The Indian government’s inter-ministerial committee has released a report proposing changes to the regulation of nutraceuticals, sparking mixed reactions from the industry. A key recommendation involves transferring oversight of disease risk reduction (DRR) claims to the Central Drugs Standard Control Organisation (CDSCO), a move aimed at curbing exaggerated health claims but seen as burdensome by many stakeholders.
The 20-page report, authored by a panel of eight experts, including FSSAI CEO Shri G. Kamala Vardhana Rao and CDSCO Drugs Controller General Dr. Rajeev Singh Raghuvanshi, outlines strategies for regulating products such as vitamins, minerals, amino acid supplements, Foods for Special Dietary Uses (FSDU), and Foods for Special Medical Purposes (FSMP).
Key Recommendations
1. Regulating DRR Claims: The committee proposed that DRR claims should fall under CDSCO’s jurisdiction, requiring clinical evidence to substantiate such claims. Currently, many nutraceuticals are marketed with bold claims lacking adequate scientific backing.
2. FSSAI’s Role: The Food Safety and Standards Authority of India (FSSAI) would focus on nutritional and general health claims, as defined under the Food Safety Act and FSS (Claims and Advertisement) Regulations, 2018.
3. Good Manufacturing Practices (GMP): A separate set of GMP requirements for health supplements and nutraceuticals was suggested.
Industry Concerns
The proposal to transfer DRR claims to CDSCO has raised concerns about operational complexities, particularly for smaller businesses.
1. Cost and Complexity: Dr. Vaibhav Kulkarni, honorary secretary of the Health Foods and Dietary Supplements Association (HADSA), noted that smaller firms might struggle to meet the clinical trial requirements, which are both costly and time-consuming.
2. Label Changes: Existing products may need to alter their labels or remove claims, creating additional pressure on supply chains.
3. Multiplicity of Authorities: Former FSSAI director Pradip Chakraborty highlighted potential duplication of requirements for importers, who would need approvals from both FSSAI and CDSCO.
Calls for Balanced Regulation
While some stakeholders see the proposed measures as a way to deter misleading claims, others argue that FSSAI must enhance its capability to evaluate clinical evidence if it retains control over DRR claims.
“The drug authority is better equipped to validate strong claims,” said Dr. Kulkarni. However, he emphasized the need for fair evaluation processes to prevent companies from abandoning product launches due to delays or rejections.
Next Steps
The recommendations are not yet final and will require parliamentary approval, including amendments to the Food Safety and Standards Act. The process could take one to two years or longer.
Industry experts have urged stakeholders to substantiate their objections to the proposal with strong evidence, ensuring that any adopted changes are both practical and beneficial to public health.
As the debate unfolds, the nutraceutical sector braces for potential disruptions, with the outcome likely to shape the future of health supplements and functional foods in India.