Indian Pharmacopoeia Commission Research Articles

Pattern of adverse drug reactions reporting in two medical colleges of Tripura, India: a cross sectional study

Background: India as an important clinical trial hub in the world. In clinical trials, many of the drug issues related to the safety are inadequately studied in highly selected and limited number of patients. Due to introduction of many new drugs in the country, it has become essential to have an effective Pharmacovigilance system nationwide. Under reporting of ADRs is widespread and a daunting challenge in Pharmacovigilance programme of India (PvPI).Methods: A cross sectional study was conducted for two months with the objective to study the pattern of ADRs reporting in two teaching hospitals of Tripura. The data were collected in “Suspected ADR reporting forms” of Indian Pharmacopoeia Commission (IPC). Suspected ADRs were assessed for causality using Naranjo ADR probability scale.Results: 44 ADR reporting forms were received with 58 ADRS. Among them, Gastrointestinal System ADRs were the highest (25.86%). More ADRs were seen in males than females (52.27% vs 47.72%). 68.18% cases had the medication through oral route. Out of all ADRs, 67.24% were Type A reactions. Most of the reactions reported, were mild (90.9%) based on modified Hartwig severity scale. Most of the ADRs reported were of probable causality (score 5-9) measured by Naranjo’s Algorithm.Conclusions: This study would definitely give an insight into the pattern of ADRs in tertiary health care centers and may help to increase awareness of health care provider for further Pharmacovigilance studies.

Pharmacovigilance in India and its Impact in Patient Management

ABSTRACT Pharmacovigilance is the pharmacological science relating to the detection, assessment, understanding, and prevention of adverse effects, particularly the long-term and short-term adverse effects of drugs or treatment. The World Health Organization (WHO) established pharmacovigilance Programme for International Drug Monitoring in response to the thalidomide disaster detected in 1961. India joined the WHO adverse drug reaction (ADR) monitoring program based in Uppsala, Sweden, in 1998. The Central Drugs Standard Control Organization (CDSCO), Directorate General of Health Services, under the aegis of the Ministry of Health and Family Welfare, Government of India, in collaboration with Indian Pharmacopoeia Commission, Ghaziabad, is a National Coordinating Centre (NCC). Adverse drug reaction monitoring centers (AMCs) under the Pharmacovigilance Programme of India (PvPI) play a vital role in the collection and follow-up of ADR reports from the patients, as drug trials in animals and humans (Phase I–III) do not predict accurately the adverse drug events. Patients with chronic kidney disease (CKD)/liver disease are at risk of enhanced drug-related events. These patients should be closely monitored for any adverse events and it should be reported. Thus, inculcating the habit of ADR reporting will help in generating data specific to Indian population and will contribute toward patient safety. This will also help in modifying the treatment given to the patients, as early identification of ADRs will help in reducing morbidity and mortality in patients. How to cite this article Sharma G, Kumar R, Singh J, Bhandari V, Singh N. Pharmacovigilance in India and its Impact in Patient Management. Curr Trends Diagn Treat 2017;1(1):27-33.

Adverse Reactions after Hepatitis B Vaccination: A Retrospective Analysis Using Spontaneous Reports

: Background: Safety of vaccines is more critical because they are used for immunization in children and Hepatitis-B vaccination is included in national immunization schedule for neonates and infants in India. The National Coordination Centre (NCC)-Pharmacovigilance Programme of India (PvPI), Indian Pharmacopoeia Commission (IPC) monitors the adverse drug reactions/Adverse events (ADR/AE) associated with the drugs used in the country through WHO reporting system, VigiFlow. Objective of the study is to analyse ADR/AEs associated with Hepatitis B vaccination reported to NCC-PvPI through Vigi- Flow database. Methods: Retrospective analysis of the VigiFlow data were extracted and analysed with respect to patient demography, profession of reporter, system organ class (SOC) affected, causality assessment, seriousness of adverse event and year wise analysis of reported ADRs. Results: During the study period 295 ADR/AEs were reported following Hepatitis B vaccination. The adverse reactions following Hepatitis B immunization were primarily reported in infants (55.2 %) in age group 1-2 years. The causality assessment showed that 42.7% of the adverse events are probable/likely associated with Hepatitis B vaccination. Most of the cases were reported by the physician. The two main ADRs were fever 58.9% and injection site pain 11.5%. Conclusion: Data analyzed in our study showed only non-serious reactions were reported due to hepatitis B vaccination. Data also clearly showed that there is a need for reporting ADR/AEs associated with quality of vaccines that may affect safety of the vaccine, which may be possible by amending the suspected adverse drug reaction reporting form of NCC-PvPI.Key words: NCC-PvPI, Hepatitis B vaccine, ADR/AE, VigiFlow, System organ class (SOC)

