This document provides an overview of the Pharmacy Act of 1948 in India. The key points are:
1. The Pharmacy Act established the Pharmacy Council of India (PCI) as the central regulatory body for pharmacy education and practice. It also established State Pharmacy Councils (SPCs).
2. The PCI and SPCs set standards for pharmacy education, approve pharmacy colleges and courses, maintain registers of pharmacists, promote continuing education, and regulate pharmacy practice.
3. The PCI prescribes regulations for pharmacy programs including admission criteria, curriculum, practical training requirements, and infrastructure standards that colleges must meet.
4. To be registered as a pharmacist, one must have a recognized pharmacy
This topic gives the introduction and need of group of laws that were introduced in the profession of pharmacy-under subject -Pharmaceutical Jurisprudence
Drug & Cosmetic ACT 1940 & Rules 1945 unit I.pptxGayatriBahatkar1
Objectives, Definitions, Legal definitions of schedules to the Act and
Rules
Import of drugs – Classes of drugs and cosmetics prohibited from import, Import under
license or permit. Offences and penalties.
Manufacture of drugs – Prohibition of manufacture and sale of certain drugs,
Conditions for grant of license and conditions of license for manufacture of drugs,
Manufacture of drugs for test, examination and analysis, manufacture of new drug, loan
license and repacking license.
This topic will help you to-
Understand Pharmaceutical legislation.
Analyze the different recommendations of DEC.
Enlist different drug acts prevailing in India
This topic gives the introduction and need of group of laws that were introduced in the profession of pharmacy-under subject -Pharmaceutical Jurisprudence
Drug & Cosmetic ACT 1940 & Rules 1945 unit I.pptxGayatriBahatkar1
Objectives, Definitions, Legal definitions of schedules to the Act and
Rules
Import of drugs – Classes of drugs and cosmetics prohibited from import, Import under
license or permit. Offences and penalties.
Manufacture of drugs – Prohibition of manufacture and sale of certain drugs,
Conditions for grant of license and conditions of license for manufacture of drugs,
Manufacture of drugs for test, examination and analysis, manufacture of new drug, loan
license and repacking license.
This topic will help you to-
Understand Pharmaceutical legislation.
Analyze the different recommendations of DEC.
Enlist different drug acts prevailing in India
These presentation describes the rules and regulations for the manufacture of drugs and grant of license. Loan License and Repacking License is also described. These presentation is the part of series Drugs & Cosmetics Act.
The pharmacy act 1948 explained in the easiest form with tricks and tips to learn. The act is about the practice of pharmacy in India. It provides with knowledge of skill and training of the personnel called pharmacists.
This presentation describes the labeling requirements for drugs and cosmetics. This covers general labeling requirements, specific labeling requirements, specimen labels, and other details regarding labeling.
This is very useful slide presentation for B.Pharm,Pharm Dand D.Pharm students not only for University exam but also job oriented exam like pharmacist, Drug inspector, GPAT etc.
Codes of pharmaceutical ethics
In relation to his trade
In relation to his Job
In relation to his Profession
In relation to Medical Profession
Pharmacist's Oath
The aim of presentation is to provide information related to pharmacy Act, 1948.
Introduction
Definition
Pharmacy Council of India
State pharmacy Council
Registration of pharmacists
Offences and penalties
These presentation describes the rules and regulations for the manufacture of drugs and grant of license. Loan License and Repacking License is also described. These presentation is the part of series Drugs & Cosmetics Act.
The pharmacy act 1948 explained in the easiest form with tricks and tips to learn. The act is about the practice of pharmacy in India. It provides with knowledge of skill and training of the personnel called pharmacists.
This presentation describes the labeling requirements for drugs and cosmetics. This covers general labeling requirements, specific labeling requirements, specimen labels, and other details regarding labeling.
This is very useful slide presentation for B.Pharm,Pharm Dand D.Pharm students not only for University exam but also job oriented exam like pharmacist, Drug inspector, GPAT etc.
Codes of pharmaceutical ethics
In relation to his trade
In relation to his Job
In relation to his Profession
In relation to Medical Profession
Pharmacist's Oath
The aim of presentation is to provide information related to pharmacy Act, 1948.
Introduction
Definition
Pharmacy Council of India
State pharmacy Council
Registration of pharmacists
Offences and penalties
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
pharmacy act 1948 .
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; It is hereby enacted as follows:—
This act gives an idea about the constitution and functions of PCI. Brief about Education Regulation in India. Registration procedure for the pharmacist in India.
The Pharmacy Act in India is a legislation that provides the legal framework for the regulation of pharmacy practice in the country. It sets out the requirements for the registration and licensing of pharmacists, as well as the standards of education and training that pharmacists must meet in order to practice. It also establishes regulatory bodies such as the Pharmacy Council of India and the State Pharmacy Councils, which oversee and enforce the law.
The Pharmacy Act in India also includes provisions related to the sale and distribution of drugs and other pharmaceutical products, as well as regulations concerning the operation and management of pharmacies. It defines the various roles and responsibilities of pharmacists, including dispensing and compounding medications, providing patient counseling and education, and collaborating with other healthcare providers.
