Last Updated on February 22, 2022
Drug Product Registration Application Types
Registration Board of DRAP under Section 7 of the Drugs Act, 1976 registers drugs (pharmaceuticals and biologicals) for human or veterinary use. Divisions of Pharmaceutical Evaluation & Registration and Biological Evaluation & Research of DRAP receive various types of applications for drug product registration as explained below. It is a pre-requisite to have a Drug Manufacturing License (DML) for manufacturers or Drug Sales License (DSL) for importers to apply for any of the following types of drug product registration.
Forms required for application
Following are the regulatory forms required for applying for various type of drug product registration for human use:
| S.No | Details | Application Form |
| 1 | New Drug / Molecule (local manufacture / import) | Form 5 F |
| 2 | Any other Drug for Import | Form 5 F |
| 3 | Locally manufactured drug with imported source of Half-Finished Products (Ready to Fill Bulk i.e., Pellets, Granules, etc) | Form 5 F |
| 4 | Generic Drugs (local manufacture) | Form 5 F |
| 5 | Drugs for Export Purpose | From 5 / 5A / 5D) |
| 6 | Drugs for export purpose on contract manufacturing basis. | Form 5 |
| 7 | Drugs for Export Purpose; where no generic product is available. | Form 5 D |
| 8 | Grant / extension of contract manufacturing permission | Form 5 F |
Requirements of Form 5 F (Common Technical Document)
Mandatory form for submission of registration application is Form 5 F. The requirements of Data submission on Form 5 F (Common Technical Document) under SRO 713(I)/2018 dated 08 June 2018 for registration of a pharmaceutical drug for human use are as follows:
| Category | Module 1 | Module 2 | Module 3 | Module 4 | Module 5 |
| New Drug Product | Yes | Yes | Yes | Yes | Yes |
| Generic Drug Product | Yes | Yes Optional: 2.3.S.2.2 2.3.S.2.3 2.3.S.2.4 2.3.S.2.5 2.3.S.2.6 2.3.S.7.2 | Yes Optional: 3.2.S.2.2 3.2.S.2.3 3.2.S.2.4 3.2.S.2.5 3.2.S.2.6 3.2.S.7.2 3.2.R.3 | Yes Optional for approved drug products in the same combination, strength, and dosage form by reference regulatory authorities adapted by Registration Board. | Yes Optional for approved drug products in the same combination, strength, and dosage form by reference regulatory authorities adapted by Registration Board. |
Guidelines
Guidance document for submission of application on Form 5 F (CTD) for registration of drugs