In blatant violation of norms, the Drugs Controller General of India (DCGI) is alleged to have approved an anti-antihistamine drug buclizine, developed by Belgium-based UCB Pharma, for appetite stimulation in children and adults without mandatory pre-approval clinical trials to test the efficacy and safety of the drug.
According to experts, buclizine is being marketed in India as an appetite stimulant in children and adults which is actually meant for symptomatic relief of nausea and vomiting, motion sickness and some allergic disorders such as rhinitis and urticaria. But even for these indications it is not approved in the US, Canada, Britain,European Union, Australia and most other countries.
Interestingly, buclizine is not approved in Belgium for appetite enhancement. The data sheet on buclizine circulated by the innovator in Belgium states that 'because of lack of approved clinical studies and scientific data, the benefit/risk is negative for the indication of buclizine for appetite stimulation'.
“If a Belgian drug is not good enough for Belgian children then how can it be safe and effective in Indian children?”, asks Dr CM Gulhati, well-known health expert and Editor of the medical journal MIMS. It must be frankly admitted that the fault lies with the DCGI whose statutory job is to protect Indians from dubious medicines but who went out of the way to approve buclizine for appetite stimulation, he said.
Dr Gulhati said that under the Drugs and Cosmetic Rules if a drug already approved for a specific disease such as allergy is proposed to be used for another indication such as appetite stimulation, then it is classified as a "New Drug" and must undergo the procedure applicable to new molecules including clinical trials in not less than 100 subjects at 3-4 sites. If the drug is intended to be used in children, then trials should first take place in adults followed by studies in children in a step down order i.e. initially in older children (9-12 years) followed by younger subjects (6-9 years) and then only in smaller children.
But, the drug has not undergone any trials for any indication in children under the age of six years anywhere. Yet it is aggressively being promoted for appetite stimulation in very young children in India, he regretted.
Interestingly, in other countries like Australia, Japan, New Zealand, Sri Lanka, Vietnam and Bangladesh, the drug is not approved, while in countries like Cambodia, the Philippines, Singapore and South Korea, the drug is banned by the authorities. Besides, the drug is withdrawn in countries like Hong Kong, Myanmar, Malaysia and Thailand.
Meanwhile, efforts to contact both the UCB and DCGI did not bear fruits.