The verdict on whether a ban should be imposed on three drugs ? anti-infective Gatifloxacin, constipation and irritable bowel relieving drug Tegaserod and anti-anxiety drug Deanxit ? in the Indian market would be out by the end of the month.
A sub-committee of Drug Technical Advisory Board (DTAB)?which recently recommended a ban on analgesic paediatric Nimesulide, a heartburn drug used in gastroesophageal reflux disease; Cisapride, a decongestant used for cold and cough; phenylpropanolamine (PPA) and human placenta extract ? would take a final call on imposing a ban on the three drugs in its next meeting likely to be held in the last week of this month. The drug controller general of India, Surinder Singh, told FE, ?We are in the process of fixing the schedule for the next meeting of the DTAB sub-committee. In this meeting, the sub-committee should be in a position to decide on whether a ban should be imposed on these three drugs?.
The three drugs command a domestic market size of close to Rs 100 crore. According to industry data, Gatifloxacin?s domestic market was valued at Rs 30 crore annually for the calender year ended December 2010, while the ophthalmological and otological market for the same drug is pegged at around Rs 20 crore for a similar period. Among major pharma firms, Dr Reddy’s markets the anti-infective drug under the brand name Gaity, while Cipla markets the drug under the brand Gatiquin, and Mankind Pharma sells the drug under the brand Gatikind. The annual market size of Deanxit in the Indian market is estimated to be around Rs 50 crore and the total market size of Tegaserod is valued at Rs 3.5 crore annually.
Deanxit is a combination of two drugs, flupenthixol and melitracen. It is not even permitted for use in Denmark ? its country of origin, and its sale is prohibited in countries including the US, Britain, Canada, Australia and Japan. Tegaserod was withdrawn from many regulated markets in 2007 because it had adverse effect related to imbalance of cardiovascular ischemic events.