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A Seminar On The Pharmacy Act, 1948 Prepared by: Guided by: Dharmishtha N. Bhakhar Mr. Sandip K. Dadhaniya M.Pharm (Q.A., Sem -II) M.Pharm (Pharmacology) Roll No.: 01 Assistant Professor Department of Quality Assurance Smt. R. B. Patel Mahila Pharmacy College, Atkot (Gujarat, India) 4/12/2012 1

Content :

Content Introduction 1.1 Pharmacy Act Objectives of Pharmacy Act Pharmacy Council of India Education Regulation(ER) Approval of Institution providing courses Withdrawal of approval 4/12/2012 2

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7. Central register of Pharmacies 8. State Pharmacy Council(S.P.C.) Registration of Pharmacists Inter-state agreement Offences & Penalties Conclusion 13. References 4/12/2012 3 Cont….

1.Introduction[1]:

1.Introduction [1] Definition [1,2] : Pharmacy is the health professional that links health science with the chemical science and it is charged with ensuring the safe & effective use of pharmaceutical drugs. 4/12/2012 4

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4/12/2012 5 Drug Development Process Quality Control Process Packaging Storage Marketing

Scope[3]:

Scope [3] 4/12/2012 6

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Status of Pharmacy in India The first institute of pharmacy was Banaras Hindu University (1932) A National Institute for Pharmaceutical Education & Research (NIPER) – Mohali Ahmedabad Hajipur Hyderabad Kolkata Guwahati Rae Bareli 4/12/2012 7 PERD Centre, Ahmedabad

Cont.:

Cont. At present many institutes in India provides course are: Diploma in Pharmacy (D. Pharm ) Bechlor of Pharmacy (B. Pharm ) Master of Pharmacy (M. Pharm ) Doctor of Philosophy (Ph.D.) Doctor of Pharmacy (Pharm. D.) The regulatory bodies to regulate the pharmacy institutes are: A.I.C.T.E. P.C.I. 4/12/2012 8

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4/12/2012 9 1.1 Pharmacy Act

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It is the act to regulate the profession of pharmacy. 4/12/2012 10 Pharmacy Act

Why Pharmacy Act ?:

Why Pharmacy Act ? In past 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. 4/12/2012 11

Cont.:

Cont. 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. 4/12/2012 12

Cont.:

Cont. To achieve this goal the Pharmacy Bill, 1947 was introduced in the Legislature which was later referred to the Select Committee. The recommendations of the Selection Committee were incorporated in the Bill. 4/12/2012 13

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List of amending acts & adaptation orders [4] 1. The Adaptation of Laws Order, 1950. 2. The Adaptation of Laws (No.3) Order, 1956. 3. The Pharmacy (Amendment) Act, 1959. 4. The Pharmacy (Amendment) Act, 1976. 5. The Pharmacy (Amendment) Act, 1982. 6. The Delegated Legislation Provisions (Amendment) Act, 1985. 4/12/2012 14

Terminology :

Terminology Medical Practitioner [6] : A person holding a qualification granted by an authority of Indian Medical Degree Act. OR A person registered in or eligible for registration in Medical register of a State meant for the registration of the persons practicing the Modern scientific system of Medicine. OR A person registered in Medical register of a state who although not falling within above two category but it declared by general or special order made by state government. 4/12/2012 15

Cont.:

Cont. A person registered or eligible for registration in the register of Dentists for a state under the Dentists Act, 1948 OR A person who is engaged in the practice of Veterinary medicines and who possesses qualifications approved by State Government. 4/12/2012 16

Registered Pharmacist[6]:

Registered Pharmacist [6] 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 or her profession or business of pharmacy. 4/12/2012 17

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4/12/2012 18 2. Objectives

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2. Objectives [2] To restore the pharmacy in health services. Raising the status of the profession of pharmacy in India. To regulate the practice of pharmacy in India. To provide uniform education and training in India. To maintain control over persons entering the profession of pharmacy. To protect the public health (medical use of the drug and drug abuse). 4/12/2012 19

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4/12/2012 20 3. Pharmacy Council of India

3.Pharmacy Council of India[4]:

3.Pharmacy Council of India [4] 4/12/2012 21

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4/12/2012 22 Composition of P.C.I. [5]

Terms of office and casual vacancies[6]:

Terms of office and casual vacancies [6] 4/12/2012 23 Nominated or elected members: holds office up to five years from the date of election. May resign his membership at any time by writing to President, such seat remain vacant. Should have to vacate his seat if he is absent without excuse, sufficient in the opinion on the Central Council for three consecutive meetings of the council.

