|Year : 2016 | Volume
| Issue : 6 | Page : 624-628
Pharmacovigilance Programme of India: Recent developments and future perspectives
Vivekanandan Kalaiselvan1, Prasad Thota1, Gyanendra Nath Singh2
1 National Coordination Centre, Pharmacovigilance Programme of , n Pharmacopoeia Commission, Ministry of Health and Family Welfare, Ghaziabad, Uttar Pradesh, India
2 Pharmacovigilance Programme of , n Pharmacopoeia Commission, Ministry of Health and Family Welfare, Ghaziabad, Uttar Pradesh, India
|Date of Submission||25-Jan-2016|
|Date of Acceptance||10-Nov-2016|
|Date of Web Publication||29-Nov-2016|
National Coordination Centre, Pharmacovigilance Programme of India, Indian Pharmacopoeia Commission, Ministry of Health and Family Welfare, Ghaziabad, Uttar Pradesh
Source of Support: None, Conflict of Interest: None
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.
Keywords: Adverse drug reaction reporting, patient safety, Pharmacovigilance Programme of India
|How to cite this article:|
Kalaiselvan V, Thota P, Singh GN. Pharmacovigilance Programme of India: Recent developments and future perspectives. Indian J Pharmacol 2016;48:624-8
|How to cite this URL:|
Kalaiselvan V, Thota P, Singh GN. Pharmacovigilance Programme of India: Recent developments and future perspectives. Indian J Pharmacol [serial online] 2016 [cited 2017 May 25];48:624-8. Available from: http://www.ijp-online.com/text.asp?2016/48/6/624/194855
The burden of adverse drug reactions (ADRs) in the global scenario is high and accounts for considerable morbidity, mortality, and extra-cost to the patients.,, In England, 0.9% of the total hospital admissions were due to ADRs during the year 1999–2008. ADRs are common in Australian healthcare system also and they contribute to 1% of hospital admissions. In the United States of America, ADRs contribute 3.4%–7% of hospital admissions. The percentage of hospital admissions due to ADRs in certain countries is 10% or more., India, with a current population of 1.27 billion, is the fourth largest producers of pharmaceuticals in the world with more than 6000 licensed manufacturers and over 60,000 branded formulations in the market. Studies revealed that ADRs are leading to hospitalization and constitute a significant economic burden on patients in India.,, A study showed that hospital admissions due to ADRs accounted for 0.7% of total admissions and deaths due to ADRs accounted for 1.8% of total admissions in a territory referral center in South India.
Therefore, medicines safety monitoring is an essential element of healthcare and for high-quality medical care. Since safety monitoring of medicines as an integral part of clinical practice, the Ministry of Health and Family Welfare (MoHFW), Government of India launched the nationwide Pharmacovigilance Programme of India (PvPI) in the year 2010 to inspire confidence and trust among patients and healthcare professionals with respect to medicines safety. Indian Pharmacopoeia Commission (IPC) under the MoHFW has been functioning as the National Coordination Centre (NCC) for PvPI since April 2011. There has been rapid progress in reporting of ADRs by the healthcare professionals in the past 5 years.
| » Establishing the Culture of Adverse Drug Reaction Reporting|| |
Currently, 179 Medical Council of India approved teaching hospitals and corporate hospitals have been identified as ADRs Monitoring Centers (AMCs) across the country. These centers are covered in four zonal offices of Central Drugs Standard Control Organization (CDSCO) for administrative and logistic purpose. These AMCs are connected with international networking (reporting through VigiFlow; WHO-Uppsala Monitoring Centre [UMC] software). These AMCs report ADRs to NCC through VigiFlow, the software owned by WHO-UMC, (Sweden). The reluctance in reporting is now changing as the PvPI has launched a complete roadmap for a proactive pharmacovigilance system which increases the awareness about the benefits of ADRs reporting. Over 5 years, the NCC has played a significant role in creating awareness among healthcare professionals about reporting ADRs that saw more than 1,49,000 ADRs reported till December 2015 [Figure 1]. Currently, the contribution of India to the WHO global Individual Case Safety Reports (ICSRs) database is 3%. The healthcare professionals are encouraged to report through feedback and Newsletters.
