Dec 17, 2024 · This 2005 amendment introduced the formal definition of a clinical trial and allowed trials in India to be conducted in step with the same trial phase of drug development as elsewhere in the …

Dec 10, 2024 · The Patents (Amendment) Act of 2005 introduced full patent protection for pharmaceutical products, which, along with regulatory reforms, has encouraged significant …

In this paper we have described the ethical deliberation and action taken by CSOs in India in response to the increase of international clinical trials after 2005.

At the same time, a number of press reports on clinical trials, in India, of drugs are given substantial incentives to recruit their own patients into these trials thus creating a major conflict of interest that …

Sep 21, 2025 · This article provides an in-depth exploration of clinical trials in India, focusing on their legal structure, ethical dilemmas, international comparison, judicial interventions, and evolving …

Although the spirit of these new laws is a welcome move, some changes are insufficient to fill the lacunae. This article summarizes these amendments and highlights the significant threats and …

Sep 3, 2025 · From approvals and trial structures to the new challenges posed by data and technology, this piece offers a clear view of where the ecosystem is headed and what it means for …

Dec 30, 2024 · proval mechanisms. India's recent regulations align with international standards and aim to improve efficiency and patient safety in clinical trials. The comparison demonstrates the …

However, these trials also introduce significant ethical and legal complexities, especially when undertaken in developing countries such as India. This paper analyzes the evolution and current …

Dec 15, 2024 · Clinical trials do form an integral part of pharmaceutical research advances, but the conduct of their activities in India raises highly serious ethical, legal, and social problems, especially …