Misplaced Pages

BGR-34: Difference between revisions

Article snapshot taken from Wikipedia with creative commons attribution-sharealike license. Give it a read and then ask your questions in the chat. We can research this topic together.
Browse history interactively← Previous editNext edit →Content deleted Content addedVisualWikitext
Revision as of 20:40, 15 December 2018 editWinged Blades of Godric (talk | contribs)Autopatrolled, Extended confirmed users, Pending changes reviewers, Rollbackers40,041 edits Add...Correct a pointTag: Visual edit← Previous edit Revision as of 20:48, 15 December 2018 edit undoWinged Blades of Godric (talk | contribs)Autopatrolled, Extended confirmed users, Pending changes reviewers, Rollbackers40,041 edits AddTags: nowiki added Visual editNext edit →
Line 18: Line 18:
There was a complete dearth of any clinical trials and no publications about any scientific research w.r.t the drug (about ], ] et al) were located either. <ref name=":3">{{Cite web|url=https://www.altnews.in/bgr-34-ime-9-drugs-safe-effective-diabetes/|title=Are AYUSH supported BGR-34 and IME-9 drugs safe and effective for diabetes?|last=Shaikh|first=Dr Sumaiya|date=2017-08-13|website=Alt News|language=en-GB|access-date=2018-12-15}}</ref><ref name=":2" /><ref name=":4">{{Cite web|url=https://thewire.in/health/bgr-34-csir-modi|title=Did CSIR's Anti-Diabetic Drug Deserve Modi's Praise?|website=The Wire|access-date=2018-12-15}}</ref>Despite being branded as an Ayurvedic product, no patent application at the National Botanical Research Institute (NBRI) corpus was recorded, either.<ref name=":3" /> There was a complete dearth of any clinical trials and no publications about any scientific research w.r.t the drug (about ], ] et al) were located either. <ref name=":3">{{Cite web|url=https://www.altnews.in/bgr-34-ime-9-drugs-safe-effective-diabetes/|title=Are AYUSH supported BGR-34 and IME-9 drugs safe and effective for diabetes?|last=Shaikh|first=Dr Sumaiya|date=2017-08-13|website=Alt News|language=en-GB|access-date=2018-12-15}}</ref><ref name=":2" /><ref name=":4">{{Cite web|url=https://thewire.in/health/bgr-34-csir-modi|title=Did CSIR's Anti-Diabetic Drug Deserve Modi's Praise?|website=The Wire|access-date=2018-12-15}}</ref>Despite being branded as an Ayurvedic product, no patent application at the National Botanical Research Institute (NBRI) corpus was recorded, either.<ref name=":3" />


One shoddy clinical trial in a single hospital involving 48 patients was uploaded to CTRI months later which asserted the trial to ‘show promising results’.<ref>{{Cite web|url=http://ctri.nic.in/Clinicaltrials/pmaindet2.php?trialid=16750&EncHid=&userName=BGR%2034|title=CTRI|website=ctri.nic.in|access-date=2018-12-15}}</ref><ref name=":3" />The Drugs & Cosmetics Act does not mandate any clinical trial for Ayurvedic medications except for a guarantee of non-toxicity but for allopathic drugs, phase 3 trials must include at-least 500 patients spanned across multiple centers.<ref>{{Cite web|url=https://thewire.in/health/bgr34-ayurveda-csir-aimil-diabetes|title=The Safety, Efficacy and Business of Publicly Funded Ayurveda|website=The Wire|access-date=2018-12-15}}</ref> A shoddy clinical trial in one of their own Ayurvedic hospitals involving 48 patients was uploaded to CTRI months later which asserted the trial to ‘show promising results’.<ref>{{Cite web|url=http://ctri.nic.in/Clinicaltrials/pmaindet2.php?trialid=16750&EncHid=&userName=BGR%2034|title=CTRI|website=ctri.nic.in|access-date=2018-12-15}}</ref><ref name=":3" />The Drugs & Cosmetics Act does not mandate any clinical trial for Ayurvedic medications except for a guarantee of non-toxicity but for allopathic drugs, phase 3 trials must include at-least 500 patients spanned across multiple centers.<ref>{{Cite web|url=https://thewire.in/health/bgr34-ayurveda-csir-aimil-diabetes|title=The Safety, Efficacy and Business of Publicly Funded Ayurveda|website=The Wire|access-date=2018-12-15}}</ref>


