Dr GN Singh, DCG(I) and Secretary-cum-Scientific Director, IPC and Dr V Kalaiselvan, Principal Scientific Officer, IPC, in an interview with Swati Rana speak on PvPI’s progress, various skill development programmes and steps taken to spread awareness in rural areas on ADR reporting
Pharmacovigilance Programme of India (PvPI) was initiated in July 2010 with an aim to monitor and report ADR across the country. Brief us on the current status of PvPI and PvPI’s short term as well long goals?
A robust and stable system of PvPI has been established under the aegis of Indian Pharmacopoeia Commission (IPC) to monitor, report, collate and analyse adverse drug reactions. In order to ensure a stable PvPI system, the guidance and support from MoH&FW, commitment and support from DCG(I) and CDSCO officials is overwhelming. Hence, the current pharmacovigilance system in India has reached an advanced stage.
Our short-term goals are to develop and implement pharmacovigilance system in India, recognising MCI-approved medical colleges as ADRs monitoring centres and encourage healthcare professionals (HCPs) in reporting adverse events associated wit the use of pharma products. Long-term goals are to expand the PvPI to all hospitals and centres of public health programmes located across the country, to develop electronic reporting system and develop reporting culture among the HCPs.
It’s being seven years since PvPI was launched in India. How was the journey so far and what were the challenges?
Yes. PvPI is seven-year-old and has become a flagship programme in the country. When we took charge as NCC, we realised that there is a huge need of capacity building at NCC and also AMC. Therefore, efforts were taken to develop infrastructure, appointing manpower etc., both national and regional level – we succeed! Also, there was a great need of training and education needed on pharmacovigilance for those working in PvPI.
In addition to this, to impart pharmacovigilance education and training, 10 zonal training centres have been identified, which are functioning under the umbrella of PvPI. PvPI also integrates with various public health programmes to monitor the safety of drugs and vaccines used in their respective programmes. NCC has introduced various tools for ADR reporting by the HCPs and patients such as reporting form in vernacular languages, mobile app and helpline (tool free). The biggest achievement, is the amendment in Schedule Y of D&C Rules 1945 for establishment of pharmacovigilance system at marketing authorisation holders.This provides a huge opportunity to the industry to participate in PvPI. Since quality management system has been put in place to manage the PvPI activities, the completeness score of the date generated from Indian patients is ahead of other countries. SMS facility (drug alert) is being well received among the HCPs. Interestingly, the PvPI data is effectively utilised by the CDSCO for taking appropriate regulatory decisions.
At present there are around 250 Adverse drug Monitoring Centre (AMC) across the country. Explain the functioning of AMC and tell us about the number of upcoming AMCs in 2017-2018.
The AMCs are responsible in monitoring and reporting ADRs. They are routinely engaged in motivating HCPs to monitor adverse events. AMCs are the backbone of PvPI in providing clinical-oriented and India-specific ADRs so that the meaningful information shall be used for protecting the safety of the population. In the upcoming year 2017-18, NCC plans to recognise 50 more hospitals as AMCs.
What are the plans to expand pharmacovigilance programme to govt as well as private hospitals? At present, how many hospitals report on ADR?
IPC, NCC-PvPI is planning to enrol all government and private hospitals to participate in PvPI. A circular from MoH&FW has been sent to states and UTs to adopt pharmacovigilance in the practice of HCPs.
In January 2017, IPC signed an MoU with National Accreditation Board for Hospitals (NABH). Tell us more on this initiative. What are the numbers of ADR reported from NABH hospitals till date?
After having an MoU with NABH, series of training programme for the NABH hospitals in reporting ADRs is conducted across the country. In order to promote ease of doing pharmacovigilance by the hospitals, reporting of ADRs to PvPI will only be accountable during the NABH accreditation or renewal (no need of duplicate reporting). Now NABH accredited hospitals begin reporting to their nearby or preferred AMCs. This arrangement will boost to monitor the safety of medicines used in private sectors.
Any further collaboration or MoU that will be signed globally?
IPC, NCC-PvPI is going to be declared as WHO collaborative centre for pharmacovigilance in national health programmes and regulatory capacity-building for pharmacovigilance in public health programmes and regulatory services in the WHO South-East Asia Region.
How PvPI is planning to expand its scope of activities to widen its reach to other healthcare professionals?
The current system of PvPI, engages with HCPs such as doctors and clinical pharmacists. Since nurses and community pharmacists are important stakeholders of pharmacovigilance, steps are being taken to motivate/ empower them in reporting ADRs.
What kind of training and skill development programmes are organised under PvPI?
As we mentioned, NCC and AMCs are jointly conducting CMEs (pharmacovigilance) programme, orientation/induction-cum training programme etc. for better pharmacovigilance and harmonised pharmacovigilance practices. In addition to this, to provide an opportunity to the HCPs and students across the country, a nationwide 10-day skill development programme is conducted by the IPC. So far, four skill development programmes have been successfully conducted where 220 participants were benefited.
What steps have been taken to spread awareness on ADR reporting in rural areas?
AMCs in association with NCC are taking keen interest to promote PvPI in rural areas. To make public aware about the benefits of PvPI, the concept and importance of ADRs reporting is covered in regional newspapers and also transmitted through radio. IPC is working with Doordarshan to spread the message of pharmacovigilance, which will go a long way to educate the public particularly in rural areas.
Road ahead for PvPI
a. Expansion of PvPI outreach to district and below level hospitals
b. Self sustainability of the programme
c. IPC to become a centre of excellence in pharmacovigilance