Report by India Education bureau, New Delhi: National Innovation Council (NIC) and the Council of Scientific and Industrial Research (CSIR) will support Kerala-based confederation of Ayurveda entrepreneurs–CARe Keralam—to identify 20 formulations for scientific validation and conduct the efficacy studies for anti-diabetic medicine for which the drug master file has been prepared for the first time.
While releasing the dossier on anti-diabetic formulation Nishaakathakaadhi kashayam (NKK) here on Saturday evening (Nov 23), NIC chairman and the PM’s Scientific Advisor Sam Pitroda said the council was ready to help CARe Keralam to prepare dossiers for 20 more formulations and support the efficacy studies.
The Confederation of Ayurvedic Renaissance Keralam Ltd (CARe Keralam), joint venture between nearly 150 Ayurveda units and the Kerala Government, successfully prepared the comprehensive dossier in a first-of-its-kind attempt to gain acceptance for the traditional medicines.
“We need to identify 20 products instead of going for pilot studies for 2000 formulations at suboptimal level and scale it up through efficacy studies to make them affordable and effective alternatives to modern drugs for diabetes,” Mr Pitroda said.
“There is no need for randomized clinical trials for herbal medicines. All what need is an efficacy study involving 500 people and prepare the comprehensive document to make it an approved drug. The council is ready to support such an attempt,” said CSIR Director General and the Secretary of the Department of Scientific and Industrial Research, Dr Sameer K Brahmachari, while receiving the dossier.
“The need of the hour is to bring our traditional knowledge to the mainstream through proper documentation and integrate them with modern medicines so that the treatment could be made accessible and affordable. Traditional medicines will be the right solutions to make drugs affordable,” Mr Pitroda said.
He also called for a national programme to support the scientific validation of traditional medicines. “India is a land of pilots with sub-optimal level of projects. Instead, we need to focus on some products and scale them up for their logical conclusion as acceptable drugs,” he said.
Dr Brahmachari said though AYUSH department was set up, it had segregated itself from the mainstream. “We have to integrate the traditional wisdom into the mainstream and the companies should come forward to scale up the efforts,” he said. “Don’t go for molecules, we should go for formulations,” he urged the industry.
CARe Keralam Managing Director Shri Karimpuzha Raman said the confederation was ready to take up more such studies on products in the coming years. He also sought the support of the government in this regard.
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.
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