India is emerging as one of the fastest-growing contract manufacturing hubs for nutraceuticals,but the lack of clearer,nutra-specific GMP guidelines could prove a stumbling block,explains Viveka Roychowdhury
India has an enviable spot in the nutraceutical universe, with various reports predicting brisk growth. But is there sufficient regulatory oversight on the quality of nutraceuticals made in India? The recent cases of cough syrups causing the deaths of children, due to the presence of unauthorised ingredients and improper manufacturing practices, are red flags that nutraceutical manufacturers must heed. Industry experts refer to the comprehensive regulations in place to regulate nutraceuticals.
Citing the regulations, Dr Pirthi Pal Singh, President & Group R&D Head, Tirupati Group, says, “The Indian Food Safety and Standards Authority of India (FSSAI) specify that all food articles falling under Food Safety and Standards (Health Supplements, Nutraceuticals, Food for Special. Dietary Use, Food for Special Medical Purpose, and Prebiotic and Probiotic Food) Regulations, 2022, are specially processed or formulated for specific nutritional or dietary purpose and shall be clearly distinguishable from foods intended for normal consumption by their special composition.”
Under these regulations, Dr Singh points out, “All nutraceutical manufacturers (need) to comply with the Good Manufacturing Practices (GMP) requirements as laid down under Schedule 4 of Food Safety and Standards (Licensing and Registration of Food Business) Regulations. It generally includes: general hygiene and sanitary practices; food operations and control; management and supervision; good quality control mechanism and well established quality assurance system. FSSAI has also designed the guidance documents for an effective Food Safety Management System to implement GMP/GHP (Good Hygiene Practices) requirements in the nutraceutical industry.”
Dr Ranjit Barshikar, CEO, QbD International, and United Nations Adviser, opines, “These GMP guidelines are comprehensive, focusing on ensuring the quality, safety, and hygiene of the final product. They align with the general principles outlined in the Food Safety and Standards (Licensing and Registration of Food Businesses) Regulation, 2011, specifically its Schedule 4, and are often supplemented by detailed guidance documents. Compliance with these regulations is critical to ensure that the products comply with GMP quality standards. This regulatory framework not only safeguards consumer health but also enhances the credibility and competitiveness of Indian nutraceuticals in the global market. It is the manufacturer’s responsibility to ensure that a nutraceutical is safe before it is marketed.”
Expanding on these regulations, Shankaranarayanan Jeyakodi, Co-founder, Zeus Hygia Lifesciences informs that, “Regulations also mandate adherence to GMP, approved ingredient lists, and specific nutrient limits, with a ban on prohibited substances like hormones and steroids. Additionally, manufacturers must conduct quality and stability testing to ensure safety and meet nutritional composition requirements, along with maintaining thorough documentation for traceability.”
Evolving regulations
Dr Singh points out that India’s nutraceutical regulations are modern and quite advanced at certain levels. He opines that the FSSAI has taken significant steps to regulate the nutraceutical sector in the past and is also looking for further improvement to align with global practices. From 2016, when the first gazette notification for nutra regulations was released, to till date, there have been many amendments in the regulations to improve the product quality and GMP among Indian food business operators (FBOs).
He points out that FSSAI operationalised the 2022 Nutra Regulations and has issued directions (licensing, schedules of permitted ingredients, new dosage formats like mouth dissolving strips, biscuits, gummies etc., GMP, labelling/claims and approval routes). That gives regulators and industry a clear legal framework to act on. FSSAI has mandated all the nutra manufacturers to have a central FSSAI license and mandated that all the nutra manufacturers to conduct a third party audit from FSSAI recognised agencies to ensure GMP.
