Goa, Telangana Regulators Granted US FDA Inspection Access in India

The US Food and Drug Administration (FDA) has announced that drug regulators from Goa and Telangana have joined the group of states overseeing the agency's inspections in India.

Goa and Telangana will join Gujarat and Karnataka, according to a global update on FDA and Office of Global Policy and Strategy developments, to become the third and fourth states to achieve this goal, with OGPS headquarters and field offices. When a government reaches that status, the FDA will notify the Central Drug Standards Organization (CDSCO), the US drug regulator.

It is considered the main medicinal capital of India. World Vaccine Capital,  Telangana accounts for more than 40% of India's total API production and more than 35% of India's total pharmaceutical production.It also accounts for 50% of India's API exports and one-third of global vaccine production.

Located on the Arabian Sea, Goa is India's smallest state by area but has a well-established pharmaceutical industry and an emerging area for the biotech and IT industries, according to a global update.

This announcement came after the two governments participated in a regulatory forum organized by the FDA India Office (INO). The first annual meeting with the Goa Drug and Food Authority (DFDA) was held on 18-19 October 2023, and the first annual meeting with the Telangana Drug Control Authority was held on 31 January 2024

The staff of the FDA spoke about the following: Elements of the Agency's Inspection Standard Operating Procedures: This process allows Indian inspectors to request to observe the FDA's inspection of pharmaceutical products. This is a planned activity under the Memorandum of Understanding signed by the FDA and India in 2020—drug administration.