CDSCO may regulate health supplements to stem unapproved claims by firms
health claims associated with supplements will be under stricter scrutiny as a government panel proposes to shift it under the control of drug regulator instead of Foods Safety and Standards Authority of India (FSSAI). The expert panel was earlier formed to look into addressing the overlapping concerns between nutraceuticals and drugs.
People in the know told ET that the panel has proposed that the claims related to cure or promise to mitigate disease disorder or condition including disease risk reduction (DRR) shall be regulated by the Central Drugs Standard Control Organisation (CDSCO). «The DRR claims or products having properties for treatment of a disease shall not be approved under FSS,» said a source, sharing that a report has been sent to the health ministry, drug regulatory authority and FSSAI.
Another person said that the same has been proposed to strengthen the regulatory mechanism for claims. «The DRR claims are widely used by manufacturers without approvals. These claims are also manipulated in such a way that mimics treatment cure of any specific disease,» he said.
The panel has suggested that FSSAI may regulate only nutritional and health claims that are listed under the FSS (claims and advertisements) Regulations 2018.
The experts have also sought that a provision be made to submit labels along with the claims and products at the time of licensing in appropriate regulations.
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