History, Objectives, Various Definitions, The Pharmacy Council of India (PCI), Functions and duties of PCI, State Pharmacy Council, Functions of The State PharmacyCouncils, Joint State Pharmacy Council, Offences and penalties and List of amending Acts and adaptation orders.
A pharmacist should never disclose any information which he has acquired during his professional activities to any third party or person unless required by law to do so. He should never betray the confidence which his patrons repose in him or which he has won by virtue of his eminent character and conduct.
Medicinal and toilet preparations act and rules,1955Ganesh Shevalkar
It is an Act with provision for levy and collection of excise duties on medicinal and toilet preparations containing alcohol, opium, Indian hemp (cannabis) or other narcotic drugs.
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.
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.
A pharmacist should never disclose any information which he has acquired during his professional activities to any third party or person unless required by law to do so. He should never betray the confidence which his patrons repose in him or which he has won by virtue of his eminent character and conduct.
Medicinal and toilet preparations act and rules,1955Ganesh Shevalkar
It is an Act with provision for levy and collection of excise duties on medicinal and toilet preparations containing alcohol, opium, Indian hemp (cannabis) or other narcotic drugs.
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.
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.
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.
objective, definition, IAEC, CPCSEA guidelines for breeding & stocking of animals, transfer of acquisition of animals for expt., power to suspect or revoke registration, offences & penalties.
The prevention of cruelty to animals act 1960Shaik Rasheed
This presentation give the complete information regarding the The Prevention of Cruelty to Animals Act 1960 including the definitions, composition of IAEC, Breeding and stocking of animals, experiments, offences and penalties.
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 Drugs and Cosmetics Act, 1940 is an Act of the Parliament of India which regulates the import, manufacture and distribution of drugs in India. The primary objective of the act is to ensure that the drugs and cosmetics sold in India are safe, effective and conform to state quality standards.
This presentation is related to the drug price control order in India. It will give an idea to the readers how the prices have been fixed for the formulations. How the price has been calculated for scheduled formulations.
Non bonded Laboratory
It means the premises or any part of the premises approved & licensed for the manufacture & storage of medicinal & toilet preparations containing alcohol, opium, Indian hemp & other narcotic drugs or narcotics on which duty has been paid.
Introduction to D & C Act 1940 and Rules 1945, Definitions, Various Schedules in D & C Rules 1945, Administration of the act and rules, Manufacturing , Distribution and sale of drug and cosmetic, Labeling and Packing of drug and cosmetic.
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.
objective, definition, IAEC, CPCSEA guidelines for breeding & stocking of animals, transfer of acquisition of animals for expt., power to suspect or revoke registration, offences & penalties.
The prevention of cruelty to animals act 1960Shaik Rasheed
This presentation give the complete information regarding the The Prevention of Cruelty to Animals Act 1960 including the definitions, composition of IAEC, Breeding and stocking of animals, experiments, offences and penalties.
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 Drugs and Cosmetics Act, 1940 is an Act of the Parliament of India which regulates the import, manufacture and distribution of drugs in India. The primary objective of the act is to ensure that the drugs and cosmetics sold in India are safe, effective and conform to state quality standards.
This presentation is related to the drug price control order in India. It will give an idea to the readers how the prices have been fixed for the formulations. How the price has been calculated for scheduled formulations.
Non bonded Laboratory
It means the premises or any part of the premises approved & licensed for the manufacture & storage of medicinal & toilet preparations containing alcohol, opium, Indian hemp & other narcotic drugs or narcotics on which duty has been paid.
Introduction to D & C Act 1940 and Rules 1945, Definitions, Various Schedules in D & C Rules 1945, Administration of the act and rules, Manufacturing , Distribution and sale of drug and cosmetic, Labeling and Packing of drug and cosmetic.
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: Objectives, Definitions, Pharmacy Council of India; its constitution and functions, Education Regulations, State and Joint state pharmacy councils; its constitution and functions, Registration of Pharmacists, Offences
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.
