Referring to the quality of probiotic products, Kanwaldeep Singh, founder and chief executive, Next Gen Pharma highlights that despite significant advances in understanding the potential uses and health benefits of some probiotic strains, clinicians, researchers, and consumers remain unclear by the ‘probiotic umbrella’ concept heavily promoted by the probiotic/pharmaceutical industry
The market for probiotics is growing exponentially – foods, dietary supplements, and drugs- for the well-being of people ranging from health conscious to those that need a treatment for disease conditions. Probiotics have come a long way, from being considered as an “adjuvant” to an independent therapy, with proven efficacies in treating difficult to treat chronic conditions or orphan disease conditions and thus addressing some of the “Unmet” needs. Take for example a proprietary mix referred to as SLAB-51 has shown promising evidence in reducing the progression of the dieses and mortality among moderate to serious COVID-19 patients. Likewise, another probiotic containing Lactobacillus brevis CD2, available under the brand Mucofan, has been proven to prevent Chemo-radiotherapy induced Oral Mucositis, a difficult to treat condition which impairs the ability to eat/chew among cancer patients, and may result in cessation of therapy.
Regulation of probiotics varies from region to region, resulting in a heterogeneous regulatory framework. Probiotics are regulated as dietary supplements unless they make disease-specific health claims, and regulation focuses on the legality of each claim based on efficacy, safety, and quality. Probiotics can also be classified as medical foods when prescribed for the dietary management of diseases needing a distinctive nutritional profile not met by a regular diet alone. A probiotic product can be classified as a medical food only if supported by high-quality clinical trials. In some countries including India, Russia etc. select Probiotics have been also registered as drugs and have been approved to treat or prevent disease conditions based on the evidence provided by clinical trials.
Despite significant advances in understanding the potential uses and health benefits of some probiotic strains, clinicians, researchers, and consumers remain unclear by the ‘probiotic umbrella’ concept heavily promoted by the probiotic/pharmaceutical industry. The umbrella concept extends the benefits obtained with a particular formulation to other probiotic products. All the information regarding the product specificity, dosage, duration of administration, combination of strains, and methods used to prepare the original studied formulations are often ignored and at times seems like “willful neglect”. Manufacturing processes, conditions, and ingredients are crucial to product performance. Even for established brands/products, changes in manufacturing location may result in a product that is not identical to the ‘original’ in terms of efficacy and safety unless appropriate measures and controls are taken. Since many probiotics’ properties are strain-specific, safety and efficacy results for specific products should not be generalized to other probiotics. Unfortunately, current trademark law and the lack of strict regulation of probiotics means that brand owners may sell any product under the same brand name, even if the new product differs significantly from the original one previously studied for safety and efficacy.
For example, In the USA, on July 23, 2019, a group of patients filed a class-action lawsuit against the sellers of the VSL#3 product manufactured by Actial/ VSL Pharmaceuticals Inc. The class action alleges that Actial/VSL developed a new VSL#3 product different from the original one. The suit alleges that the new VSL#3 is different from the formulation sold under the same trademark VSL#3 until 2016. Consumers are seeking hundreds of millions of dollars in damages. In the USA, the Federal Court since June 2019 has entered a permanent injunction against the current and former distributors of VSL#3 to stop their false advertising. The product is available in India, under the same brand VSL#3! Locally in India, a recent study published in November 2020 by an independent team of investigators from Chennai analyzed 20 most commonly available brands of probiotics and found poor correlation between the declared content on the pack and the lab results from their analysis. The regulatory loopholes thus exploited have severe implications for patients when probiotics are used as part of a treatment recommended in clinical guidelines for painful conditions such as inflammatory bowel disease, liver diseases, juvenile autoimmune diseases, etc. This leads to a very important question! Should Indian Authorities intervene? It is important for doctors to note that they become responsible for prescribing a product whose safety, efficacy and consistency of quality have not been tested and this can have serious implications, both in terms of the risk to patients and the related legal consequences. In this context, controlling probiotic products is mandatory to determine their authenticity and ensure consistency with manufacturers’ claims. Unfortunately, genomic analysis alone is not sufficient to characterize the complexity of probiotics. Genetically identical strains grown under different conditions or different culture methods have other phenotypic characteristics, such as viability, enzymatic activity, and compound metabolism. Until a few years ago, doctors and authorities did not realize the need to develop a method to verify the authenticity of probiotic products.
Probiotics represent a major opportunity in healthcare for patients and the industry alike. The sooner we have a robust, working regulatory framework suited to the Indian context, the better it will be for everyone. Given the recent focus on healthcare, a rapid response to this priority is the need of the hour.