An overview of the worldwide master key for pharmacovigilance and its role in India
Abstract
Introduction: Pharmacovigilance (PV) is defined as the science and activities related to the detection, assessment, understanding, and prevention of Adverse Drug Reactions (ADRs) and related conditions.
Methods: In the 1970s, several significant cases of ADR aided the advancement of the discipline. Between 1989 and 2004, several attempts were made to implement such a program in India, but the scheme was eventually launched in 2010 and is now operating successfully and producing positive results.
Results: The pharmacovigilance Program of India (PvPI) contributed different data to the World Health Organization (WHO) Uppsala Monitoring Center (UMC) based on the data gathered from this process. Indian regulatory have sent several alerts to stakeholders and provided the Central Drugs Standard Control Organization (CDSCO) with several recommendations. CDSCO has since advised Marketing Authorisation Holders (MAHs) to follow the same guidelines and has amended the Drugs and Cosmetics Act and Regulations to reflect this.
Conclusions: The time has come for Indian regulatory authorities to take the required action based on data generated in our country rather than data generated in several other countries.
Downloads
References
Adithan, C. (2005). National pharmacovigilance programme. Indian journal of pharmacology, 37(6), 347.
Arora D. (2008). Pharmacovigilance obligations of the pharmaceutical companies in India. Indian journal of pharmacology, 40(7), 13-16.
Bhargavi, H., Jadav, K. C., Thula, D. G., Maheswari, R. (2015). Regulatory requirements of Pharmacovigilance system and its comparison in India and USA. Journal of global trends in pharmaceutical sciences, 6(1), 2351-2356.
Biswas, P., Biswas, A. K. (2007). Setting standards for proactive pharmacovigilance in India: the way forward. Indian journal of pharmacology, 39(3), 124–128.
Biswas, P. (2014). Pharmacovigilance In India. Mann’s pharmacovigilance, 285-289.
CDSCO. (2021). Central Drugs Standard Control Organisation. Schedule Y (Amended version) 2005. Accessed on 26 April 2021.
Dhamija, P., Kalra, S., Sharma, P. K., Kalaiselvan, V., Muruganathan, A., Balhara, Y., Badani, R., Bantwal, G., Das, A. K., Dhorepatil, B., Ghosh, S., Jeloka, T., Khandelwal, D., Nadkar, M. Y., Patnaik, K. P., Saboo, B., Sahay, M., Sahay, R., Tiwaskar, M., & Unnikrishnan, A. G. (2017). Indian College of Physicians (ICP) Position Statement on Pharmacovigilance. The Journal of the Association of Physicians of India, 65(3), 63–66.
Dikshit, R. K., Desai, C., & Desai, M. K. (2008). Pleasures and pains of running a pharmacovigilance center. Indian journal of pharmacology, 40(Suppl 1), S31–S34.
Dylan Fernandes, S., Anoop, N. V., Castelino, L. J., & Narayana Charyulu, R. (2019). A national approach to pharmacovigilance: The case of India as a growing hub of global clinical trials. Research in social & administrative pharmacy : RSAP, 15(1), 109–113.
Jose, J., & Rafeek, N. R. (2019). Pharmacovigilance in India in Comparison With the USA and European Union: Challenges and Perspectives. Therapeutic innovation & regulatory science, 53(6), 781–786.
Kalaiselvan, V., Prakash, J., Singh, G. N. (2012). Pharmacovigilance program of India. Archives of pharmacy practice, 3(3), 229–232.
Kalaiselvan, V., Srivastava, S., Singh, A., & Gupta, S. K. (2019). Pharmacovigilance in India: Present Scenario and Future Challenges. Drug safety, 42(3), 339–346.
Kalaisevan, V., Kaur, I., Singh, S., Singh, G. N. (2016). Pharmacovigilance programme of India: System put in place to report adverse drug reactions. Indian journal of pharmaceutical education and research, 50(1): S212-S214.
Kulkarni R. D. (1986). Reporting systems for rare side effects of non-narcotic analgesics in India. Problems and opportunities. Medical toxicology, 1 Suppl 1, 110–113.
Lazarou, J., Pomeranz, B. H., & Corey, P. N. (1998). Incidence of adverse drug reactions in hospitalized patients: a meta-analysis of prospective studies. JAMA, 279(15), 1200–1205.
Mandal, S. C., & Mandal, M. (2017). Evolution of pharmacovigilance programme: Present status in India. Pharma times, 49(5), 31-36.
Miller, V., Nwokike, J., & Stergachis, A. (2012). Pharmacovigilance and global HIV/AIDS. Current opinion in HIV and AIDS, 7(4), 299–304.
Pharmacovigilance Programme of India. Introduction and functions. 2017. Accessed on 22 April 2021.
Pharmacovigilance Programme of India. The journey travelled and the way forward. WHO Drug Information. 2018; 32:10–17. Accessed on: 19 April 2021.
Postigo, R., Brosch, S., Slattery, J., van Haren, A., Dogne, J. M., Kurz, X., Candore, G., Domergue, F., & Arlett, P. (2018). EudraVigilance Medicines Safety Database: Publicly Accessible Data for Research and Public Health Protection. Drug safety, 41(7), 665–675.
Protocol for National Pharmacovigilance Program. CDSCO, ministry of health and family welfare, government of India; 2004. Accessed on: 17 April 2021.
PvPI. (2016). Important events. Pharmacovigilance programme of India Newsletter, 6(15):4-18.
Rahman, S. Z. (2021). Book review on ADR – adverse drug reactions. Accessed on: 21 April 2021.
Rakesh, K. R., Rakesh, K. P., Anil, B. (2012). Under reporting of ADRs by medical practitioners in India—results of pilot study. Advances in pharmacoepidemiology and drug safety, 1(3), 1-3.
Rama, P., Rodrigues, P. A., Georgy, A. (2011). Pharmacovigilance: perspectives and future challenges in Indian scenario. Asian journal of pharmaceutical and clinical research, 4(4), 1-4.
Singh GN. (2017). Director’s message. Pharmacovigilance programme of India Newsletter, 7(18), 4‑20.
Suke, S. G., Kosta, P., & Negi, H. (2015). Role of Pharmacovigilance in India: An overview. Online journal of public health informatics, 7(2), e223.
Thatte, U. M., Chaudhary, N., Gogtay, N. J. (2018). Pharmacovigilance program of India: history, evolution and current status. Adverse drug reaction bulletin, 213, 1-4.
WHO. (2006). The Safety of Medicines in Public Health Programmes: Pharmacovigilance an essential tool, World Health Organizations, 7(2), 1-34.
Thomas K. B. (1974). Chloroform: commissions and omissions. Proceedings of the Royal Society of Medicine, 67(8), 723–730.
Vakil, B. J., Kulkarni, R. D., Chabria, N. L., Chadha, D. R., & Deshpande, V. A. (1975). Intense surveillance of adverse drug reactions. An analysis of 338 patients. Journal of clinical pharmacology, 15(5-6), 435–441.
WHO. (2017). NRA meets WHO standards on vaccine regulation. Pharmacovigilance programme of India Newsletter, 7(18), 4-20.
World Health Organisation. The hidden costs of essential medicines in Essential Drugs Monitor. Essential Drugs Monitor 2003; 33:12. Accessed on: 15 April 2021.
Copyright (c) 2021 Janmejay Pant, Harneet Marwah, Ripudaman M Singh, Subhajit Hazra
This work is licensed under a Creative Commons Attribution-NonCommercial-NoDerivatives 4.0 International License.
