The Central Drugs Standard Control Organization (CDSCO) will have in place a network of 40 pharmacovigilance centers across the country within a month. All new drugs cleared during the last four years will be specifically monitored for adverse drug reactions by these centers. The centers are to come up in both government and private medical institutions.
The activities of the centers would be monitored and coordinated by six regional centers, two zonal centers and a supreme control nod at the CDSCO Headquarters in Delhi. The ambitious project of the central government is aimed at introducing a functional adverse drug reaction (ADR) monitoring system in India. The centers would also play a supportive role in increasing the clinical research activities in the country.
With this, the present ADR monitoring cell at All India Institute of Medical Sciences (AIIMS) would cease to function as a national centre and would be declared as a zonal centre. The national centre is to come up in the office of the CDSCO with a full time special officer given responsibilities of monitoring the pharmacovigilance activities in the country. The CDSCO has already identified the officer to be given charge of the national centre it is learnt.
The project is to be aided by the Word Bank for the first five years, beginning from August 2003. Highly placed sources informed that the centre has earmarked Rs 55 lakh for the initial year for having the national pharmacovigilance system in place.
According to sources close to CDSCO, the centers will be given specific targets. The targets would depend upon the number of patients handled by the medical institutions. While a peripheral center will have to forward a minimum of 30 adverse events (AE) in a month, the regional centers, all 1000-bedded hospitals, would be asked to forward 120 to 150 Aes during the period. There would be standard operating procedures (SOP) for AE recording. The clinicians in these centers would be briefed about the requirements and necessary documentation would be expected from them.
All 40 centres have been asked to give their consent in writing to function as pharmacovigilance cells from the next month.
Sources said that they have decided to record AE instead of ADR in the first place as they wanted to set roll the monitoring system. “It’s a new concept for the country. We want our clinical researchers to develop a culture of documenting adverse events. Within a very short time, we will ask them to concentrate on ADRs”, they said.
While thrust is to monitor the ADRs of all new drugs sanctioned during last four years, the centers would be asked to record “adverse drug reactions from all drugs” as well.
The centre has been working on the project for the last three years. It tried to analyse the reasons for the failure of the existing ADR monitoring systems and has incorporated all practical suggestions to rectify those defects. The CDSCO had called for a national meeting of clinical researchers a few months ago wherein the delegates where asked to prepare SOPs and also to suggest on the practical targets which they can meet. The forms prepared for recording Aes have been prepared based on the feed back from the clinicians.