The TS Drug Control Administration (TSDCA) advised clinical research organisations (CROs), Bioavailability (BA), and Bioequivalence (BE) Study Centres in hyderabad on tuesday to enter into proper contractual agreements directly with blood centres when sourcing plasma and other biological materials such as blood and serum for bioanalytical purposes.
 
"The BA/BE centres and CROs that hold requisite registrations issued by CDSCO may source plasma and other biological materials directly from blood centres after making a contractual agreement indicating the roles and responsibilities of both BA/BE centres, CROs and blood centres," a notice issued by the DG, DCA, Kamalsan stated.

The BA/BE Centres/CROs must maintain the agreement for the collection of plasma, among other things, from blood centres for analytical purposes and research samples, as well as the appropriate SOPs and labels. The notice occurred after DCA discovered instances in which BA/BE centres obtained plasma materials from third-party businesses rather than blood centres without approval. Unauthorised collection of blood components is an offence.

The agreement for the collection of plasma etc from blood centres for analytical purposes and study samples shall be maintained by the BA/BE Centres/CROs along with relevant SOPs and labels used in this regard.
 
 
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Telangana

G GOWTHAM

29/05/2024 09:57 AM