1
PHARMACY ACT, 1948
Mrs. R. H. Mishal
Incharge HOD, D. Pharm
Sir Dr. M. S. Gosavi College of Pharmaceutical Education
& Research, Nashik.
Overview
The recommendations of Drugs Enquiry Committee
and Health Survey and Development Committee, laid
the foundation for the enactment of the Pharmacy
Act, 1948.
The necessity was felt to monitor the profession of
pharmacy in the country in order to ensure that the
medicines are handled, dispensed/compounded or
sold only by the qualified persons namely, the
registered pharmacists.
2
Overview
On 4th march, 1948, the Statutory control on the
pharmacy education in the country was established
with the enactment of the Pharmacy Act, 1948 with
the preamble- “An Act to regulate the profession of
pharmacy”.
It extends to whole of India except, State of Jammu
and Kashmir.
3
Contents Outline
 Objectives, Definitions.
 Pharmacy Council of India; its constitution and functions.
 Education Regulations.
 State and Joint state pharmacy councils.
 Registration of Pharmacists.
 Offences and Penalties.
4
Object
To regulate the profession and practice of
pharmacy and to raise the status of
pharmacy in India
5
Definitions
 Central Council: The pharmacy council of India.
 Central Register: Register of Pharmacists maintained by the
Central council.
 Registered Pharmacist: A person whose name for time being is
entered in the register for pharmacists of the state, in which
he/she is for the time being residing or carrying out his
profession or business of pharmacy.
 University Grant Commission: It means the University Grant
Commission established under section 4 of the University
Grant Commission Act, 1956.
6
Definitions
 Indian University: Means an university within the meaning of
section 3 of the UGC act, 1956 and includes such other
institutions established by or under a Central Act, as the
Central Government may by notification in the official gazette
specify in this behalf.
 Repatriate: Any person of Indian origin who on account of
civil disturbances in area now forming part of Burma, Sri
Lanka or Uganda, or any other country has after the 14th day
of April 1957, left or has been displaced from his place of
residence in such area and who has since then been residing in
India.
7
Definitions
 Displaced person:
(i) Person who on account of the setting up of the Dominions of India
and Pakistan or on account of the civil disturbances or the fear of such
disturbances in area now forming part of Pakistan has on or after the
first day of March 1947, left or been displaced from his place of
residence in such area and who has since then been residing in India.
(ii) Any person who on account of the civil disturbances or the fear of
such disturbances in any area now forming a part of Bangladesh, has
after 14th day of April 1957 but before the 25th day of March 1971, left
or has been displaced from his place of residence in such area and who
has since then been residing in India.
8
Definitions
Medical Practitioner:
a) A person holding qualifications granted by an authority specified or
notified under sec. 3 of Indian Medical Degrees Act, 1916. or specified in
the schedules to the Indian Medical Council Act, 1956.
b) A person registered or eligible for registration in a medical register of the
state meant for the registration of a person practicing modern scientific
system of medicine.
c) A person registered in a medical register of the state who although not
falling within subclause (a) or (b) is declared by a general or special order
made by state government in this behalf as a person practicing the modern
scientific system of medicine for the purpose of this act
d) A person who is engaged in the practice of veterinary medicine and who
possess qualifications approved by State Government.
9
Pharmacy Council of India (Central Council) PCI
Constituted under section 3 of the chapter 1 by the
central government.
The first pharmacy council of India (P.C.I)
constituted by central government in 1949.
It is reconstituted every 5 years.
It consists of three different types of members-
1. Elected members
2. Nominated members
3. Ex-Officio members
10
Pharmacy Council of India (Central Council) PCI
Elected members
A. Six members (teachers), elected by University Grant
Commission (UGC). There is at least one teacher of each
subject i.e., Pharmacy, Pharmaceutical chemistry,
Pharmacognosy and Pharmacology.
B. One member, elected by Medical Council of India.
C. One member from each state, elected by State Council, who
shall be a registered pharmacist.
11
Pharmacy Council of India (Central Council) PCI
Nominated members
A. Six members, nominated by the Central Government of
whom at least four shall be possessing a degree or diploma in
pharmacy and practicing pharmacy or pharmaceutical
chemistry.
B. A representative of the University Grants Commission.
C. A representative of the All India Council for Technical
Education (A.I.C.T.E.)
D. One member from each state, nominated by State
Government, who shall be a registered pharmacist.
12
Pharmacy Council of India (Central Council) PCI
Ex-officio members
A. Director General of Health Services.
B. Drug controller of India.
C. Director of the Central Drug Laboratory.
13
Pharmacy Council of India (Central Council) PCI
The Executive Committee
It consists of
1. President
2. Vice president
3. Five other members elected by Central Council from amongst its
members.
Apart from this, the council also appoints
1. A registrar/ Secretary
2. 2. Other officers and servants for carrying out its statutory
functions
14
Pharmacy Council of India (Central Council) PCI
President and Vice-President of Central Council
 Elected by the members of the Council among themselves.
 The President or Vice-President shall hold office as such for a
term not exceeding five years and not extending beyond the
expiry of his term as member of the Central Council.
 He shall be eligible for re-election.
 Mode of elections- Elections under this Chapter shall be
conducted in the prescribed manner, and where any dispute
arises regarding any such election it shall be referred to the
Central Government whose decisions shall be final.
15
Functions of PCI
 To prescribe minimum standards of education required for
qualification as a Pharmacist.
 To regulate the minimum educational standards.
 To recognize qualifications granted outside the territories to
which Pharmacy Act, 1948 extends for the purpose of
qualifying for registration under the said Act.
 To compile and maintain a central register.
 All other functions that may be assigned for implementation of
the act.
16
Education Regulations
 Subject to the provision of Section 10 of the
Pharmacy Act 1948, Central Council after approval of
central government may make regulations prescribing
the minimum standards of education required for
qualification as pharmacist called “Education
Regulations”.
17
Education Regulations
 Minimum qualification for admission to the course.
 Nature and period of course of study.
 Nature and period of practical training to be undertaken after
completion of course.
 Subjects of examinations and their standard.
 The equipment's and facilities to be provided by the
Institutions to the students.
 Conditions to be fulfilled by Institutions giving practical
training.
 Conditions to be fulfilled by authorities holding approved
examinations
18
Approval of Institution/ Authorities providing
courses of Study and Examinations
1. Application by Institution/ Authority to the central
council
2. Inspection.
3. Approval.
4. Declaration
19
APPROVAL OF QUALIFICATIONS GRANTED
OUTSIDE INDIA
1. Qualification in Pharmacy granted outside India can
be recognized by PCI. This is applicable to Indian
citizens.
2. Citizens of foreign nationality can be eligible for
registration when an Indian national holding the
same qualification is allowed to enter an practice in
that country.
20
CENTRAL REGISTER
 Under the provision of pharmacy act (1976), the PCI of India
is required to maintain a Central Register.
 Each state govt. has to supply five copies of register for a state
to the central council, after the first day of April every year
 The register has to be maintained by the Registrar of PCI.
 Has to be revised suitably from time to time.
 Published in the gazette of India.
21
State Pharmacy Councils
Elected members
(i) Six members elected by registered pharmacists of the state from amongst
themselves.
(ii) One member elected by the members of Medical Council of India from
amongst themselves.
Nominated members
(i) Five members nominated by the State Government from the persons who
hold degree or diploma in pharmacy.
Ex-officio members
(i) Chief administrative Medical Officer of the state
(ii) Officer in charge of Drugs Control Organization of the State
(iii) Government Analyst.
22
Joint State Pharmacy Councils
 Two or more states enter into an agreement to form a joint state pharmacy
council.
Elected members.
(i) Registered pharmacist- 3 to 5 from each state.
