This page list down all the applicable forms, checklists and templates used for registration, renewal, variations, and other regulatory aspects of various types of therapeutic goods. These are categorized according to their applicability under following sections.
Please click on the relevant section of navigate below to view or download.
1. Drugs for Human Use
Title
Type
Published Date
Application (Form 5 F) for Registration of Drugs and Biological Products (Common Technical Document)
Form
11-02-2022
Application (Form 5-B) for Renewal of Registration of Drugs
Form
11-02-2022
Checklist for Pre-Submission Screening of Common Technical Document
Checklist
11-02-2022
Checklist for Application of Post-Registration Variation in a Registered Drug
Checklist
11-02-2022
Checklist for Product specific Inspection for local manufacturer
Checklist
19-Sep-2024
Inspection checklist for Capacity Assessment for local manufacturer
Checklist
19-Sep-2024
Inspection Checklist for Cold Chain/Storage of Drugs
Checklist
19-Sep-2024
Inspection checklist for foreign manufacturing facilities for Biologicals drug products
Checklist
19-Sep-2024
Checklist for Cold Chain Storage Facility for Importers of Biological Drugs
Checklist
19-Sep-2024
Inspection checklist for foreign manufacturing facilities for Non Biologicals drug products
Checklist
19-Sep-2024
2. Drugs for Veterinary Use
Title
Type
Published Date
Application (Form 5) For Registration of Drug For Local Manufacture
Form
11-02-2022
Application (Form 5A) for Registration of an Imported Drug
Form
11-02-2022
Application (Form 5D) for Registration of a Dosage Form Containing a New Drug Molecule or a New Combination Dosage Form
Form
11-02-2022
Application (Form 5E) for the Registration to Manufacture a Patented Drug
Form
11-02-2022
Application (Form 5-B) for Renewal of Registration of a Drug
Form
11-02-2022
Checklist for application (Form 5) For Registration of a Drug for Local Manufacture
Checklist
11-02-2022
Checklist for application of Post Registration Variation in a Registered Drug
Checklist
11-02-2022
3. Medical Devices
Title
Type
Published Date
Application (Form 1) For Grant or Renewal of An Establishment License To Manufacture Medical Devices
Form
11-02-2022
Application (Form 1A) For Grant or Renewal of Certificate To Outsource Manufacturing Processes of Medical Devices
Form
19-05-2022
Application (Form 1B) For Grant or Renewal of Permission Certificate to Outsource Analysis Of Medical Devices
Form
19-05-2022
Application (Form 2) for Grant or Renewal of an Establishment License to Import Medical Devices
Form
19-05-2022
Application (Form 6) for enlistment or renewal of class-A medical device or accessory or component for local manufacture
Form
11-02-2022
Application (Form 6-A) for Enlistment or Renewal of Class–A Medical Device or Accessory or Component for Import
Form
19-05-2022
Application (Form 7) for Registration or Renewal of Class B, C, D Medical Device or Accessory or Component for Local Manufacture
Form
11-02-2022
Application (Form 7-A) for Registration or Renewal of Class B, C & D Medical Device or Accessory or Component for Import.
Form
19-05-2022
Application (Form 9) to Import Medical Devices or Raw Material for the Experimental Purposes
Form
11-02-2022
Intimation (Form 11) of Arrival of Consignments of Imported Medical Devices or Raw Material (Other than those Imported for Personal Us
Form
11-02-2022
Application (Form 14) to Export Medical Devices for Experimental Purposes
Form
11-02-2022
Application (Form 17) for Approval of Advertisement of a Medical Device
Form
11-02-2022
Checklist for grant or renewal of an establishment license to manufacture medical devices
Checklist
11-02-2022
Checklist for grant or renewal of an establishment license to import medical devices
Checklist
11-02-2022
Checklist for enlistment or renewal of class–A medical device or accessory or component for local manufacturing.
Checklist
11-02-2022
Checklist for enlistment or renewal of class-A medical device or accessory or component for import
Checklist
11-02-2022
Checklist for registration or renewal of class B, C & D medical device/ accessory/ component for local manufacture.