The claims of BGR34 being cheaper than equivalent Allopathic drugs were also subsequently determined to be misleading.<ref name=":3" /><ref name=":1" />Consumer reviews have been mixed, all thorughout and physicians have noted safety-hazards from the usage of the drug.<ref name=":3" /><ref name=":1" />Multiple side-effects have been reported.<ref>{{Cite web|url=https://www.deccanherald.com/specials/what-ayush-and-controversy-703993.html|title=What is AYUSH and the controversy around it?|date=2018-11-20|website=Deccan Herald|language=en|access-date=2018-12-15}}</ref><ref>{{Cite web|url=http://www.microfinancemonitor.com/bgr-34-ayurvedic-diabetes-drug-bgr-34-side-effects-surface-online-availability-price/40169|title=Ayurvedic Diabetes drug BGR 34 Side Effects Surface Slowly|last=Sridhar|first=Narsing Rao|date=2015-12-25|website=Microfinance Monitor|language=en-US|access-date=2018-12-15}}</ref> The claims of BGR34 being cheaper than equivalent Allopathic drugs were also subsequently determined to be misleading.<ref name=":3" /><ref name=":1" />Consumer reviews have been mixed, all thorughout and physicians have noted safety-hazards from the usage of the drug.<ref name=":3" /><ref name=":1" />Multiple side-effects have been reported.<ref>{{Cite web|url=https://www.deccanherald.com/specials/what-ayush-and-controversy-703993.html|title=What is AYUSH and the controversy around it?|date=2018-11-20|website=Deccan Herald|language=en|access-date=2018-12-15}}</ref><ref>{{Cite web|url=http://www.microfinancemonitor.com/bgr-34-ayurvedic-diabetes-drug-bgr-34-side-effects-surface-online-availability-price/40169|title=Ayurvedic Diabetes drug BGR 34 Side Effects Surface Slowly|last=Sridhar|first=Narsing Rao|date=2015-12-25|website=Microfinance Monitor|language=en-US|access-date=2018-12-15}}</ref>
Line 27: Line 27:


A review in the '']'' critiqued the Government regulations in these areas as lackadaisical and held it to be non-satisfactory in ensuring the non-exploitation of the broader populace. It 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''.'' It also claimed that many senior scientists from CSIR were quite skeptical of such nationalistic and populist propaganda.<ref name=":5" /> A review in the '']'' critiqued the Government regulations in these areas as lackadaisical and held it to be non-satisfactory in ensuring the non-exploitation of the broader populace. It 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''.'' It also claimed that many senior scientists from CSIR were quite skeptical of such nationalistic and populist propaganda.<ref name=":5" />

In 2018, Dr Girish Sahni, Director General, CSIR claimed the drug <nowiki>''to match the efficacy level of any branded modern medicine''</nowiki>.It was also enlisted as a major achievement of CSIR under the current political regime.<ref>{{Cite web|url=https://www.dnaindia.com/delhi/report-csir-invention-bgr-34-enlisted-as-major-achievement-in-delhi-2625168|title=CSIR invention BGR-34 enlisted as major achievement in Delhi|date=2018-06-14|website=dna|language=en|access-date=2018-12-15}}</ref>


== Similar drugs == == Similar drugs ==

Revision as of 20:48, 15 December 2018

BGR-34 (Blood Glucose Regulator 34) is an Ayurvedic drug that is sold as an over-the-counter pill in India for management of type II Diabetes Mellitus. It was jointly developed by two laboratories, National Botanical Research Institute (NBRI) and Central Institute for Medicinal and Aromatic Plant (CIMAP); affiliated to the Council of Scientific and Industrial Research (CSIR) and launched by AIMIL Pharmaceuticals, in June 2016. The latter was a recipient of the AYUSH brand of the year award.

The drug was heavily criticized as a sham treatment and the clinical efficacy of the drug remains unproven courtesy a dearth of any meaningful trial.

Constitution

The raw materials are derived from six plants:- Daruharidra, Giloy, Vijaysar, Gudmar, Manjeestha and Methi; all of whom individually posses scientifically-vetted miscellaneous medicinal properties

Pharmacological claims

The formulation claims to release 34 active phytoconstituents to regulate blood glucose levels. It had also claimed to have several other side-benefits whilst being the first anti-diabetic medication to not have any side-effects.

A clinical-trial in 2018, (that was claimed to have been conducted according to the Indian Council of Medical Research (ICMR) guidelines on conducting trials of ayurvedic substances) was published in Journal of Traditional and Complementary Medicine wherein BGR-34 was successful in controlling the glycosylated haemoglobin levels of over 50% patients.

Criticism

Upon it's launch as a scientifically tested drug, multiple media-units deemed it favorably and as an extraordinarily cheap wonder-drug whilst reporting claims of high clinical efficacy in multiple clinical and animal trials from CSIR press-meets. On the ceremony of the platinum jubilee of CSIR, Prime Minister Narendra Modi mentioned the drug as an achievement of the institution.

Soon thereafter, it was subject to heavy criticism from multiple quarters for flagrant violations of established clinical standards.

There was a complete dearth of any clinical trials and no publications about any scientific research w.r.t the drug (about contraindication, toxicology et al) were located either. Despite being branded as an Ayurvedic product, no patent application at the National Botanical Research Institute (NBRI) corpus was recorded, either.

