Untested appetite-enhancing drug on sale

The drug, Buclizine (sold under the brand name of Longifene), is actually an old anti-allergic medicine, which is barely prescribed by  physicians. But the manufacturers have suddenly found an appetite-enhancing property of the drug.

Even though the drug is being sold by chemists as an appetiser, it has never undergone any clinical trial. The Drugs Controller General of India permitted selling of the drug without any trial in complete violation of Indian drug rules, reliable sources said.

Under the Drugs and Cosmetic Rules if a drug is already approved for a specific disease like allergy and is proposed to be used for another indication —for instance, 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 three to four sites, Chandra Mohan Gulhati, a former consultant to the World Health Organisation on drugs, told Deccan Herald.

If the drug is intended to be used on children, then trials should first take place on adults followed by studies on children in a step-down order, which means initially among older children (9-12 years) followed by younger subjects (6-9) years and only then among smaller children.

Buclizine did not follow this standard trial-route. “The drug was almost forgotten for the last 20 years till manufacturers started pitching it as an appetite-enhancing drug,” said a pediatrician at Sri Lakshmi Narayana Institute of Medical Sciences in Pudu­cherry, T Arun Babu, who first flagged the irregularities in the April issue of ‘Indian Journal of Pharmacology’.

“There is no registered trials of Buclizine as an appetite-enhancing drug for adults and children. No study results have been published in any peer-reviewed indexed journals. But the drug is being prescribed by doctors and sold as a popular over-the-counter medicine,” Babu said.

He added that India was the only nation where the drug was being sold for this indication.

When their response was sought on the matter, Indian officials of Belgian company UCB, which manufacturers the drug, said they could not provide any information on Buclizine because the company does not market this drug in India. The drug is marketed by a Delhi-based company and widely available all over the country. According to the detailed data sheet on Buclizine, circulated by its innovator in Belgium, “Because of lack of approved clinical studies and scientific data, the benefit/risk is negative for the indication of buclizine for appetite stimulation.” The drug has not been approved by Belgian authorities for appetite enhancement.

“If a Belgian drug is not good enough for Belgian children then how can it be safe and effective in Indian children,” Gulhati said.