Bio-Equivalence : Module 6


There should be fair understanding of regulatory requirement of India to submit application to DCGI office. The Central Drugs Standards Control Organization (CDSCO) is the agency mandated with the task of drug regulation in India to determine if rules and laws were being implemented efficiently and honestly in the interest of patients.

Below are useful few web links from CDSCO website which can be helpful in making application for NOC for conducting a Bioequivalence Study.

Approved for Marketing in India

The procedure for applying for import or manufacture of new drug for clinical trial or marketing

Checklist for applications for grant of approval of various categories of New Drug, Global Clinical trial and Bioequivalence study for export purpose

In India Bioequivalence study need to be conducted for a new drug permission. 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.

The Very Basic Requirements for filing a Bioequivalence study for a New Drug or Export Purpose

1. Annexure is basically documents available on CDSCO website and required to be submitted along with any communication done with DCGI office. It basically helps them to decide relevance of document to respective department.

2. Application in Form-44 duly signed, by the competent authority with name and designation which is required for permission of clinical trial on new drug.

3. Application in Form 12 if study drug to be imported

4. Treasury Challan of specified amount as per Drugs & Cosmetic Rules.

5. Undertaking by the Principal Investigator (PI) as per appendix VII of schedule “Y” of Drugs and Cosmetic Rules.

6. A copy of the approval granted to the BE study center by CDSCO.

7. Sponsor’s Authorization letter duly signed by the competent authority on their letterhead.

8. The IEC approved study protocols with covering following documentation like

a. Ethic Committee Approval Letter with composition and process of approval

b. The study synopsis

c. Clinical study data and published report of pharmacokinetic and pharmacodynamic study carried out in healthy volunteers/patients data published in reputed journals.

d. Regulatory status of the drug.

e. Names of the countries where the drug is currently being marketed (to be mentioned in the covering letter also).

f. Package literature on the international product

g. Complete Certificate of Analysis of same batches (both test & reference formulations) to be used in the BE study.

h. In the case of multiple doses BE study adequate supporting safety data should be submitted.

i. Informed Consent Document (English Version) and in vernacular language with translation certificate

j. Clinical Trial Liability Insurance for volunteers and undertaking from applicant regarding compensation for study related injury/death

k. Declaration of Helsinki: a ethical guideline to be followed in all human trial

l. Case Report Form (CRF)

m. Schematic Representation of Clinical Activities

n. Age, Height and Weight Chart (Life Insurance Corporation, India)

o. Study Meals Menu with Recipe

p. SAE Reporting Form

q. Randomization Schedule

r. Product Monograph

The chemical and pharmaceutical information should be provided with application to ensure the proper identity, purity, quality &  strength of  the investigational product. The amount of information needed may vary with the Phase of clinical trials, proposed duration of trials,  dosage forms and the amount of information otherwise available. 

Dr. Manoj Karwa


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