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US FDA India office to hold webinar on Jan-23 for Ayush cos on exports of Ayush products to US
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Gireesh Babu, New Delhi
December 29 , 2022
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Amidst the impetus given by the Government of India on boosting the traditional Ayurveda, Yoga and Naturopathy, Unani, Siddha, and Homoeopathy (Ayush) systems of medicines, the US FDA India office in collaboration with the Ministry of Ayush is scheduled to organise an online event for the Ayush stakeholders in the country on exports of these products to US.
The drug regulatory office will be conducting a webinar titled 'Regulatory Expectations for Ayurvedic Products' for the Ayush stakeholders in the country on January 23, with an objective to explain the different regulatory classifications under which ayurvedic products may fall and the applicable regulatory expectations for each class for entry to US.
The webinar will have sessions on helping the stakeholders to identify whether their Ayush product will fall under the category of food or drug and the further regulatory steps to be followed for both the food and drug categories. The sessions will be followed by live question and answer sessions. The virtual sessions will be free of cost, said an email to the stakeholders from Sarah McMullen, PhD, Country Director, India Office, Office of Global Operations, US FDA.
Apart from the India director of FDA, Vaidya Rajesh Kotecha, Secretary, Ministry of Ayush will participate in the opening remarks. Sessions will be conducted by Dr. Charles Wu, FDA CDER, Botanical Review Team and Dr. Haijing Hu, FDA CFSAN, Office of Dietary Supplement Programs.
The event comes at a time when the Government of India is taking various initiatives to improve global acceptance of Ayush products through scientific validation and brand building. Earlier this year, the government tied up with the World Health Organisation (WHO) to set up WHO - Global Center for Traditional Medicine (WHO - GCTM), the first and only center of its kind in Jamnagar, Gujarat. Director General-WHO had announced the establishment of WHO-GCTM in India with a vision of “Traditional Medicine for improving global health and achieving Universal Health Coverage” on November 13, 2020.
An interim office was made functional at ITRA, Jamnagar in Gujarat. WHO-GCTM strategic focus will be on evidence and learning, data and analytics, sustainability and equity, and innovation and technology to optimize the contribution of traditional medicine to global health and sustainable development.
The first Global Ayush Investment and Innovation Summit (GAIIS) 2022 held in Gandhinagar, Gujarat in April witnessed letter of intents worth more than Rs 9000 crore in major categories like FMCG, Medical Value Travel (Heal in India), Pharma, Technology & Diagnostic and Farmers & Agriculture. The first ever mega event of this scale in the Ayush sector facilitated agreements with international and national institutions and various other sectors, fueling financial considerations, mutual research and increasing Ayush reach globally, said the Ministry of Ayush.
Many new initiatives in the Ayush sector were announced by the Prime Minister at GAIIS 2022. In a major initiative, the government announced the introduction of a special Ayush Visa category for foreign nationals, who want to come to India to take advantage of Ayush therapy. A special Ayush mark for Ayush products, development of a network of Ayush parks to encourage the promotion, research and manufacturing of Ayush products across the country. These initiatives are taking shape. A new category named 'Ayush Aahar' was announced which will facilitate the producers of Ayurvedic nutritional supplements.
A significant step to achieve cooperation and facilitation of “One Herb, One Standard” was taken with the signing of MoU between the Pharmacopoeia Commission for Indian Medicine and Homoeopathy (PCIM&H) and Indian Pharmacopoeia Commission (IPC), added the Ministry. This harmonization of standards will fulfill the objective of “One Herb, One Standard and One Nation” and improve ease of doing business in India and also improve overall trade of Indian botanicals, it added.
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