pharmacy act.pptx

PHARMACY ACT

1. THE PHARMACY ACT 1948

2. INTRODUCTION Pharmacy act governs the practice of pharmacy in India. Making rights medicaments available to the public is the primary obligation of pharmacy in order to safeguard the public health. Prior to the enactment of pharmacy Act, 1948, there was practically no restriction on entry of person into the profession of pharmacy. Anybody who could read a prescription could become a pharmacist. Act passed 1948 Came into force 4 th march, 1948 Amendment 1959, 1976, 1981

3. OBJECTIVES Raising the state of profession of pharmacy India with two objects: To provide uniform education and training for the prospective pharmacist. To maintain control over the person entry the profession of pharmacy by providing for their registration in every state. 2. To ensure education and training, this act provides for the constitution of pharmacy council of I ndia. Framing the course Approving the institution 3. For registration of pharmacist in the various state, the act provides the constitution of state pharmacy council. Maintenance of register of pharmacist Control over practicing pharmacist

4. CHAPTER AND SECTION Chapter=5 Section=46 Chapter I Introduction (1-2) Chapter II PCI (section (3-18) Chapter III SPC (19-28) Chapter IV Penalty and other (41-46) Chapter V Penalty and other (41-46) Section 3 Central council constituted Section 12 Course of study Section 14 Foreign qualification Section 15 Central register Section 19 State council constituted Section 20 Interstate agreement

5. DEFINATION AGREEMENT - Means entered into under section 20 inter-state agreement regarding constitution of state council. APPROVAL - Approval by state council under section 12 (course of study and examination in pharmacy) or section 14 (foreign qualification) for qualifying for registration. CENTRAL COUNCIL- Means the pharmacy council of India constituted under section 3. CENTRAL REGISTER- Means the register of pharmacist maintained by central council under ( section 15A). REGISTER- Means register of pharmacist prepared and maintain by this act. REGISTERED PHARMACIST- Means a person whose name is entered in the register. STATE COUNCIL- Means a state council of pharmacy constituted under section 19. UNIVERSITY GRANTS COMMISSION- It means the University Grants commission established under section 4 of the university Grants commission Act, 1956.

6. REGISTERED MEDICAL PRACTITIONERS- Person holding qualification granted by an authority specified or notified under section 3 of the Indian Medical degrees Act, 1916 or as may be specified in the Schedules to the Indian medical Council Act, 1956.

7. EDUCATION REGULATION (1991) It repeal the 1981 of education regulation. As per the Section 10 of the Pharmacy Act 1948, PCI also makes regulation called education regulation with approval of central government. First education regulation are approved by the Ministry of Health and family Welfare was notified on 11 th July 1953. FIRST ER SECOND ER THIRD ER FOURTH ER 1953 1972 1981 1991

8. MINIMUM QUALIFICATION: A person who has attain the age 18 year. DURATION OF TRAINING: Not less than 250 hour for are devoted to actual dispensing of prescription in recognized hospital/dispensary or pharmacy. Not less than 500 hour the nature and period of practical training. 3. STANDARD EXAMINATION: Approval to the course of study and standard examination held by central council. The equipment and facilities to be provided for student. 4. APPROVAL OF COURSE OF STUDY AND EXAMINATION: Any institute in India conducting a course of study for pharmacist apply to central council and section deal with approval of course of study and examination under section 12 (1) approval will be granted only if the central council is satisfy. Student will be entitled to be examined under section 12 (2). Pharmacy education also comes under technical education so the AICTE also evaluate through expert committee. Sign memorandum of understanding (MOU) between AICTE and central council for approval under section 20. 5. WITHDRAWAL OF APPROVAL: Executive committee report to the central council and withdraw the approval within 3 months from the notice. IMPLEMENTATION OF THE EDUCATION REGULATION TO THE STATE: After constitute of pharmacy council in the state, the state govt. in constitution with the respect council declare the education regulation shall take effect in their respective state.

9. The central council (PCI) is constituent by the central government. Central council (PCI) constituted in 1949. Reconstituted in every 5 year. The president and vice president are nominated by its member. If the nominated member and elected member remain constant absent in 3 consecutive meeting of the central council. They have vacant seat. Elected and nominated member can resign by written by own hand writing to give president. PHARMACY COUNCIL OF INDIA

10. MEMBERS OF PCI Elected member: (Total= 8) Nominated member: (Total=9) Ex-officio member: (Total=3) 6 member: Six member including at least four member are teacher are elected by UGC. 6 member: Six member including at least four person possessing degree or diploma in pharmacy. (a) The Director general of health service 1 member: One member elected by medical council of India. 2 member: One from UGC and one from AICTE (b) The Director of central drugs laboratory 1 member: One member shall be pharmacist to represent each state elected by each state. 1 member: One registered pharmacist to represent each state nominated by state govt./Union territory (c) The Drugs controller of India

11. ROLE OF CENTRAL COUNCIL: Education regulation The Equipment and facilities to be provided for student. Approval to the course of study and examination Withdrawal of approval Central council shall appoint registrar who shall act as secretary to the council and if need as its treasure too. Central council constitute executive committee consist president and vice president and other 5 member elected by central council from among its member. Rules are made by central govt. and regulation by state govt.

