History, Objectives, Various Definitions, The Pharmacy Council of India (PCI), Functions and duties of PCI, State Pharmacy Council, Functions of The State PharmacyCouncils, Joint State Pharmacy Council, Offences and penalties and List of amending Acts and adaptation orders.
1. The Pharmacy Act 1948
Dr. Ambekar Abdul Wahid
M. Pharm, Ph.D
Department of Pharmaceutics
Dr. Vithalrao Vikhe Patil Foundation’s
College of Pharmacy
Vadgaon Gupta (Vilad Ghat) PO MIDC
Ahmednagar (MS), India
E-mail: wahidambekar@gmail.com
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2. History
In India there was no any restriction to practice the
profession of pharmacy.
Hundred of case were found by government wherein the
compounding, mixing or dispensing of medicines was
being done by persons who were not adequately educated
in this line.
These causing great harm to the health of people.
It was found necessary to enact a law for the regulation of
the profession and practice of pharmacy.
An act was promulgated in 1948 entitled the pharmacy act
1948.
3. OBJECTIVE
To regulate the pharmacy education in the country for the
purpose of registration as a pharmacist under the
pharmacy act.
Providing uniform education and training to the person
willing to enter the Profession of Pharmacy
Maintaining control over the persons entering the
Profession Pharmacy
4. Definitions
“Pharmacy Act”: An act to regulate the profession of
pharmacy.
“Registered Pharmacist”: A person whose name is for
the time being entered in the register of the state in which
he or she is for the time being residing or carrying on his
profession or business of pharmacy.
5. “Agreement" means an agreement entered into under
section 20
“Approved" means approved by the Central Council under
section 12 or section 14
"Central Council" means the Pharmacy Council of India
constituted under section 3
"Central Register" means the register of pharmacists
maintained by the Central Council under section 15 A
Definitions (Continue…)
6. "Executive Committee" means the Executive Committee
of the Central Council or of the State Council, as the
context may require;
"Indian University" means a University within the
meaning of section 3 of the University Grants Commission
Act, 1956, (3 of 1956) and includes such other institutions,
being institutions established by or under a Central Act, as
the Central Government may, by notification in the Official
Gazette, specify in this behalf;]
Definitions (Continue…)
7. “Medical practitioner" means a person:
i. Holding a qualification granted by an authority specified
or notified under section 3 of the Indian Medical Degrees
Act, 1916 (7 of 1916), or specified in the Schedules to the
Indian Medical Council Act, 1956 (102 of 1956); or
ii. Registered or eligible for registration in a medical register
of a State meant for the registration of persons practising
the modern scientific system of medicine; or
Definitions (Continue…)
8. iii. Registered in a medical register of a State, who, although not
falling within sub-clause (i) or sub-clause (ii) is declared by a
general or special order made by the State Government in
this behalf as a person practising the modern scientific
system of medicine for the purposes of this Act; or
iv. Registered or eligible for registration in the register of
dentists for a State under the Dentists Act, 1948 (16 of
1948); or
v. Who is engaged in the practise of veterinary medicine and
who possesses qualifications approved by the State
Government.
Definitions (Continue…)
9. "State Council" means a State Council of Pharmacy
constituted under section 19, and includes a Joint State
Council of Pharmacy constituted in accordance with an
agreement under section 20
"University Grants Commission" means the University
Grants Commission established under section 4 of the
University Grants Commission Act, 1956 (3 of 1956).
Definitions (Continue…)
10. The Pharmacy Council of India (PCI)
The PCI was first constituted in the year 1949.
Reconstituted every 5 years.
Composition:
A. Elected members
B. Nominated members
C. Ex-officio members
11. A. Elected members:
a) 6 members (teachers), elected by University Grant
Commission (UGC).
There is at least one teacher of each of the pharmacy,
pharmaceutical chemistry, pharmacognosy and
pharmacology.
b) One member, elected by Medical Council of India.
c) One member, elected by State Council, who shall be a
registered pharmacist.
The Pharmacy Council of India
12. B. Nominated members:
a) 6 member, nominated by the Central Government of whom
at least 4 shall be persons possessing a degree or diploma in,
and practicing pharmacy, or pharmaceutical chemistry.
b) A representative of the U.G.C. and a representative of the
All India Council for Technical Education (A.I.C.T.E.)
c) One member nominated by each State Government who
shall be a registered pharmacist.