|Figure 1: Growth of database of Individual Case Safety Reports since the inception of the Pharmacovigilance Programme of India|
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| » Completeness Score for Indian Individual Case Safety Reports|| |
UMC communicates the result of the documentation grading for the ICSRs to the national centers. The report completeness score is a score from 0 to 1 on an ICSR, calculated from the information provided in a structured format. The score depends on the required information of the field in the ADR report such as type of report, primary source, gender, and time to onset, age at onset, outcome, indication, and free text. Average completeness score for Indian ICSRs for the period of 2011–2015 is illustrated in [Figure 2].
|Figure 2: WHO-Uppsala Monitoring Centre completeness score for Indian Individual Case Safety Reports from the year 2011-2015|
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| » Integration of Pharmacovigilance Programme of India and Revised National Tuberculosis Control Program|| |
The monitoring of safety of medicines used in national health programs has been identified as a matter of concern. The safety issues are apparent in the use of medicines for the treatment of malaria, tuberculosis (TB), HIV, etc., Since inception, the Revised National Tuberculosis Programme (RNTCP), one of the largest public health programs in India, has evaluated over 70 million persons of TB and initiated treatment for over 17 million TB patients. A diagnosed TB patient on treatment under RNTCP takes more than one anti-tubercular drug simultaneously with regimens lasting from 6 months to 2 years or more. This increases the likelihood of ADRs, some of which may be severe. The overall burden of adversity directly attributable to anti-TB medicines, that is, mortality, morbidity, and reduced quality of life, is poorly documented in published literature and by the national program.
The cornerstones of pharmacovigilance apply equally to TB as to any other disease amenable to medication. Events linked to medications, particularly novel medicines or new combinations thereof, need to be recognized in a timely fashion if the events are to provide benefit to the individual patient and the public. Appropriate measures need to be put in place to ensure that harm is reduced and symptoms relieved. Healthcare workers need to be informed and trained about the methodology and routes for reporting ADRs. Keeping this in view and to improve patient care and safety in relation to the use of anti-tubercular drugs, RNTCP formally entered into collaboration with the PvPI on October 11, 2013. As a consequence, RNTCP staffs have attended IPC-WHO national workshops on pharmacovigilance held in the country. These programs are keen to customize trainings for RNTCP and take these activities further.
| » Integration of Pharmacovigilance Programme of India and National Aids Control Organization|| |
India has the third largest number of people living with HIV in the world, 2.1 million at the end of 2013 and accounts for about 4 out of 10 people living with HIV in the region, in India, the numbers of new HIV infections declined by 19%, yet it still accounted for 38% of all new HIV infections in the region. India recorded a 38% decline in AIDS-related deaths between 2005 and 2013. During this period, there was a major scale-up of access to HIV treatment. At the end of 2013, more than 700,000 people were on antiretroviral therapy (ART), the second largest number of people on treatment in any single country. During last 5 years, there were 11 ART fixed drug combination were approved for manufacturing in India. To ensure the safety of antiretroviral (ARV) medicines used in the program, IPC, NCC-PvPI, and National AIDS Control Organization formally agreed to collaborate on September 15, 2014, for setting up systems and processes for reporting, analysis, and monitoring of ADRs due to ARV medicines used in NACP.
| » Collaboration With Adverse Events Following Immunization|| |
NCC-PvPI is assisting with adverse events following immunization (AEFI) at Immunization Technical Support Unit (ITSU) which has been set up by MoHFW with Public Health Foundation of India to ensure the vaccine safety. AEFI cases which are reported to NCC are shared with ITSU on regular basis for further necessary action. To bridge the gap among PvPI, AEFI, CDSCO, and other stakeholders NCC published an exclusive issue of “PvPI Newsletter (volume 3; issue 5 2013).” The NCC officials/coordinators at AMCs participated in all AEFI workshops.
| » Collaborations With Central Drugs Standard Control Organization|| |
ADR monitoring and reporting to national regulatory authority are put in place in many countries. In India, PvPI is closely working with CDSCO, drug regulatory authority of India. CDSCO understands that pharmacovigilance plays a specialized and pivotal role in ensuring ongoing safety of medicinal products in India and it seeks inputs from NCC before taking any kind of regulatory decisions. NCC-PvPI is working in close coordination with CDSCO zonal offices also for technical, administrative, and logistics matters related to PvPI. The role of NCC in collaboration with other national and international organizations to promote patients safety is illustrated in [Figure 3].
