Asian Journal of Research in Pharmaceutical Sciences

Open Access Open Access  Restricted Access Subscription Access
Open Access Open Access Open Access  Restricted Access Restricted Access Subscription Access

Pharmacovigilance programme in India (PvPI): History, Current scenario, future aspects and role in COVID 19


Affiliations
1 NIMS Institute of Pharmacy, NIMS University, Jaipur, Rajasthan., India
2 Divine College of Pharmacy, Siwan, Bihar., India
3 Buddha Institute of Pharmacy, GIDA, Gorakhpur, U.P.,, India
4 NIMS Institute of Pharmacy, NIMS University, Jaipur, Rajasthan, India
     

   Subscribe/Renew Journal


According to WHO, Pharmacovigilance (PV) is characterized as the science and exercises identifying with the recognition, appraisal, comprehension and anticipation of unfavourable impacts or some other medication related issue. It is an important part of our medication guideline framework. As we know, India is the world's second most populated country with very nearly one billion dynamic and potential medication buyers and clients. Though our country is participating in Uppsala Monitoring Centre, its obligation to that data base is by and pretty much nothing. This issue is due to the lack of proper ADR (Adverse drug reaction) monitoring system and awareness among associates of medicines and health workers. PV program mainly aims for patient care, patient safety and monitoring of adverse drug reaction. For the accurate practice of PV in India, there are need of more clinical preliminaries and clinical examinations. For the safe and sensible use of medication, a perfectly working PV system is mandatory. PV will be invaluable in India not only for medical services experts, regulatory authorities, pharmaceutical organizations but also for the consumers to screen the medicines. This article gives a methodical audit of the pharmacovigilance program in India (PvPI) from its starting point to the current situation and furthermore examines the future parts of pharmacovigilance program in India.

Keywords

Pharmacovigilance, Adverse drug reactions, Patient care, Patient safety, PvPI.
Subscription Login to verify subscription
User
Notifications
Font Size


  • Kumar DA. Reddenna L. Basha SA. Pharmacovigilance Programme of India. Research & Reviews: A Journal of Pharmacology. 2014; 4(3):13-23.

  • Fernandes SD. Anoop NV. Castelino LJ. Charyulu RN. A national approach to pharmacovigilance: The case of India as a growing hub of global clinical trials: Research in Social and Administrative Pharmacy. 2019; 15(1):109-13. doi.org/10.1016/j.sapharm.2018.03.061

  • LihiteJ.Ratan and Lahkar Mangala. An update on the Pharmacovigilance Program of India. Frontiers in Pharmacology.2015; 6(194) doi.org/ 10.3389/fphar.2015.00194

  • Suke SG. Kosta P. Negi H. Role of pharmacovigilance in India: An overview. Online Journal of Public Health Informatics. 2015; 7(2). doi.org/10.5210/ojphi.v7i2.5595

  • Shraddha Anil Naik. Review on Pharmacovigilance. Asian J. Pharm. Res. 2020; 10(2):123-28.doi.org/10.5958/2231-5691.2020.00024.6

  • Adamu Yau.Nordin Bin Simbak. Mainul Haque. Pharmacogenovigilance: A Potential Tool in Pharmacovigilance. Research J. Pharm. and Tech. 7(12): 2014; 1476-82

  • Hailye Birhane.Mojahidul Islam. Damen H mariam. Vijender Singh. Pharmacovigilance: Adverse Drug Reactions (ADRs) in Pediatric patients in Ethiopia. Retrospective Study. Research J. Pharm. and Tech 2021; 14(3):1499-1506. DOI: 10.5958/0974-360X.2021.00266.3

  • Kalaiselvan.V.Srivastava. Singh Abhishank. Gupta SK. Pharmacovigillance program in India: Present scenario and future challenges. Archives of Pharmacy Practice. 2018; doi.org/10.1007/s40264-018-0730-7

  • Nimesh Saurabh.Chaudhary Anurag. Sharma Anjana and Kapil Dev Negi.Pharmacovigillance program of India: A review.Acta Scientific Pharmaceutical Sciences. 3.9(2019): 12-17.

