The Benefits of Partnering with a Certified Nutraceutical Manufacturer

In an interaction with Industry Outlook, Pankaj Sharma, Executive Director, Aesthetic Softcaps, shares how India’s nutraceutical sector is evolving through regulatory compliance, quality assurance, advanced manufacturing, and R&D-led customization to meet rising health-conscious consumer demand, while overcoming quality, competition, and scalability challenges to achieve global competitiveness and sustainable growth. With 31 years of rich experience in the pharmaceutical industry, Pankaj transitioned into entrepreneurship, building a group offering nutraceutical contract manufacturing, franchise marketing, in-house packaging solutions, and a global e-commerce portal—delivering quality and innovation across multiple healthcare segments.  

With India’s nutraceutical market expanding rapidly, how are certified manufacturers differentiating themselves through regulatory compliance and quality assurance to meet growing consumer demand? 

According to a new report by Grand View, Research Inc. published on 6th Dec 2024, given the projections, the Indian nutraceutical market is expected to grow at a CAGR of 13.6 percent from 2025 to 2030, reaching USD 64.83 billion by 2030, driven by increasing health awareness and demand for preventive healthcare.

Certified manufacturers in India's nutraceutical market are differentiating themselves through regulatory compliance and quality assurance by following strict guidelines set by regulatory bodies like the Food Safety and Standards Authority of India (FSSAI) to ensure consumer safety. The manufacturers are getting certifications like Good Manufacturing Practices (GMP), Good Hygiene Practices (GHP), Hazard Analysis Critical Control Points (HACCP), and ISO certification to demonstrate commitment to quality and safety. They also conduct rigorous testing, supervise production processes, and maintain documentation to ensure product quality. To expand the market rapidly, they conduct trials, study bioavailability, and develop new dosage forms to enhance product effectiveness and safety. Prioritizing transparency and labeling, they provide clear labeling with information about composition and potential effects, empowering consumers to make informed decisions.

What key challenges do Indian nutraceutical service providers face in ensuring consistent quality and efficacy, and how are advanced manufacturing practices addressing these concerns? 

Indian nutraceutical service providers face several key challenges in ensuring consistent quality and efficacy, including:

Ingredient Solubility and Stability Issues: Many nutraceutical ingredients, such as omega-3 fatty acids and curcumin, have poor solubility or stability, which can affect their bioavailability and efficacy.

Regulatory Compliance: Ensuring compliance with regulations set by authorities like the Food Safety and Standards Authority of India (FSSAI) and adhering to Good Manufacturing Practices (GMP) is crucial.

Quality Control and Testing: Rigorous testing for purity, potency, and safety is necessary to ensure product quality and prevent contamination or adulteration.

Sustainability and Environmental Concerns: Nutraceutical manufacturers must prioritize sustainable practices, such as responsible sourcing, waste reduction, and eco-friendly packaging.

Unethical competition with unregulated industry players: Organized industry manufacturers are facing stiff unethical competition from unregulated industry players which cut on crucial quality steps/procedures to save costings and offer the final product at an unbelievable price.

Advanced manufacturing practices addressing the key Concerns: Techniques like liposomes and nanoemulsions can enhance the bioavailability and stability of nutraceutical ingredients. Also, the careful selection of excipients can improve the stability, absorption, and palatability of nutraceutical products. Implementing comprehensive testing protocols and quality control measures ensures product safety and efficacy. Indian nutraceutical manufacturers are adopting sustainable practices, such as using biodegradable packaging materials, reducing waste, and promoting eco-friendly production processes.

How are evolving FSSAI regulations and global certification standards influencing the decision-making process for brands when selecting a manufacturing partner in India? 

Evolving FSSAI regulations and global certification standards are significantly influencing the decision-making process for brands when selecting a manufacturing partner in India.  

Brands prioritize manufacturing partners who can ensure compliance with FSSAI regulations, such as obtaining necessary licenses and adhering to Good Manufacturing Practices (GMP). They seek partners who maintain high-quality standards, including proper testing and inspection procedures, to ensure product safety and efficacy. They prefer partners with globally recognized certifications, such as ISO 22000 (Food Safety Management System) or HACCP (Hazard Analysis and Critical Control Points), demonstrating a commitment to food safety and quality. Also, brands consider partners who undergo regular audits and inspections by recognized agencies, such as FSSAI or by FSSAI-approved third-party audit agencies.

Brands require manufacturing partners to provide transparency in their supply chain, including sourcing raw materials, to ensure compliance with regulations and quality standards. They assess the risks associated with non-compliance and choose partners who can mitigate these risks through robust quality control and auditing processes. They prioritize partners who share similar values and are committed to working together to ensure compliance with regulations.

