The US Food and Drug Administration (USFDA) has partnered with the Drugs Control Administration (DCA) in Telangana for future initiatives. The two organizations held their first annual regulatory forum on January 31 in Hyderabad. The DCA in Telangana is working to combat the production and sale of counterfeit drugs, as well as other illegal activities that pose a serious risk to public health.
As the regulatory authority in Telangana, the DCA has implemented various measures to ensure the safety of pharmaceuticals produced in the state. These include risk-based inspections and sampling, strict testing guidelines for raw materials used in cough syrups, the creation of a vigilance cell to detect illegal activities, unannounced inspections of chemical factories, and stringent review of licenses for manufacturers.
During the forum, USFDA officials discussed the possibility of DCA inspectors from Telangana participating as observers in USFDA-led inspections. The purpose of the annual regulatory forum is to identify best practices and opportunities for collaboration between the two organizations. It also allows for an exchange of information about their respective operations and practices.
In November 2023, a team of USFDA officials visited the DCA office in Hyderabad and proposed the establishment of a “USFDA-Telangana DCA Regulatory Forum” for future collaboration. This is because Telangana has more than 214 USFDA registered manufacturing sites that produce and export medicines to the USA.
The first annual regulatory forum took place on January 31, 2024, in Hyderabad. USFDA officials, including Dr. Sarah McMullen, Dr. Phil Nguyen, Yvins Dezan, Guerlain Ulysse, Dr. Sudheendra Kulkarni, and Dhruv Shav, participated in the forum alongside DCA Telangana.
During the forum, the DCA presented an overview of its regulatory program and current initiatives, while USFDA officials discussed their recent initiatives and inspection trends in India. They also gave presentations on their medical products program, manufacturing facility oversight, and regulatory actions, as well as their approaches to the pharmaceutical quality system and risk-based inspections.
