Unit-III Pharmaceutical Jurisprudence

PHARMACY ACT 1948

The Pharmacy Act 1948 was enacted on 4.3.1948.
Then subsequently amended in 1959, 1976, 1981.
Objectives
 Restore the pharmacy profession in its due place in the health service.
 Raising the status of the profession pharmacy in India.
 To regulate the practice of pharmacy in India.
 To provide uniform education and training throughout India.
 To maintain control over persons entering the profession of pharmacy.
To serve the above objects Central Council of Pharmacy (Pharmacy Council of India-P.C.I) and State
Pharmacy Council (S.P.C) were constituted.
Pharmacy Council of India (P.C.I)
The pharmacy council of India (Central Council of India) is constituted by central government and
first pharmacy council was constituted in 1949.
It is reconstituted in every 5 years.
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.
Constitution of PCI
It consists of 3 different types of members.
 Elected Members.
 Nominated Members.
 Ex-Officio Members.
Elected members
 Six members elected by University Grant Commission (U.G.C) from amongst the teaching
staff of a university or college granting a degree or diploma in pharmacy.
 Amongst these, there should be at least one teacher each of pharmacy, pharmaceutical
chemistry, pharmacognosy and pharmacology.
 One member elected by Medical Council of India (M.C.I)
 One member – Elected by State Pharmacy Council.
Nominated members
 Six members – Nominated by Central Government (Ministry of Health and Welfare), of
which at least 4 should possess a degree or diploma in pharmacy and should be engaged in the
practice of pharmacy or pharmaceutical chemistry.
 One representative of the University Grant Commission (U.G.C) and One representative of
the All India Council for Technical Education (A.I.C.T.E)
 One Registered Pharmacist from Each State Govt/Union Territory.
Ex – Officio members
 The Director General of Health Services.
 The Director of Central Drugs Laboratory.
 The Drugs Controller of India.
The President and Vice-president of the council elected by the council members from its members.
The council shall,
Appoint a Registrar who shall act as secretary or as a treasurer too.
Appoint other officers and servants as necessary.
The central council constitute an Executive Committee consisting of,
 President
 Vice-President
 Five other members elected by central council from its members.
President, Vice-President and Nominated Members hold office for a period not exceeding 5 years.
A nominated or Elected member shall be deemed to have vacated his seat if he remains absent in 3
consecutive meetings.

Mr.T.Boopathi,M.Pharm,AP SSCOP
Unit-III Pharmaceutical Jurisprudence

Functions of PCI
A) Education Regulation (ER)
 Minimum standard of education laid down by P.C.I. are known as the ‘Education Regulation’.
 Education Regulations Prescribes:
 Minimum qualification required for registration as a pharmacist.
 Minimum qualification for admission to the course.
 Duration of training and the course (syllabus) of study to be covered.
 Conditions to be fulfilled by the academic institutions (Building, Equipments, qualifications
of staff)
 Conditions to be fulfilled by the Examining Authority (University/Board).
 Nature and period of practical training to be undertaken after completion of regular course
(500 hours training covered in a minimum of 3 months).
 The subjects of examination and minimum standard of passing.
 Conditions to be fulfilled by the Institution to be recognized for giving practical training.
 Practical training contract form for pharmacists.
B) To regulate the education regulations in the states.
C)Approval of Institution providing course and examination for pharmacists
Procedure:
 Institution has to apply to the PCI/AICTE.
 PCI/AICTE deputes its inspectors to visit the institution.
 Inspectors ascertain the facilities, whether they are in accordance with the ER or not.
Inspectors may attend any examinations to judge its standards.
 The inspectors then reports to PCI/AICTE.
 On the report of inspectors if the PCI/AICTE satisfied, it approves the course of examination.
D) Withdrawal of Approval
If any approved course of study or examination does not continue up to the standard of ER, the
council may be withdraw the approval.
E) Recognition of other Qualification
 The council may recognize any qualification granted by an authority outside India, to be
sufficient for registration as a pharmacist.
 Normally any citizen of India possessing such qualifications shall be eligible for registration.
F) Preparation and Maintenance of Central Register of Pharmacist
PCI maintains a register containing names of all persons registered as pharmacist in different states.
G) Fix the rates of Allowances of its members.
H) Decide the mode of Election.
I) Registration of Pharmacists
 The PCI is required to maintain a Central Register of pharmacists which contains the names
of all persons for time being entered in the registers of different State councils of India.
 Each state pharmacy council has to supply five copies of its register to the PCI as soon as
after 1st April every year.
 After receiving the registration details of the person in the register for a State, Registrar of
PCI enters the name of such persons in the central register.
 The central register is published in Gazette from time to time.
State Pharmacy Council (SPC)
Each state of India can constitute state pharmacy council under the provision of Pharmacy Act by
their respective State Governments.
Joint state pharmacy councils can also be constituted where two or more states agree to serve the
needs of the other participating states.