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
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:—
Indian Regulatory Requirements: Central Drugs Standard Control Organization (CDSCO). The Central Drugs Standard Control Organization (CDSCO) under Directorate General of Health Services, Ministry of Health & Family Welfare, Government of India is the National Regulatory Authority (NRA) of India. The Drugs & Cosmetics Act,1940 and rules 1945 have entrusted various responsibilities to central & state regulators for regulation of drugs & cosmetics. Vision:
To Protect and Promote public health in India.
Mission:
To safeguard and enhance the public health by assuring the safety, efficacy and quality of drugs, cosmetics and medical devices. Functions of CDSCO
Certificate of Pharmaceutical Product (COPP): The certificate of pharmaceutical product (abbreviated: CPP) is a certificate issued in the format recommended by the World Health Organization (WHO).
COPP establishes the status of the pharmaceutical product and of the applicant for this certificate in the exporting country.
It is often mentioned in conjunction with the electronic Common Technical Document (eCTD). The Certificate of a Pharmaceutical Product is needed by the importing country when the product in question is intended for registration (licensing, authorization) or renewal (prolongation) of registration, with the scope of commercialization or distribution in that country. The Certificate of a Pharmaceutical Product is needed by the importing country when the product in question is intended for registration (licensing, authorization) or renewal (prolongation) of registration, with the scope of commercialization or distribution in that country.
COPP Importance: It is needed by the importing country when the product in question is infected for Registration (Licensing and Authorization) or renewal of registration.
With the scope of commercialization or distribution in that country.
Certification has been recommended by WHO to help undersized drug regulatory authorities or drug regulatory authorities without proper quality assurance facilities in importing countries to assess the quality of pharmaceutical products as a prerequisite of registration or importation. General Requirements for Submission of Application for Issue of COPP. Documents Required for Applying for Grating or
Revalidation of COPPS:
Application from the manufacturer.
Site master file (as specified under WHO TRS 823).
Cost of manufacturing license.
List of approved products.
List of products applied for issuance of COPPS.
List of SOPs and STPs.
Stability data (3 batches) accelerated/Real-time.
List of equipments and instruments.
List of technical staff, their qualification, and experience, and approval status.
Manufacturing layout plan.
Process validation for 3 batches of each product.
Schematic diagram of water system specifying circulation loop and MOC (Material of construction).
Schematic diagram of HVAC system specifying terminal filter configuration. Export data of the last 2 years in case of revalidation.
Flow chart
Regulatory Affairs (RA), also called Government Affairs, is a profession within regulated industries, such as pharmaceuticals, medical devices, energy and banking.
Regulatory Affairs (RA), also called Government Affairs, is a profession within regulated industries, such as pharmaceuticals, medical devices, energy and banking.
History of regulatory affair. Various Regulatory Authority. Role of Regulatory Affairs Department.
Pre-clinical or Non- clinical phase of drug development . Investigational New Drug Application (IND) Importance of IND. Investigator’s Brochure (IB). The Investigator’s Brochure (IB) is a compilation of the clinical and nonclinical data on the investigational product(s) that are relevant to the study of the product(s) in human subjects. A complete and thorough investigator’s brochure should include the following: Title Page
I. A] Confidentiality Statement
II. Contents of the Investigator’s Brochure
II. A] Table of Contents
II. B] Summary
II. C] Introduction
II. D] Physical, Chemical, and Pharmaceutical Properties and
Formulation
II. E] Nonclinical Studies
II. F] Effects in Humans
II. G] Summary of Data and Guidance for the Investigator. Contents of the Investigator’s Brochure: II. A] Table of Contents
II. B] Summary:
Not longer than 2 pages.
Highlighting significant physical, chemical, pharmaceutical, pharmacological, toxicological, pharmacokinetic, metabolic and clinical information available that is relevant to the state of clinical development of the investigational product. II. D] Physical, Chemical, and Pharmaceutical Properties
and Formulation:
A description of the investigational product substances including the chemical and or structural formulae and the brief summary of the relevant physical, chemical and pharmaceutical properties.
For safety measures, a description of the formulations to be used including excipients (a substance formulated with the active ingredient of a medication) should be provided and justified if clinically relevant.
Instructions for the storage and handling of the dosage should be provided.
