Last Updated on February 15, 2021 by The Health Master
The Union health ministry has issued draft notification on New Drugs and Clinical Trials (NDCT) Amendment Rules, 2021 for inclusion of provisions related to registration of standalone Bioanalytical (BA) laboratories vide notification No, GSR 99(E) dated 05-02-2021.
To rad or download the notification No, GSR 99(E) dated 05-02-2021, click here
As per the draft rules, these rules may be called the New NDCT Amendment Rules, 2021. They shall come into force on the date of the final publication in the Official Gazette.
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.
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.
In the NDCT Rules, 2019, in Rule 2, in Sub-Rule (1), in clause (g), after the words, ‘clinical part’ and before the words, ‘or for both’, the words, ‘or analytical part’ shall be inserted.
The principal rules were published in the Gazette of India vide notification number G.S.R. 227(E), dated March 19, 2019.
To rad or download the notification No, G.S.R. 227(E), dated March 19, 2019, click here
“The following draft of certain rules further to amend the New Drugs and Clinical Trials Rules, 2019 which the Central Government proposes to make, in exercise of the powers conferred by sub-section (1) of section 12 and sub-section (1) of section 33 of the Drugs and Cosmetics Act, 1940 (23 of 1940) and in consultation with the Drugs Technical Advisory Board (DTAB) is hereby published for information of all persons likely to be affected thereby and notice is hereby given that the said draft rules shall be taken into consideration on or after the expiry of a period of fifteen days from the date on which the copies of the Gazette of India containing these draft rules are made available to public,” as per the draft notification.
Objections and suggestions which may be received from any person within the period specified above will be considered by the Central Government; Objections and suggestions, if any, may be addressed to the Under Secretary (Drugs), Union Health Ministry, Government of India, Room No. 434, A Wing, Nirman Bhavan, New Delhi – 110011 or emailed at [email protected]
BA of drugs signifies the rate and extent to which their active ingredient is absorbed systemically after dosing. Bioequivalence (BE) establishes generic drugs as interchangeable to the branded ones with similar therapeutic and side effect profiles.
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.
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 and Ethics Committee. BA laboratory is the laboratory meant for analysis of biological samples received from the BA/BE Study Centres.
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