How does one manage change of PI at the site?
● S Lakshmanan
Change of PI is a major amendment. The new PI needs to apply and seek approval on his/her name. You need to obtain EC approval of this amendment and also need to notify the DCGI office about change in PI along with the consent to withdraw from the earlier investigator.
See the guidance from DCSCO. Protocol Amendments
a. Those amendments which do not require notification to or permission of the Licensing Authority.
i) Administrative and logistic changes.
ii) Minor protocol amendments and additional safety assessments in case the institutional ethics committee has already approved these changes.
b. Those amendments which require notification to the Licensing Authority but need not wait for permission.
i) Additional investigator sites.
ii) Change in investigator with the consent to withdraw from the earlier investigator.
iii) Amended investigators brochure, amended informed consent.
c. Those amendments which require prior permission of the Licensing Authority.
i) Additional patients to be recruited.
ii) Major changes in protocol with respect to study design, dose and treatment options.
iii) Any change in inclusion or exclusion criteria.
Is it necessary to obtain DCGI approval for conducting the BE study or just apply for the import license to import the IP?
● Kavita Kesavan
You need to obtain DCGI approval and get import license. If your company is clinical research organisation, you need a letter from the sponsor authorizing you to apply and obtain DCGI approval. The approval time is usually 3-4 months.
Should the generic be approved for the same indication as that which will be used in the BE study (special cases like oncology, schizophrenia, AIDS etc)?
● Kavita Kesavan
Yes. As per new drug definition (below) change in indication would be classified the drug as a new drug.
122E. Definition of new drug. (b) A drug already approved by the Licensing Authority mentioned in Rule 21 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.
If we wish to market a product whose generic versions are already available for more than four years, would we need to apply to DCGI for permission to market?
● Kavita Kesavan
No you do not need to apply to DCGI office. You will need manufacturing license from local FDA.
What would be regulatory requirements in case if a clinical research organisation, which has DCGI approval for a study wants to transfer all activities to another clinical research organisation?
● Kavita Kesavan
The procedure would be as follows:
1) First clinical research organisation sends a letter to DCGI introducing second clinical research organisation and requesting them to transfer the permission to second clinical research organisation
2) Second clinical research organisation applies with all the documents and with a letter from sponsor about the transfer requesting for permission.
The ethics committee can be notified after the second clinical research organisation has obtained the regulatory approval in their name.