BGR-34 (Blood Glucose Regulator-34) is an Ayurvedic-derived product that is sold in India as an over-the-counter pill for the management of type 2 diabetes. It was developed in 2015 by two government-owned laboratories and launched commercially in 2016. It has been tested in only one, modest-sized, human trial. The drug has been heavily criticized, and without more clinical trials, its efficacy remains unproven. The manufacturers have refused to acknowledge the claims of inefficacy and other concerns.
Development
BGR-34 was co-developed by two national government-owned laboratories, National Botanical Research Institute (NBRI) and Central Institute for Medicinal and Aromatic Plants (CIMAP) under the patronage of the Council of Scientific and Industrial Research (CSIR). The formulation was publicized in September 2015 as NBRMAP-DB and it was launched commercially by AIMIL Pharmaceuticals (AIMIL) in June 2016. Upon launch, it was priced at ( USD) per 500 milligram tablet, which was to be consumed twice a day. CSIR has claimed BGR-34 to be the first Indian ayurvedic anti-diabetic drug and the laboratories were awarded the CSIR Technology Award in 2016 in the Life Sciences category.
Ingredients
The raw materials for BGR-34 are derived from six plants: Daruharidra (Berberis aristata), giloy (Tinospora cordifolia), vijaysar (Pterocarpus marsupium), gudmar (Gymnema sylvestre), manjeestha (Rubia cordifolia) and fenugreek (methi). They were claimed to have been chosen from an "in-depth study of over 500 renowned ancient herbs".
Medical claims
The formulation purportedly releases 34 active phytoconstituents, which work as DPP-4 Inhibitors to regulate blood glucose levels. CSIR claimed high clinical efficacy in multiple clinical and animal trials. CSIR also asserted that the drug had several side-benefits and that it can stave off dependency on insulin or other anti-diabetic medications. The product has been advertised as being free from side-effects.
A placebo-controlled clinical trial in one of CSIR's Ayurvedic hospitals involving 64 enrolled subjects (56 completed the trial) was uploaded to Clinical Trials Registry of India (CTRI) and subsequently published in European Journal of Pharmaceutical and Medical Research, a predatory journal. One summary of the trial did not show any statistical analysis but minimally asserted that the trial "show(ed) promising results" and that in light of the "significant improvement in the feeling of wellbeing, it should be further extensively used as a monotherapy/adjunctive therapy". The trial's results were publicized by a group of researchers – five from AIMIL and three doctors from the hospital – in a November-2017 conference held by the OMICS Publishing Group under the ConferenceSeries banner. OMICS is a predatory publisher with little to non-existent quality-control and their conferences have been subject to equivalent criticism. The researchers then published the same trial in a different journal: Journal of Traditional and Complementary Medicine, wherein BGR-34 was described as successful in lowering fasting blood glucose, postprandial glucose and glycosylated haemoglobin.
Reception
Upon its launch as a scientifically validated drug, which was supposedly approved by the Ministry of AYUSH, multiple media outlets deemed it favourable, and termed it to be a "breakthrough-drug", especially in light of its low price. At the ceremony of the platinum jubilee of CSIR, Prime Minister Narendra Modi mentioned the drug as an achievement of the institution.
Criticism
BGR-34 was the subject of criticism from multiple quarters. There was a prolonged absence of any published clinical trial(s) of the drug and the claims of its efficacy could not be verified. No publications in peer-reviewed journals about scientific research undertaken into the aspects of contraindication, toxicology and other problems could be located either. Despite being branded as an ayurvedic product, there was no patent application at the National Botanical Research Institute (NBRI) corpus or the Intellectual property in India portal. The claims that BGR-34 was less costly than equivalent allopathic drugs were also determined to be misleading.
Physicians noted concerns about the safety of the drug, multiple side-effects were reported and it was widely described as inefficient.