Unit Iii (Pharmacy Act) Chapter 1

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PHARMACY ACT, 1948

Pharmacy Act regulates the profession of pharmacy in India.


Since there was no legislative law and stringent regulations to control the profession of
pharmacy in India before the pre-independence, which was mishandled by persons with
no pharmacy knowledge to compound and prescribe the medicines which were leading
to cause great harm to public health, pharmacy act was framed in the year 1948 to
resolve all these issues.
This act extends to the whole part of India except Jammu and Kashmir.

The pharmacy act was passed in 1948 and then subsequently amended as follows,
• Pharmacy (amendment) Act, 1959
• Pharmacy (amendment) Act, 1976
• Pharmacy (amendment) Act, 1981
OBJECTIVES:
The main objectives of the Act are as follows,
1. Restoration of the pharmacy profession in its due place in the health service.
2. Raising the status of pharmacy professions in India.
3. To regulate the practice of pharmacy in India.
4. To provide uniform education and training throughout India.
5. To maintain control over persons entering the profession of pharmacy.

DEFINITIONS:
Central Council means the Pharmacy Council of India.
State Council means the State Council of Pharmacy constituted under the Act and includes the joint
state pharmacy councils.
Central Register means the register of Pharmacists maintained by the Central Council (Pharmacy
council of India). (Under the section 15 A)
Medical Practitioner means a person holding-medical qualification as provided in the Indian Medical
Degree’s Act or Indian Medical Council Act or a person registered or eligible for registration in the
medical Register of the State or a Dentist or a Veterinarian.
Registered Pharmacist means a person whose name, for the time being, is entered in the Register of
Pharmacists of the state in which he is for time being residing or carrying on his profession or business
of Pharmacy.
CONSTITUTION OF PHARMACY COUNCIL OF INDIA
The Pharmacy Council of India (PCI) is constituted by the Central Government every five years.
The first Pharmacy Council of India was constituted in the year, 1949.
The PCI is composed of the following members:
A. Elected members:
(i) Six members, at least one teacher each of Pharmacy, Pharmaceutical Chemistry and Pharmacognosy elected by
UGC from the teaching staff of an Indian University or an affiliated college granting a degree or diploma in
Pharmacy.
(ii) One member, elected by the Medical Council of India from amongst its members.
(iii) One member elected by each State Pharmacy Council who shall be a Registered Pharmacist.
B. Nominated members:
(i) Six members, nominated by the Central Government, including at least four persons possessing degree or
diploma in Pharmacy and engaged in the practice of Pharmacy or Pharmaceutical Chemistry.
(ii) One representative each of University Grants Commission and the All India Council for Technical Education.
(iii) One Registered Pharmacist to represent each State nominated by the State Government/Union Territory
Administration.
C. Ex-officio Members:
(i) The Director General of Health Services.
(ii) The Director of Central Drugs Laboratory.
(iii) The Drugs Controller of India.

The President and Vice-President of the Pharmacy Council are elected by its members
from amongst themselves. They have a term of office of five years. Any member
absenting without sufficient excuse is deemed to have vacated his seat from the Council. A
casual vacancy in the PCI is filled by fresh nomination or election and the person so
nominated or elected holds the office only for the remaining term.
All members of the Council are eligible for re-election or re-nomination. The Council also
appoints:
(i) A Registrar who acts as its Secretary and, if necessary, its treasurer as well,
(ii) Other officers and servants for carrying out its statutory functions.
(iii) The Executive Committee of the PCI consisting of the President (Chairman of the
Committee) and the Vice-President and five other members elected by the Central Council
from amongst its members.
Functions of Pharmacy Council of India
1. To prescribe the minimum standards of education required for qualification as a Registered
Pharmacist.
2. To regulate the minimum educational standards by inspecting the institutions.
3. To recognise the qualification granted outside the territory to which the Pharmacy Act, 1948
extends, for the purpose of qualifying for registration.
4. To compile and maintain a Central Register for Pharmacist, containing names of all Registered
persons.
5. Any other function required for the furtherance of objectives of the Pharmacy Act, 1948.
Education Regulations for Pharmacy
The Pharmacy Council of India has laid down certain minimum standards of education required as
Pharmacist. These standards are known as Education Regulations and prescribe:
(i) Minimum educational qualification required for admission to the course of Pharmacy.
(ii) Duration of course of study and training.
(iii) Nature and period of practical training to be undertaken after the completion of regular course.
(iv) Subjects of examination and the standards to be attained therein for qualification.
(v) Minimum facilities required to be provided by an institution for the conduct of course of examination and
practical training.
(vi) Conditions to be fulfilled by the authorities holding approved examinations.

Approval of Institution Providing a Course of Study and Examination for the Pharmacy Profession:
Any institute or organisation providing a course of study and examination in Pharmacy has to follow the below
procedure for the PCI approval.
1. Application by the institute: The institute proposing to conduct the pharmacy course has to apply to the PCI.
2. Inspection:
• After receiving the application, PCI instructs its inspectors to visit the institution and inspect whether the
institution has the prescribed facilities for imparting training or holding examinations in accordance with the
Education Regulations or not.
• The inspectors may also attend an examination without interfering their conduct to inspect the standards.
• After the inspection, inspectors report to the PCI about the facilities available in the institute for the course of
study and examination.
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3. Approval: If the PCI is satisfied with the report of inspectors, it may accord approval and the said course
or examination will be claimed to be approved for qualifying registration as Pharmacist.
4. Declaration: Once the institute has been approved by PCI, such approval will be published in Gazette.

