Unit-3 PHARMACY ACT 1948

PHARMACY ACT 1948

This Act was implemented in the year 1948 on the recommendations of the report of ‘Drugs Enquiry Committee’ 1931 for the following objectives to be fulfilled.

1) To provide uniform Education and training for such persons who are willing to enter the profession of pharmacy.

2) Accordingly to provide for the ‘Registration’ of only such persons who are duly qualified and trained in the courses of Pharmacy.

3) To control and prevent other persons entering this profession.

4) To control, regulate and recognize the institutions providing Pharmacy Education in India.

5) To rise the status of Profession of Pharmacy in India.

DEFINITIONS

1) Central Council (PCI): Central council is nothing but ‘Pharmacy Council of India’ which is constituted by the central government under section 3 of the Pharmacy Act 1948.

2) Education Regulations are framed and implemented by the ‘Pharmacy Council of India’ which consists of minimum requirements and standards of education to be provided for the students of pharmacy including standards prescribed for the Institutions conducting the pharmacy courses.

3) State Pharmacy Council (SPC): The ‘State pharmacy Council’ is constituted by the concerned state government under section 20 of Pharmacy Act 1948.

4) Central Register: It is the register of the ‘Registered Pharmacists’ of the entire country to be prepared and maintained by the Central Council (PCI).

5) Registered Pharmacist: A person whose name has been entered in the register of the pharmacist in the state for the time being by Registration Tribunal or the State Pharmacy Council and who is residing in the state and carrying out the profession of pharmacy.

6) Displaced Persons: are defined to include such persons who got displaced from another country and entered into India due to the partition of India and Pakistan or the persons who entered into India because of civil disturbances in Sri Lanka or Myanmar or Bangladesh before 1971 or such persons who became citizens of India due to an inclusion of a particular territory into India like Goa, Daman and Diu in 1961.

7) Repatriates are defined to include the persons of Indian origin who had settled in other countries like Sri Lanka, Indonesia, South Africa, Uganda, Malaysia, etc. who later entered into India again after independence in 1947 to settle here only and wanted to continue the profession of pharmacy.

Constitution and functions of the Pharmacy Council of India (PCI)

A. CONSTITUTION

The PCI is constituted by the central government under section 3 of the Pharmacy Act with the following elected, nominated and ex-officio members for a period of 5 years for each term. The first PCI was constituted in the year 1949.

I. Elected Members

1) Six persons from among the teachers in Pharmacy of recognized Pharmacy Educational Institutions in India to be elected by the “University Grants Commission (UGC)” of whom at least one teacher each in pharmaceutical chemistry, pharmaceutics, pharmacology and pharmacagnosy.

2) One person to be elected by the “Medical Council of India” from amongst its members.

3) One “Registered Pharmacist” to be elected from amongst the “Registered Pharmacists” of each state and union territories elected by the concerned “State Pharmacy Council”.

II. Nominated Members

4) Six persons to be nominated by the Central Government of whom at least four persons must possess at least a diploma or degree in pharmacy and should be engaged in the profession of pharmacy or pharmaceutical industry

5) One person to be nominated by the “University Grants Commission (UGC)”.

6) One representative to be nominated by “All India Council for Technical Education (AICTE)”.

7) One Registered Pharmacist to be nominated by each of the State Government and Union Territories

“Director of Central Drugs Laboratory (CDL)”.

10) The “Drugs Control General of India (DCGI)”.

The elected and nominated members hold the office for a period of five years. However they are eligible for re-election and re-nomination for the next term also. Any member can resign the membership during the term of five years. Any such resignations or death of any members during the term can be filled up only for the remaining period.

A president and vice president should be elected by the members of the PCI. A Registrar and a treasurer and other officials maybe appointed by the PCI only with appropriate salaries to carry out the day to day functioning of PCI. An executive committee may also be constituted by the members of the PCI with at least 5 members including the president and vice president.

B. Functions of PCI

Following are the important functions of the PCI:-

1) To frame and implement the “Education Regulations (E.R)” for diploma in pharmacy course (now for Pharm –D course also)

2) To control and regulate the educational institutions in pharmacy throughout the country.

3) Approval and recognition of such institutions which are conducting pharmacy courses

4) Withdrawal of approval or de-recognition of such institutions which does not fulfil the requirements as per PCI norms.

5) Approval of any qualification in pharmacy granted by a foreign university or a foreign country.

6) Preparation and maintenance of a “Central Register” of the registered pharmacists of the entire country.

7) Any other functions related to the profession of pharmacy entrusted to it by the Central Government.

STATE PHARMACY COUNCILS

Constitution:-

A state pharmacy council (SPC) is constituted by the concerned State Government or Union Territories under Section 20 of the Pharmacy Act 1948 with the following elected, nominated and ex officio members.

I. ELECTED MEMBERS

1) Six registered pharmacists of the state to be elected by the State Governmentfrom amongst Registered Pharmacists of the state.

