With increasing use of OTC drugs and irrational prescribing of drugs across the country, Drug Controller General of India (DCGI) Dr G N Singh advocates the need to sensitise medical practitioners and patients about adverse drug reactions (ADRs) for its effective monitoring as part of the Pharmacovigilance Programme of India (PvPI).  

Even as factors like sub-standard drugs, medication errors and lack of reporting culture has given a set- back to PvPI, DCGI Dr G N Singh informs, "Of the 1, 20,000 ADRs reported in the country, we are planning to analyse drugs on the basis of risk benefit ratio so that apt sensitisation and suggestions can be provided to the practitioners and patients before suspending and banning any particular drug."

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. Moreover, the regulations and review process which is lagging behind in India has further aggravated the situation.

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 and community healthcare. 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 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 (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.