AYUSH products should not claim nutraceutical value – Indian authorities

By Tingmin Koe

- Last updated on GMT

Ashwagandha, or Indian ginseng, is commonly used in ayurvedic formulations. ©Getty Images
Ashwagandha, or Indian ginseng, is commonly used in ayurvedic formulations. ©Getty Images
Ayurveda and other related drugs or products are not allowed to claim nutraceutical value, the Indian authorities said.

The Ministry of AYUSH pointed out the above in an announcement dated April 18, where it also addressed several other problematic advertisings made by AYUSH product manufacturers.

One of which was claiming nutraceutical value to Ayush drugs or products.

In India, nutraceuticals are currently regulated by the Food Safety and Standards Authority of India (FSSAI), alongside health supplements, Food for Special Dietary Use, Food for Special Medical Purpose, prebiotic and probiotic food.

Nutraceuticals should contain molecules / isolates / extract from as approved by the food authority.

They are meant to provide a physiological benefit and to help maintain good health, while not intended to treat or cure any medical condition, disease, or disorder, according to the regulations.

Ayush products, referring to Ayurveda, Siddha, Unani, and Homoeopathy, on the other hand, comprise of ayurvedic and other traditional systems of Indian medicines.

These products have seen a revival across India​ due to their efficacy and absence of side effects. For instance, ingredients commonly used in Ayurveda, such as curcumin and ashwagandha, are also increasingly used in nutraceuticals.

Still, AYUSH products and nutraceuticals do not fall in the same category and are regulated by different laws. In this case, the labelling of AYUSH products should follow the Drugs and Cosmetics Rules and advertisements to follow the Drugs and Magic Remedies Act. 

The Ministry of AYUSH also said that some Ayush manufacturers have claimed that their products were approved or certified by the ministry.

This, however, is an inaccurate claim, as the ministry does not grant manufacturing license or approval for any Ayush drug or medicines.

“Licensing by State Drug Licensing Authority shouldn’t be construed as an approval by ‘Ministry of Ayush’. License issued by state SLA is a permission to manufacturer for sale of the particular drug / product based on the fulfilment of stipulations laid down under the Drugs and Cosmetics Act, 1940 and Rules thereunder,” ​said the ministry.

Manufacturers are advised to ensure that such a claim is not present on their product label or in their advertisements.

It highlighted that any claim of “approved / certified by Ministry of AYUSH”​ on the label or advertisement of ASU&H drugs, would result in legal action against the alleged manufacturer.

Misleading claims

AYUSH manufacturers are also warned not to make misleading claims, such as advertising their products as “100 per cent safe”.

Other examples include “free from side effects”, “guaranteed treatment”, and “permanent cure”, which are misleading advertisements that go against the Consumer Protection Act, the Cable Television Networks Act, and the Emblems & Names (prevention of improper use) Act.

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