With the number of reports of Adverse Drug Reactions (ADR) going up in the recent times after extending the National Pharmacovigilance Programme, the authorities are now planning to increase the number of monitoring centres across the country in the next phase.
Currently, the programme is covered through 22 centres with the All India Institute of Medical Sciences (AIIMS) as the national coordination centre for monitoring the ADR cases in the country. The Drug Controller General has recommended to the Health Ministry to increase the number of monitoring centres to 50 in the next phase, sources said.
Though the number of cases has gone up, none of the reports however could be substantiated leading to any kind of regulatory restriction or prohibition on any drug reported under the programme in the country so far, sources added.
A National Pharmacovigilance Programme (NPVP) was undertaken on project basis in 2004 which came to an end in June, 2008. A revised pharmacovigilance programme was initiated on July 17, 2010 under the nomenclature Pharmacovigilance Programme of India (PvPI) with the AIIMS as the coordination centre.
“Under the earlier National Pharmacovigilance Programme, 11633 cases of ADRs were reported during the period 2006 to 2008. Under the new Pharmacovigilance Programme of India, 1394 cases of ADRs have been reported to September, 2010. These were reported in a couple of months, showing that there is an increase in the cases. But none them could be proved,” sources said.
Following the success of the programme, the DCGI has now recommended increasing the total number of monitoring centres by another 28 in the next couple of years. The State licensing authorities have been asked to forward the names of hospitals to be included in the programme.
“The ultimate goal is to make sure that there is an ADR monitoring cell in every medical college in the country. This will be achieved in phases and the country needs a robust system,” sources added. Pharmacovigilance involves collection of data and records of actions relating to detection, evaluation, understanding and prevention of adverse effects or any other medicine-related problems.