After HC disallows ban, govt to put warning on anti-depressant

New Delhi, 6 Nov 2013: Left red-faced after yet another drug ban order failed to pass judicial scrutiny, the government is set to pass an order that anti-depressant Deanxit should be sold with a warning in red that the drug is to be sold only on the prescription of a registered psychiatrist. A notification regarding this will soon be issued under section 26A of the Drugs and Cosmetics Act. In addition, an expert committee comprising psychiatrists and pharmacologists constituted by the Drug Technical Advisory Board will examine the safety and efficacy of the drug and make recommendations about its marketing in India. The move comes after the Health Ministry's June order suspending manufacture and sale of Deanxit — a fixed drug combination of flupenthixol and malitracen — in India was quashed by the Karnataka High Court in August. The court passed the order on a petition by the drug's Danish manufacturer, Lundbeck, and Mankind Pharma, the company marketing it in India. Deanxit was approved in India about 15 years ago, but the decision was termed illegal by the Parliamentary standing committee of health and family welfare in its 66th report last year on the ground that it leads to abnormal heart rhythms and neurological side-effects. The committee also took exception to the fact that Indians were being exposed to a drug that is banned in its country of origin, Denmark. The company was then given six months to prove the drug's safety and efficacy. When the relevant documents were submitted, questions were raised about the sample size, trial protocol, trial site, etc. But when the matter went to the Karnataka HC, the drug controller failed to defend the expert committee's decision. The quashing of the Deanxit order follows the Health Ministry's revocation of two more such orders on painkiller Analgin and diabetes drug Pioglitazone, which drew fierce opposition from a section of doctors. The ministry also failed to justify the orders before an expert committee, thus exposing loopholes in the drug regulation mechanism.

Indian Express