Overall, the Pharmacy Act in India aims to ensure the safety and efficacy of pharmaceutical care in the country by providing a legal framework for the regulation of pharmacy practice.
This PPT Covers 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
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1. Unit 4: Pharmacy act
1948
By
Dr. Eswar Gupta Maddi
Krupanidhi College of Pharmacy, Bangalore, India
2. Introduction
1.Framed in 1948, to regulate pharmacy
profession and education in India.
2.Applicable to entire India except Jammu and
Kashmir.
3. Objectives
1. Regulation of the profession of pharmacy
2. Establishment and maintenance of pharmacy
councils
3. Setting standards for pharmacy education and
practice
4. Definitions
1. Central Council: Pharmacy Council of India
2. State Council: State Pharmacy Council
3. Central Register: Register of pharmacists maintained by PCI
4. Medical Practitioner: A person holding medical qualification and
registered with state medical council.
5. Registered Pharmacist: A person whose name is entered in the state
pharmacy register.
5. CONSTITUTION OF PHARMACY COUNCIL OF INDIA
1. PCI is constituted every 5 years by the Central government.
2. First PCI was constituted in 1949.
3. It has elected members, nominated members and ex-officio members.
6. Elected Members
1. University grants commission (UGC) – elects six teachers from university /
affiliated colleges. At least one teacher should be from pharmacy,
pharmaceutical chemistry and pharmacognosy.
2. MCI: One member elected by MCI from amongst its members.
3. SPC: One member elected from each SPC among its registered
pharmacists.
7. Nominated Members
1. Central government: Six members practicing pharmacy. At least four
should possess a diploma or degree in pharmacy.
2. One representative each from UGC and All India council of technical
education (AICTE).
3. One registered pharmacist nominated by each state government.
8. Ex-officio members
• The Director General of Health Services.
• The Director of Central Drugs Laboratory.
• The Drugs Controller of India.
12. Pharmacy Council of India – Regulatory body for
Pharmacy Education and Pharmacy Practice in India
1. President and vice – president of PCI elected by its members amongst
themselves.
2. Hold 5 years term.
3. PCI appoints registrar, secretary, treasurer and other officers / servants to
carry out functions of PCI.
4. The Registrar's role is primarily administrative and involves managing the
day-to-day operations of the Council, maintaining records, and
coordinating with various committees and stakeholders.
13. 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.
14. Functions of PCI
1. To prescribe standards of education required for a person to become a
qualified registered pharmacist.
2. To inspect the institutions conducting pharmacy courses.
3. Approval and recognition of pharmacy institutions and courses.
4. Setting guidelines for curriculum and infrastructure.
5. Ensuring quality and relevance of education.
6. Ensuring that curricula are up-to-date and aligned with industry trends.
7. To compile and maintain central register of pharmacists.
8. Establishing a code of ethics for pharmacists.
9. Promoting ethical behavior and professional conduct.
10. Encouraging pharmacists to stay updated with the latest knowledge
11. Organizing seminars, workshops, and training programs.
12. To carry out any other function to meet the objectives of Pharmacy act 1948.
15. Education Regulations for Pharmacy
1. Minimum educational qualification required for admission to the course of Pharmacy.
2. Duration of course of study and training.
3. Nature and period of practical training to be undertaken after the completion of
regular course.
4. Subjects of examination and the standards to be attained therein for qualification.
5. Minimum facilities required to be provided by an institution for the conduct of course
of examination and practical training.
6. Conditions to be fulfilled by the authorities holding approved examinations.
16. Main Features of Education Regulations of PCI for D.Pharmacy
1. Requirements to be fulfilled by a Diploma in Pharmacy college.
2. 10 + 2 MPC or BiPC or MBiPC or equivalent for admission to Diploma in
pharmacy.
3. 2 Years course, syllabus and examination structure prescribed.
4. Practical training in hospital or dispensary or licenced pharmacy shop or
pharmaceutical industry.
5. 500 hours training spread over 3 months, out of which minimum 250 hours in
dispensing medicines.
6. He / She must be trained to maintain all records as required by the law.
17. Main Features of Education Regulations PCI for B.Pharmacy
1. Requirements to be fulfilled by a B.Pharm college
2. 10 + 2 MPC or BiPC or MBiPC or equivalent for admission to bachelor of
pharmacy.
3. 4 Years course, syllabus and examination structure prescribed by PCI.
4. Practical training for 150 hours after 2nd year in hospital or dispensary or
licenced pharmacy shop or pharmaceutical industry.
5. He / She must be trained to maintain all records as required by the law.
18. Main Features of Education Regulations PCI for Pharm D
1. Requirements to be fulfilled by a Pharm D college.
2. 10 + 2 MPC or BiPC or MBiPC or equivalent for admission to bachelor of pharmacy.
3. 6 Years course, syllabus and examination structure prescribed by PCI.
4. Hospital posting.― for a period of 50 hours covered in 200 days in each of second, third
& fourth year course. Each student shall submit report in prescribed format.