  • Gadhade B.Jyoti. HirayS.Rajesh. Aherkar .Y Rekha .Kalpana U.Shah.Pharmacivigillance program of India: revival of the renaissance. International Journal of Basic and Clinical Pharmacology. 2018; doi.org/10.18203/2319-2003.ijbcp20184338

  • Rajgopal Jk. Shilpi K. Ak S. Pharmacoviglance: A Review Article. Innovare Journal of Medical Sciences.2016; 2321-4406.

  • Danan G. Benichou C. Causality assessment of adverse reactions to drugs—I. A novel method based on the conclusions of international consensus meetings: application to drug-induced liver injuries. Journal of Clinical Epidemiology. 1993; 46(11):1323-30.doi.org/10.1016/0895-4356(93)90101-6

  • Lal D.Manocha S. Ray A.Vijayan VK. Kumar R. Comparative study of the efficacy and safety of theophylline and doxofylline in patients with bronchial asthma and chronic obstructive pulmonary disease. Journal of Basic and Clinical Physiology and Pharmacology. 2015; 26(5):443-51.doi.org/10.1166/jmihi.2020.3055

  • Kumar A. Past, present and future of pharmacovigilance in India. Systematic Reviews in Pharmacy. 2011; 2(1):55.

  • Gupta YK. Ensuring patient safety-launching the new pharmacovigilance programme of India. Pharma Times. 2010; 42(8):21-6.

  • Simha Haripriya.Marisarla Syamala. Mujeebuddin S.C. Pharmacovigilance system in India. International Journal of Pharmaceutical Sciences. 2020; 63(1): 73-80.

  • Ghewari PS. Salunkhe SS. Bhatia NM. Killedar SG. Chitranagari K. Strategies and current scenario of pharmacovigilance in India. Journal of Advanced Drug Delivery. 2014; 1(3):122-34.

  • Van Grootheest K. Olsson S. Couper M. de Jong‐van den Berg L. Pharmacists' role in reporting adverse drug reactions in an international perspective. Pharmacoepidemiology and Drug Safety. 2004; 13(7):457-64.doi.org/10.1002/pds.897

  • Clause S. Fudin J. Mergner A. Lutz JL. Kavanaugh MM. Fessler K. Chirumamilla S. Prescribing privileges among pharmacists in Veterans affairs medical centers. American Journal of Health-System Pharmacy. 2001; 58(12):1143-5.

  • Anirudhprasad Kancharla.Current scenario of pharmacovigilance in India and its comparison with U.S.A and E.U.The Pharma Innovation Journal.2019; 8(6): 302-7.

  • Recast EP. Directive 2010/31/EU of the European Parliament and of the Council of 19 May 2010 on the energy performance of buildings (recast). Official Journal of the European Union. 2010; 18(06):2010.

  • Bester K.Meyer H. Crowther M. Gray R. Anaesthesia for paediatric patients: Minimising the risk. South African Medical Journal. 2018; 108(6):457-9.

  • Scope of Pharmacovigilance in India – An Industry of Drug Safety, Business Alligators, Available from: https://www.businessalligators.com/scope-pharmacovigilance-india-industry-drug-safety/, last updated on: 9th Dec, 2016.

  • Guideline IH. Post-approval safety data management: definitions and standards for expedited reporting E2D. Published in the Federal Register. 2003; 68(178):53983-4.

  • Vivekanandan K. Prakash J. Singh GN. Pharmacovigilance programme of India. Archives of Pharmacy Practice. 2012; 1; 3(3):229.

  • Kalaiselvan V. Kumar R. Singh GN. Indian Pharmacopoeia commission's partners for promoting public health. Adv Pharmacoepidemiol Drug Saf. 2015; 4(181):2167-1052. doi.org/10.4172/2167-1052 .1000181

  • Aswath N, VT H. Pharmacovigilance, Adverse Drug Reactions and Future Aspects of Pharmacovigilance in India: A Review Article. Indian Journal of Public Health Research & Development. 2019; 1; 10(12).

