Pharmaceutical legislation in India originated to regulate the manufacturing, distribution, and sale of drugs to ensure quality and safety. A key development was the 1931 Chopra Committee, which recommended establishing regulatory bodies like the PCI and introducing comprehensive drug laws. This led to the Drug Act of 1940 and subsequent legislation like the Pharmacy Act of 1948. The overall objective of pharmaceutical legislation in India is to regulate the pharmaceutical sector and pharmacy profession to protect public health.
Introduction Central Drug Testing Laboratories & Responsibilities
Role of Central Drugs Testing Laboratory
No of laboratories in India, No of laboratories in each State
Presented by
J. Vinay Krishna
Department of Industrial Pharmacy
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.
A presentation aimed at providing information with regards to the Pharmacy Act, 1948.
-INTRODUCTION
-HISTORY OF THE ACT
-PHARMACY COUNCIL OF INDIA
-STATE PHARMACY COUNCIL
-SPECIAL PROVISIONS OF THE ACT
-OFFENCES AND PENALTIES
-CONCLUSION
-REFERENCES
Introduction Central Drug Testing Laboratories & Responsibilities
Role of Central Drugs Testing Laboratory
No of laboratories in India, No of laboratories in each State
Presented by
J. Vinay Krishna
Department of Industrial Pharmacy
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.
A presentation aimed at providing information with regards to the Pharmacy Act, 1948.
-INTRODUCTION
-HISTORY OF THE ACT
-PHARMACY COUNCIL OF INDIA
-STATE PHARMACY COUNCIL
-SPECIAL PROVISIONS OF THE ACT
-OFFENCES AND PENALTIES
-CONCLUSION
-REFERENCES
At the end of the 19th century and early 20 century use of Allopathy system increases
Drugs of natural origin: Veg, mineral oil and animals
At that time, profit became main motive than service
Overdose of quinine.A Central law to control drugs and pharmacy profession.
The poison Act, 1919 was passed on 3rd September , 1919, with a view to control the import, possession and sale of Poisons.
It extends to whole of India but is not applicable to the state J&K.
The Act of 1919 replaced the poison Act of 1904.
The term “Poison” has not been defined under the Act.
Under the Act, the central Govt. has been authorised to regulate the import of poison across, while the various State Govt. has been authorised to make rules regarding the possession and sale of poison within their respective territories.
COMMUNITY PHARMACY AND MANAGEMENT – CHAPTER -1................... (1).pptSumit Tiwari
A community pharmacy, often referred to as retail pharmacy or retail drug outlets, is places where medicines are stored and dispensed, supplied or sold
Good regulatory practice are internationally recognized process, system, tools and method for improving the quality of regulation.
It includes
1)COMMUNITY PHARMACY RETAIL AND WHOLESALE PHARMACY
-Dacumentation
-Licenses
-Renewal
-E-governance
2) HOSPITAL PHARMACY
-Dacumentation
-Licenses
-Renewal
-E-governance
3) PHARMA MANIFACTURING
-Dacumentation
-Licenses
-Renewal
-E-governance
4) IMPORT OF DRUG AND MEDICAL DEVICE
-Dacumentation
-Licenses
-Renewal
-E-governance
5) EXPORT OF DRUG AND MEDICAL DEVICE
-Dacumentation
-Licenses
-Renewal
-E-governance
This presentation includes an brief idea about the pharmacy act 1948 in India and also deals with its the chapter that included in the act.(Education Regulations, PCI, State PCI, Registration of Pharmacist , Approval of Institutions, Offences penalties 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
State pharmacy council and joint state pharmacy council:
Under the Pharmacy Act each Sate Govt. is required to constitute a state pharmacy council for the maintenance of register of Pharmacists of the State and to monitor their professional activities.
Two or more states can also enter into an agreement to form a Joint State Pharmacy Council.
A brief description of history,drugs and cosmetics acts and rules, various drug schedules included in the act and rules, brief description of drug schedules, Recent amendments, etc.
This topic gives the introduction and need of group of laws that were introduced in the profession of pharmacy-under subject -Pharmaceutical Jurisprudence
At the end of the 19th century and early 20 century use of Allopathy system increases
Drugs of natural origin: Veg, mineral oil and animals
At that time, profit became main motive than service
Overdose of quinine.A Central law to control drugs and pharmacy profession.
The poison Act, 1919 was passed on 3rd September , 1919, with a view to control the import, possession and sale of Poisons.
It extends to whole of India but is not applicable to the state J&K.
The Act of 1919 replaced the poison Act of 1904.
The term “Poison” has not been defined under the Act.
Under the Act, the central Govt. has been authorised to regulate the import of poison across, while the various State Govt. has been authorised to make rules regarding the possession and sale of poison within their respective territories.