Structural similarities to other known compounds should be mentioned. Pharmacokinetics and Product Metabolism in Humans
A summary of information on the pharmacokinetics of the investigational product(s) should be presented, including the following, if available:
Pharmacokinetics (including metabolism, as appropriate, and absorption, plasma protein binding, distribution and elimination).
Bioavailability of the investigational product (absolute, where possible, and/or relative) using a reference dosage form.
Population subgroups (e.g. gender, age, and impaired organ function).
Interactions (e.g. product-product interactions and effects of food).
Other pharmacokinetic data (e.g. results of population studies performed within clinical trial(s). . Marketing Experience
The Investigator’s Brochure should identify countries where the investigational product has been approved.
technology transfer documents confidentiality agreements, licensing, mous.pdfDr. Ambekar Abdul Wahid
A confidentiality agreement also called a nondisclosure agreement or NDA.
It is a legally binding contract in which a person or business promises to treat specific information as a trade secret and promises not to disclose the secret to others without proper authorization.
Licensing is one of those terms that are used quite frequently and hold high importance.
Licensing can be defined as a contract or agreement between two companies, where one company permits another company to manufacture its products under specified conditions and for a specified payment. Different types of licensing
The Asian and Pacific Centre for Transfer of Technology (APCTT) is a regional institution of the United Nations Economic and Social Commission for Asia and the Pacific (ESCAP) servicing the Asia-Pacific region.
The National Research Development Corporation (NRDC) was a non departmental government body established by the British Government to transfer technology from the public sector to the private sector.
TIFAC is an autonomous organization set up in 1988 under the Department of Science & Technology to look ahead in technology domain, assess the technology trajectories, and support innovation by networked actions in select areas of national importance.
Biotech Consortium India Limited (BCIL) is a public limited company, promoted by the Department of Biotechnology (DBT), Ministry of Science and Technology, Government of India and set up by All India Financial Institutions including IDBI, ICICI, IFCI, UTI and IFCI Venture Capital Funds Limited.
A platform is a group of technologies that are used as a base
or infrastructure upon which other applications, technologies
or processes are developed for the end-user.
“a common or standard method, equipment, procedure or work practice that may be applied to the research, development or manufacturing of different products ” An array of multi-disciplinary technologies covering major aspects of the drug discovery and development processes have been established in Institute of Biotechnology and Pharmaceutical Research (IBPR)
PILOT PLANT SCALE- UP TECHNIQUE
Plant, Pilot Plant, Scale-up, Objective, Significance, Steps in scale up, General considerations, Master Manufacturing Procedures, GMP consideration.
Granularity of Technology Transfer Process, Documentation, Premises and equipment Qualification and Validation. Premises and equipments. Quality control: Analytical Method Transfer. Qualification and Validation
Role of IT in Pharma Industry, Role of Pharm Industry in Indian GDP, Role of Engineers in Pharmaceutical Industry, PHARMACY INFORMATICS, Importance in Pharma Industry, Pharmacy management software, Computerized Physician Order Entry (CPOE), Bar-coded medication administration, Enterprise Resource Planning (ERP), Laboratory Information Management System (LIMS), Customer Relationship Management (CRM), Sales Force Automation (SFA) Software, Electronic Batch Records (EBR) Software
Some of the software use in pharmaceuticals Research & Development, Virtual Labs.
Drug and magic remedies (objectionable advertisement) act 1954 and rules 1955Dr. Ambekar Abdul Wahid
Definitions, Class of Prohibitions Advertisement - Section 3, Classes of exempted advertisements, Powers of entry, search etc., Offenses and penalties, Scrutiny of misleading advertisements relating to drugs, Manner in which advertisements may be sent confidentially, Case Studies.
Brief History, Objectives, Various Definitions, Authorities and officers, The Narcotic Drugs and Psychotropic Substances Consultative Committee, National Fund for Control of Drug Abuse, Prohibition, Control And Regulation, Power to control and regulate controlled substances and Offences and Penalties, small quantity and a commercial quantity for some popular drugs and Amendments.
