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Health ministry to usher in academic programmes to equip state drug regulators utilise ADR data

Shardul Nautiyal, Mumbai
Saturday, January 13, 2018, 08:00 Hrs  [IST]

In order to utilise adverse drug reaction (ADR) data collected over a period of 7 years, Union health ministry is planning to equip state drug controllers and researchers to utilise the data with help from ADR monitoring centres (AMCs) in the country through the Pharmacovigilance Programme of India (PvPI).

PvPI has so far reported around 3 lakh ADRs and has further expanded phenomenally through addition of 40 more AMCs last year.

As of today, PvPI has under its fold 250 AMCs. Around 40 AMCs were identified last year at district hospitals in the North Eastern part of India, Uttar Pradesh and Himachal Pradesh towards getting pan India ADR information.

This has given a shot in the arm to the government’s plan for rolling out PvPI at district level hospitals also. Ghaziabad based Indian Pharmacopoeia Commission (IPC) which is national coordinating centre (NCC) for PvPI in the country had last year received letter of intent from 40 district hospitals to participate as AMCs..

IPC has been assigned to update information on ADRs that is being reported in India from 250 AMCs through Vigiflow software to the Uppsala Monitoring Centre (UMC) in Sweden, which is WHO's collaborating centre for international drug monitoring.

To take the plan forward, healthcare institutions have already been provided guidelines to follow a specific protocol for prospective studies on specific drugs having ADRs. This would enable government to take regulatory decisions in an effective manner to combat ADRs.

The union health ministry has directed respective institutions to carry out studies in a focused manner related to specific drugs as per stipulated guidelines under PvPI. IPC recently came out with a draft protocol and guidelines focused on targeted drugs to generate and report India specific ADRs.

“There is an urgent need to utilise ADR data through prospective studies for proper intensive ADR monitoring, reporting and analysis. Focus is gradually moving towards not only collection of data but also its utilisation of ADR data for which guidelines on study protocol of drugs of current interest have been provided,” informs Dr V Kalaiselvan, Principal Scientific Officer, IPC, Ghaziabad.

Union health ministry launched PvPI to track ADRs in Indian population but only a small portion of healthcare professionals have formal training in pharmacovigilance (PV). CDSCO under the Union health ministry had initiated a nation-wide PvPI in July 2010.


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