5. In the fifth year, every student shall spend half a day in the morning hours attending ward
rounds on daily basis as a part of clerkship. Theory teaching in afternoon and He / She
must be trained to maintain all records as required by the law.
6. 6th Year: Internship of 2 months each in 3 specialty wards and 6 months in general
medicine.
19. CONSTITUTION OF STATE PHARMACY COUNCIL
1. SPC is constituted every 5 years.
2. Two or more states may form a joint state pharmacy council.
3. It has elected members, nominated members and ex-officio members.
22. State Pharmacy and Joint State Pharmacy Council
1. President and vice – president of SPC elected by its members amongst themselves.
2. Hold 5 years term.
3. SPC appoints registrar, secretary, treasurer and other officers / servants to carry
out functions of PCI.
4. The Registrar's role is primarily administrative and involves managing the day-to-
day operations of the Council, maintaining records, and coordinating with various
committees and stakeholders.
5. The executive committee is also constituted in a similar way as in PCI, furnishes
necessary information and annual report to PCI.
23. Functions of SPC
1. Registration of pharmacists and its record maintenance.
2. Regulation of pharmacy practice.
3. Pharmacovigilance.
4. Developing Ethical guidelines for practicing pharmacists.
5. Grievance redressal.
6. Encouraging pharmacists to stay updated with the latest knowledge.
7. Organizing seminars, workshops, and training programs.
8. Promoting public health, educating public about safe and rational use of
medicines.
9. Communicating important information / guidelines to registered pharmacists
24. Registration of Pharmacists in the First and Subsequent
Registers
1. Full name and residential address of the registered person.
2. The Date of his first entry in the Register.
3. Qualification of the person required for registration.
4. Professional address of the person and in the case of employed persons, the
details
5. of the employer.
6. Such other particulars as may be prescribed.
25. Registration of Pharmacists in the First Register
1. The State Government constitutes a Registration Tribunal - three persons and a Registrar
who also acts as its secretary.
2. The State Government then fixes a last date – for applications and fees.
3. Tribunal screens the applications and registers the qualified ones.
4. The first Register is published by the State Government.
5. Any person who is dissatisfied with the decision of the Tribunal can appeal in 60 days.
6. The decision of the State Government is final and the Tribunal has to amend the Register
in accordance.
7. Upon the constitution of the State Council, the Register is handed over into its custody.
26. Registration of Pharmacists in the First Register
1. The State Government constitutes a Registration Tribunal - three persons and a Registrar
who also acts as its secretary.
2. The State Government then fixes a last date – for applications and fees.
3. Tribunal screens the applications and registers the qualified ones.
4. The first Register is published by the State Government.
5. Any person who is dissatisfied with the decision of the Tribunal can appeal in 60 days.
6. The decision of the State Government is final and the Tribunal has to amend the Register
in accordance.
7. Upon the constitution of the State Council, the Register is handed over into its custody.
27. Qualifications for Registration as Pharmacist in First Register
Should have attained the age of 18 years.
Should pay the prescribed fee to the state council.
Should be a resident of the State or should carry out
his business or profession of pharmacy in the State.
28. 4. Have D.Pharm, B.Pharm, Pharm D, or any other equivalent degree given outside India.
5. Have any degree of an Indian university + 3 years experience in compounding and
dispensing of medicines in a hospital or dispensary or medical shop.
6. Have passed an examination recognized as adequate by the State Government
for compounders and dispensers, or
7. Have 5 Years experience in dispensing and compounding of drugs in a hospital or
dispensary prior to the date notified by the State Government for receipt of applications
forentry of names on the first Register.
29. Qualifications for Registration as Pharmacist in Subsequent
Register
Should have attained the age of 18 years.
Should pay the prescribed fee to the state council.
Should be a resident of the State or should carry out
his business or profession of pharmacy in the State.
30. 4. Have D.Pharm, B.Pharm, Pharm D, or any other equivalent degree given outside India.
5. Have any degree of an Indian university + 3 years experience in compounding and
dispensing of medicines in a hospital or dispensary or medical shop.
6. A matriculate and have passed an examination recognized as adequate by the State
Government for compounders and dispensers, or
7. A matriculate and have 5 Years experience in dispensing and compounding of drugs in
a hospital or dispensary prior to the date notified by the State Government for receipt of
applications forentry of names on the first Register.
8. Registered pharmacist of another state.
31. Removal of Names from Register
1. If the name has been entered by error, it will be removed from the register.
2. If a registered pharmacists commits an offence, irt will be removed from
register.
32. Printing of Registers
1. After formation of SPC, first register is printed.
2. Thereafter, every year after April first, supplementary registers are printed.
3. Registers should be update 3 months before the elections of the SPC.
33. Offences and Penalities
1. Falsely claiming to be registered pharmacists - Fine Rs 500.00 on first conviction
and on subsequent conviction, Rs 1000.00 and 6 months imprisonment.
2. Dispensing by unregistered persons - Fine up to Rs 1000.00 or 6 months
imprisonment.
3. Failing to surrender registration certificate on cancellation of registration - Rs 50/-
fine.
4. Obstructing Inspector of SPC into premises- 1000/- Rs or 6 months jail or both.