Around The Globe

Pharmacovigilance Programme of India (PvPI)

Q&A with the Principal Scientific Officer, Indian Pharmacopoeia Commission


n September 2017, the Secretary, Ministry of Health and Family Welfare, Government of India, released the Pharmacovigilance Guidance Document for Marketing Authorization Holders of Pharmaceutical Products in India. This Guidance, which aims to assist these Holders in establishing compliant pharmacovigilance organizations, became effective in January 2018.

In the following Q&A, Dr. Vivekanandan Kalaiselvan, who serves as Principal Scientific Officer at the Indian Pharmacopoeia Commission, explains the Pharmacovigilance Programme of India (PvPI) and his role in it.

Would you please illustrate your responsibilities as Principal Scientific Officer at the Indian Pharmacopoeia Commission (IPC), especially as they relate to the PvPI?

Well, I have been entrusted with the responsibilities to coordinate our PvPI activities mainly related to scientific and operational aspects. I have been involved in: (a) the process of establishing and strengthening reporting and processing of Adverse Drug Reaction(s) across the country; (b) developing technologies and tools for reporting; and (c) collating and analyzing the data, and communicating received information to the regulatory authority for appropriate action. In addition, I am also engaged as liaison with our Ministry of Health & Family Welfare, other groups within the government of India, regulators, and other stakeholders.

I am fortunate to work under the dynamic and visionary leadership of Dr. G N Singh, who always insists to me that we adopt transparency and accountability along with our commitment to patients and their safety. Our entire PvPI team works with passion to promote medication safety across the globe. The IPC PvPI is now a WHO Collaborating Centre, and our services help middle- and low-income countries excel.

In 2016, you were co-author on a published paper titled Pharmacovigilantes in the Pharmacovigilance Programme of India: Ideal Qualities and Skills. What ARE these ideal qualities and skills?

In fact, this article emphasis the roles and responsibilities of a professional engaged in PV activities, and attempts to address the currents issues in PV and how to tackle them by identifying specific skills and knowledge to apply. The knowledge, skills, and practicing attitudes of PV professionals are imperative to ensure better patient outcomes. In addition to professional skills and knowledge, it also recommends commitment, learning abilities, effective communication, leadership qualities, etc., as professional requirements.

What opportunities exist for patients to contribute to benefit-risk, post-market safety, and related discussions in India?

Several patient-centric initiatives have been established in PvPI to empower patient participation through adverse events reporting, such as providing patient reporting forms in vernacular languages, establishing a dedicated toll-free helpline to provide assistance in reporting, and a PvPI mobile app are noteworthy developments here. Also, the PvPI teams in the field, at ADR monitoring centres, play a crucial role in counseling patients to prevent ADRs or for better medication care.

What opportunities exist for members of organizations such as DIA to contribute to these discussions in India?

In my personal capacity, I feel there are lots of opportunities for DIA to join hands with PvPI to contribute to and promote drug safety among all stakeholders, since DIA is a very good platform for us to connect with important PV stakeholders. We look forward discussions which will benefit patients throughout India.

To further explore this topic, listen to the DIA podcast with Dr. J. Vijay Venkatraman in this issue of Global Forum.