Pharmacovigilance Programme of India: A Review

Global Journal of Medical Research: B Pharma, Drug Discovery, Toxicology & Medicine Volume 19 Issue 3 Version 1.0 Year 2019 Type: Double Blind Peer Reviewed International Research Journal Publisher: Global Journals Online ISSN: 2249-4618 & Print ISSN: 0975-5888 Pharmacovigilance Programme of India: A Review By Saurabh Nimesh, Surabhi Gupta & Kapil Dev Negi Subharti University, Meerut Abstract- In India, a proper adverse drug reaction monitoring system was started in 1986 with 12 regional centers. In 1997, India became the member of the World health organization Programme for International Drug watching managed by the Upsala Monitoring Centre, Sweden. At origination, 6 regional centers were created in Mumbai, New Delhi, Kolkata, Lucknow, Pondicherry, and Chandigarh for ADR watching within the country. Promoting safe use of drugs may be a priority of the Indian Pharmacopoeia Commission that functions as the National Coordination Centre for Pharmacovigilance Programme of India. Today, 179 adverse drug reactions monitoring centers presently report adverse events to the National coordinative centre in India. Keywords: vigiflow, UMC, death, thalidomide, reporting form, phocomelia. GJMR-B Classification: NLMC Code: QV 20.5 PharmacovigilanceProgrammeofIndiaAReview Strictly as per the compliance and regulations of: © 2019. Saurabh Nimesh, Surabhi Gupta & Kapil Dev Negi. This is a research/review paper, distributed under the terms of the Creative Commons Attribution-Noncommercial 3.0 Unported License http://creative commons.org/licenses/by-nc/3.0/), permitting all non-commercial use, distribution, and reproduction in any medium, provided the original work is properly cited. Pharmacovigilance Programme of India: A Review Keywords: vigiflow, UMC, death, thalidomide, reporting form, phocomelia. I. Introduction A ccording to World Health Organisation (WHO), Pharmacovigilance (PV) as the pharmacological science and activities relating to the monitoring, detection, assessment, understanding, and prevention of adverse drug reactions (ADRs), or any long-term and short-term medicine-related problems (Figure 1&2). Variety of ADRs associated with medication prompted the event of the science of PV [1-4]. This prompted WHO for a systematic study of ADR of medicine, that is that the starting of PV. Thenceforth variety of ADRs was detected, a number of that square measure shows in (Table 1). ADR is taken into account to be the 6th leading reason behind death. India, with a current population of 1.27 billion, is that the 4th largest producers of prescription drugs within the world with quite 6000 licensed makers and over 60000 branded formulations within the market. In the United States of America, ADRs contribute 3-7% of hospital admissions. In England, 1% chronicles of the entire hospital admissions were due to ADRs throughout the year 1999-2008. ADRs square measure common in the Australian healthcare system additionally and that they contribute to a 1% of hospital admissions [5,6]. The percentage of hospital admissions due to ADRs in bound countries is 100% or additional. Author α: M. Pharm. (Pharmacology) Research Scholar, Department of Pharmacology, Meerut Institute of Engineering and Technology, Meerut (Uttar Pradesh), India. e-mail: nimeshmiet@gmail.com Author σ: Professor& Head, Department of Pharmacology, Subharti Medical College, Subharti University, Meerut, (Uttar Pradesh), India. Author ρ: Pharmacovigilance Associate, Department of Pharmacology, Subharti Medical College, Subharti University, Meerut (Uttar Pradesh), India. Drug attributed deaths square measure calculable to be 0.19% altogether medical inpatients. About 0.40% of ADRs known were directly joined to high costs. ADRs not solely increase the mortality and morbidity; however, additionally multiply the health care value [7]. The PV effort within India is coordinated bythe Indian Pharmacopoeia Commission (IPC) and conducted by the Central Drugs Standard Control Organization (CDSCO). The most responsibility of the IPC is to keep up and develop the PV database consisting of all suspected ADR to medicines observed. IPC is functioning as a National Coordination Centre (NCC) for the Pharmacovigilance Programme of India (PvPI). NCC is working underneath the direction of a committee that recommends procedures and guidelines for regulatory interventions [8].The main responsibility of NCC is to watch all the ADR of medicines being observed within the Indian population and to develop and maintain its PV information. The aim of the commission that