In a significant policy shift to regulate health supplements, an inter-ministerial committee has recommended that supplements claiming to cure or alleviate specific diseases be classified as drugs, reported TOI.
If accepted, these products would come under the oversight of the Central Drugs Standard Control Organization (CDSCO) instead of the current regulator, the Food Safety and Standards Authority of India (FSSAI).
According to the TOI report, the committee, led by former health secretary Apurva Chandra, argued that supplements making health claims should undergo stricter scrutiny before licensing. This would also mean harsher penalties for companies making false claims about disease prevention or mitigation.
A key motivation for companies to reclassify certain products from drugs to dietary supplements has been to avoid price regulations. The National Pharmaceutical Pricing Authority (NPPA) controls drug prices to ensure affordability, but it has no authority over pricing once a drug is marketed as a food supplement. The new recommendation would bring these products back under NPPA pricing controls, potentially impacting their cost.
Additional measures proposed include establishing Good Manufacturing Practices (GMP) for supplements and setting up a dedicated monitoring cell to oversee advertising claims related to these products, noted the TOI report.
ET had earlier reported on the potential move noting the alarming issue of exaggerated health claims associated with supplements will be under stricter scrutiny.
"The DRR claims or products having properties for treatment of a disease shall not be approved under FSS," a source at told ET, sharing that a report has been sent to the health ministry, drug regulatory authority and FSSAI.
"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," another source at told ET.
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, according to the ET report.
If accepted, these products would come under the oversight of the Central Drugs Standard Control Organization (CDSCO) instead of the current regulator, the Food Safety and Standards Authority of India (FSSAI).
According to the TOI report, the committee, led by former health secretary Apurva Chandra, argued that supplements making health claims should undergo stricter scrutiny before licensing. This would also mean harsher penalties for companies making false claims about disease prevention or mitigation.
A key motivation for companies to reclassify certain products from drugs to dietary supplements has been to avoid price regulations. The National Pharmaceutical Pricing Authority (NPPA) controls drug prices to ensure affordability, but it has no authority over pricing once a drug is marketed as a food supplement. The new recommendation would bring these products back under NPPA pricing controls, potentially impacting their cost.
Additional measures proposed include establishing Good Manufacturing Practices (GMP) for supplements and setting up a dedicated monitoring cell to oversee advertising claims related to these products, noted the TOI report.
ET had earlier reported on the potential move noting the alarming issue of exaggerated health claims associated with supplements will be under stricter scrutiny.
"The DRR claims or products having properties for treatment of a disease shall not be approved under FSS," a source at told ET, sharing that a report has been sent to the health ministry, drug regulatory authority and FSSAI.
"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," another source at told ET.
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, according to the ET report.
