Dr. B. S. KUCHEKARTEXT BOOK OF PHARMACEUTICAL JURISPRUDENCE SECOND YEAR DIPLOMA IN PHARMACY {As Per E.R. 1991) DR. B. S. KUCHEKAR M. Pharm., Ph.D., LL.B., FIC Asst. Professor of Pharmaceutical Chemistry, Government College of Pharmacy KARAD, Dist. Satara (Maharashtra) 415 124 Price Rs. 85.00 NIRALI PRAKASHANPHARMACEUTICAL JURISPRUDENCE ISBN NO. 978 - 81 - 85790 - 28-0 Thirteenth Edition : December 2008 © + Author The text of this publication, oF eny part thereo, should not be reproduced or transmitted in any form or stored In any computer storage ‘system oF device for distribution incuding photocopy, recording taping or information retnaved system or reproduced on any dc, tape, perforated aia or othr information starege device ee. wtnout the writan passion ef Autror with wham the rigs are reservec. Breaeh ef this cancion {5 lable for igal azton. Every effort has been mace to avoid errors or omissions in this publication. In saite of this, errors may creep in. 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Road, Opp. Hotel Roopali, Tel: (G20) 2445 2254 / 6609 2463, Shivajinagar, Pune 411004, Manerasntra Tel : (020) 2566 3372 / 6602 2728 9/1, Montieth Road, Behind T Tel Pragati Book Centre Ambar Chambers, 28/A, Budhwar Peth, Appa Baiwant Chowk Puno : 441002, Maharashtra, Tol : (020) 20240335, 66281669 MUMBAI Pragati Book Comer Indira Niwas, 111A, Bhavani Shankar Road, Dadar (W) Mumbai 400028, Maharashtra Tel : (022) 2422 3526 / 6662 5254 me ‘wow. pragationline.com pragatibooks@vaninetCONTENTS Introduction 1. Pharmaceutical Legislation in India 1.1 - 13 2, Pharmacy and Health Care System 2.1 - 23 3._Pharmaceutical Ethics 3.1 - 3.4 4. Pharmacy Act, 1948 4.1 - 4.15 5. Drugs and Cosmetics Act, 1940 and Rules Thereunder 1945 5.1 — 5.67 6. The Narcotic Drugs and Psychotropic Substances Act, 1985 with Rules, 1985 6.1 - 6.12 7. Drugs (Price Control) Order, 1995 7.1 - 7.10 8. Medicinal and Toilet Preparations (Excise Duties) Act, 1955 and Rules Thereunder 1976 8.1 - 8.12 9. Drugs and Magic Remedies (Objectionable Advertisements) Act, 1954 and Rules 1955 91-94 10. The Poisons Act, 1919 10.1 - 10.2 11. Medical Termination of Pregnancy Act, 1971 and Rules there under 1975 11,1 - 113 12. New Drug Policy, 1994 12.1 - 12.4 * Index I1- 12 EKChapter 1 PHARMACEUTICAL LEGISLATION IN INDL PHARMACEUTICAL LEGISLATION Law intends to regulate and control various aspects of social life. The aspects may be classified as social, economical and political legislation. The Pharmaceutical Legislation is such a mixed legislation, which overlappingly covers both social and economic aspects of the society. ‘The purpose of Pharmaceutical Legislation is to ensure that the patients receive drugs of required quality, tested and evaluated for safety as well as efficacy for their intended use. It means that Pharmaceutical Legislation is associated with the health of the society. A] ORIGIN For the first time in India, a chemists; shop was opened in about 1811 by Mr. Bathgate, who came to India with East India Company in Calcutta. After one hundred years (Ge. in 1910), this firm started manufacture of tinctures and spirits Another firm Smith Stanistreet and Co. started apothecary shop in 1821 and commenced the manufacturing in 1918. Bengal Chemical and Pharmaceutical works, a small factory was started in Calcutta in 1901, by Acharya Prafulla Chandra Ray. In 1903, under the leadership of Prof. T. K. Gajjar, a small factory at Parel was started, which led to the development of other pharmaceutical units, the Alembic Chemical Works Ltd. at Baroda. ‘These units were not sufficient to fulfil the requirements of Indian public. In those days most of the medicines were being imported from abroad mainly from U.K, France and Germany. Then the situation was changed with the First World War. Cheaper drugs were imported from abroad. There were also increasing demands for indigenous drugs. The Indian and Foreign concerns entered in competition with imported medicines producing cheaper drugs. As a result, unhealthy competition grew up and the Indian market got flooded with inferior, substandard and even harmful drugs. With this issue, the public made the Government to take notice of such situation of drug trade and industry and to think of introducing effective legislation to control the import, manufacture, distribution and sale of drugs. In those days Opium Act, 1878, Poisons Act, 1919, and Dangerous Drugs Act, 1930 were in existence. But these acts were not comprehensive enough to control the prevailing chaotic and regrettable condition. Thus, as such there was no legal control on Pharmacy profession at the beginning of this century. With rapid expansion in pharmaceutical industries and market more comprehensive legislation was required. Hence, to have a comprehensive legislation, the Indian Government (1)SY. Diploma Pharmaceutical Jurisprudence 12 Pharmaceutical Legislation in India appointed a ‘Drug Enquiry Committee’ under the Chairmanship of Lt. Col. R. N. Chopra in 1981 (D. E. C. or Chopra Committee). The Committee was asked to make enquiries in the said matter and then to make recommendations for smooth control of manufacture, import, distribution and sale of drugs in the interest of public health. Recommendations of Drug Enquiry Committee: The committee submitted a comprehensive report with about 90 recommendations. The main recommendations are as follows : (1) The committee recommended the formation of Central Pharmacy Council and the Provincial (state) Pharmacy Councils which would look after the education and training of professionals, These councils would maintain the register containing the names and addresses of the Registered Pharmacists. (2) In the cecommendations, the Drugs Enquiry Committee suggested the creation of drug control machinery (Departments) at the centre with branches