Telangana becomes 4th state to have DCA drug inspectors join in USFDA inspections

Hyderabad: The US Food and Drug Administration (USFDA) has announced that drug inspectors from the Drugs Control Administration (DCA) in Telangana are now eligible to observe USFDA inspections conducted in the state.

Director General VB Kamalasan Reddy, IPS, highlighting Telangana’s accomplishment, said, “Telangana has now become the fourth state in India to reach this milestone, joining Gujarat, Karnataka, and Goa.”

The announcement was made through the USFDA’s Global Update Newsletter issued by the Office of Global Policy and Strategy (OGPS) in February 2024. The culmination of this collaboration followed the First Annual Regulatory Forum held on January 31, 2024, between the USFDA and the Drugs Control Administration, Telangana, in Hyderabad.

‘Bulk Drug Capital of India’

Telangana, often recognised as the ‘Bulk Drug Capital of India,’ contributes over 35 per cent to the total pharmaceutical production in the country. With more than 214 USFDA-registered manufacturing sites, the state plays a crucial role in the pharmaceutical landscape.

The joint regulatory forum aimed at sharing inspectional best practices for medical products and provided an opportunity for the USFDA and DCA Telangana to exchange insights into regulatory operations and compliance practices. The collaboration is facilitated by a Memorandum of Understanding (MoU) signed between the USFDA and India in 2020.

Kamalasan Reddy emphasised Telangana’s commitment to stringent regulatory initiatives, creating a regulatory environment with better oversight of pharmaceutical manufacturing processes in the state.

Opportunity to bring global standards to Telangana

The collaboration between USFDA and DCA, Telangana, is anticipated to enhance regulatory harmonisation, improve compliance with global standards, and provide better oversight of pharmaceutical manufacturing processes. The involvement of drug inspectors from Telangana in observing USFDA inspections is seen as a valuable opportunity for gaining insights into international regulatory standards and practices.

“The collaboration is expected to contribute to knowledge sharing and capacity building among regulatory authorities, ultimately ensuring the safety and quality of pharmaceutical products. This aligns with the broader goal of benefiting public health by guaranteeing the availability of safe and efficacious medicines,” said Reddy.