detection methods of Adverse drug reactions, postal survey method, Reporting of Adverse drug reactions, Preventability assessment, predictability assessments
Pharmacovigilance is the science of monitoring the effects of medicines to identify new information about drug safety and potential adverse effects. It aims to improve patient care, public health, and understanding of medication risks. Pharmacovigilance systems work to detect, assess, and prevent adverse drug reactions through alert watchfulness, careful reporting of side effects and medication errors, and implementing interventions to promote safer drug use and adherence. While clinical trials provide some safety information, pharmacovigilance is still needed after approval due to limitations of pre-market research and individual variability in drug responses.
Pharmacovigilance involves monitoring the safety of drugs on the market and preventing adverse drug reactions. It is important to assess risks and benefits of medicines to improve patient outcomes and public health. Pharmacovigilance activities include identifying, evaluating, and taking action on adverse drug events reported by healthcare professionals and the public to regulatory authorities. The goal is to communicate safety information to optimize safe use of medicines.
The document discusses adverse drug reaction (ADR) reporting tools. It provides a brief history of pharmacovigilance and describes the ADR reporting process from healthcare professionals to regional and zonal centers, and finally to national and global databases. It emphasizes the importance of post-marketing ADR monitoring to identify uncommon or rare reactions not detected during clinical trials. Key aspects like what information to report, who can report, and how to submit reports using standardized forms are summarized. Common ADR reporting software tools like Argus are also highlighted.
This document discusses pharmacovigilance, which is the science of detecting adverse effects of medications. It defines key terms like adverse drug reactions and side effects. The aims of pharmacovigilance are to improve patient safety, public health, and understanding of medication risks and benefits. Serious adverse reactions that should be reported include death, life-threatening events, hospitalization, and birth defects. Adverse reactions can be caused by intrinsic drug factors or extrinsic factors like interactions. Pharmacovigilance systems help record, analyze, and prevent medication errors to promote safer use of drugs.
Adverse drug reaction , types ,Detection and Reporting,severity and seriousness(Hartwig'severity assessment), preventibility(Schumock and thornston) and predictability, causality assessment Naranjo"s algotithm, WHO UMC causality scale
ADR Reporting Exercises for Undergraduate studentsPharmacolvigilance practs.pptxSURAJ PANCHAL
This document discusses adverse drug reactions (ADRs), including defining ADRs, differentiating them from adverse drug events, classifying types and severity of ADRs. It describes pharmacovigilance programs and processes for detecting, reporting, and assessing ADRs using tools like Naranjo's algorithm or WHO causality categories. The importance of ADR reporting to national and international centers is explained to help prevent future occurrences.
detection methods of Adverse drug reactions, postal survey method, Reporting of Adverse drug reactions, Preventability assessment, predictability assessments
Pharmacovigilance is the science of monitoring the effects of medicines to identify new information about drug safety and potential adverse effects. It aims to improve patient care, public health, and understanding of medication risks. Pharmacovigilance systems work to detect, assess, and prevent adverse drug reactions through alert watchfulness, careful reporting of side effects and medication errors, and implementing interventions to promote safer drug use and adherence. While clinical trials provide some safety information, pharmacovigilance is still needed after approval due to limitations of pre-market research and individual variability in drug responses.
Pharmacovigilance involves monitoring the safety of drugs on the market and preventing adverse drug reactions. It is important to assess risks and benefits of medicines to improve patient outcomes and public health. Pharmacovigilance activities include identifying, evaluating, and taking action on adverse drug events reported by healthcare professionals and the public to regulatory authorities. The goal is to communicate safety information to optimize safe use of medicines.
The document discusses adverse drug reaction (ADR) reporting tools. It provides a brief history of pharmacovigilance and describes the ADR reporting process from healthcare professionals to regional and zonal centers, and finally to national and global databases. It emphasizes the importance of post-marketing ADR monitoring to identify uncommon or rare reactions not detected during clinical trials. Key aspects like what information to report, who can report, and how to submit reports using standardized forms are summarized. Common ADR reporting software tools like Argus are also highlighted.
