Hyderabad: Officials of the TS Drugs Control Administration (TSDCA) can now observe operations of the US Food and Drug Administration (USFDA), the US drugs regulator announced, making Telangana the fourth state, after Gujarat, Karnataka and Goa, to avail of this facility.
Telangana, the bulk drug capital of India, accounts for more than 35 per cent of the total pharmaceutical production in India and has 214 USFDA-registered manufacturing sites —companies that manufacture and export medicines to the US, TSDCA director-general V.B. Kamalasan Reddy said on Saturday.
He said that the decision allows TSDCA inspectors to be invited to observe USFDA medical product inspections, under a memorandum of understanding signed in 2020. The USFDA made the announcement through its global update on February 14, following the first annual regulatory forum meeting with the TSDCA on January 31.
The TSDCA has taken several new initiatives, creating a stringent regulatory environment and better oversight concerning the medicines manufactured in the TS, he said.
“The joint regulatory forum with USFDA was designed to share inspectional best practices for medical products and serve as an opportunity for the USFDA and DCA Telangana to provide an overview of regulatory operations and learn about one another’s current ompliance practices to better inform future engagements,” Kamalasan Reddy said.
Collaboration between the USFDA and TSDCA can be beneficial for ensuring the safety and quality of pharmaceutical products.
“This collaboration could potentially lead to enhanced regulatory harmonisation, improved compliance with global standards, and better oversight of pharmaceutical manufacturing processes in the state,” the DG said.
