Documents to be submitted to DCGI for grant of BE NOC

The documents required for DCGI No Objection Certificate (DCGI BE NOC) for conducting a biostudy in India are general in nature, however depending on the nature of the drug,disease and studies further specific information may also be required to be furnished by the firm

Update: DCGI has revised the list of documents that needs to be submitted for grant of DCGI BA / BE NOC with effect from 01st February 2014. Check our latest post on"Documents to be submitted to DCGI for grant of BA / BE NOC – Updated FEB 2014" for the revised list of documents required for grant of DCGI BA / BE NOC.

CDSCO has come up with a publication which details on the documents required for DCGI No Objection Certificate (DCGI BE NOC) for conducting a Bioequivalence study in India. All requirements are general in nature, however depending on the nature of the drug, disease and studies further specific information may also be required to be furnished by the firm.

I. New Drugs approved within period of more than 1 year & less than 4 years:

• For New Drugs approved within period of more than 1 year & less than 4 below specified documents should be submitted.
• The treasury challan will cost Rs. 15000/.

1. Application in Form-44 duly signed, by the competent authority with name and designation.
2. Undertaking by the Principal Investigator (PI) as per appendix VII of schedule "Y" of Drugs and Cosmetic Rules.
3. A copy of the approval of the BE study centre from CDSCO.
4. Sponsor's Authorization letter duly signed on their letterhead by the competent authority.
5. study protocols.
6. Complete Certificate of Analysis of same batches (both test & reference formulations) to be used in the BE study.
7. In the case of multiple dose BE study adequate supporting safety data should be submitted.
8. In the case of Injectable preparation the sub-acute toxicity should be submitted on the product of the sponsor, generated in two species for adequate duration.
9. Depending on the nature of the drug like cytoxic agent, hormonal preparations etc. Proper justification for conducting studies on healthy volunteers/patients or male/female should be submitted.

II. New Drugs approved in India within period of 1 year:

• For New Drugs approved in India within period of 1 year below specified documents in addition to that specified in Section I, should be submitted.
• The treasury challan will cost Rs. 25000/.

1. Clinical study data and published report of pharmacokinetic and pharmacodynamic study carried out in healthy volunteers data published in reputed journals.
2. Package literature on the international product.

III. New molecule not approved in India but approved in the other countries:

• For New molecule not approved in India but approved in the other countries below specified documents in addition to that specified in Section I & II, should be submitted.
• The treasury challan will cost Rs. 25000/.

1. The study synopsis.
2. Pre-clinical single dose data and repeated dose toxicity data.
3. Regulatory status of the drug.
4. Names of the countries where the drug is currently being marketed (to be mentioned in the covering letter also.

Note: Application of BE NOC for all the drug products in modified release form irrespective of their approval status should supply all documents specified in Section - I.