Pharmacy act 1948

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1 PRESENTED BY: SANDIP GORASIYA M.PHARM SEM-2 GUIDED BY: MRS.RIDDHI MADHU M.PHARM,(Ph.D) Matushree V.B.Manvar College of Pharmacy,Dumiyani PHARMACY ACT -1948

CONTENT:

CONTENT History of Pharmacy Act Objectives Definitions The Pharmacy council of India Provincial Pharmacy Council Registration of Pharmacists Renewal Fees Removal of the names from Register Issue of duplicate Certificates of Registration Offences and Penalties 2

HISTORY OF PHARMACY ACT:

HISTORY OF PHARMACY ACT In India there was no restriction to practise the profession of Pharmacy. One could practise this profession as any other profession. Persons, having no knowledge and having no education in pharmacy or pharmaceutical chemistry or pharmacology, were engaged in this profession. 3

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Hundreds of cases were found by Government wherein the compounding, mixing, or dispensing of medicines was being done by persons who were not adequately educated in this line. These causing great harm to the health of people. It was found necessary to enact a law for the regulation of the profession and practice of pharmacy. 4

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LIST OF AMENDING ACTS & ADAPTATION ORDERS. The Adaptation of Laws Order, 1950. The Adaptation of Laws (No.3) Order, 1956. The Pharmacy (Amendment) Act, 1959. The Pharmacy (Amendment) Act, 1976. The Pharmacy (Amendment) Act, 1982. The Delegated Legislation Provisions (Amendment) Act, 1985. 5

OBJECTIVES:

OBJECTIVES To restore the Pharmacy profession in its due place in the health services. Raising the status of the profession of Pharmacy in India. To regulate the practice of Pharmacy in India. 6

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To provide uniform education and training through out India. To maintain control over persons entering the profession of pharmacy. To Protect the Public Health – Medical Use of Drugs – Drug Abuse 7

DEFINITIONS:

DEFINITIONS “Pharmacy Act” : An Act to regulate the profession of pharmacy. “Medical practitioner “-- A person, (i) Holding a qualification granted by an authority notified under section 3 of the Indian Medical Degrees Act, 1916 or specified in the Schedules to the Indian Medical Council Act 1956; OR 8

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(ii) Registered or eligible for registration in a Medical register of a State, meant for the registration of persons practicing the Modern scientific system of medicine; OR (iii) Registered in a medical register of a State, who, although not falling within above first and second clause , but is declared by a general or special order made by the State Government; OR 9

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(iv) Registered or eligible for registration in the register of Dentists for a State under the Dentists Act, 1948; OR (v) Who is engaged in the practise of Veterinary medicine and who possesses qualifications approved by the State Government. 10

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“Registered Pharmacist" : A person whose name is for the time being entered in the register of the State in which he or she is for the time being residing or carrying on his profession or business of pharmacy. 11

PHARMACY COUNCIL OF INDIA:

PHARMACY COUNCIL OF INDIA The central council (P.C.I) is constituted by the Central government. First central council was constituted in 1949. It is reconstituted every five years. 12

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CONSTITUTION OF P.C.I . : It consists of three different types of members: Elected member Nominated member Ex-officio member 13

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Elected members: Six members, elected by the University Grant commission (U.G.C). There is at least one teacher of each of the pharmaceutical chemistry, pharmacy, and pharmacognosy and pharmacology. One member , elected by Medical Council of India. One member , elected by State Council ,who shall be a registered Pharmacist. 14

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B. Nominated members: Six members, nominated by the Central Government. Of whom at least 4 shall be persons possessing a degree or diploma in, and practicing pharmacy or pharmaceutical chemistry. A Representative of the U.G.C. and a representative of the All India Council for Technical Education(A.I.C.T.E.). One member nominated by each State Government, who shall be a registered pharmacist. 15

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C. Ex-officio members: The Director General of Health Services. The Director of the Central Drugs Laboratory. The Drugs Controller of India. Executive Committee consisting of: President Vice-president Five members elected by central council from its members. 16

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President and Vice-President of Central Council shall be elected by the members of the Council from themselves. The council shall appoint, -A registrar, act as secretary -Other officer and servants. 17

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FUNCTIONS OF P.C.I. : A) Education Regulations (E.R.) - Minimum standard of education laid down by P.C.I. are known as the “Education Regulation”. They include, Minimum qualification for registration as a Pharmacist. Minimum qualification for admission to Diploma in Pharmacy. 18

