Nishaakathakaadhi kashayam (NKK), an Ayurveda formulation for diabetes currently marketed by different companies, will soon go for a controlled efficacy study after Kerala-based common facility centre –CARe Keralam- prepared a comprehensive dossier of the product successfully for the first time.

The National Innovation Council (NIC) and the Council of Scientific and Industrial Research (CSIR) will support the Confederation of Ayurvedic Renaissance Keralam Ltd (CARe Keralam) to take up the trial involving 500 persons for documenting the efficacy and safety of the formulation.

After the NIC commissioned CARe Keralam, a joint venture between 150 Ayurveda units and the Kerala Government, to take up the scientific validation of the product, the dossier was released in Delhi recently.

“There is no need for randomized clinical trials of different stages 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 Samir K Brahmachari, while receiving the dossier.

The drug master file prepared by CARe Keralam now will enable the companies to seek registration of the product as an anti-diabetes formulation in other countries, thus giving a big fillip to standardization efforts for Ayurveda products.

The CSIR and NIC also extended support to CARe Kerala to identify more such popular traditional products and take up the scientific validation, which is missing and preventing many products from being marketed as drugs.

This is the first time such a dossier was prepared for an ayurvedic product. The non-existence of in-depth studies on therapeutic actions and adverse effects of products have led to thriving of spurious products and quacks. Many have developed fear for ill effects, said CARe Kerala managing director Karimpuzha Raman.

CARe Keralam, a Common Facility Centre 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 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 licensing and GMP certification.

Speaking on the occasion, NIC chairman and scientific advisor to the PM, Sam Pitroda said the need of the hour was to bring the traditional knowledge to the mainstream through proper documentation and integrate them with modern medicines so that the treatment could be made accessible and affordable.