National Pharmaceutical Pricing Authority (NPPA) & Drug Price Control Order (...Dr. Ambekar Abdul Wahid
Introduction to NPPA, The Drug Regulatory System in India, NPPA Activities and Responsibility's, Function and Organization of NPPA, Introduction to DPCO 2013, Salient features of DPCO 2013, Prices of Bulk Drug, Retail price of Formulations, Pricing of Scheduled Formulations, Various Schedules related to DPCO Act and Amendments.
The presentation is about the basics of Sprayer dryer, its design, types of systems, process stages, Schematic representation of spray drying mechanism, and its application.
These lecture slides, by Dr Sidra Arshad, offer a quick overview of physiological basis of a normal electrocardiogram.
Learning objectives:
1. Define an electrocardiogram (ECG) and electrocardiography
2. Describe how dipoles generated by the heart produce the waveforms of the ECG
3. Describe the components of a normal electrocardiogram of a typical bipolar leads (limb II)
4. Differentiate between intervals and segments
5. Enlist some common indications for obtaining an ECG
Study Resources:
1. Chapter 11, Guyton and Hall Textbook of Medical Physiology, 14th edition
2. Chapter 9, Human Physiology - From Cells to Systems, Lauralee Sherwood, 9th edition
3. Chapter 29, Ganong’s Review of Medical Physiology, 26th edition
4. Electrocardiogram, StatPearls - https://www.ncbi.nlm.nih.gov/books/NBK549803/
5. ECG in Medical Practice by ABM Abdullah, 4th edition
6. ECG Basics, http://www.nataliescasebook.com/tag/e-c-g-basics
Title: Sense of Taste
Presenter: Dr. Faiza, Assistant Professor of Physiology
Qualifications:
MBBS (Best Graduate, AIMC Lahore)
FCPS Physiology
ICMT, CHPE, DHPE (STMU)
MPH (GC University, Faisalabad)
MBA (Virtual University of Pakistan)
Learning Objectives:
Describe the structure and function of taste buds.
Describe the relationship between the taste threshold and taste index of common substances.
Explain the chemical basis and signal transduction of taste perception for each type of primary taste sensation.
Recognize different abnormalities of taste perception and their causes.
Key Topics:
Significance of Taste Sensation:
Differentiation between pleasant and harmful food
Influence on behavior
Selection of food based on metabolic needs
Receptors of Taste:
Taste buds on the tongue
Influence of sense of smell, texture of food, and pain stimulation (e.g., by pepper)
Primary and Secondary Taste Sensations:
Primary taste sensations: Sweet, Sour, Salty, Bitter, Umami
Chemical basis and signal transduction mechanisms for each taste
Taste Threshold and Index:
Taste threshold values for Sweet (sucrose), Salty (NaCl), Sour (HCl), and Bitter (Quinine)
Taste index relationship: Inversely proportional to taste threshold
Taste Blindness:
Inability to taste certain substances, particularly thiourea compounds
Example: Phenylthiocarbamide
Structure and Function of Taste Buds:
Composition: Epithelial cells, Sustentacular/Supporting cells, Taste cells, Basal cells
Features: Taste pores, Taste hairs/microvilli, and Taste nerve fibers
Location of Taste Buds:
Found in papillae of the tongue (Fungiform, Circumvallate, Foliate)
Also present on the palate, tonsillar pillars, epiglottis, and proximal esophagus
Mechanism of Taste Stimulation:
Interaction of taste substances with receptors on microvilli
Signal transduction pathways for Umami, Sweet, Bitter, Sour, and Salty tastes
Taste Sensitivity and Adaptation:
Decrease in sensitivity with age
Rapid adaptation of taste sensation
Role of Saliva in Taste:
Dissolution of tastants to reach receptors
Washing away the stimulus
Taste Preferences and Aversions:
Mechanisms behind taste preference and aversion
Influence of receptors and neural pathways
Impact of Sensory Nerve Damage:
Degeneration of taste buds if the sensory nerve fiber is cut
Abnormalities of Taste Detection:
Conditions: Ageusia, Hypogeusia, Dysgeusia (parageusia)
Causes: Nerve damage, neurological disorders, infections, poor oral hygiene, adverse drug effects, deficiencies, aging, tobacco use, altered neurotransmitter levels
Neurotransmitters and Taste Threshold:
Effects of serotonin (5-HT) and norepinephrine (NE) on taste sensitivity
Supertasters:
25% of the population with heightened sensitivity to taste, especially bitterness
Increased number of fungiform papillae
ARTIFICIAL INTELLIGENCE IN HEALTHCARE.pdfAnujkumaranit
Artificial intelligence (AI) refers to the simulation of human intelligence processes by machines, especially computer systems. It encompasses tasks such as learning, reasoning, problem-solving, perception, and language understanding. AI technologies are revolutionizing various fields, from healthcare to finance, by enabling machines to perform tasks that typically require human intelligence.
