【EXPERT Q&A】Is it mandatory to conduct clinical trials for drug registration in India?
August 9, 2023
Source: drugdu
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Drugdu.com expert's response:
Based on the years of experience from Drugdu.com, the number and cases of clinical trials conducted in India are related to the current clinical situation and whether the original research drug is marketed locally. Specific issues require case-by-case analysis.
In general, for drug registration in India, if it is a chemical drug or a formulation, and the original research drug is already marketed in India, it can be registered as a generic drug in India, and clinical trials can be waived. Some orphan drugs, especially those that face recruitment challenges in clinical trials and are already marketed in the regulatory markets of Europe and the US, can also apply for exemption from local clinical trials.
However, for biologics such as vaccines, monoclonal antibodies, and blood products, conducting phase III (bridging) clinical trials locally is mandatory for registration in India.
Taking phase III clinical trials as an example, the number of trial participants is generally between 300-500, and the required time is about a year and a half.
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