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Indian Pharmacopoeia Commission (IPC) has started training Pharm D institutions to undertake specific projects as part of intensive adverse drug reaction monitoring exercise under the Pharmacovigilance Programme of India (PvPI) for taking regulatory decisions on specific drugs having ADRs.
IPC has recently come out with a draft protocol and guidelines focused on targeted drugs to generate and report India specific adverse drug reactions. For this, institutions are encouraged to carry out Intensive ADR monitoring for data generation as per stipulated guidelines in a focused manner related to specific drugs.
Till date, 25 Pharm D institutions have been identified to carry out such Intensive ADR monitoring exercise which will be done through a clearly defined protocol and will generate data as per health ministry stipulated guidelines in terms of reporting specific events.
“The projects undertaken by the institutions will take at least one year time to complete and the institutions have therefore been trained based on specific projects to offer clarity in the process of reporting ADRs,” informs Dr V Kalaiselvan, Principal Scientific Officer, IPC, Ghaziabad.
The exercise has been primarily initiated keeping in view that data from spontaneous reporting of ADRs have generally been mis-spelt. Specific project on diabetic drug pioglitazone and its India specific data in the country for adverse reactions leading to conditions like bladder cancer is one such case in point.
To track ADRs in Indian population, Union health ministry launched PvPI which has outreach all over the country but only a small portion of healthcare professionals have formal training in pharmacovigilance (PV).
IPC has also signed an Memorandum of Understanding (MoU) with NABH following which around 600 National Accreditation Board for Hospitals and Healthcare providers (NABH) accredited hospitals have also started reporting ADRs as part of their pharmacovigilance activities mandated by the government.
The exercise is an initiative taken by IPC to generate awareness in medical institutions to put in place effective surveillance system for detection of ADRs.
CDSCO under the Union health ministry had initiated a nation-wide PvPI in July 2010. This got further expanded and for administrative reasons was shifted to Ghaziabad based IPC.
Individual Case Safety Reports (ICSR) as part of ADRs are also 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.
Uppsala Monitoring Centre was the first WHO Collaborating Centre to be established for pharmacovigilance when, in 1978, the scientific and technical responsibility of the WHO programme for international drug monitoring was transferred to Sweden.
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