(ii) Medical council- 1 from each participating state.
Nominated members
(i) 2-4 members nominated by each State Government from the persons who
hold degree or diploma in pharmacy.
Ex-officio members
(i) Chief administrative Medical Officer of each participating state.
(ii) Officer in charge of Drugs Control Organization of each participating
State.
(iii) Government Analyst of each participating state.
23
Inspection
The state council may appoint Inspectors having the
qualifications as per the Act.
Powers:
1. Inspect any premises where drugs are compounded and
dispensed.
2. Enquire whether the person engaged in dispensing is a
registered pharmacist or not.
3. Institute prosecution under the order of the Executive
Committee of the State Council.
4. Other essential powers.
24
Registration of Pharmacist
Preparation and maintenance of register
The register shall include the following particulars, namely:
a) 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.
25
Qualifications for entry on first register
A person who has attained the age of eighteen years shall be entitled on
payment of the prescribed fee to have his name entered in the first register if he
resides or carries on the business or profession of pharmacy, in the State.
He must (a) hold a degree or diploma in pharmacy or pharmaceutical
chemistry or a chemist and druggist diploma of an Indian University or a State
Government. OR a prescribed qualification granted by an authority outside
India. OR
(b) holds a degree of an Indian University other than a degree in pharmacy or
pharmaceutical chemistry and has been engaged in the compounding of drugs
in a hospital or dispensary or other place in which drugs are regularly
dispensed on prescriptions of medical practitioners for a total period of not less
than three years. OR
26
Qualifications for entry on first register
(c) has passed an examination recognized as adequate by the
State Government for commoners or dispensers OR
(d) has been engaged in the compounding of drugs in a hospital
or dispensary or other place in which drugs are regularly
dispensed on prescriptions of medical practitioners for a total
period of not less than five years prior to the date notified under
subsection (2) of section 30.
27
Special provisions for "registration of certain
persons”
Notwithstanding anything contained in section 32, a State Council may also
permit to be entered on the register-
(a) the names of displaced persons who have been carrying on the business or
profession of pharmacy as their principal means of livelihood from a date
prior to the 4th day of March 1948, and who satisfy the conditions for
registration as set out in section 31
(b) the names of citizens of India who have been carrying on the business or
profession of pharmacy in any country outside India and who satisfy the
conditions for registration as set out in section 31.
(c) the names of persons who resided in an area which has subsequently
become a territory of India and who satisfy the conditions for registration
as set out in section 31.
28
Qualifications for entry in register
 He/ She should hold a diploma in pharmacy or pharmaceutical
chemistry.
 He/ She holds a degree in an Indian University other than
pharmacy and has been engaged in the compounding of drugs
in hospital or dispensary for a total period not less than 3
years.
 Has passed an examination recognized as adequate by the
State Government for commoners or dispensers.
29
Entry and removal of names
Entry:
 All applicants for the registration should be addressed to the Registrar of SPC.
 If the applicant has the requisite qualifications for registration, he shall direct
his or her name to be entered in the register.
 Upon entry, a certificate of registration is issued.
Removal:
 Registration by error.
 If he has been convicted of any offence in any professional aspect.
 30day period for appealing.
 Surrender of certificate of registration and publication in the official gazette.
30
Offences and Penalties
Offences Penalties
Falsely claims to be a registered
pharmacist
First Conviction: Fine up to Rs.500.
Subsequent Conviction: Fine up to
Rs.1000 and/or 6 months
imprisonment.
Dispensing by an unregistered person 6 months of imprisonment or a fine of
up to Rs1000 or both.
Failure to surrender the Certificate of
registration
Fine of Rs.50
Obstruction of state pharmacy council
inspectors
Imprisonment of up to 6 months or a
fine up to Rs1000 or both
31
References
Pharmaceutical Jurisprudence– B. S. Kuchekar and
A. M. Khadatare.
32
33
Thank You

Chapter 3. Pharmacy Act, 1948

  • 1.