This document discusses pharmacovigilance, which is the science of detecting adverse effects of medications. It defines key terms like adverse drug reactions and side effects. The aims of pharmacovigilance are to improve patient safety, public health, and understanding of medication risks and benefits. Serious adverse reactions that should be reported include death, life-threatening events, hospitalization, and birth defects. Adverse reactions can be caused by intrinsic drug factors or extrinsic factors like interactions. Pharmacovigilance systems help record, analyze, and prevent medication errors to promote safer use of drugs.
Adverse drug reaction , types ,Detection and Reporting,severity and seriousness(Hartwig'severity assessment), preventibility(Schumock and thornston) and predictability, causality assessment Naranjo"s algotithm, WHO UMC causality scale
ADR Reporting Exercises for Undergraduate studentsPharmacolvigilance practs.pptxSURAJ PANCHAL
This document discusses adverse drug reactions (ADRs), including defining ADRs, differentiating them from adverse drug events, classifying types and severity of ADRs. It describes pharmacovigilance programs and processes for detecting, reporting, and assessing ADRs using tools like Naranjo's algorithm or WHO causality categories. The importance of ADR reporting to national and international centers is explained to help prevent future occurrences.
The thalidomide tragedy of the late 1950s demonstrated the importance of pharmacovigilance. Pharmacovigilance is the monitoring of medications post-marketing to identify adverse drug reactions. It aims to improve patient safety and assess medication risks and benefits. The thalidomide birth defects showed that not all adverse effects are found in clinical trials. Healthcare professionals and patients can report any serious or non-serious adverse reactions to their nearest monitoring center. Reported reactions are analyzed for new safety signals and to continuously evaluate medications' risk-benefit profiles. Ongoing pharmacovigilance is important for patient safety and optimal drug use.
Regulatory terminology of ADR and Establishing pharmacovigilance center's i...SIRAJUDDIN MOLLA
This document defines various regulatory terminology used in pharmacovigilance and adverse drug reaction reporting. It defines terms related to side effects like adverse events, serious adverse events, adverse drug reactions, and others. It also defines drug safety terms like causal relationship, important medical events, and temporal relationship. Further, it defines risk terminology like identified risks, potential risks, important risks, and missing information. Finally, it defines general pharmacovigilance terms like company core data sheet and company core safety information. The document provides clear definitions for specialized terminology to establish a common understanding in the field of pharmacovigilance.
The document discusses the history and importance of pharmacovigilance. It describes how the thalidomide disaster in the 1950s showed that drugs approved for use can still cause undetected harmful effects. Pharmacovigilance aims to improve patient safety by monitoring drugs after approval to identify adverse effects. It outlines key governing bodies like the WHO and methods used like individual case reports and periodic safety update reports. The document emphasizes that pharmacovigilance is needed because clinical trials prior to approval are limited in detecting rare or long-term effects.
HERE I INCLUDED HISTORY, RESPONSIBILITIES, TERMINOLOGY AND METHODS INVOLVED .
HOPE IT WILL BE USEFUL FOR YOU TO UNDERSTAND THE BASICS OF PHARMACOVIGILANCE.
This document discusses pharmacovigilance, which involves monitoring the safety of drugs after they have been approved. It defines pharmacovigilance and explains why it is needed given limitations of clinical trials. It describes types of adverse drug reactions and how they are classified. It outlines the goals and processes of pharmacovigilance programs, including reporting adverse reactions, conducting causality assessments, and submitting periodic safety update reports. The overall aim is to ensure safe and effective use of medicines through continual monitoring and regulatory action.
The document discusses pharmacovigilance and adverse drug reactions (ADRs). It provides historical context on important events that increased focus on pharmacovigilance like the Thalidomide disaster. It describes the need for pharmacovigilance due to limitations of preclinical and clinical trials. It outlines the aims, methods like spontaneous reporting and causality assessment, and programs in India and by the WHO. It defines ADRs and provides classifications. In summary, the document overviews the importance and process of pharmacovigilance in monitoring drug safety post marketing.
This document discusses adverse drug reactions (ADRs). It defines ADRs and provides various classifications based on type, onset, and severity. It also outlines methods for detecting, reporting, and assessing causality of ADRs. Key points covered include pre-marketing and post-marketing surveillance strategies, the roles of healthcare professionals in detection, and the importance of reporting all suspected ADRs to pharmacovigilance centers. Preventing ADRs requires rational prescribing, risk communication, and close patient monitoring.