|Figure 3: Coordination of Indian Pharmacopoeia Commission with other organizations|
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| » Education and Training on Pharmacovigilance at Regional Training Centers|| |
A primary objective of NCC-PvPI is to promote the safest use of medicines through contributing to appropriate education in pharmacovigilance and training activities across the country. The NCC identified nine Regional Training Centers (RTCs) such as JSS Medical College, Mysore; Seth GS Medical College and KEM Hospital, Mumbai; Postgraduate Institute of Medical Education and Research, Chandigarh; Institute of Post Graduate Medical Education and Research, Kolkata; All India Institute of Medical Sciences, Bhopal; B. J. Medical College, Ahmedabad; Silchar Medical College and Hospital; All India Institute of Medical Sciences, Rishikesh; and Nizam's Institute of Medical Sciences, Hyderabad. These centers provide continual training to the personnel at AMC of their respective regions.
| » Communications|| |
NCC is committed to communicate the findings of PvPI to stakeholders and public with respect to importance of ADRs and reporting them, information about benefit-harm and effectiveness-risk, rational use of medicines, etc. A variety of methods for PvPI communication is used by NCC as follows.
The websites of CDSCO (www.cdsco.nic.in) and NCC (www.ipc.gov.in) are important tools for communication to the stakeholders and public seeking specific information. PvPI documents on these websites can be searched by navigating from the home page. Examples of documents on these websites include list of AMCs, how, what, and where to report ADRs, newsletters, training module, guidance document, etc.
Since medicines safety communications with healthcare professionals, patients, and the general public must be focused on joint responsibility for safe and rational therapy, NCC communicates the findings in national newspapers, electronic media, etc., on regular basis.
PvPI Newsletter is unique among healthcare professionals because it focuses on the ADRs-related informations. Three issues per year guides how to take a leading role in monitoring, reporting, and preventing ADRs. It is available in a convenient electronic format and printed version is circulated to AMCs, corporate hospitals, academic institutions, health departments, etc.
NCC publishes original and review articles on PvPI in national and international journals.,,,,,,,,,,,
| » Helpline Facility to Provide Assistance in Adverse Drug Reaction Reporting|| |
To enhance the participation of patients, healthcare professionals, and the pharmaceutical industry in enhancing medicines safety by reporting suspected ADRs to the PvPI, NCC recently launched a helpline number (toll free), i.e., 1800 180 3024 facility for reporting adverse events. This facility was dedicated to the nation on October 11, 2013. This may be one of the innovative methods to create awareness and to reach every corner of the country for the pharmacovigilance activity. This facility will be useful for the healthcare professionals those who are working in tertiary healthcare system to report ADRs. Adverse events-related information which received at NCC will be communicated to nearest AMCs for validating the reports. Since sending timely feedback or acknowledgement will build public confidence recently this facility has been upgraded by sending short message service feedback/acknowledgment to the ADRs reporters.
| » Android Mobile Application for Adverse Drug Reaction Reporting|| |
In developing countries such as India, under-reporting of ADR remains serious concern. In India, IT is becoming a great facilitator for promoting public health. India is cementing its place IT sector through mobile connections to reach every individual in a population of 1.27 billion where approximately 77.58% population is already using mobile phones. Hence, it is more rationale to introduce the concept of PvPI to stakeholders through mobile phones. NCC-PvPI in technical collaboration with NSCB Medical College, Jabalpur, developed a mobile application for the healthcare professionals to promote easy and instant reporting of ADR. This facility was launched by Secretary Health, MoHFW, Government of India, on May 22, 2015.
| » Utilization of Periodic Safety Update Reports Reporting|| |
Periodic safety update reports (PSURs) are a tool to monitor the safety of ongoing medicines in the market. In India, marketing authorization holders (MAHs) are required to prepare PSURs and to submit them to CDSCO twice in a year for 2 years and annually for another 2 years. Since PSURs are not directly linked with PvPI, NCC has taken the initiatives in collaboration with CDSCO to utilize the data for PvPI. The first interactive session on “Review of Periodic Safety Update Report/Post Marketing Surveillance Data and Pharmacovigilance Planning of Marketed Products” was held on December 18 and 19, 2013 at New Delhi. Representatives from MAHs, CDSCO, and NCC-PvPI were participated and discussed the issues and roadmap for better coordination and participation of MAHs in PvPI.
