Telangana drug regulator becomes eligible to observe USFDA inspections

Telangana has become the fourth state in India to become eligible to observe the inspections, joining Gujarat, Karnataka, and Goa.

The US drug regulator, announced in its ‘Global Update Newsletter’ from its Office of Global Policy and Strategy (OGPS) that officers of the Drugs Control Administration (DCA), Telangana, have joined the group of eligible states to observe inspections conducted by the USFDA in India.

The ‘First Annual Regulatory Forum’ between the USFDA and DCA was held on January 31, 2024, in Hyderabad. After the joint regulatory forum, the USFDA made this announcement through its official newsletter, DCA Director General V. B. Kamalasan Reddy said on Saturday.

“This allows Drugs Inspectors of DCA, Telangana, to be invited to observe select USFDA medical product inspections, which is one of the activities planned and performed under a ‘Memorandum of Understanding’ that the USFDA signed with India in 2020,” he said in a statement.

Telangana, often referred to as the ‘Bulk Drug Capital of India’, accounts for more than 35 per cent of the total pharmaceutical production in India. It has more than 214 USFDA-registered manufacturing sites, i.e., pharmaceutical companies that manufacture and export medicines to the US.

As the state regulatory authority of Telangana, DCA has taken several new regulatory initiatives, thus creating a stringent regulatory environment and better oversight with respect to the medicines manufactured in Telangana, he said.

The joint regulatory forum with USFDA was designed to share inspectional best practices for medical products and served as an opportunity for the USFDA and DCA Telangana to provide an overview of regulatory operations and learn about one another’s current compliance practices to better inform future engagements. Collaboration between the USFDA and DCA, Telangana, can be beneficial for ensuring the safety and quality of pharmaceutical products, Kamalasan Reddy said.

Allowing Drugs Inspectors from the DCA to observe USFDA inspections in Telangana can provide them with valuable insights into international regulatory standards and practices. The DCA DG said this collaboration could potentially lead to enhanced regulatory harmonisation, improved compliance with global standards, and better oversight of pharmaceutical manufacturing processes in Telangana.

It can also facilitate knowledge sharing and capacity building among regulatory authorities, ultimately benefiting public health by ensuring the availability of safe and efficacious medicines, he added.

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