After 14-yr slumber, DCGI wakes up to side effects of ‘wonder drug’

Fourteen years after giving it the go ahead, the Drug Controller General of India (DCGI) has finally woken up to the need to check if the anti-depressant “wonder drug” Deanxit was indeed effective and had no adverse health effects.The drug controller has given six months’ notice to the manufacturers and marketing firms of Deanxit (a fixed dose combination (FDC) of Flupenthixol and Melitracen) to prove its efficacy, failing which it will be banned in view of its reported adverse effects on patients in India.It was the DCGI itself which had in 1998 allowed the manufacture and market of the controversial anti-anxiety drugs, even though no mandatory clinical trial has been done on Melitracen – one of its two ingredients — in India.The Pioneer in May 2011 too had reported that the anti-anxiety drug is being frequently prescribed by private doctors in India despite its sale being prohibited in the country, and banned even in the country of its origin Denmark besides all the developed countries. Denmark-based company Lundbeck is marketing and manufacturing the drug in India.The DCGI’s move to ban the drug comes only after the Parliamenary panel on health last year questioned the drug regulator’s decision to allow the sale of the controversial medicine in the market.A recent order issued by the DCGI’s GN Singh said, “In view of the concerns raised on the (safety of the) drugs, it has been decided that the manufacturer of the drug shall be instructed to establish the safety and efficacy of the FDC of Flupenthixol and Mlitracen within six months, failing which the drugs would be considered for being prohibited for manufacture and marketing in the country.” 

While not naming Lundbeck, Singh noted that concerns have also been raised that there must be some very good reasons for the Danish Medicine Agency (Denmark) not to approve a domestically developed drug where an anti-depressants drug would be perhaps in a greater demand than in India.“The drug is not marketed in major developed countries such as UK, US, Ireland, Canada, Japan and Australia,” said the DCGI letter issued recently to all the State drug controllers across the country to take appropriate step in this direction.Curiously, while the drug is being touted as a “wonder drug” by the private psychiatrists who have been prescribing it at the drop of hat for treating anxiety cases, doctors from Government hospitals do not recommend its usage.Dr Chandra Gulati, editor of MIMS India, a well-known drug Journal, said, the DCGI should have banned it long ago but for unknown reasons, it has cleared the combination drugs without mandatory clinical trials in India. “Also, 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.