The document discusses several regulatory agencies that oversee medicines and medical devices. The United States Food and Drug Administration (USFDA) regulates food, drugs, cosmetics, and medical devices in the US. The Medicines and Healthcare products Regulatory Agency (MHRA) regulates medicines and medical devices in the UK. The Central Drugs Standard Control Organization (CDSCO) regulates drugs and cosmetics in India under the Ministry of Health and Family Welfare. Each agency is responsible for ensuring the safety and efficacy of products under its purview.
This presentation gives a brief knowledge of CIOMS, its history, missions and collaborations of CIOMS. This presentation also contains CIOMS organizational structure, detailed knowledge of CIOMS Former and Present Working Groups. This will also guide about CIOMS form, its reporting and details to be filled while reporting an ADR.
Anatomic Therapeutic Chemical Classification, Defined daily dose, Drug utilis...Dr.Amreen Saba Attariya
detailed information about Anatomic Therapeutic Chemical Classification, Defined daily dose, Drug utilisation, DU90%, WHO Collaborting Centre for drug statistic methodology, DDD/1000inhabitants/day, DDD/100beddays, DDD/1000inhabitants/year, Pediatric DDD, ATC & DDD in drug utilisation research, Electronic Prescribing, Guidelines for ATC classification & DDD assignment 2016
This presentation gives a brief knowledge of CIOMS, its history, missions and collaborations of CIOMS. This presentation also contains CIOMS organizational structure, detailed knowledge of CIOMS Former and Present Working Groups. This will also guide about CIOMS form, its reporting and details to be filled while reporting an ADR.
Anatomic Therapeutic Chemical Classification, Defined daily dose, Drug utilis...Dr.Amreen Saba Attariya
detailed information about Anatomic Therapeutic Chemical Classification, Defined daily dose, Drug utilisation, DU90%, WHO Collaborting Centre for drug statistic methodology, DDD/1000inhabitants/day, DDD/100beddays, DDD/1000inhabitants/year, Pediatric DDD, ATC & DDD in drug utilisation research, Electronic Prescribing, Guidelines for ATC classification & DDD assignment 2016
Anatomical Therapeutic Chemical Classification System and Defined Daily Doses...Balwant Meshram
The Anatomical Therapeutic Chemical (ATC) classification system and the Defined Daily Dose (DDD) is the WHO recommended measuring unit which is being used for drug utilization studies. This system is internationally accepted and the users are also increasing. While measuring the drug use, the classification system and unit of measurement, both are important.
Organization and objectives of ICH, expedited reporting, ICSR, PSURs, post approval expedited reporting, pharmacovigilance Planning, good clinical practices
- Whilst the realization of the CTD took many years, there is now a common format for the submission of Marketing Authorizations Applications across the three ICH regions - Europe, Japan and the USA.
- This should facilitate pharmaceutical companies to make simultaneous filings in the ICH regions as it will eliminate the extensive work previously required to convert, for example, a US dossier to an EU dossier and vice versa.
Anatomical Therapeutic Chemical Classification System and Defined Daily Doses...Balwant Meshram
The Anatomical Therapeutic Chemical (ATC) classification system and the Defined Daily Dose (DDD) is the WHO recommended measuring unit which is being used for drug utilization studies. This system is internationally accepted and the users are also increasing. While measuring the drug use, the classification system and unit of measurement, both are important.
Organization and objectives of ICH, expedited reporting, ICSR, PSURs, post approval expedited reporting, pharmacovigilance Planning, good clinical practices
- Whilst the realization of the CTD took many years, there is now a common format for the submission of Marketing Authorizations Applications across the three ICH regions - Europe, Japan and the USA.
- This should facilitate pharmaceutical companies to make simultaneous filings in the ICH regions as it will eliminate the extensive work previously required to convert, for example, a US dossier to an EU dossier and vice versa.
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Differences between Verification, Calibration and Validation
Dr. Deepak
December 8, 2017
7 Comments
Data Scrutiny is important before reporting
Data Scrutiny is important before reporting
You have perhaps come across these terms in laboratory documents and wondered that they convey the same meaning so where is the need for different terminology.