Cont.:

Cont. A casual vacancies in the above cases can be filled by fresh nomination or election. The person so elected or nominated can hold the office only for a remainder of the term for which the member whose place he takes. 4/12/2012 24

President & Vice-President of Central Council[6]:

President & Vice-President of Central Council [6] President & Vice-president holds an office for Up to five years Not exceeding beyond expiry of his term If his term expires before expiry of the full term & if he is re-elected or re-nominated, he will continue to hold the office as President or Vice-President of council for the full term. 4/12/2012 25

Executive Committee[6]:

Executive Committee [6] 4/12/2012 26 Executive Committee [6]

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To prescribe minimum standard of education required for qualifying as a pharmacist. Framing of Education Regulations prescribing the conditions to be fulfilled by the institutions seeking approval of the PCI for imparting education in pharmacy. To ensure uniform implementation of the educational standards throughout the country. 4/12/2012 27 Functions and duties of P.C.I. [4]

Cont.:

Cont. Inspection of Pharmacy Institutions seeking approval under the Pharmacy Act to verify availability of the prescribed norms. To approve the course of study and examination for pharmacists i.e. approval of the academic training institutions providing pharmacy courses. 4/12/2012 28

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To withdraw approval, if the approved course of study or an approved examination does not continue to be in conformity with the educational standards prescribed by the PCI. To approve qualifications granted outside the territories to which the Pharmacy Act extends i.e. the approval of foreign qualification. To maintain Central Register of Pharmacists. 4/12/2012 29 Cont.

Staff remuneration and allowance[6]:

Staff remuneration and allowance [6] The Central Council may : Appoint a registrar who may act as a secretary. Appoint such other officers and servants as considered necessary to enable it to carry out its function. From the Registrar or any other officer or servant takes such security for the due performance of his duties as council may consider necessary. 4/12/2012 30

Cont.:

Cont. Central Council may fix: a. The remuneration and allowance for the president, vice president and other members of the council. b. Pay and allowances and other service conditions of officers and servants of the council. 4/12/2012 31

Power of the Central Council to make the regulation[6] :

Power of the Central Council to make the regulation [6] The Central Government lay down the rules for The management of its property and maintenance and auditing of the accounts. Holding of meetings. Fixing functions, duties & power of Executive Committee, President & Vice-President Qualification. Terms of office, power and duties of secretary Inspector and other officers of the council. 4/12/2012 32

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4/12/2012 33 4. Education Regulation

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Central Council after approval of the Central Government may make the regulation prescribing the minimum standard of education required for qualification of pharmacist called EDUCATION REGULATION . 4/12/2012 34 4.Education Regulation [6]

ER prescribes::

ER prescribes: Minimum qualification for admission to the course. Nature of period of course of the study. Nature of period of practical training to be undertaken after the completion of the regular course. The subjects of examination. 4/12/2012 35

Cont.:

Cont. The equipments and facilities to be provided by the institutions to the students undergoing approved course of study. Conditions to be fulfilled by institutions giving practical training. Conditions to be fulfilled by authorities holding approved examinations. 4/12/2012 36

Cont.:

Cont. Central Council before submitting the ER to the Central Government for the approval, send copies of draft of ER and subsequent amendments to all state governments and take into consideration the comments of any state government received within three months. The Executive Committee, time to time reports to the Central Council on efficacy of ER. 4/12/2012 37

Application of Education Regulation to States[6]:

Application of Education Regulation to States [6] After the constitution of the State council, the State Government may at any time, by notification in the Official Gazette declare that ER shall take effect in the state. If however, no such declaration has been made, the ER shall take effect in the state after three years from the date of constitution of the State Council. 4/12/2012 38

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4/12/2012 39 5. Approval of institution or authorities providing courses of study and examination

5.Approval of institution or authorities providing courses of study and examination[6] :

