A panel of experts formed by the Indian government have proposed the implementation of stricter regulations on nutraceuticals and dietary supplements.
The group recommend that product labels and their claims should be submitted when applying for a license.
According to the experts, this will reduce the current issues surrounding exaggerated product claims and false labelling.
With the Indian government keen to further regulate the nutraceutical market, the panel has suggested that companies in this sector should be required to adhere to stricter regulations surrounding advertising.
The government originally formed this panel in February to evaluate how to approach regulating the nutraceutical sector within the country — with potential plans to place functional ingredients under the remit of CDSCO, India's apex drug regulator.
So, what's to change?
Vitamins, amino acids and minerals
According to a government-released report, the panel has proposed to switch the regulatory authority of certain functional food and nutraceutical products to the CDSCO.
This includes vitamins, amino acids and minerals.
However, the panel recommends that the food standards authority continues to have control over the vitamins, minerals and amino acids added into macronutrient-rich foods.
Health claims
Additionally, the Food Safety and Standards Authority of India (FSSAI) will only be resonsible for enforcing nutrition and health claims listed under the FSS regulations of 2018 — meaning that CDSCO would be responsible for the regulation of claims that a supplement or nutraceutical could "cure or treat any specific disease, disorder or condition".
The panel also believes that regulations should be tightened when discussing product approvals, manufacturing and continued surveillance of such products.
Pre and probiotics
When discussing the future of probiotics in the regulatory space, the panel believed that this subset of nutraceuticals could still be managed by the FSSAI.
The report stated: “The prebiotic and/or the pure culture of probiotic with excipient base and in the dosage forms as mentioned in D&C Act to be regulated by CDSCO and will not fall under the purview of FSSAI."
Good manufacturing practices
As well as the tightening of aspects of label and formulation, the group believes that there should be a list of good manufacturing practices (GMP) requirements for dietary supplements, nutraceuticals and functional foods.
These would likely be included in the FSS Regulations of 2011.
Tighter botanical extract regulations
Finally, the panel placed a focus on botanicals and ayurvedic drug ingredients — suggesting that products making health claims should be regulated by the Ministry of Aysuh.
Those who do not make disease risk reduction claims could fall under the FSSAI's jurisdiction, according to the board.
The report concludes: "These recommendations will buld consumer confidence in nutraceutical products, while focusing on their safety. With these recommendations, stakeholders can work towards a balanced regulatory environment that maximises benefit and supports responsible industry practices."