Withdrawal of Approval:
A notice of intention to withdraw approval is sent by the PCI to the executive committee if the committee
finds that an approved course of study or approved examination is no longer in compliance with the
Education Regulations. The institution in question has three months to make a representation to the PCI
through the state government, after which the PCI decides whether to withdraw or continue the approval.

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Approval of Qualification Granted Outside India:
• If a convincing enough assurance of the necessary ability and knowledge is provided, the PCI may accept
any pharmacy degree awarded by an authority outside of India as acceptable for the purpose of being
eligible to register as a pharmacist under this act.
• Citizens of India can apply for this.
• When an Indian citizen with the same legal qualification is permitted to join and practice pharmacy in
this country, nationals of other countries with qualifications awarded there will be eligible for registration in
this country.

Central Register:
• 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 AND JOINT STATE PHARMACY COUNCILS
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.
• 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 renomination.
• 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 Councils and Joint State Pharmacy Councils


I. Inspection by State Councils: The State and Joint State Pharmacy Councils with permission from the
respective State Governments may appoint a sufficient number of Inspectors having prescribed qualification:
(i) To inspect any premises where drugs are compounded or dispensed.
(ii) To enquire whether the dispensing or compounding of drugs is done by registered pharmacists or not.
(iii) To investigate any complaint made in writing regarding contravention of the Act.
(iv) To institute prosecution under the direction of the Executive Committee of the State.
(v) To exercise such other powers as may be necessary for certain provisions of the Act.
II. Registration of Pharmacists in the First and Subsequent Registers:
• The Pharmacy Act, 1948 provides for the registration of Pharmacists in all the states of India. The first
Register of Pharmacists in a State is required to be prepared by the State government.
• State Pharmacy Councils are responsible for the maintenance of the first and subsequent Registers where
pharmacists’ names are to be entered.
• Every year, before the end of June, State councils are required to pay Central council, a sum equivalent
to one fourth of fees prescribed by the PCI during the period of 12 months before the end of 31st March.
• The Register of Pharmacists includes the following particulars:
(i) Full name and residential address of the registered person.
(ii) The Date of his first entry in the Register.
(iii) Qualification of the person required for registration.
(iv) Professional address of the person and in the case of employed persons, the details of the employer.
(v) Such other particulars as may be prescribed.
Qualifications for Entry of a Person into the First Register:
A person whose name has to be entered into the First Register should have the following
qualifications:
(i) Should have attained the age of 18 years.
(ii) Should pay the prescribed fee to the state council.
(iii) Should be a resident of the State or should carry out his business or profession of pharmacy in
the State.
(iv) Should have the following qualifications.
(a) A pharmacy degree or diploma, a pharmaceutical chemistry degree, a chemist and druggist
diploma from an Indian university , or any other qualification obtained outside of India that is
accepted as sufficient for registration
(b) A degree of an Indian university other than a degree or diploma in Pharmacy or Pharmaceutical
chemistry and engaged in dispensing and compounding of drugs in a hospital or dispensary or any
other place where drugs are regularly dispensed on the prescription of a Registered Medical
Practitioner for a time period of not less than 3 years,
(c) Have passed an examination recognised as adequate by the State Government for
compounders and dispensers, or
(d) Have an experience of not less than five years in dispensing and compounding of drugs
in a hospital or dispensary or any other place where drugs are regularly dispensed on the
prescription of a Registered Medical Practitioner, prior to the date notified by the State
Government for receipt of applications for entry of names on the first Register.
Subsequent Registers:
After the preparation of the first Register and before the Education Regulations have taken
effect in a state, a person desirous of having his name registered in the Subsequent Register
has to qualify for the following particulars:
(i) Should be at least 18 years of age.
(ii) Should have paid the prescribed fee.
(iii) Should be a resident of the State or should carry out his business or profession of
pharmacy in the State.
(iv) Should fulfil the following requirements:
(a) Requirements as prescribed for registration and where no such requirements have been prescribed, possess the
qualifications which would have entitled him to have his name registered on the first Register and is at least
matriculate, or
(b) Is a Registered Pharmacist in another State, or
(c) Have an education obtained outside of India that is accepted as sufficient for registration, or at the very least the
high school degree needed following the implementation of the Education Regulations.
Removal of Names from the Register: The names of the registered persons may be removed from the register on
the following reasons:
1. If his name has been entered into the Register by error, misrepresentation or suppression of facts.
2. If he has been convicted of an offence in any professional respect which in the opinion of Executive Committee
renders him unfit to be on the Register of Pharmacists.
3. If a person employed under him in connection with any business of pharmacy has been convicted of any offence
or has been found guilty of any infamous conduct, such that if he himself was a Registered Pharmacist, his name
would have been removed from the Register.
OFFENCES AND PENALTIES:
The offences and penalties of the Pharmacy Act are as follows;

Sl. No. OFFENCES PENALTIES


A. Fine upto Rs 500/- on first conviction.
1 False claiming to be a registered pharmacist. B. Fine of Rs 1000/- and/or 6 months
imprisonment of any subsequent conviction.

6 months imprisonment or Rs 1000/- fine or


2 Dispensed by unregistered pharmacist
both

3 Failure to surrender of Certificate of Registration. Fine upto Rs 50/-

6 months imprisonment or Rs 1000/- fine or


4 Obstructing State Pharmacy council inspectors
both

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