    1 PHARMACY ACT, 1948 Mrs.R. H. Mishal Incharge HOD, D. Pharm Sir Dr. M. S. Gosavi College of Pharmaceutical Education & Research, Nashik.
  • 2.
    Overview The recommendations ofDrugs Enquiry Committee and Health Survey and Development Committee, laid the foundation for the enactment of the Pharmacy Act, 1948. The necessity was felt to monitor the profession of pharmacy in the country in order to ensure that the medicines are handled, dispensed/compounded or sold only by the qualified persons namely, the registered pharmacists. 2
  • 3.
    Overview On 4th march,1948, the Statutory control on the pharmacy education in the country was established with the enactment of the Pharmacy Act, 1948 with the preamble- “An Act to regulate the profession of pharmacy”. It extends to whole of India except, State of Jammu and Kashmir. 3
  • 4.
    Contents Outline  Objectives,Definitions.  Pharmacy Council of India; its constitution and functions.  Education Regulations.  State and Joint state pharmacy councils.  Registration of Pharmacists.  Offences and Penalties. 4
  • 5.
    Object To regulate theprofession and practice of pharmacy and to raise the status of pharmacy in India 5
  • 6.
    Definitions  Central Council:The pharmacy council of India.  Central Register: Register of Pharmacists maintained by the Central council.  Registered Pharmacist: A person whose name for time being is entered in the register for pharmacists of the state, in which he/she is for the time being residing or carrying out his profession or business of pharmacy.  University Grant Commission: It means the University Grant Commission established under section 4 of the University Grant Commission Act, 1956. 6
  • 7.
    Definitions  Indian University:Means an university within the meaning of section 3 of the UGC act, 1956 and includes such other institutions established by or under a Central Act, as the Central Government may by notification in the official gazette specify in this behalf.  Repatriate: Any person of Indian origin who on account of civil disturbances in area now forming part of Burma, Sri Lanka or Uganda, or any other country has after the 14th day of April 1957, left or has been displaced from his place of residence in such area and who has since then been residing in India. 7
  • 8.
    Definitions  Displaced person: (i)Person who on account of the setting up of the Dominions of India and Pakistan or on account of the civil disturbances or the fear of such disturbances in area now forming part of Pakistan has on or after the first day of March 1947, left or been displaced from his place of residence in such area and who has since then been residing in India. (ii) Any person who on account of the civil disturbances or the fear of such disturbances in any area now forming a part of Bangladesh, has after 14th day of April 1957 but before the 25th day of March 1971, left or has been displaced from his place of residence in such area and who has since then been residing in India. 8
  • 9.
    Definitions Medical Practitioner: a) Aperson holding qualifications granted by an authority specified or notified under sec. 3 of Indian Medical Degrees Act, 1916. or specified in the schedules to the Indian Medical Council Act, 1956. b) A person registered or eligible for registration in a medical register of the state meant for the registration of a person practicing modern scientific system of medicine. c) A person registered in a medical register of the state who although not falling within subclause (a) or (b) is declared by a general or special order made by state government in this behalf as a person practicing the modern scientific system of medicine for the purpose of this act d) A person who is engaged in the practice of veterinary medicine and who possess qualifications approved by State Government. 9
  • 10.
    Pharmacy Council ofIndia (Central Council) PCI Constituted under section 3 of the chapter 1 by the central government. The first pharmacy council of India (P.C.I) constituted by central government in 1949. It is reconstituted every 5 years. It consists of three different types of members- 1. Elected members 2. Nominated members 3. Ex-Officio members 10
  • 11.
    Pharmacy Council ofIndia (Central Council) PCI Elected members A. Six members (teachers), elected by University Grant Commission (UGC). There is at least one teacher of each subject i.e., Pharmacy, Pharmaceutical chemistry, Pharmacognosy and Pharmacology. B. One member, elected by Medical Council of India. C. One member from each state, elected by State Council, who shall be a registered pharmacist. 11
  • 12.
