DTAB Forms Expert Panel To Review Deanxit Ban Issue

New Delhi, 7 Jan 2019: The Drug Technical Advisory Board (DTAB) has formed an expert sub-committee to look into the safety and efficacy of the controversial anti-depressant drug Deanxit, a fixed dose combination (FDC) of flupenthixol and melitracen that ran into legal wrangle in India following a health ministry ban.

The five-member expert panel headed by Dr. Nilima Kshirsagar, Chair in Clinical Pharmacology, Indian Council of Medical Research, will examine the issue and submit report for further consideration of the board. The panel could co-opt other experts from relevant fields to accomplish the task.

The ministry had suspended the manufacturing and marketing of the FDC way back in 2013. Following the suspension, drug manufacturers, Bengaluru-based Lundbeck India and Delhi-based Mankind Pharma, have filed separate writ petitions in the Karnataka High Court against the move. A single bench of the court quashed the suspension and asked the government to reconsider the issue afresh and take a decision in accordance with the law. The matter was then placed before the DTAB, and based on its recommendation the government had again prohibited the FDC. The drug makers later approached the court and obtained a favourable order last year.

Subsequently, the Central Drugs Standard Control Organisation had asked manufacturers to submit technical literature to the directorate in order to examine the matter in the subject expert committee (SEC). While Lundbeck India decided not to commercialise Deanxit in India, Mankind had presented their proposal before the SEC for neurology and psychiatry earlier this year.

It may be noted that the combination medication is not approved in countries such as in the US, Britain, Denmark, Canada, Japan and Australia. During the case hearing, the government had also argued that melitracen is not effective as a single agent in depression and use of flupenthixol is linked to serious neurological side effects.

The SEC had asked the drug maker to revise the phase IV trial protocol with a randomised, double blind study. The Dr Kshirsagar-led panel is expected to examine the results of this study before finalising their report.

The firm has been directed to define safety and efficacy assessment criteria in the protocol, calculate sample size and submit details of the study sites along with undertaking by the investigators as per Schedule-Y of the Drug & Cosmetics Rules of 1945.Pharmabiz