New Delhi: The Union Health Ministry has prohibited 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.”
According to a notification from the ministry, 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.
The matter was examined by a subject expert committee constituted by the government.
The committee stated that no clinical trial study report on human beings to justify the use of Buclizine as an appetite stimulant has been produced by the manufacturers and hence, the committee had not recommended the continued marketing of the drug as an appetite stimulant.
The Drugs Technical Advisory Board had also recommended 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”.
“After examination of the recommendations of the Subject Expert Committee and Drugs Technical Advisory Board, the Central Government is satisfied that the use of said drug Buclizine do not have any therapeutic value claimed for as an appetite stimulant and is likely to involve risk to human beings,” the notification said.