Today a growing number of particularly the aging population wants to live a healthy life without consuming much of chemical drugs, which in turn is becoming a key growth driver for nutraceutical products across the world. Further, increasing interest towards preventive healthcare and self-medication with ‘Over The Counter (OTC)’ products are the additional factors boosting the growth of the nutraceutical products market in India.
It has been reported that by 2020, the number of senior citizens (60 plus age group) is expected to exceed 1.0 billion, with around 70% of them living in the developing world. This further highlights the growth potential of the nutraceutical industry in countries like India with rising per capita income.
Evolution of the terminology ‘Nutraceuticals’:
Dr. Stephen DeFelice of the ‘Foundation for Innovation in Medicine’ coined the term ‘Nutraceutical’ from “Nutrition” and “Pharmaceutical” in 1989. The term nutraceutical is now being commonly used in marketing for such products but has no regulatory definition, other than dietary or nutritional supplements.
It is interesting to note that the dietary supplement industry defines nutraceuticals as, “any nontoxic food component that has scientifically proven health benefits, including disease treatment and prevention.”
Perhaps because of this reason, it is very often claimed by the manufacturers of nutraceutical products that these are not just dietary supplements, but also help prevention and/or treatment of many disease conditions.
In India, nutraceuticals are being promoted to and even prescribed by the medical profession, not just as nutritional supplements but also with off-label claims for the treatment of disease conditions, like arthritis, osteoporosis, cardiology, diabetes, pain management etc.
Are nutraceuticals then ‘Nutritional Supplements’ or ‘Medicines’?
When for any nutraceutical, claims are made either for cure of a specific disease condition or for prevention of a particular ailment, the product assumes the status of a drug substance, which needs to be approved by the drug regulator with undisputed and demonstrable evidence of efficacy and safety on patients.
Thus, the questions that may be very appropriately raised, whether or not such product claims are backed by robust clinical data for efficacy and safety on long term use and whether or not such data have also been published in the peer review journals? The answer will probably be an unambiguous ‘No’.
Unfortunately, clinical trial data proving efficacy and safety are not required for nutraceutical products to get their marketing approval in India, as long as the manufacturers do not put any medicinal or therapeutic claims both on the product label and also in their promotional literature.
However, in practice, making off-label therapeutic claims for nutraceutical products in general, though illegal, are more a routine than exceptions in India.
Relaxed regulatory process for marketing approval of Nutraceutical Products:
As stated above, nutraceutical products do not go through the rigors of stringent regulatory process as followed for the marketing approval of any drug with similar claims. Due to this reason, nutraceutical products currently fall within a grey zone, which has not yet gone through intensive scientific scrutiny for their safety and efficacy on patients, in general.
As a result of such relaxed regulatory framework, the nutraceutical products industry also prompts to flag many ethical issues, which include concerns over inadequate disclosure of science based information particularly on the surrogate therapeutic claims based merely on anecdotal evidence, as a part of intensive off-label sales and marketing efforts on their part.
Off-label therapeutic claims for any product are even otherwise illegal in India, like in many other countries.
Appropriate measures by the Government need to be put in place sooner, not only to plug the regulatory loopholes for off-label therapeutic claims, but also to ensure that marketing malpractices are not followed by their manufacturers to boost the sales turnover. This is necessary keeping especially the health outcomes and safety of the patients in mind.
How effective and safe are the nutraceuticals?
As stated above, currently many nutraceuticals are being directly promoted just like any other modern medicines, in the garb of nutritional supplements, to the medical profession, but with illegal claims and intent without being supported by data that can pass through scientific or regulatory scrutiny.
Thus the questions that one can raise logically are as follows:
- What happens when the nutraceutical products fail to live up to the tall claims made by the respective manufacturers on their efficacy and safety profile?
- Are these substances safe, just because not enough data has been generated on their toxicity profile?
The New Zealand Medical Journal (Vol. 118 No 1219 ISSN 1175 8716) in an article titled, “Lead poisoning due to ingestion of Indian herbal remedies” reported about dangerous and life threatening lead poisoning as follows:
“We believe that our cases of lead poisoning was predominantly due to ingestion of lead contaminated Indian herbal medicines, and it is the first such case to be reported in New Zealand.”
Similarly, Times Health in its March 15, 2010 reported that dangerous “lead poisoning in Indian children in the Boston area were linked to consumption of Indian spices.”
Taking lessons from all these, incidence like ‘Tylenol tragedy’ must not be allowed to be repeated in India, the risk of which primarily lies within inadequate quality and safety standards arising out of overall gross deficiency in the product security measures for many of such substances.
Importance of robust clinical data for therapeutic claims:
Therapeutic efficacy of a drug in the treatment of a disease condition is established with pharmacokinetic, pharmacodynamics, other pre-clinical and clinical studies. Some experts believe that these studies are very important for nutraceutical products, as well, especially when therapeutic claims are made on them, directly or indirectly, as these substances are also involved in a series of reactions within the body.
Similarly, to establish any long term toxicity problem with such products, generation of credible clinical data including those with animal reaction to the products, both short and long term, using test doses several times higher than the recommended ones, is critical. These are not usually followed for nutraceutical products in India, even when therapeutic claims are being made.
The experts, therefore, quite often say, “A lack of reported toxicity problems with any nutraceutical should not be interpreted as evidence of safety.”