PHARMACOVIGILANCE: AN INEVITABLE PATH TOWARDS DRUG SAFETY IN INDIA

Thalidomide disaster is one of the overturn jolt in the field of allopathic medicine that attracted the attention of practitioner all over the world towards adverse effects of drugs, then only the actual concept of monitoring of adverse drug reactions came into limelight. Pharmacovigilance is t he science and activities relating to the detectio n, assessment, understanding and prevention of adverse effects or any other p ossible drug - related problems . Pharmacovigilance not only allopathic drugs; but also include herbals, traditional medicines, blood products (Haemovigilance) , biological (biovigila nce), medical devices (materiovigilance) & vaccines. United Kingdom firstly introduced the yellow card for adverse drug reaction reporting. In India pharmacovigilan ce came into existence in 2010. Indian pharmacopoeia commission (IPC) is the national coordi nating centre for pharmacovigilance program of India, responsible for collection, assessment of reported ADRs from the various adverse drug rea ction monito ring centers & pharmaceutical co mpanies, also consulting central drug standard control organization (CDSCO) in generation of signal. IPC is also collaborating with World health organization (WHO) drug safety program. Main source of data collection of ADRs is spontaneous reporting method & mainly from healthcare professionals. For drugs, IPC - suspected ADRs reporting form for healthcare Professionals is used for reporting ADRs by doctors. IPC - has currently availed the ADRs reporting form for patie nt in english & local languages . National institute of b iologicals - has availed the form for Haemovigilance . Pharm acovigilance target to wards signal detection , creating warning, restricting drug use, sometimes withdrawal of drug from market & finally decreasing mortality & risk of ADRs in patients.

Mobile application an approach to enhance easy adverse drug reactions reporting in India

Technology in healthcare system has proved its significance. Mobile phones are assessed by the endless users in Indian population. Looking towards the pervasive usage of mobile phones can be contextualize in healthcare system to deliver health benefits in our population. Indian Pharmacopoeia Commission is functioning as National Coordination Centre for Pharmacovigilance Programme of India (PvPI). PvPI in technical collaboration with Netaji Subash Chandra Bose (NSCB) Medical College, Jabalpur developed Mobile (android) app for Adverse Drug Reactions (ADRs) reporting. This is a paperless, simple and quickly assessed through which ADRs can be reported. Morover causality algorithm is objective based rather than subjective. This facility will reduce the workload of healthcare professionals in reporting ADRs. This innovative development would be effective tool in promoting welfare of the patients.

An overview of the pharmacovigilance system in India

AbstractPharmacovigilance (PV) has witnessed several advancements throughout the world over the past few decades. This review provides an overview of the PV system in India, focusing on the current scenario, its development, the challenges faced, and the interventions suggested for its improvement. The Pharmacovigilance Program of India (PvPI) is playing a major role in gathering drug safety related data and adding it to the WHO database. PvPI fulfills the minimum requirements given by the WHO for any functional national Pharmacovigilance system. The Indian Pharmacopoeia Commission (IPC) is the national coordinating center under PvPI. PV in India relies mainly upon the spontaneous reporting of adverse drug events. The major challenge for PV in India is under-reporting. However, there is an improvement in the number of submitted reports after regular training and awareness programmes, which have been conducted by the IPC. The regular and periodic circulation of the ‘PvPI Newsletter’ by the IPC has also bee...

Pharmacovigilance Programme of India: System put in place to Report Adverse Drug Reactions.

