This document discusses pharmacovigilance in India, both past and present. It notes that India did not previously have a formal pharmacovigilance system, but initiated activities in 1986 and joined the WHO program in 1997. The National Pharmacovigilance Program was launched in 2004 and became operational in 2005. It has since expanded to include 90 monitoring centers across India. The program aims to ensure drug safety, identify new adverse drug reactions, and support regulatory decision making. Future prospects include expanding the program further and implementing hemovigilance and biovigilance initiatives to monitor blood and medical devices.
pharmacovigilance, adverse effects, causality assessment,methods, who-umc method with case study, FOR DOWNLOAD PPT MAIL ME ON iamgauravchhabra@gmail.com
pharmacovigilance, adverse effects, causality assessment,methods, who-umc method with case study, FOR DOWNLOAD PPT MAIL ME ON iamgauravchhabra@gmail.com
Pharmacovigilance is science of detection,
assessment, reporting and prevention of adverse
reactions to drug(s).
Major aims of pharmacovigilance are:
1. Early detection of hitherto unknown adverse
reactions and interactions
2. Detection of increases in frequency of (known)
adverse reactions
3. Identification of risk factors and possible
mechanisms underlying adverse reactions
4. Estimation of quantitative aspects of benefit/risk
analysis and dissemination of information needed to
improve drug prescribing and regulation.
Requirements And Guidelines For Permission To Import / or Manufacture of New Drugs For Sale or To Undertake Clinical Trials
Schedule Y was introduced under the Drugs and Cosmetics Act 1940, to
introduce requirements for countries to get permission for:
Importing
Manufacturing new drugs
Conducting Clinical Trials.
Application for permission
Clinical Trial
Studies in specific population
Post marketing surveillance
Special studies: BA/BE studies
Spontenous adr reporting in india
PASSIVE survillence system, data assement
data aciqsition, data interpretation, what all information required in ADR form, WHEN TO REPORT
BLUE CARD,YELLOW CARD, WHO CODES
Concept of Pharmacovigilance, history and development of pharmacovigilance, WHO International drug monitoring programme, Pharmacovigilance programme of India
The safety monitoring in a clinical trail accompanies by common practices in safety monitoring, communicating safety information among stakeholders in a clinical trail.
detection methods of Adverse drug reactions, postal survey method, Reporting of Adverse drug reactions, Preventability assessment, predictability assessments
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.
A brief description about Pharmacovigilance, aims and scope, need of pharmacovigilance, programs by WHO for international drug safety monitoring, UMC, VIGIBASE, WHO causality assessment scale and specific regulatory bodies of various countries
SEVERITY AND SERIOUSNESS ASSESSMENT OF ADR’S
Definitions, Severity assessment, Seriousness assessment
Naranjo algorithm, Preventability assessment
By
Ms. B. Mary Vishali
Department of Pharmacology
If you are marketing your product in India you should comply these area of regulation.We give Services in getting manufacturing licences
ACCREDITED CONSULTANTS PVT.LTD
info@acplgroupindia.co.in
+919310040434
Pharmacovigilance is science of detection,
assessment, reporting and prevention of adverse
reactions to drug(s).
Major aims of pharmacovigilance are:
1. Early detection of hitherto unknown adverse
reactions and interactions
2. Detection of increases in frequency of (known)
adverse reactions
3. Identification of risk factors and possible
mechanisms underlying adverse reactions
4. Estimation of quantitative aspects of benefit/risk
analysis and dissemination of information needed to
improve drug prescribing and regulation.
Requirements And Guidelines For Permission To Import / or Manufacture of New Drugs For Sale or To Undertake Clinical Trials
Schedule Y was introduced under the Drugs and Cosmetics Act 1940, to
introduce requirements for countries to get permission for:
Importing
Manufacturing new drugs
Conducting Clinical Trials.
Application for permission
Clinical Trial
Studies in specific population
Post marketing surveillance
Special studies: BA/BE studies
Spontenous adr reporting in india
PASSIVE survillence system, data assement
data aciqsition, data interpretation, what all information required in ADR form, WHEN TO REPORT
BLUE CARD,YELLOW CARD, WHO CODES
Concept of Pharmacovigilance, history and development of pharmacovigilance, WHO International drug monitoring programme, Pharmacovigilance programme of India
The safety monitoring in a clinical trail accompanies by common practices in safety monitoring, communicating safety information among stakeholders in a clinical trail.
detection methods of Adverse drug reactions, postal survey method, Reporting of Adverse drug reactions, Preventability assessment, predictability assessments
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.
