India becomes 7th largest contributor to WHO–UMC’s international drug safety database

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In a strategic development, the Indian Pharmacopoeia Commission (IPC) which acts as the National Coordination Centre (NCC) for the Pharmacovigilance Programme of India (PvPI) informed that the country’s contribution to WHO-UMC global safety database has increased up to 2 per cent in 2013.

According to the Commission, the contribution of the country in the year 2012 was 0.5 per cent, which in 2013 rose, making India as the seventh largest contributor among other member countries participating in the WHO Programme for international drug monitoring. According to Dr V Kalaiselvan, senior scientific officer from the IPC India is the fifth largest country in Asia and seventh in the world for its contribution in reporting highest percentage of ADRs to global safety database.

World Health Organisation‘s (WHO’s) Uppsala Monitoring Centre (UMC) in Sweden, which is WHO’s collaborating centre for international drug monitoring, contains the received individual case safety reports (ICSRs) from its 117 official member countries. Interestingly, IPC also has access to the ADR data from the UMC, which enable them to have access to data on international adverse reactions to drugs, to formulate drug safety measures within India.

It is understood that, WHO has developed a common reporting form with agreed guidelines for entering information in a compatible systems for transmitting, storing, retrieving and disseminating data to formulate an effective international system on ADR .The UMC works by collecting, assessing and communicating information from national pharmacovigilance programmes of their member countries in regards to the safety, efficacy an d risks-benefits ratio associated with the drugs.

India became member of WHO–UMC international drug monitoring programme in the year 1998 and since then India is continuously contributing to global safety database. In 2005, India was engaged in pharmacovigilance activities by starting up the ‘National Pharmacovigilance Programme’, but this programme was not able to generate sufficient data in order to identify the signal and after few years was stopped. To address the lacunae, in July 2010, a new pharmacovigilance programme called the PvPI was launched.

“This present programme has been structured taking into consideration the past deficiencies. Under NCC-PvPI, India’s contribution of ICSRs to global safety databse i.e Vigibase is approximately 78,000 ICSRs, this data is sufficient for signal detection and making important regulatory recommendation regarding the drug safety. In future, India is expected to achieve such operational efficiencies that would make our PvPI Programme a benchmark for global drug monitoring,” Dr Kalaiselvan informed.

IPC has undertaken a lot of efforts to enhance ADRs reporting, like establishing ADRs monitoring centres across the country, integrating with national health programme like revised national tuberculosis control programme (RNTCP) and adverse events following immunisation (AEFI), coordination with pharma companies etc. Recently the IPC had also upgraded its existing helpline facility for providing assistance in timely reporting of ADRs by introducing the SMS acknowledgement service.

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