The adverse drug reaction data submitted by six countries including India, where nimesulide has been given marketing approvals, has shown that India, the largest populated country in the list is the only one which has not recorded even a single instance of nimesulide induced ADR during the past several years.
According to the figures appearing in the latest issue of the Monthly Index of Medical Specialties (MIMS), while countries like Switzerland, Belgium, Finland and Italy have come up with ADR data on nimesulide, there has been no such recorded instance within the country.
The MIMS has highlighted this as an example of the dismal state of ADR monitoring capacities within the country. It says that medical students in the country are not taught the art of monitoring ADRs. "Secondly, a huge majority of doctors do not maintain records on their patients. They do not even seek information required to determine side effects such as weight, use of medications including OTC products taken during the past three months with dose, date of starting and stopping, and the condition for which they were taken. Without this basic information, ADRs cannot be determined," it has observed.
According to the MIMS statistics, Ireland, having a population of 4 million has recorded 25 ADRs, Switzerland (7 million) - 33 ADRs, Belgium (10 million) - 83 ADRs, Finland (5.5 million) - 109 ADRs and Italy (57 million) - 225 ADRs whereas India, with a 1000 million population has not been able to generate even a single ADR data.
It has also pointed out that India's contribution to worldwide collection of data on drugs' side effects is dismal. "One has just to go through four issues of WHO pharmaceuical Newletter published in 2002 to realize that the safety information of not even one drug was internationally amended based on Indian input," it explained.
The importance of post-marketing screening of adverse drug reactions (ADR) can hardly be over emphasized. Before a drug is introduced into the market, it is usually tested in no more than a thousand patients. Adverse reactions that occur in 1 in 1,000 or more cases cannot be detected prior to marketing. Side effects are always a serious challenge. In United States, 3 to 5 per cent of all hospital admissions are due to drug reactions. While every country would like to monitor ADRs, presently only a few have the competence, capacity and infrastructure required to do so, it said.
According to Dr C M Gulhati, editor MIMS, ADR findings from developed countries cannot be ignored. "Even if we have our own drug surveillance system, ADR findings from developed countries will continue to play a decisive role. In the absence of locally reported ADRs, we may not prohibit the sale of a globally discarded drug but it will die a natural death sooner or later. Prescribers will simply switch to non-controversial alternatives," he stated.
"Doctors cannot assess side effects on their own. Several institutions and experts are required to do so. Drug regulatory authorities, doctors, pharmacologists, pharmacists, dentists, epidemiologists, statisticians and an efficient infrastructure are all essential prerequisites. Do we have these elements in place?" the MIMS report asks.
Dr Gulhati feels that ADR reporting in countries like Britian, Canada, Sweden and New Zealand are better because there is a legal binding which makes such reporting mandatory. "In Ireland, for example, 50 per cent of ADRs are reported by family doctors, 25 % by drug companies, 13.6 % by specialists, 10 % by pharmacists, 1 percent by nurses and 0.2 % by dentists. On the other hand, in India, over 80 per cent of Indian population is dependent on private practitioners. Unless family doctors, now numbering over 206,000 are actively involved in ADR monitoring, no worthwhile outcome is likely," he said.