A brief description about Pharmacovigilance, aims and scope, need of pharmacovigilance, programs by WHO for international drug safety monitoring, UMC, VIGIBASE, WHO causality assessment scale and specific regulatory bodies of various countries
SEVERITY AND SERIOUSNESS ASSESSMENT OF ADR’S
Definitions, Severity assessment, Seriousness assessment
Naranjo algorithm, Preventability assessment
By
Ms. B. Mary Vishali
Department of Pharmacology
If you are marketing your product in India you should comply these area of regulation.We give Services in getting manufacturing licences
ACCREDITED CONSULTANTS PVT.LTD
info@acplgroupindia.co.in
+919310040434
AN OVERVIEW AND IMPORTANCE OF PHARMACOVIGILANCERamakrishna K
An introduction to pharmacovigilance, basic types like active pharmacovigilance and passive pharmacovigilance, purpose, adverse event reporting, data processing, causality, assessement, signal detection, risk management plans and analysis
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Introduction to Drug Safety & Pharmacovigilance Process Work Flow for Pharmaceuticals, Bio-Pharmaceuticals, Medical Devices, Cosmeceuticals and Foods.
Contact:
"Katalyst Healthcares & Life Sciences"
South Plainfield, NJ, USA
info@KatalystHLS.com
Pharmacovigilance (PV) is defined as the science and activities relating to the detection, assessment, understanding and prevention of adverse effects or any other drug-related problem.
a presentation in CME activities by Saad Specialist Hospital, KSA
Drug Safety & Pharmacovigilance - Introduction - Katalyst HLSKatalyst HLS
Introduction to Drug Safety & Pharmacovigilance in Pharmaceuticals, Bio-Pharmaceuticals, Medical Devices, Cosmeceuticals and Foods.
Contact:
"Katalyst Healthcares & Life Sciences"
South Plainfield, NJ, USA
info@KatalystHLS.com
History and Progress of Pharmacovigilance, Significance of Safety Monitoring, Pharmacovigilance in India And International Aspects, WHO International Drug Monitoring Programme, WHO and Regulatory Terminologies of ADR, Evaluation of Medication Safety, Establishing Pharmacovigilance Centres in Hospitals, Industry and National Programmes Related to Pharmacovigilance, Roles and Responsibilities in Pharmacovigilance, International Non-Proprietary Names for Drugs, International Classification of Diseases, Passive and Active Surveillance, Comparative Observational Studies, Targeted Clinical Investigations and Vaccine Safety Surveillance, Aris G Pharmacovigilance, VigiFlow, Statistical Methods for Evaluating Medication Safety Data
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Pharmacovigilance (PV) is defined as the science and activities relating to the detection, assessment, understanding and prevention of adverse effects or any other drug-related problem. WHO established its Programme for International Drug Monitoring in response to the thalidomide disaster detected in 1961. Together with the WHO Collaborating Centre for International Drug Monitoring, Uppsala, WHO promotes PV at the country level. At the end of 2010, 134 countries were part of the WHO PV Programme. The aims of PV are to enhance patient care and patient safety in relation to the use of medicines; and to support public health programmes by providing reliable, balanced information for the effective assessment of the risk-benefit profile of medicines.
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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.
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The French Revolution, which began in 1789, was a period of radical social and political upheaval in France. It marked the decline of absolute monarchies, the rise of secular and democratic republics, and the eventual rise of Napoleon Bonaparte. This revolutionary period is crucial in understanding the transition from feudalism to modernity in Europe.
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Biological screening of herbal drugs: Introduction and Need for
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Antifertility, Toxicity studies as per OECD guidelines
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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.
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http://sandymillin.wordpress.com/iateflwebinar2024
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2. • PHARMACOVIGILANCE :
“SCIENCE & ACTIVITIES RELATING TO THE
DETECTION, ASSESSMENT, UNDERSTANDING
& PREVENTION OF ADVERSE EFFECTS OF
DRUGS OR ANY OTHER DRUG RELATED
PROBLEM”.
3. INTRODUCTION
• INDIA DID NOT HAVE ANY FORMAL PVG
SYSTEM IN THE PAST TO DETECT ADVERSE
REACTIONS TO DRUGS AS ONLY FEW DRUGS
WERE DISCOVERED IN INDIA
• INDIA’S REGULATORY AGENCIES BASED THEIR
SAFETY ASSESSMENT OF DRUGS ON DATA
DERIVED FROM LONG TERM USE IN
US, EUROPE & JAPANESE MARKETS.
4.
5. • FORMAL PVG ACTIVITIES WERE INITIATED IN
INDIA AROUND 1986.
• IN 1997 INDIA JOINED THE ADVERSE DRUG
REACTION MONITORING PROGRAMME OF
WHO.
