Page 1 : PHARMACY ACT 1948, , CHAPTER NO 3, , SHREE GURUDATTA SHIKSHAN SANSTHA’s, , COLLEGE OF PHARMACY, MANUR, KALWAN, ACADEMIC YEAR 2020-21, Mr Zaki Iqbal Ansari, Senior Lecturer, Mobile No:9970863641, , Email.ID:
[email protected], , ---------------------------------------------------------------------------------------------------------------Subject: Pharmaceutical Jurisprudence (0814), Chapter No 03, , Pharmacy Act 1948, Contents:, 1)Objectives, 2)Definitions, 3)Pharmacy council of India, 4)Education Regulation, 5)State Pharmacy Council, 6)Joint State Pharmacy, 7)Registration of Pharmacists, 8)offences and Penalties, , Object of the Act:, The pharmacy act was passed in 1948 with main object to regulate the profession of, pharmacy and to control the course of pharmacy. For this object the act provides the, constitution of pharmacy council of India.PCI is responsible for regulation of profession of, pharmacy and also provide minimum standards for diploma course in pharmacy. The act also, provides central council (PCI)which constitute state pharmacy council for registration of, pharmacist. Therefor following are the three main object of Pharmacy Act1948., 1)Constitution of Pharmacy Council of India. (PCI), 2)Constitution of state pharmacy council for registration of pharmacist. (SPC), 3)Formation of education regulation (ER)to guide the person regarding syllabus and, course of pharmacy., , ANSARI ZAKI IQBAL, , S.G.S.S.COLLEGE OF PHARMACY
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PHARMACY ACT 1948, , CHAPTER NO 3, , Definition:, a) Central Council: It means Pharmacy council of India constituted u/s 3 of pharmacy Act, 1948., b) Central Register: It means the Register of Pharmacist maintain by central council., c) University Grant Commission:(UGC) It means the university grand commission, establish u/s 4 of university grand commission act 1956., d)state council: It means the state council of pharmacy constituted u/s 19 and include joint, state pharmacy council constituted u/s 20 of Pharmacy act 1948., e) Registered Pharmacist: It means a person whose name is for the time being entered in the, register of state, in which he is for the time being residing or carrying his profession or, business of pharmacy., f) Displaced person: It means, i)Any person who has been left or has been displaced from place of his residence in Pakistan, on or after 1st of march 1947 on account of civil disturbances or fear and since then residing, in India or, ii)any person who has left or has been displaced from the place of his residence in, Bangladesh after 14th of April,1957 but before 25th of march 1971 on account of civil, disturbances or fear and since residing in India., g) Repatriates: It means any person of Indian Origin who has left or has been displaced from, place of his residence in Burma, Shrilanka, Yoganda or any other country after 14th April, 1957 on account of civil disturbances or fear and since they residing in India., , Pharmacy Council of India (PCI), The first PCI was constituted in 1949 and it is reconstituted every after five years. The PCI, consists of following members., I)Elected members, II)Nominated members, III)Ex-officio members, I)Elected members:, i)Six members elected by UGC (University grant commission) from among teachers working, in Indian University of college. One member should be teacher of the subject pharmaceutical, chemistry or pharmacognosy., ANSARI ZAKI IQBAL, , S.G.S.S.COLLEGE OF PHARMACY
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PHARMACY ACT 1948, , CHAPTER NO 3, , ii)One member elected from among themselves by member of MCI (Medical council of, India), iii)One registered pharmacist from each state elected from member of SPC(state pharmacy, council), II)Nominated members:, i)Six members are nominated by central government out of which four members should be, possess degree or diploma in pharmacy or should be pharmacy teacher., ii)One representative from UGC., iii)One representative from AICTE (All India council for Technical Education, iv)One representative from each state pharmacy council. (SPC), III)Ex-officio members:, i)The Director General of Health service (DGHS), ii)The Drug Controller of India (DCI), iii)The Director of Central Drug Laboratory (CDL), , Constitution for members of PCI:, The president and vice president shall be elected by the members of PCI themselves. The, president and vice president hold office not more than five years. The secretory of the PCI is, also elected from the members of PCI. If any elected or nominated members are remain, absent from continuous three meeting without any sufficient reason the member may be, suspended or removed from the membership. The vacant seat can be filled by new member, but the membership is only remaining period of time. The elected or nominated members of, PCI hold the office only for five years from the date of appointment. If any member wants to, resign from membership, he can resign by writing to