New Delhi: Physicians have commonly prescribed probiotics, especially to children suffering from mild gastrointestinal infections, likely with the intention of curbing usage of antibiotics, for over a decade.
But now—probably driven by self-administration and preventive use of probiotics, besides doctors’ prescriptions—two brands in the category, Enterogermina and Econorm, have made it to the list of top selling drugs in India.
According to market research firm Pharmarack, the two brands together saw sales worth nearly Rs 40 crore in March, while over the past one year, the sales clocked in by them crossed over Rs 450 crore. In March, they were among the top 100 medicine brands sold in the country.
In India, drugs worth Rs 18,000-20,200 crore are sold every month, and Augmentin, an antibiotic by UK-based pharma giant GSK, is the top selling drug through most of the months of the year, raking in nearly Rs 58-70 crore monthly, or about Rs 700-820 crore annually.
However, the Pharmarack report from March noted that the sale of probiotic microbes grew at a rate of 13.5 percent over the past year, against the overall growth of 7.5 percent in the pharma market.
“…Probiotic microbes grew at 13.5 percent as antibiotic usage remained high due to post-seasonal infections. Growing awareness of microbiome health could also be a reason for wider use of probiotics in the country,” read the report seen by ThePrint.
It featured Enterogermina, a supplement by Sanofi India, that comes in the form of oral suspension of 5 ml vial each, among six medicines with the highest evolution index (EI) in the country. EI is measurement of a product or brand’s growth relative to its market.
Eneterogermina, the Pharmarack report shows, had an EI of 125 percent over the last one year, while Econorm—a similar brand by Hyderabad-based pharma major Dr Reddy’s Laboratories, sold in the form of capsule as well as oral powder—was right behind with an EI of 118 percent.
According to doctors, the trend suggests a clear and growing popularity of probiotic brands in the country, likely propelled by a mix of both physician-driven usage and general consumer adoption.
“Traditionally, probiotics were recommended by doctors, especially in cases involving gastrointestinal (GI) issues, but over time, they have entered the general health and wellness space, and are now often consumed directly by people, without medical guidance,” Dr Gaurav Mehta, consultant for gastroenterology and hepatology and transplant hepatology at Mumbai’s Kokilaben Dhirubhai Ambani Hospital, told ThePrint.
ThePrint reached out to Sanofi and Dr Reddy’s over email for comments on how they view the rapid growth of the sale of their products. The response is awaited.
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Hype about drugs aiding gut health
Enterogermina contains Bacillus Clausii, and is often prescribed for diarrhoea, antibiotic-associated gut flora imbalance and digestive disturbances. On its website, Sanofi also promotes it for preventive usage against stomach disorders.
Econorm, enriched with Saccharomyces boulardii, is particularly beneficial in managing acute diarrhoea, irritable bowel syndrome (IBS) and antibiotic-induced dysbiosis, or an imbalance of gut microbiome, said Dr Kunal Das, director and head of department of gastroenterology at Yashoda Super Speciality Hospital, Ghaziabad.
But clinicians and specialists told ThePrint that probiotics have received a lot of attention in recent years, especially on social media, often because of influencers and those promoting such products.
Kerala-based gastroenterologist and health researcher Dr Rajeev Jayadevan pointed out that probiotics are basically samples of bacteria that live in our gut without causing disease. “There are many types of bacteria, and each individual has a separate and distinct ‘garden’ made of different types of bacteria in various numbers and concentrations. In other words, the microbiome of one individual will be different from that of another,” he said.
In the body of a given individual, there are minor variations of this microbiome over a period of time. As a baby is born, there are no bacteria in the gut, but within a few days, bacteria from the environment enter the gut, and as the baby grows, a microbiome is eventually formed.
Sometimes, this microbiome can be destroyed by courses of antibiotics, but they typically grow back and get restored.
“The reported benefits of probiotics did not really match the clinical outcomes seen in actual practice,” Dr Jayadevan said.
He also stressed that many of the so-called improvements are due to placebo effect, which means that the patient feels that the dosage is worthwhile, and attributes natural improvement of one’s health to administration of such products.
Though randomised controlled trials have been done for several decades, the evidence has been far from overwhelming, he added. “There is no single probiotic, which is proven to be a panacea or a cure for any medical condition.”
‘Misinformation & misunderstanding’
Experts also caution that the probiotic market is ridden with misinformation and misunderstanding, even though in many cases, the side-effects could be minimal.
When given as pills, bacteria may get killed by the stomach acid. “Therefore, just because a person swallows these bacteria, it does not mean that from next week onwards, the listed bacteria will take up positions in the person’s gut,” Dr Jayadevan pointed out.
The newly introduced bacteria face resistance by existing bacteria in the gut, and might even be prevented from colonising it. Even if partial colonisation occurs, once the original bacteria grow back, these changes may get erased.
There is some evidence that administering certain probiotics may prevent antibiotic-associated diarrhoea, which include Clostridiodies difficile—a common pathogen behind the condition.
But a more effective method will be to avoid unnecessary antibiotic use rather than overuse of probiotics, experts insist.
“While chief constituents of Enterogermina and Econorm have been shown to have some beneficial effect on changed gut microbiome, especially in the context of gastrointestinal disorders, affecting disease outcomes, the effect of such strains on healthy gut, when used for a long period of time, is not at all clear,” said immunologist Dr Dipyaman Ganguly. Ganguly is the head of the department of biology, Trivedi School of Biosciences at Ashoka University.
Since self-administration creates that undesired possibility, he said, strictly enforcing physician-supervised intake is warranted.
Specialists also underline that these products tend to be relatively expensive. A 5 ml vial of Enetreogermina, for instance, costs upwards of Rs 60, while a strip of Econorm containing 5 capsules of 250 mg each costs over Rs 220.
There are several others sold as supplements rather than drugs, which means there are no stringent norms governing their composition, dosage or strain specificity.
“Different probiotic strains serve different purposes, and what may be effective in Western populations might not have the same result in Indian patients due to varying gut microbiomes and environmental factors,” Mehta said.
In this context, blindly consuming probiotics based on trends or marketing can be misleading, and sometimes even ineffective, the doctor added, stressing that their usage should ideally be based on clinical indication and professional advice.
(Edited by Mannat Chugh)
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