USFDA joins hands with DCA Telangana for future strategic initiatives

The inaugural "Annual Regulatory Forum" between USFDA and Drugs Control Administration, Telangana, took place here on Wednesday.

Drugs Control Administration, Telangana, remains committed to combating the menace of spurious drugs, actively working to expose illegal activities such as unlicensed drug manufacturing in chemical factories, unlawful stocking and sale of drugs, and the manufacturing of drugs disguised as food products. These activities pose a serious risk to public health.

As the State Regulatory Authority of Telangana, contributing to over 35 per cent of pharmaceutical production in India, Drugs Control Administration, Telangana, has implemented various regulatory initiatives.

These include risk-based inspections, risk-based sampling, stringent testing guidelines for raw materials such as Glycerin and Propylene Glycol to ensure the safety of cough syrups, the establishment of a vigilance cell for detecting clandestine activities, unannounced inspections of chemical/intermediate units, and a stringent review process for licensing manufacturers. These measures create a robust regulatory environment and enhance oversight concerning medicines manufactured in the State of Telangana.

A team of USFDA officials, led by Dr Sarah McMullen, Country Director, US FDA Indian Office, proposed the "US FDA – Telangana DCA Regulatory Forum" during their visit to the Drugs Control Administration office at Vengalrao Nagar, Hyderabad, on November 2, 2023. This forum aims to facilitate future strategic collaboration and initiatives, given that Telangana State hosts more than 214 USFDA registered manufacturing sites, i.e., pharmaceutical companies exporting medicines to the USA.

The "First Annual Regulatory Forum" between USFDA and Drugs Control Administration, Telangana, occurred on Wednesday in Hyderabad. Dr. Sarah McMullen, along with other USFDA officials, including Dr Phil Nguyen, Yvins Dezan, Guerlain Ulysse, Dr. Sudheendra Kulkarni, and Dhruv Shav, actively participated in this event.

During the forum, Drugs Control Administration, Telangana, provided a comprehensive presentation on its regulatory program overview, current operations, and initiatives.

Dr. Sarah McMullen presented an overview of recent USFDA initiatives and inspection trends in India. USFDA officials shared insights on the Medical Products Program, mechanisms for manufacturing facility oversight, regulatory actions, approaches to the Pharmaceutical Quality System, and a risk-based approach for GMP inspections.

Discussions also revolved around the 'Observed Inspection SOP,' exploring the possibility of future participation of Drugs Control Administration, Telangana, inspectors as 'observers' in US FDA-led inspections.

The annual regulatory forum serves as a platform for USFDA and Drugs Control Administration, Telangana, to identify best practices, foster strategic collaboration, and exchange insights. It provides an invaluable opportunity for both entities to present an overview of their operations and learn about each other's current practices for potential future engagements, a statement here said.