India is emerging rapidly as a global research and development hub for nutraceuticals. The country conducts nutraceutical clinical trials at lower costs while ensuring that the quality meets international standards. Nutraceutical clinical studies in India follow a regulated pathway, requiring approvals from both an Ethics Committee and the Central Drugs Standard Control Organization (CDSCO). It ensures scientific integrity and compliance through a streamlined review process.

Consequently, demands in the field of preventive healthcare solutions and individual nutrition continue to grow. The multicultural nature of the Indian population, with over 1.4 billion people, facilitates meaningful and efficient research. India benefits from cost efficiency, a diverse patient pool, and extensive scientific expertise in facilitating clinical trials. Hence, the above strengths make India a desirable place to test next-generation wellness products. 

To understand India’s position in this global landscape, it’s pertinent to examine how different countries regulate nutraceuticals. Let’s look at how nutraceuticals are classified in different regions, including India.

Classification of nutraceutical products in India and across the globe

• The Food Safety and Standards Authority of India (FSSAI) describes nutraceuticals as special nutrition foods. This information focuses more on preventing diseases rather than curing them. 
• The Food Safety and Standards Act of 2006 and the Nutraceutical Regulations of 2016 outline seven categories for nutraceuticals in India. These include health supplements, special dietary foods, medical purpose foods, functional foods containing botanicals, probiotic/prebiotic foods, and novel foods. 
• While the products themselves remain essentially the same, different countries classify nutraceuticals differently. In the USA, they are referred to as dietary supplements and regulated as non-drug products under the Dietary Supplement Health and Education Act (DSHEA). 
• The EU enforces stricter regulations on food supplements, requiring safety evidence and pre-approved health claims under the Food Supplements Directive 2002/46/EC. 
• In Japan, these products are categorized under Foods for Specified Health Uses (FOSHU) or Foods with Function Claims (FFC), which include items developed for specific health benefits supported by scientific evidence.

Why conduct clinical trials for nutraceutical products?

Health claims on nutraceuticals such as supplements, probiotics, herbs, and functional foods often lack evidence on safety and effectiveness. This article outlines how and why nutraceutical clinical trials are essential for validating claims and generating reliable evidence on their health benefits. This evidence is crucial for building confidence among regulators and consumers.

Human studies, in a way, are useful in determining safety and proving health claims. This is a step forward in the nutraceutical science involving the application of evidence-based information.

These clinical validation needs are driving significant market growth, particularly in India. 

Global and Indian nutraceutical clinical trial landscape

The global nutraceutical sector is growing rapidly as people focus more on preventing diseases rather than just treating them. The USA, Japan, and Europe lead in conducting clinical research on nutraceuticals. However, India is quickly becoming an important center for conducting nutraceutical trials. 

This growth is driven by greater health awareness and increasing cases of chronic diseases such as diabetes and obesity. The focus on immunity after the pandemic and government support have further accelerated this trend. These developments are creating valuable opportunities to conduct clinical trials in India that can prove the safety and effectiveness of nutraceuticals across different populations.

Globally, many nutraceutical studies are being registered and conducted to provide evidence for safety and efficacy, meeting evolving regulatory and consumer demands. In India specifically, between 2019 and 2024, a total of 111 nutraceutical clinical studies have been registered, as reported in a recent review article. 

The country is becoming an attractive place for nutraceutical research for several key reasons, as discussed below.

Advantages of conducting nutraceutical clinical trials in India

1. Cost and resource efficiency

• Clinical trials in India cost significantly less than in Western countries due to lower operational expenses and efficient regulations. For instance, in the U.S, the cost per participant is substantially higher across all phases. Whereas in India, the average per-patient cost for a late-phase trial is much lower.
• Despite lower costs, high scientific standards are maintained for conducting clinical trials in India.
• India’s large and willing participant pool further helps maintain high retention rates during trials. This enables nutraceutical companies to conduct quality trials within their budgets. It also minimizes expenses related to participant dropouts, delays in enrollment, and extended recruitment efforts. 

2. Diverse and relevant population

• India is a country with a rich genetic variety. As such, India presents unique opportunities for observing how different genetic backgrounds respond to nutrition. This helps in developing targeted health solutions for diverse populations worldwide. The age distribution in India further enhances the importance of this research.
• While certain nutraceuticals have consistent effects across all populations, several nutraceuticals work differently in different people. This is where India’s genetically and ethnically diverse population becomes valuable for research.
• For example, products like curcumin, omega-3 fatty acids, and probiotics need to be studied across diverse groups because:
  • Curcumin exhibits variations in bioavailability linked to genetic polymorphisms. 
  • Likewise, omega-3 fatty acids show differing cardiovascular benefits depending on variations in genes like FADS. 
  • Even probiotic formulations (e.g., Lactobacillus strains) demonstrate variable gut colonization patterns influenced by host genetics and microbiome diversity. 
• India’s diverse population allows researchers to understand how these products work across different genetic backgrounds. Hence, it makes it possible to determine which products work best for whom. This diversity helps ensure that nutraceuticals are both effective and safe for more people. 