COMMUNITY PHARMACY AND MANAGEMENT – CHAPTER -1................... (1).pptSumit Tiwari
A community pharmacy, often referred to as retail pharmacy or retail drug outlets, is places where medicines are stored and dispensed, supplied or sold
Good regulatory practice are internationally recognized process, system, tools and method for improving the quality of regulation.
It includes
1)COMMUNITY PHARMACY RETAIL AND WHOLESALE PHARMACY
-Dacumentation
-Licenses
-Renewal
-E-governance
2) HOSPITAL PHARMACY
-Dacumentation
-Licenses
-Renewal
-E-governance
3) PHARMA MANIFACTURING
-Dacumentation
-Licenses
-Renewal
-E-governance
4) IMPORT OF DRUG AND MEDICAL DEVICE
-Dacumentation
-Licenses
-Renewal
-E-governance
5) EXPORT OF DRUG AND MEDICAL DEVICE
-Dacumentation
-Licenses
-Renewal
-E-governance
This presentation includes an brief idea about the pharmacy act 1948 in India and also deals with its the chapter that included in the act.(Education Regulations, PCI, State PCI, Registration of Pharmacist , Approval of Institutions, Offences penalties 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
State pharmacy council and joint state pharmacy council:
Under the Pharmacy Act each Sate Govt. is required to constitute a state pharmacy council for the maintenance of register of Pharmacists of the State and to monitor their professional activities.
Two or more states can also enter into an agreement to form a Joint State Pharmacy Council.
A brief description of history,drugs and cosmetics acts and rules, various drug schedules included in the act and rules, brief description of drug schedules, Recent amendments, etc.
This topic gives the introduction and need of group of laws that were introduced in the profession of pharmacy-under subject -Pharmaceutical Jurisprudence
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.
In ancient India the sources of drugs were of vegetable, animal and mineral origin.(Ayurveda).They were prepared empirically by few experienced persons. Knowledge of that medical system was usually kept secret within a family (Folkore).There were no scientific methods of standardization of drugs.
Pharmaceutical legislation in India, Pharmaceutical LegislationRajkumarKumawat11
Pharmaceutical legislation, Pharmaceutical legislation in India, topic of Pharmaceutical Jurisprudence for pharma students, Chopra committee, DEC, Drug Enquiry Committee, Legislation
Pharmaceutical Legislations – A brief review, Introduction, Study of drugs enquiry committee, Health survey and development committee, Hathi committee and Mudaliar committee
The Roman Empire A Historical Colossus.pdfkaushalkr1407
The Roman Empire, a vast and enduring power, stands as one of history's most remarkable civilizations, leaving an indelible imprint on the world. It emerged from the Roman Republic, transitioning into an imperial powerhouse under the leadership of Augustus Caesar in 27 BCE. This transformation marked the beginning of an era defined by unprecedented territorial expansion, architectural marvels, and profound cultural influence.
The empire's roots lie in the city of Rome, founded, according to legend, by Romulus in 753 BCE. Over centuries, Rome evolved from a small settlement to a formidable republic, characterized by a complex political system with elected officials and checks on power. However, internal strife, class conflicts, and military ambitions paved the way for the end of the Republic. Julius Caesar’s dictatorship and subsequent assassination in 44 BCE created a power vacuum, leading to a civil war. Octavian, later Augustus, emerged victorious, heralding the Roman Empire’s birth.
Under Augustus, the empire experienced the Pax Romana, a 200-year period of relative peace and stability. Augustus reformed the military, established efficient administrative systems, and initiated grand construction projects. The empire's borders expanded, encompassing territories from Britain to Egypt and from Spain to the Euphrates. Roman legions, renowned for their discipline and engineering prowess, secured and maintained these vast territories, building roads, fortifications, and cities that facilitated control and integration.
The Roman Empire’s society was hierarchical, with a rigid class system. At the top were the patricians, wealthy elites who held significant political power. Below them were the plebeians, free citizens with limited political influence, and the vast numbers of slaves who formed the backbone of the economy. The family unit was central, governed by the paterfamilias, the male head who held absolute authority.
Culturally, the Romans were eclectic, absorbing and adapting elements from the civilizations they encountered, particularly the Greeks. Roman art, literature, and philosophy reflected this synthesis, creating a rich cultural tapestry. Latin, the Roman language, became the lingua franca of the Western world, influencing numerous modern languages.
Roman architecture and engineering achievements were monumental. They perfected the arch, vault, and dome, constructing enduring structures like the Colosseum, Pantheon, and aqueducts. These engineering marvels not only showcased Roman ingenuity but also served practical purposes, from public entertainment to water supply.
Francesca Gottschalk - How can education support child empowerment.pptxEduSkills OECD
Francesca Gottschalk from the OECD’s Centre for Educational Research and Innovation presents at the Ask an Expert Webinar: How can education support child empowerment?
