Shelf life Extension from CDSCO | Drug for Importer -CliniExperts

Shelf life Extension

Permission for Shelf life Extension is a post registration process and is obtained from the Import & Registration Division of CDSCO. When the manufacturer finds that the shelf life of the product is more than that claimed on the label, from further stability testing of his product, after obtaining the registration certificate, he can apply for the Shelf Life Extension.

A preformed checklist is required to be followed to obtain this permission which has following documents:

Covering letter
Copy of manufacturing license
Copy of Real time and Accelerated stability data for the applied drugs
Certificate of Analysis (COA) from three consecutive batches of the product
Original Purchase order from overseas/Indian buyer for the applied products
Shelf-life approval of the products from National Regulatory Authority
An undertaking from overseas/Indian buyer
Original Labels of the product

After obtaining the Shelf Life Extension from CDSCO for the product, the manufacturer can claim for the provided shelf life on the labels and market in the importing country.

Reference

Import & Registration Division, Central Drugs Standard Control Organization (CDSCO), Directorate general of health services (DGHS), Ministry of Health and Family Welfare, Government of India. Available at https://cdsco.gov.in/opencms/export/sites/CDSCO_WEB/Pdf-documents/import-registration/import_checklist.pdf. Accessed on- 20th April 2016.