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After last week’s setback in the Supreme Court, the Food Safety & Standards Authority of India (FSSAI) has set in motion the process of notifying guidelines for proprietary foods, health supplements and additives, which were not covered under the food safety regulations of 2011. The latter operationalises the Food Safety & Standards, Act, 2006.
The drawback of the 2011 regulations are that it covers only 377 food items, implying that only these products are standardised and the rest are not. The new draft guidelines, which have been put up on the FSSAI website for public comments, cover almost 1,000 items under health supplements and nutraceuticals. Another 5,000-6,000 items have been included under the category of foods. The latter includes everything from proprietary to functional to novel foods and additives.
Public comments have been invited till September 23, after which FSSAI will include the feedback and suggestions appropriately in the draft guidelines. After that, the guidelines will move to the law ministry, and then Parliament, following which it is expected to be notified, persons in the know said.
Most food and health care companies expect the guidelines to be notified by early next year owing to the urgency of the matter. More importantly, the draft guidelines will get India up-to-speed with international standards under Codex Alimentarius - global standards and codes of practice related to foods, food production and food safety.
While India is a signatory to Codex, its norms are yet to be followed in India. The draft guidelines, according to R K Sanghavi, chairman, neutraceutical sub-committee, Indian Drug Manufacturers Association of India (IDMA), would align India with international standards. “The proposed regulations are positive from the point of view of companies as well as consumers as there will be specific regulations and standards which were hitherto absent in India.”
It was IDMA along with a city-based company called Vital Neutraceuticals that had first moved the Bombay High Court last year challenging the FSSAI’s product approval process based on what they termed ‘arbitrary’ guidelines. The problem had emerged because of the limited number of categories covered under the food safety regulations of 2011, compelling the regulator to find a ‘middle path’ to resolve the issue of clearing products that were not standardised. The product approval process was positioned as a solution, but it soon hit a rough patch owing to repeated advisories that the regulator would issue.
The Supreme Court last week deemed the entire process as invalid following an appeal by FSSAI that it stay the order passed earlier by the Bombay High Court in the matter.
The Bombay High Court had also ruled the product approval process as illegal (this was in the Vital versus FSSAI case) after hearing detailed arguments from all sides.
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While food and health care companies will no longer have to abide by any ‘arbitrary’ product approval process, it still does not mean they can get away, sources in the know said. FSSAI is said to be pushing hard to ensure these draft guidelines are notified, since it will ensure there are proper rules and regulations for all categories of food and health care products.
IN A NUTSHELL
- The draft guidelines, put up on the FSSAI website, cover almost 1,000 items under health supplements and nutraceuticals
- Public comments have been invited till Sept 23
- After inclusion of these feedback, the guidelines will move to the law ministry, and then Parliament
