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, the pharmacy act was framed in the year 1948 to resolve all these issues.
This act also provides regulations for the good conduct of pharmaceutical education, revising the curriculum to gain academic and practical training for the pharmacists by framing standard guidelines. This act extends to the whole part of India except Jammu and Kashmir.
objectives of Pharmacy Act
The main objectives of the Pharmacy Act, 1948 are:
I. To provide uniform education and training to those persons willing to enter the pharmacy profession.
II. To maintain control over the persons of the pharmacy profession by registering them as registered pharmacists in every state and union territory.
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).
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 (PCI)
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 recognize the qualification granted outside the territory to which the Pharmacy Act, 1948 extends, to qualify for registration.
4. To compile and maintain a Central Register for Pharmacists, 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 a 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 a regular course.
(iv) Subjects of examination and the standards to be attained therein for qualification.
(v) Minimum facilities are 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.
Main Features of Education Regulations – 91:
According to ER-91, a candidate has to undergo practical training after having appeared in Diploma in Pharmacy Part-II examination in one or more of the following institutions:
(i) Government hospitals/dispensaries.
(ii) Other hospitals dispensaries recognized by the PCI.
(iii) Licensed pharmacy, chemists, and druggists shops.
(iv) Licensed drug manufacturing units.
Practical training should be for a minimum of 500 hours spread over not less than three months out of which not less than 250 hours must be devoted to actual dispensing of preparations. In the course of practical training, the trainee should have exposure to:
(i) Working knowledge of records required by various acts covering the profession of Pharmacy.
(ii) Practical experience in:
(a) The manipulation of pharmaceutical apparatus in common use.
(b) The reading, translation, and copying of prescriptions including checking of dose.
(c) The dispensing of prescriptions illustrating the commoner methods of administering medications.
(d) The storage of drugs and medical preparations.
These Education Regulations are approved by the central government. However, before submitting ER or any amendment to the central government for approval, the Pharmacy Council of India sends copies to all State Governments and takes into consideration the comments of any state government received within 3 months from the date of furnishing draft ER. The ER is notified in the official gazette by the central government.
Approval of Institution Providing a Course of Study and Examination for the Pharmacy Profession: Any institute or organization 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 deputes its inspectors to visit the institution and inspect whether the institution has the prescribed facilities for imparting training or holding examinations by the ER or not. The inspectors may also attend an examination without interfering with 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.
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:
If the executive committee reports to the PCI that an approved course of study or an approved examination does not continue to conform with the Education Regulations, the PCI gives notice of its intention to withdraw its approval. The said institution should make a representation within the 3 months to PCI through state government and PCI then decides to either continue the approval or to withdraw.
Approval of Qualification Granted Outside India:
The PCI may approve any qualification in Pharmacy granted by an authority outside India, to be approved qualification to qualify for registration as a pharmacist under this act, if a sufficient guarantee of the requisite skill and knowledge affords. This applies to Indian citizens.
Other countries’ citizens holding a qualification granted there, shall be eligible for registration in this country when an Indian national holding the same qualification by law is allowed to enter and practice the profession of pharmacy in this country.
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 person’s registration details in the register for a State, the 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 Council
Each state of India can constitute a state pharmacy council under the provision of the 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 composition of State and Joint State Pharmacy Councils is as follows:
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 a 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 the Central council, a sum equivalent to one-fourth of fees prescribed by the PCI during 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.
(ii) 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.
For preparing the first Register, the State Government constitutes a Registration Tribunal comprising of three persons and a Registrar who also acts as its secretary. The State Government then appoints a date before which all registration applications, accompanied by the prescribed fee should reach the Registration Tribunal. On receipt of the applications, the tribunal then examines all the applications up to the appointed date and when satisfied that an applicant is duly qualified, directs his or her name to be entered into the Register. The first Register is published by the State Government. Any person who is dissatisfied with the decision of the Tribunal can appeal to the authority appointed by the Government within 60 days of such publication on this behalf. The decision of the State Government is considered to be final and the Tribunal has to amend the Register by the directions of the Government. Upon the constitution of the State Council, the Register is handed over into its custody.
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 degree or diploma in Pharmacy or Pharmaceutical Chemistry or a Chemist and Druggist Diploma of an Indian University or a State Government or possess any other qualification granted outside the India which is recognized as adequate for registration, or
(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 not less than 3 years, or
(c) Have passed an examination recognized 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, before the date notified by the State Government for receipt of applications for entry of names on the first Register.
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.
(ii) Should be a resident of the State or should carry out his business or profession of pharmacy in the State.
(iv) Should fulfill 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) Possess a qualification granted outside India which is recognized as adequate for registration and is at least matriculate qualification required after Education Regulations have taken effect.
Special Provisions for Registration of Certain Persons:
The Pharmacy (Amendment) Act of 1959 made some special provisions for certain classes of persons affected by the partition of the country in 1947. These provisions apply to those who migrated to India or resisted in a place that became Indian territory. These provisions became effective after years of commencement of Pharmacy (Amendment) Act, 1959 which made special provisions for the following persons:
1. Persons holding a degree or diploma in pharmacy, pharmaceutical chemistry, or a chemist and druggist diploma of an Indian University or a State government or have passed an examination recognized by the state government as adequate for compounders and dispensers and who were eligible for registration between the closing of the First Register and the date when Education Regulation came into effect.