in all the states. (3) The committee also recommended the establishment of a well-equipped Central Drug Laboratory (CDL) with competent Staff and experts for an efficient and speedy working of Drug Control Department. It was also suggested that the small laboratories would work under the guidance of Central Drug Laboratory. Due to Second World War in 1939, there was delay in introduction of legislation as per the recommendations of Drugs Enquiry Committee, which was considered as an urgent by Indian Government. Finding the Government, reluctant to implement the recommendations of DEC, the demand and pressure from the public was increased to implement the said recommendations. Ultimately, an Import of Drugs Bill was introduced in 1937 in Legislative Assembly, to control import of drugs. The Government preferred to refer the Bill to Select Committee. The Bill was limited only to the import of drugs and the question of manufacture and sale of drugs was left untouched. Hence, the Select Committee pressed for comprehensive legislation not only to control imports but also to control and regulate manufacture, sale and distribution of drugs in the country. B] SCOPE AND OBJECTIVES The Drug Bill was introduced in 1940 in the Legislative Assembly. After considering the report of Select Committee, Drug Bill 1940 was passed. It came into force as Drug Act 1940 after seven years i.e. in 1947. Since then the Drug Act has been ammended many times and at present the Act covers the provisions related to Drugs, Cosmetics, Ayurvedic, including Unani and Homoeopathic medicines. The present Drugs and Cosmetics Act is an improved version over the Drug Act, 1940. The main object of this Act is to regulate the import, manufacture, distribution and sale of Drugs and Cosmetics. The Central Government has made a number of Rules for the manufacture, distribution and sale of drugs and cosmetics in India entitled "The Drugs and Cosmetics Rules 1945'. These act and rules are ammended from time to time.SY. Diploma Pharmaceutical Jurisprudence 13 Pharmaceutical Legislation in India With the achievement of Independence in 1947, the rest of the required caactments were also passed following the recommendations of DEC. The Pharmacy Act, 1948 was passed with the object to regulate the profession of Pharmacy in India. In 1954, ‘The Drugs and Magic Remedies (Objectionable Advertisements) Act' was passed with the main aim to control cortain types of advertisements related to drugs and to prohibit certain kinds of advertisements related to magic remedies. ‘The Medicinal and Toilet Preparations (Excise Duties) Act, 1955 was passed providing for the levy and collection of duties of excise on medicinal and toilet preparations containing alcohol, opium, Indian hemp or other narcotic drugs and narcotics. The Central Government has framed certain Rules under the provisions of this Act, called as ‘The Medicinal and Toilet Preparations (Excise Duty) Rules 1956". Under the essential commodities Act, 1955, and in supersession of the Drugs (Prices Control) Order 1979, the Central Government made the Drugs (Prices Control) Order 1987. In 1985, the ‘Narcotic Drugs and Psychotropic Substances Act, was passed along with the Rules repealing the Dangerous Drugs Act, 1930 and Opium Act, 1878. The main object of this act is to consolidate and amend the law relating to Narcotic Drugs and to make stringent provisions for the control and regulations of operations relating to Narcotic Drugs and Psychotropic Substances and for the matters connected therewith. The Prevention of Illicit ‘Traffic in Narcotic Drugs and Psychotropic Substances, Ordinance, 1988 is supplemented to this act. There are also some other enactments,which are directly or indirectly related to manufacture, distribution and sale of Drugs and Pharmaceuticals in India. These are (1) Prevention of Food Adulteration Act, 1954 and Rules (2) The Industries (Development and Regulations) Act, 1951 (3) The Industrial Employment (Standing Order) Act, 1946 and rules (4) Industrial Dispute Act, 1947 (5) Factory Act, 1948 (6) The Indian Patent and Design Act 1970 (7) The Trade and Merchandise Mark Act, 1958 (8) The Epidemic Diseases Act, 1897 (9) Shops and Esteblishments Acis of respective states RKChapter 2 PHARMACY AND HEALTH CARE SYSTEM ‘The interdependence between Pharmacy and Medicine runs back through countless ages. During Vedic times, medical treatment was associated with religious services in India. Hindu Medicines (Ayurvedic medicines), begin with the ‘Atharva Veda' which contains a list of disoases with thoir symptoms in the form of incantation. Ayurveda, tho science of longevity is appended to Atharva Veda. In Rig - Veda many medicinal herbs are described and water is prescribed as the best cure of most diseases. In Vedic times,-the physicians and surgeons lived in Garden Houses and cultivated the required medicinal plants. There were no separate professions of Medicine and Pharmacy. A Physician prepared his own medicines. Sometimes the family members of patients also were asked to prepare the remedies from medicinal plants. Sushruta and Charaka are the two great names in Ayurveda. Charaka composed a book of information on Ayurvedic medicines called as ‘Charaka Samhita’ which is still used in India. When Muslim came and ruled India, they brought their Unani system of medicine. With the change in the pattern of society, both the systems, Ayurvedic and Unani showed considerable changes, During the 18" century the systems of medicines were advanced with the time and came into existence the organization of Hospital. Since, then the hospital organization is working with the aim of attaining, maintaining and promoting the health of the nation, where the services of different health professionals are utilised. The health professionals such as clinical