We plan to conduct a randomised trial on use of four intravenous anti epileptic drugs. All the drugs are approved for use by DCGI. Does the study require approval from DCGI office?

New drugs as defined under Rule 122-E of Drugs and Cosmetics Rules include:

• Unapproved drugs,
• Modified or new claims e.g.
• New indications,
• New dosage forms (including sustained release dosage form); and
• New route of administration of already approved drugs and combination of two or more drugs.

A new drug shall continue to be considered as new drug for a period of four years from the date of its first approval or its inclusion in the Indian Pharmacopoeia, whichever is earlier.

It would be critical to check whether the intravenous formulation is approved roved in India by DCGI office. If not approved, it would be considered a new drug. In such a case, you would need permission from DCGI office to conduct the clinical trial.

Also, if the formulation was approved less then 4 years ago, it would be considered a new drug. In such a case, you would need permission from DCGI office to conduct the clinical trial.

If there is an SAE in a PMS study on device, approved by EC notified and to DCGI, is it mandatory to report the SAE to DCGI?
You need to consider the objective of this PMS study. If the study was mandated by DCGI office, as per DCGI approval letter for marketing of this device, you need to report the SAEs as per norms for clinical trials. If the study is not mandated by DCGI office, then you need to report the SAEs, as per regulatory requirements of spontaneous reporting.

Is audio video recording required while taking consent from volunteers during screening process?
The CDSCO draft guidelines for audio-visual (AV) recording refer to informed consent, and do not mention anything about screening consent.  As the purpose of screening consent is to assess eligibility for participation in a clinical trial/BE study, AV recording of the consent for screening process should be done.

Is NABL accreditation is adequate for BA/BE studies for any regulatory submission or is CAP accreditation needed?
The scope of NABL/CAP accreditation does not cover bioequivalence specifically. Both accreditations are meant for clinical pathology/biochemistry. The foreign sponsors prefer CAP accredited labs as central labs for safety assessments.

What would be the Indian regulatory perspective for phase III for a foreign NDA, to be conducted only on Indian patients, with a molecule that is approved globally but not approved in India?
As per 2014 CDSCO checklist for global clinical trials, details of the trial in other countries/regulatory approval from other countries are required. In addition, the sponsor has to give an undertaking that the sponsor will market the drug in India after successful completion of clinical trial. For an Indian only trial, this information would not be available. Hence,  the DCGI office is unlikely to approve a global clinical trial, which is conducted only in India and the results would be submitted to foreign regulatory agency.