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Indian nutraceutical companies grapple with a maze of global regulatory challenges
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Nandita Vijayasimha, Bengaluru
July 30 , 2025
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Indian nutraceutical companies are increasingly looking to expand into global markets, but navigating the complex web of international regulations poses a significant hurdle. The industry sees the need to setting standards together instead of getting caught in a maze of issues.
According to Gaurav Soni, co-founder & managing director, Botanic Healthcare, Indian nutraceutical companies often face a real headache trying to navigate the incredibly complex world of international regulations. Sure, our own Food Safety and Standards Authority of India (FSSAI) has set guidelines for local products. But these often do not quite line-up with the rules set by big global players like the US FDA, EFSA, or Australia's TGA.
This mismatch creates a ton of headaches for Indian exporters. We are talking about everything from how ingredients get approved, to what health claims you can make, to allowed dosage limits, and even what needs to go on a label. Something that sails through FSSAI approval here might need a complete overhaul or a whole new round of clinical trials just to be accepted in Europe, the US, or Australia. In this way it is challenging to bare the compliance costs and the product launch also gets delayed because of the same reason, he added.
This is not just a minor annoyance but it is a huge challenge, especially for our small and medium-sized businesses and those innovative startups with global ambitions. Without more regulatory harmony, India simply cannot capture the full potential of the booming worldwide demand for nutraceuticals, Soni told Pharmabiz in an email.
It is crystal clear that we desperately need more cross-border cooperation and smarter, more adaptable policy changes. Industry leaders are already championing the idea of a unified ‘nutraceutical code’ which is a way to bring Indian standards closer to those internationally recognized frameworks, he noted.
The need of the hour is expedited approvals for ingredients that are already recognized worldwide. There is a need for official acknowledgment of international monographs and reference materials. There needs to be incentives for companies to get global certifications like US FDA-GMP, EU-GMP, and NSF. Another is a central digital hub that gives us real-time regulatory intelligence across different countries with a big push for collaborative research on safety and effectiveness, pointed out Soni.
Noting that it is heart-warming to see that Indian businesses are not just sitting back, Soni said that companies are instead actively implementing international best practices, investing into clinical research, seeking third-party certifications, adopting open sourcing, and focusing on sustainable manufacturing. “Now we view this is just not good business but a responsible, science-driven approach helping to position Indian products on the global stage as trustworthy, legitimate, and truly superior solutions,” he said.
India has a capability to contribute to the global regulatory conversation. By blending our traditional health systems, like Ayurveda, along with scientific capabilities, we can help craft entirely new frameworks for safe and effective botanical and functional food ingredients worldwide. Here we are ready to lead, said the Botanic Healthcare co-founder and managing director.
The nutraceutical industry in the country is pursuing innovation, coupled with stronger international cooperation and standardized regulations. With this India is not just participating in the global nutraceutical game anymore. The industry here is actually in a position to note merely engaged in the marketing nutraceutical products but cementing a spot as an absolutely crucial player in the entire global health and wellness arena with real impact, said Soni.
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