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 brand’, which puts additional emphasis on sourcing the right ingredients. According to her, “These ingredients are first sent to NABL accredited labs for rigorous quality checks which include efficacy, nutrient profiling, any filler ingredients, heavy metals and toxicity check, potential allergens. Only once it clears all checks, we use them in the final production. Also, each batch is lab tested for quality and safety.” Another USP that OZiva plays on is the claim to be India’s first ‘Clean Label Active Nutrition brand’ that offers protein blends, plant-based micronutrients and plant nutrition for special dietary needs.

Keeping the product mix fresh with new launches and going global

The fourth strategy is to constantly update the product mix, with new launches, which means gauging customer preferences. Expansion into different geographies too may need products specific to different consumers. Of course, most new launches will focus on the COVID-19 pandemic.

Dr Nair of Pankajakasthuri says his formula to remain relevant over the past three decades is the uniqueness and novelty of the products they have formulated. According to him, “Right from the time of inception, we had taken a route different from other Ayurvedic organisations. When modern Ayurvedic formulations are labelled as re-engineered and repurposed, we have always believed in inventing new formulations based on the tenets of Ayurveda. The results are products like Breathe Eazy for asthma, Orthoherb for joint pains, Ilogen for diabetes, Anticid for gastritis, etc., among 100 plus such unique formulations. In fact, a handful of such formulations are so unique that we don’t find similar products in Ayurveda. A product like Zingivir-H, I believe would change the way modern doctors used to look at Ayurvedic products.”

Companies like Upakarma and OZiva see the COVID-19 pandemic as an opportunity to serve up new products to an expanding customer base. As Kaushik puts it, “After the onset of COVID-19 people have grown more conscious around their immunity and overall well-being. … So yes we are in the process of rolling out some great new health and wellness products.”

The increased demand and new launches will need expansion and Kaushik confirms that they are in the process of procuring additional machinery and increase the production lines of manufacturing partners.

At OZiva, Gill says that R&D is a critical part of their business and it’s a continuous process, as they keep coming up with new innovative products. OZiva is currently a sub Rs 50 crores brand that has grown 7X in the last 12 months on the back of new categories and building strong technology and content-based ecosystem.

While Gill’s OZiva can scale up 4x with the current setup and processes, companies like Upakarma are busy expanding their logistics to cope with in-creasing within the country as well as launching globally. “We are ramping up and focusing on a well-strategised supply chain to make sure our consumers get best quality supply easily and on time”, signs off Kaushik. After gaining a strong presence in the north-west region, Upakarma Ayurveda plans to expand their reach in the eastern and southern regions of India. With innovations in the pipeline, the company also plans to expand its product infrastructure with ayurvedic beauty and hair products. Besides, the ayurvedic company is on its way to expand globally with the US, Mexico, Canada, UAE/Middle East Asia, and Europe.

Dr Nair of Pankajakasthuri Herbals India sees a very bright future for his company, with the growing acceptance of Ayurvedic products in India as well as abroad and with the kind of products in their portfolio. His company has grown from a single-digit turnover when they started three decades back, to a three-digit turnover today; mainly from two markets in southern India. Other south markets have started showing better prospects in the last couple of years. He believes that they haven’t even tapped five per cent of the Indian market.

More specifically, Dr Nair points out that a product like Breathe Eazy, meant for building respiratory immunity and helped millions in its 32 years of existence, has found the right connect with many new users during the COVID times. This has inspired the company to look beyond south markets sooner than they originally thought and that would have a very positive impact on their revenue outlook for the future. Dr Majeed of Sami-Sabinsa Group also indicates that the company has had an average growth of 20-25 per cent YoY over the last three years, and they hope to do the same this year as well.

As we approach the dreaded winter months, some cities and states in India are already heading towards a second wave of COVID-19 infections. The festival season is also sure to give further impetus to all coronaviruses. India’s AYUSH sector sees this pandemic as an opportunity to grow market share but only time will tell which brands surf the wave and which ones sink. More importantly, let’s hope that the COVID-19 churn weeds out the imposters and the AYUSH sector becomes both faith and evidence-based.

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