12 years after it was approved for sale in India, government bans Buclizine drug1 min read . Updated: 20 Dec 2018, 12:00 AM IST
The government notification dated 13 December, however, allowed the marketing of the drug for symptomatic treatment
New Delhi: The government has banned the use of the drug Buclizine as an appetite stimulant, almost 12 years after it was approved to be sold in India. Developed by Belgium-based UCB, the drug was being sold as syrups and tablets by Mankind Pharma in India.
The government notification dated 13 December, however, allowed the marketing of the drug for symptomatic treatment of various allergic conditions such as rhinitis, conjunctivitis and urticaria and for prevention and treatment of motion sickness.
Sold as Longifene in India, the anti-histamine drug came 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.
The the Drugs Technical Advisory Board (DTAB) in a meeting on 29 November deliberated on the proposal to ban the manufacture or distribution of the drug as an appetite stimulant.
The board recommended constituting a sub-committee to examine the continued marketing of the drug for indications other than appetite stimulant.
Mankind Pharma, which acquired the drug from UCB in 2012, said approvals were taken from the Drug Controller General of India 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," said a company spokesperson.
“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 (Drug Controller General of India) 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 the company spokesperson.