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BGR-34 (Blood Glucose Regulator 34) is an Ayurvedic drug, sold as an over-the-counter pill in India for management of Diabetes mellitus type 2. It was developed by two government-laboratories in 2015 and commercially launched in 2016.

The drug has been heavily criticized as a sham treatment and the clinical efficacy of the drug remains unproven courtesy a dearth of any rigorous clinical trial. The manufacturers have refused to buy the claims of inefficacy and other raised concerns.

Development

The drug was jointly developed by two government laboratories, National Botanical Research Institute (NBRI) and Central Institute for Medicinal and Aromatic Plant (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 commercially launched by AIMIL Pharmaceuticals, in June 2016 priced at 5 INR (0.07 USD) per 500 milligram tablet which was to be consumed twice a day. CSIR has claimed it to be the first Indian ayurvedic anti-diabetic drug and the laboratories were awarded the CSIR Technology Award, 2016 in the Life Sciences category.

Constitution

The raw materials are derived from six plants:- Daruharidra, Giloy, Vijaysar, Gudmar, Manjeestha and Methi; all of which individually possess scientifically-vetted miscellaneous medicinal properties. They were claimed to be chosen from an 'in-depth study of over 500 renowned ancient herbs' pending which the ratios were optimized.

Ayurveda is a system of medicine with historical roots in the Indian subcontinent and practices derived from it form a type of alternative medicine. Whilst some researchers consider it to be pseudoscientific, others consider it a protoscience or trans-science system instead.

Pharmacological claims

The formulation claims to release 34 active phytoconstituents to work as a DPP-4 Inhibitor and thus, regulate blood glucose levels. CSIR had also claimed that the drug has several other side-benefits and can stave off dependency on insulin or other allopathic drugs.It was also advertised to not have any side-effects.A trial on animals had supposedly exhibited a success rate of ~67%.

A clinical trial in one of their own Ayurvedic hospitals involving 56 (48) patients was uploaded to Clinical Trials Registry of India (CTRI) months later and subsequently published in European Journal of Pharmaceutical and Medical Research, a predatory journal. It did neither show any pharmacokinetic data nor any mathematical result in the form of numbers or graph but minimally asserted the trial to ‘show 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 same results were also 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 near-unanimously held to be a predatory publisher with little to non-existent quality-control and their conferences have been subject to equivalent criticism.

The very same group of researchers (sans two of the doctors) ran a clinical-trial (which was claimed to have been conducted according to the Indian Council of Medical Research (ICMR) guidelines on conducting trials of ayurvedic substances) in 2018 and published the findings in the Journal of Traditional and Complementary Medicine. BGR-34 was determined to be successful in controlling the glycosylated haemoglobin levels of about 50% patients.Noticeable reduction in fasting blood glucose levels and postprandial glucose levels were also simultaneously observed.

Reception

Upon its launch as a 'scientifically validated' drug, which was approved by the Ministry of AYUSH, multiple media-units deemed it favorably and hailed it as a 'breakthrough-drug' especially in light of its supposedly cheap price. Claims of high clinical efficacy in multiple clinical and animal trials were reported from CSIR quarters. On the ceremony of the platinum jubilee of CSIR, Prime Minister Narendra Modi mentioned the drug as an achievement of the institution.

Criticism

The drug was subject to heavy criticism from multiple quarters.

There was initially a complete dearth of any published clinical trials of the drug and the claims of efficacy could not be any verified. No publications about any scientific research undertaken regarding the drug (about contraindication, toxicology et al.) can 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 of BGR34 being cheaper than equivalent Allopathic drugs were also determined to be misleading. Physicians have noted safety-hazards from the usage of the drugand multiple side-effects have been reportedand it has been near-unanimously described to be inefficient by medical practitioners. Consumer reviews have been mixed, all throughout the years.

In October 2016, the Advertising Standards Council of India banned an advertisement of BGR-34 which claimed to ''cure Type 2 Diabetes Mellitus without any side effects''. It held the advertisement to not only violate the The Drugs & Magic Remedies Act by offering to cure an incurable disease but also under the purview of disseminating unsubstantiated claims without any corresponding data.

Mohan Nair, a veteran pharmaceutical scientist and advisor to National Task Force on Phyto-pharmaceuticals expressed his concern in exposing the populace to a drug not validated by any trial and about the potential hampering of the credibility of CSIR. Sankaran Valiathan, chairman of the Task Force on Ayurvedic Biology of the Department of Science and Technology criticized the CSIR on making unsubstantiated claims and releasing a drug without evaluating the safety and efficacy components. Ms Shailaja Chandra, former Secretary, Department of AYUSH, termed the entire fracas as something that can bring the entire Ayurveda and the research work done for long into disrepute.Avinash Bhondwe, senior vice-president of the Indian Medical Association commented that there was a absence of any comprehensive clinical study on most AYUSH drugs and urged the FDA to take measures.

A Lancet paper described the boom of alternative therapies for diabetes in India as a hype and pointed to multiple systemic reviews that highlighted several methodological problems with the studies and trials conducted by AYUSH and associates. It also criticized the ICMR guidelines that waived or relaxed the rules for rigorous pharmacological and toxicology studies for Ayurvedic products, provided that the medicines were “prepared in same way as mentioned in ancient Ayurvedic treatises".

In an article at Journal of Ayurveda and Integrative Medicine, Bhushan Patwardhan critiqued the Government regulations in these areas as lackadaisical and held it to be non-satisfactory as to ensuring the non-exploitation of the broader populace. He also noted a long-prevalent pattern of the CSIR investing efforts into launching multiple drugs with obscure scientific credentials that often fizzed off after a gala launch and described it to be primarily inept and with a potential to erode the credibility of Indian traditions and knowledge heritage. He also claimed that many senior scientists from CSIR were quite skeptical of such 'populistic and market driven propaganda' and the preference to undertake scientific research by the means of media-headlines rather than by publications in credible scientific journals were worrying. The concerns have been echoed in other quarters.

Response

Despite longstanding concerns and criticism, the CSIR has continued to hail it as a revolutionary innovation.In response to a question in Rajya Sabha, Shripad Naik, Union Minister of State, Ministry of AYUSH claimed that BGR-34 was ''scientifically tested and very effective in treating type 2 Diabetes'' and that the drug has been successful.

Dr Girish Sahni, Director General, CSIR in 2018 went on to claim the drug ''to match the efficacy level of any branded modern medicine'' and it was subsequently enlisted as a major achievement of CSIR under the current political regime.There have been an aggressive marketing of the drug and it has been inducted into the Anti-Diabetes Campaigns by Central and state authorities.

Similar drugs

Multiple anti-diabetic ayurvedic drugs have been developed and licensed to private industries, for production.

Central Council for Research in Ayurvedic Sciences (CCRAS), an autonomous body of the Ministry of AYUSH derived a second drug for diabetes called AYUSH-82 (containing five herbal ingredients:-Karela, Jamun, Amra, Gudmar and Shilajeet) from BGR-34. CCRAS scientists claimed that it permanently cures type-II-diabetes within a span of six months and that it had no side-effects. The distribution and manufacturing rights were granted to Kudos laboratories who subsequently re-branded it as IME9.

Similar criticisms about absence of rigorous pharmacological studies and lack of meaningful clinical trials (coupled with publications in dubious predatory journals) were noted.

References

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• Drugs in India
• Ayurvedic medicaments
• Alternative medical treatments