At 6 am on September 13, the CSIR handle on X.com published the following post about an "anti-diabetic medicine" called either "Daiba 250" or "Diabe 250", developed at the CSIR-Indian Institute of Integrative Medicine (IIIM):

Its "key features", according to the CSIR, are that it created more than 250 jobs and that Prime Minister Narendra Modi "mentioned the startup" to which it has been licensed in his podcast 'Mann ki Baat'. What of the clinical credentials of Diabe-250, however?

Diabe-250 is being marketed on India-based online pharmacies like Tata 1mg as an "Ayurvedic" over-the-counter tablet "for diabetes support/healthy sugar levels". The listing also claims Diabe-250 is backed by a US patent granted to an Innoveda Biological Solutions Pvt. Ltd. Contrary to the CSIR post calling Diabe-250 "medicine", some listings also carry the disclaimer that it's "a dietary nutritional supplement, not for medicinal use".

("Ayurveda" is within double-quotes throughout this post because, like most products like Diabe-250 in the market that are also licensed by the Ministry of AYUSH, there's no evidence that they're actually Ayurvedic. They may be, they may not be — and until there's credible proof, the Ayurvedic identity is just another claim.)

Second, while e-commerce and brand pages use the spellings "Diabe 250" or "Diabe-250" (without or without the hyphen), the CSIR's social media posts refer to it as "Daiba 250". The latter also describe it as an anti-diabetic developed/produced with the CSIR-IIIM in the context of incubation and licensing. These communications don't constitute clinical evidence but they might be the clearest public basis to link the "Daiba" or "Diabe" spellings with the CSIR.

Multiple product pages also credit Innoveda Biological Solutions Pvt. Ltd. as a marketer and manufacturer. Corporate registry aggregators corroborate the firm's existence; its CIN is U24239DL2008PTC178821). Similarly, the claim that Diabe-250 is backed by a US patent can be traced most directly to US8163312B2 for "Herbal formulation for prevention and treatment of diabetes and associated complications". Its inventor is listed as a G. Geetha Krishnan and Innoveda Biological Solutions (P) Ltd. is listed as the current assignee.

The patent text describes combinations of Indian herbs for diabetes and some complications. Of course no patent is proof of efficacy for any specific branded product or dose.

The ingredients in Diabe-250 vary by retailer and there's no consistent, quantitative per-tablet composition on public pages. This said, multiple listings name the following ingredients:

• "Vidanga" (Embelia ribes)
• "Gorakh buti" (Aerva lanata)
• "Raj patha" (Cyclea peltata)
• "Vairi" or "salacia" (often Salacia oblonga), and
• "Lajalu" (Biophytum sensitivum)

The brand page also asserts a "unique combination of 16 herbs" and describes additional "Ayurveda" staples such as berberine source, turmeric, and jamun. However, there doesn't appear to be a full label image or a quantitative breakdown of the composition of Diabe-250.

Retail and brand pages also claim Diabe-250 "helps maintain healthy sugar levels", "improves lipid profile/reduces cholesterol", and "reduces diabetic complications", sometimes also including non-glycaemic effects such as "better sleep" and "regular bowel movement". Several pages also include the caveat that it's a "dietary nutritional supplement" and that it's "not for medicinal use". However, none of these source cite a peer-reviewed clinical trial of Diabe-250 itself.

In fact, there appear to be no peer-reviewed, product-specific clinical trials of Diabe-250 or Daiba-250 in humans; there are also no clinical trial registry records that were specific to this brand. If such a trial exists and its results were published in a peer-reviewed journal, it hasn't been cited on the sellers' or brand pages or in accessible databases.

Some ingredient classes in Diabe-250 are interesting even if they don't validate Diabe-250 as a finished product. For instance, Salacia spp., especially S. reticulata, S. oblonga, and S. chinensis have been known to be α-glucosidase inhibitors. In vitro studies and chemistry reviews have also described Salacia spp. can be potent inhibitors of maltase, sucrase, and isomaltase.

In one triple-blind, randomised crossover trial in 2023, biscuits fortified with S. reticulata extract reduced HbA1c levels by around 0.25% (2.7 mmol/mol) over three months versus the placebo, with an acceptable safety profile. In post-prandial studies involving healthy volunteers and type 2 diabetes, several randomised crossover designs had lower post-meal glucose and insulin area under the curve when Salacia extract was co-ingested along with carbohydrate.

