The Central government has formed a panel to check the possibility of bringing nutraceuticals under the ambit of the CDSCO from the FSSAI.
Drugs Control Administration(DCA) of Telangana has seized materials which are licensed as nutraceuticals but sold as drugs. (Creative Commons)
The Drugs Control Administration (DCA) of Telangana on Saturday, 17 February, conducted a raid at the facilities of Sri Bluten Pharmacy in the Pet Basheerabad area of Quthbullapur on the outskirts of Hyderabad.
During the operation, officials identified the product “Vitency Capsules”, which had been illicitly manufactured under a Food Safety and Standards Authority of India (FSSAI) licence.
The capsules were found to be manufactured at Knox Life Sciences in the Solan district of Himachal Pradesh and were being illegally marketed by Axenic Healthcare, Hyderabad, as a food product or nutraceutical.
The product “Vitency Capsules” claims on the label that it contains vitamins in quantities falling within the therapeutic dose range.
“Therefore, according to Schedule-V of The Drugs and Cosmetics Act and Rules, the product is considered a ‘drug’ used to treat vitamin deficiencies,” said DCA Director General VB Kamalasan Reddy in a statement.
He added that the product must be manufactured only under a “drug licence” issued under the Drugs and Cosmetics Act, adhering strictly to the “Good Manufacturing Practices” (GMPs) outlined in Schedule-M of the Drugs Rules. Additionally, it must meet the quality standards prescribed in the Schedule-V of Drugs Rules and the Indian Pharmacopoeia (IP), as mandated.
This is not the only case of drugs being sold as nutraceutical products after being manufactured under a licence from the FSSAI.
“Similar cases of ‘drugs’ being manufactured under a ‘food licence’ were previously detected by the DCA Telangana, in November 2023 and January,” said Reddy.
“They were declared as ‘spurious’ by the Drugs Control Laboratory, Hyderabad, as the contents of the active ingredients were found to be ‘NIL’ (i.e., zero drug) in the said products,” he added.
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.
These nutraceuticals being sold as drugs under FSSAI regulations is causing harm to the people.
“The drugs, which are falsely manufactured and sold under a food licence, are not produced in accordance with the GMPs, and often fail to meet the quality standards prescribed in the Indian Pharmacopoeia. Such products pose serious risks to patients’ health and may have severe implications,” said Kamalasan Reddy.
On 17 February, a LinkedIn user named Sumeet Pallav shared a story about such a product. The author shared a personal tragedy of losing their father due to the consumption of an herbal product called “Fat Burner”, which was purchased online.
“We all hear or use these so called herbal/organic products very casually thinking it’s natural with no harm or side effect. We are wrong. My dad passed away within 10 days from his first symptom [sic],” he wrote.
He had ordered an herbal medicine from Facebook called “Fat Burner”, wrote Pallav, adding that it was a powder the man consumed on an empty stomach for just four days.
“Starting 5th day, he had complete loss of appetite.A man weighing 90+ kgs and 5’11 height, was having just one chapati in whole day. What happened to him in medical language was DILI (Drug Induced Liver Injury). An injury which immediately damaged his liver beyond repair.And within no time led to multi organ failure, [sic]” said Pallav.
He wrote his father wasn’t exactly fit earlier, but he wasn’t critically ill either.
“Like most 60+ , he had comorbidities. From the conversation I had with him, he was guided by a doctor from this company ‘Sky Herbal Life’ which manufactured this drug. He explained a Dr. Gupta about his existing problems and the doctor continued guiding him on how to consume this powder. A capsule was also prescribed called “Keto” which dad didn’t use [sic],” said Sumeet Pallav.
He pointed out that the company’s product uses the FSSAI & ISO certification logo on its products.
Dr Cyriac Abby Philips, a hepatologist based out of Kerala, pointed out that the ingredients of the product that Sumeet’s father took were green tea extracts (not green tea) and Garcinia cambogia (Malabar tamarind).
“Both are well documented and both in fact have warnings from the medical science community as well as health regulatory bodies from scientifically progressive societies, as severe liver toxic agents that can lead to the fatal condition the man suffered from – Acute Liver Failure [sic],” said Philips on X (formerly Twitter).
“Studies have shown that epigallocatechin gallate (EGCG) in green tea extracts and hydroxycitric acid in Garcinia are toxic compounds in isolation, and worse when they are together – like seen in this product [sic],” he added.
The doctor also said that these products did not help people lose weight. They were, in fact common causes for severe liver injury and liver failure, he noted.
“And no doctor will tell you this because they fear the industry and are happy with a 9 to 5 clinical job. This has been known since decades. Why are our people not aware of this? Why is the health regulatory body not telling the public this, or putting up warnings or banning these shitty products off the shelf?” asked Philips.
Please read this and share widely.
A LinkedIn post from a person named Sumeet has been sent to me multiple times. I have also been tagged on this post many times. I think it’s important for me to share my concerns here as well, because it’s the right thing to do and… pic.twitter.com/uB5Ef9uOmE
— TheLiverDoc (@theliverdr) February 18, 2024
The Union government has formed a panel to examine the possibility of bringing nutraceuticals under the ambit of the apex drug regulator — the Central Drugs Standard Control Organisation (CDSCO) — instead of the food regulator FSSAI to address regulatory challenges and promote consumer safety.
Government sources said that the challenges in uniform implementation and enforcement, interchangeable usage of the same nutrient or ingredient at different doses for pharma and nutraceutical use, and overlap in phylactic and therapeutic usage, along with disease risk reduction claims, were discussed with CDSCO officials in a recent meeting.
“Several issues were discussed, following which a high-level committee under the chairmanship of the secretary of the Union Ministry of Health was constituted to review the regulatory challenges in nutraceutical and drugs to ensure consumer safety,” a source said.
The committee has as its members the secretary of the Ministry of Ayush, the secretary of the Ministry of Food Processing Industries, the secretary of the Department of Pharmaceuticals, the chief executive officer of the FSSAI, the Drugs Controller General of India, the director general of the Indian Council of Medical Research and the Director General of Health Services as members.
During the meeting, some officials noted that many health supplements like probiotics, vitamins, minerals and botanicals also have therapeutic uses and many companies are shifting from the CDSCO to the FSSAI for approval of ingredients that are akin to drugs such as melatonin and zinc carnosine due to unclear demarcation.
Some officials said several supplements were marketed with disease management or disease risk reduction claims, considering that the same ingredients were permitted in both drugs and nutra regulations, the sources stated.
“Besides, there is no mandatory medical supervision for products covered under nutra regulations as a result people might consume it for longer duration and/or in higher doses which might prove harmful,” the sources said.
Officials said due to unsupervised usage of supplements, people end up consuming supplements along with drugs that might interact with each other and cause adverse effects on their health.
Due to availability of health supplements over the counter, there are chances of consuming multiple nutrients whose action might be antagonistic to each other, like calcium from a multi-mineral supplement might affect the absorption of iron.
“The committee will identify the feasibility of regulating probiotics or prebiotics in food and drug formats. It will also examine if there is a need and possibility of bringing nutraceuticals and health supplements under the ambit of the CDSCO,” another official source said.
The panel is also expected to explore the feasibility of price control for categories covered under nutraceutical regulations, besides, examining the feasibility of GMP provisions and certification for nutraceuticals and similar products in alignment with schedule M of drugs.
(With PTI inputs)
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