practitioner, nurses, technicians, medical social workers, dieticians and pharmacists ote, are together referred as Health Care Team. The, Allopathic system of medicine was introduced by the British when they ruled India. In those days pharmacy education was started in India to train the professionals. Some pharmaceutical associations were also formed. The tendency to specialization has affected the separation of Pharmacy from Medicine with little overlapping of jurisdiction and practice. Then the function of physician is to diagnose disease and to recommend the treatment through prescription, while pharmacist has to dispense the medicines according to the prescriptions. During the last 5 to 6 decades, complex and potent organic compounds are introduced as medicines. Being potent, these are to be administered with great care and in standardized dosage forms like tablets, capsules and injections etc. Such complex and potent dosage forms can not be dispensed or prepared in very small scale maintaining their strength and stability each time. They are to be manufactured in pharmaceutical industries with subsequent quality control. (2.1)S,Y. Diploma Pharmaceutical Jurisprudence 22 Pharmacy and Heath Care System With the developing trend in the science and technology, as well as in the potent of synthetic drugs, pharmacists responsibility is increased to give the information to the prescriber and the patients regarding the use, side effects ete. of such drugs in the interest of the public health. Pharmacist is legally held responsible for the quality of the products which he distributes, Because of such responsibility the Law requires that the distribution activity of all drugs be restricted to the pharmacist. As per the discussions held at British Pharmaceutical Conference in 1963 a pharmacist is regarded as an expert on drugs while a medical practioner is concerned with diagnosis and treatment. A pharmacist has to deal with the whole range of drugs. Accordingly, the pharmacy education is so framed that he gets all knowledge about the drugs. Now-a-days pharmacist is no longer regarded as a dispenser or compounder. The dispensing pharmacy is gradually emerging in clinical pharmacy. So, many changes are required to be made in the concept of Pharmacy. Pharmacist has to play an important consultative and management role. He should be responsible for planning and establishment of proper pharmacy services. Health care system is highly influenced by the changes such as economical, political and technological changes, Evolutionary changes in the practice of pharmacy will continue to have an impact on changing health care system. Some important aspects of health care are outlined in the report of the International Conference on primary health care held in Sept. 1978 at Alma Ata to achiove the goal 'Health for all by 2000 A D. They are : (1) Education concerning prevailing health problems and the methods of identifying, preventing and controlling them. (2) Promotion of food supply and proper nutrition. (3) Prevention and control of locally epidemic diseases. (4) Provision of essential drugs. (5) Appropriate treatment of common diseases. (6) Immunisation against the major infections and diseases. (D_ Availability of health professionals. (8) National Health Care Policy. Moreover, this report was regarded as the basic requirement to be supplemented according to the economic and social values of the nation and its public. To achieve the goal, "Health for all by 2000 A.D.", necessary supporting pharmaceutical services are required to be extended and organised, which is possible only when pharmacy ultimately and the pharmacist has been aceepted as an important member of health care team. ‘The profession of pharmacy in our country presently consists of : (1) Academic Pharmacists (2) Industrial Pharmacist (3) Hospital Pharmacist (4) Community PharmacistsS.Y. Diploma Pharmaceutical Jurisprudence 23 Pharmacy and Health Care System All the Pharmacists working in different fields of the profession are directly or indirectly related to nations health. Community Pharmacists and Hospital Pharmacists are the health professionals for the safe and effective use of the drugs. Pharmacist has specialized knowledge regarding the drugs, and their therapeutic actions. As he has the information about the drugs he is very close to prescriber or physicians. Similarly, the dispensing and compounding activities and his ability to give health related informations bring him closer to the patients or public. He serves as a link between physician and the patients. Pharmacist has to play an important role in the areas such as : (1) Prescription adherance. (2) Storage and distribution of drugs. (3) Drug choice. (4) Drug monitoring. (5) Information and education. (6) Clinical Pharmacokinetics. (7) Research and development and many other health activities. In nutshell, the Pharmacist is responsible for ensuring that the right patient is receiving the right medicine in the right dose for the right condition in the right dosage form and at the right frequency and hence, he is considered as an integral part of the health care system. Pharmacy Council of India has reconsidered the pharmacy education (D. Pharm.) and introduced new subjects such as Health Education and Community Pharmacy and Hospital and Clinical Pharmacy, the knowledge of which will definitely help the pharmacist in contributing to the Nations Health. KXChapter 3 PHARMACEUTICAL ETHICS ETHICS AND LAW Ethics means moral principles. It is a science of moral duty. A code of ethics is a carefully formulated system of principles or rules of practice for the guidance of a particular group of individuals, such as the members of a profession. The development of Code of Ethies is an indication of the evolution and growth of moral consciousness. ‘There