By Reya Mehrotra
In 2020, Dabur, which had extended had a monopoly in the Chyawanprash market place, all of a sudden faced a slew of competitors all promoting ‘clinically tested and proven’ immunity boosters. Dabur, as well, rolled out a entire new variety of immunity-boosting solutions that had been clinically tested.
In a world post coronavirus, clinical trials look to have grow to be synonymous with authenticity. As the world waited with bated breath for vaccines to come out, buyers realised how crucial a portion clinical trials play in proving the efficacy of a solution. And this is now manifesting in how they purchase other solutions as properly. Taking a cue, brands, be it skincare, healthcare or FMCG, are going the clinical trial route to market and sell their solutions.
A new era
Dabur India’s head of Ayurveda investigation Rajiva Rai shares that clinical research at Dabur are performed as portion of investigation & improvement (R&D) activities to reiterate the security and efficacy of the solutions and not purely for branding purposes, but agrees that it does provide an benefit to communicate the distinct options of the solution in a scientific way to buyers and, therefore, is generally excellent for brand promotion. “As e-commerce is increasing, consumer awareness is also growing and they are increasingly seeking products with better quality and research data,” says Rai.
Clinical trials are taking the shape of brand identities and partly influencing acquire behaviour, provides Shankar Prasad, founder of skincare brands Plum and Phy. But, Prasad says, other things like brand reputation, evaluations, peer suggestions and ingredient list are also critical determinants of acquire behaviour.
Both the on the net purchasing boom and the pandemic are driving the transform, believes Karan Daftary, worldwide vice-president, SIRO Clinpharm, a clinical investigation services enterprise which has performed a total of 56 research in the dermatology therapeutic region and 10 research in the nutrition sector. Talking about the need to have for transparency, he says, “The in-built feedback mechanism on e-commerce websites can be viewed by other consumers and competitors. Therefore, any claim made by a company about their products should be transparent. Further to the government-issued guidelines on Covid-19 prevention, the usage of disinfectants witnessed a surge and their claims do need data to prove their efficacy. The Ayurvedic sector, too, faced huge challenges in generating authentic scientific data for consumers.”
Yet clinical trials have their personal footing when it comes to overall health-associated claims. A new study, for instance, relooks at the advantages of almonds in a entire new viewpoint. A six-month trial (which concluded in 2021) performed by the University of California and funded by the Almond Board of California identified that every day consumption of almonds alternatively of calorie-packed snacks enhanced measures of each wrinkle severity and skin pigmentation in postmenopausal females. Forty-nine healthier postmenopausal females with Fitzpatrick skin sort 1 or 2 (characterised by enhanced tendency to burn with sun exposure) participated in the randomised controlled trial.
After coronavirus, the need to have for clinically-backed claims may possibly look critical for brands, but the pandemic alone is not accountable for the trend, which has, in truth, existed for at least 5 years now, shares Radhika Iyer Talati, founder, Beauty By Anahata, an organic beauty and wellness brand. “However, post Covid-19, fear regarding skin and overall health has increased the demand. It opened our eyes to the need for natural and organic products,” Talati adds.
Prasad of Plum and Phy agrees, saying that the spurt in the clinical test trend has largely been driven by the growing demand for transparency from buyers as they want the claims verified. “Until a year ago, consumers were more focused on ingredients and their benefits. The pandemic has in general increased the respect and awareness for science- and data-driven decision-making,” he says.
For Kama Ayurveda, clinical trials do not pertain to the dynamics of a pre- and post-Covid era, but as a modal and scientific backing to the claims the solutions permit. Rai of Dabur concurs. “Consumers have always preferred quality and scientifically-tested/studied products. It has got nothing to do with Covid,” he says, adding, “Consumers are deeply concerned about the impact of Covid-19 both from a health and economic perspective. And this is reflected more in their purchase behaviour where we are seeing more and more consumers making online purchases.”
The influencer advertising dynamic
When social media boomed, influencer advertising became the new profession for lots of. From celebrities to unknown men and women, everybody cashed in on the trend. Brands happily turned to influencers with social media followers operating into millions to market their solutions by sending out free of charge samples or acquiring into paid partnerships. It was all going properly when in February this year, the Advertising Standards Council of India (ASCI) issued draft guidelines for influencers on digital media platforms to safeguard customer interest. Plus, the pandemic, as well, reiterated the need to have for more clinically-backed claims rather than a word from an influencer.
The regulation tends to make sense as the influencer advertising market is estimated in between $75 million and $150 million, as per AdLift, a digital advertising agency. According to the new guidelines, an influencer has to specify if their content is by means of a paid partnership, an advertisement visible on all mediums like phones, tablets, and so forth, prominently. The final suggestions are to be announced in mid-April.
With the new regulations in spot and as clinical trials grow to be one of the new advertising tools, influencer advertising is most likely to be impacted. However, the 2021 Business Insider Intelligence report nevertheless suggests that, by 2022, brands will commit upto $15 billion on influencer advertising, up from $8 billion in 2019.
Behind the scenes
The method of clinical trials ranges from sector to sector and may perhaps take days to be performed. It is typically substantial. Prasad shares that their complete variety of Phy solutions (for males) are dermatologically and clinically tested, whilst Plum solutions undergo clinical trials as these claim hypoallergenicity or suitability for sensitive skin. It is a mix of clinical, as properly as human trials. Explaining the method, he says, “For dermatological testing, there’s typically a ‘patch test’ done on the inner forearm, where a small sample of the product to be tested is applied and any signs of irritation are looked for by trained dermatologists for safety. We use internationally-certified clinical testing agencies for this purpose.”