5.Approval of institution or authorities providing courses of study and examination [6] Applicability by institution / authority to the Central Council: An institution which conducts course of study or holds an examination for the pharmacist, has to apply the Central Council for approval of the course or examination. 4/12/2012 40

Cont.:

Cont. Inspection: Central Council after receiving such application depute its inspectors to visit the Institution to ascertain whether the Institution has the prescribed facilities for imparting training or holding examination in accordance with the regulation or not. Inspector may also attend any examination, to judge its standards without interfering with its conduct. The inspector then report to the council on the sufficiency or otherwise of the facilities available in the institution and on the conduct and standards of the examination held. 4/12/2012 41

Cont.:

Cont. Approval: on the report of the inspector, if the council is satisfied that the course or examination under consideration is under conformity with ER, it may accord approval to it and the said course of examination shall be deemed to be approved for qualifying for registration as a pharmacist under the Act. Declaration: declaration of approval made by resolutions is passed at a meeting of the Central Council and published in official Gazette. 4/12/2012 42

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4/12/2012 43 6. Withdrawal of approval

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Executive Committee 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, withdrawal 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. 4/12/2012 44 reports 6.Withdrawal of approval [6] NOTICE to institution

Cont.:

Cont. Taking into consideration, representation received from authority 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. 4/12/2012 45

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4/12/2012 46 7.The Central Register of Pharmacists

7.The Central Register of Pharmacists[6] :

7.The Central Register of Pharmacists [6] Central Council has to maintain in a prescribed manner a register of pharmacist to be known as the Central Register which contains name of all persons whose names 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. 4/12/2012 47

Cont.:

Cont. Registrar of 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 and publish it in the Gazette of India. After receiving the report of a registration of a person in the register for a State, the Register of Central enters the name of such person in the Central Register. 4/12/2012 48

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4/12/2012 49 8. State Pharmacy Council

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4/12/2012 50 Composition of State Pharmacy Council [6] Elected members Nominated members Ex-Officio members

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Gujarat State Pharmacy Council Contact Person : Mr. Gilbert C. Makwan (Additional Registrar) Postal Address : Block-O/4, New Mental Hospital Complex, Asarva , Ahmedabad - 380 016, Gujarat, India. Contact Numbers : +91-79-22681012 +91-79-22680060 Email Address : pharmacy-guj@nic.in Visiting Days & Timings : Monday, Wednesday and Friday (Except Public Holidays) 11.00 AM to 1.30 PM 4/12/2012 51

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4/12/2012 52

Functions of State Pharmacy Council[4]:

Functions of State Pharmacy Council [4] Registration of pharmacists in the state. Preparation and maintenance of register. Fix the rates of remuneration and allowances to its officers. Appoint inspector to, Inspect premises where drug are dispensed, Enquire whether dispensing is carried out by registered pharmacist or not, Investigate any complaint. Decide mode of elections. 4/12/2012 53

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Staff remuneration and allowance Terms of office and casual vacancies President and vice-Presidents of the council All of above matters are same as mentioned in P.C.I. 4/12/2012 54

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4/12/2012 55 9. Registration of Pharmacists

9. Registration of Pharmacists[4]:

9. Registration of Pharmacists [4] The Pharmacy Act,1948, provides for the registration of pharmacists . There are two types of register, 1)First register 2)Subsequent register 4/12/2012 56

Preparation and maintenance of register[4] :

Preparation and maintenance of register [4] The register shall include the following particulars, namely: 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. 4/12/2012 57

Preparation of first register[4]:

Preparation of first register [4] 4/12/2012 58

Cont.:

Cont. 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. 4/12/2012 59

Qualifications for entry on first register[4] :

Qualifications for entry on first register [4] 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 4/12/2012 60

Cont.:

Cont. Qualification granted by authority outside India which is adequate for registration OR Degree of an Indian universities with not less than 3 years experience in dispensing in hospital OR Passed an examination for dispensers recognized by state government OR Not less than 5 years experience of compounding prior to the date notified by Tribunal. 4/12/2012 61

Requirements for subsequent registration[4]:

Requirements for subsequent registration [4] 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. 4/12/2012 62

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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. 4/12/2012 63

Requirements for subsequent registration[4]:

