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PHARMACY ACT, 1948
Prepared & presented by
Priyanka Deshmukh
1. To make better provisions for regulating profession and
practice of pharmacy.
2. To raise the status of "Profession of Pharmacy" in India.
3. To constitute 'Pharmacy Council of India' for setting new
standards in 'Pharmacy’.
4. To regulate Pharmacy Institutions providing pharmacy
education.
5. To provide constitution and functions of State Pharmacy
Councils, for registration of pharmacists.
6. To regulate the professional activities of pharmacists.
O
B
J
E
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T
I
V
E
❖ Central Council : The pharmacy council of India constituted under section 3 of
the pharmacy Act,1948.
❖ Central Register : Register of pharmacists maintained by pharmacy council of
india under section 15-A.
❖ Medical Practitioner:
a) A person holding a qualification granted by an authority specified under sec.3 of
Indian Medical Degress Act,1916. OR
b) A person who is engaged in the practice of veterinary medicine and who
possesses qualification approved by State Government.
❖ Registered Pharmacists :A person whose name for the time being is entered in
the register of pharmacists of the state, in which he is for the time being carrying
on his profession of pharmacy.
Displaced Persons:
Displaced Person means: any person
who has left or has been displaced from
place of his residence in Pakistan on or after
1st March, 1947, on account of setting up of
dominions of India and Pakistan or on
account of civil disturbances or fear thereof
and since then residing in India, or
Repatriates:
Repatriate means, any person of
Indian origin, who has left or has been
displaced from place of his residence, in
Burma, Sri Lanka, Uganda or any other
country, after 14th April, 1957, on account
of civil disturbances or fear thereof and
since then residing in India.
❑ University Grants Commission (UGC): The university grants commission
established under section 4 of the University Grants Commission Act,1956.
❑ Indian University :
University within the meaning of
section 3 of the University Grants Commission Act,1956.
It also includes such other institution under a Central Act
and notified in this behalf by the central government,
in the official gazette.
❑ Executive Committee:
Executive Committee
means, executive committee
of Central Council or State
Council as the context may
require.
❑ state council
It means state pharmacy
council constituted under
section 19 and also includes
joint state pharmacy council
constituted under section 20
of the Act.
➢ The PCI was first constituted in the year 1949.
➢ Reconstituted every 5 years.
• Composition:
1) Elected Members
2) Nominated Members
3) Ex- officio Members
PHARMACY COUNCIL OF INDIA
The executive committee of PCI:
➢ Constitution:
A) Ex- officio members-
1. President who shall be chairman of the
committee.
2. Vice- president.
B) Five members-
Elected by central council from its
members.
A.Elected Members B. Nominated Members C.Ex- officio Members
1.Six members elected by
UGC from among teacher
working in Indian university
of college. One teacher
should be teacher of subject
pharmaceutical chemistry or
pharmacognosy.
1. Six members are
nominated by central
government out of which
four members should be
posses degree or diploma in
pharmacy or should be
pharmacy teacher.
1. Director, General of
health services.
2. One member Elected from
among themselves by
member of Medical council
of India.
2. One registered
pharmacist to represent
each state nominated by
state government.
2.The Drugs Controller of
India.
3. One registered pharmacist
from each state elected from
member of state pharmacy
council.
3. One representative of
UGC and AICTE
3.The Director of Central
Drug Laboratory.
1. To regulate pharmacy institutions providing pharmacy
education.
2. To maintain central register of pharmacists.
3. To approve course of study and examinations in
pharmacy.
4. To frame periodically education regulation with approval
of central government for setting new standards in
pharmacy education.
5. To recognize foreign qualifications in pharmacy for
purposes of registration.
6. PCI grants the approval to institute for the running
course of pharmacy.
7. PCI withdrawal the approval of the institute if required.
2. Minimum qualifications for admission to 1st
Year of Diploma in Pharmacy.
3. Nature of course of study and its duration.
4. Approval of Institutions conducting course of
study.
5. Scheme and mode of examinations.
1. Qualifications for pharmacists.
6. Approval of examinations.
Education
Regulation
▪ Under section 10 of
Pharmacy Act,1948 the
PCI is empowered to
frame ‘Education
Regulations’.
