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Industry awaiting committee decision on manufacturing of nutraceuticals at drug facility
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Nandita Vijayasimha, Bengaluru
June 27 , 2024
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The pharmaceutical as well as the nutraceutical industries in the country are eagerly awaiting the decision of the high-powered committee constituted to address the overlapping issues encountered during the manufacturing of nutraceuticals within drug manufacturing facilities.
This decision is crucial as it will likely clarify regulatory and operational aspects that affect both these sectors, potentially influencing production processes, compliance requirements, and market dynamics. The outcome could have significant implications for manufacturers and consumers, shaping the future landscape of these intertwined sectors, Dr DBA Narayana, CSO, Ayurvidye Trust told Pharmabiz.
Two important aspects coming out of this is, firstly nutraceutical regulation was not forced in India. Consumers globally wished to move from illness centric healthcare to wellness centric healthcare. In this role of health supplements, diets, nutraceuticals got the attention. It was US and China that brought in regulations for nutraceuticals and supplements and India followed. It took a large group of scientists and the foods authority among others to work almost 8 to 9 years before the nutraceutical regulations in India was notified, he stated.
Current issue is that vitamins which were earlier covered as drugs and licensed under drugs regulations are now in the nutraceutical norms notified in 2016. The nutraceutical regulation clearly states that vitamins and minerals should be either equal to or less than one RDA (required daily allowance). Vitamins and minerals co-exist with food and drugs. When fruits known for vitamins are consumed it could be up to one RDA which means it is higher than the safety level. India has moved forward opting out of RDAs based on the western countries format. In 2010, the National Institute of Nutrition, Hyderabad and ICMR published the RDA level for Indians based on dietary habits, height and weight and other factors, which has been updated in 2020 to offset the deficiencies for below one RDA.
In 2019, when this issue was being debated, discussions took place between DCGI and the FSSAI chief. It was then decided that products containing vitamins and minerals below or equal to one RDA would co-exists under food regulations. Products containing these at levels above one RDA would be regulated under drugs regulations. Industry lauded this went ahead to innovate their products adding probiotics, herbs, enzymes and other ingredients so that it is not purely vitamins or minerals preparation. This led to many nutraceutical products getting out of drug license and getting manufactured in the same premises where pharmaceuticals were manufactured. It appears that large number of vitamins and minerals have moved into foods category as supplements with health claims. The high-power committee is looking in to this.
The issue now is that if many of the health supplements go back to drug category regulations, most believe it would be retrograde step. India will be looking different and WTO signatories may have problems as these nutraceutical regulations went through WTO consultations. Current exports may also get affected to need new registration under different categories, said Dr Narayana.
If the issue is about health claims being made, government can strengthen the approval process. Foods and nutraceutical regulations have a process in place applicable for disease risk reduction with claims to be made ‘only after prior approval from FSSAI’. But health claims for supplements/nutraceuticals do not need such prior approval. It may be appropriate to bring out a guidelines to make health claims of nutraceuticals and supplements on lines similar to global scientific thinking and enforce the same stringently, said Dr Narayana.
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