The move has been prompted by the unregulated sale and use of various supplements
Guidelines: All health products that claim to have medicinal properties to cure or treat various illnesses will have to be registered with the Drug Regulatory Authority (DRA), as required by the recently released health supplement guidelines.
Following unregulated availability and use of health supplements, like weight loss products and nutritional supplements, DRA drafted the guidelines to help the authority regulate such products in the market henceforth.
DRA officials said if ingredients or therapeutic value of the health supplements exceed the World Health Organisation standards, it must be considered a medicine, which means it needs to be registered.
“We’ll regulate the products in the market in line with the guidelines,” drug controller Sonam Dorji said. “The guideline will also help us understand whether or not the products are of medicinal purpose.”
In absence of a guideline earlier, DRA termed such health products as ‘borderline products’, as they were neither under food nor medicine category. DRA has always maintained that the increasing health products in the market were a concern.
The guideline defines health supplement as any products used to supplement a diet with benefits beyond those of normal food, or to support or maintain the healthy functions of the human body. They include nutritional and herbal/botanical products and others with medicinal claims of general well being. The products can be administered in small unit dosage like capsules, powders, soft gels, tablets or liquid dosage.
However, the products should not contain substances above the specified limit. Besides, the products should be of acceptable standards of quality, have adequate shelf life, proper packaging, and labelling. The products should be manufactured from manufacturers, who take responsibility in ensuring that products are safe and the label information is not misleading.
The guideline prohibits advertisement or promotion of any health supplement for medicinal purposes like treatment and prevention of any disease or disorder. The health supplements’ claims must not encourage or condone excess consumption of a food, state, suggest or imply that a balanced and varied diet cannot provide appropriate quantities of nutrients and make reference to recommendations of individual doctors or health professionals, among others.
Today, the market is flooded with products, like nutritional supplements and weight loss products in various forms that are fast gaining popularity among consumers. The products come in the form of liquid, tea, coffee, and capsules. Imported from India, Thailand, China, Taiwan, and the Middle East, the products usually boast of several benefits.
Pharmaceutical, groceries, and garment shops all sell them. Some products are not labelled in English, while some come with a host of advice on the labels, like avoiding alcohol, fatty food and following an exercise regime while using it.
With such concerns, DRA had also put forward the issue to health ministry’s medical board, after which they came up with a comprehensive guideline.
Some consumers, who used the products, complained of several side effects, but said they hadn’t raised the issue to the concerned agencies.
However, with the guideline in place now, consumers can report any adverse reaction or side effects related to the use of the health supplements to DRA’s national pharmacovigilance centre. Besides consumers or patients, health professionals or a competent person can also lodge a complaint with the centre.
Only if the products meet the specified levels in the guidelines, pharmacies and grocery shops are allowed to sell them.
“If the product makes specific clinical claims, clinical evidence supported by research or literature review (including traditional knowledge) must be submitted,” the guideline states.
A pharmaceutical shop owner in town said DRA had taken samples of the products available in the market although they haven’t started monitoring yet.
“We’ve stopped importing products that has side effects like the weight loss product in the form of coffee,” a shop owner in town said. “But other slimming products available are laxatives, which is not a concern.”
Although the guideline would help DRA officials to regulate the health products, officials said it would require coordination among all stakeholders.
“Lack of coordination among agencies hamper monitoring of such products,” drug controller Sonam Dorji said, adding that monitoring of health supplements also involves Bhutan Agriculture and Food Regulatory Authority’s (BAFRA) role. “But it’s ambitious at present.”
However, BAFRA officials said the role of monitoring of such products in the market lies with DRA. “We don’t monitor such products as of now, we focus more on food safety issues,” an official said.
By Kinga Dema