A little insight will help you understand the fine differences between them. Giving their concise definitions may suffice to gain a basic understanding but to help you get a clearer understanding I have attempted to offer clarity on the terms in context of routine activities in analytical laboratories as I believe that giving real life examples rather than recalling definitions serves the purpose better and makes you remember what is being conveyed longer.
Along with their definitions, I have also pointed out the difference between calibration and validation, and also the difference between calibration and verification. So you will be able to use these terms appropriately.
Let’s first explore what these terms mean:
Verification
In simple terms verification means confirming the authenticity of activities or data before communication to concerned parties. It is important that the results communicated by you are free from errors. Essentially verification comprises of multiple checks on supplies, samples and data before forwarding the results of your testing activities. Majority of the checks can be carried out by you but it is advised that independent assistance be taken for rechecking the data before submission.
Self Checks
The Correct sample was taken up for analysis.
The Sample description, analysis instructions were verified before start of analysis.
The Equipment and glassware used were calibrated.
Recommended grades of chemicals from reliable sources were used.
Weight readings were correctly recorded and entered in calculations.
Recommended environmental conditions were maintained throughout the analysis.
Independent checks
It is strongly recommended that independent rechecking be carried out by a set of trained individuals before the analysis results are consolidated for report generation.
The Sample is analyzed as per the customer’s requirements. As an example in pharmaceutical analysis the tests are conducted in compliance with USP, BP, IP, etc.
If sample information such as name, batch number, date of manufacture, date of expiry, sample source, etc are entered correctly or not in reports.
Entered data matches with the data in the w
Calibration of laboratory instrum
The Food and Drug Administration (FDA or USFDA) is an agency of the United States Department of Health and Human Services, one of the United States federal executive departments.
The FDA is responsible for protecting and promoting public health through the regulation and supervision of food safety, tobacco products, dietary supplements, prescription and over-the-counter pharmaceutical drugs (medications), vaccines, biopharmaceuticals, blood transfusions, medical devices, electromagnetic radiation emitting devices (ERED), veterinary products, and cosmetics.
The FDA also enforces other laws, notably Section 361 of the Public Health Service Act and associated regulations, many of which are not directly related to food or drugs.
These include sanitation requirements on interstate travel and control of disease on products ranging from certain household pets to sperm donation for assisted reproduction.
In this slides contains recall classification, strategy, effect of recall system and case study.
Presented by: V.Nabi Rasool. (Department of pharmaceutical analysis and quality assurance)
RIPER, anantapur.
Medical Devices Law 2015 (Addition by DRAP)Bilal Mumtaz
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Title: Sense of Smell
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 primary categories of smells and the concept of odor blindness.
Explain the structure and location of the olfactory membrane and mucosa, including the types and roles of cells involved in olfaction.
Describe the pathway and mechanisms of olfactory signal transmission from the olfactory receptors to the brain.
Illustrate the biochemical cascade triggered by odorant binding to olfactory receptors, including the role of G-proteins and second messengers in generating an action potential.
Identify different types of olfactory disorders such as anosmia, hyposmia, hyperosmia, and dysosmia, including their potential causes.
Key Topics:
Olfactory Genes:
3% of the human genome accounts for olfactory genes.
400 genes for odorant receptors.
Olfactory Membrane:
Located in the superior part of the nasal cavity.
Medially: Folds downward along the superior septum.
Laterally: Folds over the superior turbinate and upper surface of the middle turbinate.
Total surface area: 5-10 square centimeters.
Olfactory Mucosa:
Olfactory Cells: Bipolar nerve cells derived from the CNS (100 million), with 4-25 olfactory cilia per cell.
Sustentacular Cells: Produce mucus and maintain ionic and molecular environment.
Basal Cells: Replace worn-out olfactory cells with an average lifespan of 1-2 months.
Bowman’s Gland: Secretes mucus.
Stimulation of Olfactory Cells:
Odorant dissolves in mucus and attaches to receptors on olfactory cilia.
Involves a cascade effect through G-proteins and second messengers, leading to depolarization and action potential generation in the olfactory nerve.
Quality of a Good Odorant:
Small (3-20 Carbon atoms), volatile, water-soluble, and lipid-soluble.
Facilitated by odorant-binding proteins in mucus.
Membrane Potential and Action Potential:
Resting membrane potential: -55mV.
Action potential frequency in the olfactory nerve increases with odorant strength.