• THE NATIONAL PHARMACOVIGILANCE
PROGRAMME (NPP) WAS LAUNCHED BY
CDSCO ON NOV 23,2004 WHICH BECAME
OPERATIONAL FROM JAN 1,2005.
6. • THE NPP WAS BASED ON THE
RECOMMENDATIONS MADE IN THE WHO
DOCUMENT TITLED “ SAFETY MONITORING
OF MEDICINAL PRODUCTS-GUIDELINES FOR
SETTING UP & RUNNING A PVG CENTRE”.
7. • UNDER THE NPP A NPAC WAS CREATED
UNDER THE CHAIRMANSHIP OF DCGI &
APPROVED BY MINISTRY OF HEALTH & FAMILY
WELFARE VIDE ORDERS DATED 12TH MARCH
2004.
8. • HOWEVER DUE TO SOME TECHNICAL
DIFFICULTIES THE NPP HAD TO BE CLOSED IN
2008.
• IT WAS AGAIN RESURRECTED AS THE
PHARMACOVIGILANCE PROGRAMME OF
INDIA(PvPI) IN 14/07/2010 DUE TO THE
DEDICATED EFFORTS OF PERSONNEL
WORKING IN THIS FIELD.
9. • UNDER THE PvPI- AIIMS, NEW DELHI WAS THE
NATIONAL CO-ORDINATING CENTRE; WITH
TWO ZONAL CENTRES ; FIVE REGIONAL
CENTRES & AN INCREASING NUMBER OF
PERIPHERAL CENTRES.
10.
11. • IN ORDER TO ENSURE IMPLEMENTATION OF
THE PROGRAMME IN A MORE EFFFECTIVE
WAY THE NCC AT AIIMS NEW DELHI WAS
SHIFTED TO INDIAN PHARMACOPOEIA
COMMISSION, GHAZIABAD ON 15/04/2011.
12. MISSION
• TO SAFEGUARD THE HEALTH OF THE INDIAN
POPULATION BY ENSURING THAT THE
BENEFITS OF USE OF MEDICINES OUTWEIGH
THE RISKS ASSOCIATED WITH ITS USE.
13. VISION
• TO IMPROVE PATIENT SAFETY & WELFARE IN
THE INDIAN POPULATION BY MONITORING
THE DRUG SAFETY & THEREBY REDUCING THE
RISK ASSOCIATED WITH USE OF MEDICINES.
14. OBJECTIVES
• To create a nation-wide system for patient safety reporting.
• To identify & analyse the new signal(ADR) from the reported cases.
• To analyse the benefit risk ratio of marketed medications.
• To generate evidence based information on safety of medicines.
• To support the regulatory agencies in the decision making process
on use of medicines.
• To communicate the safety information on use of medicines to
various stakeholders to minimise the risk.
• To emerge as a national centre of excellence for pharmacovigilance
activities.
• To collaborate with other national centres for the exchange of
information & data management.
• To provide training & consultancy support to other national
pharmacovigilance centres located across globe.
15. SHORT TERM GOALS
• To develop & implement pharmacovigilance
system in india.
• To enrol initially all MCI approved medical
colleges in the programme covering
north, south, east & west of india.
• To encourage healthcare professionals in
reporting of adverse reaction to
drugs, vaccines, medical devices & biological
products.
• Collection of case reports & data.
16. LONG TERM GOALS
• To expand the pvg programme to all hospitals
(govt & private) & centres of public health
programmes located across india.
• To develop & implement electronic reporting
system( e-reporting).
• To develop reporting culture amongst
healthcare professionals.
• To make ADR reporting mandatory for
healthcare professionals.
17.
18.
19. The programme will be administered &
monitored by the following two committees:
• Steering committee.
• Strategic advisory committee.
20. Technical support will be provided by the
following panels:
• Signal review panel
• Core training panel
• Quality review panel.
24. The ADR reports will be collected from the
following centres:
• MCI approved medical colleges & hospitals
• Private hospitals
• Public health programmes
• Autonomous institutions(ICMR etc).
25.
26. Composition of the working group
Pharmacovigilance programme of
india
Secretary cum scientific director-
Indian pharmacopoeia commission
Ghaziabad(U.P)----Dr. G.N.Singh;
Chairman ex-officio.
Head of department, department of
pharmacology, AIIMS, New Delhi-
Prof y. k. gupta ; member.
27. Three nominees of drugs controller
general(india)-members
1)Mr.A.K.Pradhan; Dy.drugs controller; CDSCO
headquarter, FDA bhawan, new delhi.
2)Dr.G.Parthasarathy, Professor & Head
Pharmacy practices; JSS college of pharmacy;
Mysore.
