01 January 2019 | News
The Gazette of India notification of guidelines for phytopharmaceutical drug development offers opportunity to leverage traditional knowledge for drug development based on modern science and modern medicine principles
India is known for its traditional systems of medicine for health care. The resource base to support delivery through such a system has been developed systematically over the years and is continuously being strengthened and positioned to attract the global attention. For the centuries, India has also been at the forefront for the use of medicinal and aromatic plants.
The Gazette of India notification of guidelines for phytopharmaceutical drug development offers an opportunity to leverage traditional knowledge for drug development based on modern science and modern medicine principles.
In order to leverage the effort, the Council of Scientific & Industrial Research (CSIR), Department of Biotechnology (DBT) and Indian Council of Medical Research (ICMR) have entered into Memorandum of Understanding (MoU) for inter-ministerial cooperation. The focus is on boosting innovative research on phytopharmaceuticals.
About the MoU
The MoU amongst CSIR, DBT and ICMR is for mutual collaboration to develop phytopharmaceutical products for therapeutic use following international standards and norms for establishing safety, quality, standardization and efficacy. The effort would beto take forward the leads already existing with CSIR, DBT and ICMR and develop specific collaborative projects in the domain aiming at rigorous modern scientific testing and development of standard products to maintain global competitiveness.
The role of each agency has been defined in the MoU. CSIR will be responsible for undertaking the R&D for developing desired phytopharmaceutical leads (both with short term & long term translational period), which can be taken forward for positioned product development following DCGI regulatory guidelines; pre-clinical pharmacology; CMC and IND enabling studies; and safety and regulatory toxicity studies. DBT would be responsible for identifying the leads based on its extra-mural research, providing funds for R&D projects taken under the MoU and preparation of respective sections of IND dossier in mutual collaboration with ICMR. Preparation of IND dossier and its submission to DCGI, preparation of clinical trials protocols, obtaining regulatory clearance for clinical trials and conducting trials with the compilation of results etc. would be the responsibility of ICMR.
This synergetic approach being put in the country for the first time would lead to taking up of the identified activities in the mission mode through best of the institutions in the Country. The CSIR had launched “Phytopharmaceutical Mission” about a year back