Adaptation Towards the Sense of Smell:
Rapid adaptation within the first second, with further slow adaptation.
Psychological adaptation greater than receptor adaptation, involving feedback inhibition from the central nervous system.
Primary Sensations of Smell:
Camphoraceous, Musky, Floral, Pepperminty, Ethereal, Pungent, Putrid.
Odor Detection Threshold:
Examples: Hydrogen sulfide (0.0005 ppm), Methyl-mercaptan (0.002 ppm).
Some toxic substances are odorless at lethal concentrations.
Characteristics of Smell:
Odor blindness for single substances due to lack of appropriate receptor protein.
Behavioral and emotional influences of smell.
Transmission of Olfactory Signals:
From olfactory cells to glomeruli in the olfactory bulb, involving lateral inhibition.
Primitive, less old, and new olfactory systems with different path
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!
Prix Galien International 2024 Forum ProgramLevi Shapiro
June 20, 2024, Prix Galien International and Jerusalem Ethics Forum in ROME. Detailed agenda including panels:
- ADVANCES IN CARDIOLOGY: A NEW PARADIGM IS COMING
- WOMEN’S HEALTH: FERTILITY PRESERVATION
- WHAT’S NEW IN THE TREATMENT OF INFECTIOUS,
ONCOLOGICAL AND INFLAMMATORY SKIN DISEASES?
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- GENE THERAPY
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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.
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Tom Selleck Health: A Comprehensive Look at the Iconic Actor’s Wellness Journeygreendigital
Tom Selleck, an enduring figure in Hollywood. has captivated audiences for decades with his rugged charm, iconic moustache. and memorable roles in television and film. From his breakout role as Thomas Magnum in Magnum P.I. to his current portrayal of Frank Reagan in Blue Bloods. Selleck's career has spanned over 50 years. But beyond his professional achievements. fans have often been curious about Tom Selleck Health. especially as he has aged in the public eye.
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Introduction
Many have been interested in Tom Selleck health. not only because of his enduring presence on screen but also because of the challenges. and lifestyle choices he has faced and made over the years. This article delves into the various aspects of Tom Selleck health. exploring his fitness regimen, diet, mental health. and the challenges he has encountered as he ages. We'll look at how he maintains his well-being. the health issues he has faced, and his approach to ageing .
Early Life and Career
Childhood and Athletic Beginnings
Tom Selleck was born on January 29, 1945, in Detroit, Michigan, and grew up in Sherman Oaks, California. From an early age, he was involved in sports, particularly basketball. which played a significant role in his physical development. His athletic pursuits continued into college. where he attended the University of Southern California (USC) on a basketball scholarship. This early involvement in sports laid a strong foundation for his physical health and disciplined lifestyle.
Transition to Acting
Selleck's transition from an athlete to an actor came with its physical demands. His first significant role in "Magnum P.I." required him to perform various stunts and maintain a fit appearance. This role, which he played from 1980 to 1988. necessitated a rigorous fitness routine to meet the show's demands. setting the stage for his long-term commitment to health and wellness.
Fitness Regimen
Workout Routine
Tom Selleck health and fitness regimen has evolved. adapting to his changing roles and age. During his "Magnum, P.I." days. Selleck's workouts were intense and focused on building and maintaining muscle mass. His routine included weightlifting, cardiovascular exercises. and specific training for the stunts he performed on the show.
Selleck adjusted his fitness routine as he aged to suit his body's needs. Today, his workouts focus on maintaining flexibility, strength, and cardiovascular health. He incorporates low-impact exercises such as swimming, walking, and light weightlifting. This balanced approach helps him stay fit without putting undue strain on his joints and muscles.
Importance of Flexibility and Mobility
In recent years, Selleck has emphasized the importance of flexibility and mobility in his fitness regimen. Understanding the natural decline in muscle mass and joint flexibility with age. he includes stretching and yoga in his routine. These practices help prevent injuries, improve posture, and maintain mobilit
Report Back from SGO 2024: What’s the Latest in Cervical Cancer?bkling
Are you curious about what’s new in cervical cancer research or unsure what the findings mean? Join Dr. Emily Ko, a gynecologic oncologist at Penn Medicine, to learn about the latest updates from the Society of Gynecologic Oncology (SGO) 2024 Annual Meeting on Women’s Cancer. Dr. Ko will discuss what the research presented at the conference means for you and answer your questions about the new developments.