is a difference between Law and Ethics. Law is defined as 'Rules of human conduct binding all persons in a state or nation'. While Ethics is defined as ‘Rules by which a profession regulates actions and sets standards for all its members. ‘The major difference between the two is in the method of enforcing compliance with the rules. If a law is broken, a violator may be subjected to punishment, a fine or imprisonment or both or the violator may be subjected to considerable monetary penalties in a civil action. If rules of ethics (professional conduct) are broken, the professional body may subject the violator to loss of professional previleges. Codes of professional ethics often set standards of conduct which differ from the standards of law. Law may prevent one from causing injury to another, but it can't force him to help his neighbour in hours of need. Helping the neighbour is the function of ethics. Drugs and Cosmetic Act and Rules prevent a pharmacist from selling drugs of substandard qualities but can't prevent from selling the drugs at a cheaper rate than that of his fellow pharmacist in his area which is not ethical. Such unhealthy tendancies which are not within the purview of Law can be settled with code of ethics. Ethically, a pharmacist can't be incharge of a medical store when he is drunk. It is said that a man without ethics is an uncivilised man in a civilised situation. PHARMACEUTICAL CODE OF ETHICS Students in professional education must become competent in their profession. So he must be able to place his skills within the context of society. Every professional practitioner needs social understanding to do his work well. Professional competence and ethical behaviour are necessary for practice of any profession. Professions would be lost without their ethical codes. ‘Therefore, it is the duty of all those involved in pharmacy field to be sure that the pharmacist in training knows the standards of professional conduct (code of ethics) and understands that deviation from those standards can not maintain the status of pharmacy profession. Pharmacy being a profession, requires knowledge, skill and integrity on the part of those engaged in it. This profession is associated with medical profession in the responsible duties of preserving the public health. Also, it deals with dispensing the useful and some times useful and dangerous agents to cure the disease. Therefore, the members of pharmacy @.1)SY. Diploma Pharmaceutical Jurisprudence 3.2 Pharmaceutical Ethics profession should be united on some general principles to be observed in their several relations to each other, to medical profession and to the public. Professional ethics for pharmacy ere necessary in the public interest to ensure an efficient pharmaceutical servi Pharmacy Council of India has formulated the code of ethics for the guidance of pharmacists. Such code of ethics covers the rules or the principles to be observed by the pharmacist while dealing himself with his job, his patrons and the public, his fellow pharmacists and the member of medical and other health profession. PROFESSIONAL CONDUCT Standards of professional conduct for pharmacy profession are necessary in the public interest to ensure an efficient pharmaceutical service. In addition to give such service, the pharmacist should also avoid any objectionable acts or omissions. The pharmacist should maintain good social career and have an attitude of service and sacrifice in the interests of the suffering humanity. In handling, selling, distributing and dispensing of medical substances, including poisons and potent drugs, a pharmacist along with the members of medical profession is responsible for safeguarding the health of the public. The pharmacist should at all times be ready to assist colleagues with information or advice. The pharmacist should recognise their responsibilities and fulfil professional obligations honourably and with due regard for the welfare of the society. PHARMACIST IN RELATION TO HIS JOB Pharmaceutical Services : 1. A pharmacist should provide an officient and reasonably comprehensive pharmaceutical services through the medical store or pharmacy. 2. Such services include supply of commonly required medicines without undue delay and furnishing the emergency supply at all times Pharmacy/Drug Store : 3, In every pharmacy/drug store, there should be a qualified pharmacist to have personal control over the pharmacy. The pharmacist shall be primarily responsible for the observance of proper standards of conduct in connection with it. 4. A pharmacy should be planned in such a way that there is no accidental contamination in the preparation, dispensing and supply of medicines. 5. The appearance of the premises should reflect the professional character of pharmacy and indicate to the public that the practice of pharmacy is the main purpose of the establishment. Prescriptions : 6 Prescriptions presented for dispensing should not be discussed with patients or others regarding the merits and demerits of their therapeutic efficiency. 7. After receiving the prescriptions, a pharmacist should not even show any expression on his face so that the patients will lose their faith in the physicians or prescribers.$.Y. Diploma Pharmaceutical Jurisprudence 3.3 Pharmaceutical Ethics 8 No addition, omission, or substitution of ingredients in a prescription should be made without the consent of prescriber or physician whenever possible except in an emergency. 9. In case of any cbvious error in the prescription, it should be referred back to the prescriber for necessary correction or approval of the change suggested. 10, If at all the change in the prescription is necessary in the interest of the health of the patient, it should not affect the reputation of the physician or the prescriber. 