Checklist
11-02-2022
Checklist for registration or renewal of class B, C & D medical device or accessory or component for import
Checklist
11-02-2022
Checklist for the Inspection of Establishment license to Import Medcial Device( Good Storage practices )
Checklist
19-09-2024
4. Health & OTC Products
Title
Type
Published Date
Application (Form 1) for Enlistment of Firm as Manufacturer
Form
11-02-2022
Application (Form 2) for Enlistment of Firm as Importer
Form
11-02-2022
Application (Form3) for enlistment of locally manufactured product with general claim
Form
11-02-2022
Application (Form4) for Enlistment of Locally Manufactured Product with Therapeutic Claim
Form
11-02-2022
Application (form 5) for enlistment of imported product
Form
11-02-2022
Application (form 9) for issuance of GMP certificate or Free sale certificate or COPP
Form
11-02-2022
Form 11 warranty that products do not contravene with provisions of DRAP ACT and rules
Form
11-02-2022
Form 12 Authority Letter by Manufacturer or Importer to Authorized Agent for Distribution
Form
11-02-2022
Checklist for Application of Site Verification and Layout Plan Approval
Checklist
11-02-2022
Checklist for Application of Revised Layout Plan and Additional Section
Checklist
11-02-2022
Checklist for Applications of Enlistment of Firm as Manufacturer of Alternative Medicines and Health Products
Checklist
11-02-2022
Checklist for Applications of Enlistment of Firm as Importer of Alternative Medicines and Health Products
Checklist
11-02-2022
Checklist for Form 3 (for the enlistment of locally manufactured product with general or traditional claim)
Checklist
11-02-2022
Checklist for Form 4 (for the enlistment of locally manufactured product with therapeutic claim)
Checklist
11-02-2022
Checklist for Form 5 (for the enlistment of imported product)
Checklist
11-02-2022
Checklist for Application for enlistment of firm and its products on Contract Manufacturing
Checklist
11-02-2022
Checklist for Application for issuance of GMP certificate
Checklist
11-02-2022
Checklist for application of Change in Shelf Life of an Enlisted Product
Checklist
11-02-2022
Checklist for Application of Post Enlistment Variations
Checklist
11-02-2022
Checklist for inspection of manufacturing units of alternative medicines and health products
Checklist
19-09-2024
Inspection performa for verification of storage facilities of alternative medicine and health products
Checklist
19-09-2024
Checklist for product specific inspection for extension in shelf life
Checklist
19-09-2024
Checklist for verification of testing facility for minerals
Checklist
19-09-2024
Inspection performa for capacity assessment inspection
Checklist
19-09-2024
5. Controlled Substances
Title
Type
Published Date
Performa for Submitting Consumption Record for the Allocation of the Drug(S) Containing Controlled Substances to be Submitted Along with the Quota Application by the Hospital
Form
11-02-2022
Performa to Submit Manufacturing Record for an Year
Form
11-02-2022
Performa to submit Primary Sale Record for an Year
Form
11-02-2022
Performa to submit Secondary Sale Record for an Year
Form
11-02-2022
Undertaking for Fulfillment of Conditions of Previous Allocation of Controlled Substance
Template
11-02-2022
Undertaking for Licit Manufacturing of Controlled Substance
Template
11-02-2022
Performa to Submit Detail of Quantity of Controlled Substance(s) to be Destroyed/Disposed Off
Form
11-02-2022
Check List For Application of Allocation Of Quota Of Controlled Substances For Export Purpose
Checklist
11-02-2022
Check List For Application of Allocation Of Quota Of Controlled Substances to Tertiary Care Hospitals (Located in ICT)
Checklist
11-02-2022
Check List for Allocation of Quota of Controlled Substance(s) to Local Manufacturers
Checklist
11-02-2022
6. Licensing and Inspections
Title
Type
Published Date
Application (Form 1) for Grant of Drug Manufacturing License
Form
11-02-2022
Application (Form 1-A) of Renewal of DML
Form
11-02-2022
Undertaking for application of change in technical staff
Template
11-02-2022
Application (Form 3) for Grant of Drug Manufacturing License for Experimental Purposes
Form
11-02-2022
Checklist for application of Site Verification
Checklist
11-02-2022
Checklist for application of approval of layout plan
Checklist
11-02-2022
Checklist for Application of Grant of APIs
Checklist
11-02-2022
Checklist for Application of approval of technical staff
Checklist
11-02-2022
Checklist for Application of issuance of new or duplicate inspection book
Checklist
11-02-2022
Checklist for Application of Attestation of DML