Abstract: Dear Editor, Adverse drug reaction (ADRs) is response to a drug which is noxious and unintended and which occurs at doses normally used in human for the prophylaxis, diagnosis or treatment of disease, or for the modification of physiological function.1 ADRs are one of the major public health issues and found to cause of morbidity and mortality.2 The impact of ADRs in India is significant and leads to the enormous burden to the public. Therefore, Ministry of Health & Family Welfare (MoHFW), Government of India launched a nationwide Pharmacovigilance Programme of India (PvPI) in the year 2010 to monitor the safety of drugs. Indian Pharmacopoeia Commission (IPC) under the MoHFW functions as National Coordination Centre (NCC) for PvPI. To monitor and report ADRs to NCC, teaching hospitals and corporate hospitals have been identified as ADRs Monitoring Centres (AMCs).3-5 Read more...

Adverse drug reaction profile of microtubule-damaging antineoplastic drugs: A focused pharmacovigilance study in India.

Objectives:The aim of the study was to analyze the adverse drug reaction (ADR) profile of microtubule-damaging antineoplastic drugs (taxanes and vinca alkaloids) and to look for unexpected ADRs among the local population. Focused study on these drugs, rampantly used in oncology department for a wide variety of tumors including early and advanced malignancies, would enable better treatment care by physicians.Materials and Methods:Data on ADRs were collected from the cancer patients belonging to both gender and of all ages, on taxanes- or vinca-based cancer chemotherapy and reported in the Indian Pharmacopoeia Commission form. Causality was assessed using the WHO criteria and Naranjo's Algorithm. Preventability and severity of ADRs were also assessed.Results:A total of 97 ADRs were reported among 488 patients on microtubule-damaging anticancer drugs admitted over a period of 1 year. The incidence rate was 19.87%. Gastrointestinal system (40.2%) was the most affected followed by bone marrow (33%) and skin (8.2%). The highest incidence of ADRs was reported among paclitaxel (54.6%), and vincristine (39.2%). Most of the reported ADRs were of milder nature and preventable. The WHO causality assessment scale indicated 71.1% possible reactions.Conclusions:This study showed that most ADRs are preventable with effective ADR monitoring. There is a great need to create awareness among healthcare professionals regarding the importance of the pharmacovigilance system. Judicious use of the preventive measures will lead to a reduction in the incidence of ADRs due to the drug armamentarium, thereby enabling additional economic benefit to the patient and society.

Pharmacovigilance Programme of India: Recent developments and future perspectives.

Promoting safe use of medicines is a priority of Indian Pharmacopoeia Commission that functions as the National Coordination Center (NCC) for Pharmacovigilance Programme of India (PvPI). One hundred and seventy-nine adverse drug reactions (ADRs) monitoring centers currently report ADRs to NCC. Current India contribution to global safety database reaches 3% and the completeness score is 0.93 out of 1. NCC is taking several measures to enhance patient safety including capacity building for monitoring, surveillance, collaboration with national health programs and other organizations to increase ADR reporting and to ensure that PvPI is a vital knowledge database for Indian regulators. The Central Drugs Standard Control Organization has notified important safety label changes on drugs such as carbamazepine and piperacillin + tazobactam in the year 2015, other drugs are under monitoring for regulatory interventions.

Pharmacovigilance in radiopharmaceuticals.

Indian Pharmacopoeia Commission is Committed for maintaining the standards of drugs including Radiopharmaceuticals (RPs) by publishing Indian Pharmacopoeia. These RPs are being used in India for diagnostic or therapeutic purpose. RPs though contain relatively small quantities of active ingredient and administered in small volumes could cause some adverse reactions to the patients. The objective of presenting this article is to introduce the system of adverse drug reaction reporting to the nuclear medicine fraternity who are dealing with RPs.

Implementing the Principle of the 3 Rs Through the Indian Pharmacopoeia.

Quality and safety tests are required for regulatory approval of drugs and pharmaceuticals in the country to guarantee minimum safety standards, and most of these tests include animal usage. In the case of biological medicines, these safety and quality tests have to be performed on a batch-to-batch basis and require a large number of animals. Russell and Burch's 1959 principle of the 3 Rs- replacement, reduction, and refinement-is now being increasingly adopted worldwide, and various national and international pharmacopoeias have taken initiatives to safeguard animals. This article details the Indian Pharmacopoeia Commission's initiative to implement the 3 Rs through the Indian Pharmacopoeia. Explored are the deletion of animal tests, such as the abnormal toxicity test at final lot for biologicals; the replacement of in vivo methods by in vitro methods; the reduction in the number of animals used where deletion of the animal test is not possible; and the refinement of tests to cause minimal suffering to the animals. In Indian Pharmacopoeia 2014, pyrogen testing using rabbits has been replaced by the bacterial endotoxin test in the majority of biological monographs-keeping in view international trends and, especially for vaccine monographs, validated in vitro tests such as the bacterial endotoxin test as an alternative to the pyrogen test where justified and authorized. Steps are taken for introducing a single-dilution assay for the potency testing of diphtheria and tetanus vaccine (adsorbed) with the aim of minimizing number of animals used. The justified and authorized use of animals in drug manufacturing, analytic laboratories, and research will not only help in the expedited development/production of drugs but also be useful in protecting and promoting animal health.

