In order to expand its scope, the pharmacovigilance, which is currently restricted till clinical data collection on adverse drug reactions (ADRs), will soon also include pharmaco-genomics under it as a part of the scientific component of Pharmacovigilance Programme of India (PvPI) to address concerns of vulnerable populations susceptible to adverse drug events induced by a certain drug triggered due to genetic factors.
The Indian Council of Medical Research (ICMR) has identified it as a key priority area among others to be implemented by putting them under the funding mode through investigator initiated focused projects in a comprehensive manner. The other priority areas also include anti-diabetic drugs, application based PvPI, making general practitioners adopt PvPI in a practical manner.
The ICMR is the apex body in India for the formulation, coordination and promotion of biomedical research. It is one of the oldest medical research bodies in the world. The ICMR is funded by the government of India through the department of health research, ministry of health and family welfare.
Says Dr Y K Gupta, national scientific co-ordinator, PvPI, "A case in point 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. Pharmacogenomics will help preempt the indication/diseased condition in similar such cases so that preventive clinical measures can be taken timely."
There is a word of caution for all providers that carbamazepine re-administration should be avoided in the patient with a previous history of SJS or adverse skin reaction. 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 health care professionals making them uncomfortable as well as unwilling to be part of studies undertaken to reduce DID.
In India, several individual case reports have been published related to specific iatrogenic disease but a comprehensive study on this problem is not yet published. The true incidence or prevalence of DID in our country is not known. The magnitude of adverse drug reactions which includes DID is huge.
Considering its importance, the 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 for administrative reason to handle huge infrastructure and was therefore shifted to Ghaziabad based Indian Pharmacopoeia Commission (IPC).
In the US, it was reported that ADRs account for more than one lakh death each year and it is between the fourth and sixth leading cause of death. In our country, we do not have statistics on DID but the total ADRs in PvPI database for the last few years are nearly 1.5 lakh.