Central Government recognised that the use of the drug Buclizine as appetite stimulant for human use is not rational and due to lack of clinical trials Government prohibited the manufacture, sale and distribution of Buclizine for the indication “as appetite stimulant”.
This matter had been examined by the Subject Expert Committee (SEC) constituted by the Central Government and they stated that no clinical trial study report on human beings to justify the use of the Buclizine as an appetite stimulant has been produced by the manufacturers and hence, the said committee has not recommended the continued marketing of the aforesaid drug as an appetite stimulant.
The Drugs Technical Advisory Board (DTAB) has also considered the said matter and recommended for 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 SEC and DTAB, 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.
Now, therefore, in exercise of the powers conferred by section 26A of the Drugs and Cosmetics Act, 1940 (23 of 1940), the Central Government, on being satisfied that it is hereby necessary and expedient in public interest to do so regulates the manufacture, sale or distribution of Buclizine and its formulations for use in human beings subject to the 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”.
