Mankind Pharma faces setback: Government prohibits Buclizine as Apetite Stimulant

This came after the Central Government was satisfied that the use of said drug Buclizine does not have any therapeutic value claimed for as an appetite stimulant and is likely to involve risk to human beings.

New Delhi: Through a recent gazetted notification, 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 a 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,

This comes after the matter has been examined by the Subject Expert Committee constituted by the Central Government and the said Committee has 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 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 Subject Expert Committee and Drugs Technical Advisory Board, the Central Government became 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;

Hence, 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 a conspicuous manner on the package insert and promotional literature of Buclizine and its formulation with the words “Not to be used as appetite stimulant”.

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The move will come as a major setback to Indian pharma giant Mankind Pharma, whose product Longifene is popular amoungst children for an increase in appetite

Developed by Belgium-based UCB Pharma and sold as Longifene by Mankind Pharma in India, this anti-histamine drug has been under the scanner, after it was found that it had not undergone clinical trials to test its efficacy and safety even in the country of origin

Mankind Pharma, which acquired the drug from UCB in 2012, earlier had informed Livemint necessary approvals were taken from the Drug Controller General of India (DCGI) in 2006 to sell the drug as an appetite stimulant and as an anti-allergic in 2010.