Nutraceuticals: Should patients not be told or an unnecessary financial burden?

 Nutraceuticals: Should patients not be told or an unnecessary financial burden?

With the expansion of the market for nutraceuticals and dietary supplements in Nepal, debates have increased about their registration, quality, price, recommendation, and sales and distribution.

A patient goes to the hospital with general weakness, fatigue, or body aches. After an examination, the doctor recommends vitamins, minerals, omega-3, probiotics, or other supplements along with medicine. When it comes time to pay the bill for the medicine at the pharmacy, patients are shocked. Supplements are actually very expensive. And the question arises in their minds – are all these medicines not to be taken?

The market for nutraceuticals and dietary supplements is expanding in Nepal. There is a constant debate about their use, registration, quality, price, medical recommendation, and sales and distribution.

This raises the main question – are nutraceuticals a real need of patients or not?

What are nutraceuticals?

Nutraceuticals are food-based or health supplement products that provide nutritional support and health.

Products such as vitamins, minerals, probiotics, fish oil, herbal extracts, amino acids, etc. fall under this category. Products such as multivitamins, omega-3, probiotics, calcium-vitamin D, collagen, and protein supplements are available in the market. Such products are mainly used to provide nutritional support, health support, or to meet nutritional needs in certain situations.

However, since these products are available in the market in the form of tablets, capsules, syrups, or powders, it may be difficult for consumers to distinguish between drugs and health supplements. This is why the question of how to regulate the production, registration, quality, health claims, and sale and distribution of nutraceuticals has become important.

This question has given rise to another debate in Nepal: should nutraceuticals be viewed as drugs or as food or health supplements?

Are nutraceuticals drugs?

Legally and scientifically, not all nutraceuticals are drugs. While drugs are intended to diagnose, treat, or prevent disease, nutraceuticals are primarily used for nutritional supplementation and health support. In many countries, such products are classified as food supplements or dietary supplements.

However, in practice, the problem arises when products marketed as health supplements are promoted or recommended in connection with the treatment, control, or prevention of disease. In such a situation, the question arises as to where to place the product between drugs and food supplements.

In Nepal, many nutraceuticals are also available in the form of tablets, capsules, and syrups. Since the forms look like drugs, it can be difficult for the general consumer to distinguish between drugs and supplements.

Therefore, the main question is not only whether the product is in tablets or capsules; it is in which category should it be placed based on its purpose, composition, health claims, scientific evidence, and use. This very question of classification and regulation has further complicated the controversy surrounding nutraceuticals in Nepal.

Nutraceuticals: How are they registered and regulated?

The main legal basis for drug regulation in Nepal is the Drugs Act, 2035. However, a clear and separate classification and regulatory system is required for modern nutraceuticals. There is a need to clarify its legal status based on the composition, purpose, health claims and potential risks of the product.

The Department of Food Technology and Quality Control has been registering and regulating dietary supplements under the Dietary Supplement Guidelines, 2072. The department has a provision for new registration and renewal of such products.

On the other hand, if a product claims to treat, prevent or have medicinal effects or is used as a medicine, its regulation becomes a matter under the Department of Drug Control. Therefore, food supplements brought to the market for nutritional supplementation or health support and products with medicinal claims and uses cannot be viewed on the same basis.

For this reason, the classification, registration, quality, health claims and regulation of nutraceuticals need to be clear. For this, it seems necessary to clarify the responsibilities between the Department of Food Technology and Quality Control and the Department of Drug Management, and to establish a uniform regulatory system and effective coordination on a scientific and legal basis.

Why should nutraceuticals not be kept in pharmacies?

The Department of Drug Management had issued a notice on the sale and distribution of medicinal supplements on 25 Poush 2081 BS and a notice on the advertisement and use of medicinal products on 21 Chaitra 2081 BS. In which, the concerned parties were warned to sell, distribute and advertise the relevant materials in accordance with the prevailing legal provisions and prescribed standards.

The main concern of the Department of Drug Management is to prevent products that do not meet quality, safety, effectiveness and regulatory standards from reaching consumers. If a product is brought to the market with medicinal uses or medicinal claims, it is natural to raise questions about its regulatory status, quality and safety standards.

However, no nutraceutical can be called illegal just on the basis of not being registered with the Department of Drug Management. It is necessary to look at the nature of the product, regulatory classification and registration with the concerned body. Products registered as food supplements under the Department of Food Technology and Quality Control and products not registered with any body are treated in the same light.

It is not appropriate to look at it.

But the regulation of medicinal claims and products used that are not registered or go beyond their approved classification is a different matter.

Doctors prescribing nutraceuticals, pharmacy in action?

This question is the most controversial. Organizations including the Pharmacy Association in Nepal have accused some doctors of prescribing nutraceuticals that are not registered with the Department of Drug Regulation. However, not all doctors can be accused in the same way. Many doctors prescribe supplements on scientific grounds to patients with real nutritional deficiencies.

Pharmacy professionals have a different question. They say that if doctors are prescribing such products, why is only pharmacy the target of action? The Nepal Pharmacy Association had publicly raised the question and demanded that the rules be applied equally to doctors, importers and sellers.

Nutraceuticals: Really necessary or unnecessary expense?

The answer depends on the patient's condition. Supplements may be useful if a person has vitamin D deficiency, iron deficiency, pregnancy, malnutrition, and medical tests show a deficiency.

But there is no strong scientific evidence that all nutraceuticals provide additional benefits to the average healthy person. The effects of some products may be limited or uncertain.

The tendency to prescribe expensive supplements without testing in many cases has been questioned. Even the Department of Drug Administration has expressed concern that some products are prescribed without assessing the need for them.

Why are nutraceuticals expensive?

The price of nutraceuticals can be affected by branding, import costs, advertising, packaging, and marketing promotion through medical recommendations. Since the price regulation system for such products is different from that of drugs, the price of products with the same nutrient can vary greatly from company to company.

Critics ask, why should patients ultimately bear the additional financial burden when brand and marketing promotion prevail over need and scientific evidence? Therefore, transparency, evidence-based recommendations, and consumer interests need to be prioritized in the pricing of nutraceuticals.

What is needed now?

It is not enough to limit the debate on nutraceuticals in Nepal to the two poles of drugs or food supplements. A clear regulatory framework is needed that covers product classification, scientific evidence, quality, safety, health claims, labeling, advertising, and price transparency. Consumers should be able to identify which drugs are which food supplements.

Consumers have the right to easily obtain information about their composition, scientific evidence, how to use them, and what their costs and potential risks are.

Ultimately, the focus of regulation should be on the safety of patients and consumers, not industry or business.