▪ The education regulations
prescribe the minimum
standards of education for
pharmacists, which
include
8. Periods and other conditions of practical training.
9. Equipments and facilities to be provided by the institutions
running approved course of study.
10. Conditions to be fulfilled by the examining authority.
11. Conditions to be fulfilled by the institution for giving
training
7. Eligibility for appearing in examination at the Diploma in
Pharmacy Part I &Part II examinations.
Education
Regulation
1. Framed by the PCI under section 10 of Pharmacy
Act,1948.
2. PCI permits, regulates and approves pharm. D. course
under section 12 of the Act.
3. This course is allowed for 30 intakes in approved
degree in pharmacy institutes.
4. This course is of 6 years after 10+2 or D. pharm.
5. The course is broad based practical oriented with
special emphasis on clinical and community pharmacy.
6. The final year of course is internship in hospital.
7. There is a provision for direct admission to 4 th year of
pharm D. course after B. Pharm
Pharm. D.
Regulations
2008
B. Pharm.
Course
Regulations
2014
1. Framed by the PCI under section 10 of Pharmacy Act,1948.
2. PCI permits, regulates and approves B. PHARM course under section 12 of the
Act.
3. These regulation prescribe following:
i. Minimum qualifications for admissions.
ii. Syllabus of course.
iii. Course of study.
iv. Scheme of examinations.
v. Practical training
vi. Conditions to be fulfilled by the course conducting
institution.
vii. Conditions to be fulfilled by the examing authority.
viii.Approval of B. Pharm courses and examinations.
1. Framed by the PCI under section 10 of Pharmacy Act,1948.
2. PCI permits, regulates and approves M.PHARM course under section 12 of the Act.
3. These regulation prescribe following:
i. Minimum qualifications for admissions.
ii. Selection of post graduate students.
iii. Course of study.
iv. Scheme of examinations.
v. Training programme.
vi. Eligibility for conducting post graduate pharmacy course.
vii. General conditions to be observed by teaching institution.
viii.Conditions to be fulfilled by the course conducting
institution.
ix. Conditions to be fulfilled by the examing authority.
x. Approval of B. Pharm courses and examinations.
xi. Approval of M. PHARM courses and examinations.
M. Pharm.
Course
Regulations
2014
Approval of institution / authorities providing courses of study and
examinations
1. Application
➢ Apply the central council for its approval of the courses or examinations.
➢ Central council appoints inspectors to visit the institution.
➢ Inspector attend any examination during the courses of inspection to judge its standard.
➢ Inspector prepared detailed report of inspection and send it to central council.
➢ If central council is satisfied then institution possesses the prescribed facilities as per ER.
➢ Made by passing the resolution in the meeting of the council and then published in the official
gazette.
2. Inspection-
3.Approval-
4. Declaration-
Executive committee reports central council that institution holding an approved
course of study does not continue to be in conformity with ER
Central council give notice to authority
The said authority make representation within 3 months and forward to central
council Through the state government.
Council declare the course of study or examination shall be deemed
Withdrawal of approval
STATE PHARMACY COUNCIL
Section 19 of pharmacy ACT, 1948.
JOINT STATE PHARMACY COUNCIL
Section 20 of pharmacy ACT, 1948.
STATE PHARMCY COUNCIL JOINT STATE PHARMACY COUNCIL
➢ Elected Members
1.Six members – Elected from amongst
themselves by registered pharmacist of
the state.
2.One member elected by the Medical
Council of State.
➢ Elected Members
1.Registered pharmacists- 3 to 5 from each
state instead of 6 in a single state council.
2.Medical Council- one each state.
➢ Nominated Members
1.Five members- Nominated by the State
Govt.
➢ Nominated Members
1.Government nominees-2 to 4 from each
state instead of 5
➢ Ex- officio Members-
1.Chief Administrative Medical Officer
2.Officer in- charge of Drugs Control
Administration of State.
3.Government Analyst
➢ Ex- officio Members-
1.Chief Administrative Medical Officer
2.Officer in- charge of Drugs Control
Administration.
3.Government Analyst
Functions of State Pharmacy Council or Joint State Pharmacy
Council:
1. Registration of pharmacists and maintenance of Registers of State.
2. Removal of names of registered pharmacists from the Register.
3. Printing of Registers of State.
4. To monitor and regulate professional activities of pharmacists of
State.
