EU, UK and Aussie regulators focus on Ranbaxys Toansa plant
After USFDA, even the other drug regulators are being more vigilant about the Toansa manufacturing plant of Ranbaxy in Punjab. Following the import ban laid by USFDA on the products manufactured at this plant, the EU, UK and Aussie drug regulators are now evaluating the details of USFDA’s inspection of Toansa plant.
These drug regulators are interested in assessing the impact of this import ban on the Ranbaxy products that are marketed in their countries. The Toansa plant contributes to about 70% of the API that the company produces internally. As USFDA identified data integrity issues during their inspections and considered this as a violation of good manufacturing practice (GMP) standards, the global regulators are even more concerned.
The IK drug regulator, MHRA stated that they are aware of the findings regarding GMP violations are Toansa plant. However, presently there is no evidence that the products going to the EU and UK market, manufactured at this plant are defective. Hence they stated that consumers can continue their use as suggested. TGA of Australia is awaiting details from the USFDA after which a decision about the safe use of medicines manufactured at this plant will be taken.
Following the footsteps, drug regulators from some other countries too plan to inspect the same facility and confirm the safety.