The World Bank supported National Pharmacovigilance Programme of the Central Government remains a non-starter even after one year of the finalization of the project details. Though the Central Drugs Standard Control Organization (CDSCO) had envisaged putting in place a national network of 40 pharmacovigilance centres by August 2003, there is yet no progress in this direction, it is learnt. The delay in the materialization of the programme has put on hold the Union Health Ministry's plan to strictly monitor all new drugs cleared during the recent years for adverse drug reaction.

According to informed sources, the implementation of the programme was currently delayed after the new minister wanted to go through the specifics of the programme before giving a go ahead. The national plan drawn by CDSCO had envisaged pharmacovigilance centres coming up both in government and private medical institutions across the country.

The key aspect of CDSCO plan was to decentralize the ADR monitoring activities and have the entire programmes monitored and coordinated by six regional centres, two zonal centres and a supreme control nod at the CDSCO headquarters in Delhi. The CDSCO had felt that these centers could also play a supportive role in increasing the clinical research activities in the country.

In the absence of a workable alternative, the present ADR monitoring cell at All India Institute of Medical Sciences (AIIMS) is continuing to function as the Apex ADR monitoring centre. This would have become one of the zonal centres with the announcement of the new programme. Though the CDSCO had almost finalized the persons who had to be given charge of the entire programme, the change of guard at the centre is known to have warranted changes in those lists. The new team is likely to be finalized after receiving the Union Minister's approval.

The project was supposed to be aided by the Word Bank for the first five years, beginning from August 2003. The centre had also earmarked Rs 55 lakh for the initial year for having the national pharmacovigilance system in place.

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 system and has incorporated all practical suggestions to rectify those defects. The CDSCO had called for a national meeting of clinical researchers last year wherein the delegates where asked to prepare SOPs and also to suggest on the practical targets which they can meet.

However, there are experts who disagree with the view that the new system is fool proof. They point out the failure to implement the programme for the last one year as proof for its impractical nature. "No where in the world is there a similar ADR monitoring system. One cannot expect the doctors to participate wholeheartedly in the programme. What you need is a centralized system with sufficient dedicated personnel to carry out the work," they opine.