Experts are now gearing up for the next step, which is to hold clinical trials and toxicity studies before seeking permission from the Ministry of Ayush and the Drug Controller of India (DCI) for commercial production.
The project was undertaken jointly by the Department of Biotechnology (DBT), under the Ministry of Science and Technology, the International Centre for Genetic Engineering and Biotechnology and Ranbaxy Research Laboratory (now owned by Sun Pharma), and employed Ayurveda in devising the drug.
According to Professor Vaidya KS Dhiman, Director General of CCRAS, the Double-Blind Placebo-Controlled Clinical Trial, which is a medical study involving human participants and is an internationally accepted method of testing is going on in the medical colleges of Belgaum and Kolar.
This drug has been made with seven herbal ingredients which are in use in Ayurveda system of medicine since centuries, Dhiman said.
As such, there is no direct references and description regarding dengue in Ayurveda and Siddha literature.
“We started working on making this drug in 2015 and in the process pilot studies were conducted in Medanta Hospital, Gurgaon, and in the medical colleges of Belgaum and Kolar which proved the clinical safety and efficacy of this drug in the management and treatment of dengue. We had prepared the drug by June last year,” Dhiman said.
During the pilot study, 90 patients were given this drug in highly concentrated liquid form. But in the ongoing clinical trial, the drug is given in tablet form.
Dengue is caused by the Aedes aegypti mosquito which breeds in clean water. The symptoms of dengue include high fever, joint pains, headache, nausea, vomiting, dip in blood pressure along with a characteristic skin rash.
Though the fever does not last beyond a week, in some cases there is a severe drop in the level of platelets which turn fatal.
At present, there is no specific drug or antibiotic to treat dengue and the treatment focuses on providing relief from the symptoms. Rest and fluid intake for adequate hydration is important.
Dengue, a mosquito-borne viral disease, poses a significant global public health risk. In tropical countries such as India, where periodic dengue outbreaks can be correlated to the high prevalence of the mosquito vector circulation of all four dengue viruses (DENVs) and the high population density, a drug for dengue is being increasingly recognised as an unmet public health need.
According to WHO, dengue is the fastest growing mosquito-borne disease in the world today, causing nearly 400 million infections every year.
India in 2017 has seen 15, 7220 cases of dengue and 250 deaths due to the disease (till December 24), as per the National Vector Borne Disease Control Programme (NVBDCP) data. In 2016, the country registered 129166 cases and 245 deaths.