12. STATE PHARMACY COUNCIL: State pharmacy council and joint state council are also constitute under this act by the state govt. Two or more state may however agree to have agree to have a joint council for definite or indefinite period of time. The president and vice president of state council are elected by the members from amongst themselves. The council may appoint a registrar and such other officer and staff as may be qualified. Duration of each council is 5 year.

13. MEMBERS OF STATE PHARMACY COUNCIL: Member State Pharmacy council Joint State Pharmacy council Elected member (Total=7) Six registered pharmacist elected from amongst them. One member elected by amongst themselves by the member of medical council of state 3-5 registered pharmacist of each participating state elected from amongst themselves. One member elected by medical council of the each state from amongst its member. Nominated member (Total=5) Five member of whom at least 3 member shall be possess degree or diploma nominated by state govt. 2-4 member nominated by each participating sate of whom more than half shall be possessing degree or diploma. Ex-officio member (Total=3) Chief administrative medical officer of the state Officer-in-charge of drug and cosmetic act Govt. analyst under the drug and cosmetic act

14. ROLE OF STATE PHARMACY COUNCIL: 1. Preparation and maintenance of register: State Pharmacy Council of each state shall prepare and maintain the register of pharmacist as per the provisions of the Pharmacy Act, 1948. 2 . Entry and removal of name from register: Registrar of each State Council shall enter the names of such persons qualified by Registration Tribunal appointed by State Council. Under certain circumstances State Pharmacy Council may remove the name of registered pharmacist from the register. REGISTRATION OF PHARMACIST: Name of the registered pharmacist are entered in the registers maintained by the state council and central council. Following points include- Full name and residual address Date of the first admission Qualification for registration Professional address Other

15. Allowed to enter the practice of pharmacy Person having qualification handling storage compounding and dispensing etc. of the drug Name of registered pharmacist are entered in the register maintained by state and central council FIRST REGISTER: State govt. are constitute a registration tribunal who is responsible for the preparation and maintenance of the first register in each state. Tribunal consist of 3 person and registrar also appoint who act as its secretory. First register are published by state govt.

16. Qualification for entry of first register: A person who has attain the age 18 year: Hold degree or diploma in pharmacy or pharmaceutical chemistry or a chemist or a druggist of an Indian university or a state govt. Hold a degree of Indian university other than a degree or diploma in pharmacy or pharmaceutical chemistry and has been engaged in compounding of drug in a hospital or dispensary or other place which drugs are regularly dispensed for total of not less than 3 years. Has passed an examination recognized an adequate by the state govt. for compound or dispensers. Has engaged in the compounding of drug in a hospital or dispensary or other place in which drug are regularly dispensed or prescription of medical practitioners. Has not less than 5 year experience of compounding and dispensing in hospital or dispensing.

17. 2. SUBSEQUENT REGISTER: After the preparation of the first register and before the education regulation have taken effect in a state, a person desirous of having his name registered in the subsequent register. Satisfy the condition prescribed and approved by central govt. It should be 18 year of age It should have paid the prescription fee. It should be a resident of the state or should carry out his business or profession of pharmacy in the state. It should fulfill the following requirements. Requirements prescribed for the registration It is a registered pharmacist in the state. Possess qualification for the registration

18. CENTRAL REGISTRAR OF PHARMACIST: INSPECTION BY STATE COUNCIL: Central council is required to maintain a register of pharmacist known as central register. State govt. appoint suitable number of inspector having prescribed qualification to inspect premises where drug are dispensed and compound. REGISTRATION AFTER FORMATION OF STATE PHARMACY COUNCIL: Registrar is of the opinion that the applicant has got the required qualification for the registration he may direct his or her name to be entered in the register. Person whose application for registration has been rejected by the registrar may appeal to the state council within 3 month rejection The decision of state council shall be final.

19. REGISTRATION OF PHARMACIST: After entry of name of a person in register Register or issue him a certificate of registration (renewal annually) Registration is valid up to 31 st December of the year of registration but can be renewed on payment of prescribed annual fees

20. REMOVAL OF NAMES FROM REGISTER: The executive committee of the state council may order that a name of register pharmacist shall be removed from register. If name has been entered in the register by error or on account or misrepresentation or suppression of material fact. If has been convinced of an offence in any profession respect. If a person employed to work under him in connection with any business of pharmacy has been convicted of any such offence or has been found guilty of any such infamous conduct, such that if he was registered pharmacist itself his name would have been removed from register. PRINTING OF REGISTER- printing of register after 1 st April by registrar of state council. RESTORATION TO REGISTER: The state council may at any time, for reasons appearing sufficient to it, order that upon payment of the prescribed fee the name of a person removed from the register be restored thereto. Provided that where an appeal against such order has been rejected by the State Government, an order for restoration of the name shall not take effect until it has been confirmed by the State Government. No order refusing to enter a name on the register or removing a name from the register can be challenged in any court. If the registrar is satisfied that a certificate of registration has been lost or damaged, he may issue a duplicate on payment of the prescribed fee.

21. OFFENCE AND PENALTIES: Sr.No. OFFENCE PENALTIES First conviction Second conviction 1. Falsely claiming to be registered pharmacist Rs. 500/- Rs. 1000/6 month 2. Dispensing by unregistered person Rs. 1000/6 month - 3. Failing to surrender certificate of registration Rs. 50/ - 4. For obstructing state pharmacy council inspector Rs. 1000/6 month -