Following setting up of a task force to link Pharmaco-vigilance Programme in India (PvPI) with pharmaco-genomics, the government is now planning to get funding on project mode to help expand the scope of pharmaco-vigilance in India.
With this, PvPI will include pharmaco-genomics under it as a part of its scientific component to address concerns of vulnerable populations susceptible to adverse drug events induced by a certain drug triggered due to genetic factors.
An amount of around Rs.50 lakh is being planned to be reserved with help from the Union health ministry in the initial phase to expand the scope of pharmaco-vigilance and include pharmaco-genomics as its scientific component.
Said a senior pharmaco-vigilance official, “This would be a major breakthrough as PvPI is currently restricted till clinical data collection on adverse drug reactions (ADRs). Meanwhile, with the task force in place, projects will also be easily funded now.”
The Indian Council of Medical Research (ICMR) has also identified it as a key priority area to be implemented by putting it under the funding mode through investigator initiated focused projects to be dealt in a comprehensive manner. The other priority areas also include anti-diabetic drugs, application based PvPI and making general practitioners adopt PvPI in a practical manner.
A case in point to support the need for pharmaco-genomics in PvPI is of Stevens-Johnson syndrome (SJS) which is a rare but life-threatening skin reaction disease in a certain set of population and carbamazepine is one of its most common causes. Says Dr Y K Gupta, national scientific co-ordinator, PvPI, “Pharmaco-genomics will help preempt the indication or diseased condition in similar such cases so that preventive clinical measures can be taken timely."
Drug induced disease (DID) or iatrogenic disease is an ever enduring concern for patients, healthcare professionals and health administrators. In spite of being a major concern in clinical practice, DID has not been given the due attention it deserves. One of the reasons for this may be that DID causes apprehension among healthcare professionals making them uncomfortable as well as unwilling to be part of studies undertaken to reduce DID.
Central Drugs Standard Control Organisation (CDSCO), under the Union health ministry had initiated a nation-wide PvPI in July 2010. Dr Y K Gupta is credited to have started PvPI in 2010 at AIIMS with support from CDSCO and government of India. This got further expanded and for administrative reasons was shifted to Ghaziabad based Indian Pharmacopoeia Commission.