The Pharmacy Council of India
13. C. Ex-Officio Members:
a) The Director general of Health Services.
b) The Director of Central Drug Laboratory.
c) The Drug controller of India.
The Pharmacy Council of India
14. Executive Committee Consisting of:
President
Vice – President
(President and Vice – President of Central Council shall be
elected by the members of the Council from themselves.)
Five members elected by Central Council from it’s
members.
The Pharmacy Council of India
15. The Council shall appoint:
A Registrar act as a secretary.
Other officer and servants.
The elected and nominated members of the council hold
office for a period of 5 years, but they can resign their
membership at any time, by writing to the president of the
council.
All members are eligible for re-election of re-nomination.
The Pharmacy Council of India
16. Functions and duties:
A. Design of the educational pattern:
To frame an educational structure for the would be
pharmacist and to keep it tuned to the changing needs
with passage of time .
The standards of education for pharmacist framed by the
council are known as the Educational Regulations and
amongst other things prescribe. As-
a. Minimum qualification for admission to the course.
The Pharmacy Council of India
17. b) Duration of the training and the course of study to be
covered.
c) Equipments and facilities to be provided by the
institutions.
d) Giving practical training.
e) Holding approved examinations.
(After the formation of the state councils the State
Government were supposed to publicize the Education
Regulations in the States in consultation with the respective
State Pharmacy Council.)
The Pharmacy Council of India
Functions and duties (Continue…)
18. B. Approval of Institutions/withdrawal of approvals:
An institution or authority, which conducts a course of study
or hold an examination for the pharmacists, has to apply to
the Pharmacy Council of India for approval of the course or
the examination.
The council may depute its inspectors to visit the institution
to check whether the prescribed facilities for imparting
training or holding examinations are in accordance with the
Education Regulations or not.
The Pharmacy Council of India
Functions and duties (Continue…)
19. It may also require inspectors to attend any examination, to
judge its standard without interfering with its conduct.
The Inspectors then report to the council.
If on the report of the Inspector, the council is satisfied then
it gives approval to it and then the said course or
examination shall be deemed to be approved for qualifying
for registration as pharmacist under the act.
If any approved course of study or examination does not
continue to be in conformity with the Education
Regulations, then the council withdraw the approval.
The Pharmacy Council of India
Functions and duties (Continue…)
20. C. Maintenance of Central Register of Pharmacists:
Under the provision of the pharmacy (Amendment) Act
1976, the Pharmacy Council of India is required to
maintain a register containing names of all persons
registered as pharmacists in different states.
This register has to maintained by the registrar of the
Council and has to be revised suitably from time to time
and published in the Gazette of India.
The Pharmacy Council of India
Functions and duties (Continue…)
21. State Pharmacy Council
It also consists of three different types of members: Elected,
nominated and ex-officio.
A. Elected members:
Six members, elected from amongst themselves by
registered pharmacist of the state.
One member elected from amongst themselves by the
member of each Medical Council of the State.
22. B. Nominated members:
Five members, of whom at least three shall be possessing a
degree or diploma in pharmacy or pharmaceutical chemistry
or to be registered pharmacists, nominated by the state
government.
C. Ex-Officio Members:
Chief administrative medical officer of the state.
Government Analyst nominated by state government
under the drug and cosmetic act 1940.
Officer in charge of drugs control organization of the
state.
State Pharmacy Council
23. Where two or more States enter into an agreement to form
a joint State Pharmacy Council :
Registered pharmacist – 3 to 5 from each state instead of 6
in the single State Council.
Government Nominees – 2 to 4 from each State instead of 5.
Medical Council Nominee – one from each State.
Chief Administrative Medical Officer, Government Analyst
and Officer in–charge, Drug Control - Ex-officio from each
state.
24. Each Council shall have a president and vice-president,
elected by the members from amongst themselves
provided that for five years from the first constitution of the
council.
The president will be nominated by the State Government
and if he is not already a member, he becomes a member
of the council in addition.
The State Council are, before the end of June in each year,
required to pay to the PCI a sum of equivalent to one-
fourth of the fees.
