Data required to be submitted by an applicant for grant of permission to import or manufacture a new drug already approved in the country

Introduction
- A brief description of the drug and the therapeutic class.
Chemical and pharmaceutical information
- Chemical name, code name or number, if any; non-proprietary or generic name, if any, structure; physico-chemical properties
- Dosage form and its composition
- Test specifications
- active ingredients
- inactive ingredients
- Tests for identification of the active ingredients and method of its assay
- Specifications of finished product
- Outline of the method of manufacture of active ingredient and finished product
Marketing information
- Proposed package insert or promotional literature
- Draft specimen of the label and carton
Special studies conducted with approval of Central Licencing Authority
- Bioavailability or Bioequivalence and comparative dissolution studies for oral dosage forms
- Sub-acute animal toxicity studies for intravenous infusions and injectables.

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