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BP 505 T (Pharmaceutical Jurisprudence) Theory
UNIT-III
Pharmacy Act –1948: Objectives, Definitions, Pharmacy Council of India; its
constitution and functions, Education Regulations, State and Joint state pharmacy
councils; constitution and functions, Registration of Pharmacists, Offences and
Penalties
Medicinal and Toilet Preparation Act –1955: Objectives, Definitions, Licensing,
Manufacture In bond and Outside bond, Export of alcoholic preparations, Manufacture
of Ayurvedic, Homeopathic, Patent & Proprietary Preparations. Offences and Penalties.
Narcotic Drugs and Psychotropic substances Act-1985 and Rules: Objectives,
Definitions, Authorities and Officers, Constitution and Functions of narcotic &
Psychotropic Consultative Committee, National Fund for Controlling the Drug Abuse,
Prohibition, Control and Regulation, opium poppy cultivation and production of poppy
straw, manufacture, sale and export of opium, Offences and Penalties.
Prepared By-
Mr Chandan Das
Associate Professor
The Pharmaceutical College, Barpali
Pharmacy Act –1948
Objectives, Definitions, Pharmacy Council of India; its constitution and functions, Education
Regulations, State and Joint state pharmacy councils; constitution and functions, Registration
of Pharmacists, Offences and Penalties
Definition
It is an act An Act to regulate the profession of pharmacy whereas it is expedient to make better
provision for the regulation of the profession and practise of pharmacy and for that purpose to
constitute Pharmacy Council. The Act was promulgated in the Year 1948 [1].
The PCI was first constituted in the year 1949 and reconstituted every 5 years.
In modern perspective, a pharmacist is a regarded as a member of health care team or an
essential component of health system. The primary obligation of pharmacy is to safeguard the
public health by making available the right medicaments. Medicines are of vital importance
and hence their handling, compounding, dispensing and storage etc, need a thorough and
specialized knowledge, skill and training of the personnel called pharmacists. The desired
knowledge, skill and training are provided through the pharmacy courses [2].
Objectives
Regulating and Raising the Status of the Profession of Pharmacy in India.
Providing uniform education and training to the persons willing to enter the profession
of Pharmacy.
Maintaining control over the persons entering the profession of Pharmacy.
To constituent ‘Pharmacy Council of India’ for setting new standards in ‘Pharmacy
Education’.
To provide constitution and functions of ‘State Pharmacy Council’ for registration of
pharmacists.
To regulate the activities of pharmacists [3,4].
PHARMACY COUNCIL OF INDIA
In January 2015, the Pharmacy Council of India has published the new pharmacy practice
regulations 2015 to regulate pharmacy in India [1]. The important provisions are:
a) The drugs can be dispensed only by a qualified registered pharmacist.
b) Registered pharmacists shall not give his registration certificate at more than one
pharmacy.
c) Registered pharmacist shall also comply with the dress code by wearing white coat and
apron with a badge displaying the name and registration number.
d) Every registered pharmacist shall dispense only those medicines as prescribed by the
registered medical practitioner.
e) Every registered pharmacist shall maintain the medical or prescription records
pertaining to the patients for a period of 5 years from the date of commencement of the
treatment as per regulations.
f) Pharmacist should promote the rational use of drugs.
g) Other guidelines regarding ethical conduct of pharmacists.
The Central Government constitute a Central Council (Pharmacy Council of India). The
th
PCI was constituted on 9 August, 1949 under section 3 of the Pharmacy Act. The council
consisting of the following members:
A. Elected members:
a) Six members including at least one teacher each in pharmaceutical chemistry,
pharmacology and pharmacognosy on the teaching staff of an Indian University or an
affiliated college granting a degree or diploma in pharmacy. These members are elected
by the University Grant Commission.
b) One member elected by the Medical Council of India from amongst its members.
c) One member who shall be registered pharmacist to represent each State elected by State
Council from amongst its members.
B. Nominated members
a) Six members including at least four persons possessing degree or diploma in pharmacy
and engaged in the practice of pharmacy or pharmaceutical chemistry, nominated by
the Central Government.
b) A representative each of the University Grants Commission and All India Council for
Technical Education.
c) One registered pharmacist to represent each State nominated by the State Government
/ Union Territory Administration.
C. Ex-officio member
a) The Director General of Health Services.
b) The Director of Central Drugs Laboratory.
c) The Drugs Controller of India.
If the ex-officio member under C (a) & (b) are unable to attend any meeting they can authorize
a person each in writing to attend the meeting.
Function of Pharmacy Council of India (PCI)
The main functions of Pharmacy Council of India are:
a) To prescribe minimum standard of education required as a pharmacist.
b) Drafting of Education of Regulations to be fulfilled by the institutions for the approval,
for imparting education in pharmacy.
c) To provide uniform implementation of the educational standards throughout the
country.
d) Inspection of Pharmacy Institution to verify availability of the prescribed forms.
e) To recognize the course of study and examination for pharmacists.
f) To withdraw approval, if institution does not confirm educational standards prescribed
by the PCI.
g) To approve qualifications granted outside the territories to which the Pharmacy Act
extends i.e., the approval of foreign qualification.
h) To compile and maintain Central Register of Pharmacist.
President and Vice-president of Central Council
a) The President and Vice-President of the Central Council are elected by the members of
the Council from amongst themselves. They hold office for a period not exceeding five
years and not extending beyond the expiry of their term as the members of the Central
Council, they are however eligible for re-election.
b) If the term of the President or Vice-President as member of the Central Council expires
before the expire of the full term for which he is elected, he shall, if he is re-elected or
re-nominated as a member of the Central Council, continue to hold office, as the
president or Vice-President for the full term for which he is elected to such office.
c) Elections are to be conducted in the prescribed manner and in case of any dispute the
same can be referred to the Central Government whose decision shall be final.
Terms of Office and casual vacancies.
a) Any nominated or elected member shall hold office for a term of five years from the
date of his nomination or election or until his successor has been dully nominated or
elected.
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