How to Make a Field invisible in Odoo 17Celine George
It is possible to hide or invisible some fields in odoo. Commonly using “invisible” attribute in the field definition to invisible the fields. This slide will show how to make a field invisible in odoo 17.
Macroeconomics- Movie Location
This will be used as part of your Personal Professional Portfolio once graded.
Objective:
Prepare a presentation or a paper using research, basic comparative analysis, data organization and application of economic information. You will make an informed assessment of an economic climate outside of the United States to accomplish an entertainment industry objective.
Welcome to TechSoup New Member Orientation and Q&A (May 2024).pdfTechSoup
In this webinar you will learn how your organization can access TechSoup's wide variety of product discount and donation programs. From hardware to software, we'll give you a tour of the tools available to help your nonprofit with productivity, collaboration, financial management, donor tracking, security, and more.
Embracing GenAI - A Strategic ImperativePeter Windle
Artificial Intelligence (AI) technologies such as Generative AI, Image Generators and Large Language Models have had a dramatic impact on teaching, learning and assessment over the past 18 months. The most immediate threat AI posed was to Academic Integrity with Higher Education Institutes (HEIs) focusing their efforts on combating the use of GenAI in assessment. Guidelines were developed for staff and students, policies put in place too. Innovative educators have forged paths in the use of Generative AI for teaching, learning and assessments leading to pockets of transformation springing up across HEIs, often with little or no top-down guidance, support or direction.
This Gasta posits a strategic approach to integrating AI into HEIs to prepare staff, students and the curriculum for an evolving world and workplace. We will highlight the advantages of working with these technologies beyond the realm of teaching, learning and assessment by considering prompt engineering skills, industry impact, curriculum changes, and the need for staff upskilling. In contrast, not engaging strategically with Generative AI poses risks, including falling behind peers, missed opportunities and failing to ensure our graduates remain employable. The rapid evolution of AI technologies necessitates a proactive and strategic approach if we are to remain relevant.
4. PJ (Syllabus) THEORY:50Hours(2Hrs./week)
1.Historical background of Druglegislation in India.
4Hrs
Origin and nature of pharmaceutical legislation in
India, its scope and objectives. Evolution of the
"Concept of pharmacy" as an integral part of the
Health care system.
2.Code of Ethics for Pharmacists. 4Hrs
Principles and significance of professional ethics,
critical study of code of pharmaceutical ethics
drafted by PCI regarding to pharmacist in relation to
his job, to his trade, and to medical profession.
5. 3.Pharmacy Act 1948 6Hrs
Definition, PCI and State Councils, Composition and
Function, Preparation of Registers and qualifications
for entry into registers, Educational Regulation and
Approval of Courses and Institutions, Offences and
Penalties
4.Medicinal and ToiletPreparations(Excise Duties)
Act 1955, Rules 1976. 5Hrs
Definitions, restricted and unrestrictedpreparations,
Manufacturing in bond and outside bond.
6. 5. DrugPrice Control Order 6 hrs
6.Drugsand Magic Remedies (Objectionable
Advertisements)Act 1954. 5 hrs
General study of the Act, objectives , special
reference to be laid on Advertisements,
magic remedies and objections1 and
permitted advertisements -diseases which
cannot be claimed to be cured.
7. 7. Drugs and Cosmetics Act 1940, Rules 1945.
15Hrs
General study of the Drugs and cosmetics Act
and the Rules there under. Definitions and salient
features related to retail and whole sale distribution
of drugs.
The powers of Inspectors, the sampling
procedures and the procedure and formalities in
obtaining licenses under the rule.
Facilities to be provided for running a
pharmacy effectively.
General study of the schedules with special
reference to schedules C,C1,F,G,J,H,P and X and
salient features of labeling and storage conditions of
8. 8.Narcotic Drugs and Psychotropic Substances Act,
and Rules there under 6hrs
Definition, Prohibited and controlled operation,
cultivation of poppy plants, sale of opium, import
and export of narcotics as amended to date,
Offences and corresponding penalties.
9.Poisons Act 1919(as amended to
date) 3hrs
9.Medical termination of pregnancy act 1970 and
rules 1975 4hrs
13. Jurisprudence is the science and the phylosophy of law
PJ in pharmacy is designed to introduce basic elements
of the legal system.
To conduct business
Practice the Profession
Practice of pharmacy becomes more complex and
the legal and ethical liability of the pharmacist
increases.
So for professional man like pharmacist,ignorence
is no excuse for breach of law. Therfore every
pharmacist should have the knowledge of
Pharmaceutical Jurisprudence.
14. Purpose of PJ in pharmacy.
To understand their legal and ethical
responsibilities and thereby to avoid the
pitfalls that lead to litigation.
Serve as a text providing the students
with some insight into the legal aspects of
the practice of his profession.
