Describe the rules that surround the development and registration of a new drug along with its companion diagnostic test kit in your region.

Background: You are part of a consulting firm hired by a small US pharmaceutical company currently developing a novel drug that targets non-small cell lung cancer (NSCLC) with a specific genetic mutation along with a companion diagnostic test kit to identify target patients for the treatment. The company would like to develop and market its products globally either through out-licensing, partnering, or on its own and would like to understand what it will take to bring this product to market in different regions.

Assignment:Country India. Describe the rules that surround the development and registration of a new drug along with its companion diagnostic test kit in your region. Describe relevant cultural aspects that must be kept in mind to effectively conduct business in the country and include recent examples and trends.

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