| » Availability of Medicine Side Effect Reporting Form for Consumers in Different Vernacular Languages|| |
Patients or consumers are the end users of pharmaceutical products, to ensure the safe use of them is the ultimate goal of pharmacovigilance activities. In an increasing number of countries, patients are now allowed to report ADRs to the spontaneous reporting system.,,,, Option of ADRs reporting by patients to PvPI was started at NCC-PvPI on August 1, 2014. Patient or his/her representative (relative) are encouraged to report ADRs either directly to the NCC-PvPI through toll free helpline number: 1800-180-3024 or E-mail id: firstname.lastname@example.org or to their nearest AMC under PvPI by submitting “Medicines Side Effect Reporting form for Consumers” (blue form) which can be downloaded from the official website of IPC www.ipc.gov.in  and by the end of 2015, this form is available in ten vernacular languages such as Hindi, Kannada, Malayalam, Assamese, Bengali, Odiya, Tamil, Telugu, Gujarati, and Marathi.
| » Future Perspectives|| |
NCC has mandated the RTCs to organize advance level training for the personnel's of all AMCs under their respective regions and one CME in pharmacovigilance at an AMC under their region to increase the awareness of healthcare professionals about the ADR reporting. In near future, all Medical Council of India approved institutions will be enrolled under the PvPI. As IPC was recognized as the WHO Collaborating Center for medicines and vaccine safety in the South East Asia region during 38th Annual Meeting of National Pharmacovigilance Centers participating in the WHO program for international drug monitoring, plan to initiate, and coordinate with countries in South East Asia region for potential signals from the built safety database. NCC is in a process of developing and promoting an effective channel for ADRs reporting such as online reporting system.
| » Conclusion|| |
ADRs reporting through PvPI improved with the measures such as education, training, and provision of technical assistance. The PvPI is a vital knowledge databases for Indian drug regulation. The CDSCO has notified important safety label changes for carbamazepine and piperacillin + tazobactam in the year 2015. The PvPI plans to expand its scope of activities to widen its reach to other healthcare professionals and to strengthen measures for capacity building.
We are thankful to MoHFW, Government of India, for the administrative and financial support. We are also thankful to all the stakeholders of PvPI for their contributions.
Financial Support and Sponsorship
Conflicts of Interest
There are no conflicts of interest.
| » References|| |
Pirmohamed M, James S, Meakin S, Green C, Scott AK, Walley TJ, et al.
Adverse drug reactions as cause of admission to hospital: Prospective analysis of 18 820 patients. BMJ 2004;329:15-9.
Davies EC, Green CF, Taylor S, Williamson PR, Mottram DR, Pirmohamed M. Adverse drug reactions in hospital in-patients: A prospective analysis of 3695 patient-episodes. PLoS One 2009;4:e4439.
Bates DW, Spell N, Cullen DJ, Burdick E, Laird N, Petersen LA, et al.
The costs of adverse drug events in hospitalized patients. Adverse Drug Events Prevention Study Group. JAMA 1997;277:307-11.
Wu TY, Jen MH, Bottle A, Molokhia M, Aylin P, Bell D, et al.
Ten-year trends in hospital admissions for adverse drug reactions in England 1999-2009. J R Soc Med 2010;103:239-50.
Runciman WB, Roughead EE, Semple SJ, Adams RJ. Adverse drug events and medication errors in Australia. Int J Qual Health Care 2003;15 Suppl 1:i49-59.
Hamilton HJ, Gallagher PF, O'Mahony D. Inappropriate prescribing and adverse drug events in older people. BMC Geriatr 2009;9:5.
Moore N, Lecointre D, Noblet C, Mabille M. Frequency and cost of serious adverse drug reactions in a department of general medicine. Br J Clin Pharmacol 1998;45:301-8.
Griffin JP. The evolution of human medicines control from a national to an international perspective. Adverse Drug React Toxicol Rev 1998;17:19-50.
