The Government may soon ban the controversial anti-anxiety drug
Deanxit, a combination of two psycho-active agents being frequently
prescribed by private doctors in India. A Government panel has pointed
out the addictive potential of the drug as harmful side effects.
The technical panel of the Drug Controller General of India in its latest report to be discussed on May 5 has said that it (Deanxit) has potential for addiction (among users). The panel comprising medical experts also said that it has side effects such as drowsiness or dizziness, dry mouth, constipation, weakness or tiredness, excitement, anxiety or nightmares.
The finding will be reviewed by the Drugs Technical Advisory Board (DTAB), the highest decision-making body under the Union Health Ministry on technical matters related to health issues.
Sources said the panel without making any specific recommendations has pointed that the combination of flupentixol and melitracen produced by a firm Lucdbeck from Denmark is used widely by private sector for treating depression and anxiety.
Interestingly, the medical fraternity dealing with the psychiatric cases is divided over the health impacts of Deanxit which is banned in its country of origin, Denmark, but is being freely sold here.
What’s more, even though no mandatory clinical trial has been done on melitracen — one of its two ingredients- in India, it is touted as a “wonder drug” by the private psychiatrists who have been prescribing it at the drop of hat for treating anxiety cases.
However, doctors from Government hospitals do not recommend its usage. Dr Rajesh Sagar, Additional Professor of Psychiatry, AIIMS, says that he never ever prescribed the medicine to his patients. “In fact, in AIIMS no one is prescribing this drug as no proper trial has been done on it. Moreover, anti-psychotic drugs should not be given for anxiety symptoms.”
He was of the view that the drug is being aggressively marketed by the company among non-psychiatric doctors who are prescribing it at the cost of health of the patients.
The medicine has no presence in Government-run hospitals such as GB Pant Hospital and Institute for Human Behaviour and Allied Science (IHBAS) in Delhi, known for best psychiatric treatment in the country.
Dr Deepak Kumar (Psychiatric) from IHBAS said the drug is banned in many nations due to its health hazards. “There are no clinical trials in India. Moreover, one of the two ingredients, melitracen is not approved yet in the country. The drug is freely available in India, even though the fixed-dose combination has been banned in advanced countries due to health hazards. It’s strange why it’s still being sold in the country.”
Dr Chandra Gulati, editor of MIMS India, a drug Journal, too maintained, “Interestingly, melitracen is not approved in India. So how can you approve a combination of which one of the ingredients is not approved?”
“Also, this drug is made in Denmark. However, it is not approved for use in Denmark 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,” he argued.
Gulati said that the drug is 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 drug addicts.
The DGCI should have banned it long ago but for unknown reasons, it has cleared the combination drugs without mandatory clinical trials in India, he added.