Checklist
11-02-2022
Checklist for Application of Change in Management/ Title of the Pharmaceutical Firm
Checklist
11-02-2022
Checklist for Application of Grant of Repacking Products
Checklist
11-02-2022
Check List for application of cGMP Certificate issuance
Checklist
11-02-2022
Form 7; Statement Showing Quarterly Production
Form
11-02-2022
Checklist for Dosage Form Sections Inspection (Grant/Renewal)
Checklist
19-02-2024
7. Product Recalls
Title
Type
Published Date
Form for Recall Assessment
Form
11-02-2022
Logbook Template for Recall
Template
11-02-2022
Template for Recall Letters Notice to Distributors/ Marketing Company/ Stockists / Retailers
Template
11-02-2022
8. Costing & Pricing
Title
Type
Published Date
Application for Price Revision of Locally Manufactured Drugs
Form
11-02-2022
Application for Price Revision of Imported Finished Drugs
Form
11-02-2022
Application for Price Revision of Imported Drugs for Repacking
Form
11-02-2022
Check list for application of fixation of Maximum Retail Price (MRP) of Originator Brand of New Chemical Entity (NCE) & New Biological Entity (NBE)
Checklist
11-02-2022
Check list for application of fixation of Maximum Retail Price (MRP) of Generic Brand of New Chemical Entity (NCE) & New Biological Entity (NBE)
Checklist
11-02-2022
Check list for application of price increase of Maximum Retail Price (MRP) under hardship category
Checklist
11-02-2022
Check list for application of verification of Maximum Retail Price (MRP) of additional pack or changed of pack size
Checklist
11-02-2022
Check list for application of verification of Annual Increase in MRPs of drugs
Checklist
11-02-2022
9. Clinical Trials, Bioavailability and Bioequivalence Studies
Title
Type
Published Date
Application(Form II) for Approval and Registration of Clinical Trial
Form
11-02-2022
Application (Form II-A) for approval and registration of bio-equivalence or bio-availability study
Form
09-06-2023
Application (Form I) for license to act as center, clinical trial site, CRO or laboratory
Form
11-02-2022
Application (Form III) for renewal of license to act as center, clinical trial site, CRO or laboratory
Form
11-02-2022
Checklist for Application for Approval of Clinical Trials and Bio-availability/ Bio-equivalence Studies
Checklist
11-02-2022
Checklist for Applications for Grant of License to BABE Studies Centre, CRO, Clinical Trial Site or Bio-analytical Laboratory for Clinical Research
Checklist
11-02-2022
10. Advertisement of Therapeutic goods
Title
Type
Published Date
Application (Form 8) for Approval of Advertisement of Therapeutic Goods
Form
11-02-2022
Form for complaint (against advertisement of therapeutic goods remedy treatment offer of treatment)
Form
11-02-2022
11. Import & Export
Title
Type
Published Date
Check List for Application of Clearance of Import Cases
Checklist
11-02-2022
Check List for Application of Drugs Import License
Checklist
11-02-2022
Check List for Application of License to Import Small Quantities of Drugs for Clinical Trials, Examination, Test or Analysis
Checklist
11-02-2022
Checklist for Application of No Objection Certificate (NOC) for Donation of Medicines
Checklist
11-02-2022
Check List for Application of NOC to Export Drugs
Checklist
11-02-2022
Checklist for Application of Import of Medicine for Personal Use
Checklist
11-02-2022
Checklist for Application of Export of Medicine for Personal Use
Checklist
11-02-2022
Checklist for issuance of No Objection Certificate (NOC) to import unregistered/ unavailable medicines for use in hospitals & institutions only
Checklist
11-02-2022
Form 1; Intimation Regarding Import
Form
11-02-2022
Form 2; Application for License to Import Drug(s)
Form
11-02-2022
Form 3: Undertaking to Accompany an Application for License to Import Drug
Form
11-02-2022
Form 4; Application for License to Import Drugs for the Purpose of Clinical Trial, Examination, Test or Analysis
Form
11-02-2022
Form 7; Batch Certification
Form
11-02-2022
Form 8; Intimation of Arrival of Consignment (s) of Imported Drug (s) Other Than Those Imported for Personal Use
Form
11-02-2022
Form 10; Application for License to Export Drugs
Form
11-02-2022
Form 11; Form of Undertaking to Accompany an Application for an Export License
Form
11-02-2022
Form 12; Application for Export of Small Quantities of Drug (S) for the Purpose of Clinical Trials, Examination, Test or Analysis or for Personal Use
Form
11-02-2022
12. Budget & Accounts
Title
Type
Published Date
Central Research Fund Receipt Voucher
Form
11-02-2022
Checklist for Application for Deposition of Central Research Fund
