A recent study by Booz Allen Hamilton in the US finds that drug companies are mostly meeting their post-marketing surveillance (PMS) obligations in the US. Dow Jones Newswires reports that 80 per cent of the PMS studies that Booz reviewed were either meeting their deadlines, were submitted to the FDA for review, or were already completed. Booz reveiwed more than 1,500 open post-marketing reviews.
The purpose of PMS is primarily patient safety. It is now an established fact that even after extensive human trials a drug may throw up side-effects when consumed by the community at large. These might be new side-effects, or the extent of known risks might be greater than estimated at the time of approval. Recent recalls include Merck’s painkiller Vioxx which became the subject of millions of dollars worth of lawsuits. A PMS mechanism is expected to capture this early on.
In India, too, there is a law that mandates PMS. (Check out the Drugs & Cosmetics Act on http://www.cdsco.nic.in). But does anyone know whether it is being made to work? Drug industry executives speaking off-the-record say it is observed more in the breach. It would be a good idea for the DCGI to commission a study. Somehow I don’t see that happening in a hurry, however.