11, A pharmacist should not recommend any particular prescriber, unless he is specially asked to do so, Drugs/Ingredients : 12, While dispensing the prescription, the ingredients or drugs must be weighed or measured correctly as the ease may be by scales or measures. 13. Pharmacist should always use drugs and medicinal preparations of standard quality. 14. Drugs or medicine likely to cause addiction or other form of abuse should not be supplied when there is reason to suppose that it is required for such purpose. Practical Training : 15. While imparting practical training the incharge pharmacist should see thet the trainees acquire sufficient technique and skill. 16. No certificate should be granted to the trainee pharmacist before completion of prescribed period for training or without undergoing practical training or unless the trainee acquires sufficient knowledge. PHARMACIST IN RELATION TO HIS TRADE Price structure : 1. Prices of drugs and medicinal preparations charged from the customers should be fair and including dispensing and compounding charges without unduly taxing the purchaser. Fair Trade Practice: 2. A pharmacist should not make any attempt to capture the business of fellow pharmacist by unhealthy competition or cut-throat competitions, that is by offering reduced price, gifts, prizes, ete. 3. Trade marks, labels, symbols or any other signs of other pharmacists should not be copied or imitated 4. Drugs or other ingredients required, should always be purchased from reputable sources. Hawking of drugs and other: 6. Hawking of drugs and medicines should not be practised and any attempt should not be made to collect the orders from door to door. 6. Self servicing method in the pharmacy or drug stores should not be allowed as it would encourage self medication which is undesirable and dangerous.SY. Diploma Pharmaceutical Jurisprudence 34 Pharmaceutical Ethics Advertisement and Display : % ‘The pharmacist should not make such advertisements which contaii There should not be any display or advertisement on the premises, in the news paper or elsewhere regarding the abilities and services provided by the pharmacy. (i) Misleading or exaggerated statements or claims. (ii) A guarantee of therapeutie efficacy. (iii) An offer to refund money paid. (iv) An appeal to fear. (v) The word ‘cure' in reference to an ailment or symptoms of ill-health. PHARMACIST IN RELATION TO MEDICAL PROFESSION As 6. A pharmacist, under no circumstances, should practice medicine, that is diagnosing diseases and prescribing medicines. However, in case of accidents or emergencies, he may render first aid services, A pharmacist should not recommend any particular medical practitioner, unless specially asked for. Pharmacist should never enter into any secrete agreements with the medical profession, physicians, dentist, veterinary surgeons to offer them commission or gifts by recommending his dispensary or drug store. Pharmacist should not have any clandestine or underhand arrangement with any physician. Pharmacist is a link between medical profession and public. He should be constantly in touch with modern development in pharmacy and allied fields. He should be expert in the field of pharmacy so that he may advice the physicians on pharmaceutical matters. By enlarging his store of knowledge he may be able to educate the public to maintain their health. Pharmacists should neither discuss physician's prescriptions with customers nor disclose to them the composition of prescriptions. PHARMACIST IN RELATION TO HIS PROFESSION 1 2. ‘A pharmacist should observe the law and ethical principles to maintain the standard of the profession A pharmacist should extend the help and co-operation to his fellow pharmecist in an emergency and legitimate needs. A pharmacist should try to weed out the undesirable corrupt or dishonest conduct of the member of his profession maintaining its status in society. ‘A pharmacist should have a fair knowledge of laws of the state and nation pertaining to food, drug, pharmacy education, health ete. A pharmacist should have an upto date knowledge of professional matters. He should associate himself with various pharmaceutical organizations, the aims and objects of which are compatible with this code of ethics. A pharmacist should not perform such acts which will bring discredit to his profession or to himself. eKChapter 4 PHARMACY ACT, 1948 [A] INTRODUCTION AND OBJECT Before Independence, there were no regulations for the profession and practice of Pharmacy. Drug Enquiry Committee recommended that the persons practicing Pharmacy ie. the persons responsible for compounding and dispensing of medicines should have a proper educational background. Health Survey and Development Committee also made similar type of recommendations, consequently the Pharmacy Act came into force in March 1948. ‘The Pharmacy Act, 1948 is passed with the main object to regulate the profession and practice of Pharmacy and to raise the status of profession of pharmacy in India. To achieve this object, the Act provides for the constitution of Pharmacy Council of India, (Central Council) which is responsible for evolving educational standards and regulations for the Diploma Course in Pharmacy through Education Regulations. The Act, in addition to Central Council, provides for the constitution of State Pharmacy Councils for the registration of Pharmacists and for regulating their professional activities. DEFINITIONS 1, Central Council : The Pharmacy Council of India. 2. Central Register : Register of pharmacists maintained by the Central Council. 