Similarly, berberine-based neutraceuticals (such as those including Berberis aristata) have shown glycaemic improvements in the clinical literature (at large, not specific to Diabe-250) in people with type 2 diabetes. However, these effects were often reported in combination with other compounds and which researchers also indicated depended strongly on formulation and dose.

Finally, a 2022 systematic review of "Ayurvedic" medicines in people with type 2 diabetes reported heterogeneous evidence, including some promising signals, but also emphasised methodological limitations and the need for randomised controlled trials of higher quality.

Right now, if Diabe-250 works as advertised, there's no scientific proof in the public domain, especially in the form of product-specific clinical trials that define its composition, dosage, and endpoints.

In India, Ayurvedic drugs come under the Drugs & Cosmetics Rules 1945. Labelling provisions under Section 161 require details such as the manufacturer's address, batch, and manufacturing and expiry dates while practice guides also note the product license number on the label for "Ayurvedic" drugs. However, several retail pages for Diabe-250 display it as a “dietary nutritional supplement" and add that it's "not for medicinal use”, implying that it's being marketed with supplement-style claims rather than as an Ayurvedic “medicine” in the narrow regulatory sense — which runs against the claim in the CSIR post on X.com. Public pages also didn't display an AYUSH license number for Diabe-250. I haven't checked a physical pack.

A well-known study in JAMA in 2008, of "Ayurvedic" products purchased over the internet, found that around 20% of them contained lead, mercury or arsenic, and public-health advisories and case reports that have appeared since have echoed these concerns. This isn't a claim about Diabe-250 specifically but a category-level risk of "Ayurvedic" products that are available to buy online and which are compounded by the unclear composition of Diabe-250. The inconsistent naming also opens the door to counterfeit products that are also more likely to be contaminated.

Materials published by the Indian and state governments, including the Ministry of AYUSH, have framed "Ayurveda" as complementary to allopathic medicine. For example, if a person with diabetes chooses to try "Ayurvedic" support, the standard advice is to not discontinue prescribed therapy and to monitor one's glucose, especially if the individual is using α-glucosidase-like agents that alter the post-prandial response.

In sum, Diabe-250 is a multi-herb "Ayurvedic" tablet marketed by Innoveda for glycaemic support and has often been promoted with a related US patent owned by the company. However, patents are not clinical trials and patent offices don't clinically evaluate drugs described in patent applications. That information can only come from clinical trials, especially when a drug is being touted as "science-led", as the CSIR has vis-à-vis Diabe-250. But there are no published clinical trials of the product. And while there's some evidence for some of its constituents, particularly Salacia, to reduce post-prandial glucose and to effect small changes in the HbA1c levels over a few months, there's no product-specific proof.

Heidi Ledford had a tragic and powerful story published yesterday in Nature, about a team of scientists at the CSIR-Institute of Genomics and Integrative Biology racing to develop a CRISPR treatment for Uditi Saraf, a young girl whose brain was losing neurons due to a very rare, very aggressive genetic condition called FENIB. The story’s power comes from what it reveals about several facets of developing new treatments, looking for a cure for a rare disease, the importance of state support as well as control, the fact of the existence of neglected diseases, the demands made of clinical researchers, self-sufficiency in laboratory research infrastructure, and of course the cost of treatment. But most of all, it is a critical study of time. Uditi passed away four months after one of the researchers working on a CRISPR-based treatment for her told her parents they’d be ready with a solution in six. But even before her passing, there was time, there was no time, there was hurry, and there were risks.

Uditi’s disease was caused by a mutation that converts a single DNA base from a ‘G’ to an ‘A’. A variation on CRISPR genome editing, called base editing, could theoretically correct exactly this kind of mutation (see ‘Precision gene repair’). … But Rajeev and Sonam saw an opportunity for hope: perhaps such a therapy could slow down the progression of Uditi’s disease, buying time for scientists to develop another treatment that could repair the damage that had been done. The Sarafs were on board.

…

There were a lot of unknowns in the base-editing project. And in addition to the work on stem cells in the lab, the team would need to do further experiments to determine which base-editing systems would work best, where and how to deliver its components into the body, and whether the process generated any unwanted changes to the DNA sequence. They would need to do experiments in mice to test the safety and efficacy of the treatment. They also needed to get Ghosh’s facility approved by India’s regulators for producing the base-editing components.

