Abstract

INDIA’S REGULATORY TRANSITION: FROM GENERIC GIANT TO INNOVATION HUB

Barkha Gupta, Narender Kumar Ahuja, Deepika Yadav and Shiv Kumar Yadav*

ABSTRACT

Globally, India is recognized as the “Pharmacy hub of the world” and is the largest supplier of generic medicines. However, a robust regulatory framework is essential to sustain growth and foster innovation in the pharmaceutical industry, especially given the evolving landscape, the rise of medical devices, and advancements in clinical research. These modern challenges are not adequately addressed by the Drugs and Cosmetics Act of 1940, which was enacted during the colonial era. This article explores India’s trajectory toward becoming a global innovation hub and highlights the urgent need for regulatory reforms. Emphasizing quality over quantity, India is currently transitioning from a leader in the production of generic drugs to a pharmaceutical hub driven by innovation. Simultaneously, the nation aims to establish itself as a hub for medical devices, which are presently governed by outdated regulations under the Drugs and Cosmetics Act.

Keywords: Generic, Innovation, Stringent, PIC/S, WHO, ICH and PNDT guidelines.