16. Pharmaceutical legislation ?
Law/ Legislation- Intends to regulate and
control various aspect of social life
Aspects –Social, Economical and Political
legislation.
Pharmaceutical legislation ?
It is mixed legislation, which overlappingly
coversboth social and economic aspects of
the society.
18. Write a note on origin of
pharmaceutical legislation inIndia.
Historyof Pharmaceutical units
Year Name of Founder Name of shop/
Industry
Year of
commencem
e ntof
manufacturing
1811 Mr.Bathgate (East
India Company)
Chemist Shopin
Calcutta
1910
1821 Mr.SmithStainstreet
and Co.
Apothecary Shop 1918
1901 Acharya Praffula
Chandra Ray
(Calcutta)
Bengal Chemicals
and
Pharmaceutical
Works
1903 Prof.T.K Gajjar Factory at Parel
Alembic Chemical works,Baroda
19. Reasonsfor formation of Chopra Committee
1.These units were not sufficient to fulfil the
requirements of IndianPublic.
2.Drugs were imported form UK, Germany and
France.
3.During first world war cheaper drugs were
imported into India, which increased the
demand for indigenousdrugs.
4.Unhealthy competition grew up and Indian
market wasflooded with inferiorquality drugs.
20. 5. Public pressurized
effective legislation to control
government to introduce
import,
manufacture, distribution and sale of drugs.
6. There was no legal and effective control on
pharmacy profession.
7. Hence to have a comprehensive legislation, the
Indian government appointed a ‘ Drug Enquiry
Committee’ under the chairmanship of Lt. Col.
R.N. Chopra in 1931. this was formally known as
DEC Or Chopra Committee.
21. What were the
recommendations of Drug
enquiry Committee
90 RECOMMENDATIONS.
1.Formation of Central Pharmacy Council
andState PharmacyCouncil. (PCI)
2. Creation of Drug Control Machinery.
(DCM)
3.Establishment of well equippedCentral
DrugLaboratory,andState Drug
Laboratory. (CDL)
22. Implementations:-
Due to Second World War in 1939, there
wasdelay in introduction of the legislation.
Government was reluctant to implement
the recommendations of DEC, and the
public waspressurizing the government.
Finally an Import of Drug Bill was
introduced in 1937.
This bill dealt with only import of drugs and
manufacturing and sale of drugs was not
included.
23. Scope and objective
1. Drug bill was introduced in 1940 in legislative assembly,
and Drug Bill 1940 was passed, which came to force in
1947. since then drug act was amended many times
and at present it covers the provisions related to
Drugs, Cosmetics, Ayurvedic, including Unani
and Homeopathic medicines.
24. The present Drug and Cosmetic Act is an
improved version of the Drug Act, 1940.
the main objective of this act was to
regulate the import, manufacture,
distribution and sale of drugs and cosmetics
in India.
The Central Government made several
rules entitled the Drug and Cosmetic
Rules 1945. These act and rules were
amended from time to time
25. 2. The Pharmacy act 1948 was passed with
the main objective to regulate the profession of
Pharmacy in India.
3. In 1954 the Drug and Magic Remedies
Act was passed with the main aim to control
certain types of advertisements related to drug
and to prohibit certain types of advertisements
related to magic remedies.
4. Medicinal and Toilet Preparations
(Excise duty) Act, 1955 was passed providing
for the levy and collection of duties of excise on
medicinal and toilet preparations containing
alcohol, opium Indian hemp or other narcotic
drugs.
26. 5 . The Drugs Prices control order 1987
was passed with the main objective to regulate
the fair price of medicine in India.
6. In 1985 Narcotic Drugs & Psychotopic
Substance Act, was passed. The main
objective of this act was to consolidate and
amend the laws relating to narcotic drugs and
Psychotropic substance.
27. Other acts includedwere:-
Prevention of food Adulteration act,1954 and rules.
TheIndustries (Development and Regulations)Act,1951.
TheIndustrial Employment (Standing order) Act 1946 and
rules.
Industrial DisputeAct,1947.
FactoryAct, 1948.
TheIndian Patent and DesignAct 1970.
TheTrade and Merchandise Mark, 1958.
TheEpidemic DiseaseAct, 1897.
Shopsand Establishment acts of respective states.
28. Frequently asked questions.
1. What is the objective of
Pharmaceutical Legislation in India?
2. Write a note on origin/
Pharmaceutical Legislation inIndia.
3. What were the recommendations
of Drug Enquiry Committee?
4. Write a short note on scope and objectives
of Pharmaceutical Legislation inIndia.
29. WHATYOUHAVELEARNINTHISCHAPTOR
1. Definations- Pharmaceutical Jurisprudence,
legislation, Pharmaceutical Legislation.
2.Origin/ History of Ph legislation in india.
3. Reasons for formation of Chopra Committee
4. Recomendations of Chopra Committee.
5. Implementations
6. Scope and objective
