Daybreak - The govt wants to move nutraceuticals under drug regulator's domain. Here's why

Episode Date: February 21, 2024

India’s nutraceutical market is estimated  to be worth $4-5 billion and the government expects it to be worth almost five times more in the next two years. As important as it is to monitor the rapidly growing market, regulations have not really kept up. In a post-pandemic world where preventive healthcare has become all the rage, a dangerous situation is being created. Health supplement makers are flouting RDA guidelines and consumers have been paying little attention.Now, the health ministry of India is planning to move nutraceuticals from under the ambit of FSSAI, the food regulator to CDSCO, the drugs regulator. According to reports, the Ministry has also proposed forming a committee chaired by the Secretary of Health to address overlapping concerns between Nutraceuticals and Drugs. Tune in to find out more.Daybreak is produced from the newsroom of The Ken, India’s first subscriber-only business news platform. Subscribe for more exclusive, deeply-reported, and analytical business stories

Hi, this is Rohan Dharma Kumar. If you've heard any of the Ken's podcasts, you've probably heard me. My interruptions, my analogies and my contrarian takes on most topics. And you might rightly be wondering why am I interrupting this episode too. It's for a special announcement. For the last few months, I and Sita Raman Ganeshan, my colleague and the Ken's deputy editor, have been working on an ambitious new podcast. It's called Intermission.

We want to tell the secret sauce stories of India's greatest companies. Stories of how they were born, how they fought to survive, how they build their organizations and culture, how they manage to innovate and thrive over decades, and most importantly, how they're poised today. To do that, Sita and I have been reading books, poring over reports, going through financial statements, digging up archives, and talking to dozens of people. And if that wasn't enough, we also decided to throw in video into the mix. Yes, you heard that right. Intermission has also had to find its footing in the world of multi-camera shoots in professional studios, laborious editing, and extensive post-production. Sita and I are still reeling from the intensity of our first studio recording.

Intermission launches on March 23rd. To get an alert as soon as we release our first episode, please follow intermission on Spotify and Apple Podcasts or subscribe to the Ken's YouTube channel. You can find all of the links at the ken.com slash I am. With that, back to your episode. Do you take any health supplements? Maybe iron tablets or calcium or those cute-looking multivitamin gummies?

If you do, then why and when did you start? I'm asking because lately, And you must have noticed this too, I'm sure. Almost everybody around us is taking something or the other. India's nutraceutical market is estimated to be about $4 to $5 billion. And the Ministry of Food Processing Industries expects it to be worth five times more in the next two years. Nutraceuticals are basically products with specific health benefits. For example, Gersinia, Cambodia, which is a popular world.

weight loss supplement. Both nutraceuticals and dietary supplements are non-pharmaceutical product. Nutraceuticals are supposed to provide health benefits beyond the basic nutritional value and help prevent and treat diseases. We see them both all the time in the form of tablets, capsules, gummies, powders, health drinks and energy balls. But tell me one thing. How many of us actually consult a doctor before taking these supplements. It's rare, right? For example, a lot of women, once they cross 30, casually start popping vitamin B12,

vitamin D, calcium, and iron supplements. Why? Because that is what popular science tells us. But did you know that there is something called vitamin poisoning and it can cause intestinal bleeding, liver damage and a bunch of other dangerous issues? Now, with a market that is growing so far, and the thousands of products that are available,

it is becoming increasingly difficult for the government to monitor each and every product. So far, the food regulator of India, FSSAI, which governs the nutraceutical industry, has been keeping a check for quality and safety in the manufacturing and sale process. But like I said, it is turning out to be very challenging. The market is projected to double in size in the next five years.

So now the Health Ministry of India is planning to move nutraceuticals from under the ambit of the food regulator to the Drugs Regulator, the Central Drug Standard Standard Control Organization or CDSCO. According to reports earlier this week, the ministry has also proposed forming a committee chaired by the Secretary of Health to address overlapping concerns between nutraceuticals and drugs. The committee is supposed to have representatives from the food regulator, the drug regulator, the Indian Council of Medical Research or ICMR, the Ministry of Ayush and the Department of Pharmaceuticals. But here's the thing. The government still wants the industry to grow. In fact, it wants nutraceuticals to turn into a $100 billion market. Welcome to Daybreak, a business podcast

from the Ken. I'm your host, Nekda Sharma, and I don't chase the new cycle. Instead, thrice a week on Mondays, Wednesdays and Fridays, I will come to you with one business story that is worth understanding and worth your time. Today is Wednesday, the 21st of February. You know, late last year, the New York Times ran a very interesting survey. They asked a simple question, how useful are supplements? And the answer, according to the American Food and Drug Administration or the FDA, was not very. Because of the boom in the category, even the FDA has had a hard time trying to keep an eye on all the health supplements available in the market. It actually had to carry out a bunch of awareness programs to deal with all the misinformation out there about health supplements. And one important thing that they pointed out was that dietary supplements fall under the category of food, not medication.