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
2. ContentsContents
IntroductionIntroduction
United State Food And DrugUnited State Food And Drug
AdministrationAdministration (USFDA)(USFDA)
Medicines And HealthCare ProductsMedicines And HealthCare Products
Regulatory AgencyRegulatory Agency (MHRA)(MHRA)
Central Drug Standard ControlCentral Drug Standard Control
OrganizationOrganization (CDSCO)(CDSCO)
ReferencesReferences
07/09/1607/09/16 Sagar SavaleSagar Savale 22
3. INTRODUCTIONINTRODUCTION
WHAT IS REGULATION?WHAT IS REGULATION?
WHY REGULATION?WHY REGULATION?
WHAT IS REGULATORY AGENCY?WHAT IS REGULATORY AGENCY?
07/09/1607/09/16 Sagar SavaleSagar Savale 33
4. United State Food And DrugUnited State Food And Drug
AdministrationAdministration (USFDA)(USFDA)
07/09/1607/09/16 Sagar SavaleSagar Savale 44
5. History:-:-
Firstly it was a division of Chemistry,Firstly it was a division of Chemistry,
then named asthen named as The Bureau OfThe Bureau Of
Chemistry.Chemistry.
In Jully1930,the name wasIn Jully1930,the name was
shortened toshortened to Food And DrugFood And Drug
Administration.Administration.
Up to 1940,FDA was underUp to 1940,FDA was under
Department Of Agriculture.Department Of Agriculture.
In 1968,it become part ofIn 1968,it become part of PublicPublic
Health ServiceHealth Service within Healthwithin Health
Education And Welfare (HEW)Education And Welfare (HEW)..07/09/1607/09/16 Sagar SavaleSagar Savale 55
6. FDA’s Mission:-:-
According to FDA ModernisationAccording to FDA Modernisation
Act,1997-Act,1997-
To promot Public Health.To promot Public Health.
To communicate with representativesTo communicate with representatives
of other countries.of other countries.
07/09/1607/09/16 Sagar SavaleSagar Savale 66
7. FDA’s Organisational Units Are-FDA’s Organisational Units Are-
Center For Food Safety And AppliedCenter For Food Safety And Applied
NutritionNutrition (CFSAN)(CFSAN)
Center For Drug Evaluation AndCenter For Drug Evaluation And
ResearchResearch (CDER)(CDER)
Center For Veterinary MedicineCenter For Veterinary Medicine (CVM)(CVM)
Center For BiologicsCenter For Biologics (CBER)(CBER)
Center For Devices And RadiologicalCenter For Devices And Radiological
HealthHealth (CDRH)(CDRH)
07/09/1607/09/16 Sagar SavaleSagar Savale 77
8. Food safetyFood safety
Approval and safetyApproval and safety
of food additivesof food additives
Cosmetic safetyCosmetic safety
Labeling-food,Labeling-food,
cosmetics andcosmetics and
dietary supplementsdietary supplements
Center For FoodCenter For Food
Safety And AppliedSafety And Applied
NutritionNutrition (CFSAN(CFSAN))
07/09/1607/09/16 Sagar SavaleSagar Savale 88
9. Restaurants and grocery storesRestaurants and grocery stores
Meat,poultry,eggsMeat,poultry,eggs (USDA)(USDA)
Advertising for dietary supplements,Advertising for dietary supplements,
food,cosmeticsfood,cosmetics (FTC)(FTC)
AlcoholAlcohol (Alcohol and Tobacco Tax and(Alcohol and Tobacco Tax and
Trade Bureau)Trade Bureau)
WaterWater (Environmental Protection(Environmental Protection
Agencies)Agencies)
07/09/1607/09/16 Sagar SavaleSagar Savale 99
10. Center For DrugCenter For Drug
Evaluation AndEvaluation And
ResearchResearch (CDER)(CDER)
Rx,Generic,OTC DrugsRx,Generic,OTC Drugs
-NDAs and ANDAs-NDAs and ANDAs
Good ManufacturingGood Manufacturing
PracticePractice
Adverce eventAdverce event
reportingreporting
Rx Drugs advertising.Rx Drugs advertising.
