Capsules of controversy: India’s growing appetite for dietary supplements

The Food Safety and Standards Authority of India (FSSAI) uncovered a rather disturbing trend last year. A nationwide enforcement drive revealed that over 15 per cent of tested health supplement samples failed to meet regulatory standards. This revelation highlights the growing pains of a sector that promises health benefits to millions of consumers.

The matter at hand

From corner stores to high-end pharmacies, shelves are increasingly stocked with an array of colorful bottles promising everything from enhanced immunity to Herculean strength. From Patanjali selling the so-called ‘Ayurvedic’ products to multiple companies selling various brands of protein shakes, India’s booming supplements industry is expanding faster than a yogi’s lung capacity during pranayama. But as this wellness wave washes over the nation, it brings with it a tide of questions: Are we witnessing a genuine health awakening, or merely falling prey to clever marketing? Are these supplements truly fulfilling their intended purpose? And in this unregulated sea of pills and powders, how can consumers navigate safely to true well-being? 

Industry growth and societal impact

It’s important to understand that explosive growth isn’t just about numbers; it reflects a changing India. Modern lifestyles are increasingly prioritising health and well-being, driving demand for vitamins, minerals, protein powders, and herbal extracts. This rise reflects a broader shift towards preventive healthcare, fueled by growing health consciousness, changing dietary patterns, and the prevalence of lifestyle-related diseases such as obesity, diabetes, and cardiovascular ailments. At the same time, as disposable incomes rise and Western fitness trends permeate social media feeds, millions of Indians are reaching for that promised quick fix to bridge the gap between their aspirations and realities Yet, beneath the glossy veneer of before-and-after photos and celebrity endorsements lies a murky world of questionable claims and potential health risks. 

Challenges and risks

Projected to reach INR 491.4 billion by 2032, the sector stands at a crossroads where responsible oversight could ensure sustainable growth while safeguarding the public interest. However, the current ‘not so’ regulated environment has led to issues such as mislabeling, false advertising, and the sale of substandard products, potentially exposing consumers to health risks and financial exploitation. Balancing the industry’s economic benefits and innovation potential with stringent quality control and consumer protection remains a crucial challenge for this sector.

Modern medicines face strict approval processes under the Central Drugs Standard Control Organization, while nutraceuticals, considered food products, are regulated by the Food Safety and Standards Authority of India (FSSAI). This results in inconsistent regulations and guidelines that fail to cover the entire scope of the industry. The FSSAI approval process is relatively simple, requiring a list of ingredients from their approved list, quantities, and product details. However, clinical trials are only required for new ingredients or unsubstantiated claims, leading to many products making unverifiable health claims based on existing studies or literature. Mislabeling and false advertising are rampant, undermining consumer trust and safety. For example, The FSS (Nutra) Regulations, 2022, aim to prevent disease cure claims, but many companies still make such assertions.

Furthermore, there is ambiguity in the industry regarding the classification of health supplements as either food or drugs. This confusion affects regulatory processes and compliance requirements. The absence of guidelines for conducting clinical trials and making efficacy claims can lead to the flooding of the market with products that manufacturers have not sufficiently tested for safety and effectiveness. Developing a robust policy framework, one that promotes research and development within the sector is essential for pushing innovation and the development of new, scientifically-backed products.

Quality control issues

The regulatory framework lacks stringent quality control measures, resulting in the circulation of substandard products that may pose health risks to consumers. Even where regulations exist, enforcement is often weak, leading to widespread non-compliance. Limited capacity for market surveillance and product testing hampers the ability to effectively monitor the quality and safety of health supplements in the market. Testing is expensive, with FSSAI earmarking Rs 15,000 per sample for nutraceutical testing, but many states lack accredited government labs, relying on private labs instead.

Contamination with pesticides, heavy metals, and microbes is another significant concern, as clean materials are challenging to source and concentration processes can increase contamination levels. Some recent cases indicate toxicity from certain herbs themselves, like giloy, is linked to liver injury. The industry also has many small players and third-party manufacturers, complicating regulations and often producing low-quality products due to cost pressures. Misbranding is common; a Karnataka drive against the illegal sale of protein powders by FSSAI found that two-thirds of collected samples were misbranded, with legal action against the companies involved.

Marketing and ethical concerns

Marketing strategies contribute significantly to supplement use. Aggressive multi-level marketing by nutrition brands and implicit faith in natural products drive supplement use. This can lead to serious health consequences, as seen in the case of a Mumbai woman who developed health problems due to high levels of lead in a supplement promoted via WhatsApp. There is a critical need for ethical marketing practices to ensure consumers are not misled by unverified health claims.

From better to best

To unleash the full potential of India’s health supplements industry, a collaborative and comprehensive approach is essential. Establishing a dedicated regulatory framework that defines clear guidelines for product registration, quality control, and labeling requirements for dietary supplements, similar to those for drugs and foods, is crucial. Once such a framework comes to practice it will not just ease access to genuine products but will also provide more credibility to the industry. 

Fostering public-private partnerships between the government, industry stakeholders, and research institutions can drive innovation, promote research and development, and facilitate best practices. By leveraging all stakeholders’ expertise and resources, the industry can stay abreast of the latest scientific advancements, develop cutting-edge products, and ensure compliance with global quality standards.

At the same time, nationwide campaigns to educate consumers about the benefits, proper usage, and potential risks of health supplements are critical. This will empower consumers to make informed choices and discourage the consumption of counterfeit or dubious products, fostering a well-informed consumer base that builds trust, promotes responsible consumption, and drives sustainable growth.

Furthermore, the industry should embrace self-regulation by establishing stringent quality control measures, adhering to good manufacturing practices (GMP), and adopting voluntary codes of conduct. This proactive approach will promote transparency, build consumer trust, and drive industry-wide accountability, ultimately enhancing the health supplements sector’s reputation and credibility.

An end to a beginning

As India’s supplement industry stands at this crucial juncture, the words of Mahatma Gandhi resonate: “It is health that is real wealth and not pieces of gold and silver.” The path forward demands a delicate balance between innovation and regulation, between profit and public welfare. With thoughtful oversight and a commitment to quality, India’s supplement sector can truly become a cornerstone of national health, transforming not just bodies, but the very fabric of wellness in society. The capsules of today may well be the catalysts for a healthier, more vibrant India tomorrow – but only if we also swallow the hard pill of responsibility.