Pharmacy Act 1948

PHARMACEUTICAL
JURISPRUDENCE
Syllabus:
Jurisprudence:
The theory or
 UNIT I- Drugs and Cosmetics Act, 1940 and its rules 1945 philosophy of law
 UNIT II - Drugs and Cosmetics Act, 1940 and its rules 1945.
 UNIT III:
 Pharmacy Act –1948
 Medicinal and Toilet Preparation Act –1955
 Narcotic Drugs and Psychotropic substances Act-1985 and Rules
 UNIT IV
 Study of Salient Features of Drugs and magic remedies Act and its rules
 Prevention of Cruelty to animals Act-1960
 National Pharmaceutical Pricing Authority
 UNIT V
 Pharmaceutical Legislations
 Code of Pharmaceutical ethics
 Medical Termination of pregnancy act
 Right to information Act
 Introduction to Intellectual Property Rights (IPR)
PHARMACY ACT 1948
T.Y. B. Pharm (R-2019)

2024-25
SYLLABUS 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

HISTORY
 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.
 In the absence of any uniform regular course for the training of
pharmacist in the country in the Pre-independent era, the necessity
was also felt to introduce a professional course of instruction for
minimum qualification of registration as pharmacist, in order to create
requisite qualified manpower to manage the affairs of profession of
pharmacy in the country.
 The drugs are life-saving and also potent which require proper
handling at the counters in retail-outlets and hospitals.
 Their mishandling by nonqualified persons shall play havoc with
national health care system.
 It is to overcome this obstacle the Pharmacy Bill was
introduced in 1945
 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 following preamble.
Introduction
 The pharmacy education and profession in India up to graduate level is
regulated by the Pharmacy Council of India (PCI), a statutory body governed by
the provisions of the Pharmacy Act 1948 passed by the Indian Parliament.
 The Pharmacy Act 1948 was enacted on 04.03.1948 with the following
preamble: “An Act to regulate the profession of pharmacy. Whereas it is
expedient to make better provision for the regulation of the profession and
practice of pharmacy and for that purpose to constitute Pharmacy Councils".
 The PCI was constituted on 09.08.1949 under section 3 of the Pharmacy Act.
PCI
OBJECTIVES:
 Regulation of the Pharmacy Education in the Country for the purpose of registration as a
pharmacist under the Pharmacy Act.
 Regulation of Profession and Practice of Pharmacy.
 Prescribing the minimum standard of education required for qualifying as a pharmacist i.e.,
framing of education regulations prescribing the conditions to be fulfilled by the
institutions seeking approval of the PCI for imparting education in pharmacy.
 Ensuring uniform implementation of the educational standards throughout the country.
 Approving the courses of study and examination for pharmacists i.e. approval of the
academic training institutions providing pharmacy courses.
 Withdrawing approval if the courses of study does not continue to be conformity with the
educational standards prescribed by the PCI.
 Maintaining Central register of Pharmacists.
CONSTITUTION Pharmacy
Council of India
(PCI)
Ex-Officio Nominated Elected

Members members members
EX-OFFICIO MEMBERS
 Director-General of Health Sciences, Govt. of India or his/her nominee.
 Drugs Controller General of India or his/ her nominee.
 Director, Central Drugs Laboratory (CDL), Kolkatta.

ELECTED MEMBERS
 Six members of whom at least one teacher of each of the subjects of Pharmacy,
Pharmaceutical Chemistry, Pharmacology and Pharmacognosy elected by
University Grant Commission (UGC) from amongst teacher of Indian Universities
or affiliated colleges imparting diploma or degree in pharmacy.
 One member elected by from amongst its members of Medical Council of India.
 One member each elected by the State Pharmacy Council of each state who
should be a registered pharmacist.
NOMINATED MEMBERS
 Six members nominated by the Government of India, Ministry of Health and
Family Welfare, of which at least 4 should possess degree or diploma in
pharmacy qualification and should be practicing pharmacy or pharmaceutical
chemistry.
 One representative each from UGC and All India Council of Technical Education
(AICTE).
 One member representing each State Government or Union Territory who shall
be a registered pharmacist nominated by the respective State Government or
Union Territory.
 https://www.pci.nic.in/
Executive Committee of PCI
President Members- 5
Vice-president (Elected by Central
Chairman of the Ex- officio member council amongst
committee other members)
Holds office for a period of 5 years

