Telangana and Goa regulators qualified to observe US FDA inspections in India

The US Food and Drug Administration (FDA) announced that Goa and Telangana's regulatory bodies can now observe inspections conducted by the FDA in India. These states join Gujarat and Karnataka, becoming the third and fourth states, respectively, to achieve this status, according to the FDA's Office of Global Policy and Strategy (OGPS).

Telangana, known for its significant contribution to India's pharmaceutical sector, accounts for over 40% of the country's active pharmaceutical ingredients (API) production and a substantial portion of global vaccine production. Goa, despite being India's smallest state, has emerged as a pharmaceutical hub and is attracting attention from the biotechnology and IT industries.

This announcement follows the participation of both states in joint regulatory forums organized by the FDA's India Office (INO). These forums aim to enhance Indian regulators' capacity for regulatory oversight of medical products by familiarizing them with FDA inspectional practices and facilitating their qualification to observe FDA inspections.