ADR MONITORING IN COMMUNITY PHARMACY.pdfAmeena Kadar
This document discusses the role of community pharmacists in adverse drug reaction (ADR) monitoring. It outlines how community pharmacists can identify ADRs, assess causality, document reactions, and report serious reactions. It also describes India's Pharmacovigilance Program of India and how it coordinates ADR monitoring and reporting nationally. The document advocates for continuous pharmacy education programs to train pharmacists in proper ADR monitoring and reporting.
This document discusses pharmacovigilance, materiovigilance, and haemovigilance programs in India. It defines key terms like adverse drug reactions, serious adverse reactions, causality assessment, and dechallenge/rechallenge. It describes the Pharmacovigilance Programme of India (PvPI) including its aims, ADR monitoring centers, and methods used to communicate drug safety alerts. Reporting procedures for healthcare professionals to report adverse drug events to PvPI are also outlined.
Spontaneous Reporting and Prescription Event Monitoring.pptxDrRajeshHadia
This document discusses pharmacovigilance and post-marketing drug safety monitoring. It defines key terms like adverse drug reaction and signal. It explains limitations of pre-approval clinical trials in detecting all ADRs. Various pharmacovigilance strategies are outlined like spontaneous reporting, prescription event monitoring, and case studies. Reporting procedures and timelines are provided. The national pharmacovigilance program in India is described with its structure and operations. Benefits and limitations of spontaneous reporting are highlighted. Prescription event monitoring is explained as a form of post-marketing surveillance.
This document provides an overview of pharmacovigilance presented by Dr. S P Srinivas Nayak. It begins with a case study of a patient who experienced an allergic reaction after receiving ondansetron. It then defines key terms like adverse drug reaction and adverse event. It describes different types of ADRs based on factors like onset, mechanism and severity. It discusses pharmacovigilance including definitions, objectives, ADR reporting and the pharmacist's role in detecting, assessing and managing ADRs. The presentation concludes with definitions of key pharmacovigilance concepts and a thank you from Dr. Nayak.
Pharmacovigilance is the science of monitoring the safety of medicines. It aims to detect adverse effects from drugs, understand their causes, and prevent patient harm. Pharmacovigilance programs collect reports of adverse drug reactions and analyze the data to identify safety issues, quantify risks, and communicate safety information to patients and healthcare professionals. The ultimate goals are to protect patients and promote the safe use of medicines.
Pharmacovigilance involves monitoring adverse drug reactions (ADRs) that are detected after drugs receive marketing approval. ADRs are defined as harmful effects from normal drug dosages. Several types of ADRs exist and can be serious or severe. Possible causes include drug interactions and underlying medical conditions. Reporting and monitoring ADRs through pharmacovigilance aims to improve patient safety and reduce risks from drug use.
This document discusses pharmacovigilance and the need for monitoring drug safety post approval. It describes how historical drug safety issues like the Elixir Sulfanilamide and Thalidomide tragedies revealed limitations in pre-approval testing and established the need for ongoing pharmacovigilance. The aims, application and reporting processes of pharmacovigilance are outlined along with terminology and examples of regulatory actions taken based on adverse event reporting.
Pharmacovigilance is the science of monitoring the safety of medicines. It plays a key role in identifying adverse drug reactions and preventing harm to patients. The goal of pharmacovigilance is to monitor drug safety, identify health risks, and prevent harm through careful tracking of side effects from clinical trials through a drug's entire lifecycle on the market. Major organizations like the FDA, EMEA, and WHO work to coordinate pharmacovigilance efforts internationally and protect public health.
Reporting Methods _ Global Pharmacovigilance1Hafsa Hafeez
This document discusses pharmacovigilance reporting methods and signal detection in the USA. It outlines several methods for reporting adverse drug reactions including passive surveillance like spontaneous reporting and case series, as well as active surveillance through sentinel sites and clinical investigations. It describes the FDA's role in pharmacovigilance including maintaining the FAERS database and evaluating safety signals. Signals are detected through data mining this database and can be validated by obtaining additional information from various sources.
