Buclizine, an anti-histamine drug, has come under the scanner of regulatory authorities, after it was found that the drug has not undergone clinical trials to test its efficacy and safety even in the country of origin
New Delhi: Buclizine, a widely recommended appetite stimulant for picky eaters, is likely to be prohibited for sale in India, almost 12 years after it was approved to be sold in India, two people aware of the matter said.
Developed by Belgium-based UCB Pharma and sold as Longifene by Mankind Pharma in India, this anti-histamine drug has come under the scanner of regulatory authorities, after it was found that the drug has not undergone clinical trials to test its efficacy and safety even in the country of origin.
India’s drug advisory body, the Drugs Technical Advisory Board (DTAB) is likely to deliberate on the matter at its next meeting slated for May.
“Aggressively promoted as an appetite stimulant for young children, the drug is available both as a syrup and a tablet. The drug has come under the lens as it is not marketed as an appetite stimulant even in its country of origin. The government is considering to prohibit the sale and distribution of the drug as appetite stimulant under the provisions of section 26 A of Drugs and Cosmetics Act, 1940," said one of the people cited above.
Mankind Pharma, which acquired the drug from UCB in 2012, said 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.
“It is a very well established product in the chambers of paediatricians. Two out of five children face appetite problems. We acquired this product from UCB in 2012 and UCB being a multinational company wanted their house to be in order. So they applied for DCGI approval and got it approved in 2006 as an appetite stimulant. After that, they applied for other indication as an anti allergic and got an approval in 2010," said a Mankind Pharma spokesperson.
Mankind Pharma, which is one of the leading companies marketing Longifene, says the product is safe and has a significant presence in India. “We record a turnover of Rs14 crore from this product and about 42 lakh tablets are sold every year. It is approved in countries like Malaysia, Singapore, Argentina and several others as appetite stimulant. Probably the market is not available in the innovator country and that’s why it is not used as appetite stimulant in Belgium," added the spokesperson.
While some paediatricians prescribe the product aggressively and believe that its absence from the market will not be a good idea, others say that prescribing a drug to boost appetite is “unscientific".
“There is no medicine that should be used for enhancing appetite. Growth and nutrition in children are inter-linked and there is no medicine which will independently and singularly increase appetite. Balanced nutrition, absence of disease and physical activity are the three best modalities to enhance growth and nutrition," said Dr Sanjeev Bagai, vice-president and director, Manipal hospital Dwarka.