The much-hyped National Pharmacovigilance Programme, flagged off by the union health minister about nine months ago, is yet to begin in its right earnest. Though the Central Drugs Standard Control Organization (CDSCO) has finalised the list of coordinating centres at the regional level, the centres are not fully functional so far. The CDSCO sources have also expressed unhappiness over the slow progress in the implementation of the programme.
Meanwhile, the regional centres have said that the funds that were promised to them as part of the programme are yet to reach them. "There has been no major directives from the CDSCO in this regard," they say.
The National Pharmacovigilance Advisory Committee (NPAC) formed to oversee the performance of various Zonal, Regional and Peripheral Centres has so far been meeting to take quick decisions on drugs that were voluntarily withdrawn by the innovator companies in developed markets. The previous NPAC meetings had called for the ban on Rofecoxib and Valdecoxib formulations in the country. Though the committee maintains that the decisions were based on internal evaluations, the decisive factor in both the cases were the adverse data that was available globally against these drugs. Unless the peripheral and regional centers are activated, NPAC will have no other role to play.
The CDSCO is supposed to provide 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 submit audited statement of accounts within 3 months of completion of the financial year to National Centre at CDSCO headquarters. Receiving blank ADE forms from 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 center etc. are also part of their envisaged functions.
With the number of new drugs being regularly approved for marketing in India, it was felt that a vibrant Pharmacovigilance system is necessary in the country to protect our population from the potential harms that may be caused by some of these new drugs. Unfortunately, the preparations are yet to pick up pace.