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Laxmi Yadav, Mumbai March 31 , 2017
Even though the Pharmacovigilance Programme of India (PvPI) has done remarkable work in improving the reporting rate of adverse drug reactions (ADRs.in the country, it is yet to evolve a standardised financial model to sustain in its activities.

The government has set aside Rs.250 crore for PvPI during the 12th Five Year Plan (2012-17) to enable better scrutiny of the safety and efficacy of the medicines consumed within the country. There is no clarity on the revenue generation model for maintaining and strengthening the drug safety programme thereby raising concern over its sustainability in long term.

Besides lack of clarity on their revenue model, the PvPI programme which contributed to Uppsala Monitoring Centre with 2.5 lakh ADR reports, received mainly from its 202 ADR centres comprising of government, non government teaching hospitals, specialised and corporate hospitals across the country, and to a lesser extent from the industry, has fallen short of a mechanism to involve state drug regulators in strengthening its activities.

Though pharma industry has been encouraged to submit ADRs due to their pharmaceutical products to Indian Pharmacopoeia Commission (IPC), NCC-PvPI in xml-E2B format since 2015, there is hardly any mechanism for PvPI to provide feedback to the industry on their ADR data. The PvPI received encouraging response from the industry whose contribution to it was around 19 per cent of the total reports received by PvPI.

The PvPI also needs to come out with a framework to do away with ambiguity in ADR reporting by industry. At present it is not clear if a system exists within PvPI to rein in duplication of ADR reports related to a pharmaceutical product coming from a pharma company as well as healthcare professionals.

In a bid to reach out to wider population, IPC had collaborated with vital bodies-- Indian Council for Medical Research, Indian Medical Association as well as several public health programmes and institutions-- Revised National Tuberculosis Control Programme, National AIDS Control Organization, Adverse Event Following Immunization, National Vector Borne Disease Control Programme. It also launched consumer reporting forms in 10 regional languages to promote consumer involvement in reporting ADRs.Mobile app and helpline were also introduced for ADR reporting.

“All these initiatives helped PvPI achieve their short-term objective of developing and implementing a pharmacovigilance system pan India and collecting case reports and data related to drugs, vaccines, medical devices and biological products from concern stakeholders including physicians and industry. The programme is on the path of realising its long term goal to become a benchmark of pharmacovigilance globally”, stated Dr J Vijay Venkatraman, managing director & CEO, Oviya MedSafe – a pharmacovigilance consulting firm, on the sidelines of his talk on Indian Pharmacovigilance at the DIA Conference held in Mumbai on 24th & 25th March 2017.

“However, lack of clarity of pharmacovigilance regulations, absence of quality metrics and limited guidance availability are affecting pharma industry's compliance to PvPI. Although there is sufficient pharmacovigilance expertise in the country, very little of it is being utilized for Indian pharmacovigilance. Existing expertise is limited to collection and networking of data. Developing PV expertise in signal generation, system management along with capacity building at all levels in line with global standards should be focused upon to improve PvPI outcome.”

“This approach will help do away with the excessive dependence on Uppsala Monitoring Centre's database. Besides this, a slew of steps need to be adopted to strengthen PvPI including collaboration with global regulatory agencies viz. PMDA, US FDA, EMA, clearly defined responsibilities among governmental agencies, encouraging ADR reporting through social media, providing enforcement powers to IPC to ensure PV compliance and so on”, he added.

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