LabelingLabeling
07/09/1607/09/16 Sagar SavaleSagar Savale 1010
12. Center For Veterinary MedicinesCenter For Veterinary Medicines
(CVM)(CVM)
Pet Food StandardsPet Food Standards
Safe And EffectiveSafe And Effective
Animal DrugsAnimal Drugs
WHAT CVMWHAT CVM NOTNOT
REGULATE:-REGULATE:-
Animal VaccinesAnimal Vaccines
(USDA)(USDA)
Meat ProductsMeat Products
(USDA)(USDA)07/09/1607/09/16 Sagar SavaleSagar Savale 1212
13. Center For BiologicsCenter For Biologics (CBER)(CBER)
Blood SupplyBlood Supply
Vaccines for human useVaccines for human use
Allergenic material andAllergenic material and
AntitoxinsAntitoxins
WHAT CBER DOESWHAT CBER DOES
NOTNOT REGULATEREGULATE
OrgansOrgans (HRSA)(HRSA)
DrgsDrgs
07/09/1607/09/16 Sagar SavaleSagar Savale 1313
16. Summary:-Summary:-
To avoid confusion consumer should alwaysTo avoid confusion consumer should always
remember, what USFDAremember, what USFDA
CONTROLS NOT CONTROLSCONTROLS NOT CONTROLS
Food:-Food:-
Bottled water meat, poultryBottled water meat, poultry
Consumer product:-Consumer product:-
radiation emitting remaining consumerradiation emitting remaining consumer
device productsdevice products
Drugs:-Drugs:-
advertising of OTCadvertising of OTC
drugsdrugs
In this way FDA protects all consumersIn this way FDA protects all consumers
in US with broad umbrella of safeguard.in US with broad umbrella of safeguard.07/09/1607/09/16 Sagar SavaleSagar Savale 1616
17. Medicines And Healthcare ProductsMedicines And Healthcare Products
Regulatory AgencyRegulatory Agency (MHRA)(MHRA)
MHRA was setup in 1,April 2003 fromMHRA was setup in 1,April 2003 from
merger of Medicines Control Agency(MCA)merger of Medicines Control Agency(MCA)
and Medical Devices Agency(MDA).and Medical Devices Agency(MDA).
The MHRA is executive agency of theThe MHRA is executive agency of the
Department Of Health, United Kingdom.Department Of Health, United Kingdom.
MHRA is Government agency that isMHRA is Government agency that is
responsible for ensuring that medicinesresponsible for ensuring that medicines
and medical devices are safe andand medical devices are safe and
effective.effective.07/09/1607/09/16 Sagar SavaleSagar Savale 1717
18. Mission And Values:-Mission And Values:-
Mission:-Mission:-
To enhance and safeguard healthTo enhance and safeguard health
of public.of public.
Values:-Values:-
IntegrityIntegrity
ResponsivenessResponsiveness
ProfessionalismProfessionalism
ImpartialityImpartiality
ConsistencyConsistency
07/09/1607/09/16 Sagar SavaleSagar Savale 1818
19. Aims And Objectives:-Aims And Objectives:-
Aims:-Aims:-
Protect public healthProtect public health
Promoting public healthPromoting public health
Improving public healthImproving public health
Objectives:-Objectives:-
Minimize the cost of regulationMinimize the cost of regulation
Support innovation and product developmentSupport innovation and product development
Communicate with other Government bodiesCommunicate with other Government bodies
and regulatory agencies world wideand regulatory agencies world wide
07/09/1607/09/16 Sagar SavaleSagar Savale 1919
20. Co-relation:-Co-relation:-
MHRA have to maintain contact with,MHRA have to maintain contact with,
National Patient Safety AgencyNational Patient Safety Agency (NPSA)(NPSA)
Health Protection AgencyHealth Protection Agency (HPA)(HPA)
National Institute For Clinical ExcellenceNational Institute For Clinical Excellence
Health development AgencyHealth development Agency (HAD)(HAD)
European Medicine AgencyEuropean Medicine Agency (EMA)(EMA)
