Even as the Kerala based common facility centre, Care-Keralam, completed the scientific validation study of a 5000 year old ayurvedic formulation and submitted the dossier to the Department of Ayush and to the sponsored agency, National Innovation Council (NIC) in February last year, no further step could be taken on the document by the central or state governments, or any central research body, it is learnt.

The validation study was conducted on the advice of Sam Pitroda, chairman of the NIC and it had funded an amount of Rs. 25 lakh for documentation and preparing the drug master file (dossier) on the efficacy of the anti-diabetes Ayurveda formulation, Nizhakathakadi Kashaayam, which is now marketed across the country by several companies. It was the first scientific documentation held on the efficacy of an Indian herbal drug and took more than two years to complete it.

The research study was conducted at the well equipped laboratory facilities of the Confederation of Ayurvedic Renaissance Keralam Ltd (CARe Keralam) at Thrissur to record the scientific evidence of preventing diabetes at its initial stage, said Bhagyanath Menon, managing director of the Centre. He said through proper documentation, the traditional knowledge of healing can be brought to the mainstream.

The drug master file prepared by Care-Keralam was intended for registering the product in foreign countries as an anti-diabetes formulation . This dossier was the first one prepared on the efficacy of an Indian herbal medicine following the department of Ayush guidelines for clinical trials for Ayurveda products.

The DMF (dossier) contained the product profile, manufacturing process, toxicity studies, analytical studies and anti-diabetic activity in rodents with streptzotocin-induced diabetes. Further, it contained formats for regulatory submission, drug licensing and GMP certification, said Dr. Joy Varghese, executive director of Care-Keralam.

The MD, B N Menon, said Care-Keralam has submitted 14 more proposals to undertake validation studies and on completing the projects, Indian traditional manufacturers can market their products to foreign countries as drugs. All these proposals have been made following the suggestions of Sam Pitroda, chairman of the NIC. Out of the 14 proposals, four have been given to the National Innovation Council, eight have been submitted to the Department of Ayush and two proposals have been presented before the state government.