MANAGEMENT OF ATRIOVENTRICULAR CONDUCTION BLOCK.pdfJim Jacob Roy
Cardiac conduction defects can occur due to various causes.
Atrioventricular conduction blocks ( AV blocks ) are classified into 3 types.
This document describes the acute management of AV block.
Anti ulcer drugs and their Advance pharmacology ||
Anti-ulcer drugs are medications used to prevent and treat ulcers in the stomach and upper part of the small intestine (duodenal ulcers). These ulcers are often caused by an imbalance between stomach acid and the mucosal lining, which protects the stomach lining.
||Scope: Overview of various classes of anti-ulcer drugs, their mechanisms of action, indications, side effects, and clinical considerations.
TEST BANK for Operations Management, 14th Edition by William J. Stevenson, Ve...kevinkariuki227
TEST BANK for Operations Management, 14th Edition by William J. Stevenson, Verified Chapters 1 - 19, Complete Newest Version.pdf
TEST BANK for Operations Management, 14th Edition by William J. Stevenson, Verified Chapters 1 - 19, Complete Newest Version.pdf
Flu Vaccine Alert in Bangalore Karnatakaaddon Scans
As flu season approaches, health officials in Bangalore, Karnataka, are urging residents to get their flu vaccinations. The seasonal flu, while common, can lead to severe health complications, particularly for vulnerable populations such as young children, the elderly, and those with underlying health conditions.
Dr. Vidisha Kumari, a leading epidemiologist in Bangalore, emphasizes the importance of getting vaccinated. "The flu vaccine is our best defense against the influenza virus. It not only protects individuals but also helps prevent the spread of the virus in our communities," he says.
This year, the flu season is expected to coincide with a potential increase in other respiratory illnesses. The Karnataka Health Department has launched an awareness campaign highlighting the significance of flu vaccinations. They have set up multiple vaccination centers across Bangalore, making it convenient for residents to receive their shots.
To encourage widespread vaccination, the government is also collaborating with local schools, workplaces, and community centers to facilitate vaccination drives. Special attention is being given to ensuring that the vaccine is accessible to all, including marginalized communities who may have limited access to healthcare.
Residents are reminded that the flu vaccine is safe and effective. Common side effects are mild and may include soreness at the injection site, mild fever, or muscle aches. These side effects are generally short-lived and far less severe than the flu itself.
Healthcare providers are also stressing the importance of continuing COVID-19 precautions. Wearing masks, practicing good hand hygiene, and maintaining social distancing are still crucial, especially in crowded places.
Protect yourself and your loved ones by getting vaccinated. Together, we can help keep Bangalore healthy and safe this flu season. For more information on vaccination centers and schedules, residents can visit the Karnataka Health Department’s official website or follow their social media pages.
Stay informed, stay safe, and get your flu shot today!
Surgical Site Infections, pathophysiology, and prevention.pptx
The Pharmacy act 1948
1. The Pharmacy Act 1948
Dr. Ambekar Abdul Wahid
M. Pharm, Ph.D
Department of Pharmaceutics
Dr. Vithalrao Vikhe Patil Foundation’s
College of Pharmacy
Vadgaon Gupta (Vilad Ghat) PO MIDC
Ahmednagar (MS), India
E-mail: wahidambekar@gmail.com
1
2. History
In India there was no any restriction to practice the
profession of pharmacy.
