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Need to assess drug behaviour in population for effective pharmacovigilance in India

Shardul Nautiyal, Mumbai
Saturday, December 27, 2014, 08:00 Hrs  [IST]

In order to boost Pharmacovigilance (PV) in India, there is a need for a participation from all the stakeholders to address issues in ADR reporting and analysis, considering the fact that drug is new for the first few years and its behaviour has to be assessed in the context of the patients. Regulations governing the respective drug should also be based on the respective population of the country.

These were some of the thoughts shared during the Pharmacovigilance Symposium titled ‘Comprehensive Pharmacovigilance for India – The Road Ahead’ held in Mumbai recently. It was organised by Pharmacovigilance Working Group (PVWG) of the Indian Society for Clinical Research (ISCR). All stakeholders of Pharmacovigilance in India such as the pharma industry, CROs, pharmacovigilance service providers, investigators, clinicians, academia and the PvPI deliberated their views during the event.

Speaking during the sidelines of the event, Dr YK Gupta National Scientific Coordinator, Pharmacovigilance Program of India (PvPI) said,"There is a need to move towards translational pharmacovigilance and made a part of the policy. This will also have a bearing on the causality assessment and clinical trial related pharmacovigilance to arrive at the translational utility of pharmacovigilance programme in India."

Talking about the issues to be addressed in pharmacovigilance, Dr Nilima Kshirsagar, National Chair in Clinical Pharmacology, ICMR (Indian Council of Medical Research), said, "Certain factors need to be addressed like multiple systems of medicine, OTC drug use, irrational prescribing of drugs, sub-standard drugs, medication error, no reporting culture and lack of industry- government co-operation for effective pharmacovigilance."

It also came to the fore that there is no representative epidemiological data on drug utility and outcomes of treatments. Moreover, the regulations and review process is lagging behind in India.

Dr J Vijay Venkatraman, executive committee member, ISCR, while giving his presentation said market for PV is forecasted to grow at a CAGR of 12.9 per cent till 2019. North America constituted the largest market for global PV market in 2012 and Asia-Pacific is predicted to foresee a highest growth rate of 15.2 per cent by 2019.
"Growth opportunities for Pharmacovigilance in India lie in clinical safety, post-marketing safety, medical writing, regulatory affairs, quality assurance, auditing, academic institutes, hospitals and regulatory authority of PvPI, " he added.

Dr G Parthasarathi, dean, Faculty of Pharmacy, JSS University, Mysore spoke on "The Growth of Pharmacovigilance as an Academic Discipline".

Dr Bhaswat Chakraborty, Senior VP, Research and Development Core Committee, Cadila Pharmaceuticals spoke on "The Significance of Data Mining in Pharmacovigilance."

While Dr V Kalaiselvan, Principal Scientific Officer, Pharmacovigilance Programme of India (PvPI) apprised about the journey of PvPI since July 2010 and the vision for the future, Dr JA Jayalal, National Co-ordinator, Academic Wing, Indian Medical Association (IMA) spoke on "Pharmacovigilance in the eyes of the clinician community". His presentation told about understanding of pharmacovigilance as a science from a clinician perspective.

A panel discussion was moderated by Dr Partha Gokhale, Head Clinical Operations, Boehringer Ingelheim India Private Ltd on evolving appropriate clinical safety regulations for India. Panelists discussed on the current challenges for investigators, challenges while responding to health authorities and determination of causality. Panelists included Dr Harshada Kudalkar from KEM Hospital, Pune, Dr Mukul Manchanda frm Medanta Institute of Clinical Research, Dr Rajnish Nagarkar from Curie Manavata Cancer Centre, Nashik and Dr G Parthasarathi from JSS University, Mysore.

Moin Don, CEO & Founder - PVCON, moderated a panel discussion on the experience of Indian Pharma in complying with global and Indian pharmacovigilance obligations. Panelists discussed on how do you interpret the regulation and the PV practices in pharma Industry in India. Panelists who participated were Dr Kamlesh Patel from Abbott Healthcare, Dr Manoj Swaminathan from Sun Pharma and Dr Anand Harugeri from AstraZeneca. The panel discussion drew special attention to the current pharmacovigilance practices followed in the Indian pharmaceutical industry and the experience of these pharma companies in complying with both global and Indian pharmacovigilance obligations.

Dr Deepa Arora, vice president, Pharmacovigilance & Global Head, Drug Safety & Risk Management, Lupin, moderated on the emergence and promise of pharmacovigilance as an outsourced industry in India and perspectives from service providers. Panelists were Dr J Vijay Venkatraman from Oviya MedSafe and Dr Sumit Verma from APCER Pharma.


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