India’s Central Drugs Standard Control Organization (CDSCO) recently issued the required list of documents needed to conduct bioequivalence studies for export purposes. There have been a growing number of applications filed by manufacturers, importers, and CRO’s requesting approval to carry out BE studies on India subjects.
If the BE study is on a new molecule not approved in India, but approved in other countries, the following documents are required:
- Application in Form-44 duly signed, by the competent authority with name and designation.
- 25,000 rupees /- as per Drugs & Cosmetic Rules.
- Undertaking by the Principal Investigator (PI) as per appendix VII of schedule “Y” of Drugs and Cosmetic Rules.
- A copy of the approval granted to the BE study centre by CDSCO.
- Sponsor’s Authorization letter duly signed by the competent authority on their letterhead.
- The study protocols.
- The study synopsis.
- Pre-clinical single dose data and repeated dose toxicity data.
- Clinical study data and published report of pharmacokinetic and pharmacodynamic study carried out in healthy volunteers/patients data published in reputed journals.
- Regulatory status of the drug.
- Names of the countries where the drug is currently being marketed (to be mentioned in the cover letter also).
- Package literature on the international product.
- Complete Certificate of Analysis of same batches (both test & reference formulations) to be used in the BE study.
- In the case of multiple dose BE study adequate supporting safety data should be submitted.
- 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.
- 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.
For new drugs approved in India within a period of 1 year, applicants should submit all of the following documents except for items 7-8 and 10-11. For new drugs approved in India for more than 1 year but less than 4 years, applicants should submit all of the following documents except for items 7-12.