Panel seeks immediate step on anti-depressant
The parliamentary standing committee on health and family welfare in its recent report has asked the government to take “immediate action” over popular anti-depressant Deanxit (Flupen-thixol+Melitracen).
The committee in its earlier report tabled last year in Parliament had earlier raised its concerns on the safety and efficacy of a widely known drug marketed in India.
Citing that the marketing approval for the drug was given without mandatory trials, it said that the approval was “irregular” and unlawful and the committee, therefore, reiterated for concrete and exemplary action on the functionaries in the DCGI office for having approved the “questionable” drug.
While the drug was approved in the country in 1998, the FDC of Flupenthixol+Melitracen is not marketed in major developed countries like the United States, Britain, Ireland, Canada, Japan and Australia. Even Denmark did not approve of this domestically-developed drug.
“Why should the people of India consume a questionable drug approved in a questionable manner even for a day longer, more so when the drug regulator of the innovator country Denmark is not allowing its use within its jurisdiction but allowing its export to developing countries with weak or non-existent drug regulation.”
Opining that there must be some reason for Danish medicine agency (Denmark) not to approve a domestically-developed drug, the committee had felt that the Drug Controller General of India (DCGI) should have gone into the reasons for not marketing the drug in major developed countries like the US, Britain, Ireland, Canada, Japan, Australia etc.
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