Should Nutraceuticals also follow ‘Evidence-Based Medicine (EBM)’ standards?
The term and concept of EBM originated at McMaster University of Canada in early 1990 and has been defined as “the integration of best research evidence with clinical expertise and patient values” (Sackett, 2000).
EBM is thus a multifaceted process of systematically reviewing, appraising and using clinical research findings to aid the delivery of optimum clinical care to patients. EBM also seeks to assess the strength of evidence of the risks and benefits of any particular treatment claim.
Thus many global pharmaceutical companies believe that EBM offers the most objective way to determine and maintain consistently high quality and safety standards of healthcare products in the healthcare practice.
EBM concept, I reckon, is important in the context of nutraceuticals too, because over a period of time more and more users of nutraceuticals will tend to look for authentic scientific evidence within a clinical set up for such products. It is about time that EBM standards are followed for nutraceutical products, as well, by the regulators.
Global pharma companies focus on EBM:
So far, the large global pharmaceutical players have been focusing mainly, if not only on EBM. Companies like, GlaxoSmithKline (GSK), were reported to have discontinued marketing those products, which do not fall under ‘Evidence Based Medicines (EBM)’, even in India.
The global nutraceuticals market is currently estimated to be around US$ 117 billion and expected to reach US$ 177 billion by 2013 with a CAGR of 7%, driven mainly by ‘functional foods’ segment with a CAGR of 11%. The top countries in this category are Japan, USA and Europe with the former two together enjoying around 58% market share of the total nutraceuticals consumption of the world.
In 2009 Indian nutraceuticals market was around US$ 1.0 billion growing at 5% (IMS), around 55% of which being functional foods. As per IMS about 2800 brands were competing in the nutritional market in 2009.
The prices of most nutraceuticals products with off-label therapeutic claims, being outside government price regulations in India, are usually quite high.
Although India’s current market share of the global nutraceuticals market is around 1%, a report from PwC predicts that India will join the league of top 10 by 2020, primarily driven by the ‘functional foods’.
The status of nutraceuticals in the USA:
In the USA, Congress passed the ‘Dietary Supplement Health and Education Act’ in 1994. This act allows ‘functional claims’ to Dietary supplements without drug approval, like “Vitamin A promotes good vision” or “St. Johns Wort maintains emotional well-being”, as long as the product label contains a specific disclaimer that the said claim has not been evaluated by the FDA and that the product concerned is not intended to diagnose, treat, cure or prevent disease.
The above Act bestows some important responsibility on the doctors in particular, who are required to provide specific and accurate scientific information for nutraceutical products to their patients. This process assumes critical importance as the patients would expect the doctors to describe to them about the usefulness of nutraceutical products as alternatives to approved drugs. In such cases, if any doctor recommends a dietary supplement instead of pharmaceutical products, the doctor concerned must be aware of the risk that the patient’s health may suffer, for which the affected patient could sue the doctor for malpractice.
It is difficult to understand why is the Indian regulator not following, at least, the above practices in the country.
Only ‘Patented Traditional Medicines’ will soon require mandatory clinical trials:
Here comes possibly the beginning of a refreshing change in the drug regulatory mindset for nutraceuticals in the country.
It has recently been reported that all new traditional medicines will need to undergo clinical trials before their regulatory marketing approval in India.
However, it has also been clarified that “such products will include only the new patented drugs and not the classical formulations that find mention in India’s ancient texts, some of which are 5,000 years old.”
However, it defies scientific logic, when one argues that anecdotal evidence of last 5,000 years should be accepted as robust data for proven efficacy and safety of nutraceutical products on patients, especially during their longer term use, for the reasons as mentioned above.
Thus, this initiative of the government though commendable, will by no means ensure safety and efficacy of existing nutraceutical products making therapeutic claims – off-label or otherwise in their sales and marketing promotion to the medical profession.
An immediate action:
Nutraceutical products, wearing a tag of providing desirable therapeutic benefits with less or no side effects as compared to conventional medicines, is showing just a moderate growth in India, despite being within a favorable pricing and a relaxed regulatory environment.
As deliberated above, it may take some time for the drug regulator to grant marketing approval of nutraceutical products with therapeutic claims based only on robust clinical data for efficacy and safety. Till such time this happens, the Drugs Controller General of India (DCGI) without fail should make a statement, something like the following, mandatory on the packaging of all nutraceutical products, just as what has been done by the US-FDA:
“All claims made for this product have not been evaluated by the DCGI and the product is not intended to diagnose, treat, cure or prevent any disease.”
I reckon, the nutraceutical products segment with surrogate or off-label therapeutic claims, is just a growing bubble, as it were, which continues to be well protected by faith and hope of the patients, in the absence of stringent drug regulatory measures for substantiation of specific medicinal claims with predictable efficacy and safety profile.
This bubble could easily burst… decisively, if generation of clinical data on safety and efficacy ever becomes mandatory regulatory requirements for getting marketing approval of nutraceutical products in India claiming therapeutic benefits, off-label or otherwise. In which case, to meet those stringent drug regulatory requirements, commensurate increase in price for such products could indeed make commercial survival of this industry extremely challenging.
By: Tapan J Ray
Disclaimer: The views/opinions expressed in this article are entirely my own, written in my individual and personal capacity. I do not represent any other person or organization for this opinion.