The ground reality
However, is there sufficient regulatory oversight on the quality of nutraceuticals made in India? Unlike the older and more established pharmaceutical sector, there is no statistical data available on the number of GMP inspections of nutraceutical manufacturing sites. Dr Singh cautions that while India has laid a solid regulatory foundation, the effectiveness depends on consistent enforcement, industry compliance, and consumer awareness. As demand grows, we need to ramp up industry-wide voluntary standards, shared testing databases, and certified-supplier lists to raise quality bars above global standards. As a long time GMP auditor in the pharma sector who consults on Quality by Design / CGMP in the biopharma sector, Dr Barshikar too sounds a cautionary note. He rues the fact that in reality, the pharma sector itself requires adequate resources for GMP inspections periodically, at the manufacturing sites. “The nutraceutical industry lacks stringent regulation compared to the pharmaceutical industry. A similar situation may be prevailing at nutraceuticals manufacturing sites as well. Normally, thousands of nutraceuticals samples are tested by FSSAI for quality, periodically.
Tapping the opportunity
There is no doubt that the nutraceuticals sector is poised for growth, especially in countries like India. As per a Fortune Business Insights report, the global nutraceuticals market size was valued at $458.55 billion in 2024. The market is projected to grow from $500.62 billion in 2025 to $986.85 billion by 2032, exhibiting a CAGR of 10.18 per cent during the forecast period.
Asia Pacific dominated the nutraceuticals market with a market share of 39.84 per cent in 2024, supported by rising population, disposable income, and health awareness. Increasing consumer preference for functional foods and beverages is fueling growth across countries like China, India, and Southeast Asia.
The Fortune Business Insights report references the Government push for the sector, citing the Government’s launch of eight nutraceutical products under the Pradhan Mantri Bhartiya Janaushadhi Pariyojana to boost immunity. A Kearney report pegs Asia Pacific as the world’s largest nutraceuticals market, growing at a CAGR of 8.8 per cent. In India, the market is valued at $8 billion and is growing at 11 per cent CAGR (2023–2027).
The global nutraceuticals market is valued at more than $520 billion and is growing at 8 to 9 per cent CAGR. The same factors that made India a pharma contract manufacturing hub hold true for nutra contract development and manufacturing organisations (CDMOs).
Citing stats, Dr Singh says, “The global nutraceutical CDMO is valued at approximately $140 billion (2023) and is projected to grow at about 11 per cent CAGR through 2030. India is emerging as one of the fastest-growing contract manufacturing hubs for nutraceuticals, currently valued at about $13 billion and growing at about 14 per cent CAGR. Indian CDMOs like Tirupati Group are expanding their footprints at the global platforms and bridging domestic innovation with global outsourcing opportunities.”
The good news is that CDMOs have helped democratised the nutra opportunity, proving that size is not always required to “One big change that India has witnessed in the last two decades, and especially postCOVID pandemic, is an increasing number of first generation entrepreneurs, start-ups, D2C brands, and SMEs who often use CDMOs and private label manufacturers for ready to launch products, thereby avoiding capex, and accelerating speed to market.”
According to Dr Singh, one of the prime reasons for manufacturing of high quality nutraceutical products in India is that majority of the Indian CDMOs and manufacturers have their plants constructed based on global/WHO GMP, ensuring high-quality compliance.
The regulator FSSAI is also encouraging the Indian industries by organising events like “World Food India” and “Global Food Regulators Summit” that help nutra companies to showcase their capabilities to the world. Dr Singh narrates that regulatory bodies across the globe are now connecting directly with the Indian food regulators through such events.
But global growth comes with its own growth pains. On a cautionary note, Dr Singh alludes to the regulatory complexity and compliance burden associated with tapping international markets, as FSSAI rules require strict adherence to the law of the land, which is slightly different from the rest of the world. For example, new ingredients will need special approval before those ingredients can be sold in the Indian market.
Challenges along the way
Nutraceutical manufacturers face many challenges when complying with regulations designed for medicines. As Jeyakodi succinctly puts it, “Applying GMPs designed for synthetic pharmaceuticals to nutraceuticals, especially those of natural origin, presents unique and significant challenges. Unlike pharmaceuticals, which consist of standardised, single-molecule active ingredients, natural nutraceuticals are complex, highly variable, and susceptible to different forms of contamination. These biological inconsistencies complicate the control and validation processes central to pharmaceutical GMPs.”