and they said that any substance claiming to treat, diagnose, prevent, mitigate or cure a disease is a drug. It is not a supplement. In India too, it is not like the government is waking up to health supplements right now. It had first introduced norms through the Food Safety and Standards Regulation of 2016. But the industry has been growing very fast and the regulations have not been able to keep up. Two years ago, the ACP or the Association of Consumer Protection ran a survey. They looked at more than 15 nutraceutical and health supplement products which were being sold online. The results were scary.

For example, vitamin D supplements contained 5,000 international units or IUs. This, dear listener, is more than eight times the prescribed limit. The maximum is supposed to be 600 IU-privile. per day for men and women. The ACP sent the report to the Union Health Ministry and the regulator to draw their attention to the issue. You know, before the pandemic hit us, India's nutritional market was mostly dominated by special dietary foods or protein powders. But COVID changed everything. People began taking preventive health care very seriously. And along with it, the nutraceutical market expanded quite dramatically in the country. People are now ready to pay a good amount of their

money for these products. A February 2020 report by the consulting firm EY said that more than 80% of Indians saw healthy as a more important buying factor after the pandemic. And a little less than half of the respondents said that they would pay a premium for products promoting health and wellness. But how many of them actually check the label for the ingredients? How many know what is the prescribed limit? And most importantly, are health supplement makers following the standard prescription dosage in the products that they offer. Stay tuned to find out more. The Food Safety and Standards Act of 2006 prescribes ingredients, which is a list of plant extracts, molecules and so on for the production of nutraceuticals.

We spoke to Pradeep Chakrabarti, a former director at the Food Safety and Standards Authority of India. He told us that a company has to use ingredients from this prescribed lists, and also according to the recommended dietary allowance or RDA prescribed by Indian standards. Anything else is a contravention. But the February 2021 study by the ACP found many cases where companies were were not complying with the act. One example is vitamin D3 supplements by Now Foods, which is a US-based company that sells its products on various e-commerce platforms in India, including 1MG and Flipcut.

The label clearly says that each capsule contains 5,000 IUs, and it recommends taking one capsule once every two days. But you won't believe that 5,000 IUs is more than 6,000. 100% higher than the prescribed limit. Think about that. Then there is the Nutraceutical brand and consumer nutrition platform HealthCarts vitamin D3. The product is available in soft gel form and is recommended for daily use or as prescribed by a physician. But the label on the product does not mention the recommended dietary allowance or RDA.

And though it exceeds the allowed RDA limit for vitamin D, it is a label on. at least within the tolerable upper limit of 100 MCG per day. The study by ECP has listed many other supplements with an excessive range of RDAs, but healthcare professionals are not too concerned. Now though, there is a growing interest from foreign companies in India's market. And because of this, something quite unique is happening. Industry players from the country themselves are demanding that regulation, be implemented strictly.

But that is not the only concern, of course. They say that they're also worried about general public health. For example, Dr. Anish Desai, who is the founder and chief executive of IntelliMed Healthcare Solutions and a member of the expert Nutraceutical Advocacy Council, told us that anything above prescribed limits or out of the schedule list can have counter-effects. Industry experts have also been demanding stricter control over the sale of health supplements and nutraceuticals in the online space, especially because it is also where foreign companies have carved their niche. Dr. Desai told us that e-commerce sites are getting away by saying that they're just the service providers

and that the product manufacturers should be held responsible. So while this to and fro continues and until the government comes up with a business, appropriate regulations that are up to date with this rapidly growing industry, please check the label of that multivitamin gum that you are going to order online. Daybreak is produced from the newsroom of the Ken, India's first subscriber-focused business news platform. What you're listening to is just a small sample of our subscriber-only offerings. A full subscription unlocks daily long-form feature stories, newsletters, subscriber-only apps and podcast extras.

Head to the Ken.com and click on the red subscribe button on the top of the website. I am Snigda Sharma, your host and today's episode was edited by my colleague Rajiv Sien.