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Duration of training and course of study to be covered. Condition to be fulfilled by the academic Institution and by the Examining Authority. Nature and period of practical training . The subjects of examination and minimum standard of passing. Condition to be fulfilled by the institution to be recognized for giving practical training. Practical training contract form for Pharmacists. 19

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B) To regulate the Education Regulation in the states. C) Approval of the Institutions providing course and examination for the pharmacists. Procedure: i) Institution has to apply to P.C.I/A.I.C.T.E. ii) P.C.I/A.I.C.T.E. deputes its inspector to visit the institution. iii) Inspector then reports to council on which if council is satisfied , it approves the course of examination. 20

PROVINCIAL PHARMACY COUNCIL:

PROVINCIAL PHARMACY COUNCIL Classification: Provincial pharmacy council Separate state council Inter state agreement (S.P.C.) Joint state- state council of- council 1state serve the - (J.P.C.) need of other- state 21

CONSTITUTION OF S.P.C.:

CONSTITUTION OF S.P.C. It consists of three different types of members: Elected member Nominated member Ex-officio member. A . Elected member: 1) six members, elected from amongst themselves by registered pharmacists of the State; 2) one member elected from amongst themselves by the members of each Medical Council of the state. 22

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B . Nominated member 1) Five members, of whom at least three shall be possessing a degree or diploma in pharmacy or pharmaceutical chemistry or be Registered Pharmacists, nominated by the State Government. C. Ex-officio member 1) Chief administrative medical officer of the State. 2) Government analyst nominated by State government under the D & C act 1940. 3) Officer in charge of drugs control organisation of the State. 23

JOINT STATE PHARMACY COUNCIL:

JOINT STATE PHARMACY COUNCIL Two or more State Governments can agree that the State Council of one State is to serve the needs of the participating States. Composition of Joint State Councils: It consists of three different types of members: Elected member Nominated member Ex-officio member. 24

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A . Elected member : 1) 3-5 members elected amongst themselves by the Registered Pharmacists of each of the participating States. 2) One member elected from amongst themselves by the members of each Medical Council of each State. B . Nominated member: 1) 2-4 members nominated by each participating state, of whom more than half possess a degree or diploma in pharmacy or be Registered Pharmacist. 25

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C. Ex-officio member: 1) The Chief administrative medical officer of each participating State. 2) The Government Analyst of each participating state. 3) The officer in-charge of drugs control organisation of each participating State. Executive Committee consisting of: President Vice-president The such other number of the member. 26

REGISTRATION OF PHARMACISTS:

REGISTRATION OF PHARMACISTS The Pharmacy Act,1948, provides for the registration of pharmacists . There are two types of register, 1)First register 2)Subsequent register 27

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The Preparation and maintenance of Register: The Register shall include the following particulars, namely: a) The full name and residential address of the registered person; b) The date of his first admission to the register; c) His qualifications for registration; d) His professional address, and if he is employed by any person, the name of such person; e) Such further particulars as may be prescribed. 28

PREPARATION OF FIRST REGISTER:

PREPARATION OF FIRST REGISTER For the preparation of the first register, the State Government has to constitute a Registration Tribunal . The Tribunal consisting of : - Three persons, - A Registrar ,act as Secretary. 29

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- Tribunal fixes the date on or before which all applications for registration with prescribed fees are accepted. - All applications are examined. - If tribunal is satisfied, it directs the entry of the name of the applicant on the register. 30

QUALIFICATIONS FOR ENTRY ON FIRST REGISTER:

QUALIFICATIONS FOR ENTRY ON FIRST REGISTER Applicant should be at least 18 years old. Applicant should reside or carries on the business or profession of pharmacy in the concerned State. Applicant should hold, A degree or diploma in pharmacy OR pharmaceutical chemistry OR Chemist and Druggist diploma OR 31

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c) Qualification granted by authority outside India which is adequate for registration. OR d) Degree of an Indian universities with not less than 3 years experience in dispensing in hospital. OR e) Passed an examination for dispensers recognized by state government . OR f) Not less than 5 years experience of compounding prior to the date notified by Tribunal. 32

SUBSEQUENT REGISTERS:

