The research projects will be assigned to the seven NIPERs.
The Department of Pharmaceuticals may seek budgetary support to fund early stages of drug clinical trials. The research projects will be assigned to the seven National Institutes of Pharmaceutical Education and Research (NIPERs) that function under the department. These institutes will focus on developing new drugs for neglected diseases like malaria and tuberclosis.
“We are not seeking budgetary support for existing drug research funding mechanisms. They will continue to be run by other departments (science & technology, health). We are looking at creating new funding mechanisms to support early drug discovery programmes that the country needs,” said a senior chemicals ministry official.
“Phase I and II clinical trials will add a lot of value to Indian drug discovery programmes. NIPERs will be asked to take up such projects in association with other research institutes. We need to create an atmosphere of translational research,” he added.
The focus on research and development is based on the fact that early drug discovery programmes are the most risky and only a fraction of potential drug molecules prove to be safe, efficacious and commercially viable.
Early stages include phases I and II trials. In phase I, a drug or a treatment is tested on a group of 20-80 people for the first time to evaluate its safety, determine the dosage range and identify the side effects. The phase II trials are conducted on a larger group (100-300) to test the effectiveness and safety of a drug or a treatment.
The department feels NIPERs can hand over the potential drug candidates that clear the first two phases to the industry for conducting the final, or phase III, trials. This involves a large group of people (1,000-3,000) and is meant to confirm the drug’s effectiveness, its side effects and compare its merits vis-à-vis existing treatments. It is on the basis of phase III trials that the regulator gives marketing approvals.