the president of PCI.The vacant seat can, be filled by re-election or re-nomination but the membership is only for reaming period of, time. Every member is eligible for re-election and re-nomination., , Function of PCI:, The PCI is constituted under Pharmacy Act to carry the following functionsi)To regulate Pharmacy Institution specially Diploma Pharmacy through Education., ii)The PCI grant the approval to the institute for running the course of pharmacy., iii)PCI withdrawal the approval of the institute if required., iv)PCI prescribe the minimum standard of education require for qualification as a pharmacist, i.e.ER., v)PCI recognise minimum qualification for foreigner for purpose of registration., ANSARI ZAKI IQBAL, , S.G.S.S.COLLEGE OF PHARMACY
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PHARMACY ACT 1948, , CHAPTER NO 3, , vi)It maintain the central register for pharmacist which contain name of all registered, pharmacist of different states., , Education Regulation (ER):, Under the pharmacy Act 1948the PCI finalised the education regulation after approval of, central government. The education regulation (ER) is the minimum standard of education for, qualification as a Pharmacist. ER consists of following points which are called as minimum, standard of Pharmacy education., i)Minimum qualification for admission to pharmacy course., ii)Nature and duration of course for study., iii)Approval of the Institute conducting course of pharmacy., iv)Nature and duration of practical training to be taken after the completion of the course., v)The different subject to be studies during the course., vi)The subject of examination and mode of examination., vii)Approval of examination board., viii)The equipment’s and facilities to be provided by the institute during the course to be, study., ix)Staff and infrastructure to be provided by the institute., x)Condition to be fulfilled by the examination board., xi)Condition to be fulfilled by the institute for giving practical training., , Approval of the Institute:, If any institute want to start the pharmacy course or conduct the pharmacy course, the, authorities of the institute has to apply to PCI for approval the PCI (under section) u/s 12 of, pharmacy act provide the approval of the pharmacy course to the institute. When institute, apply for approval, after receiving such application from the institute (SIF)the PCI deputed, inspector to visit the institute. On visit to the institute the inspector physically verifies, facilities provided by the institute or facilities available as per ER. The inspector sends the, report to the PCI about the facilities available and standard of examination. The inspector, may also attend any examination to observed the standard of examination. The same report is, sends to PCI by the Inspector., On the basis of the report of the inspector if council is satisfied then approval may be given to, the institute. The approval should be on the basis of report of the inspector. If any approved, institute does not provide facilities as per education regulation continuously then notice may, be given to the authority of institute. In these cases, the approval may be withdrawn from the, institute and institute is given three months for clarification. The institute can apply within, , ANSARI ZAKI IQBAL, , S.G.S.S.COLLEGE OF PHARMACY
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PHARMACY ACT 1948, , CHAPTER NO 3, , three months for approval of the institute. After getting report from institute the PCI may give, the approval only after fulfilment of different conditions., , Central Register:, A central Register is a register of Pharmacist maintain in prescribed manner by the central, council (PCI)u/s 15 is known as central register, which contain names of all person enter in, register of their state., The central register contains name of all person whose name is enter as a registered, pharmacist in the register of state council. The state council maintain the record of all, registered pharmacist of their state. Each state council supply the report of registered, pharmacist of their state to the central council in five copies after 31st of march or 1st day of, April every year. After receiving the report of registered pharmacist from each state the, registrar of central council enters the name of person in the central register. The registrar of, central council keeps up to date record of registered pharmacist and revised time by time. The, central register is called as public documents., , State Pharmacy Council:, The pharmacy act 1948 u/s 19 provide provision for constitution of state pharmacy, council(SPC).The state pharmacy council consist of following members., I)Elected members, II)Nominated members, III)Ex-officio members, I)Elected members:, i)six members elected from among themselves by registered pharmacist of state., ii)One member elected by state medical council from among themselves., II)Nominated members:, i)Five members nominated by state government of whom at least three members should have, degree or diploma in pharmacy and should be a registered pharmacist., III)Ex-officio members:, i)The chief administrative medical officer of the state., ii)The officer in charge of drug control department of the state., iii)The government analyst deputed by state government., , Constitution of members of SPC:, The members of SPC elect president and vice president from among themselves. The, members are given membership for five years only. All members are eligible for re-election, ANSARI ZAKI IQBAL, , S.G.S.S.COLLEGE OF PHARMACY
