Telangana DCA, USFDA collaborate for future strategic initiatives

HYDERABAD: Telangana Drug Control Administration and the United States Food and Drug Administration (USFDA) established a collaboration on Wednesday to create an effective regulatory framework and plan for future strategic initiatives.

In a significant step toward this partnership, a team led by Dr. Sarah McMullen, Country Director of the US FDA Indian Office, visited the Drugs Control Administration office in Vengal Rao Nagar, Hyderabad, on November 2, 2023.

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With Telangana playing a substantial role, boasting more than 214 USFDA registered manufacturing sites, the proposal for the establishment of the 'US FDA Telangana DCA Regulatory Forum' materialized. The outcome was the 'First Annual Regulatory Forum,' which took place on January 31, 2024, in Hyderabad.

Key USFDA officials, including Dr. Phil Nguyen, Yvins Dezan, Guerlain Ulysse, Dr. Sudheendra Kulkarni, and Dhruv Shav, actively participated in discussions aimed at fostering collaboration and ensuring pharmaceutical safety.

During the forum, Telangana Drugs Control Administration (DCA) presented an overview of its regulatory programs, current operations, and initiatives to secure the pharmaceutical landscape in Telangana. Dr. Sarah McMullen shared insights into recent USFDA initiatives and inspection trends in India, emphasizing the importance of a risk-based approach for Good Manufacturing Practice (GMP) inspections.

A noteworthy discussion point focused on the 'Observed Inspection SOP,' setting the stage for Telangana DCA inspectors to participate as 'observers' in US FDA-led inspections.

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This annual regulatory forum symbolized a strategic collaboration between the USFDA India Office and the Drugs Control Administration, Telangana, designed to identify best practices and initiatives for the future. The platform facilitated the exchange of operational overviews and provided a valuable opportunity for both entities to learn about each other's practices, enhancing their engagement in ensuring pharmaceutical safety and quality.

In an ongoing effort to combat the proliferation of counterfeit drugs, the Telangana Drugs Control Administration (DCA) has intensified its regulatory initiatives, targeting illegal activities such as unlicensed drug manufacturing and unlawful sales. Telangana, a key contributor to over 35 percent of India's pharmaceutical production, has implemented a series of measures, including risk-based inspections and stringent testing guidelines, to safeguard public health.