Pharmacies Under Pressure Due to Ambiguous Regulation of Nutraceutical Distribution
– 6 February 2025 (Magh 24, 2081 B.S)
Nutraceuticals, or dietary supplements, are food products or their components that contribute to improving health, preventing diseases, or assisting in treatment. They are considered a balance between nutrition and medicine and are generally based on vitamins, minerals, amino acids, and botanicals.
In Nepal, several challenges have emerged in the distribution of nutraceuticals, hindering the sector’s development. The primary issue is legal conflict and regulatory ambiguity. There is a dispute between the Department of Drug Administration (DDA) and the Department of Food Technology and Quality Control (DFTQC) over classification. While the DFTQC registers them as “dietary supplements,” the DDA claims they possess medicinal properties, creating a dual regulatory system. This has caused confusion among both entrepreneurs and consumers.
Similarly, the lack of coordination between the two departments has made market regulation difficult. Products registered by one department are sometimes declared “illegal” by the other, negatively affecting the pharmacy profession. As a result, entrepreneurs face financial setbacks, and the stability of pharmacies has come under threat.
Globally, in developed countries, nutraceuticals and dietary supplements are distributed both through pharmacies and departmental stores. In Nepal, however, the DDA has repeatedly issued press releases prohibiting the sale of such products from pharmacies.
This has further complicated pharmacy operations. The DDA allows pharmacies to sell only products registered with its office. Yet, when physicians recommend nutraceuticals for patients, pharmacies are compelled to provide them for the sake of consumer convenience, thereby exposing themselves to legal risks.
Another significant issue lies in the outdated legal framework. The Drugs Act, 2035 (1978) does not define modern products such as nutraceuticals, resulting in impractical regulatory procedures.
To resolve these problems, the Drugs Act must be amended to clearly define nutraceuticals. Both departments should develop a joint policy and implement an integrated regulatory process. Quality control mechanisms must be stringent, pricing should be closely monitored by relevant authorities, stricter rules should be imposed on prescribers, and awareness campaigns should be launched to provide consumers with accurate information.
If these issues are addressed, the safe and organized distribution of nutraceuticals in Nepal will become possible, ensuring that the general public has access to high-quality products at affordable prices.
-Tek Bahadur B.K.
