Anti-diabetic Ayurvedic drug: Did it deserve Modi’s praise?
Lauding the achievements of the Council of
Scientific and Industrial Research (CSIR) on its platinum jubilee
earlier this week, Prime Minister Narendra Modi had made a special mention of
the “BGR-34”
ayurvedic anti-diabetic drug that it had launched with much fanfare in June.
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”.
Jointly developed at CSIR’s two institutes in
Lucknow — the National Botanical Research Institute (NBRI) and the Central
Institute for Medicinal and Aromatic Plants (CIMAP) — BGR-34 is sold online by
a private company in New Delhi in an attractive package with the CSIR logo to
generate confidence in the public.
The drug is said to contain extracts from
four plants mentioned in ayurveda and so, according to NBRI principal scientist
A.K.S. Rawat, has no side-effects.
Calling drugs “traditional” simply because
they consist of medicinal plants mentioned in ayurvedic texts, is not correct,
says Sankaran Valiathan, Chairman of the Task Force on Ayurvedic Biology of the
Department of Science and Technology and an Honorary Advisor to Manipal
University.
“They
are, in fact, new drugs and should undergo the full range of efficacy and
safety tests for approval. It is even worse that CSIR is making unsubstantiated
claims on ayurvedic drugs,” Valiathan, a recipient of the Padma Vibhushan,
India’s second-highest civilian honour, told this correspondent.
Nitya Anand, a legendary figure on the Indian
drug research scene and former director Lucknow’s Central Drug Research Institute,
concurred. “The Drug Controller General
of India now has a special category of drugs for herbal medicines
(phyto-pharmaceuticals) that require to be properly standardized, tested and
registered with it” before marketing, on similar lines to synthetic drugs,
he said over phone.
It is a “very serious matter” if this
procedure has not been followed in the case of BGR-34, he added.
“Such
populistic and market-driven propaganda actually tarnishes the credibility of
CSIR, India’s largest scientific network,” Mohan Nair, a veteran pharmaceutical scientist
and adviser to National Task Force on Phyto-pharmaceuticals, told
IANS.
“I feel
very concerned about the lack of transparency in the approval and marketing of
BGR-34, exposing our population to a drug not fully validated by any standards,”
he added.
In a harsh editorial, the Journal of
Ayurveda and Integrative Medicine, a peer-reviewed publication of
Elsevier (which opened its doors 130 years ago), said there is no information
about this product on the CSIR, NBRI or CIMAP websites; no research
publication; and no record of clinical trials.
Creating headlines in popular print and
electronic media instead of publishing in scientific journals “is certainly worrying and calls for serious
introspection”, the journal said and cautioned that “in the interest of public health, it is crucial to critically look at
the validity of scientific evidence in support of various claims”.
Neither CSIR Director General Girish Sahni
nor the NBRI’s Rawat replied to this correspondent’s request for comments on
the questions raised by the journal, which also warned that “the absence of contra-indications for
administration of the BGR-34 is a serious omission and has implications for
patient safety”.
The editorial also refers to concerns of some
experts in the field of ayurveda. It quotes Y.K. Gupta, a pharmacologist at New
Delhi’s All India Institute of Medical Sciences (AIIMS), as saying that in the
case of BGR-34, “marketing strategy has
taken predominance over hardcore science”.
Shailaja Chandra, a former Secretary to the
Ayush Ministry, which deals with ayurveda, has also warned that advocacy
through commercial publicity can lead to self-treatment “which is fraught with
needless risks and brings the entire science of ayurveda into disrepute”.
“The
traditional knowledge from ayurveda is certainly valuable for discovering new
drugs for diabetes,” Bhushan Patwardhan, professor of health sciences at Pune
University said, adding: “But it should be based on scientific
evidence for safety, quality and efficacy”, which is absent in the case of
BGR-34.
In contrast, he said, discovery of artemisinin
from traditional Chinese medicine — which has become a drug of choice for
treatment of malaria and got its inventor a Nobel Prize — required over three
decades of rigorous scientific work.
“India
needs to follow the robust path of discoveries like reserpine (derived from the
sarpagandha Indian snakeroot), used to treat high blood pressure and not
succumb to cheap publicity or short-term economic gains that will eventually
erode the credibility of India’s traditional knowledge heritage,”
Patwardhan said.
“At the
same time, government regulations, oversight and surveillance is required to
ensure that gullible patients are not exploited by misleading commercial
advertisements promoting various products by making unrealistic claims,” he
added.
According to Patwardhan, BGR-34 is not the
first ayurvedic diabetic drug to be commercialised without scientific
validation. He says no published scientific papers are available regarding
Ayush-82 — another anti-diabetic drug — developed by the Central Council for
Research in Ayurvedic Sciences under the Ayush Ministry and commercialised
recently.
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