Pharmacovigilance involves monitoring the safety of drugs at all stages, from development through post-marketing. It aims to detect, understand, and prevent adverse drug reactions through activities like adverse event reporting, drug monitoring, and studying medication errors and drug-related deaths. Pharmacovigilance is important for protecting public health as patterns of drug use change over time with globalization and advances in technology and medicine.
The thalidomide tragedy of the late 1950s demonstrated the importance of pharmacovigilance. Pharmacovigilance is the monitoring of medications post-marketing to identify adverse drug reactions. It aims to improve patient safety and assess medication risks and benefits. The thalidomide birth defects showed that not all adverse effects are found in clinical trials. Healthcare professionals and patients can report any serious or non-serious adverse reactions to their nearest monitoring center. Reported reactions are analyzed for new safety signals and to continuously evaluate medications' risk-benefit profiles. Ongoing pharmacovigilance is important for patient safety and optimal drug use.
Regulatory terminology of ADR and Establishing pharmacovigilance center's i...SIRAJUDDIN MOLLA
This document defines various regulatory terminology used in pharmacovigilance and adverse drug reaction reporting. It defines terms related to side effects like adverse events, serious adverse events, adverse drug reactions, and others. It also defines drug safety terms like causal relationship, important medical events, and temporal relationship. Further, it defines risk terminology like identified risks, potential risks, important risks, and missing information. Finally, it defines general pharmacovigilance terms like company core data sheet and company core safety information. The document provides clear definitions for specialized terminology to establish a common understanding in the field of pharmacovigilance.
The document discusses the history and importance of pharmacovigilance. It describes how the thalidomide disaster in the 1950s showed that drugs approved for use can still cause undetected harmful effects. Pharmacovigilance aims to improve patient safety by monitoring drugs after approval to identify adverse effects. It outlines key governing bodies like the WHO and methods used like individual case reports and periodic safety update reports. The document emphasizes that pharmacovigilance is needed because clinical trials prior to approval are limited in detecting rare or long-term effects.
HERE I INCLUDED HISTORY, RESPONSIBILITIES, TERMINOLOGY AND METHODS INVOLVED .
HOPE IT WILL BE USEFUL FOR YOU TO UNDERSTAND THE BASICS OF PHARMACOVIGILANCE.
This document discusses pharmacovigilance, which involves monitoring the safety of drugs after they have been approved. It defines pharmacovigilance and explains why it is needed given limitations of clinical trials. It describes types of adverse drug reactions and how they are classified. It outlines the goals and processes of pharmacovigilance programs, including reporting adverse reactions, conducting causality assessments, and submitting periodic safety update reports. The overall aim is to ensure safe and effective use of medicines through continual monitoring and regulatory action.
The document discusses pharmacovigilance and adverse drug reactions (ADRs). It provides historical context on important events that increased focus on pharmacovigilance like the Thalidomide disaster. It describes the need for pharmacovigilance due to limitations of preclinical and clinical trials. It outlines the aims, methods like spontaneous reporting and causality assessment, and programs in India and by the WHO. It defines ADRs and provides classifications. In summary, the document overviews the importance and process of pharmacovigilance in monitoring drug safety post marketing.
This document discusses adverse drug reactions (ADRs). It defines ADRs and provides various classifications based on type, onset, and severity. It also outlines methods for detecting, reporting, and assessing causality of ADRs. Key points covered include pre-marketing and post-marketing surveillance strategies, the roles of healthcare professionals in detection, and the importance of reporting all suspected ADRs to pharmacovigilance centers. Preventing ADRs requires rational prescribing, risk communication, and close patient monitoring.
ADR MONITORING IN COMMUNITY PHARMACY.pdfAmeena Kadar
This document discusses the role of community pharmacists in adverse drug reaction (ADR) monitoring. It outlines how community pharmacists can identify ADRs, assess causality, document reactions, and report serious reactions. It also describes India's Pharmacovigilance Program of India and how it coordinates ADR monitoring and reporting nationally. The document advocates for continuous pharmacy education programs to train pharmacists in proper ADR monitoring and reporting.
This document discusses pharmacovigilance, materiovigilance, and haemovigilance programs in India. It defines key terms like adverse drug reactions, serious adverse reactions, causality assessment, and dechallenge/rechallenge. It describes the Pharmacovigilance Programme of India (PvPI) including its aims, ADR monitoring centers, and methods used to communicate drug safety alerts. Reporting procedures for healthcare professionals to report adverse drug events to PvPI are also outlined.
