The Union government is now working to increase the number of pharmacovigilance centres in the country from the current 90 to 150 by March end 2014. All these 150 colleges will be authorized to report any adverse drug reaction in the country.

So far in the last one and half years, 54,000 adverse drug reactions were reported and evaluated. In the next three to six months there will be stringent regulations which will call for a ‘box warning’ on labels of drug packs indicating the adverse drug reactions, Dr GN Singh, drugs control general of India (DCGI) told Pharmabiz on the sidelines of the national training workshop on ‘Secured Medicines and Robust pharmacovigilance’ organised by The Partnership for Safe Medicines India.

There is need to address the issue of drug safety in patient care and with this intention the government is now looking to expand the adverse drug monitoring centres from the current 90 to another 60 only to increase the monitoring of reactions.

Currently there are 90 ADR centres in India of which 11 are in Karnataka. In fact the highest number of ADRs are coming in from Karnataka followed by Tamil Nadu, he said.

Meanwhile, Karnataka government is now insisting the Union government to come out with an adverse drug reaction reporting training for public and healthcare as part of its pharmacovigilance initiative.

In this regard, it is now proposing to the government that the process of adverse drug monitoring should be on similar lines that of the national programmes like the pulse polio, pentavalent vaccine immunization and the weekly iron and folic acid administration.

There is need for massive education and training for adverse drug reaction reporting among the public and patients, Madan Gopal, principal secretary, Karnataka department of health and family welfare said. We need to educate not just clinicians but the entire spectrum of patients, pharmacists and public to create an awareness on long term adverse drug affects on patients. ADR can improve health and safety of people, he added.

According to Bejon Misra, founder, The Partnership for Safe Medicines India, there is an easy reporting mechanism for pharmacovigilance where clinicians can be empowered to save the patients. Now there is need to increase the number of ADR centres. Pharma companies undertaking phase IV studies which is Post Marketing Surveillance should also adopt ADR.

India needs a National Medication Policy where audit of not just chemist shops should be undertaken but also prescriptions. We also need to assess the legal implications of ADR for clinicians, said PS Bhagavan, registrar, Karnataka State Pharmacy Council.