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Unified mechanism under FSSAI for nutraceuticals would help rather than having two authorities: Expert
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Gireesh Babu, New Delhi
November 19 , 2024
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A unified mechanism under Food Safety & Standards Authority of India (FSSAI) would streamline regulation on nutraceuticals, reduce duplication, and ensure consistent enforcement across the sector, rather than having two authorities working independently, said Sanjaya Mariwala, founder president of Association of Herbal and Nutraceutical Manufacturers of India (AHNMI), and executive chairman and managing director, OmniActive Health Technologies.
An inter-ministerial committee formed by the Union health ministry has recommended amendments to the Food Safety and Standards Act, 2006 and regulations on nutraceuticals and health supplements, to shift regulation of certain items to the drug regulatory authority and bring in standards including the Good Manufacturing Practices (GMP) for health supplements and nutraceuticals.
“The inter-ministerial committee of MoHFW has proposed reforms clarifying the roles of FSSAI and CDSCO (Central Drugs Standard Control Organisation) in regulating the nutraceutical industry. However, placing disease-treatment claims under CDSCO could be a retrograde step, creating redundancies and complicating compliance," he opined. Mariwala is also the president of IMC Chamber of Commerce and Industry.
Given that nutraceuticals are discretionary, over-the-counter purchases, the primary concern is not price control but rather the need to curb misleading health claims, especially those related to disease risk reduction. Stricter oversight would protect consumers by removing deceiving products, but it must be balanced to avoid stifling credible industry players committed to safety and innovation, he said.
The Advertising Standards Council of India (ASCI) has recommended intensifying its review of product claims and taking strict action against companies making false statements through advertisements and other promotional materials.
"FSSAI should be empowered to act on ASCI’s findings and address violations to support this. A unified mechanism under FSSAI would streamline regulation, reduce duplication, and ensure consistent enforcement across the sector, rather than having two authorities working independently," said Mariwala.
One of the committee's recommendations to implement customised GMP for nutraceuticals is a crucial step in ensuring adherence to high-quality standards and best practices, thereby safeguarding consumer interests.
"Strengthening FSSAI’s role, in collaboration with ASCI and through close cooperation between the government and industry, would establish a balanced regulatory framework that will foster innovation and safety, driving sector growth. These suggestions would also enhance India’s position in the global nutraceutical market, ensuring long-term success,” he averred.
The inter ministerial committee, formed earlier this year under the chairmanship of the then health secretary Apurva Chandra to look into the regulatory purview of nutraceuticals in the country, recommended that in terms vitamins, minerals and amino acid supplements, the mere combination including single use of nutrients specified in Schedule-I of Nutra regulation may not be regulated by FSSAI.
Vitamin, minerals and amino acids added in food (as defined in the FSS Act 2006) (containing macronutrients such as protein, carbohydrate and fat providing significant calories), may be retained under the purview of FSSAI, but the formulations having vitamins, minerals and amino acids with dose and/or dosage formats and permitted excipients as defined in rule D&C Act shall be shifted under the purview of Central Drugs Standard Control Organisation (CDSCO).
Section 22 (1) (a) &(b) of FSS Act, which defines the nutraceuticals and health supplements, need to be holistically re-examined in terms of the existing formats and in light of the amendments proposed. Suitable options may be explored to distinguish or define the formats clearly by obtaining legal opinion in the proposed amendments. Further amendment in Nutra regulations and in related regulations may be made subsequent to the amendment of the FSS Act, added the committee.
Observing that claims related to Disease Risk Reduction (DRR) are widely used by manufacturer without approvals and often misused or manipulated, the committee suggested that the claim to cure or mitigate any specific disease, disorder or condition including DRR shall be regulated by the CDSCO, while FSSAI may regulate only nutritional and health claims that are listed under FSS (Claims and Advertisements) Regulations, 2018. The DRR claims listed under this regulation may not be applicable for products categorised under nutraceutical regulations.
To strengthen the regulatory mechanism for claims, a provision has to be made to submit labels along with the claims and product at the time of licensing in appropriate regulations, it added.
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