2. Persons approved as Qualified Persons before 31st December 1969 for compounding and dispensing of medicines under the Drugs and Cosmetics Act, 1940 and Rules.
3. Displaced persons from Bangladesh who left Bangladesh after 14th April 1957 but before 25th March 1971 and Repatriates from Burma, Srilanka, Uganda, or any other country who left or were displaced from such country between 14th April 1957 and 25th March 1971 and were carrying out the business or profession of pharmacy as the principal means of their livelihood for a total period of five years before the date of application.
4. Citizens of India who had been engaged in the business or profession of pharmacy abroad and satisfied the conditions for registration in the first register of the respective Indian State Councils.
5. Persons who have been engaged in the dispensing of drugs in a hospital or dispensary or another place where the drugs are dispensed regularly on prescriptions of Registered Medical Practitioners for five years before the date appointed.
Removal of Names from the Register:
The names of the registered persons may be removed from the register for 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 offense in any professional respect, the Executive Committee’s opinion 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 offense or has been found guilty of any infamous conduct, such that if he was a Registered Pharmacist, his name would have been removed from the Register.
However, under this section, action against the Pharmacist can only be taken if it is proved that:
(a) The offense or infamous conduct was instigated or connived at by the Registered Pharmacist, or
(b) The Registered Pharmacist himself has been guilty of such an offense during 12 months preceding the offense.
(c) Any person employed by the Pharmacist for purpose of the business of pharmacy has been guilty of similar offense during the preceding 12 months and the Registered Pharmacist had, or reasonably ought to have had, knowledge of such previous offense.
(d) The offense or infamous conduct continued over a period, the registered pharmacist had or reasonably ought to have, knowledge of continuing the offense or infamous conduct.
(e) The act is an offense under the Drugs and Cosmetics Act, 1940. The Pharmacist had not used his intelligence to ensure that the provisions of the Act were being complied with at his place of business and by persons employed by him by persons under his control.
An order of removal of names of persons from the register may direct that the person whose name is removed shall not be eligible for registration either permanently or for time being under this act. The order of the Executive Committee is subject to confirmation by the State Pharmacy Council and does not take effect until after three months from the date of such confirmation.
Any person aggrieved by the order for removal of his name from the register may appeal within 30 days from the communication to him of confirmation of the order by the State Council and the State Government decision is final. A person whose name has been removed from the register has to surrender his registration certificate to State Pharmacy Council Registrar and the name so removed is published in the Gazette.
Printing of Registers:
After the commencement of the Pharmacy (Amendment) Act, 1959, as soon as may be after the 1st April, every year, the registrars of the State Council were required to print the registers as they stood on that date. They are also required to print as soon as may after the 1st April in each year, copies of the annual supplement to register, showing all additions to, and other amendments, in the said register. The registrar should bring up-to-date the respective registers, three months before ordinary elections of the State Council are held and print copies of the register. Such copies should be made available to persons applying for the same, on payment of the prescribed charge. Such copies are the evidence that on the date referred to in the register of annual supplement, the persons, whose names are entered therein, were registered pharmacists.
Offenses and Penalties
The offenses and penalties of the Pharmacy Act are as follows;
Falsely claiming to be a registered pharmacist: Any person who falsely claims to be a registered pharmacist and/or uses in connection with his name or title any words or letters to show that his name has been entered in the register of Pharmacist, such person is punishable on first conviction with a fine extending up to 500 rupees and a fine up to 1000 rupees and imprisonment for up to 6 months on second or subsequent conviction. The use of words, Pharmacist, Chemist, Druggist, Pharmacist, Dispenser, Dispensing Chemist, or any combination of such words shall be deemed to suggest that a person is a Registered Person.
If a person is a Registered Pharmacist in another state and at the time of making such acclaim, has filed an application for registration in the state, he shall not be deemed to be guilty of the offense.
Dispensing by Unregistered Persons:
After the date notified on this behalf, by the State Government, no person other than a Registered Pharmacist can dispense, mix or compound drugs on the prescription of a medical practitioner. This, however, does not apply to dispense of medicines by a Medical Practitioner to his patients, or with the permission of the State Government to the patients of other medical practitioners.
Dispensing by unregistered persons is punishable with imprisonment of up to six months or a fine of up to 1000 rupees or both. Cognizance of this offense can be taken only on the complaints by the state government or by an officer authorized on this behalf or by the order of the Executive Committee of the State Pharmacy Council.
Failing to Surrender Certificate of Registration:
If any person, whose name has been removed for the time being from the Register, fails to surrender his certificate of registration without sufficient reason is punishable with a fine of up to 50 rupees. Cognizance of this offense shall not be taken except by an order of the Executive Committee of the State Pharmacy Council.
Penalty for Obstructing Inspectors:
Any person willfully obstructing Inspector of State Pharmacy Council shall be liable to imprisonment of up to 6 months or a fine of up to 1000 rupees or both.
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