Indication:
Depression
Depression
INFORMATION- UPDATE
FDC OF FLUPENTIXOL+ MELTRACEN :
PROHIBITION BY HEALTH MINISTRY RECONFIRMED
A report of the Parliamentary Committee on Health had held that the import licence
and marketing approval given by the Drug Controller General , India, (DCGI) to the
Fixed Dose Combination of Flupenthixol + Melitracen was unlawful on the following
counts:
1.Drugs and Cosmetic Rule 30-B bans imports and marketing of any drug the use of
which is prohibited in the Country of Origin. The FDC of Flupenthixol with Melitracen
is prohibited for sale and use in Denmark, its country of origin. The Committee
further noted that there must be some good reasons for Danish Drug Authority not to
approve a domestically developed drug for use within the country.
2. Since melitracen was not individually approved earlier in India , the Combination had
to undergo all phases of clinical trials(Phase I, II, and III) trial, if given by DCGI was
in violation of rules.
3. Before approving a New Drug , it is mandatory to conduct clinical trials individually
for all the different indications. A perusal of the Marketing Approval shows that the
approved indications were-
( i).Psychological depression (ii) Depressive neurosis
(iii) Masked depression (iv).Psychosomatic affections accompanied by anxiety and
apathy. The Drug Controller of India failed to give details of trials at 3-4 sites with at
least 100 patients for each indication as required by law.
4.The product was illegally being promoted for two unapproved indications
i.e. Menopausal depression , Dysphoria and depression in alcoholics and drug
addicts
5. The Committee felt that the DCGI should have gone into reasons for not marketing
the drug in major developed countries such as United States, Britain,Ireland, Canada
Japan, Australia just to mention a few
5.The Committee recommended that in view of the unlawful approval granted to the
drug, the matter should be re-examined keeping in mind the regulatory status in
well developed Countries like Denmark, the Country of Origin, the United States,
Britain, Canada, European Union and Japan etc. (Reference: 59th and 66th Reports
of the Parliamentary Committee on Health and Family Welfare http:// rajyasabha.inc.in)
6.The marketing approval of the drug was suspended on June 18,2013 by the Ministry of
Health and Family Welfare for the manufacture and sale. However, in response to
petitions filed by two manufacturers ,the Karnataka High court quashed the suspension
order on legal grounds. Without commenting on the merit of the case, the Court directed
that MoHFW should take a decison one way or the other by following legal procedure
7.The matter was referred to yet another expert Committee which meeting on August 23,2013 came to the conclusion the drug was risky and hence should be banned. Among other drawbacks, an anti-depressant melitracen when combined with antispychotic flupentixole carried additional risks
8.The decision to ban the drug was reconfirmed by the Drugs Technical Advisory Board
in its meeting held on November 25,2013.
(MIMS- FEB.2014)
Adverse Reaction:
Drowsiness, dry mouth, constipation, vomiting, dyspepsia,
Diarrhoea, abdominal pain, nausea, flatulance
Extrapyrimidal effects, espeicially in the initial phase of treatment.
Tachycardia, palpitations, prolonged QT interval, hypotension
Thrombocytopenia, neutropenia, leukopenia, aganulocytosis,
Dyspnoea, myalgia, muscle rigidity, micturation disorder,
Urinary retension, increased appetite and weight,
Abnormal glucose tolerance, and LFTs,
Insomnia, depression, nervousness, agitation, libido decreased.
Contra-Indications:
Circulatory collapse, depressed level of consciouness due to any cause, comasevere depression requiring hospitalisation or electroconvulsive therapy
not recommended for use in states of excitement or overactivity
Special Precautions-
unsafe in porphyia
caution when used in patients with epilepsy.
Parkinsons disease narrow angle glaucoma, prostrate hypertropthy,
hyperthyroidism, liver disease, cardiac disease, or arrhythmias,
severe respiratory disease, renal failure,
myasthenia gravis,
patients with hypersensitivity to antipsychotics,
close monitoring for changes in behaviour, sucidal thoughts,or
clinical worsening during initial phase of treatment
may impair control of diabetes, monitor blood glucose in diabetes
withdrawal should be gradual
Manufacturer Details