In order to expand Pharmacovigilance Programme of India (PvPI) in the country to register adverse drug reactions (ADRs) effectively, the Indian Pharmacopoeia Commission (IPC) is planning to expand the PvPI in the Union Territory (UT) of Jammu and Kashmir (J&K) with focus on North Eastern (NE) states.
As of today, India has set up a total of 300 ADR monitoring centres (AMCs).
“IPC is in the process of identifying hospitals in J&K as there are only 4 AMCs in the Union Territory (UT) of J&K,” according to a senior health ministry official.
The Ghaziabad-based IPC had earlier issued letter of intent (LoI) for prospective AMCs for voluntary reporting of ADRs due to C-19 drugs by healthcare professionals.
Central Drugs Standard Control Organisation (CDSCO) had launched PvPI in July 2010 with Ghaziabad-based IPC as the National Co-Ordinating Centre (NCC).
As per the mandate of PvPI, pan-India ADR information will be taken forward with all district hospitals in the country and implemented at PHC and taluka level health centres. This will augment government’s plan to roll out the PvPI at district level hospitals across the country.
Drug Controller General of India (DCGI) in the past had also recommended to explore possibilities of identifying district hospitals in NE states to be developed as AMCs.
Medical colleges, hospitals and institutes approved by the Medical Council of India (MCI) can also act as AMCs. Once enrolled, they are assigned to efficiently collect the adverse event information from the patients, do follow up with them to check the completeness of the ADR reports.
IPC has been assigned to update information on ADRs that is being reported in India from across all its centres through Vigiflow software to the Uppsala Monitoring Centre (UMC) in Sweden, which is WHO’s collaborating centre for international drug monitoring.
The union health ministry has also mandated AMCs across the country to report SAEs due to medical devices as part of the Materiovigilance Programme of India (MvPI).
The MvPI, being coordinated by the IPC at Ghaziabad, was launched in 2015. IPC functions as the NCC and SCTIMST in Thiruvananthapuram acts as the collaborating centre. Technical support is being provided by the National Health Systems Resource Centre (NHSRC) in New Delhi.
The purpose of the programme is to study and follow medical device associated adverse events (MDAE) and enables dangerous ones to be withdrawn from the market.
MvPI is meant to enable safety data collection in a systematic manner so that regulatory decisions and recommendations on safe use of medical devices for India could be based on data generated in India.
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