Mr.T.Boopathi,M.Pharm,AP SSCOP
Unit-III Pharmaceutical Jurisprudence

 The President and Vice-President of the State Councils are elected by the members from
amongst themselves. Both the nominated and elected members of the Council can hold office
for a term of five years.
 Any member absenting without sufficient excuse is deemed to have vacated his seat from the
council. A casual vacancy in the Council is usually filled by fresh nomination or election. All
members of the Council are eligible for re-election or re-nomination.
 Like the PCI, State and Joint State Pharmacy Councils also usually appoint a Registrar (who
may also act as its Secretary and Treasurer) and other necessary officers and staff as may be
required to carry out its functions under the Pharmacy Act.
 An Executive Committee is also constituted in similar way to that of PCI and its function is to
furnish necessary information and annual report to the PCI.
Functions of State Pharmacy Council (SPC)
 Registration of pharmacists in the state (First register, Subsequent register).
 Preparation and maintenance of register.
 Fix the rates of remuneration and allowances to its officers/members.
State council may appoint inspector
a) To inspect any premises where drugs are compounded or dispensed.
b) Enquire whether compounding and dispensing is carried out by registered pharmacist or not.
 To investigate any complaint.
 Decide mode of elections.
Registration of Pharmacist
The pharmacy Act 1948, provides for the registration of pharmacists.
A) First Register
B) Subsequent Register
A) First Register
State pharmacy council constitutes from the First Register’s registered pharmacists. Previously there
was no provision for the registration.
So there was no S.P.C. There were no Registered Pharmacists, though unofficial and unqualified
person were following/exploiting/performing the profession.

Mr.T.Boopathi,M.Pharm,AP SSCOP
Unit-III Pharmaceutical Jurisprudence

Procedure for preparing First Register

For the preparation of First Register in a state the state government has to constitute a Registration
Tribunal.
The Tribunal consists of,
 Three persons
 Registrar acts as Secretary.
 Tribunal fixes the date before which all the applications in prescribed form with fees are
accepted.
 All applications are examined.
 If the Tribunal is satisfied, it directs his/her name to be entered in the register.
Qualification for First Register
 A degree or diploma in pharmacy or pharmaceutical chemistry (or)
 Chemist and Druggist diploma (or)
 Qualification granted by an authority outside India which is recognized to be adequate for
registration (or)
 A degree of an Indian universities with not less than 3 years experience in dispensing and
compounding of drugs in a hospital or dispensary (or)
 Passed on examination for compounders and dispensers recognized by state government (or)
 Not less than 5 years experience of compounding and dispensing in a hospital or dispensary
prior to the date notified by Tribunal.
 The first registrar is published by state government.
 A person who is dissatisfied, has the right to appeal within 60 days.
 The decision of the state government is considered to be final.
B) Subsequent Register
From the registered pharmacists of the first register the constitution of the state pharmacy council take
place.
The first register and application fee are then hand over to the SPC.
Procedure for Subsequent Register
 After the formation of state council, applications are invited within a fixed (due) date,
addressed to the Registrar of the state council.
 Upon receipt of application, if the registrar is of the opinion that the applicant has the
requisite qualifications, he may direct his/her name to be entered in the Register.
 If any application has been rejected by Registrar, he/she may appeal to the state council
within 3 months of the rejection.
 The decision of the state council shall be final.
 Requirement and Qualification for Subsequent Register
Requirement
 Applicant should be at least 18 years of age.
 Applicant should reside or carry on business or profession of pharmacy in the concerned state.
Qualification for Subsequent Register
There are 3 different types of qualifications prescribed.
1.After the preparation of the first register and before E.R. take effect.
2.After the Education Regulations take effect.
3.Special Provisions.
1.After the preparation of the first register before E.R. take effect
a) Satisfy the conditions prescribed by the central council or
If no such requirements have been prescribed – possess the qualifications which would have entitled
them to have their name on the first register and are at least matriculates or
b) Registered pharmacist in another state or
c) Possess qualification for registration granted outside the states and
are at least matriculates.
2.After the Education Regulation take effect
a)Those who have passed an approved examinations.

