Widely recommended as an appetite booster for weight gain in children and babies in the country for the last two decades despite no clinical trials, popular drug Buclizine is likely to be no longer marketed for the same.
The Drugs Technical Advisory Board (DTAB), highest decision making body of the Health Ministry on technical issues pertaining to drugs, in its meeting recently, has recommended prohibition on the Buclizine drug for manufacture or sale or for distribution as appetite stimulant “in public interest”.
However, Buclizine will be continued to be allowed for marketing for the indications “symptomatic treatment of various allergic conditions (rhinitis, conjunctivitis and urticaria) and for prevention and treatment of motion sickness.”
The move to ban the drug follows observations by the Parliamentary Standing Committee in its last year report, in which it raised concerns that various drugs, including the Buclizine as appetite stimulant were approved without ensuring and safety and efficacy and any clinical trial.
Raising concern on safety and efficacy of Buclizine as an appetite stimulant, the panel also noted that the drug is used in children, for which no scientific data are available, said a senior official from the Drug Controller General of India(DCGI), which had given approval to the drug in 2006.
Though the drug manufacturer presented the summarised data, it could not provide any clinical trial study report on adult or children to justify the use of the drug as an appetite enhancement.
The panel also noted that the drug is banned due to adverse drug reactions in countries with well-developed and efficient regulatory system, including USA, UK, EU, Australia, Japan and Canada.
“In this context, it recommended that its manufacture, import and marketing of should be immediately put under suspension till the safety of the drug is examined and established in the country,” the official added.
A sub-committee comprising of Dr B Suresh, Dr Shiv Kumar Sarin and Dr S K Acharya has also been constituted to examine continued marketing of the drug for other indications and submit its report.
Buclizine was originally developed by the Belgium-based UCB Pharma as an anti-histamine and has been approved in several countries as treatment to prevent motion sickness and allergies but not to boost appetite or growth in children.
