Following a recent post on social media and hearsay, the Drug Regulatory Authority (DRA) on December 7 issued a notification against the Oriens products that were being sold without the authority’s approval.
The notification states that use of such unregistered products may pose health risks to people.
The DRA also notified those individuals and agents involved in the products’ promotion, distribution, sale and advertisement to refrain from such practices.
Prior to the notification, on December 4, DRA issued a letter to the Country Manager of Oriens Bhutan stating the requirement of Oriens products for DRA’s approval.
“A review of the product sample/product manual against our guidelines shows that many Oriens products claims efficacy in diseases/conditions or bear functional benefits,” states the letter.
The letter also states that some Oriens products will be prohibited for sale/import due to claims on prohibited disease and conditions.
Talking to Business Bhutan, the officiating Chief of Post Marketing Control Division, DRA, Pelden Chenjor, said that the notification is meant to create awareness among the public on the risks associated with such unregistered products like Oriens products which claims health benefits without the approval of the DRA.
“It is to prevent or discourage individuals or agents involved in the promotion, distribution, sale and advertisement of such products in the country,” he said.
The Country Manager of Oriens Bhutan, Pushpa Raj, said that the meeting with DRA yesterday was fruitful. “We have been asked by DRA to do the registration at the earliest and also to appoint a pharmacist ,” he said.
However, Pushpa Raj said that the claims on the efficacy of the product in diseases/conditions were never made by them. Oriens, he said, is a chemical-free company and the products are all food supplements, cosmetics and agricultural products.
Meanwhile, Pelden Chenjor said that non-compliance to the notice would lead to seizure of medicines compounded with monetary fines as these products were sold and distributed from unauthorized sources or personnel.
He also said that distributor would have to embargo the products and give certain timeline for registration. “Failing to do within the stipulated timeline would be liable for seizure of products,” he said.
Oriens is a research–based nutraceutical company based in India that produces nutritional supplements, according to the products’ official website.
Lucky Wangmo from Thimphu