Policy & Ethicsnon animal modelsadaptive trialsndct 2019
India Simplifies Rules to Spur Drug Development
6.0
Indian experts argue that simplifying regulations and adopting AI, non-animal preclinical methods, and innovative clinical trial designs could lower drug development costs and stimulate new-molecule research, especially for rare diseases. The article cites CDSCO oversight under NDCT-2019, projected Indian pharma revenue of about $130 billion by 2030, and high R&D costs ($100 million–$1 billion) as barriers; it urges policy changes including Rule 101 orphan-drug provisions.
Key Points
- 1Report projects India pharma revenue reaching $130 billion by 2030, driven mainly by generics.
- 2Noting R&D costs of $100 million–$1 billion deter new-molecule development, especially for rare diseases.
- 3Recommend regulatory simplification, AI, non-animal models, and adaptive trials to reduce costs and incentivize innovation.
Scoring Rationale
Policy-oriented and practical recommendations with credible authorship, but limited novelty and lacking formal government or empirical evidence.
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