Jeyakodi lists challenges with raw materials, ranging from natural variability of ingredients, as the phytochemical “fingerprint” of natural ingredients can vary significantly based on factors such as plant age, time of harvest, soil, and weather conditions. This natural inconsistency makes it difficult to ensure batch-to-batch uniformity, a cornerstone of pharmaceutical GMPs.
nother factor, as nutraceutical supply chains are often fragmented and rely on multiple suppliers from different geographical regions. This complexity makes it difficult to trace ingredients and monitor the conditions under which they were cultivated, harvested, and processed.
He also highlights the risk of adulteration and contamination, as natural materials carry inherent risks of contamination from pesticides, heavy metals, mycotoxins, or microbes. Ensuring consistent purity is a major hurdle, and adulteration with cheaper or unauthorised substances is also a risk. On the manufacturing and quality control front Jeyakodi cites standardisation of extracts, method validation and testing, and stability testing.
Regulatory and documentation challenges stem from regulatory ambiguity, as the regulatory landscape for nutraceuticals is less clearly defined and standardised compared to pharmaceuticals, and it can vary significantly by country. This creates confusion for manufacturers attempting to achieve compliance and validate product claims. Inconsistent recordkeeping is another challenge, as robust documentation is a core GMP requirement. For natural ingredients with complex and fragmented supply chains, maintaining the necessary records—from initial sourcing to final product testing—can be very difficult. Jeyakodi also lists scientific and efficacy challenges, referring to the lack of scientific evidence.
He explains that while pharmaceuticals must demonstrate safety and efficacy through rigorous, randomised controlled clinical trials, many nutraceuticals lack this level of scientific evidence. This makes it difficult to substantiate product claims in a manner consistent with pharmaceutical regulations. Bioavailability issues are another challenging area, as nutraceuticals can have questionable bioavailability, meaning the body may not be able to effectively absorb or utilise the nutrients. This is a major limitation and a factor that may not be fully addressed by GMPs designed for more bioavailable synthetic compounds.
Agreeing with this sentiment, Dr Singh says, “Nutraceutical products are among the most complex and challenging to develop due to the combination of multiple active ingredients in a single dosage form. Developing analytical methods for such complex formulations and that too at very low concentrations, remains a true scientific challenge.”
In Dr Barshikar’s book, the main challenges are related to quality mindset, regulatory compliance, facility and equipment, and testing from safety perspectives. Secondly, product standardisation, relating to variability in ingredient quality and effectiveness remains a concern.
He also flags labeling as a challenge, with the Food Safety and Standards, Regulations, 2016, outlining essential labelling requirements for nutraceuticals. Labels must avoid claims about preventing, curing, or treating diseases and only include statements about the product’s impact on structure, function, or general wellbeing if scientifically validated. Fourth on Dr Barshokar’s list is the availability of experimental data.
Summing up, Singh says, “The Indian nutraceutical regulatory framework is evolving toward a more balanced, fit-for-purpose model; however, it still needs clearer, nutraspecific GMP guidance that reflects the biological variability of natural materials while maintaining safety, consistency, and consumer trust.”
GMP compliance as an innovation moat
Given the complexity and challenges of adhering to GMP norms, companies will need to frame GMP compliance as an innovation moat to justify the significant capex. Jeyakodi agrees, saying that robust GMP adherence fosters an innovation moat by creating a quality-led innovation framework and enabling complex, high-value product development.
It also allows companies to secure intellectual property (IP) and proprietary processes. Perhaps most importantly, GMP adherence reduces product recalls and waste. By minimising contamination, errors, and inconsistencies, GMP lowers the risk of costly and reputation-damaging product recalls. This operational efficiency and risk reduction directly contribute to the longterm return on investment (ROI) for capex.
Taking this reasoning a step further, Jeyakodi believes that GMP adherence can also become part of a branding strategy, to position a company as a premium, trustworthy, and science-backed brand, justifying the cost of capex to consumers. In his view, this approach could build and communicate consumer trust, support premium pricing, enable brands to make robust, substantiated health claims, and facilitate global market entry. Finally, this can reinforce the brand narrative, supported by tangible certifications, and foster customer loyalty and advocacy, which are invaluable for long-term growth.
Thus, while the FSSAI evolves to more nutra-specific regulations, it will be up to nutraceutical manufacturers to keep pace and position themselves as reliable and safe brands worthy of consumer trust.
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