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PHARMACY ACT 1948, , CHAPTER NO 3, , and re-nomination. The president and vice president is responsible to hold office for five, years. If any member remains absent without sufficient reason for three continuous meeting,, he shall be deemed to have vacant his membership. If any members want to resign from, membership he may resign by witting to president. The vacant seat can be filled by fresh, nomination or election only for remaining period of time., , Functions of SPC:, SPC carry the following functions:, i)Registration of Pharmacist and maintenance of register of state., ii)Removal of name of registered pharmacist from the register., iii)Printing of register of pharmacist of the state., iv)Sending the register to the PCI for central Register., i)Registration of Pharmacist: To control the entry of only those persons having scientific and, professional knowledge in the profession of pharmacy the pharmacy act provide provision for, registration of pharmacist by state pharmacy council., The person having required qualification training experience for compounding dispensing of, drug are only allow for registration. The name of Registered pharmacist is entered in the, register maintain by SPC. These registers are hand over to central council (PCI) every year, after 31st of March. The register contains following information of registered pharmacist., a) Full name and residential address of registered pharmacist., b) Qualification for registration., c)Date of his first admission to the register., d)Professional address and name of employer., e) Any other information as may be prescribed., , FIRST REGISTER:, The state Government constitute SPC which are responsible for preparation of first register., For preparation of first register the state council constitute Registration Tribunal which, consist of three members and registrar., The registrar is responsible to specify the date for submission of application for registration, along with prescribed fees. The application forms and fees should be reached to the office on, or before prescribed date. The application forms are examined by registration tribunal and if, it is found that qualification is sufficient for registration then his or her name is entered to the, register., , ANSARI ZAKI IQBAL, , S.G.S.S.COLLEGE OF PHARMACY
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PHARMACY ACT 1948, , CHAPTER NO 3, , The first register so prepare is published in the prescribed manner by the state government, registration certificate is given by the registrar to every person whose name is enter in the, register., , Qualification for entry to first register (Criteria for entry to first register):, The person who has attained the age of 18 years shall have his name in first register on, payment of prescribed fees. Such person who carry the business and profession of pharmacy, in the state should have following qualification then his or her name is enter in the first, register., a) A degree or diploma in pharmacy or pharmaceutical chemistry or chemist or druggist, diploma of Indian university of state government or, b) A degree of Indian university other than degree in pharmacy or pharmaceutical chemistry, and have experience more than three years in compounding of drugs in hospital and, dispensary where drugs are dispensed or prescribed or, c) Has passed examination recognised by state govt. for compounding and dispensing or, d)Has not less than five years’ experience of compounding and dispensing of drugs in, hospital or dispensary where drugs are dispensed on prescription of RMP., , SUBSEQUENT REGISTER:, After appointment of date of application for registration in first register by state pharmacy, council the person who has attained the age of 18 years shall be entitled to have his name in, the register. The registration is only after the payment of prescribed fees to the office. The, person whose name is entitled for entry in subsequent register should have following, qualification., a) He should attain the age of 18 years., b) satisfy the condition prescribed for registration and his name is enter in the FIRST, REGISTER or, c)Carries the business of pharmacy or profession of pharmacy in the state or, d)satisfy the condition approved by central council or, e) if a registered pharmacist in another state., After first and subsequent register, the person is given registration certificate along with, registration number., , SPECIAL PROVISION FOR REGISTARTION OF DISPLACED, PERSON:, The pharmacy act amended act 1956 and 1959made certain special provision of registration, of displaced person. The classes of person include, ANSARI ZAKI IQBAL, , S.G.S.S.COLLEGE OF PHARMACY
