Allowed to sell for 14 years, drug put on notice now

Jan 30 2013, 10:06 IST
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SummaryIt’s a drug that was introduced over 14 years ago, approved by the country’s drug regulator

It’s a drug that was introduced over 14 years ago, approved by the country’s drug regulator. The same regulator has now put the manufacturers on notice, with the approval it gave having been questioned by a parliamentary committee.

Deanxit is an antidepressant marketed by a Danish company but banned in Denmark itself. Marketed mostly in small countries, it is a combination of flupenthixol and melitracen, the latter never approved in India. Deanxit has been reported to cause abnormal heart rhythms in combination with other drugs.

Earlier this month, the Drugs Controller General of India gave the company six months to establish the drug’s safety and efficacy, failing which the drug could be banned. The DGCI had approved the drug in 1998.

The ultimatum follows last year’s report of the parliamentary standing committee on health and family welfare, which slammed the DGCI for having given Deanxit “illegal” approval. Rule 30 (B) of the Drugs and Cosmetics Act says that a drug not approved in the country of its origin cannot be approved in India. Moreover, melitracen, apart from having never been approved individually in India, is a little-known drug that it is not part of the course in any medical school in the country.

In his January 10 order, DGCI Dr G N Singh cites several grounds, including the drug’s banned status in the country of its origin and its absence in major markets such as the United States, Britain, Ireland, Canada, Japan and Australia. “The issue of safety and efficacy of the FDC (fixed drug combination) is under examination in consultation with the experts committee,” the order says. “In view of concerns raised on the drug, it has been decided that the manufacturer of the drug shall be instructed to establish the safety and efficacy of the FDC of flupenthixol+melitracen tablets within six months, failing which the drug would be considered for being prohibited for manufacture and marketing in the country.”

Dr Singh did not respond to attempts to contact him over the initial approval and the current order.

Drug experts call the order a “cover-up” for the DGCI’s disregard for rules. “It does not hold anybody responsible for the blatant violations that gave Deanxit its approval in the first place,” says Dr C M Gulhati, editor of the Monthly Index of Medical Specialties. “It just tries to pass the blame on to the company whereas the fact of the matter is that they had

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