I. To inspect any premises where drugs are compounded or dispensed and submit written
report to Registrar of State Council.
II. To enquire whether person engaged in compounding or dispensing of drugs is
registered pharmacist.
III. To investigate any complaint made in writing, in respect of contravention pharmacy act
1948 and report to the registrar of state council.
IV. To institute prosecution under the order of executive committee of the state council.
V. To execute such other powers to give effect to the provisions of pharmacy act, 1948
and rules thereunder.
Duties/power of drug inspector
Registration of pharmacists
Name of registered pharmacists are entered in the registers maintained by State
Councils and the Central Council.
The register includes the following particulars:
1. Full Name and Residential Address of registered pharmacist.
2. Date of his First Admission to Register.
3. Qualification for Registration.
4. Professional Address, Name of Employer, if employed.
5. Such other particulars as may be prescribed.
Register of pharmacist prepared under chapter IV of the pharmacy act by the state
government before constitution of state council.
Preparation of first register:
1. The state government appoints the Registration Tribunal consisting of 3 persons
and also appoints a secretary and registrar of the tribunal.
2. The tribunal then appoints the date before which all applications for registrations
along with prescribed fees should reach the tribunal.
3.The tribunal examines all applications received within a given date and if it is
satisfied that an applicant is duely qualified for registration, it will direct his or her
name to enter in the register.
4.The first register so prepared, is then published in a manner directed
by state government.
5.The registration certificates in prescribed formates are issued to
persons whose name are entered in first register.
Qualifications for entry on first register
A person above 18 years of age who carries business or profession of pharmacy in the
State, on payment of prescribed fee, is entitled for entry of name in first register, if:
Has been engaged
in compounding of
drugs in a hospital
or dispensary or
other place in
which drugs are
regularly
dispensed for a
period of more
than five years.
Has passed an
examination
recognized by
the state
government
for
compounders
or dispensers
Holds degree of an
Indian university other
than degree in
pharmacy or
pharmaceutical
chemistry and has
been engaged for a
total period of more
than3 years in
compounding of drugs
in hospital or
dispensary or other
place in which drugs
are regularly
dispensed on
prescription of
medical practitioner
Holds Degree or
Diploma in
Pharmacy of
Pharmaceutical
Chemistry or a
"Chemist and
Druggist Diploma
of an Indian
University or
State
Government" or a
qualification
granted outside
India and
approved under
Section 14
✓ Register of pharmacist prepared under chapter IV of the pharmacy act by the
state council after first register.
✓ A person for registration should be of at least 18 years of age and should reside
or carry on the business in the state and should have qualification.
✓ Satisfies prescribed conditions, approved by central council or where no
conditions are prescribed, conditions for entry of name in first register and has
passed a matriculation or equivalent examination, or
✓ He is a registered pharmacist in other state, or
✓ Possesses qualification granted by an authority outside india, approved under
section 14.
SUBSEQUENT REGISTER
Removal of names from Register
1. Due to error, misrepresentation, or suppression of material facts.
2. If he has been convicted of any offences in any professional aspect.
3. Order passed by executive committee of state council after making due enquiries and
giving opportunity to the person concerned to explain his conduct.
4. 30 day period for appealing.
5. Removal of name may be either permanent or only for the specified period of time.
6. To surrender the certificate of registration to the registrar of the state of the council.
1. Falsely claims to be a registered pharmacist.
Any person who falsely claims to be a ‘ Registered Pharmacists’ OR
Uses in connection with his name, words, letters, reasonably calculated to show
that his name is entered in the register of pharmacists.
First Conviction: Fine up to Rs.500.
Subsequent Conviction: Fine up to Rs.1000 and/or 6 months imprisonment.
2. Dispensing by an unregistered person.
Person other than RP shall prepare, compound, mix or dispense any medicine
on prescription of medical practitioner.
6 months of imprisonment or a fine of up to Rs.1000 or both.
3. Failure to surrender the Certificate of registration.
Any person whose name has been removed from the register
without sufficient reasons.
Fine of Rs.50
4. Obstruction of state pharmacy council inspectors.
Any person wilfully obstructing an inspector in exercise of
powers under the pharmacy act,1948
Imprisonment of up to 6 months or a fine up to Rs.1000 or both.
