India is a leader in global generic pharmaceuticals manufacturing. However, many generics manufactured in India are at the end of their respective product life cycle, with limited new research and development taking place on new drugs.Furthermore, our country has a high burden of both communicable and non-communicable diseases and is vulnerable to epidemics. In order to keep pace with global innovation and to improve health outcomes, there is a need to foster R&D for new and cost-effective therapies. With the aim to take India at global map in terms of R&D innovations in the area of drug development in our country, the Department has initiated a new program on “Drug Development” with a vision to develop indigenous and cost-effective new drugs
The goal of this Call is to support milestone-driven proposals focused on lead optimization and preclinical testing of candidate therapeutics for the given four diseases (Tuberculosis, Cardio-Vascular Diseases (CVD), Chronic Obstructive Pulmonary Diseases (COPD) and Cancer (oral, head and neck, cervical and breast cancer). All proposed studies must be directed to regulatory submission in India and therefore this Call excludes basic research, studies of disease mechanisms or epidemiological studies. Applications are expected to have defined Milestones and Timelines detailing how the project will move forward with identified key Go / No Go decision points. Of the Drug Development stages as defined below, this Call is intended for research and development activities focused ONLY on Lead optimization and preclinical development and Clinical therapeutic validation to a point where there is sufficient scientific evidence to justify filing for regulatory approval: I. Lead optimization and preclinical development: These activities are expected to be carried out under requirements of the New Drugs and Clinical Trial Rules, 2019. Processes by which additional alterations to an identified therapeutic lead may be made in conjunction with preclinical assessments of its in vivo pharmacokinetics, efficacy, and safety. The goal is to generate a lead clinical candidate, establish industrially feasible synthesis, generate chemical and pharmaceutical information on the proposed drug substance and drug product, and associated data package that supports regulatory approval for the initiation of clinical validation. Lead optimization and preclinical development studies include proof of efficacy in more animal models of disease, establishment of pharmacokinetics of the therapeutic as well as in vivo studies exploring its safety/toxicity. II. Clinical therapeutic validation: Studies conducted in human patient populations to fully understand the efficacy and safety profiles of a compound and its associated target.
The proposals can be submitted at DBT eProMIS portal :
All above should also send a soft copy of their application to (firstname.lastname@example.org) and two hard copies should also be sent to: Dr. Vinita N. Chaudhary, Scientist ‘E’, Department of Biotechnology, Block- 2, Room No.705, 7th floor, CGO Complex, Lodhi Road, New Delhi – 110003.
Proposals may be submitted online in the DBT R&D format through DBT- eProMIS (http://dbtepromis.nic.in/Login.aspx) under Category of Area-‘Drug Development’, clearly stating ‘Proposal against Call for Proposal’. Subsequently, two hard copies should also be sent to: Dr. Vinita N. Chaudhary, Scientist ‘E’, Department of Biotechnology, Block- 2, Room No.705, 7thfloor, CGO Complex, Lodhi Road, New Delhi – 110003.
Announcement Date: 01-01-2020
Last Submission Date: 29-02-2020