3. Infrastructure and investigator strength

• India has established a strong framework for clinical trials, making it a competitive hub for nutraceutical research. The nation is home to well-equipped hospitals, contract research organizations (CROs), and the best research institutions capable of managing all phases of clinical development.
• India possesses a skilled workforce and numerous research sites, capable of meeting the standards of good clinical practice globally. In addition, indian researchers have specialization in relevant areas such as nutrition science, herbal medicine, and clinical pharmacology.

4. Regulatory and policy support

 4.1 Regulatory framework

India’s nutraceutical sector once faced uncertainty due to overlapping rules between food and drug authorities. Products with health claims often fell into a grey area, slowing research and clinical validation.

However, recent reforms by the Central Drugs Standard Control Organization (CDSCO) have changed this. Clear guidelines now distinguish nutraceuticals with therapeutic or functional claims from regular supplements, creating defined rules for clinical studies.

This has made India a stronger hub for conducting nutraceutical clinical trials by:

• Defining protocols for clinical evaluation and validation
• Streamlining safety and efficacy assessments
• Aligning regulations with global standards
• Shortening approval timelines and reducing uncertainty

  4.2 International harmonization 

• Regulatory alignment with global standards: Adherence to ICH-GCP standards enhances global credibility and acceptance of the nutraceutical clinical trial data. India has adopted ICH-GCP guidelines, which strengthen the reliability of research conducted here. Furthermore, India supports the establishment and operation of GCP-compliant facilities for conducting clinical trials. These facilities are equipped with trained staff knowledgeable in GCP principles, as mandated by CDSCO under the New Drugs and Clinical Trials Rules, 2019.

  4.3 Research and development networks

• The India Nutraceutical and Translational Research (INTENT) program and the Indian Council of Medical Research (ICMR) actively conduct nutraceutical research. They offer standardized clinical trials, funds for validation studies, and opportunities for academia/industry collaboration.

While India offers these significant advantages, global sponsors often have concerns about conducting research in emerging markets. Here’s how India addresses these challenges.

Key challenges and practical solutions

Conducting clinical trials for nutraceuticals in India presents several unique challenges, varying from regulatory, ethical, to even operational factors. Below is an overview of key challenges:

1. Ambiguity in regulations: Nutraceuticals in India are regulated by both the FSSAI and the CDSCO, leading to confusion and overlapping requirements. Products making drug-like claims may fall under stricter pharmaceutical rules. It may lead to misclassifying products, varied interpretations, and licensing delays. 
2. Recruitment and retention issues: Participant dropout is one of the key challenges in conducting nutraceutical clinical trials in India. As high dropout rates often occur due to socioeconomic factors, migration, and low awareness of nutraceutical benefits, enrollment and follow-up are more complex in diverse populations.
3. Subjective interpretation of regulations: Regulations can be general, and their interpretation can be subjective. This makes it difficult for sponsors, especially stakeholders from other countries, to navigate the approval process efficiently.
4. Ethics committee inconsistencies: The performance and training of Institutional Ethics Committees (IECs), particularly in smaller cities, can be inconsistent, potentially leading to delays or non-uniform review processes.
5. Ensuring informed consent: India’s diverse linguistic and cultural landscape can complicate the informed consent process, requiring careful, context-appropriate communication to ensure participants fully understand the study’s risks and benefits.

These challenges, however, could be addressed by:

1. Engaging local partners who have good experience and knowledge helps sponsors navigate the requirements of the FSSAI and CDSCO frameworks. It ensures proper documentation and classification before a product is launched or a clinical trial is initiated. 
2. Also, pre-consultation with regulatory authorities from the outset helps to align with CDSCO and FSSAI guidelines. This facilitates faster approvals, cost efficiency, and adherence to Good Clinical Practice (GCP) standards modeled on ICH-GCP.
3. Partnering with experienced investigators or CROs right from the start. Early collaboration not only helps in understanding research needs but also helps to assess site viability and community readiness. Through early site feasibility assessments, sponsors can confirm patient access and avoid potential recruitment delays.
4. Selecting Ethical Committees and trial sites with proven track records in nutraceuticals ensures access to GCP-adherent infrastructure like bioanalytical labs and trained staff. Also, by collaborating with investigators early to adopt standardized operating procedures (SOPs) for EC reviews, sponsors obtain an advantage over faster approvals.
5. By partnering with local experts from institutions like ICMR-affiliated centers or experienced Contract Research Organizations (CROs) who have access to regional linguists, cultural anthropologists, and community networks. They will have the knowledge to identify dialect-specific needs, as well as provide necessary information in terms of endpoints, as required in clinical trials.

With the above points, India is well-positioned for nutraceutical clinical trials due to strong standardization and collaborative strategies, despite specific challenges.

Conclusion

India is ready to lead the global nutraceutical clinical trial industry. The country has proven it can deliver through affordable clinical trials, diverse research participants, and strong scientific facilities. Government programs like INTENT and support from FSSAI and ICMR are boosting nutraceutical research further. As more people look for ways to stay healthy and prevent illness, India is moving in the right direction to grow in this field.

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