Then there was the pandemic:

In December 2019, the Sarafs moved back to India. … Then the COVID-19 pandemic struck, and in January 2021, Uditi was hospitalized with severe COVID-19. She spent 20 days in the hospital and her health was never the same, says Sonam. Communication became increasingly difficult for Uditi and she began to pace the house incessantly, rarely even going to sleep. The Sarafs decided to speed up the base-editing project by funding a second team in India.

Developing treatments takes time. Uditi’s story was a one-off, a singular disease that few researchers on the planet were working on, so developing an experimental alternative based on cutting-edge medical technology was a reasonable option. And yet:

Meanwhile, Devinsky had petitioned a US foundation to devise a different experimental treatment called antisense therapy for Uditi. … The treatments didn’t work. And the experience taught Rajeev and Sonam how long it could take to get approval to try an experimental therapy in the United States. They decided Uditi’s base-editing therapy should also be manufactured and administered in India.

Uditi didn’t live long enough to receive treatment that could have slowed FENIB’s progression — hopefully long enough for researchers to come up with a better and more long-lasting solution. Now, after her death, the thinking and effort that motivated the quest to find her a cure has shifted to the future tense.

It will take years to establish the techniques needed to create rapid, on-demand, bespoke CRISPR therapies. Most people with these conditions don’t have that kind of time. … Rajeev has urged Chakraborty to finish the team’s studies in mice, so that the next person with FENIB will not have to wait as long for a potential treatment. … “We are not really trying as aggressively as we did earlier,” he says.

When the health of a loved one is rapidly deteriorating, the clock of life resets — from the familiar 24-hour rhythms of daily life to days that start and end to the beats of more morbid milestones: a doctor’s visit, a diagnostic test result, the effects of a drug kicking in, the chance discovery of a new symptom, an unexpected moment of joy, the unbearable agony of helplessness. The passage of time becomes distorted, sometimes slow, sometimes too fast. People do what they can when they can. They will take all their chances. Which means the chances they encounter on their way matters. Technological literacy and personal wealth expand the menu of options. The Sarafs knew about CRISPR, had a vague idea of how it worked, and could afford it, so they pursued it. They came really close, too; their efforts may even prove decisive in pushing a cure for FENIB past the finish line. For those who don’t know about CRISPR-based therapies and/or don’t have the means to pay for it, the gap between hope and cure is likely to be more vast, and more dispiriting. And one chapter of the Sarafs’ journey briefly threatened to pull them to this path — just as it relentlessly threatens to waylay many families’ laborious pursuits to save the lives of their loved ones:

The Sarafs studied what they could find online and tried the interventions available to them: Indian ayurvedic treatments, a ketogenic diet, special schools, seeing a slew of physicians and trying out various medicines.

Ledford’s narrative doesn’t get into who these physicians were, but let’s set them and the special schools aside. Just this morning, I read a report by Rema Nagarajan in The Times of India that a company called Natelco in Bengaluru has been selling human milk even though its license was cancelled two years ago. Specifically, the FSSAI cancelled Natelco’s license in 2021; a few months later, Natelco obtained a license from the Ministry of AYUSH claiming it was selling “Aryuevdic proprietary medicine”. When the Breastfeeding Promotion Network of India complained to the ministry, the ministry cancelled its license in August 2022. Then, a month later, the Karnataka high court granted an interim stay on this cancellation but said the respondents — AYUSH representatives in Karnataka, in the Karnataka licensing authority or from the ministry — could have it vacated. They didn’t bother. In June 2023, the ministry filed objections but nothing more. It finally moved to vacate the stay only in March this year.

Natelco’s case is just one example. There are hundreds of companies whose charade the Ministry of AYUSH facilitates by allowing specious claims ranging from “Ayurvedic toothpaste” to calling human breast milk “Ayurvedic medicine”. This is not Ayurveda: very few of us know what Ayurveda is or looks like; even Ayurveda itself doesn’t belong in modern medicine. But together with the FSSAI, the food regulation body notorious for dragging its feet when the time comes to punish errant manufacturers, and a toothless advertisement monitoring regime, the Indian food and beverages market has provided a hospitable work environment for quacks and their businesses. And inevitably, their quackery spills over into the path of an unsuspecting yet desperate father or mother looking for something, anything, that will help their child. When faced with trenchant criticism, many of these business adopt the line that their products are not unsafe. But they are terribly unsafe: they steal time to do nothing with it, taking it away from a therapy or a drug that could have done a lot. Such cynical alternatives shouldn’t be present anywhere on any family’s path, yet the national government itself gives them a license to be.

Featured image credit: Sangharsh Lohakare/Unsplash