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DCGI approval required for trial of new topical formulation

Dr arun Bhatt
Tuesday, May 31, 2016, 08:00 Hrs  [IST]

Can a patient be re-screened for a lab test value that has been corrected after appropriate therapy as the initial lab testing did not meet the inclusion criteria? Do regulatory authorities accept such practice?

Dr Yogesh

There is no specific regulatory guidance on the issue of re-screening of a patient in clinical trial.

Hence, one needs to consider several issues before deciding whether to re-screen a subject or not.

Concerning re-screening, the approved protocol should state the criteria for re-screening, considering safety/ethical implications as well as any impact to the data integrity and statistical analysis. If re-screening is not defined in the protocol, then the question is: What’s the purpose of re-screening.
  • Is the patient undergoing re-screening just to fulfil inclusion criteria? If the protocol does not mention re-screening process, then the re-screening implies a change in inclusion criteria. Any change in inclusion/exclusion is considered major amendment by CDSCO and will require their approval.
  • If such a scenario repeats, would you re-screen all such patients? This would require a protocol amendment.
Also one needs to consider EC approval letter.

As per ICH GCP 3.3.7, the EC approval should specify that no deviations from, or changes of, the protocol should be initiated without prior written IRB/IEC approval/favourable opinion of an appropriate amendment, except when necessary to eliminate immediate hazards to the subjects or when the change(s) involves only logistical or administrative aspects of the trial (e.g., change of monitor(s), telephone number(s)).

Also as per ICH GCP 4.5.2     The investigator should not implement any deviation from, or changes of the protocol without agreement by the sponsor and prior review and documented approval/favourable opinion from the IRB/IEC of an amendment, except where necessary to eliminate an immediate hazard(s) to trial subjects, or when the change(s) involves only logistical or administrative aspects of the trial (e.g., change in monitor(s), change of telephone number(s)).

If after considering all these issues, you want to re-screen the subject, you should consult the EC and the study sponsor to determine whether repeat screening of these subjects is acceptable.

There will also be a need for re-consent from the subject. The re-consent process should include information regarding the need for re-screening.
If the re-screening is permitted, the site should ensure that the deviation is reported, approved and documented appropriately.

If one lab wants to do a basic research, can it approach an independent Ethics Committee for approval of such research study?
Gajjela Praveen

As per EC registration requirements, an independent EC can review and approve study only the study protocols and other documents of bioavailbility/ bioequivalence studies of approved drug molecules. Hence, an independent EC cannot approve a clinical trial. However, lab basic research would not qualify for definition of a clinical drug trial. Hence, such basic research can be approved by an independent EC.

We have formulated an advanced topical formulation for arthritis patients and like to do clinical trial, which is not meant for regulatory submission, the product is already in Indian market. Do we need DCGI approval? As per DCGI notification dated 10.11.15, DCGI permission is not required for such trials.
Sudheer Kumar

This circular has been replaced with a Gazette G.S.R. 313(E) of 16 Mar 16, which concerns academic trials. See below:

No permission for conduct of clinical trial intended for academic purposes in respect of approved drug formulation shall be required for any new indication or new route of administration or new dose or new dosage form where, (a) the trial is approved by the Ethics Committee; and (b) subject to the provisions of sub-rule 5, the data generated is not intended for submission to licensing authority.

The Ethics Committee shall however inform the licensing authority about the cases approved by it and also about cases where there could be an overlap between the clinical trial for academic and regulatory purposes and where the said authority does not convey its comments to the Ethics Committee within a period of thirty days from the date of receipt of communication from the Ethics Committee, it shall be presumed that no permission from the licensing authority is required.

A pharma company clinical trial is not an academic trial. Also As per Rule 122 E a drug in new dosage form is new drug.

A drug already approved for certain claims, which is now proposed to be marketed with modified or new claims, namely, indications, dosage, dosage form (including sustained release dosage form) and route of administration.
So the clinical trial of new advanced topical formulation will require DCGI approval.

Dr Arun Bhatt is a Consultant - Clinical Research & Development,
Mumbai. Readers can send their queries at:arun_dbhatt@hotmail.com
Readers can send their queries at: arun_dbhatt@hotmail.com


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Falguni Jul 18, 2016 11:01 AM
If the FDA has withdrawn the OGD guidance for particular molecule in that case what are the path ways \ roadmaps to proceed the CT study protocol for submission in US?
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