Hundred of case were found by government wherein the
compounding, mixing or dispensing of medicines was
being done by persons who were not adequately educated
in this line.
These causing great harm to the health of people.
It was found necessary to enact a law for the regulation of
the profession and practice of pharmacy.
An act was promulgated in 1948 entitled the pharmacy act
1948.
3. OBJECTIVE
To regulate the pharmacy education in the country for the
purpose of registration as a pharmacist under the
pharmacy act.
Providing uniform education and training to the person
willing to enter the Profession of Pharmacy
Maintaining control over the persons entering the
Profession Pharmacy
4. Definitions
“Pharmacy Act”: An act to regulate the profession of
pharmacy.
“Registered Pharmacist”: A person whose name is for
the time being entered in the register of the state in which
he or she is for the time being residing or carrying on his
profession or business of pharmacy.
5. “Agreement" means an agreement entered into under
section 20
“Approved" means approved by the Central Council under
section 12 or section 14
"Central Council" means the Pharmacy Council of India
constituted under section 3
"Central Register" means the register of pharmacists
maintained by the Central Council under section 15 A
Definitions (Continue…)
6. "Executive Committee" means the Executive Committee
of the Central Council or of the State Council, as the
context may require;
"Indian University" means a University within the
meaning of section 3 of the University Grants Commission
Act, 1956, (3 of 1956) and includes such other institutions,
being institutions established by or under a Central Act, as
the Central Government may, by notification in the Official
Gazette, specify in this behalf;]
Definitions (Continue…)
7. “Medical practitioner" means a person:
i. Holding a qualification granted by an authority specified
or notified under section 3 of the Indian Medical Degrees
Act, 1916 (7 of 1916), or specified in the Schedules to the
Indian Medical Council Act, 1956 (102 of 1956); or
ii. Registered or eligible for registration in a medical register
of a State meant for the registration of persons practising
the modern scientific system of medicine; or
Definitions (Continue…)
8. iii. Registered in a medical register of a State, who, although not
falling within sub-clause (i) or sub-clause (ii) is declared by a
general or special order made by the State Government in
this behalf as a person practising the modern scientific
system of medicine for the purposes of this Act; or
iv. Registered or eligible for registration in the register of
dentists for a State under the Dentists Act, 1948 (16 of
1948); or
v. Who is engaged in the practise of veterinary medicine and
who possesses qualifications approved by the State
Government.
Definitions (Continue…)
9. "State Council" means a State Council of Pharmacy
constituted under section 19, and includes a Joint State
Council of Pharmacy constituted in accordance with an
agreement under section 20
"University Grants Commission" means the University
Grants Commission established under section 4 of the
University Grants Commission Act, 1956 (3 of 1956).
Definitions (Continue…)
10. The Pharmacy Council of India (PCI)
The PCI was first constituted in the year 1949.
Reconstituted every 5 years.
Composition:
A. Elected members
B. Nominated members
C. Ex-officio members
11. A. Elected members:
a) 6 members (teachers), elected by University Grant
Commission (UGC).
There is at least one teacher of each of the pharmacy,
pharmaceutical chemistry, pharmacognosy and
pharmacology.
b) One member, elected by Medical Council of India.
c) One member, elected by State Council, who shall be a
registered pharmacist.
The Pharmacy Council of India
12. B. Nominated members:
a) 6 member, nominated by the Central Government of whom
at least 4 shall be persons possessing a degree or diploma in,
and practicing pharmacy, or pharmaceutical chemistry.
b) A representative of the U.G.C. and a representative of the
All India Council for Technical Education (A.I.C.T.E.)
c) One member nominated by each State Government who
shall be a registered pharmacist.
The Pharmacy Council of India
13. C. Ex-Officio Members:
a) The Director general of Health Services.
b) The Director of Central Drug Laboratory.
c) The Drug controller of India.
The Pharmacy Council of India
14. Executive Committee Consisting of:
President
Vice – President
(President and Vice – President of Central Council shall be
elected by the members of the Council from themselves.)
Five members elected by Central Council from it’s
members.
