purpose of the Act for which rules have been framed under the Act would be defeated. The object of the Act being to eradicate the evils and abuse of drugs, sub-rule (19) of Rule 65 has to be interpretated in that light and has to be read in conjunction with Rule 61 and sub-rule (2) of Rule 65 of the Rules. If these rules are read together, it will be found that the drugs supplied in a container marketed by manufacturer for which the prescription of a registered medical practitioner is necessary cannot be sold or supplied without under the supervision of a qualified person. This aspect may be examined from another angle, namely, that the whole set of rules must be read as a whole and one provision of the Rules should be construed with reference to other provisions in the same set of Rules so as to make whole set of Rules consistent. Such a construction has the merit of avoiding any inconsistency or repugnancy either within a rule or between a rule and other part of rules. It is function of the Court to harmonise the two provisions of the Rules otherwise what has been provided for compliance would be taken away by the other provisions of the Rule which is in direct conflict of the object of the Act. Infact the entire rules have to be read as part of integral whole. If sub-rule (19) of Rules 65 is interpreted in the light of argument of learned Counsel for the petitioners, the other provisions of Rules namely, Rule, 65 and sub-rule (2) of Rule 65 would be redundant. Infact the entire rules have to be read as part of integral whole. If sub-rule (19) of Rules 65 is interpreted in the light of argument of learned Counsel for the petitioners, the other provisions of Rules namely, Rule, 65 and sub-rule (2) of Rule 65 would be redundant. We are, therefore, of the view that sub-rule (19) of Rule 65 does not permit the sale of drugs in a container marketed by the manufacturer without the assistance of qualified person. We, accordingly, reject the argument of the learned Counsel for the petitioners. 25. The result of the aforesaid discussion is that a dealer holding licence in Forms 20 and 21 for retail sale of drugs is required to employ the services of qualified persons and supply such drugs under this direct supervision even if drug in a container marketed by the manufacturer is to be sold for which prescription of the registered medical practitioner is necessary. 26. Much has been said about the shortage of qualified persons or registered pharmacists. This contention was disputed on behalf of the respondents and also by the association of registered pharmacists. However, the legality of the provisions cannot be decided on the basis of this fact. If qualified person or registered phar macist is not available. The provisions of the law cannot be allowed to be violated and the petitioners cannot be allowed to sell medicines if it cannot be sold under law without employing services of qualified persons. The Court cannot given any kind of relaxation on that basis. It is for the petitioners to raise the question before appropriate authorities who may consider the prevailing situation and may take appropriate action. 27. A grievance was also raised that pharmacists, even though engaged, do not attend to their duties and one pharmacist is engaged for many shoos and thus no useful purpose is served. It has also been submitted that qualified persons or registered pharmacists misuse their position, leave their job after some time even without giving any notice and the medical owners are left in a very heldpless situa tion. In this regard no relief can be granted in these petitions. We can only suggest petitioners to approach the appropriate Government or the Pharmacy Council of India to formulate regulations for providing effective control and check against the registered pharmacists to prevent any misuse of their position as alleged. 28. In this regard no relief can be granted in these petitions. We can only suggest petitioners to approach the appropriate Government or the Pharmacy Council of India to formulate regulations for providing effective control and check against the registered pharmacists to prevent any misuse of their position as alleged. 28. On over all consideration of the provisions of the Act and the Rules, we are of the opinion that the petitioners are not entitled for any relief. We respectful ly agree with the view expressed by the Division Benches in cases M/s J. Das Brothers v. Union of India and others, 1992 (1) E. F. R. 606; Amod Kumar Agarwal v. Union of India and others 1994 (1) E. F. R. 219 and Writ Petition No. 1755 of 1991, Laxmi Medical Stores and others v. Union of India and others, decided on 24-2-1994 by a Division Bench of Lucknow Bench of this Court. 29. The writ petitions are accordingly dismissed. However, there will be no order as to costs. Petitions dismissed. .