Spontaneous Reporting and Prescription Event Monitoring.pptxDrRajeshHadia
This document discusses pharmacovigilance and post-marketing drug safety monitoring. It defines key terms like adverse drug reaction and signal. It explains limitations of pre-approval clinical trials in detecting all ADRs. Various pharmacovigilance strategies are outlined like spontaneous reporting, prescription event monitoring, and case studies. Reporting procedures and timelines are provided. The national pharmacovigilance program in India is described with its structure and operations. Benefits and limitations of spontaneous reporting are highlighted. Prescription event monitoring is explained as a form of post-marketing surveillance.
This document provides an overview of pharmacovigilance presented by Dr. S P Srinivas Nayak. It begins with a case study of a patient who experienced an allergic reaction after receiving ondansetron. It then defines key terms like adverse drug reaction and adverse event. It describes different types of ADRs based on factors like onset, mechanism and severity. It discusses pharmacovigilance including definitions, objectives, ADR reporting and the pharmacist's role in detecting, assessing and managing ADRs. The presentation concludes with definitions of key pharmacovigilance concepts and a thank you from Dr. Nayak.
Pharmacovigilance is the science of monitoring the safety of medicines. It aims to detect adverse effects from drugs, understand their causes, and prevent patient harm. Pharmacovigilance programs collect reports of adverse drug reactions and analyze the data to identify safety issues, quantify risks, and communicate safety information to patients and healthcare professionals. The ultimate goals are to protect patients and promote the safe use of medicines.
Pharmacovigilance involves monitoring adverse drug reactions (ADRs) that are detected after drugs receive marketing approval. ADRs are defined as harmful effects from normal drug dosages. Several types of ADRs exist and can be serious or severe. Possible causes include drug interactions and underlying medical conditions. Reporting and monitoring ADRs through pharmacovigilance aims to improve patient safety and reduce risks from drug use.
This document discusses pharmacovigilance and the need for monitoring drug safety post approval. It describes how historical drug safety issues like the Elixir Sulfanilamide and Thalidomide tragedies revealed limitations in pre-approval testing and established the need for ongoing pharmacovigilance. The aims, application and reporting processes of pharmacovigilance are outlined along with terminology and examples of regulatory actions taken based on adverse event reporting.
Pharmacovigilance is the science of monitoring the safety of medicines. It plays a key role in identifying adverse drug reactions and preventing harm to patients. The goal of pharmacovigilance is to monitor drug safety, identify health risks, and prevent harm through careful tracking of side effects from clinical trials through a drug's entire lifecycle on the market. Major organizations like the FDA, EMEA, and WHO work to coordinate pharmacovigilance efforts internationally and protect public health.
Reporting Methods _ Global Pharmacovigilance1Hafsa Hafeez
This document discusses pharmacovigilance reporting methods and signal detection in the USA. It outlines several methods for reporting adverse drug reactions including passive surveillance like spontaneous reporting and case series, as well as active surveillance through sentinel sites and clinical investigations. It describes the FDA's role in pharmacovigilance including maintaining the FAERS database and evaluating safety signals. Signals are detected through data mining this database and can be validated by obtaining additional information from various sources.
Pharmacovigilance involves monitoring the safety of drugs at all stages, from development through post-marketing. It aims to detect, understand, and prevent adverse drug reactions through activities like adverse event reporting, drug monitoring, and studying medication errors and drug-related deaths. Pharmacovigilance is important for protecting public health as patterns of drug use change over time with globalization and advances in technology and medicine.
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Chapter wise All Notes of First year Basic Civil Engineering
Syllabus
Chapter-1
Introduction to objective, scope and outcome the subject
Chapter 2
Introduction: Scope and Specialization of Civil Engineering, Role of civil Engineer in Society, Impact of infrastructural development on economy of country.
Chapter 3
Surveying: Object Principles & Types of Surveying; Site Plans, Plans & Maps; Scales & Unit of different Measurements.
