The Health Ministry's plans to come out with a comprehensive nutraceutical policy has received a boost with the expert committee headed by Dr R A Mashelkar deciding to recommend the urgent need to create a new category under Food Safety Laws to cover the regulatory aspects of dietary supplements/food supplements/nutraceuticals. The committee has observed that product with therapeutic or medical claims based on ingredients in the products or the product per se should be excluded from the new category and brought under Drug Laws.

The committee felt the need for sub-categories and separate definitions and regulations for products for preventive and maintenance use, products for specific health use, fortified products, dietary ingredients etc. The regulations should also include guidelines on good manufacturing practices for these products, it has opined.

A careful examination of the vitamin and mineral content of products that are currently under food laws and drug laws has been called for. "Vitamins and minerals below those meant for therapeutic activity may be removed from the drug laws and covered under the new category under food laws. Alternatively evaluate whether both options of either manufacturing and selling vitamins and mineral products as medicines through doctors as drugs or as food supplements under certain circumstances can be possible leaving the industry to have a choice and follow specific regulations. This is a critical area and needs special attention", the committee has noted.

The committee has warned of permitting the blending of specific medicinal herbs known in Indian Systems of Medicine with vitamins and minerals as scientific data or such combinations and their safety, bioavailability, efficacy, are too scanty or not at all available. Manufacturers desirous of marketing such combinations should be made to provide evidence of safety and efficacy over conventional formulations, the committee said.

Reviewing the current situation, the committee noted that there is no clarity in regard to regulatory policies and procedures concerning safety, quality, claims, labeling, classification etc of products, which are not claimed or considered as medicines but are consumed and propagated for certain health benefits or nutritional advantages. These products however do not even fit into the domain of conventional or regular foods, under the regulatory scheme of PFA etc.

The committee said that due to the existing unclear situation, food supplement type of products are being introduced and sold either under "proprietary foods" or even licensed under P&P medicines category. "It is not known whether or not enough safety and efficacy data are available on such products. However strong ingredient claims are made, as proof of functionality is not legally required in India".

The committee is to have the view that the new law for this purpose should notify a negative list of not permissible items and asks the industry to provide safety and efficacy data. "Alternatively based on vast experience of Indian PFA so far, we should automatically recognize the current list of ingredients and fortified foods as also automatically provide approval for all items recognized as Generally Considered As Safe (GRAS) and those approved under codex alimentarius. The regulation may provide for procedure to get new ingredients under the new category as GRAS or approved ingredient", the committee has suggested.

It has also highlighted the need for storage conditions, labeling guidelines and information dissemination to the consumers so as to promote greater access to such products. Labeling guidelines need to be clear, exhaustive and allow only factual claims, the committee has noted.

Nutraceutical segment is a new and emerging category of ingredients and products across the world.