Health Ministry To Amend NDCT Rules For Registration Of Standalone BA Labs

Mumbai, 2 Dec 2020:

The Union health ministry is planning to amend the New Drugs and Clinical Trial (NDCT) Rules, 2019 for inclusion of provisions related to registration of standalone Bioanalytical (BA) laboratories.

Bioequivalence (BE) establishes generic drugs as interchangeable to the branded ones with similar therapeutic and side effect profiles. BA of drugs signifies the rate and extent to which their active ingredient is absorbed systemically after dosing. 

Representations were made that the BA laboratory involved in analysis of the biological samples of BA/ BE studies are part of BA/BE Study Centre and hence need to be regulated along with the BA/BE Study Centres.

As per the Rule 2(g) of NDCT Rules 2019, "Bioavailability and bioequivalence study centre” is defined as -"BA and BE study centre” means a centre created or established to undertake BA or BE study of a drug for either clinical part or for both clinical and analytical part of such study.

However, this existing definition is not covering stand alone analytical laboratories.

It was proposed to amend the NDCT Rules -2019 to include the provision of registration of stand-alone Bio-analytical laboratories by inserting the word analytical part in the definition as follows - "BA and BE study centre” means a centre created or established to undertake BA study or BE study of a drug for either clinical part or analytical part or for both clinical and analytical part of such study.

The Union health ministry had notified the NDCT Rules, 2019 dated March 19, 2019 under the provisions of the D&C Act, 1940.

These Rules are today applicable to all new drugs, investigational new drugs for human use, clinical trial, BE study, BE study and Ethics Committee. BA laboratory is the laboratory meant for analysis of biological samples received from the BA/BE Study Centres.Pharmabiz