The Ministry of Health and Family Welfare has come with new regulations regarding clinical trials of drugs in India called New Drugs and Clinical Trials Rules, 2019 with the objective to make the country more favourable for clinical research and drug development. These new rules will apply to all […]
The Ministry of Health and Family Welfare has come with new regulations regarding clinical trials of drugs in India called New Drugs and Clinical Trials Rules, 2019 with the objective to make the country more favourable for clinical research and drug development. These new rules will apply to all new drugs, investigational new drugs for human use, clinical trial, bioequivalence study and Ethics Committee.
The new regulations will reduce the time of approval of a new drug discovered in the country to 30 working days. This is great news for local drug development. The approval time for a drug discovered outside the country will be 90 days. This will help India to participate in global drug development and research.
For the first time in India, Orphan Drugs have been defined as a drug intended to treat conditions which affect not more than five lakh patients in India. There will be fee waivers for orphan drug trials. This will encourage more research and development for rare diseases in India.
In situation where the evidence for clinical safety and efficacy have been established even if the drug has not completed the all or normal clinical trial phases, the sponsor or applicant may apply to the licensing authority for expedited review process wherein the licensing authority will examine and satisfy the following conditions –
This forward step of the Government of India will change the scenario of Clinical Research in the country and will ensure the initiation of new drug development and quicker access to new treatment for patients.
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