It will also act as a point of reference on how to effectively report ADRs to the relevant authorities as per IPCs requirements when need arises. Dr Kalaiselvan informed that experts from the Pharmacovigilance Programme of India (PvPI) and CDSCO will be drafting this guidance document in consultation with the stakeholders based on their current requirements for good pharmacovigilance practices in a simplified format.
Interestingly, the need to have such a unique guidance document was raised by all the stakeholders including regulators during a recently concluded meeting that was held in Delhi.
“In response to the tremendous feedback we got from our stakeholders we have decided to go ahead with this idea. It will certainly strengthen the PvPI further as it will provide an insight to the stakeholders on the best pharmacovigilance practices to be followed. Most importantly, it will enable us to specify our requirements and expectations from the industry on when, how and where of the whole process with better clarity,” he added.
IPC which acts as the National Coordination Centre (NCC) for the PvPI just recently completed five years. Impressed by its huge achievement, recently the government also announced its plan to constitute a centre of excellence (CoE) specifically dedicated for the PvPI. This initiative is to enable focused and robust action plan specifically designed to strengthen it further.
Pharm.D @ SRIPMS-CBE-TN