Where two or more States enter into an agreement to
form a joint State Pharmacy Council :
25. Functions of The State Pharmacy
Councils
A. Maintenance of registers:
The Register shall include the following particulars
namely-
The full name and residential address of the registered
person.
The date of his/her first admission to the register.
His/her qualifications for registration.
His professional address, and if he is employed by any
person, the name of such person.
26. Entry and Removal of Names:
After an appointed date, all applications for registration
should be addressed to the registrar of the State Pharmacy
Council.
The applicant has the requisite qualifications for registration,
he may direct his or her name to be entered in the register.
Person whose names have been removed from the registers of
other State shall not be entitled to registration unless the
State Council gives its consent thereto.
Functions of The State Pharmacy
Councils
27. Upon entry of the name of person in the register, the
Registrar is required to issue to him a certificate of
registration in the prescribed form.
On payment of the fees, the registrar is required to issue a
receipt thereof and such receipts are deemed to be proofs of
renewal of registration.
Functions of the state pharmacy
councils
28. Removal of name from the register:
The name of a pharmacist may be removed from the register
on following counts:
If his name has been entered in register by error.
If he has been convicted of an offence in any professional.
Any pharmacist ,who is held guilty and whose name has
been removed from register, shall continue to remain a
registered pharmacist for the next three months and only
after the expiry of that period he shall cease to be a
registered pharmacist.
Functions of the state pharmacy
councils
29. A person aggrieved by the order directing the removal of
his name, may appeal to the State Government within 80
days whose decision shall be final.
A person whose name has been removed from the
register, is required to surrender his certificate of
registration to the registrar of the Pharmacy Council
concerned.
If it feels that the offence was a minor nature, it may warn
the pharmacist and stop the consideration of his case for
a specified period, during which the pharmacist should
prove himself to be of good behavior.
Functions of the state pharmacy
councils
30. But in cases of serious professional neglect or criminal
conviction, his name may be removed.
Pharmacist can, however appeal to the high court against
the decision of Statutory Committee.
Functions of the state pharmacy
councils
31. Printing of Registers
The Register of the State Pharmacy Council were required
to publish the Registers on the first April following the
beginning of the Pharmacy (Amendment) Act.
Later on, each year after the first of April, they were to
publish supplements to the Registers showing all additions
or changing.
These Registers and supplements are deemed to be proof
that the persons, whose name are contained therein, are
registered pharmacist.
32. Inspection by State Council
The State Pharmacy Council have been empowered to
appoint suitable number of Inspectors having prescribed
qualifications to inspect premises where drugs are
dispensed or compounded.
33. Renewal Fees
The state govt. by notification in the official gazette, direct
that for the retention of the name in the register.
In order to retain the name in the register, renewal fee shall
be paid to the state government as may be prescribed.
Where a renewal fee is not paid by the due date, the
Registrar shall remove the name of the defaulter from the
register.
On payment of the renewal fee, the Registrar shall [issue a
receipt there for and such receipt shall be proof of renewal
of registration].
34. Offences and penalties
Offences Penalties
Falsely claims to be a
registered pharmacist.
• Fine up to Rs.500.00 on
first conviction.
• Fine up to Rs.1000.00 and
or 6 months imprisonment
of any subsequent
conviction.
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.
35. List of amending Acts and
adaptation orders
1. The Adaptation of Laws Order, 1950.
2. The Adaptation of Laws (No.3) Order, 1956.
3. The Pharmacy (Amendment) Act, 1959 (24 of 1959)
4. The Pharmacy (Amendment) Act, 1976 (70 of 1976)
5. The Pharmacy (Amendment) Act, 1982 (22 of 1982)
6. The Delegated Legislation Provisions (Amendment) Act,
1985 (4 of 1986).
36. References
1. Pharmaceutical Jurisprudence. Agarwal S.B. Tata
Publishers
2. A text book of forensic pharmacy by N.K Jain.
Vallabh Prakashan.
3. Handbook of drug law by M. L. Mehra.
4. Forensic pharmacy, 9th edition. Nirali Prakashan by
Kuchekar B.S.
5. Pharmaceutical regulatory affairs by Subrahmanyam
C.V.S and Thimma Setty J. Vallabh Prakashan.