Haemovigilance study at a tertiary care hospital in the north‐east of India

Background and AimBlood transfusion is a frequent and integral part of critical patient care. Even though life‐saving, it could be occasionally risky and result in a spectrum of adverse events. Haemovigilance programme is a standard set‐up to monitor the entire transfusion chain, evaluate and analyse the data to improve patient's safety. The haemovigilance programme has been established in India very recently. We report the implemented haemovigilance programme at a tertiary care hospital in the north‐east of India.Methods and MaterialsThis study was prospective and observational. It was carried out for a period of 9 months, from September 2013 to May 2014, in the State of the Art Model Blood Bank, Gauhati Medical College and Hospital, Guwahati, Assam, India. Transfusion reaction reporting forms, which are supplied by the Indian Pharmacopoeia Commission, were utilized to collect the data.ResultsA total of 51 000 blood components were transfused and 106 adverse events reported during the period of the study. The major stakes of adverse events were febrile non‐haemolytic transfusion reactions (50%), pruritus (17·92%) and rigour/chills (11·32%). All the adverse events were found to be Grade 1 (non‐severe) type, and there were no severe or life‐threatening adverse events.

Role of Pharmacovigilance in India: An overview

Pharmacovigilance (PV) plays a key role in the healthcare system through assessment, monitoring and discovery of interactions amongst drugs and their effects in human. Pharmaceutical and biotechnological medicines are designed to cure, prevent or treat diseases; however, there are also risks particularly adverse drug reactions (ADRs) can cause serious harm to patients. Thus, for safety medication ADRs monitoring required for each medicine throughout its life cycle, during development of drug such as pre-marketing including early stages of drug design, clinical trials, and post-marketing surveillance. PV is concerns with the detection, assessment, understanding and prevention of ADRs. Pharmacogenetics and pharmacogenomics are an indispensable part of the clinical research. Variation in the human genome is a cause of variable response to drugs and susceptibility to diseases are determined, which is important for early drug discovery to PV. Moreover, PV has traditionally involved in mining spontaneous reports submitted to national surveillance systems. The research focus is shifting toward the use of data generated from platforms outside the conventional framework such as electronic medical records, biomedical literature, and patient-reported data in health forums. The emerging trend in PV is to link premarketing data with human safety information observed in the post-marketing phase. The PV system team obtains valuable additional information, building up the scientific data contained in the original report and making it more informative. This necessitates an utmost requirement for effective regulations of the drug approval process and conscious pre and post approval vigilance of the undesired effects, especially in India. Adverse events reported by PV system potentially benefit to the community due to their proximity to both population and public health practitioners, in terms of language and knowledge, enables easy contact with reporters by electronically. Hence, PV helps to the patients get well and to manage optimally or ideally, avoid illness is a collective responsibility of industry, drug regulators, clinicians and other healthcare professionals to enhance their contribution to public health. This review summarized objectives and methodologies used in PV with critical overview of existing PV in India, challenges to overcome and future prospects with respect to Indian context.

System of adverse drug reactions reporting: What, where, how, and whom to report?

