The Indian Pharmacopoeia Commission (IPC) is soon expected to bifurcate and start hemovigilance and biovigilance programme under the aegis of the Pharmacovigilance Programme of India, to ensure better steps to safeguard the health of the patients in the country. It is understood that under the proposed plan the Pharmacovigilence Programme of India (PvPI) will act as the nodal agency under which this two programmes will be initiated as separate and independent functions.

National Institute of Biologicals (NIB), an autonomous institution under the Ministry of Health & Family Welfare (MOHFW) set up to ensure the quality of biologicals and vaccines in the country, will act as the centre for collection and analyses of all the data relating to both this programme under the PvPI programme. The data through them will be further submitted to the national coordinating centre (NCC) at Indian Pharmacopoeia Commission (IPC), which is also the NCC for the PvPI. It is understood that all the operations relating to these programme will be carried out under the guidance of Dr. Surinder Singh, deputy director (QC) and director of the NIB, who also had been the Drug Controller General of India (DCGI) in the past.

A highly placed source from the health ministry informed that this initiative will help in bringing a better delivery of healthcare services through improved understanding of quality and safety issues relating to all the biological and blood related products circulating in the country. This also highlights the growing importance of the biological and blood products in the PvPI programme that will help in streamlining a better monitoring function of these products in the drug regulatory system of the country as per the Indian requirement for safeguarding the interest of the patients.

At present, hemovigilance which covers the quality and efficacy of the blood products and biovigilance which deals with safety parameters of biotech products are classified under the pharmacovigilance programme only and not as a separate programme. With this initiative, the commission plans to broaden its scope to emphasis more on the other aspects of healthcare more predominately for patients welfare.

Sources inform that officials from the drug regulatory body along with the officials from the IPC are working on this matter from last one month and are still deliberating on the various aspects on the same. In fact, they are expected to come about with a definite plan in about four months as per highly placed courses