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PHARMACY
ACT 1948
UNIT-3
Definitions
Central Council means the
Pharmacy Council of India.
State Council means the State
Council of Pharmacy constituted
under the Act and includes the joint
state pharmacy councils.
Central Register is the Pharmacists
register maintained by the Central
Council (Pharmacy Council of India).
Definitions
Medical Practitioner means a person
holding medical qualification as provided in
the Indian Medical Degree’s Act or Indian
Medical Council Act or a person registered or
eligible for registration in the medical
Register of the State or a Dentist or a
Veterinarian.
Registered Pharmacist means a person
whose name, for the time being, is entered in
the Register of Pharmacists of the state
where he is for time being residing or
carrying on his profession or business of
Pharmacy.
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.
Elected
Members
Six members representing various
areas like Pharmacy,
Pharmaceutical Chemistry, and
Pharmacognosy.
One member from the Medical
Council of India.
One member from each State
Pharmacy Council who is a
Registered Pharmacist.
Nominated
Members
One representative from the
University Grants Commission
and the All India Council for
Technical Education.
One Registered Pharmacist
nominated by each
State/Union Territory.
Ex-officio
Members
Director General of Health
Services
Director of Central Drugs
Laboratory
Drugs Controller of India
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.
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
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.
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
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
Institutions Providing Courses
Application by the institute to PCI
Inspection by PCI's inspectors
Approval if facilities meet standards
Publication of approval in Gazette
Withdrawal of Approval
PCI's notice of intention
Institution's representation within 3 months
PCI's decision to continue or withdraw approval
Approval of Qualifications Outside India
Approval based on skill and knowledge guarantee
Eligibility for Indian and other countries' citizens
Registration of Pharmacists
PCI's Central Register of
pharmacists
Submission of State council
registers
Inclusion in the central register
and publication in Gazette
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.
THE COMPOSITION OF STATE AND JOINT STATE
PHARMACY COUNCILS
THE COMPOSITION OF STATE AND JOINT STATE
PHARMACY COUNCILS
THE COMPOSITION OF STATE AND JOINT STATE
PHARMACY COUNCILS
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.
FUNCTIONS OF STATE
PHARMACY COUNCILS AND
JOINT STATE PHARMACY
COUNCILS
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.
REGISTRATION OF
PHARMACISTS IN THE
FIRST AND SUBSEQUENT
REGISTERS
First Register - Preparation
Prepared by the State government
Role of State Pharmacy Councils
Annual fees to the Central Council
Information in Register
Full name & address
Date of entry
Qualifications
Professional address
Other particulars
The First Register
The Process of Registration as mandated by the
State Government
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
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
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
QUALIFICATIONS
FOR ENTRY INTO
THE FIRST REGISTER
Understanding the Criteria under the Pharmacy
Act, 1948
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
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
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
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
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
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
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
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.
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.
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.
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
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
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.
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
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
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

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

  • 2. Definitions Central Council means the Pharmacy Council of India. State Council means the State Council of Pharmacy constituted under the Act and includes the joint state pharmacy councils. Central Register is the Pharmacists register maintained by the Central Council (Pharmacy Council of India).
  • 3. Definitions Medical Practitioner means a person holding medical qualification as provided in the Indian Medical Degree’s Act or Indian Medical Council Act or a person registered or eligible for registration in the medical Register of the State or a Dentist or a Veterinarian. Registered Pharmacist means a person whose name, for the time being, is entered in the Register of Pharmacists of the state where he is for time being residing or carrying on his profession or business of Pharmacy.
  • 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 Six members representing various areas like Pharmacy, Pharmaceutical Chemistry, and Pharmacognosy. One member from the Medical Council of India. One member from each State Pharmacy Council who is a Registered Pharmacist.
  • 6. Nominated Members One representative from the University Grants Commission and the All India Council for Technical Education. One Registered Pharmacist nominated by each State/Union Territory.
  • 7. Ex-officio Members Director General of Health Services Director of Central Drugs Laboratory Drugs Controller of India
  • 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 PCI's Central Register of pharmacists Submission of State council registers Inclusion in the central register and publication in Gazette
  • 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