acts just like the NCC for PvPI is for the safety of the patient, and the population with relevancy use of the drug. The Commission has become operational from 1st January 2009 an associate autonomous body, absolutely supported by the central government with specific fund allocations under the administrative control of the Ministry of Health and Family Welfare [9]. The Secretary, Ministry of Health and Family Welfare, is the Chairperson and therefore the Chairman-Scientific Body is that the Co-Chairman of the Commission. The Secretary-cum Scientific Director is that the Chief Scientific and Executive officer of the Commission. The CDSCO, Directorate General of Health Services underneath the aegis of Ministry of Health & Family Welfare, Government of India unitedly with IPC, Ghaziabad is initiating a nation-wide PV program for shielding the health of the patients by reassuring drug safety. The program shall be coordinated by the IPC, as an NCC. The center can operate underneath the superintendence of a steering committee. The PvPI was initiated by the government of India on 14th July 2010 with the All India Institute of Medical Sciences (AIIMS), New Delhi as the NCC for monitoring ADRs in the country for safeguarding public health. Within the year 2010, 22 ADR monitoring center, as well as AIIMS, came upon underneath this program [10-13]. To confirm the implementation of this program in an exceedingly method, the NCC was shifted from the AIIMS to the IPC, Ghaziabad, Uttar Pradesh on 15th April 2011 (Figure 3). © 2019 Global Journals Year system was started in 1986 with 12 regional centers. In 1997, India became the member of the World health organization Programme for International Drug watching managed by the Upsala Monitoring Centre, Sweden. At origination, 6 regional centers were created in Mumbai, New Delhi, Kolkata, Lucknow, Pondicherry, and Chandigarh for ADR watching within the country. Promoting safe use of drugs may be a priority of the Indian Pharmacopoeia Commission that functions as the National Coordination Centre for Pharmacovigilance Programme of India. Today, 179 adverse drug reactions monitoring centers presently report adverse events to the National coordinative centre in India. 9 Global Journal of Medical Research ( BD ) Volume XIX Issue III Version I Abstract- In India, a proper adverse drug reaction monitoring 2019 Saurabh Nimesh α, Surabhi Gupta σ & Kapil Dev Negi ρ Pharmacovigilance Programme of India: A Review Pharmaceutical Industries Health Care National Coordination Centre Year 2019 Professionals World Health Organization National Regulatory Authority Global Journal of Medical Research ( BD ) Volume XIX Issue III Version I 10 Other Established Regulatory Authorities Figure 1: Diagrammatic representation of the Pharmacovigilance Figure 2: Pharmacovigilance framework Table 1: Nine examples of serious & unexpected ADR cause to drugs [14] Sr. No. 1 2 3 4 5 6 7 8 9 © 2019 1 Global Journals Drug Chloroform (Anaesthetic) Sulphanilamide (Elixir) Thalidomide Clioquinol Practolol Benoxaprofen Terfenadine Rofecoxib Veralipride Year 1848 1937 1961 1970 1975 1982 1997 2004 2007 Serious & unexpected adverse event Episode of ventricular fibrillation & death Death Amelia, phocomelia &dysmelia Subacute nephropathy Sclerosing peritonitis Nephrotoxicity&cholestatic jaundice Torsade de pointes Cardiovascular effects Anxiety, depression & movement disorders Year 2019 Pharmacovigilance Programme of India: A Review Figure 3: Pharmacovigilance Programme of India II. History of the Pharmacovigilance Programme in India The concept of PV is not new, because the time of Charak Samhita in 700 BC had cautioned that properly understood however improperly administered drug is Vagueness poison and Vagbhatta- a physician represented adverse events, reason, delayed ADRs to Ayurvedic Drugs’ around 500 AD. After that, many reports of ADRs from India area unit found within the history of modern medicine, but there was no systematic effort of ADR monitoring since the primary try was created in 1989 [15,16]. III. Scope of the Pharmacovigilance Programme of India Before registration and selling of drugs within the country, its safety and efficaciousness expertise area unit primarily based totally on the employment of the drugs in clinical trials. These trials in the notice common ADR. Some vital reactions, like those, that take a protracted time to develop, or those, that occur seldom, might not be detected in clinical trials. Additionally, the controlled conditions beneath that medicines area unit utilized in clinical trials don't essentially