FSSAI has introduced food safety audits to strengthen the food safety surveillance system and encourage self-compliance. FSSAI's Food Safety Training & Certification (FoSTaC) program aims to create a pool of trained food safety supervisors and promote a culture of food safety in India.

In what ways are certified nutraceutical manufacturers leveraging R&D capabilities to offer customized formulations that align with emerging consumer health trends in India?

Certified nutraceutical manufacturers in India are leveraging R&D capabilities to offer customized formulations that cater to emerging consumer health trends. Here are some ways they're doing it:

Innovative Drug Delivery Systems: Companies today are developing novel drug delivery systems, such as Oral Thin Film (OTF) and Orally Disintegrating Strips (ODS), to enhance the efficacy and bioavailability of nutraceuticals.

Personalized Nutrition: Manufacturers are creating customized formulations that address individual health needs and preferences, aligning with the growing trend of personalized nutrition.

Natural and Organic Products: With the increasing demand for natural and organic products, companies are focusing on herbal supplements and Ayurvedic nutraceuticals that combine traditional wisdom with modern science.

Sports Nutrition and Performance Enhancement: Nutraceutical manufacturers are developing products that cater to the growing demand for sports supplements and performance-enhancing nutraceuticals among athletes and fitness enthusiasts.

Mental Health and Wellness: Companies are creating products that address mental health concerns, such as cognitive function and mood regulation, using science-backed ingredients and formulations.

Customized Solutions for Specific Health Concerns: Manufacturers are offering customized solutions for specific health concerns, such as joint health, cardiovascular support, and digestive health, using innovative ingredients and delivery systems.

How are contract manufacturing models in the Indian nutraceutical industry evolving to enhance scalability, cost efficiency, and faster go-to-market strategies for brands? 

The Indian nutraceutical industry's contract manufacturing models are evolving to enhance scalability, cost efficiency, and faster go-to-market strategies for brands through several key developments. Companies are leveraging the latest technologies & software to optimize supply chains, improve product development, and reduce time-to-market. AI tools have been deployed for streamlining processes from ideation to commercialization, enabling evidence-backed, high-science products. Contract manufacturers are ensuring adherence to good manufacturing practices (GMP) and regulatory standards, such as those set by the Food Safety and Standards Authority of India (FSSAI). This enhances product quality and safety.

India's rich biodiversity and heritage in Ayurveda are being tapped to develop innovative, plant-based nutraceuticals. Public-Private Partnerships (PPPs) between government bodies, academia, and private players are accelerating R&D and fostering innovation. Investments in supply chains and cold storage are reducing wastage and improving operational efficiency. This enables contract manufacturers to provide scalable and cost-effective solutions. Consistency in quality is being ensured through stringent checks and balances, mitigating the risk of subpar products entering the market and eroding consumer trust.

Some notable benefits of these evolving contract manufacturing models include:

Faster Time-to-Market: With streamlined processes and advanced technologies, products can be developed and launched faster.

Cost Efficiency: Optimized supply chains, reduced wastage, and improved operational efficiency contribute to cost savings.

Scalability: Contract manufacturers can scale up production to meet growing demand, ensuring a steady supply of products to brands.

Increased Competitiveness: India's nutraceutical industry is becoming more competitive globally, with the potential to reach $100 billion by 2047.

How will advancements in quality control and automated production shape the future of India’s certified nutraceutical manufacturing sector?

Advancements in quality control and automated production are transforming India's certified nutraceutical manufacturing sector in several ways including advanced analytical techniques like High-Performance Liquid Chromatography (HPLC), Gas Chromatography (GC), and Mass Spectrometry (MS) to ensure accurate quantification and purity of nutraceuticals.  Manufacturers adhere to Good Manufacturing Practices (GMP) and regulatory standards set by the Food Safety and Standards Authority of India (FSSAI), ensuring product safety and efficacy. Increasing efficiency, automated production lines enable large-scale manufacturing while maintaining high-quality standards, reducing human error, and improving product consistency. Companies are developing novel drug delivery systems, such as Oral Thin Film (OTF) and Orally Disintegrating Strips (ODS), to enhance product efficacy and bioavailability.

Stringent quality control measures and automated production processes ensure high-quality products, boosting consumer trust and confidence. Indian nutraceutical manufacturers are becoming more competitive globally, with the potential to reach $100 billion by 2047. Manufacturers are adopting sustainable practices, such as responsible sourcing, waste reduction, and eco-friendly packaging, to reduce their environmental footprint.

With advancements in technology, manufacturers can develop customized nutraceuticals catering to individual health needs and preferences. Integration of digital tools for real-time monitoring and data analytics will enhance manufacturing efficiency, quality control, and product development. Standardization of quality and safety regulations will facilitate international trade and collaboration, driving growth in the Indian nutraceutical industry.