Q. We want to send the biological samples outside India for genetic testing. How do we get permission??
● Suresh Lakhani

You need to apply to Directorate General of Foreign Trade (DGFT) with the number and volume of blood samples in prescribed form. Along with this you need to attach the DCGI approval. The DCGI office requires an undertaking from the central lab for genetic testing that the samples exported from India will be used only for the testing as per approved protocol and will not use for any commercial purpose. The DGFT will refer the application to DCGI for cross checking on the approval. Once they receive DCGI agreement, DGFT Delhi will send the letter to the DGFT of the city where the company is registered. The local DGFT issues the license to export.

Q. Will it be a good idea for India to have a central ethics committee along the lines of UK? Who will audit IECs in India?
● Hardik Parmar

There is already a Central Ethics Committee on Human Research in ICMR which was involved in development of ICMR guidelines. ICMR has an ethics committee which reviews research proposals of national importance. I feel for a large country such as ours, idea of central ethics committee is quite a challenging task. Most of the industry has faced a lot of problems from such centralized bodies working from Delhi.

At present, there is no audit of EC process. However, FERCI and ICMR are working on the audit of IECs.

Q. As per Drug and Cosmetic Act 1945 a new drug shall continue to be considered as new drug for a period of 4 years from the date of its first approval or its inclusion in the Indian Pharmacopeia, whichever is earlier. If the first approval of a new drug was in 2004 and is included in Indian pharmacopeia of 2007, do we need DCGI approval?
● Inder Sharma

You have to count 4 yrs from the exact date of DCGI (month/year) approval or date of inclusion in pharmacopoeia. In this case, DCGI approval was in 2004. This date is earlier then the pharmacopoeia date. Hence, 4 yrs from DCGI date should be considered i.e. 2008. The current month is May 2008. If the DCGI approval is May 2004, then you need to take DCGI permission. If the DCGI approval date is before May 2004, the drug will not be considered as new drug.

Q. A As per Schedule Y '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'. Is this timeline for unexpected serious adverse event occurring in India or globally?
● Kavita Kesavan

This is for unexpected SAE reported from Indian sites in India.

Q. Is there any requirement to submit a safety update for clinical trial annually?
● Kavita Kesavan

There is no specific requirement for annual clinical trial safety update. The DCGI approval letter for clinical trial protocol approval asks the sponsor to submit the trial status annually. This will include the AE/SAE status.

Q. What type of CMC data are to be submitted for biotech products?
● Namrata Nadkarni

Indian GCP Appendix III describes format for submission of preclinical and clinical data for R-DNA based vaccines, diagnostics and other biologicals. The relevant extract is given below:

A: Specification and characterization information on R-DNA vaccines and biological products

1 Description in details of the method of r-DNA products:
(a) host cells,
(b) gene construct,
(c) vector construction including a description of the source and function of the component parts of the vectors,
(d) source and diagram of the plasmid(s) used,
(e) all intermediate cloning procedures, and
(f) transfection methods.

2 Description of the method of sequence verification (such as restriction enzyme mapping, PCR etc.).

3 Description on identity-physical, chemical, immunological and biological wherever applicable
(a) Description on recombinant DNA products:
(1) Primary structure (Amino acid sequences)
(2) Secondary structure (disulfide linkages etc.)
(3) Post-translation modification (glycosylation etc.)
(b) Monoclonal antibodies (if applicable): identity by rigorous immunochemical and physicochemical characterization.

4 Potency
(a) Production of specific antigen in transfected cell line,
(b) Immune response in mice,
(c) Hypersensitivity (Guinea pig maximization test), and
(d) Permissible limits of potency.

5 General safety test

6 Data on sterility tests as per Indian Pharmacopeia guidelines

7 Data on purity of recombinant product
(a) Limits of purity,
(b) Characterization of minor impurities like RNA, protein and genomic DNA,
(c) Permissible limits of moisture, if lyophilized, and
(d) Pyrogenicity

8 Description of constituent materials like preservatives etc.

9 Data on stability of finished formulation as per IP (Indian pharmacopeia) guidelines.