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WHO’s Uppsala Monitoring Centre looks to make India as hub for pharmacovigilance training

Nandita Vijay, Bengaluru
Tuesday, December 24, 2013, 08:00 Hrs  [IST]

The World Health Organisation’s Uppsala Monitoring Centre is now looking to make India as a hub for pharmacovigilance training. The Organisation recognised India’s concerted efforts in the area of pharmacovigilance but observed that the country needed to play a bigger role in the global landscape of adverse drug reaction (ADR) monitoring.

“India should be made as hub for pharmacovigilance training.  The country needs to sustain the pace of patient safety and improve the drug reaction reporting culture in India among doctors. It will need to also adopt VigiLyze to have a global view of ADR and adopt the VigiMed communication platform to enable easy access to safety concerns in other countries besides check regulatory status and expedite sharing of drug information,” said Sten Olsson, WHO Programme Expert and head of the Global Outreach Department at the Uppsala Monitoring Centre.

Pharmacovigilance network which was established and linked via Vigiflow software is implemented in 50 countries. India seems to have used it most extensively with 62,000 report submissions. Of the total 8.5 million ADR case reports submissions, India is ranked fifth in Asia accounting for 0.7 per cent of the global data base. In this regard, WHO sees that India could soon overtake China and therefore needs to be made as a hub for pharmacovigilance training, he said.

According to Olsson, the next step that India needed to embark on was to upload the Indian Individual Case Safety Reports (ICSR) files from the pharma companies in VigiFlow as it ensure uniform database for analysis.

“We are looking out to build permanent structures for training in India. The VigiFlow module for web-based reporting would help India see a transformation in its healthcare with methodical analysis of electronic heath records and patient data access which could be integrated into the CDSCO website and accessed for regulatory approvals,” he noted.

India also needs to develop substandard/ spurious/ falsely-labelled/ falsified/ counterfeit (SSFFC) clusters in  pharmacovigilance data. This calls for its increased participation in pharmacovigilance on a global platform. There is need for greater capacity building, e-learning, webinar and greater familiarity with the pharmacovigilance tool kit, said Olsson who was in Bengaluru in connection with IPSCON 2013.

Although India has a long way to go in the area of pharmacovigilance, yet it has created a momentum in ADR monitoring. WHO is now satisfied that reporting from India is adequate and total in terms of providing the basic information. The big advantage was that the 62,000 case reports submitted as seen to be of high quality and worthwhile to be analyzed, stated Olsson.

What we have observed is that India needs to look around and be part of the international meeting space. Therefore we do expect, India to participate at international events. This is because the country needs to be part of a larger global platform and garner the  confidence in pharmacovigilance registrations, said Olsson.

Another observation is that India being a hub of vaccine manufacturers needs to take on targeted and spontaneous monitoring in vaccine for ADR which is not done as yet. India cannot overlook this, going by the vast reporting on ADRs for vaccines coming in from the West world, he noted.


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