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US FDA Officials Visits Telangana DCA to Map Out Drug Quality & Safety Measures

Written by : Dr. Aishwarya Sarthe

November 3, 2023

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The visit involved discussions on various measures and strategies to enhance the quality control processes in the pharmaceutical sector. 

In a significant development in the pharmaceutical regulatory sphere, officials from the United States Food and Drug Administration (US FDA) visited the Drug Control Administration (DCA) of Telangana, located in Vengal Rao Nagar, Hyderabad. 

The objective of this meeting was to discuss initiatives aimed at ensuring the stringent implementation of regulatory standards to safeguard the quality and safety of drugs and medicines produced by the pharmaceutical, biotech, and related industries.

The visit involved discussions on various measures and strategies to enhance the quality control processes in the pharmaceutical sector. 

During the discussions, Director General Kamalasan Reddy highlighted the adoption of risk-based sampling techniques and the issuance of advisories to the industry regarding the testing of raw materials, particularly Glycerin and Propylene Glycol, to monitor DEG and EG content. 

He underlined the department's commitment to ensuring the quality of raw materials used in drug production by pharmaceutical companies, elaborating on the operations of the vigilance cell.

Expressing satisfaction with the visit, Kamalasan Reddy revealed the proposal put forth by US FDA authorities to establish a 'US FDA and Telangana DCA Regulatory Forum.' 

The primary objective of this forum is to explore observed inspections, with the intent to involve DCA Telangana inspectors as observers in US FDA-led inspections, thereby fostering strategic collaboration and initiatives between the two regulatory bodies.

This collective effort marks a significant step towards the shared goal of safeguarding public health and bolstering the integrity of the pharmaceutical industry.

In addition, Telangana's Drug Control Administration has introduced a Centralized Toll-Free Number (1800-599-6969) for the public to report grievances, credible complaints, and information regarding illegal drug sales, spurious drugs, and issues related to drug quality, price, availability, and misleading advertisements in Telangana.


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