The pharmacovigilance programme, which has been ignored for years after its launch in 2004, is likely to be strengthened with the Drug Controller General (India) launching steps to improve the regulatory framework and fortify the network of adverse drug reaction centres.
The DCGI office has already made a proposal to the Health Ministry to look into the possibility of setting up special cells for pharmacovigilance, as a mandatory provision, both in all the existing and new medical colleges in the country with a view to improve the functioning of the national pharmacovigilance programme (NPP), DCGI, Dr Surinder Singh, informed Pharmabiz.
Besides, the DCGI is also planning to interlink all the existing pharmacovigilance centres and the proposed cells in the medical colleges to ensure a strict monitoring. Dr Singh said he had already created a separate cell in his office for pharmacovigilance to coordinate and monitor the programme, and also build up a comprehensive mechanism.
The USFDA, which has been helping the Indian regulatory authorities on improving the functioning of the CDSCO, has also identified pharmacovigilance as a key area of focus. The experts from the American agency will be holding a series of workshops to train the Indian officials on the pharmacovigilance affairs. Besides interlinking the centres, there is also a plan to create a database on adverse drug reactions so that the post-marketing surveillance is made stricter and increase patient safety.
India launched the NPP in 2004 with the help of World Bank. Under NPP, there are 21centres, including two zonal centres at All India Institute of Medical Sciences, New Delhi covering north and east. The KEM Hospital at Mumbai monitors southern and western regions in India. There are five regional Pharmacovigilance Centres at Kolkata, Pondicherry (JIPMER), Nagpur and Mumbai with two centres. There are several periphery centres including Bangalore at the Victoria Hospital, Goa, and Mysore within JSS College of Pharmacy.
Though the government had announced to increase the number of ADR centres, it did not come up as promised and the functioning of the programme has not been very effective.