India is all set to get best practice guidelines to develop standards for botanical ingredients used in nutraceuticals industry. A working group is expected to come out with a white paper on the science-based criteria for these standards and submit it to FSSAI by February 2019.
The working group has been formed by the United States Pharmacopeial Convention (USP) and the Association of Analytical Communities (AOAC) International India to lay the guidelines for quality standards of Schedules IV and VI of the nutraceuticals regulation listing plant or botanical ingredients and nutraceuticals ingredients. The two schedules belong to the regulation - Food Safety and Standards (Health Supplements, Nutraceuticals, Food for Special Dietary Use, Food for Special Medical Purpose, Functional Food and Novel Food) Regulations, 2016.
In this regard, in an exclusive interaction with FnB News, Zeenat Khan, senior manager, USP, informed, “During the AOAC 5th annual conference on February 28, 2018, USP and AOAC India section formed a working group to draft guidelines on botanicals standards of food supplements which are published under FSSAI nutraceuticals regulations in January 2018.”
Khan elaborated, “Currently, there are two active working groups working under the aegis of India section of AOAC International (a) Ensuring Quality of Food Supplements Containing Botanicals and (b) Rapid Microbiology Methods and the Regulatory Environment.”
She added, “The main objective of these groups is to collate the best analytical practices around the world and put together robust proposals on various facets of food analysis in consultation with relevant stakeholders.”
Delving deeper, Khan stated, “We do have various standards recognised in the FSSAI regulations e.g., the Ayurvedic Pharmacopoeia of India, United States Pharmacopoeia, British Pharmacopeia, Indian Pharmacopeia, etc. wherein quality standards of such botanicals are included. However, the main objective for the USP-AOAC working group is to harmonise the best practices around the world and come up with comprehensive and robust recommendations or guidelines for quality of botanical raw materials and intermediates. This can potentially be used by FSSAI for implementation of nutraceuticals regulations.”
According to her, once this basic framework is established, the working group will start deliberating on the standards of the plant/botanical ingredients that are part of the nutraceuticals regulations, which include identity, strength/composition, limit of contaminants, etc. of the plant material.
Representation from companies such as Amway, Dabur, GSK, Himalaya, Hamdard Laboratories and Natural Remedies participate in the working group. “The group has discussed the guidelines for botanical monographs and the prioritisation criteria and is actively working on the subject,” she revealed.
Apart from presenting to FSSAI for consideration, the guidelines will be posted on the AOAC India website for comments. Further, they will be presented in the forthcoming Annual Conference of the India Section of AOAC International to be held from February 28 - March 1, 2019, in New Delhi.
