The National Pharmacovigilance Advisory Committee (NPAC) has asked all peripheral adverse drug reaction (ADR) monitoring centres to monitor 11 drugs for possible adverse drug reactions. The peripheral centres are yet to report any serious adverse drug reaction in any of these cases, it is learnt.
According to sources, the drugs that have been selected for initial focus are Phenylbutazone, Cisapride, Furazolidone, Statins, Phenylpropanolamine, Droperidol, COX-II inhibitors, Nimesulide, Analgin, Sildenafil and Gatifloxacin. While these drugs would be specifically monitored, the centres have also been asked to report any adverse drug reaction that may come to their notice.
The National Pharmacovigilance Programme, initiated as part of the World Bank assisted capacity building project in drugs and food sector last year, is functional through a net work of Zonal, Regional and Peripheral centres. The Central Drugs Standard Control Organisation (CDSCO) is responsible for providing required staff, equipment and operational support to the zonal centres. AE Reporting forms, various books and periodicals, MIS reporting forms are to be provided by the CDSCO, which will also provide funds for zonal / regional / peripheral interaction meetings twice a year.
The zonal centres are required to maintain the accounts as per the project requirements and as per the institution's systems. It has to review the account statements received from regional centres and submission of audited statement of accounts within 3 months of completion of the financial year to National Centre at CDSCO H.Q. Receiving blank ADE forms form National Pharmacovigilance Centre, maintaining log of all ADE forms and ADE notification forms, ensuring a minimum of 100 filled up ADE forms from their own centre etc are all their proposed objectives.