3)Dr.Bikas Medhi; Dept of pharmacology;
PGIMER Chandigarh.
28. A nominee from a medical institution run by central
government (to be nominated by the chairperson, steering
committee)-member
• Dr. shakthi kumar gupta; HOD, Hospital administration &
MS; AIIMS new delhi.
Two nominees from medical institutions run by the state
government(to be nominated by chairperson, steering
committee)-members.
• Dr.Nandhini; Head, Dept of pharmacology; madras medical
college
Chennai.
• Dr.Urmila Thatte, Dept of Clinical Pharmacology;
Seth G Medical College & KEM hospital, panvel , Mumbai.
29. A nominee from a pharmacy institution ( to be nominated
by the chairperson, steering committee)
• Dr.sanjay singh; Professor of pharmaceutics; Institute of
technology; Banaras hindu university, Varanasi; member
A nominee from a nursing institution ( to be nominated by
chairperson, steering committee)
• Shri t.dileep kumar ; President; Indian nursing council ;
kotla road, new delhi; member.
Officer incharge (pharmacovigilance cell) Indian
pharmacopoeia commission( to be nominated by
chairperson working group)
• Dr.jai prakash;Principal scientific officer; Member secretary.
30. What to report?
• All adverse events suspected to be caused by new drugs &
drugs of current interest(published by CDSCO from time to
time)
• All suspected drug interactions
• Any Drug or adverse event leading to:
Death
Life threatening reaction
Hospitalisation
disability
Congenital anomaly
required intervention to prevent permanent impairment or
damage.
31. Who can report?
Any health care professional
• doctors
• dentists
• nurses
• pharmacists.
32. Where to report?
Completed ADR reporting forms shall be
returned to Pvg centre from where it was
received.
33. What happens to the information
submitted?
• Information shall be handled in strict
confidence.
• Shall be Forwarded to higher pvg centres
where causality analysis shall be done, data
analysed statistically & forwarded to global
pvg database managed by WHO Uppsala
monitoring centre in Sweden.
34. Also it can lead to the following:
• Follow up investigations
• Appropriate package insert changes
• Educational initiatives on proper use of
medicines.
• Changes in the scheduling or manufacture of
medicine to make them safer.
35. Minimum Requirements to report
ADR
• An identifiable pt
• A suspect medicinal product
• An identifiable reporting source
• An event or outcome
39. CURRENT STATUS OF PvPI
• Total number of ADR monitoring centres: 90.
• Total number of proposed ADR monitoring
centres: - 47(govt-27; private-20)
• Number of ADRs committed by NCC to WHO-
UMC- 35,008.
• Number of ADRs under assessment of NCC- 4308.
• Number of reports reverted back to AMCs- 37.
• Total number of ADRs under PvPI- 39353.
40. NUMBER OF ADR MONITORING
CENTRES
• SOUTH ZONE-25 AMC’S
• NORTH ZONE-28 AMC’S
• WEST ZONE-20 AMC’S
• EAST ZONE-17 AMC’S.
41. IN KARNATAKA THE RECOGINISED ADR
MONITORING CENTRES ARE AS FOLLOWS:
• St.Johns medical college:Dr.PadminiDevi
• Bangalore Medical college & research institute-
Dr. C.R. Jayanthi.
• Kasturba Medical college, Manipal- Dr.K.L.Bairy.
• Vydehi institute of medical sciences & research
centre - Dr.Prathibha Nadig.
• SDS tuberculosis research centre & Rajiv Gandhi
institute of chest diseases- Dr.Shashidhar buggi.
42. • JSS Medical College Hospital- Dr.Parthasarathi G
• Belgaum Institute Of Medical Sciences- Dr.Basavaraj
Kotintot.
• Karnataka Institute Of Medical Sciences-
Dr.Janaki.R.Torvi.
• Vijayanagara Institute of Medical Sciences-
Dr.Laxminarayana.
• Mandya Institute of Medical Sciences-
Dr.Nagabhushan.
• Bidar Institute of Medical Sciences-
Dr. B.O. Hanumanthappa.
44. HEAMOVIGILANCE & BIOVIGILANCE
• Was launched on 10th dec 2012
• NIB is the co-ordinating centre for BvPI .
• The programme has currently 60 medical
colleges in its network & is growing further.
45. Defn-HEMOVIGILANCE
• A set of surveillance procedures covering the
whole transfusion chain ( from collection of
blood & its components to the follow up of
recipients) intended to collect & assess
information on unexpected or undesirable
effects resulting from the therapeutic use of
labile blood products & to prevent their
occurrence or recurrence.