With growth in India’s economy and middle class has come new diseases heretofore not that pervasive in India, such as diabetes. India has the most diabetics in the world. With nearly 70 million diabetics in the country by 2025, according to some sources, the country is hitting an alarming mark, representing a 266% increase in the condition.

Awareness of diabetes in India also continues to grow, triggering an interest and demand for effective treatments. With rapid urbanization and resulting lifestyle changes comes growing numbers of diabetic patients, driving growth of the condition. With such vast numbers, a large and lucrative health product market emerges to address growing diabetic conditions—especially for type 2 diabetes. Traditional medicinal companies in India seek to protect market share from drug producers in Europe, America, and Japan, for example. Hence, in some cases, elements from scientific, government and traditional therapies may experience a confluence of interests. The development and commercialization of one type 2 diabetes treatment, BGR-34, is a case in point.

Government Labs Create “Validated Herbal Product”

Recently, Indian news outlets raised the awareness of this diabetes crisis and discussed how the Council of Scientific and Industrial Research (CSIR), via its constituent laboratories called CSIR-Central Institute of medicinal & Aromatic Plants (CSIR-CIMAP), Lucknow, and CSIR-National Botanical Research Institute (CSIR-NBRI), have developed a scientifically validated herbal product called NBRMAP-DB, an anti-diabetic formulation based on Ayurvedic medicine. The underlying intellectual property for this product was licensed to M/s AIMIL Pharma Ltd. in Delhi, who are manufacturing and marketing this herbal-based drug known as BGR-34 across this vast country.

Clinical Trials

Apparently, once the license was secured, M/s AIMIL Pharmaceuticals (AIMIL Pharmaceuticals) executed a clinical trial centering on BGR-34, which was registered in the clinical trial registry of India (Registration number: CTRI/2016/11/007476). Furthermore, the formulation has revealed, according to press releases submitted to Indian news outlets, therapeutic efficacy for treating newly diagnosed type 2 diabetes as found in independent clinical trials conducted at Banaras Hindu University (BHU) in Varanasi, India.

BGR-34

There is not substantial evidence that it, in fact, does. Standing for Blood Glucose Regulatory-34, it represents an Ayurvedic-derived product developed and sold in India as an over-the-counter tablet for the management of type 2 diabetes. As previously mentioned, it was developed by two government-owned laboratories and licensed to M/s AIMIL Pharmaceuticals for commercialization.

The medicine was tested in only one modestly-sized clinical trial with the results being published in the European Journal of Pharmaceutical and Medical Research. Of course, this drug has been significantly critiqued and without more randomly controlled trials, it would be difficult to accept any commercial claims. According to one scathing account, the BG4-34 anti-diabetic drug turned out not to be rather pricey, and it later emerged that the clinical trials conducted on its behalf didn’t follow international guidelines and also deviated from Indian law. According to this piece, the Advertising Standards Council of India banned its advertisement as an anti-diabetic medication. In another critical article, the author, Seema Singh, notes that although the Prime Minister hailed the drug as the “first” Ayurvedic medicine for diabetes, the evidence still isn’t there.

Does a New Government Department Offer Scientific Therapeutic Legitimacy?

Back in 2014, the Modi government created a ministry called AYUSH, standing for the Department of Ayurveda, Yoga and Naturopathy. AYUSH was placed in a department under the Health Ministry with a name called the Department of Indian Systems of Medicine and Homeopathy (ISM&H).  The ministry of AYUSH helped develop BGR-34 in collaboration with CSIR and CCRAS, reported Dr. Sumaiya Shaikh in 2017. Ms. Shaikh wrote that Alt News sources have found that both BGR-34 and another drug known as AYUSH82 (sold as IME9) have been improperly commercialized—lacking sufficient in-human clinical trials while depending too heavily on pre-clinical animal testing for the majority of commercial claims. Moreover, Ms. Shaikh reports that these and other “Ayurvedic” drugs reveal a plethora of side effects that contrast to claims. Ms. Shaikh reports that these manufactures don’t acknowledge claims of inefficacy and other concerns, such as adverse side effects.

