Hyderabad: Over-the-counter (OTC) supplements have become ubiquitous, as people pursue health and wellness. From fitness enthusiasts stocking up on protein powders and multivitamins to individuals relying on herbal remedies for ailments, the supplement industry is booming.
According to reports, the dietary supplement market in India is projected to reach $10 billion by 2025. However, this growth comes with a critical gap – regulation.
Currently, supplements can be marketed without stringent scrutiny, often leading to exaggerated claims and, in some cases, harmful side effects.
In an attempt to address this issue, an inter-ministerial committee, headed by former health secretary Apurva Chandra has reportedly suggested that supplements that claim to cure or mitigate any specific disease should be considered as a drug and, hence be brought under the purview of the Central Drug Standards Control Organisation (CDSCO).
Dr Arvinder Soin, Chairman and Chief Surgeon at Medanta Institute of Liver Transplantation, told South First that this is a welcome shift for many reasons.
“Health supplement nutraceuticals are a relatively unregulated segment of OTC products that are often consumed inappropriately based on market push and non-medical advice. Even vitamins and heavy metals in supplements especially when sold or taken in higher doses for ‘enhanced effect’ may be toxic to the liver, kidneys and other organs,” Dr Soin said.
“For example, excessive copper and arsenic are toxic to the liver, while mercury is toxic to the nervous system,” he added.
Dr Soin noted that the quality, formulation and scientific evidence supporting the use of supplements are all very variable.
“Bringing their approval within the ambit of CDSCO will ensure improvement in these standards. This coupled with Ministry of Health guidelines on their use will ensure that good quality products reach the right consumer for the right reasons and dosages,” he said.
“However, one should guard against too stringent a control on pricing since that may promote cheap low-quality generic alternatives,” he added.
Healthcare providers have commended this recommendation and said that the government must seriously look into formulating a comprehensive policy to regulate supplement approvals and also monitor nutraceutical markets.
Dr Kiran Madala, State Media convener for Indian Medical Association from Telangana, spoke to South First about the importance of regulating supplements.
He explained that “dietary supplement” is a broad term encompassing everything from individual nutrients such as vitamins A, B, C, D, E, and K, and minerals like calcium, to multivitamins and specialised “senior” formulas containing various combinations of vitamins, minerals, phytonutrients, and other compounds.
According to Harvard Health University, dietary supplements are partially regulated by the FDA in the USA. “Literature shows that, in India, 50 percent of the population consumes dietary supplements in some form. However, excessive intake can cause harm, and their role in curing diseases has not been scientifically confirmed yet,” Dr Madhala explains.
Dr Sudhir Kumar, Consultant neurologist from Apollo Hospitals in Hyderabad agrees that health supplements should be brought under Drug Controller General of India (DCGI). As of now, it is considered as nutraceuticals so they don’t come under DCGI and it can be sold over the counter without any charges.
Dr Sudhir says that while supplements are often considered harmless, the reality is far more nuanced. Many products on the market lack scientific backing for their claims.
Without regulatory oversight, manufacturers are free to market supplements as “magic cures” for everything from hair loss to weight loss. This creates a dangerous environment where consumers are misled and sometimes put at risk.
“Because there is no scrutiny by DCGI, patients can fall for such false claims and even for serious illnesses, they may end up taking just the supplements. They may not consult a doctor to take proper medicines. This could result in disease getting worse and not better,” Dr Sudhir added.
Dr Rajeev jayadevan, Convener, Scientific Committee and former president of IMA Cochin, agrees that consumption of health supplement is often taken lightly by the general public.
“Unlike prescription medicines that are given after clinical evaluation along with doctors’ advice on how much and how long to consume, when to stop and what to expect, health supplements are over-the-counter, and lay people have the impression that they are all safe,” he told South First.
However, there is little standardisation in the quality and safety of supplements. Contaminants such as heavy metals, pesticides, or unapproved pharmaceutical ingredients are not uncommon in unregulated products. Such issues are particularly concerning in a country like India, where healthcare literacy varies widely, say doctors.
Doctors argue that unregulated supplements may contain harmful or banned substances. For instance, bodybuilding supplements have been found to contain steroids, which can lead to long-term health complications, including liver damage and hormonal imbalances.
Dr Jayadevan says that there are well established cases of supplements containing harmful ingredients which range from heavy metals to pesticides and steroids.
He says, “Unregulated and indiscriminate use of supplements has been shown to lead to severe health problems including liver failure. Even Vitamin D, when taken in excess, can cause serious and life threatening health problems.”
The public gets misled by unproven and baseless claims such as “immunity booster” and “liver detox”. As a result, public tend to take such products in excess at times while ignoring real health advice from doctors, for instance like when they are being asked to stop drinking.
Health is a serious topic and one shouldn’t do things like following the advice of random people doing social media reels.
Citing a study, Dr Madhala says, “Journal of the American College of Cardiology (JACC) published a series of reviews about nutritional supplements and heart. The take-home message on multivitamins — gleaned from 22 trials comparing multivitamins to placebo — remains the same: These supplements do not lower the risk of heart attack, stroke, or death over all. One of the top reasons people take supplements is the promise of better heart health.”
Additionally, Dr Sudhir points out that without proper scrutiny, there is no price limit for the nutraceuticals and health supplements.
Regular drugs prescribed by doctors come under the preview of National Pharmaceutical Pricing Authority (NPPA), which regulates the cost of most essential and life saving drugs.
But, when it comes to “dietary supplements,” many companies selling them charge whatever they want, adding further burden to a patient’s pockets. They often make exaggerated claims about their products, misleading consumers into spending large sums of money on ineffective or unsafe remedies.
However, establishing clear distinctions between food, supplements and drugs will be essential to avoid regulatory overlaps with FSSAI. Also, supplement manufacturers may face increased costs and time to market the products if this policy is brought in.
This policy to regulate is expected to face strong resistance from supplement manufacturing industry as it can mean potential loss of profit margins, less sales and stricter compliance requirements.
Doctors however insist that while challenges exist, bringing in a policy around this is a vital step for consumer’s safety and industry credibility.
