India's adverse event reporting "alarming"

The World Health Organization has criticized India's pharmacovigilance reporting levels as "alarming," according to a report in the Indian on-line business magazine, Pharmabiz.com. A WHO chief program officer, Sten Olsson, was speaking at the invitation of the Institute of Clinical Research of India.

Among Mr Olsson's objections, is that the New Dehli-based federal regulator employs only 25 staff to oversee drug clearances for the entire country, which has 1.1 billion inhabitants. By contrast, Mr Olsson noted, Sweden, a country with only nine million people, has 250-300 drug regulators with the same responsibilities.

Mr Ollson said: "pharmacovigilance is crucial because while clinical trials involve several thousands, there are several cases of adverse drug reactions during the course of medication. There is a need for massive awareness and education of the role of such reactions, which could be fatal if not reported in time."