EDUCATIONAL REGULATIONS
 Section 10 of Pharmacy act

 Central council make education regulation after approval from Central
government prescribe minimum standard of education required for
qualification as Pharmacist.
- Minimum qualification for admission to course
- Nature and period of course of study
- Nature and period of practical training
- Subjects of examination and standards attained therein
- Equipment and facilities
- Conditions to be fulfilled by institution
APPLICATION OF ER TO STATES
 After constitution of state council and after consultation with state

council, by notification in official gazette declare implementation of
ER in state.
 If no such declaration has been made, then after 3 years from the
date of constitution of state council, the ER shall take effect.
PHARM. D. REGULATION 2008
 Pharm. D. (6 years)
 Pharm. D. (3 years)
Approval of institutions
 Application of institution/ authority to the central council
 Inspection
 Approval
 Declaration
Withdrawal of Approval
• Notice to institute
• Representation within 3 months
• Decision
REPORTING TO CENTRAL GOVERNMENT
 Minutes of meeting
 Accounts
 Management of property
 Election conduction
 Powers and duties of Executive committee

CENTRAL REGISTER OF PHARMACIST
 Section- 15A of amendment act 1976

 Every state has to supply five copies of register to central council before
1st day of April every year.
 Registrar of State council inform central council about amendment in
register time to time.
STATE PHARMACY COUNCIL
a) Six members, elected from amongst themselves by registered pharmacists of the State;
For Joint state council- NLT 3 and NMT 5 from each state
a) Five members, of whom at least three shall be persons possessing a prescribed degree or
diploma in pharmacy or pharmaceutical chemistry or registered pharmacists, nominated
by the State Government;
For Joint state council- NLT 2 and NMT 4 from each state
a) One member elected from amongst themselves by the members of each Medical Council
or the Council of Medical Registration of the State, as the case may be:
https://www.mspcindia.org/Default.aspx
Ex-officio members
 The Chief Administrative Medical Officer of the State or if he is unable to attend any
meeting, a person authorised by him in writing to do so;
 The officer-in-charge of Drugs Control Organization of the State under the [Drugs and
Cosmetics Act, 1940 (23 of 1940)], ex officio or if he is unable to attend any meeting, a
person authorised by him in writing to do so;]
 The Government Analyst under the [Drugs and Cosmetics Act, 1940 (23 of 1940)], ex
officio, or where there is more than one, such one as the State Government may appoint
in this behalf:
Maharashtra State
pharmacy council
 President and vice-president
 Terms of office
Powers of inspectors-
 Inspect any premises where drugs are compounded or dispensed
 Enquire whether a person engaged in compounding and dispensing of

drugs is a registered pharmacist or not.
 Investigate any complaint received in writing.
REGISTRATION OF PHARMACIST
 Chapter 4 of Pharmacy act 1948
 The register shall include-
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.
QUALIFICATION FOR ENTRY IN FIRST REGISTER
 Degree or diploma in Pharmacy/ Pharmaceutical chemistry
 Degree other than pharmacy/ pharmaceutical chemistry:
engaged in compounding of drugs in hospital or dispensary of
other place for a period of NLT 3 years
 Passed examination recognized by state Govt. for compounders
and dispensers.
 NLT 5 years of experience of compounding in hospital, dispensary
or other place.
 Removal and restoration of name in register
Offences and Penalties-

Offences Penalties
Falsely claiming to be registered Pharmacist Rs. 500 or 6 months imprisonment on first
conviction and Rs. 1000 or both on subsequent
Dispensing by unregistered person Rs. 1000 or 6 months imprisonment or both
Failure to surrender certificate of registration Fine of Rs. 50
Obstruction of state pharmacy council Fine of Rs. 1000 or 6 months imprisonment or

inspectors both
REFERENCE
 Forensic Pharmacy by Dr. B.S. Kuchekar, A.M.

Khadatare and S.C. Itkar

Pharmacy Act 1948

Uploaded by

Copyright:

Available Formats

Pharmacy Act 1948

Uploaded by

Document Information

Copyright

Available Formats

Share this document

Share or Embed Document

Sharing Options

Did you find this document useful?

Is this content inappropriate?

Copyright:

Available Formats

Pharmacy Act 1948

Uploaded by

Copyright:

Available Formats

PHARMACEUTICAL

T.Y. B. Pharm (R-2019)

 Pharmacy Council of India; its constitution and functions,

 State and Joint state pharmacy councils; constitution and functions,

 Offences and Penalties

Ex-Officio Nominated Elected

 Drugs Controller General of India or his/ her nominee.

 Director, Central Drugs Laboratory (CDL), Kolkatta.

Holds office for a period of 5 years

 Section 10 of Pharmacy act

 After constitution of state council and after consultation with state

 Powers and duties of Executive committee

 Section- 15A of amendment act 1976

 Enquire whether a person engaged in compounding and dispensing of

a) the full name and residential address of the

Offences and Penalties-

Dispensing by unregistered person Rs. 1000 or 6 months imprisonment or both

Failure to surrender certificate of registration Fine of Rs. 50

Obstruction of state pharmacy council Fine of Rs. 1000 or 6 months imprisonment or

 Forensic Pharmacy by Dr. B.S. Kuchekar, A.M.

You might also like