Report by India Education bureau, New Delhi: An Ayurvedic
formulation widely prescribed for diabetics has been scientifically
validated and its process standardised in a landmark study that could
enable the traditional Indian system of medicine gain far greater
acceptance globally.
The dossier or drug
master file on the anti-diabetic formulation Nishaakathakaadhi kashayam
(NKK) which will be released here tomorrow was prepared by the
Confederation of Ayurvedic Renaissance Keralam Ltd (CARe Keralam) and
commissioned by the National Innovation Council (NIC).
Shri.
Sam Pitroda, NIC Chairman and the Prime Minister’s Scientific Advisor,
will hand over the dossier to Dr Sameer K Brahmachari, Director General
of the Council of Scientific and Industrial Research (CSIR) and
Secretary, Department of Scientific and Industrial Research, Govt. of
India, at a function at Kerala House at 5 pm today (Saturday). Senior
CARe Keralam officials including Shri Karimpuzha Raman, Managing
Director, and Shri Simson Jose, Executive, Cluster Innovation Centre,
will be present on the occasion.
CARe
Keralam, a Common Facility Center established in Koratty in Thrissur
district of Kerala, with the support of the AYUSH department, Govt. of
India, conducted a comprehensive multidisciplinary study on the NKK’s
eight raw materials, and the Ayurvedic product formulated from them,
demonstrating its efficacy and toxicity on rats.
The
dossier is the first of its kind in Ayurveda and contains quality
control parameters for the medicine’s ingredients, product profile,
manufacturing process, toxicity studies, and anti-diabetic activity in
rats with Streptzotocin-induced diabetes. In addition, it also contains
formats for regulatory submission, drug licencing and GMP
certification.
NKK is already marketed by
different companies and the process standardisation will be of great
value to them. The dossier can also be used for preparing drug master
files for registering Nishaakathakaadhi kashayam in other countries as
an anti-diabetic drug.
Besides the benefits
to industry in terms of marketing and sales, this pioneering study will
pave the way for further investigations into the compounds identified
from the formulations and their targeted site could lead to new
information and possible patents.
The study
highlights the need for conducting similar research on all classical
herbal formulations to help Ayurveda gain its deserved space in modern
science.
For centuries, the age-old system remained a
non-controversial and well-accepted practice in healthcare. But poor
regulatory mechanisms and inadequate research on formulations and
manufacturing processes meant Ayurveda never came to the forefront of
modern scientific research.
With no
insistence on in-depth scientific studies on the therapeutic actions and
the adverse effects of medicines, spurious products and quacks have
thrived in Ayurveda. Many people have developed a fear of Ayurvedic
preparations because of the reported ill-effects of unscientific
formulations.
Controlled studies that conclusively
demonstrate the efficacy and safety of Ayurvedic products have therefore
become a necessity. Adequate preclinical as well as clinical safety and
efficacy data are also essential regulatory requirements in many
countries, the lack of these have limited the export potential of
Ayurveda to a few neutraceutical formulations.
The
NIC has come forward to address the problem by supporting research and
innovation in Ayurveda. Its initiative has also helped establish
technical collaborations between CARe Keralam and CSIR, and this has
strengthened the scientific capability of the cluster.
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