The office of the Drugs Controller General of India (DCGI) is closely examining the safety profile of paroxetine, a well-known anti-depressant, following reports emerging from the western world about its possible adverse side effects. The Indian manufacturers of the drug include Cipla (Parotin), IPCA (Pari), Intas (Pexep) and Ranbaxy (Raxit).

The reports from countries like UK and US suggest that the innovator company Glaxo Smithkline (GSK) might have concealed certain negative results of a larger clinical trial from the drug regulatory authorities while applying for marketing approval for the first time. While the initial clinical trial conducted by GSK came out with positive results on adolescents and adults, the second trial, the larger one, seems to have indicated that the drug was of no use for adolescents and was likely to induce suicidal tendencies in certain youngsters.

The DCGI has taken serious note of the development and has decided to understand the current stand taken by regulatory authorities like US FDA and UK MCA. The DCGI's attempt is in response to a court case filed in the US against GSK alleging that the company had concealed details of the larger clinical trial from the authorities. In the civil lawsuit, the New York State Attorney General, Eliot Spitzer, has claimed that the company suppressed the results of at least four different studies that showed that the drug (Paxil in the US), was at best no more effective than a placebo and at the worst was harmful. According to the lawsuit, in one case, up to 6.5 per cent of the sample taking the drug had developed suicidal tendencies, compared to 1.1 per cent in the placebo group.

According to Ashwini Kumar, DCGI, the authority's attempt is to understand the Indian experience with the drug. "The international scenario would be presented before medical experts and opinion sought from medical practitioners before arriving at a conclusion. The side effects of the drug are well known and our attempt would be to see if product insert," he said.

According to him, the side effects of the drug are clearly mentioned on the product insert. "The drug is not banned in any country. We are aware of the side effects. What we need to see now is whether there are any adverse side effects beyond what has been warned," he said.

The DCGI approval clearly states that the drug is not recommended for children below 12 years. The medical practitioners feel that the drug is rarely administered to children below 12 years as depression is mainly a problem of the adolescent age group. They feel the use of drug has to be restricted in the case of adolescents also and not just the children.

Commenting on the Indian experience in post marketing surveillance of drugs, he said that the companies are giving mandatory PMS report for all new drugs approved since 2002. "However, we are yet to see any negative reports as the new drugs approved here are already tested and approved in several countries before they are manufactured here," he opined.