Are there any guidelines for clinical trials of medical devices?
Bhaskar

In August 2010, CDSCO had released guidance document on requirements for conducting clinical trials of medical devices. The requirements are similar to drugs. The application should include:

1) Covering letter, 2) Form 44, 3) Fee in TR6 challan, 4) Delegation of responsibility, 5) Protocol, 6) Global regulatory status of the device, 7) Investigator’s undertaking, 8) Ethics committee approval, 9) Informed consent form, 10) Case record form, 11) Patient record form, 12) Relevant published literature, 13) Investigator’s brochure, 14) Suspected unexpected serious adverse reaction (SUSAR), 15) Affidavit from the sponsor, 16) Any other specific relevant information, 17) Clinical study report, if any.

There are several annexures to be appended to the application. Some of these are standard e.g. protocol, SAE reporting form etc. However, there are some annexures which require specific details of the device.

Annexure I form 44 covers particulars of subject device e.g. composition of device, specifications/standards of device, qualitative and quantitative particulars of the constituents, sterility and stability of the product, labeling details, risk classification (in country of origin as well as in 5 GHTF countries i.e. EU, USA, Japan, Canada, Australia), regulatory status of the subject device (particularly 5 GHTF countries i.e. EU, USA, Japan, Canada, Australia)
Annexure II covers Technical Data and Annexure V describes Phase Study Assessment.

If a global CT is going on and India being one of the countries, is it mandatory to submit the foreign SUSARs to the DCGI?
Ashish Chavda
Yes, Indian GCP and Schedule Y do not differentiate between local or foreign SAEs/SUSARs. See Below.

Schedule Y
(iv) Any unexpected serious adverse event (SAE) (as defined in GCP Guidelines) occurring during a clinical trial should be communicated promptly (within 14 calendar days) by the sponsor to the licensing authority and to the other investigator(s) participating in the study.

Indian GCP
3.1.10. Safety Information:
Sponsor is responsible for the ongoing safety evaluation of the product. The sponsor should promptly notify all concerned of findings that could adversely affect the safety of the subjects, impact the conduct of the Study or alter the Ethics Committee’s approval / favorable opinion to continue the Study. The Sponsor, together with Investigator(s), should take appropriate measures necessary to safeguard the study subjects.

3.1.11. Adverse Drug Reaction Reporting:
The Sponsor should provide ADR / AE reporting forms to the Investigator(s) / Institution(s). The sponsor should expedite the reporting to all concerned (including the Ethics Committee and the regulatory authorities) of all serious and/or unexpected adverse drug reactions

In the Ethics Committee membership list two lawyers are present. One can act as legal expert and other one act as lay person. Is this right? Please clarify.
Asif
Dictionary defines lay person as a person who does not have specialized or professional knowledge of a subject. A lawyer is a specialist in law. Hence, a lawyer cannot be considered a lay person.

If the quote “ 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” is true does FDC having individual molecules in IP cease to exist as new drug?
Anand P
Please see definition of new drug under rule 122E. FDC is a separate category under new drug. The 4-yrs clause applies to a single drug not FDC.

122 E (c) A fixed dose combination of two or more drugs, individually approved earlier for certain claims, which are now proposed to be combined for the first time in a fixed ratio, or if the ratio of ingredients in an already marketed combination is proposed to be changed, with certain claims, viz. indications, dosage, dosage form (including sustained release dosage form) and route of administration

Do we need to take approval from the DCGI office for the research studies/ dissertations to be conducted on an old drug for a new indication?
Dr Harsha M Shetty
If a company is sponsoring the study with an objective of obtaining registration for additional indication, DCGI approval is needed. If you are conducting an Investigator initiated study for research purpose/dissertation, the requirements for regulatory approval is not clearly defined.

Dr Arun Bhatt is currently, president, ClinInvent, Research Pvt Ltd, Mumbai. Readers can send their queries at: arunbhatt@clininvent.com