World Health Organization chief programme officer Sten Olsson has deplored the poor rate of reporting in pharmacovigilance in the country and has termed the situation in the country as alarming. "The rate of reporting the adverse drug reaction (ADR) in the course of the treatment is low in India primarily because of lack of awareness", he said.
Expressing concern over the Indian scenario, Olsson said that, globally the pharmacovigilance is as low as five per cent in the best of circumstances. But, the Indian rate of below one per cent is the lowest rate in pharmacovigilance in the world.
The WHO official is here in India on the invitation of the Institute of Clinical Research of India. The officer was appalled to find that the Indian drug regulatory board, New Delhi, had only 25 people to oversee the drug clearances in the country. In Sweden, which has a population of 9 million, there are anywhere between 250-300 drug regulatory officials overseeing the operations.
"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 need for massive awareness and education on the role of such reactions, which could be fatal if not reported on time. Therefore, there is a serious need for both medical professionals and patients to be constantly vigilant," he averred.
India is not among the countries that have made pharmacovigilance mandatory for health professionals. "Health professionals cannot ignore this critical part of the healthcare because it is a matter of concern for patients and professionals," Olsson stated.
It is also every patient's right to report on drug reactions. This is why countries have made provisions for patients to report directly to the regulatory authority. This is particularly important in countries where the practice of self-medication is high, he said.
It is crucial to include pharmacovigilance in healthcare initiatives in the country where massive distribution of medicines takes place without any questions asked.
In 2004, the Ministry of health and family welfare set up a nationwide network to build a comprehensive pharmacovigilance data system. It also saw the formation of the National Pharmacovigilance Advisory Committee (NPAC) chaired by the Director General of Health Services and the Drug Controller General of India (DCGI), who is the member secretary of the Committee. In fact, the National Pharmacovigilance Programme for India, which became functional in 2005 was sponsored by the World Health Organization (WHO) and funded by the World Bank.0 Today, NPAC supervises 24 peripheral centres.
It consists of two zonal centres. The south and west centres are operating at the Department of Clinical Pharmacology, Seth G S Medical College and KEM Hospital, Mumbai. The north and east centre functions at the Department of Pharmacology, Amrita Institute of Medical Sciences, New Delhi. Pharmacovigilance efforts can assist in detecting the spurious drugs in the market and also ensure improved post marketing surveillance and other drug data to be submitted by the Indian pharma manufacturers during product clearances.