What is the role of DCGI, DGHS, DGFT and HMSC towards giving permission to export/exchange biological materials for clinical trials? Who is the licensing authority and to whom one should apply?
Dr Sreevatsa
For clinical trials sponsored by a pharma company export is permitted after obtaining no objection certificate from DCGI office. DGFT/ICMR/HMSC permission is not required. ICMR/HMSC permission is required if an institution is participating in collaborative research with foreign institutions.

Is it necessary to get HMSC clearance for observational studies for Indian- International Collaborative Research?
J Vijayakumar
Please see HMSC guideline below. Health research would include observational studies applications for research projects involving foreign assistance/collaboration in biomedical/health research are to be submitted to ICMR (IHD) for approval of Govt. of India through Health Ministry's Screening Committee (HMSC). The ICMR is the secretariat of HMSC.

Can a person with an MD in alternative medicine become a co-investigator as per current Indian regulation?
Bhavik Shah
As per Indian GCP he cannot become co-investigator. See the definition below Indian GCP co-investigator.

A person legally qualified to be an investigator, to whom the investigator delegates a part of his responsibilities.

How to change the labelling of the investigational product (IP) during the clinical study in case there is extension of the use by date of IP?
Prasad Vaishampayan
Please see the EU Commission guidance below Volume 4 GMP Annex 13 manufacture of investigational medicinal products July 2003. If it becomes necessary to change the use-by date, an additional label should be affixed to the investigational medicinal product. This additional label should state the new use-by date and repeat the batch number. It may be superimposed on the old use-by date, but for quality control reasons, not on the original batch number. This operation should be performed at an appropriately authorised manufacturing site. However, when justified, it may be performed at the investigational site by or under the supervision of the clinical trial site pharmacist, or other health care professional in accordance with national regulations. Where this is not possible, it may be performed by the clinical trial monitor(s) who should be appropriately trained. The operation should be performed in accordance with GMP principles, specific and standard operating procedures. If it becomes necessary to change the use-by date, an additional label should be affixed to the investigational medicinal product. This additional label should state the new use-by date and repeat the batch number. It may be superimposed on the old use-by date, but for quality control reasons, not on the original batch number. This operation should be performed at an appropriately authorised manufacturing site. However, when justified, it may be performed at the investigational site by or under the supervision of the clinical trial site pharmacist, or other health care professional in accordance with national regulations. Where this is not possible, it may be performed by the clinical trial monitor(s) who should be appropriately trained. The operation should be performed in accordance with GMP principles, specific and standard operating procedures and under contract, if applicable, and should be checked by second person. This additional labelling should be properly documented in both the trial documentation and in the batch records.

How should sponsor ensure that the Hospital Ethics Committee meets the prescribed GCP guidelines? Can sponsor have the access to the SOPs of Ethics Committee to assess it?
Nitin Chandurkar
Yes, most sponsors request a copy of SOPs to assess EC's compliance to regulations/guidelines.

Is it mandatory to register the studies conducted for already approved drug in approved indication on clinical trial registry of India?
Nitin Chandurkar
All trials approved by DCGI must be registered on CTRI. Registration of other trials is voluntary



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