New Delhi: A high-level interministerial panel has recommended regulation of health supplements such as vitamins, minerals, prebiotic and probiotic formulations in dosage strength as pharmaceutical products in order to ensure better due diligence before their approval, and to control production quality and price.
The panel has also suggested that while the Food Safety and Standards Authority of India (FSSAI) may continue to regulate nutritional and health claims made by nutraceuticals, their claim to cure or mitigate any specific disease, disorder or condition including disease risk reduction should be regulated by the Central Drugs Standard Control Organisation (CDSCO).
The eight-member committee, constituted in January this year and headed by former Union health secretary Apurva Chandra, submitted its report to the government this month. ThePrint has accessed a copy of the report.
According to the report, the panel had been tasked to review the regulatory purview of nutraceuticals on account of overlapping issues of nutraceuticals with drugs.
“This was considered necessary because of the challenges in uniform implementation and enforcement, interchangeable usage of the same nutrient or ingredient at different doses for pharma and nutraceuticals use and overlap in prophylactic & therapeutic usage along with disease risk reduction claims,” the report says.
Nutraceuticals include products with bioactive substances, and herbs and minerals or those dietary supplements which have therapeutic activity. These normally include health supplements like probiotics, health drinks, antioxidants, vitamins, minerals and amino acids.
The panel has noted that India’s nutraceuticals market was in 2020 valued at $4-5 billion in terms of sales but is poised to take the lead globally, with projected growth of over $18 billion by 2025.
In 2017, the Indian nutraceutical market accounted for a mere 2 percent of the global market share, but by 2019, its value had increased significantly. By the end of 2023, it was estimated that the Indian market would account for a minimum of 3.5 percent of the global nutraceutical market.
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Panel’s observations
The panel has highlighted in its report that Section 22 of the Food Safety and Standards (FSS) Act, 2006, permits the use of nutrients (vitamins and minerals) in products such as health supplements and nutraceuticals in amounts not exceeding the recommended daily allowances (RDA) prescribed by the Indian Council of Medical Research (ICMR)- National Institute of Nutrition.
In addition, the FSS (Nutra) Regulations, 2022, also specify that the quantity of nutrients added shall not exceed the RDA as specified by the ICMR, whereas Schedule V of the Drugs and Cosmetics (D&C) Rules, 1945, specifies the prophylactic and therapeutic doses of vitamins to be used in patent and proprietary medicines.
The vitamin preparations with prophylactic and therapeutic claims were previously recommended to be regulated under the D&C Act 1940 and Rules, the panel noted.
It, however, observed that no amendments in the D&C Rules have been made, due to which there is apparent regulatory overlap of provisions under the FSS Act and D&C Act, which leads to undemarcated regulatory and enforcement purview.
“Due to this overlap most companies prefer to position their products as health supplements under the FSSAI to avoid the more onerous D&C Act regime with respect to demonstration of efficacy of their product through clinical trials, which is a mandatory requirement for drugs under the Drugs and Cosmetics Act,” the panel has said in its report.
It also observed that “pharmaceutical companies are shifting their products from the drug category to the dietary supplement segment to escape governmental price regulations” by the National Pharmaceutical Pricing Authority.
Some experts underlined that the weak regulatory framework for nutraceutical products derived from food sources that offer health benefits beyond basic nutrition, has created a major gap that needs to be addressed.
“Clear regulatory policies for nutraceuticals are more likely to ensure product safety and quality, ensuring that nutraceuticals meet strict safety standards with appropriate testing and certifications to guarantee their efficacy, health claims, accurate labelling and transparency regarding ingredients and dosage,” Delhi-based public health nutrition specialist Dr Sujeet Ranjan told ThePrint.
There is a need for a regulatory framework that is more aligned with the distinct characteristics of nutraceuticals, providing the necessary oversight while encouraging innovation within this growing sector, Ranjan added. “It is crucial that we balance consumer protection with the promotion of beneficial health supplements.”
Drawing the boundaries
The committee, which comprised the secretaries of the pharma department, food processing industries ministry and AYUSH (traditional medicine) ministry; chief executive of FSSAI; Drugs Controller General of India; ICMR director general; Director General of Health Services and Chandra as members, held four meetings over the year and also sought suggestions from nutraceutical industry associations.
In its 20-page report, the panel has said that mere combinations of vitamins, minerals and amino acids should not be regulated by the FSSAI but the CDSCO, however, the food regulator can continue to regulate food items containing macro and micronutrients.
Also, the panel has said that the FSS Act, 2006, should be amended accordingly and legal opinions should be sought to distinguish between the two formats (supplements added to food and those in dosage strength) clearly.
It has also underlined that disease reduction claims are more widely used by manufacturers without approvals and these claims are manipulated in a way that mimics treatment, cure, mitigation or prevention of any specific disease, disorder or condition.
“FSSAI may regulate only nutritional and health claims that are listed under FSS (Advertising and Claims) Regulations, 2018, while the claim to cure or mitigate any specific disease, disorder or condition including disease risk reduction (DRR) shall be regulated by CDSCO,” the panel says in its report.
It recommends that to strengthen the regulatory mechanism for claims, a provision should be made for companies to submit labels (in supplement products) along with the claims and product at the time of licensing in appropriate regulations.
The report says that while food containing added prebiotics and probiotics may continue to be regulated by the FSSAI, the pure culture of probiotic with excipient base and in dosage form should be regulated by the CDSCO and nutra regulations should be amended accordingly.
Additionally, there should be a separate provision for Good Manufacturing Practices (GMP) requirements for nutraceutical products in the FSS (Licensing and Registration of Food Businesses) Regulations, 2011.
According to the panel, products with botanicals, plants isolate, molecule or extracts making disease reduction claims could fall under the purview of the Ministry of Ayush, but those not making these claims can be regulated by the FSSAI.
It has further suggested that the apex food regulator may consider examining advertisements related to nutraceutical products and establish a dedicated cell for their monitoring.
The apex food regulator, the committee has said, can continue to regulate Foods for Special Dietary Uses (FSDU) meant for weight management, geriatric population, pregnant and lactating women and sportspersons, and Foods for Special Medical Purposes (FSMP) intended for disorders such as diabetes, high blood pressure, celiac disease, sleep management and other health conditions.
The nutra regulations, however, need to be further amended to ensure their safety and efficacy.
(Edited by Nida Fatima Siddiqui)
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