2) One member to be elected by the State Medical Council (SMC) from amongst its members.

II. NOMINATED MEMBERS

3) Five persons to be nominated by the state government of whom at least three persons should posses a degree or diploma in Pharmacy or be a Registered Pharmacist.

III. EX - OFFICIO MEMBERS

4) Chief Administrative Medical Officer (Director of Health Services) of the State.

5) Drugs Controller of the State.

6) Government Analyst of the State Drugs Testing Laboratory.

JOINT STATE PHARMACY COUNCIL (JSPC)

Constitution:-

A Joint State Pharmacy Council maybe constituted by an agreement between two or more states under Section 20 A of The Pharmacy Act 1948.

It is constituted by the following elected, nominated and ex officio members

I. ELECTED MEMBERS

1) Three to five Registered pharmacists to be elected by the State Government from amongst Registered Pharmacists of each state.

2) One member to be elected by the State Medical Council (SMC) of each state from amongst its members.

II. NOMINATED MEMBERS

3) Two to Four persons to be nominated by each state government of whom at least 50% of them should posses a degree or diploma in Pharmacy or a Registered Pharmacist.

III. EX OFFICIO MEMBERS

4) Chief Administrative Medical Officer (Director of Health Services) of each State.

5) Drugs Controller of each State.

6) One Government Analyst of the each State Drugs Testing Laboratory.

The elected and nominated members hold the period for five years. However they are eligible for re-election and re-nomination for the next term also. Any member can resign the membership during the term of five years. Any such resignations or death of any members during the term can be filled up only for the remaining period.

A president and vice president should be elected by the members of the SPC/JSPC. A Registrar and treasurer and other officials maybe appointed by the SPC/JSPC only with appropriate salaries to carry out the day to day functioning of SPC/JSPC. An executive committee may also be constituted by the members of the SPC/JSPC with at least 5 members including the president and vice president and at least three other members to the committee.

Functions of SPC/JSPC:-

1) Registration of the eligible pharmacists in the state as “Registered Pharmacists”.

2) Accordingly preparation and maintenance of a register comprising the list of “Registered Pharmacists” in the State.

3) To appoint inspectors to inspect the premises where the drugs are sold/ dispensed and compounded.

4) To carry out any other functions related to the profession of pharmacy entrusted to it by the concerned State governments.

Education Regulations [ER]

“Education regulations” are framed and implemented by P.C.I. under section 10 of the pharmacy act which prescribes the minimum standards of education and training for a pharmacist and also various standards prescribed for the institutions conducting the pharmacy course.

Following are the standards and conditions prescribed under ER:-

1. Minimum qualification for admission to D-PHARM course.

2. Nature and period of course [presently 2 year’s course + training period].

3. Various subjects and syllabus to be studied during the course.

4. Practical training to be undergone after completion of the course.

5. Equipment, staff and facilities to be provided by the institutions conducting the pharmacy course.

6. Conditions to be fulfilled by the institutions [hospitals, pharmacies etc] providing the practical training for the students after the course.

7. Approval /recognition of the institutions conducting pharmacy courses.

8. Conditions to be fulfilled by the authorities conducting D – PHARM exams including minimum marks to be secured for passing the subject and the exams in each year.

The latest ER has been implemented in 1991 which has been replaced by the earlier ER of 1981, 1971 and 1961. Each time the D-PHARM course content has been revised and improved to provide better education and training for the students.

Registration of pharmacists

Registration of pharmacist has been classified into the following types

1] First Registration [by registration tribunal]

2] Subsequent Registration:

A] Before ER are enforced in the state.

B] After ER are enforced in the state.

First Registration [by Registration tribunal]

First Registration of qualified and eligible pharmacists is / was carried out by a Registration Tribunal constituted by each of the state government. Accordingly a state government constitutes the Registration tribunal having at least three members including a Registrar. The Registration tribunal shall invite applications from the eligible candidates prescribing a registration fees and a final date for submission of applications. The applicants shall submit the applications along with the prescribed fees within the due date by providing the following information in their applications:-

1. Full name, father’s name and date of birth

2. Residential\official address of the applicant

3. His or her qualification prescribed for registration

4. Any other information as required by the tribunal. The following qualifications are prescribed for registration in The First Register

1. The person should have completed 18 years of age

2. Should be residing in the state where they are carrying out the pharmacy profession

3. Should have completed at least a diploma or a degree in pharmacy or any other equivalent qualification in pharmacy approved by P.C.I.

Should have completed any degree of an approved and recognized university with at least 3 years of experience in compounding and dispensing of drugs.

Should have completed any compounders / chemists and druggists course approved and conducted by the state government and approved by P.C.I. with at least 5 years of experience in compounding and dispensing of drugs.

Should have at least 5 years of experience in compounding and dispensing of drugs irrespective of any basic educational qualification.

