DR. G.N. SINGH
Indian Pharmacopoeia Commission, Ghaziabad
The Pharmacovigilance Program of India (PvPI) was launched with a broad objective to safe guard the health of 1.27 billion people of India. Adverse drug Reactions (ADRs) are reported from all over the country to NCC-PvPI, which also work in collaboration with the global ADR monitoring centre (WHO-UMC), Sweden to contribute in the global ADRs data base. NCC-PvPI monitors the ADRs among Indian population and helps the regulatory authority of India (CDSCO) in taking decision for safe use of medicines. I invite all the health care professionals and patients/consumers to join us in our mission to promote patient safety.
From the Desk of Secretary-cum- Scientific Director
Since its initiation in 2010, the Pharmacovigilance Programme of India (PvPI) has been enriching the quality of performance and expanding its fields activity. The quality parameters in respect of signal detection, quality review, training programmes and other activities have been maintained at higher than the expected levels.
With in a span of five years PvPI has become a formidable force at international level the best pharmacovigilance practices including Adverse Drug Reactions (ADRs) reporting and providing skill development. The Individual Case Safety Reports (ICSRs) are collected/collated in a scientific way and analysed to facilitate appropriate decisions at CDSCO.
A significant scope in extension of PvPI activities exists for moving ahead, connecting a network of ADR reporter over the country and earning trustworthiness of the masses. NCC-PvPI is fast extending its activities within the country and abroad for ensuring the safety of drugs.
I take this opportunity to appreciate the zeal with which the staff under PvPI work and wish them to take guard of public health within the country and bring laurels to the Nation.
The Central Drugs Standard Control Organisation (CDSCO), New Delhi, under the aegis of Ministry of Health & Family Welfare, Government of India has initiated a nation-wide pharmacovigilance programme in July, 2010, with the All India Institute of Medical Sciences (AIIMS), New Delhi as the National Coordinating Centre (NCC) for monitoring Adverse Drug Reactions (ADR) in the country to safe-guard Public Health. In year 2010, 22 ADR monitoring centres (AMCs) including AIIMS, New Delhi had been set up under this Programme. To ensure implementation of this programme in a more effective way, the National Coordinating Centre was then shifted from the All India Institute of Medical Sciences (AIIMS), New Delhi to the Indian Pharmacopoeia Commission (IPC), Ghaziabad, (U.P.) in April, 2011.
The mission of PvPI is to safeguard the health of the Indian population by ensuring that the benefit of use of medicine outweighs the risks associated with its use. Since there exist considerable social and economic consequences of adverse drug reactions and the positive benefit/cost ratio of implementing appropriate risk management - there is a need to engage healthcare professionals and the public at large, in a well structured programme to build synergies for monitoring adverse drug reactions in the country.
The purpose of the PvPI is to collate data, analyze it and use the inferences to recommend informed regulatory interventions, besides communicating risks to healthcare professionals and the public. The broadened patient safety scope of pharmacovigilance includes the detection of medicines of substandard quality as well as prescribing, dispensing and administration errors. Counterfeiting, antimicrobial resistance, and the need for real time surveillance in mass vaccinations are other pharmacovigilance challenges which need to be addressed.
The vision of PvPI is to improve patient safety and welfare in Indian population by monitoring drug safety and thereby reducing the risk associated with use of medicines.The ultimate safety decisions on medicines may need considerations of comparative benefit/risk evaluations between products for similar indications, so the complexity is great.
Pharmacovigilance activities may be undertaken by several organizations, individuals and agencies. The Pharmacovigilance Programme of India fulfills the minimum requirements that should be present in any functional national pharmacovigilance system, as per WHO, which include the following:
Once the Medical institute is enrolled as an AMC under PvPI, the AMC starts reporting ICSRs to NCC via a VigiFlow. These ICSRs are then assessed at NCC for quality of data and if found valid, they are further committed to the global drug monitoring centre “Uppsala Monitoring Centre” in Sweden. But if the data is not complete or valid, then the ICSRs are reverted back to their concerned AMC with the query or necessary comments, so that the respective ICSR can be corrected or completed and sent to NCC again for evaluation. The data from NCC is also sent to CDSCO, as and when required.
Following chart explains the flow of data at regional, national and international level:
The quality of the ICSR is assessed for completeness of information and is reviewed for:
Data collected in Pharmacovigilance can be used in a variety of ways: