Pharmaceutical Jurisprudence (BP505T) Unit-3 Pharmacy Act.pptx

This PPT Covers Pharmacy Act –1948: Objectives, Definitions, Pharmacy Council of India; its
constitution and functions, Education Regulations, State and Joint state pharmacy
councils; constitution and functions, Registration of Pharmacists, Offences and Penalties

1. Pharmacy Act 1948 UNIT-3

2. Definitions

3. Definitions

4. Introduction The Pharmacy Council of India (PCI) is constituted by the Central Government every five years. The first Pharmacy Council of India was constituted in the year, 1949. The PCI is composed of Elected members, Nominated members, and Ex-officio members.

5. Elected Members

6. Nominated Members

7. Ex-officio Members

8. Leadership The President and Vice-President of the Pharmacy Council are elected by its members from amongst themselves. They have a term of office of five years. Any member absent without sufficient excuse is deemed to have vacated his seat from the Council. A casual vacancy in the PCI is filled by fresh nomination or election, and the person nominated or elected holds the office only for the remaining term.

9. Additional Appointments All members of the Council are eligible for re-election or re-nomination. The Council also appoints: Registrar's role as Secretary and possibly Treasurer Other officers and servants Executive Committee Composition

10. Functions of Pharmacy Council of India 1. To prescribe the minimum standards of education required for qualification as a Registered Pharmacist. 2. To regulate the minimum educational standards by inspecting the institutions. 3. To recognize the qualification granted outside the territory to which the Pharmacy Act, 1948 extends to qualify for registration. 4. To compile and maintain a Central Register for Pharmacists, containing the names of all Registered persons. 5. Any other function required for the furtherance of objectives of the Pharmacy Act, 1948.

11. Education Regulations (ER-91) The main features are Minimum educational qualification for admission Duration of the course of study and training Nature and period of practical training Subjects of examination and qualification standards Minimum facilities required in institutions Conditions for approved examinations

12. Practical Training Minimum of 500 hours over 3 months Emphasis on actual dispensing (at least 250 hours) Exposure to records, pharmaceutical apparatus, prescriptions, and storage of drugs

13. Institutions Providing Courses Application by the institute to PCI Inspection by PCI's inspectors Approval if facilities meet standards Publication of approval in Gazette

14. Withdrawal of Approval PCI's notice of intention Institution's representation within 3 months PCI's decision to continue or withdraw approval

15. Approval of Qualifications Outside India Approval based on skill and knowledge guarantee Eligibility for Indian and other countries' citizens

16. Registration of Pharmacists

17. STATE AND JOINT STATE PHARMACY COUNCILS Each state of India can constitute a state pharmacy council under the provision of the Pharmacy Act by their respective State Governments. Joint state pharmacy councils can also be constituted where two or more states agree to serve the needs of the other participating states.

18. The composition of State and Joint State Pharmacy Councils

19. The composition of State and Joint State Pharmacy Councils

20. The composition of State and Joint State Pharmacy Councils

21. President and Vice-President elected by members. Both nominated and elected members are eligible. Five-year term for all members. Eligible for re-election or re-nomination. Unexcused absence leads to seat vacancy. New nominations or elections fill casual vacancies. Like the PCI, State, and Joint State Pharmacy Councils also usually appoint a Registrar (who may also act as its Secretary and Treasurer) and other necessary officers and staff.

22. Functions of State Pharmacy Councils and Joint State Pharmacy Councils

23. Inspection by State Councils To inspect any premises where drugs are compounded or dispensed. To enquire whether the dispensing or compounding of drugs is done by registered pharmacists or not. To investigate any complaint made in writing regarding contravention of the Act. To institute prosecution under the direction of the Executive Committee of the State. To exercise such other powers as may be necessary for specific provisions of the Act.

24. Registration of Pharmacists in the First and Subsequent Registers

25. First Register - Preparation Prepared by the State government Role of State Pharmacy Councils Annual fees to the Central Council

26. Information in Register Full name & address Date of entry Qualifications Professional address Other particulars

27. The First Register The Process of Registration as mandated by the State Government

28. The First Register Composition of the Registration Tribunal 3 persons A Registrar who acts as secretary Role of the State Government Constituting the Registration Tribunal Appointing a date for receiving applications Application Procedure Applications to be submitted before the appointed date Must be accompanied by the prescribed fee

29. The First Register Examination of Applications The tribunal examines all applications up to the appointed date Criteria for qualification Publication of the First Register Published by the State Government Names are entered only after approval from the Tribunal Appealing the Tribunal's Decision The 60-day window for appeal Authority appointed by the Government to handle appeals

30. The First Register Final Decision and Amendments State Government's decision is final Amendments to the Register as per Government directions Transfer to State Council Register handed over to the State Council for custody

