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

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 …

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.

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 …

Indian Good Clinical Practices (GCPs) guidelines were adopted in December 2001 and amended in 2005. These mandatory guidelines cover all biomedical research in India at all stages of …

But, after the 2005 amendment to the Schedule Y of the Act, parallel global clinical trials are possible and India now permits concomitant phase 2 and phase 3 trials.

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 …

In light of the challenges faced by the clinical trial industry, the Indian government has implemented several reforms aimed at attracting global studies. One of the significant changes …

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 …

Feb 26, 2025 · In 2005, when the Agreement on Trade Related Aspects of Intellectual Properties (“TRIPS”) became operational, it was guaranteed for India to become a global hub of …