The Pharmacy Council of India
15. The Council shall appoint:
A Registrar act as a secretary.
Other officer and servants.
The elected and nominated members of the council hold
office for a period of 5 years, but they can resign their
membership at any time, by writing to the president of the
council.
All members are eligible for re-election of re-nomination.
The Pharmacy Council of India
16. Functions and duties:
A. Design of the educational pattern:
To frame an educational structure for the would be
pharmacist and to keep it tuned to the changing needs
with passage of time .
The standards of education for pharmacist framed by the
council are known as the Educational Regulations and
amongst other things prescribe. As-
a. Minimum qualification for admission to the course.
The Pharmacy Council of India
17. b) Duration of the training and the course of study to be
covered.
c) Equipments and facilities to be provided by the
institutions.
d) Giving practical training.
e) Holding approved examinations.
(After the formation of the state councils the State
Government were supposed to publicize the Education
Regulations in the States in consultation with the respective
State Pharmacy Council.)
The Pharmacy Council of India
Functions and duties (Continue…)
18. B. Approval of Institutions/withdrawal of approvals:
An institution or authority, which conducts a course of study
or hold an examination for the pharmacists, has to apply to
the Pharmacy Council of India for approval of the course or
the examination.
The council may depute its inspectors to visit the institution
to check whether the prescribed facilities for imparting
training or holding examinations are in accordance with the
Education Regulations or not.
The Pharmacy Council of India
Functions and duties (Continue…)
19. It may also require inspectors to attend any examination, to
judge its standard without interfering with its conduct.
The Inspectors then report to the council.
If on the report of the Inspector, the council is satisfied then
it gives approval to it and then the said course or
examination shall be deemed to be approved for qualifying
for registration as pharmacist under the act.
If any approved course of study or examination does not
continue to be in conformity with the Education
Regulations, then the council withdraw the approval.
The Pharmacy Council of India
Functions and duties (Continue…)
20. C. Maintenance of Central Register of Pharmacists:
Under the provision of the pharmacy (Amendment) Act
1976, the Pharmacy Council of India is required to
maintain a register containing names of all persons
registered as pharmacists in different states.
This register has to maintained by the registrar of the
Council and has to be revised suitably from time to time
and published in the Gazette of India.
The Pharmacy Council of India
Functions and duties (Continue…)
21. State Pharmacy Council
It also consists of three different types of members: Elected,
nominated and ex-officio.
A. Elected members:
Six members, elected from amongst themselves by
registered pharmacist of the state.
One member elected from amongst themselves by the
member of each Medical Council of the State.
22. B. Nominated members:
Five members, of whom at least three shall be possessing a
degree or diploma in pharmacy or pharmaceutical chemistry
or to be registered pharmacists, nominated by the state
government.
C. Ex-Officio Members:
Chief administrative medical officer of the state.
Government Analyst nominated by state government
under the drug and cosmetic act 1940.
Officer in charge of drugs control organization of the
state.
State Pharmacy Council
23. Where two or more States enter into an agreement to form
a joint State Pharmacy Council :
Registered pharmacist – 3 to 5 from each state instead of 6
in the single State Council.
Government Nominees – 2 to 4 from each State instead of 5.
Medical Council Nominee – one from each State.
Chief Administrative Medical Officer, Government Analyst
and Officer in–charge, Drug Control - Ex-officio from each
state.
24. Each Council shall have a president and vice-president,
elected by the members from amongst themselves
provided that for five years from the first constitution of the
council.
The president will be nominated by the State Government
and if he is not already a member, he becomes a member
of the council in addition.
The State Council are, before the end of June in each year,
required to pay to the PCI a sum of equivalent to one-
fourth of the fees.
Where two or more States enter into an agreement to
form a joint State Pharmacy Council :
25. Functions of The State Pharmacy
Councils
A. Maintenance of registers:
The Register shall include the following particulars
namely-
The full name and residential address of the registered
person.
The date of his/her first admission to the register.
His/her qualifications for registration.
His professional address, and if he is employed by any
person, the name of such person.
26. Entry and Removal of Names:
After an appointed date, all applications for registration
should be addressed to the registrar of the State Pharmacy
Council.
