|
DTAB asks manufacturers of flupenthixol+melitracen FDC to submit safety, efficacy data by March 15
|
|
Arun Sreenivasan, New Delhi
February 20 , 2019
|
|
|
An expert panel of the Drugs Technical Advisory Board (DTAB) has asked
the manufacturers of the controversial fixed dose combination (FDC) of
flupenthixol and melitracen, an anti-depressant medication, to submit
scientific evidence to prove its safety and therapeutic justification by
March 15.
The DTAB has formed a five-member expert
sub-committee, headed by Dr. Nilima Kshirsagar, Chair in Clinical
Pharmacology at Indian Council of Medical Research, to look into the
issue after a health ministry ban on the drug and subsequent legal
wrangle. According to official sources, the panel has decided to seek
relevant data from drug makers at its meeting held on February 6.
The
flupenthixol-melitracen combination drug is available across the
country under different brand names including Forcalm, Flupen Plus,
Placida, Franxit and Restfull.
The health ministry first
suspended the FDC in question way back in 2013, prompting two drug
manufacturers, Bengaluru-based Lundbeck India and Delhi-based Mankind
Pharma, to file writ petitions in the Karnataka High Court against the
move. A single bench of the court quashed the suspension and asked the
government to consider the issue afresh. Though the government again
prohibited the FDC on the recommendation of the DTAB, the drug makers
approached the court and obtained a favourable order last year.
The
five-member expert panel has now asked manufacturers to submit details
of all active ingredients, composition, strength and dosage. Evidence of
therapeutic value claimed of the FDC, in the form of text articles in
peer-reviewed journals, could be furnished. The companies are also
directed to provide pharmacokinetic or pharmacodynamics rationality with
half-life details of individual ingredients and published or original
data regarding its efficacy.
The sub-committee is expected to
submit its report for further consideration of the board after examining
these details. The panel may co-opt other experts from relevant fields
to accomplish the task.
The DTAB panel will also consider the
regulatory status of the drug in other countries, which might weaken the
argument of drug firms. The combination medication is not approved in
countries such as in the US, Britain, Denmark, Canada, Japan and
Australia. During lawsuit hearings, the government has argued that
melitracen is not effective as a single agent in depression and use of
flupenthixol is linked to serious neurological side effects.
Last
year, public health activist and Ranbaxy whistle blower Dinesh Thakur
had filed a public interest litigation in the Delhi High Court seeking a
ban on flupenthixol-melitracen FDC, citing patient safety issues. The
next hearing of the case is scheduled to be held next month.
|
|
|
|
|
|
|
|
TOPICS
|
That foods might provide therapeutic benefits is clearly not a new concept. ...
|
|
|
|
|