replicate the method they will be utilized in observe. For a drug to be thought-about safe, its expected advantages ought to be more than any associated risks of harmful reactions. So, to achieve a comprehensive safety profile of drugs, a continuous post-marketing monitoring system, i.e. PV is crucial. To monitor the security of drugs, information from several sources is employed for PV [17]. These embrace spontaneous ADRs coverage mechanism; medical literature published worldwide; action taken by regulative authorities in alternative countries. Since there exist substantial social and economic consequences of ADRs and therefore the positive benefit/cost magnitude relation of implementing applicable risk management -there may be a have to be © 2019 Global Journals Global Journal of Medical Research ( BD ) Volume XIX Issue III Version I 11 Pharmacovigilance Programme of India: A Review compelled to interact health care professionals and therefore the public at massive, during a well-structured program to make synergies for watching ADRs within the country. The PvPI aims is to collate data, method and analyze it and use the inferences to advocate regulative interventions, besides human action risks to health care professionals and therefore, the public [18]. Year 2019 Management of the IV. Pharmacovigilance Programme of India Global Journal of Medical Research ( BD ) Volume XIX Issue III Version I 12 This is headed by the Secretary cum scientific Director: Dr. Gyanendra Nath Singh, who is working with the help of Advisor and National Scientific Coordinator supported by the several committees like- Steering Committee, Working Group, Quality Review Panel, Core Training Panel, etc. involving experts from all over the country.Current Status of NCC-PvPI Presently the PvPI program has more than 200 Adverse Drug Monitoring Centres (AMCs) involving all states and Union Territories through-out India[19]. V. Reporting of Adverse Drug Reactions Suspected ADR reporting forms for health care professionals (Figure 4) and consumers (Figure 5) a unit available on the website of IPC to report ADR. To get rid of barrier in ADR reporting, the consumer reporting form is available in 10 vernacular languages (Hindi, Tamil, Telugu, Kannada, Bengali, Gujarati, Assamese, Marathi, Oriya, and Malayalam). ADRs will be conjointly reportable via PvPI helpline number (18001803024) on week days from 9:00 am to 5:30 pm. The mobile Android application for ADR reporting has conjointly been created available to the general public [20]. © 2019 1 Global Journals Year 2019 Pharmacovigilance Programme of India: A Review Global Journal of Medical Research ( BD ) Volume XIX Issue III Version I 13 Figure 4: Suspected ADR reporting form for Healthcare professionals © 2019 Global Journals Year 2019 Pharmacovigilance Programme of India: A Review Global Journal of Medical Research ( BD ) Volume XIX Issue III Version I 14 Figure 5: ADRs reporting form for consumers © 2019 1 Global Journals Year The WHO Program for International Drug Monitoring provides a forum for WHO member states that has India to collaborate within the monitoring of drug safety. At intervals the Program, individual case reports of suspected ADRs are collected and keep in an exceedingly common information, presently containing over 3.7 million case reports. Since 1978, the Uppsala Monitoring Centre (UMC) in Sweden has dispensed the Program. The UMC is accountable for the gathering of knowledge concerning ADRs from around the world, particularly from countries that are members of the WHO together with India. Member countries send their reports to the UMC wherever they are processed, evaluated, and entered into the WHO International information. When there are several reports of adverse reactions to a particular drug, this process may lead to the detection of a signal- an alert about a possible hazard communicated to member countries. This happens solely once elaborated analysis and expert review. These ADR reports are assessed regionally and will cause the action at intervals in the country. Through membership of the WHO International Drug Monitoring Program, a rustic will recognize if similar reports are being created elsewhere. India is a country with a large patient pool and healthcare professionals, yet ADR reporting is in its infancy (Table 2) [21-23]. Table 2: Responsibilities & functions of the stakeholders in the program Centre ADR monitoring centre PvPI AMC other than medical colleges [Corporate hospitals, autonomous institutes, Pharmaceutical industry and public health Programmers] Pharmacovigilance