National Pharmacovigilance Programme
The nation wide programme, sponsored and coordinated by the country’s central drug regulatory agency – Central Drugs Standard Control Organization (CDSCO) – to establish and manage a data base of Adverse Drug Reactions (ADR) for making informed regulatory decisions regarding marketing authorization of drugs in India for ensuring safety of drugs.
The National Pharmacovigilance Centre at CDSCO coordinates the programme. The National Centre will operate under the supervision of the National Pharmacovigilance Advisory Committee (NPAC) to recommend procedures and guidelines for regulatory interventions.
Objectives of the Programme
Broad objectives of the Programme
- To foster the culture of AE notification and reporting
- To establish a viable and broad-based ADR monitoring program in India
Specific objectives of the Programme
- To create an ADR database for the Indian population
- To create awareness of ADR monitoring among people
- To ensure optimum safety of drug products in Indian market
- To create infrastructure for ongoing regulatory review of PSURs
The National Pharmacovigilance Advisory Committee (NPAC) will oversee the performance of various Zonal, Regional and Peripheral Centres and will perform the functions of “Review Committee” for this program. The NPAC will also recommend possible regulatory measures based on pharmacovigilance data received from various centres.
National Pharmacovigilance Programme comprises of twenty-four Peripheral Pharmacovigilance Centers pooling their data at five Regional Pharmacovigilance Centers, which in turn funnel their data to the two Zonal Pharmacovigilance Centers.
ZONAL PHARMACOVIGILANCE CENTER
Large healthcare facilities attached with medical colleges in metro cities identified by the CDSCO for the purpose. They would act as third level centres in the administrative structure of the NPPI. They will function as First contact ADE data collection units also.
Zonal Pharmacovigilance Centres to coordinate the nationwide programme. For the North-East Region Department of Pharmacology at All India Institute of Medical Sciences, New Delhi is designated as Zonal Pharmacovigilance Centre.
AIIMS Zonal Pharmacovigilance Center is engaged in collecting, analyzing the data and submit consolidated information to the National Pharmacovigilance Centre where National Pharmacovigilance Advisory Committee would evaluate the data and recommends appropriate regulatory interventions.
Process of informing by a notifier to any participating Pharmacovigilance centre about the occurrence of a suspected ADE. The process may involve informing over telephone, in person, email, fax or any other means of communication-verbal or written. All notifiers must give their contact details.
Appropriate and adequate measures must be taken to keep track of the notifier. Any follow up action will be initiated on a notification only after the due verification of the notifier. If the notifier cannot be traced back, it will be recorded on the notification slip before closing the case.