Medical devices notified under D&C Act need import licence

If a drug gets approved in US and EU (but yet not in India) then for clinical trial applications going forward, can we use the EU SmPC document  instead of an IMPD in the dossier to be submitted to the DCGI office?

GCT check list of 2014 requires IB, IMPD and package insert (if the drug is marketed). Also, the checklist also has requirements of summarizing all info as per the format provided. Hence, So, SmPC may not serve the purpose.

What is retention quantity of clinical trial batch samples for phase studies (1, 2, 3 &4).

Indian GCP 3.1.9.   supply, storage and handling of pharmaceutical products
The sponsor should maintain sufficient samples from each batch and keep the record of their analyses and characteristics for reference, so that if necessary an independent laboratory may be able to recheck the same.

The Drugs and Cosmetics Act and Rules Part VII manufacture for sale [or for distribution] of drugs other than homoeopathic medicines includes following statement:

The licensee shall maintain reference samples from each batch of the drugs manufactured by him in a quantity which is at least twice the quantity of the drug required to conduct all the tests performed on the batch.

What penal actions US FDA can take if noncompliance is detected during a clinical trial inspection?

The US FDA inspection guidance includes the actions FDA can take if the inspectors report noncompliance during inspection of a clinical trial. These include:

For sponsor and/or investigator

• Placing a clinical hold on the study.
• Withdrawal of approval of IDE application
• Rejection of data from that site.
• Initiation of disqualification proceedings
• Refusal to approve or license.
• Withdrawal of approval
• Civil/criminal actions.

For IRB

• Withhold approval of new studies that are conducted at the institution or reviewed by the IRB
• Direct that no new subjects may be recruited for ongoing studies
• Terminate ongoing studies
• Refer pertinent matters, with headquarters concurrence, to other Federal, State, or local agencies for such action as that agency deems appropriate
• Disqualification of an IRB or institution.

Is an import license required for import of non-notified devices?

On 8 January 2013, CDCSO issued a notification, which states:

Medical devices which are notified under Drugs & Cosmetics Act 1940 require registration certificate in Form 41 and import license in Form 10 to import the device in India. However, the devices which do not attract provisions of Drugs & Cosmetics Act 1940 and Rules there under may be released by concerned port officer without insisting on no objection certificate from CDSCO office.