SUBSEQUENT REGISTERS Procedure for subsequent registration: From the registered pharmacists of the first register constitution of State council take place Application are invited within fix date , addressed to the registrar If registrar found that applicant has requisite qualification, he may direct his/her name to be entered in register. 33

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If application has been rejected by registrar , he/she may appeal to state council within 3 months of the rejection. The decision of the state council shall be final. 34

REQUIREMENTS FOR SUBSEQUENT REGISTRATION:

REQUIREMENTS FOR SUBSEQUENT REGISTRATION Applicants should be at least 18 years of the age. Applicants should carry on the profession of the pharmacy in the concerned state. 35

QUALIFICATIONS FOR SUBSEQUENT REGISTRATION:

QUALIFICATIONS FOR SUBSEQUENT REGISTRATION There are 3 different types of qualifications prescribed: 1) After the preparation of first register and before E.R. take effect. 2) After E.R. take effect. 3) Special provisions. 36

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37 After the preparation of First register and before E.R. take effect a) Satisfies the conditions prescribed by the Central Council OR b) A registered pharmacist in another State. OR c) Possesses a qualification for registration granted outside the states and are atleast matriculates.

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2) After the Education regulations take effect: Those who have passed an approved examination OR Those who possesses a qualification granted by authority outside India and recognize by the P.C.I.OR Those who are Registered Pharmacist in another State. 38

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3) Special provisions: Provision made under The Pharmacy Act 1959, apply to persons; Affected by the partition in 1947 Due to reorganization of the state in 1956 Migrated to India Provision made under The Pharmacy Act 1976; Those who possess degree or diploma in pharmacy or Pharmaceutical chemistry. OR Chemist & druggist diploma of Indian university . OR 39

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Passed an examination recognized for dispenser by State government . OR Person approved as “Qualified persons” before 31 st December 1969 under D & C Act. Any displaced persons from Bangladesh , Burma ,Uganda , Sri Lanka, were carrying profession of pharmacy for period of 5 years prior to date of application. 40

RENEWAL FEES:

RENEWAL FEES Retention of a name on the register , subject to the payment of prescribed fee annually before the 1 st day of April. If a renewal fee is not paid by the due date, the Registrar shall remove the name of the defaulter from the register. Provided that a name so removed may be restored to the register on such conditions as may be prescribed. 41

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On payment of the renewal fee, the Registrar shall issue a receipt therefore and such receipt shall be proof of renewal of registration. Entry of additional qualifications obtained by registered pharmacist shall be entered in the register on payment of prescribed fees. 42

REMOVAL OF NAME FROM REGISTER:

REMOVAL OF NAME FROM REGISTER The name of Pharmacist may be removed from register, i) If his name has been entered into the register by error. OR ii) If he has been convicted of any offence in any professional respect which renders him unfit to be kept in the register. OR 43

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iii) If the employed person is registered pharmacist , his name may be removed from register . If, Convicted of offence or held guilty of infamous conduct. Offence was investigated by registered pharmacist himself. If the repetition of similar offence or conduct during the period of 12 month. 44

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Pharmacist may go to the appeal to the State Government within 30 days. A person whose name has been removed from the register is required to surrender his certificate or registration to the Registrar. 45

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Issue of duplicate certificates of registration: Where it is shown to the satisfaction of the Registrar that a certificate of registration has been lost or destroyed, the Registrar may, on payment of the prescribed fee , issue a duplicate certificate in the prescribed form. 46

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47 OFFENCES PENALTIES 1. Falsely claiming to be a registered pharmacist. 1.(a) Fine up to Rs. 500.00 on first conviction. (b) Fine up to Rs. 1000.00 and/or 6 months imprisonment of any subsequent conviction. 2. Dispensed by unregistered persons. Exception: Medical practitioners. 2. 6 months imprisonment OR Fine up to Rs. 1000.00 OR Both. 3.Failure to surrender certificate of registration. 3. Fine up to Rs. 50.00 4.Obstructing State pharmacy council Inspectors. 4. 6 months imprisonment OR Fine up to Rs. 1000.00 OR Both.

REFERENCES:

REFERENCES 1) www.pci.nic.in/contents.htm 2) Dr.G.K.Jani , Pharmaceutical Jurisprudence, 5 th edition 2005-2006,Atul prakashan, Ahmedabad, page no 15-27. 3) http://144.16.72.182/vigyan/pharm.htm 48

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THANK YOU 49