Some states like Rajasthan, Madhya Pradesh, Uttar Pradesh and Bihar are lagging behind in terms of coming out with publications, drug utilisation researches (DUR) and reports for effective adverse drug reaction (ADR) reporting in the country due to lack of awareness and resource crunch in healthcare institutions among other issues.
DUR becomes more relevant as government is in the process of implementing pharmacovigilance programme in over 360 medical colleges in the country. According to experts, there is therefore an urgent need for Drug Utilisation Research across the country to evaluate the pattern of drug use in the population through rational usage of drugs and following standard guidelines to arrive at preventive ADRs.
"Currently, ADR data available is inadequate as it does not represent population which consumes the drug or to which the drug has been prescribed for," says Dr Nilima Kshirsagar, National Chair in Clinical Pharmacology, Indian Council of Medical Research (ICMR).
It has been given to understand that there is a need for quantifying ADR with the help of Technical data associates in ADR Monitoring centres (AMCs) to assess drug behaviour in the Indian population. Informs Dr V Kalaiselvan, principal scientific officer, Pharmacovigilance Programme of India (PvPI),"Of 150 ADR Monitoring Centres set up under the Pharmacovigilance Programme of India (PvPI), Technical Data Associates (TDAs) are working in 82 centres as of today. They are working in coordination with IPC, Ghaziabad for final analysis and reports."
In order to address the problem in its entirety, Dr Nilima Kshirsagar suggests, "There is a need to generate representative epidemiological data on drug utility and outcomes of treatments through more studies from private hospitals and community healthcare. India needs to develop a reporting culture of ADRs in the form of publications, drug utilisation research and reports to boost regulatory decisions."
In addition to this, there is a need for reporting ADR effectively as India has been lagging behind in terms of lag time for withdrawal of drugs vis-a-vis the developed countries over the past few years. India has witnessed three blockbuster drug withdrawals in the past 10 years.
Four nodal centres in KEM, Nair, Sion, JJ Hospital has been authorised by the central government to quantify ADR data. TDAs are accountable for collecting information from the patients, performing follow up with them, entering information in the prescribed software (Vigiflow) and sending them to the Indian Pharmacopoeia Commission (IPC) for further analysis and documentation. Only 90 centres have the Swedish software Vigiflow which helps in accurate reporting of ADRs.
IPC also updates information on ADRs that is being reported in India from across all its centres through VigiFlow to the Uppsala Monitoring Centre (UMC) in Sweden, which is WHO's collaborating centre for international drug monitoring.