WHO South-East Asia Journal of Public Health
  • 174
  • Home
  • Print this page
  • Email this page
Home About us Editorial board Search Ahead of print Current issue Archives Submit article Instructions Subscribe Contacts Login 

 Table of Contents  
Year : 2014  |  Volume : 3  |  Issue : 2  |  Page : 194

Helpline facility to assist reporting of adverse drug reactions in India

Pharmacopoeia Commission, Ministry of Health and Family Welfare, Rajnagar, Ghaziabad, India

Date of Web Publication22-May-2017

Correspondence Address:
Vivekanandan Kalaiselvan
Principal Scientific Officer, Indian Pharmacopoeia Commission, Ministry of Health and Family Welfare, Sector 23, Rajnagar, Ghaziabad, Uttar Pradesh 201002
Login to access the Email id

Source of Support: None, Conflict of Interest: None

DOI: 10.4103/2224-3151.206737

Rights and Permissions

How to cite this article:
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

How to cite this URL:
Kalaiselvan V, Mishra P, Singh GN. Helpline facility to assist reporting of adverse drug reactions in India. WHO South-East Asia J Public Health [serial online] 2014 [cited 2022 Dec 2];3:194. Available from: http://www.who-seajph.org/text.asp?2014/3/2/194/206737

We wish to draw colleagues’ attention to the launch of a helpline facility for health-care professionals and the public -especially those in rural areas – to report adverse drag reactions to the Indian Pharmacopoeia Commission (IPC). In 2010, the Ministry of Health and Family Welfare, Government of India, launched the nationwide Pharmacovigilance Programme of India (PvPI) to monitor the safety of medicine. IPC, an autonomous institution, established under the Ministry of Health and Family Welfare, Government of India, Ghaziabad, has been functioning as the National Coordination Centre (NCC) for PvPI since April 15th 2011.[1] The main responsibility of the NCC is to monitor adverse reactions to medicines observed in the Indian population and to develop and maintain its own pharmacovigilance database.[2] Adverse drag reaction monitoring centres (AMCs) have been set up across the country by the PvPI; there are currently 150 of these centres, which monitor the adverse drag reactions and report to the NCC. This system allows health-care professionals to report any adverse drag reactions in their areas of work, but may not bridge the gap between general public and NCC.

Therefore, to extend the PvPI to remote areas and to give scope for health-care professionals in corporate hospitals, tertiary hospitals and private clinics, as well as patients, to report adverse drag reactions directly to NCC, a toll-free helpline (1800 180 3024) has been set up by the NCC. This facility, which was launched on 11 October 2013, provides assistance in reporting adverse reactions associated with the use of medicines, with the aim of ensuring patient safety. Essential information, such as what to report, how to report, where to report, etc. is provided on the helpline by a dedicated pharmacist during working hours (Monday to Friday 09:00 to 17:00); outside these hours, callers may leave a message on an interactive voice response system. Health-care professionals and non-health-care professionals can use the helpline to report both serious and non-serious adverse reactions related to any medicinal product, including drags, vaccines, medical devices, blood products, nutritional/dietary supplements and herbal products. The person reporting is asked whether he or she is a health-care professional, non-health-care professional or patient. Patients/consumers only are also required to provide their name, address and contact details.

The reported information is passed on to the respective AMCs for validation and assessment of causality. It is then entered into VigiFlow, a web-based individual case safety report management system that was specifically designed for use by national centres in the World Health Organization (WHO)-Uppsala Monitoring Centre for International Drag Monitoring. This facility has been upgraded by introduction of an SMS service to acknowledge the reports of adverse drag reactions received through the toll-free helpline. This will enable the NCC to send SMS acknowledgement and feedback to all those reporting adverse drag reactions, which will make the service more user friendly and build confidence for all stakeholders of PvPI.

The helpline is an important and useful tool for direct reporting of suspected adverse drag reactions by hospital pharmacists/ clinicians from all types of hospitals, as well as private clinics and nursing homes. Provision of the helpline service contributes to the quality of care provided by the NCC and provides benefits to the national database.

Source of Support: Nil.

Conflict of Interest: None declared.

Contributorship: All authors contributed to the preparation of this Letter

  References Top

Kalaiselvan V, Jai Prakash, Gyanendra Nath Singh. Pharmacovigilance Programme of India. Archives of Pharmacy Practice. 2012;3:229-232.  Back to cited text no. 1
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 Pharmacovigilance. 2014;2(1): 119. doi: 10.4172 /2329-6887.1000119. http://esciencecentral.org/journals/ weight-gain-in-association-with-insulin-use-an-analysis-of-individual-case-safety-reports-an-indian-database-2329-6887-2-119.pdf – accessed 6 August 2014.  Back to cited text no. 2

This article has been cited by
1 Materiovigilance: Concept, Structure and Emerging Perspective for Patientís Safety in India
Farazul Hoda,Rishabh Verma,Mawrah Arshad,Ali Nasir Siddiqui,Mohammad Ahmed Khan,Mohammad Akhtar,Abul Kalam Najmi
Drug Research. 2020; 70(09): 429
[Pubmed] | [DOI]
2 Implementation of adverse event reporting for medical devices, India
Shatrunajay Shukla,Madhur Gupta,Sabitri Pandit,Milu Thomson,Abhimanyu Shivhare,Vivekanandan Kalaiselvan,Gyanendra Nath Singh
Bulletin of the World Health Organization. 2020; 98(3): 206
[Pubmed] | [DOI]
3 Medicine Safety Monitoring in Pediatric Population in India
Ismeet Kaur,Vivekanandan Kalaiselvan,Gyanendra N. Singh
The Indian Journal of Pediatrics. 2016; 83(5): 479
[Pubmed] | [DOI]
4 Reporting of adverse drug reactions due to cardiovascular drugs in India: A national duty
Vivekanandan Kalaiselvan,Ismeet Kaur,Vipin Kumar,Gyanendra N. Singh
Indian Heart Journal. 2015; 67(6): 613
[Pubmed] | [DOI]
5 System of adverse drug reactions reporting: What, where, how, and whom to report?
Vivekanandan Kalaiselvan,Pranay Kumar,Prabhakar Mishra,Gyanendra Singh
Indian Journal of Critical Care Medicine. 2015; 19(9): 564
[Pubmed] | [DOI]
6 Self-Reporting of Adverse Drug Reactions in Iraqi Hospitals: Patientís Perspectives
Kadhim Ali Kadhim
Pharmacology & Pharmacy. 2015; 06(12): 566
[Pubmed] | [DOI]


Similar in PUBMED
   Search Pubmed for
   Search in Google Scholar for
Access Statistics
Email Alert *
Add to My List *
* Registration required (free)

  In this article

 Article Access Statistics
    PDF Downloaded249    
    Comments [Add]    
    Cited by others 6    

Recommend this journal