Proforma for submitting application to IBSC/RCGM  to carry out research and development work on GMOs/LMOs/r-DNA products/pharmaceuticals    

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1.         Name of the Applicant

Designation

(a) Address (Registered Office)

 

Telephone No.

Telex No.

Fax No.

            E-mail

 

(b) Address (Research Station)

 

Telephone No.

Telex No.

Fax No.

            E-mail

 

2.         Basic information on application:

 

2.1         Purpose

2.2         New                                                                         Yes                        No

2.3         Ongoing Project                                                        Yes                        No

If yes, No. & Date(s) of previous Permit(s) issued :

2.4         If yes, briefly state the purpose for which permission(s) granted.

2.5         Category of experiments as per the Guidelines of DBT

 

3.                   Objectives of the proposal

 

4.         Description of the GMOs employed in the research proposal (in scientific terms; for new application only)

 

4.1        Description of GMOs

4.2        Description of the target gene(s)

4.3               Number of copies of the genes incorporated

4.4               Description of the target gene product(s)

 

 

5.         Details on:

 

5.1        Source of nucleic acid(s):

5.2               Nucleic acid sequence (Please enclose the nucleic acid sequence map of the target gene):

5.3               Vector(s) (Please enclose the map of the vector gene):

5.4               Host(s) that carrying the vector(s)/ target gene(s):

5.5               Manipulative procedures:

            5.6       Anticipated functions of Product(s)

 

6.      Summary of the proposed work plan utilizing GMOs (please check it from the following areas and provide the details of work plan).

 

6.1        Basic transformation and laboratory work to assess the expression of the target gene         

6.2               Standardization of fermentation procedures below 20 lt. capacity (if applicable)

 

7.                    Assessment of toxicity and allergenicity of the product (if yes, please provide the following information)

 

i)                    Production / fermentation procedures adopted

ii)                   Purification procedures adopted; state briefly the processing chemicals used in the purification steps.

iii)                 Physico-chemical characterization of the product; please provide limits of residues with there characterization/ identification.

iv)                 Biochemical/immunological characterization of the product

v)                  Information on Five batches production data

vi)                 Toxicity and Allergenicity protocols and the address of the lab/ Institute where these studies are proposed to be conducted.

vii)               Institutional Animal Ethics Committee's Approval.

viii)              Acceptability criteria of the bulk and the formulated material wherever ready for animal experiments.

 

8.         Site/ Location of the research work:

 

9.         Proposed containment facility (Please indicate the level of containment proposed and attach IBSC inspection report):

 

10.        Standard operating procedures (SOPs) for decontamination and disposal mechanisms

 

 

11.        Risk management measures practiced (Emergency plan)

 

 

12.        Any other relevant information

 

 

13.        Declaration:

 

I declare that the information provided in the above format is correct and accurate to the best of my knowledge. The "Safety Guidelines" brought out by the Department of Biotechnology, Ministry of Science & Technology, Govt. of India will be and is being strictly followed.  In case any untoward incident occurs, the Chairman of the IBSC and the Member-Secretary of the RCGM will be informed immediately.

 

 

Place:

 

 

Date:                                                                                         Signature of the Applicant          

 

 

14.      Recommendations:

 

The proposal set out above has been considered by the "Institutional Biosafety Committee" in its meeting held on ___________ and is forwarded to RCGM for further necessary action.

 

 

 

Place:

 

Date:                                                                             Signature of the Chairman, IBSC

 

 

(Note: Please submits 20 copies of the application to the Department of Biotechnology for placing the same in the meeting of RCGM)