The applicant has the requisite qualifications for registration,
he may direct his or her name to be entered in the register.
Person whose names have been removed from the registers of
other State shall not be entitled to registration unless the
State Council gives its consent thereto.
Functions of The State Pharmacy
Councils
27. Upon entry of the name of person in the register, the
Registrar is required to issue to him a certificate of
registration in the prescribed form.
On payment of the fees, the registrar is required to issue a
receipt thereof and such receipts are deemed to be proofs of
renewal of registration.
Functions of the state pharmacy
councils
28. Removal of name from the register:
The name of a pharmacist may be removed from the register
on following counts:
If his name has been entered in register by error.
If he has been convicted of an offence in any professional.
Any pharmacist ,who is held guilty and whose name has
been removed from register, shall continue to remain a
registered pharmacist for the next three months and only
after the expiry of that period he shall cease to be a
registered pharmacist.
Functions of the state pharmacy
councils
29. A person aggrieved by the order directing the removal of
his name, may appeal to the State Government within 80
days whose decision shall be final.
A person whose name has been removed from the
register, is required to surrender his certificate of
registration to the registrar of the Pharmacy Council
concerned.
If it feels that the offence was a minor nature, it may warn
the pharmacist and stop the consideration of his case for
a specified period, during which the pharmacist should
prove himself to be of good behavior.
Functions of the state pharmacy
councils
30. But in cases of serious professional neglect or criminal
conviction, his name may be removed.
Pharmacist can, however appeal to the high court against
the decision of Statutory Committee.
Functions of the state pharmacy
councils
31. Printing of Registers
The Register of the State Pharmacy Council were required
to publish the Registers on the first April following the
beginning of the Pharmacy (Amendment) Act.
Later on, each year after the first of April, they were to
publish supplements to the Registers showing all additions
or changing.
These Registers and supplements are deemed to be proof
that the persons, whose name are contained therein, are
registered pharmacist.
32. Inspection by State Council
The State Pharmacy Council have been empowered to
appoint suitable number of Inspectors having prescribed
qualifications to inspect premises where drugs are
dispensed or compounded.
33. Renewal Fees
The state govt. by notification in the official gazette, direct
that for the retention of the name in the register.
In order to retain the name in the register, renewal fee shall
be paid to the state government as may be prescribed.
Where a renewal fee is not paid by the due date, the
Registrar shall remove the name of the defaulter from the
register.
On payment of the renewal fee, the Registrar shall [issue a
receipt there for and such receipt shall be proof of renewal
of registration].
34. Offences and penalties
Offences Penalties
Falsely claims to be a
registered pharmacist.
• Fine up to Rs.500.00 on
first conviction.
• Fine up to Rs.1000.00 and
or 6 months imprisonment
of any subsequent
conviction.
Dispensing by an
unregistered Person
• 6 months of imprisonment
or a fine of up to Rs1000
or both.
Failure to surrender the
certificate of registration
• Fine of Rs.50
Obstruction of state
pharmacy council
inspectors
• Imprisonment of up to 6
months or a fine up to
Rs1000 or both.
35. List of amending Acts and
adaptation orders
1. The Adaptation of Laws Order, 1950.
2. The Adaptation of Laws (No.3) Order, 1956.
3. The Pharmacy (Amendment) Act, 1959 (24 of 1959)
4. The Pharmacy (Amendment) Act, 1976 (70 of 1976)
5. The Pharmacy (Amendment) Act, 1982 (22 of 1982)
6. The Delegated Legislation Provisions (Amendment) Act,
1985 (4 of 1986).
36. References
1. Pharmaceutical Jurisprudence. Agarwal S.B. Tata
Publishers
2. A text book of forensic pharmacy by N.K Jain.
Vallabh Prakashan.
3. Handbook of drug law by M. L. Mehra.
4. Forensic pharmacy, 9th edition. Nirali Prakashan by
Kuchekar B.S.
5. Pharmaceutical regulatory affairs by Subrahmanyam
C.V.S and Thimma Setty J. Vallabh Prakashan.