By Reya Mehrotra
In 2020, Dabur, which had long had a monopoly in the Chyawanprash market, suddenly faced a slew of competitors all selling ‘clinically tested and proven’ immunity boosters. Dabur, too, rolled out a whole new range of immunity-boosting products that were clinically tested.
In a world post coronavirus, clinical trials seem to have become synonymous with authenticity. As the world waited with bated breath for vaccines to come out, consumers realised how critical a part clinical trials play in proving the efficacy of a product. And this is now manifesting in how they buy other products as well. Taking a cue, brands, be it skincare, healthcare or FMCG, are going the clinical trial route to promote and sell their products.
A new era
Dabur India’s head of Ayurveda research Rajiva Rai shares that clinical studies at Dabur are conducted as part of research & development (R&D) activities to reiterate the safety and efficacy of the products and not purely for branding purposes, but agrees that it does provide an advantage to communicate the distinct features of the product in a scientific way to consumers and, hence, is always good 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 purchase behaviour, offers Shankar Prasad, founder of skincare brands Plum and Phy. But, Prasad says, other factors like brand reputation, reviews, peer recommendations and ingredient list are also important determinants of purchase behaviour.
Both the online shopping boom and the pandemic are driving the change, believes Karan Daftary, global vice-president, SIRO Clinpharm, a clinical research services company which has done a total of 56 studies in the dermatology therapeutic area and 10 studies in the nutrition sector. Talking about the need 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 own footing when it comes to health-related claims. A new study, for instance, relooks at the benefits of almonds in a whole new perspective. A six-month trial (which concluded in 2021) conducted by the University of California and funded by the Almond Board of California found that daily consumption of almonds instead of calorie-packed snacks improved measures of both wrinkle severity and skin pigmentation in postmenopausal women. Forty-nine healthy postmenopausal women with Fitzpatrick skin type 1 or 2 (characterised by increased tendency to burn with sun exposure) participated in the randomised controlled trial.
After coronavirus, the need for clinically-backed claims might look important for brands, but the pandemic alone is not responsible for the trend, which has, in fact, existed for at least five 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 increasing demand for transparency from consumers 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 don’t pertain to the dynamics of a pre- and post-Covid era, but as a modal and scientific backing to the claims the products allow. 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 marketing dynamic
When social media boomed, influencer marketing became the new profession for many. From celebrities to unknown people, everyone cashed in on the trend. Brands happily turned to influencers with social media followers running into millions to promote their products by sending out free samples or getting into paid partnerships. It was all going well when in February this year, the Advertising Standards Council of India (ASCI) issued draft rules for influencers on digital media platforms to protect consumer interest. Plus, the pandemic, too, reiterated the need for more clinically-backed claims rather than a word from an influencer.
The regulation makes sense as the influencer marketing industry is estimated between $75 million and $150 million, as per AdLift, a digital marketing agency. According to the new rules, an influencer has to specify if their content is through a paid partnership, an advertisement visible on all mediums like phones, tablets, etc, prominently. The final guidelines are to be announced in mid-April.
With the new regulations in place and as clinical trials become one of the new marketing tools, influencer marketing is likely to be impacted. However, the 2021 Business Insider Intelligence report still suggests that, by 2022, brands will spend upto $15 billion on influencer marketing, up from $8 billion in 2019.
Behind the scenes
The process of clinical trials ranges from sector to sector and may take days to be conducted. It is often extensive. Prasad shares that their entire range of Phy products (for men) are dermatologically and clinically tested, while Plum products undergo clinical trials as these claim hypoallergenicity or suitability for sensitive skin. It is a mix of clinical, as well as human trials. Explaining the process, 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 process is even more intensive. The brand conducted its first ever trial in 2017 for its Bringadi Intensive Hair Treatment Oil and found it fit for reducing flaky scalp, treating scalp infections, deep conditioning the hair and reducing hairfall. The trials were conducted on humans who were screened on the basis of their skin conditions (evaluated by dermatologists), regular habits, clinical observation and medical history. It was also a blind study, which means the participants were not aware of the type of product being applied. Each of the participants was asked to fill an elaborate questionnaire for evaluation under the guidance of a clinical research associate at Mascot Spincontrol India (MSI), a clinical research organisation. The subject panel included both men and women aged between 36 and 55 years with skin concerns ranging from dull skin, pigmentary spots, crow’s feet and wrinkles. Each product application was shown first by the clinical research team after which the application was carried out at home for 28 days. During this period, the participants were evaluated at regular intervals.
Dabur India, on the other hand, established its R&D centre in 1919 to develop scientific processes and quality checks for mass production of traditional Ayurvedic medicines. However, it was not until 25 years ago that Dabur conducted its first clinical study. Its flagship products like Chyawanaprash and Amla hair oil were some of the earliest products to be tested clinically in the early 1990s. The brand’s scientific studies are conducted through a third party (Contract Research Organisation, or CRO) following all applicable guidelines and the clinical studies 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 fact, has more than 35 standard operating procedures in place to conduct such studies. “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,” offers Rai.
When it comes to Dabur’s proprietary formulations (special blends, the concepts and ingredients of which are essentially rooted in the textbooks), a rigorous research process from the initiation of development to launch is followed. From selection of ingredients, sourcing of authentic and quality raw materials to development of herbal extracts and polyherbal formulations, it is all based on various research models and a comprehensive approach to health conditions. Such proprietary Ayurveda formulations then undergo specific pre-clinical screening, tests for safety and efficacy, clinical studies, etc. Only when it passes all is the product launched.
It is, however, important to note that clinical trials differ from consumer testing, wherein brands send out products to a group of potential consumers for their inputs. At Beauty By Anahata, it is a mix of both. “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 food, brands may ditch the usual clinical trial for testing for a comprehensive study. Jalarama Reddy, AGM, new product development and factory operations at Possible, a research-driven nutrition service and healthy food products company, shares that their products are monitored for nutritional profile, shelf-life studies, chemical, microbiological and pesticidal residues at the National Accreditation Board for Testing and Calibration Laboratories (NABL). This process, he says, differs from the typical 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 important question that arises here is: how are the subjects on whom trials are to be performed selected? “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 advertisements in public places, social media, public health departments are also placed to attract and build awareness among interested volunteers. Registrations are then done through various camps at different locations. The final stage post identification of volunteers involves consent for the study and further screening requirements.
Clearly, in the post-pandemic world, clinical trial is the new mantra for brands to win over consumers’ trust and confidence.
Quotes: 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
— Shankar Prasad, founder of skincare brands Plum and Phy
Any claim made by a company about their products should be transparent
— Karan Daftary, global vice-president, SIRO Clinpharm, a clinical research services company
Post Covid-19, fear regarding skin and overall health has increased the demand. It opened our eyes for the need of natural and organic products
— Radhika Iyer Talati, founder, Beauty By Anahata, an organic beauty & wellness brand
In case of foods and food products, clinical trials are designed to examine basic health effects of complex food mixtures in healthy individuals
— Jalarama Reddy, AGM, new product development & factory operations, Possible, a nutrition service and healthy food products company
As e-commerce is increasing, consumer awareness is also growing and they are increasingly seeking products with better quality and research data
— Rajiva Rai, head, Ayurveda research, Dabur