With a view to have a tab on the antiretroviral (ARV) drugs available in the market, the Indian Pharmacopoeia Commission (IPC), the national coordinating centre for the pharmacovigilance programme of India, recently agreed to work closely with the National AIDS Control Organisation (NACO) for reporting ADRs on ARV drugs. Under this ambitious project, both the organisation will work to generate data all the ARV drugs used under the national AIDS control programme (NACP).
It is understood that the outcome of the long term use of many of the ARV drugs that are currently running in the market is still not known, which experts feel is a matter of serious concern. With anti-retroviral therapy now available free of cost to all those who need it through the ART centres located in every medical colleges, district hospitals, regulators feel that it is high time to concentrate on having an an efficient ADR reporting system for ARV drugs as well.
NACO, NCC-PvPI and WHO will be henceforth monitoring the possible recognition of new adverse reactions due to ARV drugs, while they will also be working to bridge the gap between ART centres and ADRs monitoring centre in monitoring and reporting. Dr Kalaiselvan, principal scientific officer, Indian Pharmacopoeia Commission informed that they also plan to have a standardised definitions in reporting system (software) for ARV drugs, while at the same time the NCC-PvPI and WHO will be providing training for the ART team in ADRs monitoring, reporting and causality assessment.
According to Dr Kalaiselvan this alliance is a part of the IPCs ongoing efforts to strengthen the PvPI programme further by specifically focusing on the adverse drug reactions from the ARV drugs, which are now easily available through scores of ART centres across the country. He further stressed that it is important to initiate this move as lack of data on this front can impact the confidence of the patients, leading to suboptimal levels of adherence to the treatment.
He added, “This initiative stands up as an important milestone towards streamlining the PvPI programme further, especially since there is hardly any data available on the effects of the ARV drugs on the patients across the country. In the light of better accessibility of ARV drugs throughout the country it is high time to build in a monitoring system that is specialised in identifying ADRs specifically arising out of ARV drugs.”
http://www.pharmabiz.com/NewsDetails.aspx?aid=83772&sid=1
It is understood that the outcome of the long term use of many of the ARV drugs that are currently running in the market is still not known, which experts feel is a matter of serious concern. With anti-retroviral therapy now available free of cost to all those who need it through the ART centres located in every medical colleges, district hospitals, regulators feel that it is high time to concentrate on having an an efficient ADR reporting system for ARV drugs as well.
NACO, NCC-PvPI and WHO will be henceforth monitoring the possible recognition of new adverse reactions due to ARV drugs, while they will also be working to bridge the gap between ART centres and ADRs monitoring centre in monitoring and reporting. Dr Kalaiselvan, principal scientific officer, Indian Pharmacopoeia Commission informed that they also plan to have a standardised definitions in reporting system (software) for ARV drugs, while at the same time the NCC-PvPI and WHO will be providing training for the ART team in ADRs monitoring, reporting and causality assessment.
According to Dr Kalaiselvan this alliance is a part of the IPCs ongoing efforts to strengthen the PvPI programme further by specifically focusing on the adverse drug reactions from the ARV drugs, which are now easily available through scores of ART centres across the country. He further stressed that it is important to initiate this move as lack of data on this front can impact the confidence of the patients, leading to suboptimal levels of adherence to the treatment.
He added, “This initiative stands up as an important milestone towards streamlining the PvPI programme further, especially since there is hardly any data available on the effects of the ARV drugs on the patients across the country. In the light of better accessibility of ARV drugs throughout the country it is high time to build in a monitoring system that is specialised in identifying ADRs specifically arising out of ARV drugs.”
http://www.pharmabiz.com/NewsDetails.aspx?aid=83772&sid=1
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