Express Pharma

The back-to-AYUSH wave

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The COVID-19 pandemic has seen increased interest in traditional remedies to build up personal immunity and nutrition. With India’s AYUSH ministry approving clinical studies and the WHO backing protocols for testing African herbal medicine, and most lately, the Health Minister releasing an Ayurveda and yoga-based national clinical management protocol for prevention and treatment of patients who are asymptomatic or have mild symptoms, will the COVID-19 pandemic finally bring respectability to a sector long scoffed at for being more faith than evidence-based? A review of the strategies at play, as new players plan to ride the immunity and nutrition wave, while legacy players move to the next level

On September 20, the World Health Organisation endorsed a protocol for testing African herbal medicine as potential treatments for the coronavirus which causes COVID-19 as well as other epidemics. While India’s AYUSH ministry must be feeling vindicated that they had approved clinical research studies on four Ayurvedic formulations way back on May 22, it is important to note that the WHO stressed that “phase III clinical trials are pivotal in fully assessing the safety and efficacy of a new medical product.”

The COVID-19 pandemic has seen an unprecedented interest in products with a ‘natural’ tag, as people try to undo years of unhealthy eating habits, lack of exercise and stressful work-life imbalances. While big FMCG companies such as Dabur reportedly clocked a 400 per cent surge in demand for Dabur Chyawanprash and an 80 per cent traction in Dabur Honey in the early months of the lock-down, the rising tide has lifted many newer companies and startups in the natural ingredients space. For instance, Mumbai-based OZiva reported a 40 per cent increase in queries especially in categories related to immunity and everyday fit-ness while Upakarma Ayurveda clocked a 35 per cent surge in the same categories.

But with so many brands crowding the natural space, and more joining in the gold rush triggered by the COVID-19 pandemic, how are both newbies and established brands standing out? Or will some brands lose out in the stampede? And how can they take on the cost versus benefits argument, especially when they seem to lack hard evidence and data that they are actually beneficial to users as they have not gone through the same regulatory approval process as prescription medicines? Here are some strategies at play.

Getting evidence on their side

Since none of these brands with the ‘back to nature’ tag come cheap, how are they justifying their cost versus benefits in the long run? And how do they differentiate themselves from the fly-by-night operators who are out to make quick profits?

While Ramdev Baba’s Patanjali made headlines for all the wrong reasons with what seems to be misleading claims about Coronil, many companies have been steadily gathering the evidence to support their brands.

This is where legacy brands in this space have already transitioned to the next level, by gathering evidence to back their products. And the trend has picked up the pace ever since the AYUSH ministry launched guidelines for conducting clinical trials for AYUSH products.

Dr Muhammed Majeed, Founder and Chairman, Sami-Sabinsa Group, a veteran of more than three decades, had worked with major pharma companies like Pfizer before turning entrepreneur by ‘integrating technology with Ayurveda’. He took the research route very early, and today Dr Majeed says that at least 50 per cent of the products the company markets are featured in research papers, initiated either by the Sami-Sabinsa Group or by academicians outside the company. He says his company has been following a process mentioned by Prime Minister Modi at the January 2020 Science Congress in Bengaluru where the PM had laid out a simple guideline for companies as well as start-ups when he said they have to “research, innovate, patent, produce and prosper.”

Thus collaborating and publishing research papers on their products became important to be seen as ‘evidence-based medicine’. For instance, in July, Sami-Sabinsa’s Curcumin C3 Complex, consisting of standardised turmeric extracts, was the subject of a recently published study on its effect, combined with BioPerine, on serum cytokine concentrations. The results of this randomised double-blind placebo-controlled trial were published in the peer-reviewed journal Phytotherapy Research.

Similarly, a study published in Scientific Reports in May this year, showed that in a specialised model for non-alcoholic steatohepatitis (NASH), a progressive form of non-alcoholic fatty liver disease (NAFLD), called STAM in mice wherein the disease progression is very similar to human disease, another product, LivLonga showed evidence of reducing the severity of NASH by reducing steatosis, fibrosis, oxidative stress, and inflammation.

LivLonga is a blend of three of Sabinsa’s scientifically validated natural ingredients: 250 mg of Curcumin C3 Complex Turmeric (Curcuma longa) extract, 50 mg Livinol Kokum fruit (Garcinia indica) extract and 5 mg of BioPerine Black Pepper (Piper nigrum) extract. The combination is protected by US Patent No 10653643 for liver protectant compositions and therapeutic applications.

