Clarifications on Bioequivalence (BE) Study Requirements in India

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:

  1. Application in Form-44 duly signed, by the competent authority with name and designation.
  2. 25,000 rupees /- as per Drugs & Cosmetic Rules.
  3. Undertaking by the Principal Investigator (PI) as per appendix VII of schedule “Y” of Drugs and Cosmetic Rules.
  4. A copy of the approval granted to the BE study centre by CDSCO.
  5. Sponsor’s Authorization letter duly signed by the competent authority on their letterhead.
  6. The study protocols.
  7. The study synopsis.
  8. Pre-clinical single dose data and repeated dose toxicity data.
  9. Clinical study data and published report of pharmacokinetic and pharmacodynamic study carried out in healthy volunteers/patients data published in reputed journals.
  10. Regulatory status of the drug.
  11. Names of the countries where the drug is currently being marketed (to be mentioned in the cover letter also).
  12. Package literature on the international product.
  13. Complete Certificate of Analysis of same batches (both test & reference formulations) to be used in the BE study.
  14. In the case of multiple dose BE study adequate supporting safety data should be submitted.
  15. 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.
  16. 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.