Who is M/s AIMIL Pharmaceuticals?

Launched in 1984, AIMIL Pharmaceuticals claims to be “one of the fastest growing Ayurvedic pharma companies,” promoting its vast range of Generic and Proprietary Ayurvedic (Herbal manufactured products) ethically through a large team of about 1,000 field offices to prominent institutions, such as hospitals, across India. It purports to be ISO: 9001: 2000 certified and honored with numerous awards from the Indian government. Employing between 1,000 to 5,000, it only shares annual reports on its website up to 2015-16. 

The venture was founded by K.K. Sharma, who undoubtedly is an impressive and charismatic—not to mention highly intelligent—character leading to entrepreneurial success. Sharma learned endurance and the importance of patience and strength as he grew up in Delhi after his mother departed the brutal realities of Amristar and, thereafter, arrived in Delhi during the partition of 1947 where Sharma learned survival and endurance based, in part, on those struggles around 1947’s harsh conditions. Sharma ultimately earned a B.S. in Chemistry from Indian University and learned the art and science of closing the deal as a medical representative for over 5 years. He would harness these skills later in life to achieve his dream of launching an Ayurvedic company known as AIMIL Pharmaceuticals. His vision was to combine western scientific rigor with the ancient wisdom and knowledge infused in Ayurvedic medicine. He was truly successful building a formidable company from scratch. Today, the company is publicly traded and, according to the Economic Times of India, the last update of company financials was 31, March, 2017 as per the Ministry of Corporate Affairs.

Conclusion: Health Consumer Caveat Emptor

Undoubtedly, many herbal medicine treatments have historic precedent. After all, societies and cultures in India have been operating a lot longer than Western ones. India forms one of the world’s fist civilizations (Indus Valley Civilization) along with Mesopotamia and the great civilizations of China. Its religion is arguably the world’s first organized religion, leading the way for others to follow. Individuals and groups there have been looking at and treating illness for a very long time. Hence, these herbal medicines known as Ayurvedic medicine are legitimate and accepted by considerable numbers in the society—and have, in many cases, been integrated into general wellness applications and, in some cases, directly into medical use. For example, according to some reports, more than 90% of Indians use some form of Ayurveda medicine. India is the world’s second largest populated country with 1.3 billion people; we can conclude that a lot of people are using some form of this health practice, and it must work in some ways—perhaps not well understood.

Moreover, laboratory experiments, in fact, do suggest the possibility that some substances used in Ayurveda could be developed into effective therapies. However, evidence in the Western form reveal that there is negligible evidence that they are effective as currently practiced.

For example, the U.S. National Institutes of Health (NIH) reports on the efficacy of Ayurvedic medicine and notes while a few studies suggest these preparations help manage symptoms with type 2 diabetes, most of the trials that were used to support these claims were too small or not well-designed. Hence, the NIH declared, “There is little scientific evidence on Ayurveda’s value for other health issues.” Thus, from a Western scientific perspective, the scientific data behind a Type 2 diabetic drug, such as BGR-34, is not sufficient and any claims based on scientific rigor—e.g. clinical trial results—should be significantly scrutinized.

At the end of the day, market systems are now dominating most societies, whether they go back 5,000 years or 500 years. After all, TrialSite News came across lots of evidence that Ayurvedic ventures can charge premiums for health tablets. And as health markets emerge and evolve, health consumers must continuously educate themselves as to what is truly in their best interest—this goes for eastern herbal medicine to popular nutraceuticals and supplements to western biopharma-produced drugs. As societies move into the 2020s and beyond, we become health consumers in charge of our health care destiny. When confronted with a claim for the healing powers of an herb, an elixir or a sophisticated clinical trials-tested and regulatory agency-approved drug—do your homework—talk to your physician and even consider a second opinion; look to repeatable evidence generated from well-designed, randomized, controlled trials and learn how to scrutinize what interests are funding studies and how well those studies are designed. And, importantly, remember: caveat emptor.

Source: India Education Diary

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