3. Medical Practioner : means— (a) A person holding a qualification granted by an authority specified or notified under sec. 3 of Indian Medical Degrees. Act 1916, Or specified in the schedules of the Indian Medical Council Act 1956, Or, (b) A person registered or eligible for registration in a medical register of a state meant for the registration of a person practising modern scientific system of modicine. Or, (c) A person registered in a medical register of a state who although not falling within subclause (a) or (b) is declared by a general or special order made by state Government in this behelf as a person practicing the modern scientific system of medicine for the purpose of this Act, or (a) A person who is engaged in the practice of veterinary medicine and who possesses qualification approved by State Government. 4, Registered Pharmacist : A person whose name for the time being is entered in the register of pharmacists of the state, in which he is for the time being residing or carrying on his profession or business of pharmacy. 41)S.Y. Diploma Pharmaceutical Jurisprudence 42 Pharmacy Act, 1948 5. Displaced Person : (a) A person who on account of the setting up of the Dominions of India and Pakistan or on account of the civil disturbances or the fear of such disturbances in area now forming part of Pakistan has on or after the first day of March 1947, left or been displaced from his place of residence in such area and who has since then been residing in India. (b) Any person who on account of civil disturbances or the fear of such disturbances in any area now forming part of Bangladesh, has after the 14th day of April 1957 but before the 25th day of March 1971, left or has been displaced from his place of residence in such arca and who has since then been residing in India. 6. Repatriate : Any porson of Indian origin who on account of civil disturbances in any area now forming part of Burma, Sri Lanka or Uganda, or any other country has after the 14th day of April 1957, left or has been displaced from his place of residence in such area and who has since then been residing in India. 7. University Grants Commission : It means the University Grants Commission established under section 4 of the University Grants Commission Act, 1956. 8. Indian University : It means a University within the meaning of section.3 of the University Grants Commission Act, 1956 and includes such other institutions, being institutions established by or under a Central Act, as the Central Government may, by notification in the Official Gazette’ specify in this behalf. PHARMACY COUNCIL OF INDIA Pharmacy Act, 1948 provides for the constitution of a Central Council (Pharmacy Council of India) under section 3 of the chapter 1 by the Central Government. The council consists of following members. (a) Six members, among whom there shall be at least one teacher of each of the subjects of Pharmaceutical Chemistry, Pharmacy, Pharmacology and Pharmacognosy elected by the University Grants Commission, from among persons on the teaching staff of an Indian university or a college affiliated thereto which grants degree or diploma in pharmacy. (b) Six members nominated by the Central Government of whom at least four shall be possessing degree or diploma in pharmacy and practicing pharmacy or pharmaceutical chemistry. (c) One member elected by the members of Medical Council of India amongst themselves. (a) A representative of UGC and representative of the All India Council for Technical Education. (e) One member from each state elected by the members of each State Couneil, amongst themselves shall be a registered pharmacist. (From pharmacy amendment Act 1976, one member nominated by Government of each union territory, instead of electing, who shall be eligible for registration under sec. 31).S.Y. Diploma Pharmaceutical Jurisprudence 43 Pharmacy Act, 1948 ( One member from each state, nominated by State Government, shall be a registered pharmacist. Following are the ex-officio members. () Director General of Health Services (h) Drug Controller of India. (i) Director of the Central Drugs Laboratory, FUNCTIONS OF PHARMACY COUNCIL OF INDIA (PCD The main functions of Central Council are as follows : 1. To prescribe the minimum standard of education required for qualification as a pharmacist. (This can be provided by making the rules as education regulations which prescribes minimum qualification for admission, duration of the course, details of syllabus, practical training, and examination, minimum facilities required for the conduct of course, examination and practical training). 2. To regulate the minimum educational standard. (For this purpose, Council appoints Inspectors to inspect the institutions providing the minimum standards in education in pharmacy and report on the facilities available and decides whether the institutes should be recognised or not. 3. To recognise qualifications granted outside the territories to which Pharmacy Act 1948 extends for the purpose of qualifying for registration under the said Act. 4. To compile and maintain a central register for pharmacist containing names of all persons for the time being entered in the state register. 5. Any other function that may be assigned to the Central Council in the furtherance of the objectives of the Pharmacy Act, 1948. President and Vice President of Central Council : The president and vice president of the council shall be elected by the members of the council amongst themselves. President and Vice President holds a office for a term not exceeding five years and not extending beyond the expiry of his term, as a member of council. But, if his term as a member of Central Council expires before the expiry of the full term for which he is elected as President or Vice President; and if he is re-elected or re- nominated as a member of Central Council, he can continue to hold office as President or Vice President for the full torm for which he is elected, Term of Office and Casual Vacancies : (a) Nominated or elected member shall hold office for a term of five years from the date of