programme of India, National coordinating centre, Indian pharmacopoeia commission(Ghaziabad) Zonal/Sub-zonal CDSCO Offices Central drugs standard control organizationHeadquarter (New Delhi) VII. Role Collection of ADR reports, perform follow up with the complainant to check completeness as per standard operating procedure (SOPs), data entry into Vigiflow, reporting to PvPI-NCC through Vigiflow with the source data (original) attached with each ADR caseTraining/ sensitization/ feedback to physicians through newsletters circulated by the PvPI-NCC. Collection of ADR reports, perform follow up with the complainant to check, completeness as per SOPs, report the data to CDSCO- Headquarter (HQ). Preparation of SOPs, guidance documents & training manuals, data collation, Cross-check completeness, Causality Assessment etc as per SOPs, conduct Training workshops of all enrolled centres, publication of medicines safety newsletter, reporting to CDSCO-HQ, Analysis of the Performance measurement system, Periodic safety update report, Adverse event following immunization data received from CDSCO-HQ. Provide procurement, financial and administrative support to ADR monitoring centres, report to CDSCO-HQ. Take appropriate regulatory decision & actions on the basis of recommendations of PvPI NCC at IPC, propagation of medicine safety related decisions to stakeholders, collaboration with WHO-UMC, provide for budgetary provisions &administrative support to run PvPI. Aim of the Pharmacovigilance Programme of India Pharmacovigilance has specific aims as follows: 1. Improve patient care and safety in about the use of medicines and all medical and paramedical interventions. 2. Improve public health and safety in about the use of medicines. 3. Contribute to the assessment of benefit, harm, effectiveness, and risk of medicines, encouraging their safe, rational and more effective (including cost-effective) use. 4. Promote understanding, education, and clinical training in PV and its effective communication to the public[24]. VIII. Objectives of the Pharmacovigilance Programme of India 1. To create a nation-wide system for patient safety reporting. 2. To identify and analyze the new signal ADR from the reported cases. 3. To analyze the benefit-risk ratio of marketed medications. © 2019 Global Journals 15 Global Journal of Medical Research ( BD ) Volume XIX Issue III Version I VI. World Health OrganizationUppsala Monitoring Centre & India 2019 Pharmacovigilance Programme of India: A Review Year 2019 Pharmacovigilance Programme of India: A Review Global Journal of Medical Research ( BD ) Volume XIX Issue III Version I 16 4. To generate the evidence-based information on the safety of medicines. 5. To support regulatory agencies in the decisionmaking process on the use of medications. 6. To communicate the safety information on the use of medicines to various stakeholders to minimize the risk. 7. To emerge as a national center of excellence for PV activities. 8. To collaborate with other national centers for the exchange of information and data management. 9. To provide training and consultancy support to other national PV centers located across the globe[25,26]. IX. Conclusion The adverse drug reaction observation and reporting programs or pharmacovigilance program of India is aiming to identify the risks related to the utilization of the drugs. The current analysis has disclosed opportunities or interventions particularly or avertible adverse events, which arecan to facilitate in promoting safer drug use, data to the health care professionals. Improve the standard of patient care and educate to extend awareness. Therefore, currently, this point has returned to aware the general public too for the reporting the adverse drug reaction to the nearest hospital or ADR monitoring center or the health care professionals. They will directly report the adverse drug reaction through the government. Toll-free number 18001803024, adverse drug reaction application, email, and alternative methodology like social media. Acknowledgement None Conflict of Interest The Authors declare that there is no conflict of interest. Abbreviations: WHO: World health organization, CDSCO: Central drugs standard control organization, PvPI: Pharmacovigilance programme of India, NCC: National coordinating centre, AIIMS: All India institute of medical sciences, IPC: Indian pharmacopoeia commission, PV: Pharmacovigilance, ADR: Adverse drug reaction, AMC: ADR monitoring centre, UMC: Uppsala monitoring centre. References Références Referencias 1. 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