The Union health ministry has increased the allocation towards Pharmacovigilance Programme (PvP) from Rs.25,000 in 2009 to Rs.1 crore for the fiscal 2010-11 and for the next financial year, the budget allocation could be increased to Rs.1.5 crore, stated Dr Surinder Singh, Drugs Control General of India (DCGI).
The funds are utilized for opening a dedicated pharmacovigilance centres at select medical colleges and hospitals which would require installation of the required systems and hiring of personnel.
The data on adverse drug reactions from an Indian perspective is valuable because it is generated after monitoring patients here. Out of the seven genetic pools in the world, six are found in India, which is represented by the distinct population in north, south, north east and western parts of the country.
At a seminar on Pharmacovigilance in India, Dr Singh stated that India needs a strong and aggressive adverse drug monitoring system as part of the country's post marketing surveillance.
“Indian pharma industry is the third largest in size and 13th highest in terms of volume. So far the country depended on the international regulators’ test reports to ban drugs but, in the next two years, India will be able to make a mark in this field by generating its own database of drugs,” he added.
India implemented the National Pharmacovigilance Programme in July 2010. Currently, there are 20 centres in the country and we are looking at adding more medical colleges and government hospitals. This will include six centres from Karnataka out of the proposed 18 centres in the state coming under the national PvP ambit.
India has been part of the World Health Organization (WHO)'s Adverse Drug Reaction Monitoring Programme of Uppsala, Sweden since 2004. It has been using the Vigibase and Vigiflow software mandated by Uppsala Monitoring Centre as web based management systems. Going by the capability of Indian information technology industry, we will look at developing a dedicated web based system to monitor the adverse drug reaction reports and the possible harm of medicine data which can be made available at the click of a button. Such a system will help healthcare providers at the click of a button to have access to drug alerts, banned and withdrawn medicines, stated the DCGI.