Tue Dec 30 04:30:00 UTC 2025: Here’s a summary of the text followed by a news article:
Summary:
An article from “The Hindu” discusses the high cost of drug development in India, particularly for rare diseases. It emphasizes the need to reduce these costs to encourage pharmaceutical companies to invest in new drug research and development. The article highlights the role of the Indian pharmaceutical industry in manufacturing generics, but notes their reluctance to invest in new molecules due to R&D costs. It suggests strategies like simplifying the regulatory approval process, utilizing cell-based and computational models in preclinical studies, and adopting innovative clinical trial designs (patient-centric, adaptive, master protocols, “n of 1” trials) and AI to reduce costs and accelerate drug development. The article concludes by urging India to update its regulations and incorporate these innovative approaches.
News Article:
India Aims to Slash Drug Development Costs to Boost Innovation
Bengaluru, India – December 30, 2025 – In a move aimed at stimulating innovation and making drugs more accessible, particularly for rare diseases, experts are calling for significant reductions in the cost of drug development in India. An article published today in The Hindu highlights the challenges faced by the Indian pharmaceutical industry, which primarily focuses on producing generic drugs due to the prohibitively high cost of researching and developing new molecules.
The article emphasizes the critical role the government and regulatory bodies can play in streamlining the drug approval process. Authors Alok Bhattacharya, Dr. Rakesh Mishra, and Gayatri Saberwal suggest simplifying regulations, promoting the use of cell-based and computational models in preclinical studies to replace costly animal testing, and adopting innovative clinical trial designs such as patient-centric trials and adaptive trials.
The current regulatory framework, governed by the New Drug & Clinical Trial (NDCT) Rules, 2019, is seen as cumbersome and costly. The article advocates for the integration of Artificial Intelligence (AI) into various stages of clinical trials for better prediction and monitoring.
“By simplifying regulations, incorporating innovative trial designs, and allowing for the safe use of AI, India can significantly reduce the costs associated with drug development,” states Alok Bhattacharya, honorary professor of biology at Ashoka University. “This would incentivize pharmaceutical companies to invest in the research and development of new drugs, especially for rare diseases, making them accessible and affordable for patients in India.”
The article concludes by urging a revision of the NDCT rules and the full utilization of Orphan Drug status provisions, aligning India with best practices already adopted in the U.S., UK, Japan, and the EU. The changes would allow for a waiver of local clinical trials if a drug has been approved in specific countries. The push for regulatory reform comes as India’s pharmaceutical industry is projected to reach $130 billion by 2030, highlighting the potential for growth and innovation in the sector.
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