07/09/1607/09/16 Sagar SavaleSagar Savale 2020
21. What MHRA regulate?What MHRA regulate?
MHRA regulates wide range of materials,MHRA regulates wide range of materials,
i.e. from medicines or medical devices toi.e. from medicines or medical devices to
blood and therapeutic products which areblood and therapeutic products which are
derived from tissue engineeringderived from tissue engineering
Quality, safety and effectiveness ofQuality, safety and effectiveness of
medicines and medical devicesmedicines and medical devices
07/09/1607/09/16 Sagar SavaleSagar Savale 2121
22. HOW MHRA REGULATE?HOW MHRA REGULATE?
Medicines approved by MHRA getMedicines approved by MHRA get
‘Marketing Authorization’ or License‘Marketing Authorization’ or License
Manufacturers and distributors are alsoManufacturers and distributors are also
Licensed directly by MHRALicensed directly by MHRA
Medical devices approved by privateMedical devices approved by private
sector organization called ‘Notifiedsector organization called ‘Notified
Bodies’Bodies’07/09/1607/09/16 Sagar SavaleSagar Savale 2222
23. Summary:-Summary:-
The MHRA is a responsibleThe MHRA is a responsible
Executive Agency of Department OfExecutive Agency of Department Of
Health, U.K. which works impartiallyHealth, U.K. which works impartially
to enhance and safeguard health ofto enhance and safeguard health of
public by ensuring that medicinespublic by ensuring that medicines
and medical devices are safe andand medical devices are safe and
effective.effective.
07/09/1607/09/16 Sagar SavaleSagar Savale 2323
24. Central Drug Standard ControlCentral Drug Standard Control
OrganizationOrganization (CDSCO)(CDSCO)
It is under control ofIt is under control of Ministry Of Health AndMinistry Of Health And
FamilyFamily Welfare,Welfare, Government of IndiaGovernment of India
(MOHFW)(MOHFW)
It provides general information aboutIt provides general information about
regulatory requirements of drugs, cosmetics,regulatory requirements of drugs, cosmetics,
and devices in Indiaand devices in India
It functions underIt functions under The Directorate General ofThe Directorate General of
Health ServicesHealth Services
It is Located in Nirman Bhawan, New DelhiIt is Located in Nirman Bhawan, New Delhi07/09/1607/09/16 Sagar SavaleSagar Savale 2424
25. State Drug Standard ControlState Drug Standard Control
Organization (SDSCO)Organization (SDSCO)
Activity:-Activity:-
CDSCOCDSCO
Approval of new drugApproval of new drug
Control over clinical trialsControl over clinical trials
Co-ordination withCo-ordination with
SDSCOSDSCO
SDSCOSDSCO
Regulation ofRegulation of
manufacturing, sale,manufacturing, sale,
distribution of drugsdistribution of drugs
07/09/1607/09/16 Sagar SavaleSagar Savale 2525
26. Functions of CDSCO:-Functions of CDSCO:-
Laying down standards of drugs,Laying down standards of drugs,
cosmetics, diagnostics and devicescosmetics, diagnostics and devices
To regulate market authorization of newTo regulate market authorization of new
drugdrug
To regulate standard of imported drugsTo regulate standard of imported drugs
Testing of drugs by Central Drug LabsTesting of drugs by Central Drug Labs
Publication of Indian PharmacopoeiaPublication of Indian Pharmacopoeia07/09/1607/09/16 Sagar SavaleSagar Savale 2626
27. Offices:-Offices:-
Central Government haveCentral Government have
established four zonal offices ofestablished four zonal offices of
CDSCOCDSCO
East zone -East zone - KolkataKolkata
West zoneWest zone – Mumbai– Mumbai
North zoneNorth zone – Ghaziabad– Ghaziabad
South zoneSouth zone – Chennai– Chennai ..
07/09/1607/09/16 Sagar SavaleSagar Savale 2727
28. Summary:-Summary:-
The Central Drug Standard ControlThe Central Drug Standard Control
Organization works under TheOrganization works under The
Ministry of Health and Family WelfareMinistry of Health and Family Welfare
to enforce The Drug and Cosmeticsto enforce The Drug and Cosmetics
Act 1940, with main object toAct 1940, with main object to
regulate import, manufacture, sale ofregulate import, manufacture, sale of
Drugs and Cosmetics.Drugs and Cosmetics.
07/09/1607/09/16 Sagar SavaleSagar Savale 2828