    Pharmacy Council ofIndia (Central Council) PCI Nominated members A. Six members, nominated by the Central Government of whom at least four shall be possessing a degree or diploma in pharmacy and practicing pharmacy or pharmaceutical chemistry. B. A representative of the University Grants Commission. C. A representative of the All India Council for Technical Education (A.I.C.T.E.) D. One member from each state, nominated by State Government, who shall be a registered pharmacist. 12
  • 13.
    Pharmacy Council ofIndia (Central Council) PCI Ex-officio members A. Director General of Health Services. B. Drug controller of India. C. Director of the Central Drug Laboratory. 13
  • 14.
    Pharmacy Council ofIndia (Central Council) PCI The Executive Committee It consists of 1. President 2. Vice president 3. Five other members elected by Central Council from amongst its members. Apart from this, the council also appoints 1. A registrar/ Secretary 2. 2. Other officers and servants for carrying out its statutory functions 14
  • 15.
    Pharmacy Council ofIndia (Central Council) PCI President and Vice-President of Central Council  Elected by the members of the Council among themselves.  The President or Vice-President shall hold office as such for a term not exceeding five years and not extending beyond the expiry of his term as member of the Central Council.  He shall be eligible for re-election.  Mode of elections- Elections under this Chapter shall be conducted in the prescribed manner, and where any dispute arises regarding any such election it shall be referred to the Central Government whose decisions shall be final. 15
  • 16.
    Functions of PCI To prescribe minimum standards of education required for qualification as a Pharmacist.  To regulate the minimum educational standards.  To recognize qualifications granted outside the territories to which Pharmacy Act, 1948 extends for the purpose of qualifying for registration under the said Act.  To compile and maintain a central register.  All other functions that may be assigned for implementation of the act. 16
  • 17.
    Education Regulations  Subjectto the provision of Section 10 of the Pharmacy Act 1948, Central Council after approval of central government may make regulations prescribing the minimum standards of education required for qualification as pharmacist called “Education Regulations”. 17
  • 18.
    Education Regulations  Minimumqualification for admission to the course.  Nature and period of course of study.  Nature and period of practical training to be undertaken after completion of course.  Subjects of examinations and their standard.  The equipment's and facilities to be provided by the Institutions to the students.  Conditions to be fulfilled by Institutions giving practical training.  Conditions to be fulfilled by authorities holding approved examinations 18
  • 19.
    Approval of Institution/Authorities providing courses of Study and Examinations 1. Application by Institution/ Authority to the central council 2. Inspection. 3. Approval. 4. Declaration 19
  • 20.
    APPROVAL OF QUALIFICATIONSGRANTED OUTSIDE INDIA 1. Qualification in Pharmacy granted outside India can be recognized by PCI. This is applicable to Indian citizens. 2. Citizens of foreign nationality can be eligible for registration when an Indian national holding the same qualification is allowed to enter an practice in that country. 20
  • 21.
    CENTRAL REGISTER  Underthe provision of pharmacy act (1976), the PCI of India is required to maintain a Central Register.  Each state govt. has to supply five copies of register for a state to the central council, after the first day of April every year  The register has to be maintained by the Registrar of PCI.  Has to be revised suitably from time to time.  Published in the gazette of India. 21
  • 22.
    State Pharmacy Councils Electedmembers (i) Six members elected by registered pharmacists of the state from amongst themselves. (ii) One member elected by the members of Medical Council of India from amongst themselves. Nominated members (i) Five members nominated by the State Government from the persons who hold degree or diploma in pharmacy. Ex-officio members (i) Chief administrative Medical Officer of the state (ii) Officer in charge of Drugs Control Organization of the State (iii) Government Analyst. 22
  • 23.