THANK YOU

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Pharmacy Act,1948

  • 1. PHARMACY ACT, 1948 Prepared & presented by Priyanka Deshmukh
  • 2. 1. To make better provisions for regulating profession and practice of pharmacy. 2. To raise the status of "Profession of Pharmacy" in India. 3. To constitute 'Pharmacy Council of India' for setting new standards in 'Pharmacy’. 4. To regulate Pharmacy Institutions providing pharmacy education. 5. To provide constitution and functions of State Pharmacy Councils, for registration of pharmacists. 6. To regulate the professional activities of pharmacists. O B J E C T I V E
  • 3. ❖ Central Council : The pharmacy council of India constituted under section 3 of the pharmacy Act,1948. ❖ Central Register : Register of pharmacists maintained by pharmacy council of india under section 15-A. ❖ Medical Practitioner: a) A person holding a qualification granted by an authority specified under sec.3 of Indian Medical Degress Act,1916. OR b) A person who is engaged in the practice of veterinary medicine and who possesses qualification approved by State Government. ❖ Registered Pharmacists :A person whose name for the time being is entered in the register of pharmacists of the state, in which he is for the time being carrying on his profession of pharmacy.
  • 4. Displaced Persons: Displaced Person means: any person who has left or has been displaced from place of his residence in Pakistan on or after 1st March, 1947, on account of setting up of dominions of India and Pakistan or on account of civil disturbances or fear thereof and since then residing in India, or Repatriates: Repatriate means, any person of Indian origin, who has left or has been displaced from place of his residence, in Burma, Sri Lanka, Uganda or any other country, after 14th April, 1957, on account of civil disturbances or fear thereof and since then residing in India.
  • 5. ❑ University Grants Commission (UGC): The university grants commission established under section 4 of the University Grants Commission Act,1956. ❑ Indian University : University within the meaning of section 3 of the University Grants Commission Act,1956. It also includes such other institution under a Central Act and notified in this behalf by the central government, in the official gazette. ❑ Executive Committee: Executive Committee means, executive committee of Central Council or State Council as the context may require. ❑ state council It means state pharmacy council constituted under section 19 and also includes joint state pharmacy council constituted under section 20 of the Act.
  • 6. ➢ The PCI was first constituted in the year 1949. ➢ Reconstituted every 5 years. • Composition: 1) Elected Members 2) Nominated Members 3) Ex- officio Members PHARMACY COUNCIL OF INDIA The executive committee of PCI: ➢ Constitution: A) Ex- officio members- 1. President who shall be chairman of the committee. 2. Vice- president. B) Five members- Elected by central council from its members.
  • 7. A.Elected Members B. Nominated Members C.Ex- officio Members 1.Six members elected by UGC from among teacher working in Indian university of college. One teacher should be teacher of subject pharmaceutical chemistry or pharmacognosy. 1. Six members are nominated by central government out of which four members should be posses degree or diploma in pharmacy or should be pharmacy teacher. 1. Director, General of health services. 2. One member Elected from among themselves by member of Medical council of India. 2. One registered pharmacist to represent each state nominated by state government. 2.The Drugs Controller of India. 3. One registered pharmacist from each state elected from member of state pharmacy council. 3. One representative of UGC and AICTE 3.The Director of Central Drug Laboratory.
  • 8. 1. To regulate pharmacy institutions providing pharmacy education. 2. To maintain central register of pharmacists. 3. To approve course of study and examinations in pharmacy. 4. To frame periodically education regulation with approval of central government for setting new standards in pharmacy education. 5. To recognize foreign qualifications in pharmacy for purposes of registration. 6. PCI grants the approval to institute for the running course of pharmacy. 7. PCI withdrawal the approval of the institute if required.
