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Govt to ask MCI for sensitising clinicians, hospitals to collect ADRs for all drugs soon

Shardul Nautiyal, Mumbai
Monday, March 9, 2015, 08:00 Hrs  [IST]

In order to develop effective reporting of adverse drug reactions (ADRs) in the country, government is planning to sensitise healthcare practitioners in consultation with the Medical Council of India (MCI) as a step towards quantifying ADR data for comprehensive analysis of drug behaviour in the Indian population.

Government has come out with a recommendation that ADRs should be collected for all drugs by all pharmaceutical companies, hospitals, clinician treating the patients and practicing clinicians. To take the plan forward, official sources said that MCI should be requested to take forward the process of sensitising clinicians in the hospitals to report ADRs to the Pharmacovigilance Programme of India (PvPI). Recommendation is a part of the meeting held with the officials of the Pharmacy Council of India  and Indian Council of Medial Research (ICMR) recently.

According to health ministry officials, the hospitals should also set up pharmacovigilance committees to monitor ADR and reports to be forwarded to PvPI. Periodic Safety Update Reports (PSURs) in the case of new drugs also need to be forwarded.

This is very much required as pharmacovigilance is a science and specialty and evolving in the country but research and reporting outcomes are limited. Experts inform, "Effective communication of the safety data to the public is a key challenge which need to be addressed on a war footing. Letter writing and package insert warnings are some of the conventional methods used for communication of pharmacovigilance knowledge as of today."  

Experts have also been pinpointing that data available on ADRs is also inadequate as it does not represent population which consumes the drug or to which the drug has been prescribed for. There is, therefore, no representative epidemiological data on drug utility and outcomes of treatments.

It has also been advocated that there is a need for quantifying ADR data to assess drug behaviour in the Indian population. Epidemiological data on drug utility and outcomes of treatments need to be generated through more studies from private hospitals. A reporting culture of ADRs also need to be developed in the form of publications, drug utilisation research to boost regulatory decisions.

Of 150 ADR Monitoring Centres set up under the PvPI, Technical Data Associates (TDAs) are currently working in 82 centres as of today to generate relevant ADR data in coordination with Indian Pharmacopeia Commission (IPC), Ghaziabad for final analysis. Four nodal centres in KEM, Nair, Sion, JJ Hospital has also 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  for further analysis and documentation.

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.

Pharmacovigilance Programme of India launched on July 14, 2010 is currently capturing ADR data in Indian population in a systematic way in coordination with the IPC. The main objective of the programme is to monitor ADRs in Indian population.


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