India’s nutraceutical players hope to make it big as nutra CDMOs, replicating its success as a global pharma CDMO force to reckon with. But India’s pharma story has a sobering side to it,with gaps in GMP and warning letters from global regulators.To avoid such missteps, India’s nutra CDMOs need to invest in GMP compliance from the start
“In future, nutra will get regulated like pharma, so manufacturing should be in line with pharma standards. We are preparing for it.” This quote from Shankaranarayanan Jeyakodi, Co-founder, Zeus Hygia Lifesciences, a Hyderabad-based nutra ingredients company, in our cover story, ‘India Herbal Nutra Inc: The next engine of global wellness?’, sums up the growing realisation that regulations will rule the nutraceuticals sector.
India already has a regulatory framework, with the regulator Food Safety and Standards Authority of India (FSSAI) finetuning the Food Safety and Standards (Health Supplements, Nutraceuticals, Food for Special Dietary Use, Food for Special Medical Purpose, and Prebiotic and Probiotic Food) Regulations, 2022 from time to time.
But the problem is that Good Manufacturing Practices (GMP) for chemical-based medicines cannot be applied in toto for nutraceuticals. Moreover, there is no easily available data on GMP inspections conducted on nutraceutical manufacturing units. India’s nutraceutical players hope to make it big as nutra contract development and manufacturing organisations (CDMOs), replicating its success as a global pharma CDMO force to reckon with. But India’s pharma story has a sobering side to it, with gaps in GMP and warning letters from global regulators.
To avoid such missteps, India’s nutra CDMOs need to invest in GMP compliance from the start. But while responsible nutra companies try to comply, nutraceuticals differ from pharmaceuticals and pose unique challenges.
In the story, ‘Strengthening GMPs in India’s nutra sector’, Dr Pirthi Pal Singh, President & Group R&D Head, Tirupati Group, makes that point that the sector needs clearer, nutra-specific GMP guidance that reflects the biological variability of natural materials while maintaining safety, consistency, and consumer trust.
The concern is that the rapid growth and competition to seize global market share will make companies cut corners on GMP and quality. Evolving regulations coupled with a resource-strapped regulator, and inspectors trained to inspect pharma manufacturing sites, creates confusion and chaos. Unfortunately, unethical companies thrive in this uncertainty, confident that their deliberate slips will not be detected. Such rogue nutra manufacturers may survive for a few years, but the law will catch up with them. More importantly, consumers are getting more vocal and social media channels abound with examples of users calling out brands falling short of their label claims.
Unfortunately, it only takes a few such bad apples to taint the full basket. Rebuilding consumer trust will take more time, effort and capex, than winning it in the first place. That’s a lesson the pharma sector has learnt. Let’s hope India’s nutra sector takes cues and does not take the same missteps.