Requirements for subsequent registration [4] Applicants should be at least 18 years of the age. Applicants should carry on the profession of the pharmacy in the concerned state. Qualifications for subsequent registration [4] 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. 4/12/2012 64

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After the preparation of First register and before E.R. take effect [4] 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 at least matriculates. 4/12/2012 65

Cont.:

Cont. 2) After the Education regulations take effect [4] 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. 4/12/2012 66

Cont.:

Cont. 3) Special provisions [4] 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 4/12/2012 67

Cont.:

Cont. 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. 4/12/2012 68

Renewal fees[4]:

Renewal fees [4] 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. 4/12/2012 69

Cont.:

Cont. 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. 4/12/2012 70

Removal from register[4] :

Removal from register [4] The name of Pharmacist may be removed from register, That his name has been entered into the register by error or on account of misrepresentation That he has been convicted of any offence or has been guilty of any infamous conduct in any professional respect which in the opinion of the Executive Committee, renders him unfit to be kept in the register, or 4/12/2012 71

Cont.:

Cont. If the employed person is registered pharmacist, his name may be removed from register, if he: Offence was investigated by registered pharmacist himself. If the repetition of similar offence OR conduct during the period of 12 month. 4/12/2012 72

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If any person employed by the registered pharmacist for the purposes of his business of pharmacy. The name of Pharmacist may be removed from register. If, The person has been guilty of similar offence during preceding 12 months and the registered pharmacist had knowledge of such offence. The offence had continued over a period and the registered pharmacist had the knowledge. 4/12/2012 73

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4/12/2012 74 If Registered pharmacist has not used his intelligence to see the provisions of D & C Act 1940. His name can be removed only by the Executive Committee of the S.P.C. The removal of names may either be permanent or for specified period of time.

Issue of duplicate certificates of registration[4] :

Issue of duplicate certificates of registration [4] 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. 4/12/2012 75

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4/12/2012 76 10. Inter-state Agreement

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Two or more State Government may enter into an agreement to provide- For the constitution of a Joint State Council for all the participating States, OR That the State Council of one State shall serve the needs of the other participating States. 4/12/2012 77 10. Inter-State agreements [4]

Cont.:

Cont. An agreement under this section may- Determine which of the participating State Governments shall exercise the several functions of the State Government under this Act, and the references in this Act to the State Government shall be construed accordingly; Provide for consultation between the participating State Governments either general or with reference to particular matters arising under this Act; 4/12/2012 78

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4/12/2012 79 Composition of Joint State Pharmacy Council [5] Elected members Nominated members Ex-Officio members

The Executive Committee[4] :

The Executive Committee [4] State Council constitute Executive Committee consists of President and Vice-President, ex officio members A member of the Executive Committee shall hold office as such until the expiry of his term of office as member of the State Council, but, subject to his being a member of the State Council, he shall be eligible for re-election. 4/12/2012 80

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4/12/2012 81 11. Offences and Penalties

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4/12/2012 82 82 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. 11. Offences and Penalties [4]

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4/12/2012 83 12. Conclusion

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Now a days, there is increase in number of diseases. So, to face this challenges one should to establish newer & cheaper drug with standard quality. The pharmacy act provides you to establish the whole pharmacy field with ethical and streamline point of view. So there is a need of several strong legal action that can back this novel healthcare profession. 4/12/2012 84 12.Conclusion

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4/12/2012 85 13. References

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http://www.pcpdeu.org/introduction to pharmacy www.wikipedia.org/pharmacy Jani GK. “Pharmacy Act-1948”. Pharmaceutical Jurisprudence, 7 th edition, Atul Prakashan , Page No.:8-9. www.pci.nic.in Kokate CK and Gokhale SB. “Pharmacy Act-1948”. Textbook of Forensic Pharmacy, Pharma Book Syndicate, Page No.: 20-24. Kuchekar BS, Khadatare AM, Itkar SC. Forensic Pharmacy, 5 th edition, Nirali Prakashan , Page No.: 2.1 - 2.14. 4/12/2012 86 13. References

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What is the purpose of “The Pharmacy Act, 1948” ? Describe the function of Pharmacy Council of India. And short note on Registration of Pharmacist. (16 marks) 4/12/2012 87 GTU Question

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