The issue of use of nimesulide as an anti-pyretic agent in children has generated a lot of debate in the last 24 months and I must compliment Piyush Gupta and H.P.S. Sachdev for conducting and reporting a systematic meta-analysis regarding safety of oral use of nimesulide in children. They have concluded that for short-term use (< 10 days) in children, nimesulide is as ‘safe’ or ‘unsafe’ as other analgesics-antipyretics(1). Meta-analysis provides one of the strongest scientific evidence for a research question. However, type B adverse drug reactions, which are bizarre reactions that cannot be predicted from the known pharmacology of the drug, are extremely rare occurrences. A large sample size would be required to pick up such reactions(2,3). At least 30000 people need to be treated with a drug (and their data analyzed) to be sure that a reaction with an incidence of 1 in 10000 is not missed(4). These events and reactions are best detected through post-marketing surveillance(5). Therefore, the government should establish a countrywide network operating on a continuous basis, for monitoring the safety of newly introduced, if not all, drugs. At present, departments of Clinical Pharmacology at select medical colleges and only a few centers are working in this area(6). These centers are collecting data regarding adverse drug events only from a few physicians working in the same institution. Although these efforts are laudable, they are not able to generate the kind of data, which could form the basis of corrective measures. As we are unable to generate data pertaining to side effects of drugs in our own population, we are heavily dependent on the data generated in other countries and advisory notes issued and regulatory actions taken by regulators elsewhere. And when the regulators world over are divided in their opinion about safety of a drug, Indian drug regulators are in a dilemma regarding allowing its continued production and marketing. In this context it should also be noted that adverse drug reactions (ADRs) of different type or severity might occur in Indian population due to socio-cultural and ethnic factors(6), making it imperative upon us to generate Indian data.

Previously, new drugs were introduced in the Indian market after a gap of several years. Hence the physicians and regulators here were able to draw upon the data generated in the countries that were using the drug for those years. It has been observed that the lag has now decreased considerably(7). This makes it even more pertinent for us to have an indigenous system to detect adverse drug events. The centers under the nation-wide pharmacovigilance system should collect data regarding adverse drug events from clinicians, pharmacists, nurses and lay people. The apex center under the system could collate the data and perform analytical, advisory and regulatory functions. It could put up alerts and advisory notes for the clinicians regarding ADRs and safety of drugs. At present, the clinicians are not aware of the valuable contribution that they can make in monitoring drug safety. Hence, the pharmacovigilance program should also take up educational activities in collaboration with professional bodies like the Indian Academy of Pediatrics, to inform and enlighten clinicians about the need for and advantages of an active reporting system for monitoring drug safety.

Sandeep B. Bavdekar,
Seth G. S. Medical College and
K. E. M. Hospital,
Parel, Mumbai 400012, India.
E-mail: [email protected]