    Joint State PharmacyCouncils  Two or more states enter into an agreement to form a joint state pharmacy council. Elected members. (i) Registered pharmacist- 3 to 5 from each state. (ii) Medical council- 1 from each participating state. Nominated members (i) 2-4 members nominated by each State Government from the persons who hold degree or diploma in pharmacy. Ex-officio members (i) Chief administrative Medical Officer of each participating state. (ii) Officer in charge of Drugs Control Organization of each participating State. (iii) Government Analyst of each participating state. 23
  • 24.
    Inspection The state councilmay appoint Inspectors having the qualifications as per the Act. Powers: 1. Inspect any premises where drugs are compounded and dispensed. 2. Enquire whether the person engaged in dispensing is a registered pharmacist or not. 3. Institute prosecution under the order of the Executive Committee of the State Council. 4. Other essential powers. 24
  • 25.
    Registration of Pharmacist Preparationand maintenance of register The register shall include the following particulars, namely: a) 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. 25
  • 26.
    Qualifications for entryon first register A person who has attained the age of eighteen years shall be entitled on payment of the prescribed fee to have his name entered in the first register if he resides or carries on the business or profession of pharmacy, in the State. He must (a) hold a degree or diploma in pharmacy or pharmaceutical chemistry or a chemist and druggist diploma of an Indian University or a State Government. OR a prescribed qualification granted by an authority outside India. OR (b) holds a degree of an Indian University other than a degree in pharmacy or pharmaceutical chemistry and has been engaged in the compounding of drugs in a hospital or dispensary or other place in which drugs are regularly dispensed on prescriptions of medical practitioners for a total period of not less than three years. OR 26
  • 27.
    Qualifications for entryon first register (c) has passed an examination recognized as adequate by the State Government for commoners or dispensers OR (d) has been engaged in the compounding of drugs in a hospital or dispensary or other place in which drugs are regularly dispensed on prescriptions of medical practitioners for a total period of not less than five years prior to the date notified under subsection (2) of section 30. 27
  • 28.
    Special provisions for"registration of certain persons” Notwithstanding anything contained in section 32, a State Council may also permit to be entered on the register- (a) the names of displaced persons who have been carrying on the business or profession of pharmacy as their principal means of livelihood from a date prior to the 4th day of March 1948, and who satisfy the conditions for registration as set out in section 31 (b) the names of citizens of India who have been carrying on the business or profession of pharmacy in any country outside India and who satisfy the conditions for registration as set out in section 31. (c) the names of persons who resided in an area which has subsequently become a territory of India and who satisfy the conditions for registration as set out in section 31. 28
  • 29.
    Qualifications for entryin register  He/ She should hold a diploma in pharmacy or pharmaceutical chemistry.  He/ She holds a degree in an Indian University other than pharmacy and has been engaged in the compounding of drugs in hospital or dispensary for a total period not less than 3 years.  Has passed an examination recognized as adequate by the State Government for commoners or dispensers. 29
  • 30.
    Entry and removalof names Entry:  All applicants for the registration should be addressed to the Registrar of SPC.  If the applicant has the requisite qualifications for registration, he shall direct his or her name to be entered in the register.  Upon entry, a certificate of registration is issued. Removal:  Registration by error.  If he has been convicted of any offence in any professional aspect.  30day period for appealing.  Surrender of certificate of registration and publication in the official gazette. 30
  • 31.
    Offences and Penalties OffencesPenalties Falsely claims to be a registered pharmacist First Conviction: Fine up to Rs.500. Subsequent Conviction: Fine up to Rs.1000 and/or 6 months imprisonment. Dispensing by an unregistered person 6 months of imprisonment or a fine of up to Rs1000 or both. Failure to surrender the Certificate of registration Fine of Rs.50 Obstruction of state pharmacy council inspectors Imprisonment of up to 6 months or a fine up to Rs1000 or both 31
  • 32.
    References Pharmaceutical Jurisprudence– B.S. Kuchekar and A. M. Khadatare. 32
  • 33.