New Delhi: Indian Council of Medical Research (ICMR) and Emami Healthcare have signed two memoranda of understanding (MoU), one for the development of standardized phytopharmaceutical formulation to prevent or delay the development of Type-2 Diabetes in people with pre-diabetes and another for the development of standardized herbal or ayurvedic formulation to treat sleep disorders.
The MoUs were signed by Dr Soumya Swaminathan, Director General, ICMR, New Delhi and Dr C K Katiyar, CEO, Emami Healthcare, Kolkata on May 12.
“The formulation for preventing Type-2 Diabetes will help people with pre-diabetes from not entering into the state of diabetes, while the herbal drug for sleep disorders will be for people suffering from insomnia and it will be much better than the current tranquilizers. For both these molecular herbal drugs, we have worked on medicinal plants. We are ready to move ahead with these drugs. This is where, the MoUs between ICMR and Emami happened,” Dr Soumya Swaminathan, Director General, ICMR, told ETHealthWorld.
These are basically two multicentric task force projects that have been conceived by ICMR with translational approach from identified leads and aimed to collaboratively develop phytopharmaceuticals or herbal drugs with the industry.
ICMR will mainly support and manage the pre-clinical, toxicological and clinical development phase of the product development programmes, whereas the industry will look after and undertake the chemistry, manufacturing and control (CMC) part of the product development phase.
Emami Healthcare is expected to manufacture the herbal drugs within a period of 18 months. “It’s a nice partnership because the company will take care of all CMC (Chemistry, Manufacturing, and Control) including pre-clinical toxicology, and later on ICMR will sponsor the clinical trials at AIIMS to prove the safe parameters and effectiveness of the drugs. The clinical trials period will take another 24 months because we will need to do CGI (clinical global impression) as well. After we have completed dossier of these herbal drugs, we will be able to bring them into clinical use,” added Dr Swaminathan.
“The ownership of developed products will be solely of ICMR, whereas the industry will have the first right of refusal on these developed products,” according to a statement by ICMR.
“We are very happy to collaborate with ICMR to develop herbal remedial products for treatment of pre-diabetic condition and sleep disorder problem. We look forward to our collaboration to develop effective solutions for the benefit of consumers,” said Harsha V Agarwal, Director, Emami Limited.