Biswas P, Biswas AK. Setting standards for proactive pharmacovigilance in India: The way forward. Indian J Pharmacol 2007;39:124-8.
Patel KJ, Kedia MS, Bajpai D, Mehta SS, Kshirsagar NA, Gogtay NJ. Evaluation of the prevalence and economic burden of adverse drug reactions presenting to the medical emergency department of a tertiary referral centre: A prospective study. BMC Clin Pharmacol 2007;7:8.
Raut A, Diwan A, Patel C, Patel P, Pawar A. Incidence, severity and financial burden associated with adverse drug reactions in medicine inpatients. Asian J Pharm Clin Res 2011;4:103-11.
Khan FA, Nizamuddin S, Najmul H, Mishra H. A prospective study on prevalence of adverse drug reactions due to antibiotics usage in otolaryngology department of a tertiary care hospital in North India. Int J Basic Clin Pharmacol 2013;2:548-53.
Ramesh M, Pandit J, Parthasarathi G. Adverse drug reactions in a south Indian hospital – Their severity and cost involved. Pharmacoepidemiol Drug Saf 2003;12:687-92.
Kalaiselvan V, Prakash J, Singh GN. Pharmacovigilance programme of India. Arch Pharm Pract 2012;3:229-32.
Prasad T, Kalaiselvan V, Jai P, Suinder S, Gyanendra Nath S. Weight gain in association with insulin use-an analysis of Individual Case Safety Reports in Indian database. J Pharmacovigil 2014;2:119.
Iftekar H, Kalaiselvan V, Gyanendra NS. Efficacy and safety of vildagliptin in the management of type 2 diabetes mellitus. Indian J Pharm Pract 2012;5:8-15.
Sainul Abideen P, Chandrasekaran K, Maheshwaran U, Vijayakumar A, Kalaiselvan V, Mishra P, et al
. Implementation of self reporting pharmacovigilance in anti tubercular therapy using knowledge based approach. J Pharmacovigil 2013;1:1-5.
Kalaiselvan V, Prasad T, Bisht A, Singh S, Singh GN. Adverse drug reactions reporting culture in Pharmacovigilance Programme of India. Indian J Med Res 2014;140:563-4.
Kalaiselvan V, Prasad T, Singh A. Current status of adverse drug reactions monitoring centres under pharmacovigilance programme of India. Indian J Pharm Pract 2014;7:19-22.
Kalaiselvan V, Sharma S, Singh GN. Adverse reactions to contrast media: An analysis of spontaneous reports in the database of the pharmacovigilance programme of India. Drug Saf 2014;37:703-10.
Kalaiselvan V, Gakhar S, Prasad T, Gupta SK, Singh GN. Spontaneous reporting of adverse drug reactions in geriatric patients in India. Natl J Physiol Pharm Pharmacol 2014;3:225-8.
Kalaiselvan V, Mishra P, Singh GN. Helpline facility to assist reporting of adverse drug reactions in India. WHO South East Asia J Public Health 2014;3:194.
Kalaiselvan V, Saurabh A, Kumar R, Singh GN. Adverse reactions to herbal products: An analysis of spontaneous reports in the database of the Pharmacovigilance Programme of India. J Herb Med 2015;5:48-54.
Kalaiselvan V, Kumar R, Thota P, Tripathi A, Singh GN. Status of documentation grading and completeness score for Indian individual case safety reports. Indian J Pharmacol 2015;47:325-7.
Hugman B. The Erice declaration: The critical role of communication in drug safety. Drug Saf 2006;29:91-3.
van Grootheest K, de Graaf L, de Jong-van den Berg LT. Consumer adverse drug reaction reporting: A new step in pharmacovigilance? Drug Saf 2003;26:211-7.
de Langen J, van Hunsel F, Passier A, de Jong-van den Berg L, van Grootheest K. Adverse drug reaction reporting by patients in the Netherlands: Three years of experience. Drug Saf 2008;31:515-24.
Kalaivani M, Kalaiselvan V, Dabhi K, Singh GN. Direct consumer reporting of ADRs to PvPI, a position paper of Indian pharmacopoeia commission. Adv Pharmacoepidemiol Drug Saf 2015;4:184.
[Figure 1], [Figure 2], [Figure 3]