After dillydallying for last two years, the Union Health Ministry has finally banned the distribution and sale of anti-histamine drug Buclizine as an appetite stimulant “in public interest” under the Drugs and Cosmetics Act. The drug will, however, be allowed to be marketed for “symptomatic treatment of various allergic conditions (rhinitis, conjunctivitis and urticaria) and for prevention and treatment of motion sickness.”
The Ministry has issued a notification in this regard. The ban follows recommendations from the Drugs Technical Advisory Board (DTAB) two years ago which called “prohibiting the manufacture, sale and distribution of Buclizine for the indication as appetite stimulant in public interest and continuing the marketing for the indications “symptomatic treatment of various allergic conditions (rhinitis, conjunctivitis and urticaria) and for prevention and treatment of motion sickness”.
As per the notification, the Central government regulates the manufacture, sale or distribution of Buclizine and its formulations for use in human beings, subject to conditions that the manufacturer “shall label the container of Buclizine and its formulation and also mention in conspicuous manner on the package insert and promotional literature of Buclizine and its formulation with the words ‘Not to be used as appetite stimulant’”.
It was brought to the notice of the Government that the use of the drug Buclizine as appetite stimulant for human use was not rational, the notification stated.
In fact, a Parliamentary Standing Committee in its report had raised concerns that various drugs, including the Buclizine as appetite stimulant were approved without ensuring and safety and efficacy and any clinical trial. The drug is developed by Belgium-based UCB Pharma and sold as Longifene by Mankind Pharma in India.
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. “Also, 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,” the panel had noted.