Sir, The continuous progress in medical and pharmaceutical sciences has made the availability of pharmaceutical products in the Indian market to prevent and control of several disease conditions. Irrespective of the benefits associated with the use of medicines adverse effects associated with them has emerged the challenges of monitoring Adverse Drug Reactions (ADRs) over large population base. World Health Organization (WHO) defined ADR as “A response which is noxious and unintended, and which occurs at doses normally used in humans for the prophylaxis, diagnosis, or therapy of disease, or for the modification of physiological function.”[1] To improve public health, the safe use of medicine must be monitored through an effective pharmacovigilance (PV) system. PV is defined as the science and activities relating to the detection, assessment, understanding and prevention of adverse effects, or any other possible drug-related problems.[2] Indian Pharmacopoeia Commission (IPC), Ghaziabad is functioning as a National Coordination Centre (NCC) for Pharmacovigilance Programme of India (PvPI). One Hundred and fifty ADR monitoring centres (AMCs) were established in various medical institutions/hospitals across India to monitor and collect ADR reports under NCC-PvPI.[3]

Indian Pharmacopoeia Commission's Partners for Promoting Public Health

In order to promote the awareness and to monitor the adverse drugs reactions, one of the most noteworthy nation-wide programme initiated by IPC on 15th April 2011 under the aegis of Central Drugs Standard Control Organization (CDSCO), is Pharmacovigilance Programme of India (PvPI). IPC is a National Coordination Centre (NCC) for PvPI, meant for protecting the health of the public by assuring medicines safety. PvPI monitors the benefitrisk profile of medicines & generate independent, evidence based recommendations on safety of medicines & support CDSCO for formulating safety related regulatory decisions for medicines. With a view to establish a centre of excellence for pharmacovigilance in India, NCC-PvPI collaborated with the WHO-Uppsala Monitoring Centre (UMC), Sweden & participating in International Drug Monitoring Programme & now become a significant contributor for the global drug safety database. The WHO country office for India coordinates with NCC-PvPI in terms of providing technical support for organizing training programmes, awareness programmes,meetings and updating PV toolkit etc. PvPI has been continuously taken several steps for ensuring patient safety and well being of society, in this regards PvPI expanded its patient safety programme to 150 AMCs across the country & also collaborated with different National Health Programme (AEFI, NACO, RNTCP) as it has been always preeminent to established safety and efficacy of medicines used in these NHP(s). As consumers / patients are the important allies for any country's pharmacovigilance programme, PvPI has taken step towards encouraging consumers reporting by the release of medicines side effect reporting form for consumers in different regional languages. For the last two decades, pharmacovigilance has been gaining an increasing attention. It is now, high time for national authorities, multilateral agencies, nongovernmental organizations, healthcare institutions, pharmaceutical industries & lay public to work together for the effective implementation of PvPI across the country.

Direct Consumer Reporting of ADRs to PvPI, a Position Paper of Indian Pharmacopoeia Commission

Patients/consumers are end user of medicines and should play important role in reporting the Adverse Drug Reactions (ADRs) to pharmacovigilance system. Consumers can provide detailed first-hand in formation about their experiences with medicines and how these medicines have affected their life. Direct consumer reporting leads to earlier identification and accumulation of signals and may provide neglected details related to psychiatric feelings and quality of life. Consumers may report ADRs due to “over the counter” (OTC) medicines, herbal medicines, and ADRs related to excipients and potential interactions. Direct patient/ consumer reporting will also rectify the under-reporting by patients to physician and will change the attitude related to importance of patient’s experience. NCC-PvPI (National Coordination Centre-Pharmacovigilance Programme of India), IPC (Indian Pharmacopoeia Commission) had launched “Medicines Side Effect Reporting form for Consumer” (blue form) at the National level conference on “Participation of patient/consumer organization in PvPI” on 1st August, 2014, which encourages patient or his/her representative (relative) to report ADRs directly either by submitting the form to the NCC-PvPI or to the nearest AMC (Adverse Drug Reaction Monitoring Centres) under PvPI. Consumers can also reports through toll free helpline number: 1800-180-3024 or email id: pvpi.compat@gmail.com to NCC-PvPI.

Current Status of Adverse Drug Reactions Monitoring Centres under Pharmacovigilance Programme of India

There are one hundred and fifty Adverse Drug Reactions Monitoring Centres (AMCs) across the country are functioning and reporting’s Adverse Drug Reactions to National Coordination centre (NCC), Pharmacovigilance Programme of India (PvPI) at Indian Pharmacopoeia Commission (IPC), Ghaziabad. The AMCs are established to collate data on Pharmacovigilance and forward to NCC via online software (VigiFlow). The present AMCs are Medical Council of India (MCI) approved teaching hospitals and corporate hospitals. NCC is working with AMCs to coordinate with Pharmacy institutions to enhance ADRs reporting.