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Chapter 4
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Chapter 6
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ADVERSE DRUG REACTION, types and reporting
1. MOHIT PANDEY
TEERTHANKER MAHAVEER COLLEGE OF PHARMACY
TMU, MORADABAD
ADVERSE DRUG REACTION
A
PRESENTATION
CLINICAL RESEARCH AND PHARMACOVIGILANCE
COURSE CODE :- MPL204T
FOR PARTIAL
FULLFILMENT OF
MASTER OF PHARMACY
(PHARMACOLOGY)
PRESENTED BY:-
MOHIT PANDEY
M.PHARM 2 SEM
(PHARMACOLOGY)
PRESENTED TO:-
Dr. MAYUR PORWAL
ASSOCIATE PROFESSOR
PHARMACOLOGY
2. According to WHO “A response to a drug that is
noxious and unintended and occurs at doses normally
used in man for the prophylaxis, diagnosis or therapy
of disease, or for modification of physiological
function”.
Noxious means :- injurious or harmful
2
4. MOHIT PANDEY
Pre-Marketing surveillance Post-Marketing surveillance
Phase-1
Phase-2
Phase-3
Spontaneous ADR Reporting
Epidemiological methods
Case Control Cohort Studies
4
5. MOHIT PANDEY
Post-Marketing surveillance
Pharmacovigilance methodologies are used for detection of risk and for the collection of risk information.
Two epidemiological methods are most commonly used which are:
COHORT STUDIES :- Patient exposed to a particular drug and are followed up actively and
systematically then the ADR frequencies are compared to an unexposed control population.
CONTROL STUDIES :- Individual affected by the adverse event being studied are identified. Each
case is matched with several disease ,both cases and controls are investigated their exposure to
possible causative agents prior to occurrence of the event. The odd ratio calculated on the basis of
exposure data.
5
6. 6
Any undesirable adverse event suspected
to be associated with use of drug,
biological product, herbal
drugs,cosmetics,medical devices, should
be reported.
All ADRs as a result of prescription or non
prescription.
All suspected ADR regardless of whether
or not the product was used in accordance
with the product information provided by
the company marketing the product.
Patient information.(confidential manner)
Description of adverse reactions
(laboratory results, if available are to be
included).
Information related to the suspected
drug(s).
Information about how the adverse
reaction had been managed.
Information about the reporter.
7. MOHIT PANDEY
WHO-UMC (Uppsala Monitoring Centre)
National Coordination centre (NCC)
IPC,Ghaziabad
ADR Monitoring Centre (AMC)
Healthcare professionals, patients and other
FIG.- ADR REPORTING PROCESS
7
9. Seriousness
Seriousness of an ADR is refers to its life threatening nature and is defined as
“Any untoward reaction to the medicinal product that may result in death, requires
inpatient hospitalization or results in prolongation of existing hospitalization,
results in persistent or significant disability/incapacity, is a congenital
anomaly/birth defect, or is a medically important event or reaction.”
untoward :- unexpected
Severity
The term “Severe or severity” is often used to describe the intensity of a specific
medical event ( graded as in mild,moderate,severe or lethal).
9
11. MOHIT PANDEY
Seriousness Assessment
Seriousness of reaction is categorized according to FDA criteria on the basis of their life
threatening nature.
• Death
• Life-threatening
• Hospitalization (initial or prolonged)
• Disability or permanent Damage
• Congenital Anomaly/Birth defect
11
12. MOHIT PANDEY
TERMINOLOGIES IN ADR
ADVERSE DRUG
REACTION:- Any noxious
change which is
suspected to be due to a
drug, occurs at doses
normally used in man,
requires treatment or
decrease in dose or
indicates caution in future
use of the same drug.
ADVERSE DRUG EVENT:-
Any untoward medical
occurrence that may
present during treatment
with a pharmaceutical
product but which does not
necessarily have a causal
relationship with this
treatment.
SIDE EFFECT:- This
refers to any known
effect of a
pharmaceutical
product occurring at
normal dosage which
is related to the
pharmacological
properties of the drug.
12
13. MOHIT PANDEY 13
1. Petrova G, Stoimenova A, Dimitrova M, Kamusheva M, Petrova D, Georgiev O.
Assessment of the expectancy, seriousness and severity of adverse drug reactions reported
for chronic obstructive pulmonary disease therapy. SAGE open medicine. 2017 Jan
31;5:2050312117690404.
2. Pharmacovigilance Programme of India (ipc.gov.in)