On December 13, 2018, the Central Government announced ban on the use of drug Buclizine (a appetite stimulant) which was found to be irrational for the human use. However, the drug will be available for marketing for the indications "symptomatic treatment of various allergic conditions (rhinitis, conjunctivitis and urticaria) and for prevention and treatment of motion sickness"18.
Earlier, the Subject Expert Committee constituted by the Central Government examined the matter and 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 recommended to prohibit marketing of buclizine as an appetite stimulant. Later, the Drugs Technical Advisory Board also considered the said matter and recommended for prohibiting the manufacture, sale and distribution of Buclizine for the indication "as appetite stimulant".
Therefore, in exercise of the powers conferred by section 26A of the Drugs and Cosmetics Act (the 'Act'), and after examination of the recommendations of both; SEC and DTAB committee, the Central Government has banned Buclizine as an appetite stimulant and has made it necessary and expedient in public interest to regulate 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". Section 26A is reproduced hereunder:
Power of Central Government to prohibit manufacture, etc., of drug and cosmetic in public interest.— Without prejudice to any other provision contained in this Chapter, if the Central Government is satisfied, that the use of any drug or cosmetic is likely to involve any risk to human beings or animals or that any drug does not have the therapeutic value claimed or purported to be claimed for it or contains ingredients and in such quantity for which there is no therapeutic justification and that in the public interest it is necessary or expedient so to do, then, that Government may, by notification in the Official Gazette, regulate, restrict or prohibit the manufacture, sale or distribution of such drug or cosmetic.
Buclizine is a histamine H1 receptor antagonist from piperazine derivative family, has antiemetic and antivertigo activities primarily. Buclizine exerts its anti-emetic effect by binding to and blocking the muscarinic and histamine receptors in the vomiting center of the central nervous system (CNS). This may prevent activation of the chemoreceptor trigger zone (CTZ) and may reduce nausea and vomiting. Furthermore since buclizine possesses anti-cholinergic properties as well, the muscarinic receptors are similarly blocked19.
Note – Buclizine is developed by Belgium-based UCB Pharma, which was acquired by India-based Mankind Pharma in year 2012. The Drug Controller General of India had approved this drug to sell as an appetite stimulant in 2006 and as an anti-allergic in 2010.
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