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PHARMACY ACT 1948, , CHAPTER NO 3, , i)Who had been affected by partition of the country in 1947 or, ii) By reorganisation of state in 1956 or, iii)By transfer of certain foreign settlement of India., Such classes of person if carrying the business or profession of pharmacy and satisfy the, necessary condition for registration their name should be inter in the first register of the state., , Removal of the name from register., The executive committee of state pharmacy council after giving opportunity to a person to, explain his conduct and on sufficient enquiry committee may order to remove the name of, registered pharmacist under following condition from the register., i)If name is entered in the register by error or by mis representation or, ii) If he has convicted any offence or guilty or, iii)He is having connection with any business of pharmacy who has been convicted any, offence against the pharmacy act. Such person is liable for removal of the name from the, register. The removal of the name from the register may be either permanent or for specific, period of time. The order of the committee should be confirmed by SPC and effect should be, taken within three months of the date of order. Three months is given to the person to allow, alternate arrangement for his life. A person whose name has been removed from the register, is require to surrender his registration certificate to the registrar of pharmacy council. The, name of such person shall be published in the official gazette., , Duties of Drug inspector appointed by SPC or state Government:, The SPC after approval from the state Govt. Appointed sufficient number of inspectors, having the prescribed qualification. The inspector so appointed are deemed to be public, servant and having following powers., i)To inspect any premises or place where drugs are compounded and dispensed and submit, the report in writing to the registrar of state pharmacy council., ii)To enquiry about the person who is compounding and dispensing of drugs is a registered, pharmacist or not., iii)To investigate any complaint in writing about the person in respect of contravention of, pharmacy Act., , Joint state Pharmacy Council:, Under the pharmacy act there is a provision for agreement between two or more state for, constitution of pharmacy council. These council is called as joint state pharmacy council., The joint state pharmacy council consist of following members., I)Elected members, ANSARI ZAKI IQBAL, , S.G.S.S.COLLEGE OF PHARMACY
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PHARMACY ACT 1948, , CHAPTER NO 3, , II)Nominated members, III)Ex-officio members, I)Elected members, i)Two or four members are elected from among themselves by registered pharmacist of each, state., ii)One member is elected from medical council of each state from among themselves., II)Nominated members:, i)Two or four members are nominated by each state out of which half should possess degree, or diploma in pharmacy and should be a registered pharmacist., III)Ex-officio members:, i)The chief administrator of medical officer of each state., ii) The officer in charge of drug-controlled department of each state., iii)Government analyst of each state deputed by each state government., , Offences and Penalties under Pharmacy Act:, 1)False claiming to be a registered pharmacist: Any person who falsely claimed to be a, registered pharmacist and used his name in connection with activity of registered pharmacist, shall be punishable with Rupees 500 or imprisonment up to 6 months or both. The fine may, be exceeded up to Rupees 1000 or imprisonment up to 1 year or both on subsequent, conviction., 2)Dispensing of drugs by un registered pharmacist: Any person other than registered, pharmacist dispensing any medicine for patient shall be punishment with Rupees 500 or, imprisonment for 6 months or both on first conviction. The fine may be exceeded up to, Rupees 1000 or imprisonment for 1 year or both on subsequent conviction., 3)Failure to surrender registered certificate:, If any person whose name has been removed from the register without sufficient reason fail, to surrender his certificate of registration shall be punishment with fine up to Rupees 50/4)Obstructing the Inspector:, Any person obstructing an inspector in exercise his power shall be punishable with, imprisonment up to 6 months or fine up to Rupees 1000 or both., , ANSARI ZAKI IQBAL, , S.G.S.S.COLLEGE OF PHARMACY
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PHARMACY ACT 1948, , ANSARI ZAKI IQBAL, , CHAPTER NO 3, , S.G.S.S.COLLEGE OF PHARMACY