On receiving the applications, the Registrar shall scrutinise all the applications received within the due date and register the names of all such candidates who are eligible to be registered and issue a Registration certificate as ‘Registered Pharmacist’ to the candidates . The candidates whose names are not registered due to any specific reasons may approach the concerned state governments within 60 days. The decision of the state government is final.

Once a state pharmacy council is constituted by the state government the Registration Tribunal shall handover the first register to the state pharmacy council and then cease to function.

Subsequent Registration

A. Before ER are enforced in the state:-

The following qualifications are prescribed for the Registrations of pharmacists before ER are enforced in the state which is carried out by the concerned state pharmacy councils:-

1. The person should have completed 18 years of age.

2. Should be residing in the state where they are carrying out the pharmacy profession.

3. Should have completed at least a diploma or a degree in pharmacy or any other equivalent qualification in pharmacy approved by P.C.I.

4. Should have completed any degree of an approved or recognised university with at least 3 years of experience in compounding and dispensing of drugs.

5. Should have completed any compounders / chemists and druggists course conducted by the state government and approved by P.C.I. with at least 5 years of experience in compounding and dispensing of drugs.

6. Should have completed SSLC or matriculate with at least 5 years of experience in compounding and dispensing of drugs.

7. Who is already a Registered pharmacist from another state.

8. Any foreign qualification in pharmacy approved by P.C.I.

B. After ER are enforced in the state:-

The following qualifications are prescribed for the Registration of a pharmacist after ER is enforced in the state:-

1. The person should have completed 18 years of age.

2. Should be residing in the state where they are carrying out the pharmacy profession.

3. Should have completed at least a diploma or a degree in pharmacy or any other equivalent qualification in pharmacy approved by P.C.I.

4. A Registered pharmacist of another state.

5. Any higher qualification in pharmacy like M-PHARM , PHD in pharmacy and PHARM – D or any qualification in pharmacy approved by P.C.I.

Special provisions made for Registration under Pharmacy Act [Amendment 1959 and 1971]

Pharmacy act 1948 has been amended in 1959 and 1971 providing special provisions for certain categories of persons mentioned below to get their names registered who are residing now in the country and have become citizens of India

Displaced persons ; those persons who migrated into India after the partition of the country into India and Pakistan in 1947 who could not get themselves registered earlier etc..

Repatriates; these are the persons of Indian origin [P.I.O.] who migrated into India after independence who could not get themselves registered earlier [Ex: P.I.O.’s from Sri Lanka, Indonesia, Malaysia, South Africa etc]

Persons who got affected due to Re-organisation of states in 1956

Persons who became the citizens of India after certain areas / settlements were included into India in 1961 [Ex: Goa, Daman and Diu]

Persons who got displaced from East Pakistan [the present Bangladesh] before December 1971 and who settled in India and thereby became citizens of India

Any other persons who couldn’t get themselves registered during the process of first registration for any reasons though they were in the profession of pharmacy

Removal of names from the Register

The name of a ‘Registered pharmacist’ can be removed from the Register due to any of the following reasons:-

1. If the name has been entered in the Register due to any error or misrepresentation or suppression of facts like wrong entry of name, wrong date of birth or submission of false /duplicate qualification certificates, false residential addresses etc..

2. If the person has been convicted of an offense under pharmacy act or drugs and cosmetics act which in the opinion of state pharmacy council makes him not eligible/unfit to continue as a Registered pharmacist

3. If any of his employees commits an offense under pharmacy act or D and C act which would be considered as an offense committed by a Registered pharmacist only and makes him unfit to continue as a Registered pharmacist.

4. If any person fails to get his name renewed in the Register after the date of expiry even after repeated reminder from state pharmacy council, his name maybe temporarily removed from the Register until he gets it renewed.

Any person, whose name has been removed from the Register, shall surrender the Registration certificate to S.P.C. within 90 days after the removal of his name. Removal of the name from the Register may be either temporary or permanent depending on the seriousness of the offence committed by the Registered pharmacist.

Any person who feels aggrieved of removal of his name from the Register may appeal to the state government within 30 days after the removal of his name from the Register. The decision of the State Government is final.

Offences and penalties

1. Any person who falsely claims to be a Registered pharmacist is liable to be punished with a fine up to 500 rupees on the first conviction or up to 1000 rupees fine and imprisonment up to 6 months on the subsequent conviction.

2. Any person other than a Registered pharmacist if found and proved of compounding and dispensing or selling the drugs is liable to be fined up to 1000 rupees and an imprisonment up to 6 months.

3. Any person who obstructs an inspector of S.P.C. to inspect the premises or for discharging his duties is liable to be punished with a fine up to rupees 1000 and an imprisonment up to 6 months.

4. If any person fails to surrender his Registration certificate after the removal of his- name permanently from the register within 90 days, is liable to be fined 50 rupees per day until the date of surrendering the registration certificate.

Unit-3 PHARMACY ACT 1948