For Pankajakasthuri Herbals India (Pankajakasthuri), COVID-19 marked their move from clinical trials done based on the AYUSH standards for Ayurvedic products to undertaking their first trial based on the testing protocols of modern medicine, for Zingi Vir-H, a herbo-mineral drug. It is made of a blend of seven ingredients developed by Padmasree Dr J Hareendran Nair, founder, Pankajakasthuri Herbal Research Foundation.

On July 9, Pankajakasthuri announced promising interim clinical trial results for Zingi Vir-H among patients suffering from COVID-19. Another example riding the immunity bandwagon is a combination of Corival Life Sciences’ Ayurvedic remedy Immunofree and Biogetic’s neutraceutical Reginmune. on September 25, an interim report on a clinical trial being conducted in three Indian hospitals comparing this combination with the present Government approved standard of COVID-19 care treatment of HCQ, favipiravir, azithromycin and cetirizine, reportedly revealed that patients on only Immunofree and Reginmune resolved coronavirus symptoms faster and 86 per cent of them tested negative for the coronavirus in five days. In comparison, most symptoms lasted longer on the pharmaceutical SOP and only 60 per cent tested negative on the fifth day. Of course, these are still early days and the release informs that recruitment into this trial at three hospitals was accelerated to gather more evidence.

Both Dr Majeed and Dr Nair seem least perturbed by the sudden flood of newcomers and startups to the AYUSH space.

Dr Majeed sees them (new players) as collaborators, rather than competition and looks at start-ups as potential collaborators. As he puts it, “We actually encourage start-ups, we don’t want to take them on. I do not consider any company or start-up as competition because there is so much synergy in association. For example, they may have a product idea, while I might have a development idea, I may have a market savvy and market reach. A synergy of all these things is required to make a business idea successful.”

In the same vein, Dr Nair explains, “We call ourselves a 32-year-old start-up. Out of the 100 plus unique formulations we have, only ten are being promoted. We have enough formulations in our portfolio to take on the competition for the next 15 years, even if we launch a new product once every two months. Frankly speaking, we would love to see competition coming in those categories like Breathe Eazy’s where we are having a solo run for many years. Competition would allow comparison and we would love to get compared.”

Getting the sourcing right

The second strategy is to strengthen procurement and sourcing. If this is not in place, it could be a huge barrier to scale up production and meet the sudden surge in demand. This is easier said than done, especially for natural ingredients which have growth and harvest cycles and cannot be manufactured out of thin air. In times like these, experience and the work done over the years of building relationships with suppliers pays off. But while the likes of Dr Majeed’s Sami-Sabinsa and Dr Nair’s Pankajakasthuri have three decades of experience, how are the relative newcomers faring on this count?

Vishal Kaushik, MD & Co-Founder, Upakarma Ayurveda says that they are being able to manage quite smoothly as their “stronghold on procurement procedures and good relation-ships in the herb industry” has ensured that “there have no hiccups so far in managing the additional demand in terms of starting ingredients.”

Founded in 2017 and based out of New Delhi, Kaushik explains that Upakarma Ayurveda has a multi-level procurement system of sourcing, ranging from DFF (Direct from Farmers), herb traders and local regional cultivators, from whom they reportedly procure export quality natural ingredients that match stringent international standards.

Similarly, the lockdown did pose some constraints for Aarti Gill, Co-Founder, OZiva, but she says the company works very closely with a wide network of farmers and partners to ensure seamless supply of raw materials, built up since they started in 2016. They started scaling up production in the initial days of the lockdown and hence were able to anticipate the additional demand for raw materials. She is confident that her company has tied up with the best logistics partners in India to ensure a wider reach and seamless service to its customers.

The procurement system could get quite complex, considering that companies like OZiva have more than 100 plant extracts and herbs in their products, thus making it imperative to “always work very closely with farmers and partners from across the country and globe to source them,” says Gill.

Playing the quality card

The third strategy to stand out from the herd is to highlight a USP. Most companies in this space, like pharma companies, are emphasising their stringent quality standards.

Kaushik discloses that his company has quality control as well as research teams – both consisting of technicians, doctors and physicians. All raw material, ingredients, packaging material, etc., are analysed before production, and finished goods are again tested by in-house laboratories as well as NABL accredited laboratories. Upakarma also keeps itself stocked with ready-to-use quality standard packaging to meet any additional requirements in the market. The company’s claim to fame is that it offers Shilajit in its purest form, with other products like Ashwagandha, saffron, and sweet almond oil.

Gill has positioned OZiva as a ‘clean label br