New Delhi: Conceding that existing regulations related to approval and marketing of nutraceuticals and health supplements are not adequate, the central government has formed a high-level committee to review the guidelines related to these products and suggest a new framework, ThePrint has learnt.
Nutraceuticals comprise products with bioactive substances, and herbs and minerals or those dietary supplements which have therapeutic activity. These normally include health supplements such as probiotics, health drinks, vitamins and minerals.
The panel constituted by the Union health ministry on 29 January is headed by the health secretary and also counts secretaries from the Ministry of Food Processing Industries and department of pharmaceuticals, the chief executive of Food Safety & Standards Authority of India (FSSAI), and the Drug Controller General of India (DCGI) as its members.
The other members in the committee are the director general of the Indian Council of Medical Research (ICMR) and the Director General of Health Services.
Nutraceutical products, as of now, are governed by the Food Safety and Standards (Health Supplements, Nutraceuticals, Food for Special Dietary Use, Food for Special Medical Purpose, and Prebiotic and Probiotic Food) Regulations, 2022.
But the products covered under these regulations are not permitted to make claims to prevent or treat or cure any diseases, as the norms make it clear that the products with these claims are more akin to drugs which do not fall under the ambit of the FSSAI and are to be licensed as drugs.
“We are increasingly concerned that many of these products despite getting approval as a nutraceutical are making these claims,” a senior government official told ThePrint.
“Then there is lack of clarity on which products should be defined as nutraceuticals as there are many products available in the market with the same ingredients — but are either approved as drugs, nutraceuticals or Ayush traditional medicines,” he added.
An internal note accessed by ThePrint on the constitution of the committee states that there are challenges in uniform implementation and enforcement of the regulations, mainly due to interchangeable usage of the same nutrient or ingredient at different doses for pharmaceutical and nutraceutical use.
It also underlines an overlap in prophylactic and therapeutic usage of many of the ingredients used in nutraceuticals.
Speaking to ThePrint, Ashim Sanyal, chief operating officer (COO) and secretary at Consumer VOICE, a consumer voluntary action group based in Delhi, welcomed the government’s decision to review the existing regulatory framework for health supplements.
“We have been raising this issue with various government departments for a long time and I am glad the Centre has taken a step in the right direction,” he said.
ThePrint reached health secretary Apurva Chandra over call for a comment but had not received a response by the time of publication. This report will be updated if and when a response is received.
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Why regulatory overhaul is needed
As preventive healthcare becomes a buzzword, especially after the Covid pandemic, the nutraceutical market in India is estimated to reach $18 billion by the end of 2025 as compared to $4 billion by the end of 2020.
Prasad Nakashe, partner with consultancy firm Deloitte India, pointed out that in the post-pandemic landscape, the nutraceutical market is flourishing, driven by a surge in demand for immune-boosting supplements and a growing emphasis on preventive healthcare.
This growth has attracted interest from both local pharmaceutical and consumer care firms and global nutraceutical companies eyeing India’s expanding market.
“It may be crucial to initiate a thorough review of the current regulatory landscape for nutraceuticals to ensure the safety, efficacy, and affordability of these products — the evolving dynamics in the industry necessitate a comprehensive evaluation to address potential loopholes and enhance the regulatory framework,” Nakashe said.
According to the government’s internal note, the nutraceutical sector needs a regulatory overhaul. The note cited several examples of challenges that the gaps in existing norms present.
For instance, it states that while probiotic preparations in capsule, tablet or sachet form with therapeutic claims are regulated as drugs, the same bacterial cultures with minimal food substrate are also marketed under a FSSAI licence in the form of tablet, capsule, pill and liquid drops.
Likewise, the level of nutrients — vitamins and minerals — in the various categories of nutraceutical regulations are not permitted to exceed the recommended daily allowance (RDA) in any case, except as Food for Special Dietary Use for Sportspersons (FSDU) and Food For Special Medical Purposes (FSMP).
“But the levels defined in Schedule V of the Drugs and Cosmetics Act for prophylactic use of vitamins and minerals are different from their RDA — which again causes ambiguity in regulatory demarcation of these products,” the note pointed out.
For example, the RDA of Vitamin C is 80 mg per day whereas the dosage range defined for prophylactic use in drugs is not less than 25 mg and not more than 50 mg.
Then there’s the issue of products derived from plants and Schedules II and III of the FSSAI’s nutraceutical regulations provide the list of these extracts with specified range of usage, says the note, but many of the ingredients overlap with ingredients of ayurvedic drugs. It cites the example of ashwagandha which can be licensed both as an ayurvedic drug as well as a health supplement.
‘Bid to circumvent pricing’
The health ministry also feels that due to unclear demarcation, manufacturers of health supplements are shifting from the Central Drugs Standard Control Organisation (CDSCO) to the FSSAI for approval of ingredients which are akin to drugs, such as melatonin and zinc carnosine.
Sanyal pointed out that this was mainly because getting approval for nutraceutical products was far less cumbersome than getting a licence to manufacture a drug.
The ministry, as articulated in the note, believes that this allows manufacturers to circumvent pricing, as the prices of drugs included in the scheduled list — under the Drug (Prices Control) Order, drugs are either scheduled or non-scheduled — are directly capped by the government, while drugs outside the list are permitted to raise their prices by a maximum of 10 percent every year.
“(But) there are no such limitations for nutraceutical products,” a health ministry official told ThePrint.
On top of it, the government’s note says several supplements are marketed with disease management or risk reduction claims. And there is no mandatory medical supervision for products covered under nutraceutical regulations — as a result of which-people might consume the product for a longer duration and in higher dose strength which might prove harmful, it adds.
As the nutraceutical products are easily available over the counter, people tend to consume supplements along with drugs or other supplements, which leads to unsupervised drug-nutrient or nutrient-nutrient interaction which might be antagonistic to each other.
For instance, calcium from a multi-mineral supplement might affect the absorption of iron.
These issues, therefore, need to be examined afresh, from the point of view of consumer safety, the government has said.
Nakashe, too, underlined that balancing the need for innovation and industry growth with consumer protection was essential.
“The review should consider aligning regulatory practices with evolving industry trends and international standards to foster a robust and transparent regulatory environment for nutraceutical products in India,” he stressed.
(Edited by Nida Fatima Siddiqui)
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