Doctor, can I use the new Ayurvedic medicine for Diabetes ?

A patient was  asking me.

Which one ?

The one lauded by our Prime minster .

Oh , you mean BGR 34 ?

Yes.

Then better not.

Anticipating such questions, I had studied the molecule using resources at my disposal.

It is a mixture of four herbs. Individually these herbs had undergone small lab and clinical studies with mixed results. In February the Indian government’s Council of Scientific and Industrial Research (CSIR) has come out with a mixture of these four herbs in a single tablet amidst great fanfare with backing of just one unpublished study on 48 patients.

CSIR gave the manufacturing rights to few private companies and they began bombarding the naive public with high decibel advertisements. They even claimed cure for Diabetes in a few months time. Patients could even get the medicines by courier with cash on delivery. Many of my ‘smart’ patients used this opportunity to cure themselves off the dreaded disease. Most of them came back to me admitting they were fooled.

Image Credit – Product website

Last week Prime minister Modi had this to say about BGR 34.

Recently, CSIR has developed the first Ayurvedic medicine of the country for diabetic patients. All of you are aware about the potential of this medicine. Now our goal should be to make people aware of the benefits of this medicine so that they can make best use of the same. History is witness, that in the modern era no country would develop until they don’t have science and technology.

Unlike the Prime minister most people from the medical fraternity including those from the field of Ayurveda are not so happy with the product or the way it was launched.

A leading Ayurvedic medical journal itself has come out last month with a scathing editorial about the way the government and its agencies are going about in launching products with meagre or zero clinical research data.

In the year 2010 with lot of fanfare CSIR had launched two herbal products one named Memory Plus through Central Drug Research Institute (CDRI) and another product named Asmon through Indian Institute of Chemical Biology (IICB). Today, we do not know their commercial fate, however their scientific credential still remain obscure. Earlier, sometime in 1995, CCRAS had launched antimalarial drug named Ayush 64, with lot of hype, however even after over two decades of existence it has hardly any impact even in national programs.

In contrast, systematic rigorous scientific research on traditional Chinese medicine – qinghaosu resulted in discovery of new drug – artemisinin, which has become a drug of choice as standard treatment of Malaria [2]. Ironically, when Dr Youyou Tu was receiving a Nobel Prize in 2015 in recognition of her work on artemisinin; around the same time CSIR announced another ‘breakthrough’ of a scientifically validated anti-diabetes herbal drug, named ‘BGR-34’ based on Ayurveda for management of type-II diabetes mellitus. This drug is claimed to be jointly developed by two CSIR laboratories, National Botanical Research Institute (NBRI) and Central Institute for Medicinal and Aromatic Plant (CIMAP). However, as this editorial is being written, no information about this product was available from CSIR or NBRI or CIMAP official websites. The reputed scientific database like PubMed, Scopus did not show any research article related scientific studies on BGR 34. The Clinical Trial Registry – India (CTRI) did not have any record of diabetes clinical trials registered from CSIR, NBRI or CIMAP.

In March 2016 Press Information Bureau, Government of India announced that the National Research Development Corporation (NRDC) of the Department of Scientific & Industrial Research, Ministry of Science & Technology have signed a License Agreement for commercialization of Ayush-82, an ayurvedic formulation for prevention and management of Diabetes developed by Central Council for Research in Ayurvedic Sciences (CCRAS) New Delhi, an apex organization for research in Ayurveda under the Ministry of AYUSH. According to present Chairman, NRDC, patients prefer Ayurvedic drugs as it can be seen that in the recent past NRDC licensed 12 Ayurvedic drugs developed by CCRAS to 32 companies in India. It is remarkable to take Ayush products to industries, however, in the interest of public health, it is crucial to critically look at the validity of scientific evidence in support of various claims.

A veteran pharmaceutical scientist Dr M D Nair expresses that “I feel very concerned about the lack of transparency in the approval and marketing of BGR 34 in the Indian market exposing our population to a drug not fully validated by any standards. Validation or invalidation for an indication such as Diabetes with outcomes being easily measurable to reach objective decision making on efficacy should be immediately carried out by some responsible agency. It has nothing to do with Modern versus Ayurvedic approaches. What is needed is generation of adequate statistically and clinically significant empirical evidence for efficacy and safety of the product, regardless of what system we promote”.

According to well-known pharmacologist Prof Y K Gupta from All India Institute of Medical Sciences, New Delhi “It seems marketing strategy has taken predominance over the hard core science. Having CSIR lab logo on attractive packaging of the product may generate confidence in the public, therefore it is the responsibility of CSIR to ensure that the trust on CSIR retains its credibility. CSIR lab should have clear stand if they endorse the claims!! If all is correct, we much appreciate the development of a good and effective poly herbal formulation for diabetes by a CSIR lab. If they do not fully endorse all claims of the product, it must go for more studies or alter the label claim as per the validated study results.”

Ms Shailaja Chandra, former Secretary, Department of AYUSH says “In a video clip on the internet several senior members of a Government funded research council can be viewed providing information and promoting the use of an Ayurvedic drug which is being sold commercially. The use of the product is being advised for treating a serious condition – diabetes. Such advocacy can be perilous and lead to self -treatment which is fraught with needless risks. It invites a conflict of interest charge and brings the entire science of Ayurveda and the research work done for long into disrepute”.

Even the mainstream Indian media which always speaks glowingly of Ayurveda has started questioning this.

However, going by the negative reactions of several eminent scientists and a stinging editorial in a professional journal on ayurveda, Modi appears to have chosen a wrong example to highlight CSIR’s successes.

They are questioning the scientific validity of the drug, launched in press conferences across the country and promoted through commercial advertisements, without any published scientific evidence or clinical trials to support the claims made. They note this raises doubts about the CSIR’s “moral, ethical and public health responsibility”.

Ayurveda holds the potential for research and discovery of new products to be used in scientific medicine. But forgetting scientific method and evidence gathering, that too by institutions run with public money, is not the way forward.