Nov 24, 2013

NIC Chairman Sam Pitroda to hand over drug - Nisha Katakadi Kashya- dossier to CSIR

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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