Kama Ayurveda’s testing method is even more intensive. The brand performed its very first ever trial in 2017 for its Bringadi Intensive Hair Treatment Oil and identified it match for decreasing flaky scalp, treating scalp infections, deep conditioning the hair and decreasing hairfall. The trials had been performed on humans who had been screened on the basis of their skin circumstances (evaluated by dermatologists), standard habits, clinical observation and health-related history. It was also a blind study, which suggests the participants had been not conscious of the sort of solution getting applied. Each of the participants was asked to fill an elaborate questionnaire for evaluation beneath the guidance of a clinical investigation associate at Mascot Spincontrol India (MSI), a clinical investigation organisation. The topic panel incorporated each males and females aged in between 36 and 55 years with skin issues ranging from dull skin, pigmentary spots, crow’s feet and wrinkles. Each solution application was shown very first by the clinical investigation group immediately after which the application was carried out at residence for 28 days. During this period, the participants had been evaluated at standard intervals.
Dabur India, on the other hand, established its R&D centre in 1919 to create scientific processes and high quality checks for mass production of classic Ayurvedic medicines. However, it was not till 25 years ago that Dabur performed its very first clinical study. Its flagship solutions like Chyawanaprash and Amla hair oil had been some of the earliest solutions to be tested clinically in the early 1990s. The brand’s scientific research are performed by means of a third party (Contract Research Organisation, or CRO) following all applicable suggestions and the clinical research are registered at the Clinical Trial Registry of India (CTRI), a portal of the Indian Council of Medical Research (ICMR). Dabur’s R&D centre, in truth, has more than 35 normal operating procedures in spot to conduct such research. “Pre-clinical studies may be completed within few weeks to a few months, whereas clinical studies usually take longer, which may be from a few months to more than one year, depending on the number of subjects, number of groups and many other variables involved in the study,” provides Rai.
When it comes to Dabur’s proprietary formulations (specific blends, the ideas and components of which are primarily rooted in the textbooks), a rigorous investigation method from the initiation of improvement to launch is followed. From choice of components, sourcing of genuine and high quality raw components to improvement of herbal extracts and polyherbal formulations, it is all based on several investigation models and a extensive strategy to overall health circumstances. Such proprietary Ayurveda formulations then undergo certain pre-clinical screening, tests for security and efficacy, clinical research, and so forth. Only when it passes all is the solution launched.
It is, even so, critical to note that clinical trials differ from customer testing, wherein brands send out solutions to a group of prospective buyers for their inputs. At Beauty By Anahata, it is a mix of each. “The first step of the testing process is to test on friends and family to gauge usage, texture and effectiveness of the product. We prepare a beta group this way that vets out any cons and alerts us of any updates or changes the product may need. Beta testing also allows us to understand the human side of the process. For example, a product may work well for two-three people, but the fourth person may ask for more foam. Depending on the responses we get, we further work on the product. To gain scientific confirmation of our products’ safety, usability and effectiveness, we get them tested at an FSSAI-approved lab in Vadodara, Gujarat,” shares Talati.
When it comes to meals, brands may perhaps ditch the usual clinical trial for testing for a extensive study. Jalarama Reddy, AGM, new solution improvement and factory operations at Possible, a investigation-driven nutrition service and healthier meals solutions enterprise, shares that their solutions are monitored for nutritional profile, shelf-life research, chemical, microbiological and pesticidal residues at the National Accreditation Board for Testing and Calibration Laboratories (NABL). This method, he says, differs from the standard clinical trials. “In the case of foods and food products, clinical trials are designed to examine basic health effects of complex food mixtures in healthy individuals, whereas food products testing is in terms of its nutritional profile, shelf-life studies, chemical, microbiological and pesticidal residues. Food product testing is vitally necessary to ensure that the food is free of physical, chemical and biological hazards,” Reddy explains.
An critical query that arises right here is: how are the subjects on whom trials are to be performed chosen? “The volunteers are people who are healthy and can be easily approached via recruitment agencies. Although not simultaneously, each volunteer can participate in multiple studies. They are required to follow various compliance procedures which help in achieving the desired data and undergo counselling and various social worker visits for an efficient trial,” says Daftary of SIRO Clinpharm Pharma. “The basic step is to approach recruitment agencies that already contain a huge database of people who have registered for different segments like skin trials, nutrition, hair, etc. This reduces the time in recruiting patients and ensuring trial timelines are met.”
He says that ads in public areas, social media, public overall health departments are also placed to attract and construct awareness amongst interested volunteers. Registrations are then performed by means of several camps at various places. The final stage post identification of volunteers includes consent for the study and additional screening specifications.
Clearly, in the post-pandemic world, clinical trial is the new mantra for brands to win more than consumers’ trust and self-confidence.
Quotes: Until a year ago, buyers had been more focused on components and their advantages. The pandemic has in basic enhanced the respect and awareness for science- and information-driven selection-creating
— Shankar Prasad, founder of skincare brands Plum and Phy
Any claim created by a enterprise about their solutions must be transparent
— Karan Daftary, worldwide vice-president, SIRO Clinpharm, a clinical investigation services enterprise
Post Covid-19, worry with regards to skin and all round overall health has enhanced the demand. It opened our eyes for the need to have of all-natural and organic solutions
— Radhika Iyer Talati, founder, Beauty By Anahata, an organic beauty & wellness brand
In case of foods and meals solutions, clinical trials are created to examine fundamental overall health effects of complicated meals mixtures in healthier men and women
— Jalarama Reddy, AGM, new solution improvement & factory operations, Possible, a nutrition service and healthier meals solutions enterprise
As e-commerce is growing, customer awareness is also expanding and they are increasingly searching for solutions with improved high quality and investigation information
— Rajiva Rai, head, Ayurveda investigation, Dabur