31. Qualifications for Entry into the First Register Understanding the Criteria under the Pharmacy Act, 1948

32. Qualifications for Entry into the First Register Basic Criteria for Entry Must be 18 years old Must pay the prescribed fee to the state council Must be a resident or practice in the State

33. Qualifications for Entry into the First Register Educational Qualifications - Part A A degree or diploma in Pharmacy or Pharmaceutical Chemistry From an Indian University or State Government Or other recognized qualifications outside of India Educational Qualifications - Part B A degree from an Indian University other than in Pharmacy or Pharmaceutical Chemistry Engaged in drug dispensing and compounding for not less than three years

34. Qualifications for Entry into the First Register Alternative Qualifications - Part C Have passed an examination recognized by the State Government for compounders and dispensers Alternative Qualifications - Part D Have a minimum of five years of experience in dispensing and compounding drugs before the date notified by the State Government for applications

35. Subsequent Registers: Entry Qualifications Basic Criteria for Entry Must be 18 years old Must pay the prescribed fee Must be a resident or practice in the State

36. Subsequent Registers: Entry Qualifications Basic Criteria for Entry Must be 18 years old Must pay the prescribed fee Must be a resident or practice in the State

37. Subsequent Registers: Entry Qualifications Specific Requirements - Part A Follows requirements as prescribed for registration If not prescribed, must have qualifications for the First Register Must be at least matriculate Specific Requirements - Part B Is a Registered Pharmacist in another State Specific Requirements - Part C Possesses a qualification granted outside India Must be at least matriculate qualification after Education Regulations have taken effect

38. Special Provisions for Registration Applicability Applicable to persons who migrated to India or resided in a place that became Indian territory Effective after the commencement of the Pharmacy (Amendment) Act, 1959

39. Special Provisions for Registration Provision 1 Persons with degrees/diplomas in pharmacy, pharmaceutical chemistry. Eligibility between the closing of the First Register and the effect of Education Regulation. Provision 2 Qualified Persons approved before 31st December 1969 under the Drugs and Cosmetics Act, 1940.

40. Special Provisions for Registration Provision 3 Displaced persons from specific countries and time periods. Carrying out pharmacy as their main livelihood for five years before the date of application. Provision 4 Indian citizens engaged in pharmacy abroad. Meeting conditions for registration in the first register of respective Indian State Councils. Provision 5 Engaged in drug dispensing for five years before the appointed date. In a hospital, dispensary, or another place where drugs are regularly dispensed.

41. Removal of Names from the Pharmacy Register: Criteria & Legal Framework Reasons for Removal - Part 1 Error, misrepresentation, or suppression of facts. Conviction of an offense affecting professional conduct. Reasons for Removal - Part 2 Offenses by employees under the registered pharmacist.

42. Removal of Names from the Pharmacy Register: Criteria & Legal Framework Conditions for Action Offense or conduct instigated or connived by the pharmacist Previous offenses committed by the pharmacist Offenses by employees known to the pharmacist Offense or conduct continued over a period Non-compliance with the Drugs and Cosmetics Act, 1940

43. Removal of Names from the Pharmacy Register: Criteria & Legal Framework Legal Consequences Removal may be permanent or temporary Order by the Executive Committee and confirmation by the State Pharmacy Council 3-month grace period Right to Appeal 30-day appeal window after order confirmation. The State Government's decision is final. After Removal Surrender of registration certificate Publication of removal in the Gazette

44. Printing of Pharmacy Registers: Legal Guidelines Annual Printing The requirement for State Council registrars to print the register every year after April 1. Importance of the yearly print Annual Supplements Printing of annual supplements to the register. Information contained: additions, amendments, etc.

45. Printing of Pharmacy Registers: Legal Guidelines Pre-Election Updates The requirement is to update the registers three months before State Council elections. Printing of these updated copies. Availability Copies are available to persons upon request Payment of a prescribed charge for the copy. Legal Evidence Legal validity of the printed register and annual supplements Use as evidence for confirming registered pharmacists

46. Offences and Penalties Offence 1 - Falsely Claiming to be a Registered Pharmacist False claim as a registered pharmacist Use of restricted titles Penalties on first conviction Penalties on subsequent convictions Offence 2 - Dispensing by Unregistered Persons Dispensing, mixing, or compounding drugs by unregistered persons Exceptions: Medical practitioners and with state government permission Penalties: Imprisonment or fine

47. Offences and Penalties Offence 3 - Failing to Surrender Certificate of Registration Failure to surrender registration certificate Consequence of removal from the register Penalty: Fine Offence 4 - Penalty for Obstructing Inspectors Obstruction of State Pharmacy Council Inspector Penalties: Imprisonment or fine