  • 9. 2. Minimum qualifications for admission to 1st Year of Diploma in Pharmacy. 3. Nature of course of study and its duration. 4. Approval of Institutions conducting course of study. 5. Scheme and mode of examinations. 1. Qualifications for pharmacists. 6. Approval of examinations. Education Regulation ▪ Under section 10 of Pharmacy Act,1948 the PCI is empowered to frame ‘Education Regulations’. ▪ The education regulations prescribe the minimum standards of education for pharmacists, which include
  • 10. 8. Periods and other conditions of practical training. 9. Equipments and facilities to be provided by the institutions running approved course of study. 10. Conditions to be fulfilled by the examining authority. 11. Conditions to be fulfilled by the institution for giving training 7. Eligibility for appearing in examination at the Diploma in Pharmacy Part I &Part II examinations. Education Regulation
  • 11. 1. Framed by the PCI under section 10 of Pharmacy Act,1948. 2. PCI permits, regulates and approves pharm. D. course under section 12 of the Act. 3. This course is allowed for 30 intakes in approved degree in pharmacy institutes. 4. This course is of 6 years after 10+2 or D. pharm. 5. The course is broad based practical oriented with special emphasis on clinical and community pharmacy. 6. The final year of course is internship in hospital. 7. There is a provision for direct admission to 4 th year of pharm D. course after B. Pharm Pharm. D. Regulations 2008
  • 12. B. Pharm. Course Regulations 2014 1. Framed by the PCI under section 10 of Pharmacy Act,1948. 2. PCI permits, regulates and approves B. PHARM course under section 12 of the Act. 3. These regulation prescribe following: i. Minimum qualifications for admissions. ii. Syllabus of course. iii. Course of study. iv. Scheme of examinations. v. Practical training vi. Conditions to be fulfilled by the course conducting institution. vii. Conditions to be fulfilled by the examing authority. viii.Approval of B. Pharm courses and examinations.
  • 13. 1. Framed by the PCI under section 10 of Pharmacy Act,1948. 2. PCI permits, regulates and approves M.PHARM course under section 12 of the Act. 3. These regulation prescribe following: i. Minimum qualifications for admissions. ii. Selection of post graduate students. iii. Course of study. iv. Scheme of examinations. v. Training programme. vi. Eligibility for conducting post graduate pharmacy course. vii. General conditions to be observed by teaching institution. viii.Conditions to be fulfilled by the course conducting institution. ix. Conditions to be fulfilled by the examing authority. x. Approval of B. Pharm courses and examinations. xi. Approval of M. PHARM courses and examinations. M. Pharm. Course Regulations 2014
  • 14. Approval of institution / authorities providing courses of study and examinations 1. Application ➢ Apply the central council for its approval of the courses or examinations. ➢ Central council appoints inspectors to visit the institution. ➢ Inspector attend any examination during the courses of inspection to judge its standard. ➢ Inspector prepared detailed report of inspection and send it to central council. ➢ If central council is satisfied then institution possesses the prescribed facilities as per ER. ➢ Made by passing the resolution in the meeting of the council and then published in the official gazette. 2. Inspection- 3.Approval- 4. Declaration-
  • 15. Executive committee reports central council that institution holding an approved course of study does not continue to be in conformity with ER Central council give notice to authority The said authority make representation within 3 months and forward to central council Through the state government. Council declare the course of study or examination shall be deemed Withdrawal of approval
  • 16. STATE PHARMACY COUNCIL Section 19 of pharmacy ACT, 1948. JOINT STATE PHARMACY COUNCIL Section 20 of pharmacy ACT, 1948.
  • 17. STATE PHARMCY COUNCIL JOINT STATE PHARMACY COUNCIL ➢ Elected Members 1.Six members – Elected from amongst themselves by registered pharmacist of the state. 2.One member elected by the Medical Council of State. ➢ Elected Members 1.Registered pharmacists- 3 to 5 from each state instead of 6 in a single state council. 2.Medical Council- one each state. ➢ Nominated Members 1.Five members- Nominated by the State Govt. ➢ Nominated Members 1.Government nominees-2 to 4 from each state instead of 5 ➢ Ex- officio Members- 1.Chief Administrative Medical Officer 2.Officer in- charge of Drugs Control Administration of State. 3.Government Analyst ➢ Ex- officio Members- 1.Chief Administrative Medical Officer 2.Officer in- charge of Drugs Control Administration. 3.Government Analyst
  • 18. Functions of State Pharmacy Council or Joint State Pharmacy Council: 1. Registration of pharmacists and maintenance of Registers of State. 2. Removal of names of registered pharmacists from the Register. 3. Printing of Registers of State. 4. To monitor and regulate professional activities of pharmacists of State.