nomination or election. (b) A nominated or elected member may resign his membership at any time by writing to president. Seat of such member thereupon remains vacant. (c) A nominated or elected member should have to vacate his seat if he is absent without excuse, sufficient in the opinion of the Central Council for three consecutive meetings of the council.SY. Diploma Pharmaceutical Jurisprudence 4.4 Pharmacy Act, 1948 (4) Causal vacancies as in above cases can be filled by, fresh nomination or election as the case may be. The person so elected or nominated can hold office only for a remainder of the term for which the member whose place he takes. (@) Members of Central Council can be eligible for re-nomination or re-election. Staff Remuneration and Allowance : The Central Council may : 1. Appoint a registrar who may act as a secretary, and if deemed expedient, act as a Treasurer of the council. 2. Appoint such other officers and servants as considered necessary to enable it to carry out its function. 3. From the Registrar, or any other officer or servant takes such security for the due performance of his duties as council may consider necessary. 4. With previous sanction of the Central Government, Central Council may fix : i) The remuneration and allowances for the president, vice president and other members of the council, Gi) Pay and allowances and other service conditions of officers and servants of the council The Exocutive Committee : ‘The Pharmacy Act provides, constitution of Executive committee by the Central Council : ‘The Executive committee consists of the 1. Ex, officio members : (a) president who shall be the chairman of this committee; and (b) Vice President; and 2. Five other members elected, by the Central Council from amongst its members. ‘The members of Executive committee holds the office until the expiry of his term as a member of Central Council, but if re-elected as a member of Central Council, he can hold office for residual term. Powers of the Central Council to make regulations : The council is authorised to lay down rules for its procedures, fix the rate of allowance payable to its members and members of other committee, which are previously sanctioned by Central Government and also decides modes of election. It may also lay down rules for the management of its property, and maintenance and auditing of accounts, holding of meetings, fixing functions, duties and powers of Executive Committee. president and vice-president and qualifications, terms of office, power and duties of secretary, Inspectors and other officers of the council. The council may constitute from amongst its members, such committees for general or other special purposes as deemed necessary. The council has to furnish copies of his minutes and those of Executive committee, together with a Summary of annual activities and accounts to the ‘Central Government. The Central Government may publish any report or abstract in such manner as it thinks proper.S.Y. Diploma Pharmaceutical Jurisprudence 45 Pharmacy Act, 1948 (BD) EDUCATION REGULATIONS Subject to the provision of section 10 of the Pharmacy Act 1948, Central Council after approval of the Central Government may make regulations prescribing the minimum standard of education required for qualification as pharmacist called Education Regulations and prescribe : (a) Minimum qualification for admission to the course (b) Nature and period of course of study (©) Nature and period of practical training to be undertaken after the completion of the regular course (Not less than 75 hours covered in a minimum of three months in an Institution, Hospital, Pharmacy or Dispensary recognised by Central Council). (@)_ The subjects of examination and the standard attained therein (e) The equipment and facilities to be provided by the Institutions for the students undergoing approved course of study (f) Conditions to be fulfilled by Institutions giving practical training (g) Conditions to be fulfilled by authoritics holding approved examinations Central council before submitting the Education Regulations or any amendment thereof, ‘as the case may be to the Central Government for approval, sends copies of draft of ER (Education Regulations) and all subsequent amendments to all State Governments and takes into consideration the comments of any State Government received within three months from the furnishing of the copies by Central Council. The ER then is published in Official Gazette by Central Government as directed by Central Council. The Executive Committee from time to time reports to the Central Council on the efficacy of ER and may recommend to the Central Council such amendments thereof. Application of Education Regulations to States : After the constitution of the state council under Chapter 3 and after consultation with state council the State Government may at any time, by notification in the Official Gazette declare that ER shail take effect in the state. If however, no such declaration has been made, the ERehall take effect in the state after three years from the date of the constitution of the State Council. [E] APPROVAL OF INSTITUTIONS OR AUTHORITIES PROVIDING COURSES OF STUDY AND EXAMINATIONS 1. Application by Institution/Authority to the Central Council : An Institution or Authority, which conducts course of study or holds an examination for the pharmacist, has to apply to the Central Council for approval of the course or examination. 