After much dillydallying, the Union Health Ministry has finally banned anti-depressant drugs sold under the trade names of Deanxit and Anxidreg, a combination of two psycho-active agents, after they were found to be risky to human life and their alternates were easily available.
The Drugs is already banned in Denmark, the country of its origin. A combination of Flupentixol and Melitracen, the drugs is being frequently prescribed by private doctors in India. However, last year, the Government had suspended the sale and distribution of the controversial drugs following opposition of a section of doctors who raised question about its efficacy given that its own country was not using the drug for its locals.
A Government panel too had pointed out the addictive potential of the drugs as harmful side effects. The Drugs Technical Advisory Board, a highest decision making body of the Health Ministry too in November last year recommended its discontinuation in the country. Now, a notification has been issued in this regard recently to make the decision effective.
Justifying the ban, the notification issued by Health Ministry Joint Secretary AK Panda states that the “Government was satisfied that the use of the drugs ‘fixed dose combination of Flupenthixol and Melitracen’ for human use was likely to involve risk to human beings and whereas safer alternatives to the said drug are available.”
The ban on sale and marketing has come after the manufacturers failed to establish the safety and efficacy, said an official. “These tablets are made in Denmark, though it is not approved for use in that country itself.
“According to rule 30B in the Drugs Act, any drug not approved in the country of origin cannot be used in India. Moreover, its sale is prohibited in the UK, US, Australia, Canada and Japan. Then how come it is beneficial for the patients in India,” Chandra M Gulati, editor of MIMS India, a drug journal. Gulati said that the drug was being aggressively promoted for a wide range of known and unknown disorders such as psychogenic depression, depressive neuroses, masked depression, menopausal depression, dysphoria in alcoholics and drugs addicts.
