In November 2014, the Modi govt. created a new ministry called the AYUSH, which stands for the Department of Ayurveda, Yoga and Naturopathy, Unani, Siddha and Homeopathy, with Shripad Yesso Naik appointed as the AYUSH minister of state (Independent Charge). Under UPA govt., AYUSH existed in the form of a department under the Health Ministry called the Department of Indian Systems of Medicine and Homeopathy (ISM&H). This upgrade to the ministry status also signaled an increased focus on research in alternative medicines.
The ministry of AYUSH has helped develop, in collaboration with CSIR and CCRAS, two Ayurvedic anti-diabetic drugs namely BGR34 and AYUSH82 (sold as IME9). Alt News have found that, both of these drugs have been released with insufficient clinical testing and have relied on pre-clinical animal testing for the majority of its claims. Moreover, contrary to the popular belief, in some patients, treatment with these Ayurvedic drugs have revealed a plethora of side effects; and, in contrast to its claims, have known to increase the blood glucose level to a dangerous high.
Alt News’ Research
Alt News examined the claims made by BGR34 and AYUSH82 using published scientific evidence available at Google Scholar and PUBMED. In the area of drug formulations, health practitioners use the clinical and academic research indexed by Google Scholar and PUBMED to verify and seek information regarding new drugs. As a corollary, the absence of scientific research information regarding various drugs in Google Scholar and PUBMED indicates lack of clinical research for those drugs.
In addition to Google Scholar and PUBMED, Alt News also looked at the research databases available at the ministry of AYUSH and CCRAS as well as the patents’ database (applied, granted as well as rejected) for these drugs.
Moreover, in regards to BGR34 and AYUSH82, Alt News spoke to:
Dr. Om Lakhani, MD (Medicine), DNB (Endocrinology), SCE- Endocrinology (RCP, UK) Consultant Endocrinologist at Zydus Hospital, Ahmedabad
Dr. A.K. Mangal, a Botanist and the Assistant Director (Pharmacognosy) of CCRAS, autonomous body of the Ministry of AYUSH that developed these drugs.
In the course of this article, Alt News also refers to the research and writings of:
Padmashri and President’s award winner Professor (Dr.) Anoop Misra, Director of Department of Diabetes & Metabolic Diseases, Fortis Hospitals, New Delhi
Bhushan Patwardhan, Ayurvedic Practitioner, Interdisciplinary School of Health Sciences, Savitribai Phule Pune University, Pune
BGR34 – Claims and effects
BGR34, an Ayurvedic drug for the treatment of type 2 diabetes and claims to have 34 vital phyto-constituent extracts and derivatives according to healing principles of Ayurveda that converts proinsulin to insulin. The drug also claims to produce nil side effects in comparison to Allopathic drugs.
Promotion
BGR34 is being manufactured by a private enterprise called AIMIL Pharmaceuticals which was awarded the AYUSH brand of the year in 2016 by the Union Minister of Agriculture, Purushottam Rupala.
News channels such as News 24 and ABP news aired exclusive reports along with the speech by Mr. Modi to promote its benefits and cost-effectiveness that gave an impression of it being a miraculous drug
BGR34 – Medical research
This drug has been collectively developed by two CSIR laboratories, National Botanical Research Institute (NBRI) and Central Institute for Medicinal and Aromatic Plant (CIMAP). Senior principal scientist of NBRI, Dr. AKS Rawat said that ‘BGR34 has been examined on animals and a scientific study has identified it safe and effective, with clinical studies demonstrating only 67% success’. AIMIL Pharmaceuticals also claims that BGR34 drug is manufactured according to a scientifically-proven optimised formula.
Despite the claims, Alt News found no scientific data such for human clinical trials regarding BGR34 in peer reviewed journals from PUBMED and Google scholar (accessed 25/07/17).
Similarly, pre-clinical studies (e.g. tests in animal models of diabetes) were not found for this drug in PUBMED or Google scholar databases. Also, a search for patent application at the National Botanical Research Institute (NBRI) yielded no results for this drug.
One clinical trial was found registered to CTRI (Clinical Trials Registry – India) for BGR34 in November 2016 by Dr. BP Gupta of Aggarwal Dharmath Hospital society, New Delhi that showed no pharmacokinetic data indicating any experiments conducted but simply stated that the primary outcome of this trial ‘shows promising results’ in a brief summary. This means that the registered trial showed no results at all in numbers or graph as evidence for any studies that may have been conducted using prescribed scientific methods.
The lack of scientific data and one domestic clinical trial registered with no data makes it impossible to validate the claims made vis-a-vis BGR34 and thus, raises questions regarding the integrity of these claims.
BGR34 – Side effects
Contrary to popular belief and Ayurveda claims, patients have reported gastric problems and severe allergies as a result of BGR34 treatment while others also claimed that it has simply been ineffective. Patients reported some side effects such as allergies, stomach burning and no change in sugar levels during the consumption of the drug.
However, one may not be able to say for sure that these side effects occurred as a result of BGR34, and not due to a random event due to the absence of proper clinical trial.