Setting up haemovigilance from the very first step. The Indian perspective

Background and ObjectivesSetting up a national haemovigilance programme requires meticulous planning, and the following issues need to be addressed: whether reporting will be voluntary or mandatory, what is to be reported and by whom, reporting formats and resources to sustain the programme. With this in view, it was aimed to set up a national haemovigilance programme in India.Materials and MethodsThe Ministry of Health and Family Welfare, Govt. of India had launched the national Pharmacovigilance Programme (PvPI) in July 2010, with oversight by the Indian Pharmacopoeia Commission. Adverse Drug Reaction (ADR) Centres were set up in 90 medical institutes in the country, and trained staff was recruited for data collection and submission. After the successful establishment of PvPI, the haemovigilance programme was initiated as a collaborative venture between National Institute of Biologicals (NIB) and Indian Pharmacopoeia Commission with the coordinating centre at NIB. Five expert subgroups with defined responsibilities will analyse and collate data and make evidence‐based recommendations to the regulatory authorities for blood safety initiatives and their compliance.ResultsThe initial focus is on reporting the adverse reactions as defined by the Working Party of the International Society of Blood Transfusion, reporting is voluntary, and a Guidance Document and the TRRF have been made available to the medical institute blood banks. The reporting is online through software, ‘Haemo‐Vigil’. Reporting commenced from February 2013 and till date 731 reports of adverse reaction have been submitted.ConclusionA well‐structured programme of haemovigilance has been initiated in India.

Quality Standards and Current Status of Ophthalmic Formulations in Indian Pharmacopoeia and National Formulary of India.

The global ophthalmic formulations (OFs) market is expanding dramatically with the approval of new drug formulations for a variety of ophthalmic indications by competent authorities in various countries. In India, the Central Drug Standards Control Organization (CDSCO) and Indian Pharmacopoeia Commission (IPC) are making efforts for approval and setting the standards for OFs, respectively. In fulfillment of the requirements of the Drugs and Cosmetics Act of 1940, the IPC is publishing an official book of standards for drugs known as the Indian Pharmacopoeia (IP). There are 44 ophthalmic active pharmaceutical ingredients (APIs) and combinations approved by CDSCO as of 2011; the IP 6th edition (2010) prescribes the quality standards monographs for 41 ophthalmic APIs and formulations. The IP monograph of OFs also includes description, identification, impurities, assay, and specific tests. In addition, the IPC is publishing the National Formulary of India (NFI), which covers 23 OFs for the diagnosis and treatment of various eye diseases. Both the IP and NFI play a significant role in monitoring and improving the safety and efficacy of medicines, with specific emphasis on OFs.

Simultaneous Estimation of Luteolin and Apigenin in Methanol Leaf Extract of Bacopa monnieri Linn by HPLC

Aims: To develop, validate and quantify the content of flavonoids luteolin and apigenin in aerial parts of methanol leaf extract of Bacopa monnieri (B. monnieri) by reverse phase liquid chromatography. Study Design: High Performance Liquid Chromatography Place and Duration of Study: Department of Pharmaceutical Analysis, KMCH College of Pharmacy, Coimbatore and Indian Pharmacopoeia Commission, Ghaziabad, India from 1.7.2010 to 30.6.2011. Methodology: Separation and quantification of flavonoids was performed on a C18 column (5μm, 200mm×4.6mm, id.) using potassium dihydrogen phosphate buffer (20mM, pH 3.5 adjusted with ortho phosphoric acid, v/v) and acetonitrile as mobile phase with a flow rate of 1ml/min. The column effluents were monitored at 348nm with column temperature kept at 30±1oC. Results: A validated method for simultaneous estimation of luteolin and apigenin was developed, where limits of detection and quantification was found to be 0.03 and 0.91μg/ml for luteolin, 0.041 and 0.13μg/ml for apigenin respectively. The percentage of Original Research Article British Journal of Pharmaceutical Research, 4(13): 1629-1637, 2014 1630 these phytoconstituents recovered was in the range of 98.07-99.71 (%RSD<2%). Conclusion: The developed validated HPLC method was found to be accurate, precise and robust and may be used for analysis of luteolin and apigenin in the extracts of B. monnieri.