A shoddy clinical trial in one of their own Ayurvedic hospitals involving 48 patients was uploaded to CTRI months later which asserted the trial to ‘show promising results’.The Drugs & Cosmetics Act does not mandate any clinical trial for Ayurvedic medications except for a guarantee of non-toxicity but for allopathic drugs, phase 3 trials must include at-least 500 patients spanned across multiple centers.

The claims of BGR34 being cheaper than equivalent Allopathic drugs were also subsequently determined to be misleading.Consumer reviews have been mixed, all thorughout and physicians have noted safety-hazards from the usage of the drug.Multiple side-effects have been reported.

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.

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".

A review in the Journal of Ayurveda and Integrative Medicine critiqued the Government regulations in these areas as lackadaisical and held it to be non-satisfactory in ensuring the non-exploitation of the broader populace. It 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. It also claimed that many senior scientists from CSIR were quite skeptical of such nationalistic and populist propaganda.

In 2018, Dr Girish Sahni, Director General, CSIR claimed the drug ''to match the efficacy level of any branded modern medicine''.It was also enlisted as a major achievement of CSIR under the current political regime.

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 promoted a second drug for diabetes called AYUSH-82 (containing five herbal ingredients:-Karela, Jamun, Amra, Gudmar and Shilajeet) wherein 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 absence of rigorous pharmacological studies and clinical trials were noted over here too.

References

  1. Somasekhar, M. "2 years on, markets still hypo about herbal diabetes drug". @businessline. Retrieved 2018-12-15.
  2. ^ May 19, P. T. I.; May 19, 2018UPDATED:; Ist, 2018 15:35. "Herbal drug BGR-34 helps cutting down heart attack risk : study". India Today. Retrieved 2018-12-15. {{cite web}}: |first3= has numeric name (help)CS1 maint: extra punctuation (link) CS1 maint: numeric names: authors list (link)
  3. ^ "Centre Approves Ayurvedic Drug – But Its Science is Missing". The Wire. Retrieved 2018-12-15.
  4. ^ Shaikh, Dr Sumaiya (2017-08-13). "Are AYUSH supported BGR-34 and IME-9 drugs safe and effective for diabetes?". Alt News. Retrieved 2018-12-15.
  5. "BGR-34 – Aimil Pharmaceuticals". Retrieved 2018-12-15.
  6. "Preliminary clinical assessment and non- toxicity evaluation of an ayurvedic formulation BGR-34 in NIDDM". Journal of Traditional and Complementary Medicine. 8 (4): 506–514. 2018-10-01. doi:10.1016/j.jtcme.2017.11.004. ISSN 2225-4110.
  7. "BGR-34: Herbal Anti- Diabetes Drug Launched by CSIR". www.clinicalresearchsociety.org. Retrieved 2018-12-15.
  8. www.ETHealthworld.com. "CSIR scientists develop BGR - 34, highly effective in Type 2 diabetes management - ET HealthWorld". ETHealthworld.com. Retrieved 2018-12-15.
  9. "CSIR launches ayurvedic anti-diabetic drug BGR-34 - Times of India". The Times of India. Retrieved 2018-12-15.
  10. ^ www.ETHealthworld.com. "CSIR'S anti-diabetic drug: Did it deserve Modi's praise? - ET HealthWorld". ETHealthworld.com. Retrieved 2018-12-15.
  11. "Ad promoting 'miracle' ayurvedic drug for diabetes taken off air - Times of India". The Times of India. Retrieved 2018-12-15.
  12. ^ "Did CSIR's Anti-Diabetic Drug Deserve Modi's Praise?". The Wire. Retrieved 2018-12-15.
  13. "CTRI". ctri.nic.in. Retrieved 2018-12-15.
  14. "The Safety, Efficacy and Business of Publicly Funded Ayurveda". The Wire. Retrieved 2018-12-15.
  15. "What is AYUSH and the controversy around it?". Deccan Herald. 2018-11-20. Retrieved 2018-12-15.
  16. Sridhar, Narsing Rao (2015-12-25). "Ayurvedic Diabetes drug BGR 34 Side Effects Surface Slowly". Microfinance Monitor. Retrieved 2018-12-15.
  17. ^ https://doi.org/10.1016/j.jaim.2016.08.005. {{cite web}}: Cite has empty unknown parameter: |dead-url= (help); Missing or empty |title= (help)
  18. https://www.thelancet.com/journals/landia/article/PIIS2213-8587(15)00515-X/fulltext. {{cite web}}: Cite has empty unknown parameter: |dead-url= (help); Missing or empty |title= (help)
  19. "CSIR invention BGR-34 enlisted as major achievement in Delhi". dna. 2018-06-14. Retrieved 2018-12-15.
BGR-34: Difference between revisions Add topic