  • World Health Organization. "A public health approach for scaling up antiretroviral (ARV) treatment: a toolkit for programme managers." (2003).

  • Sawarkar A. Sharma RK. Gautam V. Shramankar K. Dinodia N. Pharmacovigilance: Present status and future perspectives. The Pharma Innovation Journal. 2019; 8(8):84-92.

  • Ghewari PS, Salunkhe SS, Bhatia NM, Killedar SG, Chitranagari K. Strategies and current scenario of pharmacovigilance in India. Journal of Advanced Drug Delivery. 2014; 1(3):122-34.

  • Meher B. Need of vibrant vaccine pharmacovigilance during current global COVID-19 pandemic: More than ever. Journal of Pharmacy and Bioallied Sciences.2021;13(1):1. doi: 10.4103/jpbs.JPBS_416_20

  • World Health Organization. "Causality assessment of an adverse event following immunization (AEFI): user manual for the revised WHO classification." (2018).

  • Daley MF. Narwaney KJ. Shoup JA. Wagner NM. Glanz JM. Addressing parents’ vaccine concerns: a randomized trial of a social media intervention. American Journal of Preventive Medicine. 2018; 55(1):44-54.doi.org/10.1016/j.ampere.2018.04.010

  • Hailye Birhane. Mojahidul Islam. Damen H/mariam. Vijender Singh. Pharmacovigilance: Adverse Drug Reactions (ADRs) in Pediatric patients in Ethiopia. Retrospective Study. Research J. Pharm. and Tech 2021; 14(3):1499-1506. DOI:10.5958/0974-360X.2021.00266.3

  • Farah Hamad Farah. Pharmacovigilance Implications of some inactive Pharmaceutical Ingredients. Research J. Pharm. and Tech. 2020; 13(11):5493-5496. DOI:10.5958/0974-360X.2020.00959.2

  • Yaser M. Al Worafi, Sanah Hasan, Nageeb M. Hassan, Ahmed A. Gaili. Knowledge, Attitude and Experience of Pharmacist in the UAE towards Pharmacovigilance. Research J. Pharm. and Tech. 2021; 14(1):265-269. DOI:10.5958/0974-360X.2021.00047.0


Abstract Views: 237

PDF Views: 0




  • Pharmacovigilance programme in India (PvPI): History, Current scenario, future aspects and role in COVID 19

Abstract Views: 237  |  PDF Views: 0

Authors

Sangeet Kumar Mall
NIMS Institute of Pharmacy, NIMS University, Jaipur, Rajasthan., India
Priti Dipa
NIMS Institute of Pharmacy, NIMS University, Jaipur, Rajasthan., India
Shambaditya Goswami
Divine College of Pharmacy, Siwan, Bihar., India
Prashant Singh
Buddha Institute of Pharmacy, GIDA, Gorakhpur, U.P.,, India
Ravindra Pal Singh
NIMS Institute of Pharmacy, NIMS University, Jaipur, Rajasthan, India

Abstract


According to WHO, Pharmacovigilance (PV) is characterized as the science and exercises identifying with the recognition, appraisal, comprehension and anticipation of unfavourable impacts or some other medication related issue. It is an important part of our medication guideline framework. As we know, India is the world's second most populated country with very nearly one billion dynamic and potential medication buyers and clients. Though our country is participating in Uppsala Monitoring Centre, its obligation to that data base is by and pretty much nothing. This issue is due to the lack of proper ADR (Adverse drug reaction) monitoring system and awareness among associates of medicines and health workers. PV program mainly aims for patient care, patient safety and monitoring of adverse drug reaction. For the accurate practice of PV in India, there are need of more clinical preliminaries and clinical examinations. For the safe and sensible use of medication, a perfectly working PV system is mandatory. PV will be invaluable in India not only for medical services experts, regulatory authorities, pharmaceutical organizations but also for the consumers to screen the medicines. This article gives a methodical audit of the pharmacovigilance program in India (PvPI) from its starting point to the current situation and furthermore examines the future parts of pharmacovigilance program in India.

Keywords


Pharmacovigilance, Adverse drug reactions, Patient care, Patient safety, PvPI.

References