TSDCA advisory on blood plasma
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.
Hyderabad: The TS Drug Control Administration (TSDCA) on Tuesday advised clinical research organisations (CROs), Bioavailability (BA) and Bioequivalence (BE) Study Centres in Hyderabad, who source their plasma and other biological materials like blood and serum for bioanalytical purposes, to enter into proper contractual agreements directly with blood centres.
“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 from DG, DCA, Kamalsan Reddy on Tuesday said.
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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.
The notification come after DCA came across instances where BA/BE centres were sourcing the plasma materials from third-party entities and not from blood centres without permission. Such unauthorised collection of blood components is an offence.
