NUTRACEUTICALS AND REGULATION-- An inter-ministerial committee, formed earlier this year by the Union Health Ministry to look into the regulatory purview of nutraceuticals in the country, has recommended sweeping changes in regulations on nutraceuticals and health supplements. The committee has recommended to the government to shift regulation of certain items to the Central Drugs Standard Control Organisation (CDSCO) and bring in standards including the Good Manufacturing Practices (GMP) for health supplements and nutraceuticals. The committee was formed by the Ministry to look into various regulatory challenges in the nutraceuticals sector, including the regulation of vitamins and minerals, probiotic and prebiotics tablets and capsules, botanicals and plant extracts, claims, and pricing of nutraceuticals and health supplements. In its comprehensive recommendation, the committee has recommended that vitamins, 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), can be retained under the purview of Food Safety & Standards Authority of India (FSSAI), but the formulations having vitamins, minerals and amino acids with dose and/or dosage formats and permitted excipients as defined in D& C Act should be shifted under the purview of CDSCO. Observing that claims related to Disease Risk Reduction (DRR) are widely used by manufacturers without approvals and often misused or manipulated, the committee recommended that the claim to cure or mitigate any specific disease, disorder or condition including DRR should be regulated by the CDSCO, while FSSAI may regulate only nutritional and health claims that are listed under FSS (Claims and Advertisements) Regulations, 2018. Of course, the panel has gone down deep into the issue and has made some relevant recommendations to clean the Augean stable of nutraceutical market in the country. It is true that as the nutraceuticals are not as regulated as drugs in the country, there is a comparatively relaxed regulatory regime which paved the way for ease of business in the nutraceutical market. But, the relaxed regulatory regime in its wake brought some malpractices also in the market. Naturally, the government is concerned over consequent marketing malpractices for nutraceuticals in the country. The government’s concern is understandable given the fact that nutraceuticals are discretionary, over-the-counter products, there is need to curb misleading health claims, especially those related to disease risk reduction. Certainly, stricter oversight will protect the consumers by removing deceiving products from the market. Quite predictably, the government’s move to transfer the oversight of nutraceuticals from FSSAI to the CDSCO has not gone down well with the industry as it wanted to avoid the rigorous regulatory regime under the CDSCO. The industry and experts argue that India’s nutraceutical regulations are in line with Codex Alimentarius, a global standard set by the WHO to ensure consumer safety. They argue that FSSAI regulations are also in consistent with international practices, similar to those in the US, UK, Australia, China, Japan, and the EU. The industry argues that a unified mechanism under the FSSAI would streamline regulation on nutraceuticals, reduce duplication, and ensure consistent enforcement across the sector, rather than having two authorities working independently. They argue that FSSAI should be empowered to act on ASCI’s findings on false product claims. The industry is also of the view that 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 the growth of this fledgling sector in the country. While arguments and counter-arguments fly thick and fast, the fact remains that the nutraceutical industry has a huge opportunity ahead and the ecosystem is robust with more than 300 startups already in the sector. The government should take a balanced decision and should avoid stifling credible industry players who are committed to safety and innovation. Our Office Accredited Consultants Pvt. Ltd. B-3, Sector 6, Noida, Uttar Pradesh 201301 Mobile : 926-6665-201 Email : info@acplgroupindia.co.in