2, Inspection : Central Council, after receiving such application, depute its inspectors to visit the Institution and ascertain whether the Institution hes the prescribed facilities for imparting training or holding examination in accordance with the Education Regulations or not. Inspectors may also attend any examination, to judge its standards without interferring with its conduct. The Inspectors then report to theS.Y. Diploma Pharmaceutical Jurisprudence _ 46 Pharmacy Act, 1948 Council on the sufficiency or otherwise of the facilities available in the Institution and on the conduet and Standard of the examinations held. 3. Approval ; On the reports of the inspector if the council is satisfied that the course or examination under consideration is in conformity with ER, it may accord approval to it and the said course of examination shall be deemed to be approved for qualifying for registratioin as a pharmacist under the Act. 4. Declaration : Declaration of approval made by resolutions is passed at a meeting of the Central Council, and published in the official Gazette. Every authority in the states which conducts an approved course of the study or holds an approved examination shall furnish such information as Central Council may seek, from time to time. FH WITHDRAWAL OF APPROVAL If the executive committee reports to the Central Council that an Institution or Authority holding an approved course of study or examination does not continue to be in conformity with the ER, the Central Council may give notice to the authority concerned of its intention of withdrawing the declaration of approval accorded. The said authority then should make a representation within three months from the receipt of such notice and forward to the Central Council through the State government. Taking into consideration, representation received from authority concerned, and any observation thereon which the State Government may think to make, the Council may declare that the course of study or examination shall be deemed to be approved only on fulfillment of specified conditions. f@ QUALIFICATIONS GRANTED OUTSIDE THE territories TO WHICH THIS ACT EXTENDS Central council if satisfied with any qualification in pharmacy granted by an authority outside the territories to which Act oxtonds, affords a sufficiont guaranteo of the requisite skill and knowledge may declare such qualification to be ansapproved qualification for the purpose of qualifying for registration under this Act if granted before or after specified date. No person other than citizen of India possessing such qualification shall be deemed to be qualified for registration. Citizens of other countries, holding qualifications granted there, shall be registrable in this country when an Indian national, holding the same qualification is by law, allowed to enter and practice profession of pharmacy in that country. THE CENTRAL REGISTER OF PHARMACISTS Under the provision of the sec. 15-A of the amendment Act 1976, Central council has to maintain in a prescribed manner a register of pharmacist to be known as the Central Register which contains the names of all persons whose names are entered in the register for a state. Every state council has to supply five copies of a register for a state to the Central Council as soon as after the first day of April every year, and Registrar of State council should also inform all additions and other amendments in the register for a state, without delay to the Central Council.S.Y. Diploma Pharmaceutical Jurisprudence. 47 Pharmacy Act, 1948 Registrar of the Central Council has to keep the Central Register in accordance with the orders made by Central council and should revise the Central Register from time to time and publish it in the Gazette of India. The Central Register deemed to be public document within the meaning of the Indian Evidence Act 1872, and may be proved by the production of a copy of the register as published in the Gazette of India Registration in the Central Register : After receiving the report of registration of a person in the register for a State, the Registrar of Central Council enters the name of such person in the Central Register. o STATE PHARMACY COUNCILS Pharmacy Act under Chapter 3 provides for the constitution of State pharmacy council by every state except where a Joint State council is constituted in accordance with agreement made under section 20. Under this section two or more states may however agree to have a Joint Council for definite or indefinite periods of time. Two or more states may also agree, whereby the pharmacy Council of one state may serve the needs of the other agreeing state or states, ‘The State and Joint State Pharmacy Council consists of the following members : tate Pharmacy Council Joint State Pharmacy Council 1. Six members, elected amongst| 1. As provided in the agreement not less themselves by Registered pharmacists of] than 3 and not more than 5 members state. elected amongst the registered pharmacists of each participating state. 2. Five members nominated by State|/2 As agreement provides, not less than Government of whom at least three shall be persons possessing a prescribed degree or diploma in pharmacy or Bppemacoutcl chemistry or registered jarmacists. . One member elected by the members of| Medical Council of State amongst themselves. Ex-Officio Members Chief administrative medical officer of the State. The officer incharge of drugs control organization of the Stato; appointed under Drugs and Cosmetics Act 1940. Government Analyst appointed under Drugs and Cosmetics and 1940. If there are more than éne such Analyst, one may be nominated by Government. two and not more than 4 members nominated by each participating State Government of whom more than half should possess degree or diploma in pharmacy or pharmaceutical chemistry or be a Registered Pharmacist. One member elected by the members of each Medical Council from amongst themselves, of each participating state. Chief administrative medical officer of each participating State. Officer in-charge of drug control organization of cach participating state under DC Act 1940. Government Analyst appointed under DC Act, 1940 of each participating state.