  • 19. I. To inspect any premises where drugs are compounded or dispensed and submit written report to Registrar of State Council. II. To enquire whether person engaged in compounding or dispensing of drugs is registered pharmacist. III. To investigate any complaint made in writing, in respect of contravention pharmacy act 1948 and report to the registrar of state council. IV. To institute prosecution under the order of executive committee of the state council. V. To execute such other powers to give effect to the provisions of pharmacy act, 1948 and rules thereunder. Duties/power of drug inspector
  • 20. Registration of pharmacists Name of registered pharmacists are entered in the registers maintained by State Councils and the Central Council. The register includes the following particulars: 1. Full Name and Residential Address of registered pharmacist. 2. Date of his First Admission to Register. 3. Qualification for Registration. 4. Professional Address, Name of Employer, if employed. 5. Such other particulars as may be prescribed.
  • 21. Register of pharmacist prepared under chapter IV of the pharmacy act by the state government before constitution of state council. Preparation of first register: 1. The state government appoints the Registration Tribunal consisting of 3 persons and also appoints a secretary and registrar of the tribunal. 2. The tribunal then appoints the date before which all applications for registrations along with prescribed fees should reach the tribunal. 3.The tribunal examines all applications received within a given date and if it is satisfied that an applicant is duely qualified for registration, it will direct his or her name to enter in the register. 4.The first register so prepared, is then published in a manner directed by state government. 5.The registration certificates in prescribed formates are issued to persons whose name are entered in first register.
  • 22. Qualifications for entry on first register A person above 18 years of age who carries business or profession of pharmacy in the State, on payment of prescribed fee, is entitled for entry of name in first register, if: Has been engaged in compounding of drugs in a hospital or dispensary or other place in which drugs are regularly dispensed for a period of more than five years. Has passed an examination recognized by the state government for compounders or dispensers Holds degree of an Indian university other than degree in pharmacy or pharmaceutical chemistry and has been engaged for a total period of more than3 years in compounding of drugs in hospital or dispensary or other place in which drugs are regularly dispensed on prescription of medical practitioner Holds Degree or Diploma in Pharmacy of Pharmaceutical Chemistry or a "Chemist and Druggist Diploma of an Indian University or State Government" or a qualification granted outside India and approved under Section 14
  • 23. ✓ Register of pharmacist prepared under chapter IV of the pharmacy act by the state council after first register. ✓ A person for registration should be of at least 18 years of age and should reside or carry on the business in the state and should have qualification. ✓ Satisfies prescribed conditions, approved by central council or where no conditions are prescribed, conditions for entry of name in first register and has passed a matriculation or equivalent examination, or ✓ He is a registered pharmacist in other state, or ✓ Possesses qualification granted by an authority outside india, approved under section 14. SUBSEQUENT REGISTER
  • 24. Removal of names from Register 1. Due to error, misrepresentation, or suppression of material facts. 2. If he has been convicted of any offences in any professional aspect. 3. Order passed by executive committee of state council after making due enquiries and giving opportunity to the person concerned to explain his conduct. 4. 30 day period for appealing. 5. Removal of name may be either permanent or only for the specified period of time. 6. To surrender the certificate of registration to the registrar of the state of the council.
  • 25. 1. Falsely claims to be a registered pharmacist. Any person who falsely claims to be a ‘ Registered Pharmacists’ OR Uses in connection with his name, words, letters, reasonably calculated to show that his name is entered in the register of pharmacists. First Conviction: Fine up to Rs.500. Subsequent Conviction: Fine up to Rs.1000 and/or 6 months imprisonment. 2. Dispensing by an unregistered person. Person other than RP shall prepare, compound, mix or dispense any medicine on prescription of medical practitioner. 6 months of imprisonment or a fine of up to Rs.1000 or both.
  • 26. 3. Failure to surrender the Certificate of registration. Any person whose name has been removed from the register without sufficient reasons. Fine of Rs.50 4. Obstruction of state pharmacy council inspectors. Any person wilfully obstructing an inspector in exercise of powers under the pharmacy act,1948 Imprisonment of up to 6 months or a fine up to Rs.1000 or both.