On November 24, 2016, the food-safety watchdog of India announced that health supplements or Nutraceuticals cannot be sold as ‘medicines’ anymore. This new regulatory standard has been set for the manufacturers of Nutraceuticals and food supplements, and is aimed at controlling mislabeling of such brands. The fine prints of the notification are yet to be assessed.
On the face of it, this new announcement seems to be a good step, and would largely address a long-standing issue on the such products. Prevailing undesirable practices of labeling some pharma brands as food supplements or Nutraceuticals, with some tweaking in the formulations, mainly to avoid the risk of price control, is also expected to be taken care of by the food-safety authority of India, while granting marketing approval.
Nevertheless, it is often construed that off-label therapeutic claims, while promoting these products to the doctors, help achieving brand positioning objective as medicines, though indirectly. Appropriate authorities in India should probably resolve this issue, expeditiously.
In this article, I shall focus on the rationale behind different concerns over the general quality standards, claimed efficacy and safety profile of Nutraceuticals and food supplements, in general, and how the regulatory authorities are responding to all these, slowly, albeit in piecemeal, but surely.
The ‘gray space’ is the issue:
The close association between nutrition and health has assumed a historical relevance. Growing pieces of evidence, even today, suggests that nutritional intervention with natural substances could play an important role, especially in preventive health care. The World Health Organization (WHO) has also highlighted that mortality rate due to nutrition related factors in the developing countries, like India, is nearly 40 percent.
However, as one of the global consulting firm of repute has aptly pointed out, “At one end of this natural nutrition spectrum, are functional foods and beverages as well as dietary supplements, aimed primarily at maintaining health. On the other, more medical end of the spectrum, are products aimed at people with special nutritional needs. In the middle, is an emerging gray area of products that have a physiological effect to reduce known risk factors, such as high cholesterol, or appear to slow or prevent the progression of common diseases such as diabetes, dementia or age related muscle loss.”
This gray space between Pharmaceutical and Nutraceuticals, therefore, holds a significant business relevance, from various perspectives.
An Oasis amidst highly-regulated pharmaceuticals:
Mostly because of this gray space, several pharma companies and analysts seem to perceive the Nutraceutical segment virtually an oasis, lacking any transparent regulatory guidelines, amidst well-regulated pharma business. This perception is likely to continue, at least, for some more time.
Such pattern can be witnessed both within the local and global pharma companies, with some differences in approach, that I shall deliberate later in this article.
However, regulators in many countries, including India, have started expressing concerns on such unfettered manufacturing, marketing and other claims of Nutraceuticals. Many of them even ask, do all these Nutraceuticals deliver high product quality, claimed effectiveness and safety profile to their consumers, especially when, these are promoted by several pharma companies, though mostly off-label, to generate physicians’ prescriptions for various disease treatments?
Not just domestic pharma companies:
This concern is not restricted to the domestic companies in India.
Global pharma players, who generally believe in scientific evidence based medicines, have been reflecting an iffiness towards Nutraceuticals. For example, whereas both Pfizer and Novartis reportedly hived off their nutrition businesses, later Pfizer invested to acquire Danish vitamins company Ferrosan and the U.S. dietary supplements maker Alacer. Similarly, both Sanofi and GlaxoSmithKline also reportedly invested in mineral supplements businesses that could probably pave the way of the company’s entry into medical foods.
However, it is worth underscoring that generally the consumer arms of global pharma companies focus on OTC, and Nutraceuticals do not become an integral part of the pharma business, as is common in India.
Interestingly, not very long ago, Indian pharma industry witnessed a global pharma major virtually replicating the local marketing model involving Nutraceuticals. It also became an international news. On August 24, 2011, ‘Wall Street Journal (WSJ)’ reported that ‘Aventis Pharma Ltd. (now Sanofi India) agreed to buy the branded nutrition pharmaceuticals business of privately held Universal Medicare Pvt. Ltd for an undisclosed amount, as its French parent Sanofi looks to expand in the fast-growing Indian market.’
Universal Medicare, which posted about US$ 24.1 million revenue in the year ended March 31, 2011, will manufacture these branded Nutraceutical products and Aventis will source them from Universal Medicare on mutually agreed terms. Around 750 of the Universal Medicare’s employees also moved to the French Company along with its around 40 Nutraceutical brands, the report said.
If all these acquired brands, do not fall under the new FSSAI guidelines related to the required composition of food supplements and Nutraceuticals in India, it would be worth watching what follows and how.
Nutraceuticals are also promoted to doctors:
Let me reemphasize, India seems to be slightly different in the way most of the pharma companies promote Nutraceuticals in the country. Here, one can find very few standalone ‘Over the Counter (OTC)’ pharma or Nutraceutical product company. For this reason, Nutraceutical brands owned by the pharma companies, usually become an integral part of their prescription product-portfolio. Mostly, through off-label promotion Nutraceuticals are often marketed for the treatment or prevention of many serious diseases, and promoted to the doctors just as any other generic pharma brand.
Need to generate more scientific data based evidences:
A 2014 study of the well-known global consulting firms A.T. Kearney titled, “Nutraceuticals: The Front Line of the Battle for Consumer Health”, also recommended that ‘a solid regulatory framework is crucial for medical credibility, as it ensures high-quality products that can be relied on to do what they say they do.’............
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