These products are often marketed as nutraceuticals—derived from food sources offering health benefits beyond basic nutrition—while being sold as drugs, thus violating regulatory guidelines
Published Jan 02, 2025 | 7:00 AM ⚊ Updated Jan 02, 2025 | 7:00 AM
nutraceutical
On 27 September, the Drug Control Administration (DCA) of Telangana conducted a raid in Pedappalli district and detected Ferisyn-XT Tablets (Ferrous Ascorbate & Folic Acid Tablets) circulating in the market.
These tablets were found to be manufactured by Stallion Enterprises, located in Karnal district of Haryana, and marketed by Syndicate Medicare Pvt Ltd as a food product/nutraceutical.
The products were falsely manufactured under a ‘food licence’ (FSSAI licence) and incorrectly labeled as food products/nutraceuticals. Based on their label composition, these tablets are classified as drugs under the Drugs and Cosmetics Act, 1940.
According to DCA, such products must be manufactured exclusively under a ‘drug license’ issued under the Drugs and Cosmetics Act, 1940, and must comply strictly with the Good Manufacturing Practices (GMP) outlined in Schedule M of the Drugs Rules.
It should be noted that Ferrous Ascorbate is a compound made up of ferrous iron (Fe²⁺) and ascorbic acid (Vitamin C). It is commonly used as an iron supplement to treat or prevent iron deficiency anaemia. It is often prescribed for conditions like pregnancy, lactation, menstruation, or chronic blood loss, recommended for individuals with poor dietary iron intake, and helps replenish iron levels.
On the other hand, Folic Acid is the synthetic form of folate, a water-soluble B-vitamin (Vitamin B9) that plays a crucial role in several physiological functions. It is vital for the production of red blood cells and proper cell division.
This is one of the seizure out of 24 cases of Ferrous Ascorbate and Folic Acid found to be sold as Nutraceutical, and Not of Standard Quality(NSQ)
In Telangana, the Drug Control Administration is identifying Ferrous Ascorbate and Folic Acid Tablets that are either Not of Standard Quality (NSQ)—drugs that fail to meet the quality standards or specifications as defined under Section 16(1)(a) of the Drugs & Cosmetics Act, 1940. This section specifies that the “standards of quality” mean that the drug must comply with the standards set out in the Second Schedule of the Act.
Additionally, at many instances these products are being marketed as nutraceuticals—a product derived from food sources that provides additional health benefits, such as disease prevention or treatment, beyond basic nutritional value—while being sold as drugs, thereby violating regulatory guidelines.
As reported by CDSCO, in November 2024, the Drug Controller of Telangana tested various drugs and found five supplements of Ferrous Ascorbate, Folic Acid, and Zinc to be NSQ.
This includes Ferin-XT Tablets, Ferrigen – XT Tablets, and Ferrored-XT Tablets, all containing Ferrous Ascorbate, Folic Acid, and Zinc. These products were manufactured and marketed by a Hyderabad firm.
Ferrimack-XT Tablets contain the same ingredients, manufactured in Himachal Pradesh. Additionally, Ferrored-XT Tablets containing Ferrous Ascorbate, Folic Acid, and Zinc were produced in Gujarat, and all were found to be Not of Standard Quality (NSQ) in the month of November.
Ferin-XT, Ferrigen – XT and Ferrimack-XT don’t meet the specifications regarding the assay of Ferrous Ascorbate (Elemental Iron) as per the Standard Testing Procedure (STP). Additionally, the sample did not comply with the criteria for uniformity of weight, as per the Indian Pharmacopoeia (IP).
In the case of Ferrimack-XT, out of 20 capsules weighed, 11 capsules exceeded the 10 percent limit, with 3 capsules showing double deviations. Therefore, the sample does not meet the specifications for uniformity of weight of capsules according to IP.
Whereas Ferrored-XT label indicated Ferrous Ascorbate 100 mg, instead of Ferrous Ascorbate equivalent to Elemental Iron, making it a misbranded drug as per Section 17 of the Drugs and Cosmetics Act, 1940.
Telangana Drug Controller, in raids, found that 44 units to be sold as drugs, were nutraceutical. Interestingly almost half of it, around 19, were to be found of Ferrous Ascorbate and Folic Acid.
These were not only found in urban settings where population and demand of these drugs are quite high, but also in the rural areas.
The DCA has seized the following Ferrous Ascorbate & Folic Acid tables sold as nutraceutical since January 2024.
Nutraceuticals are a category of products that combine elements of nutrition and pharmaceuticals.
They are derived from foods, dietary supplements, or specific diets and are used to promote health and prevent or treat diseases.
Nutraceuticals may include substances such as vitamins, minerals, herbal products, and other natural compounds that have physiological benefits or provide protection against chronic diseases.
They are not regulated in the same way as pharmaceuticals, and their efficacy and safety are not always backed by the same level of scientific evidence.
The term “nutraceutical” was coined by Stephen De Felice in 1989, and is used to describe a wide range of products, including dietary fibres, probiotics, prebiotics, polyunsaturated fatty acids, antioxidants, and other natural compounds.
Nutraceuticals are marketed in various forms, such as pills and powders, or other forms not usually associated with foods.
In India, the FSSAI regulates the usage of health supplements and nutraceuticals under the Food Safety and Standards (Health Supplements, Nutraceuticals, Food for Special Dietary Use, Food for Special Medical Purpose, and Prebiotic and Probiotic Food) Regulations of 2022.
This regulation covers food items that are specially processed or formulated for specific nutritional or dietary purposes, official sources said.
The nutraceutical market in India is estimated to reach $18 billion by the end of 2025 as compared to $4 billion in 2020, according to industry data.
Nutraceuticals are not held to the same rigorous standards of testing and approval as pharmaceuticals. This regulatory gap often results in variations in product quality, safety, and effectiveness.
Manufacturers are allowed to make health claims without robust scientific evidence, misleading consumers into believing these products can treat or prevent diseases when they may not be capable of doing so.
Excessive consumption of certain nutraceuticals can lead to toxicity. For example, high doses of vitamin B6 can cause neurotoxicity, and excessive iron intake can lead to conditions like hemochromatosis.
There are reports of serious adverse effects associated with nutraceuticals, including side effects or drug interactions that have resulted in emergency room visits and hospitalisations.
Contamination of nutraceuticals with harmful substances, such as heavy metals, pesticides, or unlisted drugs, is a concern. Some herbal supplements, for instance, have been found to contain toxic compounds or adulterated ingredients.
Inconsistencies in the concentration of active ingredients are common, often due to variations in raw materials and manufacturing practices. These inconsistencies can compromise the efficacy of the product.
(Edited by Ananya Rao)