Mr.T.Boopathi,M.Pharm,AP SSCOP
Unit-III Pharmaceutical Jurisprudence

b)Those who possess a qualification granted by authority outside India and recognized by the PCI or
c)Those who are Registered Pharmacists in another state.
3.Special Provisions
Provisions made under the Pharmacy Act (Amendment) – 1959.
This provisions apply to certain classes of persons:
 Affected by partitions in 1947.
 Due to reorganization of the states in 1956.
 Migrated to India (Displaced Persons).
Provisions made under the Pharmacy Act (Amendment) – 1976.
(for displaced persons, repatriates and other persons)
 Those who possess degree or diploma in pharmacy or pharmaceutical chemistry.
 Chemist or Druggist Diploma of an Indian university or State Government.
 Person approved as ‘Qualified Person’ before 31 December 1969 under the Drugs and
Cosmetics Act and Rules
 Passed on examination recognized for compounder and dispensers by State Government.
 Any displaced person from Bangladesh, Burma, Sri Lanka, Uganda and were carrying
business or profession of pharmacy for a period of 5 years prior to the date of application.
Register of Pharmacists
 The register includes the following particulars:
 Full name and residential address of the Registered Pharmacist,
 The date of his first admission,
 Qualification,
 His professional address, and if employed, the name and address of Employer,
 Other particulars.
Renewal
 The retention of the name on the register, subject to the payment of prescribed fee annually
before the 1st April.
 If the fees is not paid, the Registrar shall remove the name from the register.
 The name may be restored to the register on the prescribed conditions have been satisfied.
 Any additional qualification obtained by Registered Pharmacist shall be entered in the register
on payment of prescribed fees.
Removal of Names From Register
The names of a pharmacist may be removed from the register on following reasons:
1.If his name has been entered in register due to error, misrepresentation or suppression of facts.
2.If he has been convicted of an offence in any professional respect, which renders him unfit to kept
in register.
3.If the employed person is registered pharmacist, on the following reasons, his name may be
removed from the register:
 Convicted of an offence or held guilty of an infamous conduct.
 Offence or infamous conduct was instigated by registered pharmacist himself.
 If the repetition of similar offence or conduct during the period of 12 months.
4.If any person employed (non-pharmacist) by the pharmacist for the purpose of business of
pharmacy, his name can be removed on following occasions
 The person (non-pharmacist) has been guilty of similar offence during the preceding of 12
months and the pharmacist had the knowledge of the offence.
 The offence or conduct had continued (by non-pharmacist) over a long period and the
pharmacist had the knowledge.
 If pharmacist did not use his intelligence to see the provisions of the Drugs and Cosmetics
Act-1940.
The names can be removed only by executive committee of the state pharmacy council only.
Pharmacist may go to appeal to the state government within 30 days.
A person, whose name has been removed from the register is required to surrender the certificate of
registration.

Mr.T.Boopathi,M.Pharm,AP SSCOP
Unit-III Pharmaceutical Jurisprudence

Offence Penalty
Fine up to Rs.500 on first conviction
Falsely claiming to be a Registered
Fine up to Rs.1000 and 6 months imprisonment
Pharmacist
for any subsequent conviction
Dispensed by unregistered persons
Exceptions
6 months imprisonment or Rs.1000 fine or Both
Medical Practitioner may dispense medicines
to their own patients
Failure to surrender certificate of registration Fine up to Rs.50
Obstructing state pharmacy council 6 months imprisonment or Rs.1000 fine or Both

Mr.T.Boopathi,M.Pharm,AP SSCOP