Application Forms

Last Updated on May 19, 2022

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.

  1. Human Drugs
  2. Veterinary Drugs
  3. Medical Devices
  4. Alternative Medicines, Health & OTC Products
  5. Controlled Substances
  6. Licensing and Inspections
  7. Product Recall
  8. Costing and Pricing
  9. Clinical Trials , Bioavailability, Bioequivalence Studies
  10. Advertisement approvals
  11. Import and Export
  12. Budget & Accounts

Please click on the relevant section of navigate below to view or download.

1. Drugs for Human Use

TitleTypePublished 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 DrugsForm 11-02-2022
Checklist for Pre-Submission Screening of Common Technical DocumentChecklist 11-02-2022
Checklist for Application of Post Registration Variation in a Registered DrugChecklist 11-02-2022

2. Drugs for Veterinary Use

TitleTypePublished Date
Application (Form 5) For Registration of Drug For Local ManufactureForm11-02-2022
Application (Form 5A) for Registration of an Imported DrugForm 11-02-2022
Application (Form 5D) for Registration of a Dosage Form Containing a New Drug Molecule or a New Combination  Dosage FormForm 11-02-2022
Application (Form 5E) for the Registration to Manufacture a Patented DrugForm 11-02-2022
Application (Form 5-B) for Renewal of Registration of a DrugForm 11-02-2022
Checklist for application (Form 5) For Registration of a Drug for Local ManufactureChecklist 11-02-2022
Checklist for application of Post Registration Variation in a Registered DrugChecklist 11-02-2022
3. Medical Devices
TitleTypePublished Date
Application (Form 1) For Grant or Renewal of An Establishment License To Manufacture Medical DevicesForm 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 devicesChecklist 11-02-2022
Checklist for grant or renewal of an establishment license to import medical devicesChecklist 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 importChecklist 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 importChecklist 11-02-2022
4. Health & OTC Products
TitleTypePublished Date
Application (Form 1) for Enlistment of Firm as ManufacturerForm 11-02-2022
Application (Form 2) for Enlistment of Firm as ImporterForm 11-02-2022
Application (Form3) for enlistment of locally manufactured product with general claimForm 11-02-2022
Application (Form4) for Enlistment of Locally Manufactured Product with Therapeutic ClaimForm 11-02-2022
Application (form 5) for enlistment of imported productForm 11-02-2022
Application (form 9) for issuance of GMP certificate or Free sale certificate or COPPForm 11-02-2022
Form 11 warranty that products do not contravene with provisions of DRAP ACT and rulesForm 11-02-2022
Form 12 Authority Letter by Manufacturer or Importer to Authorized Agent for DistributionForm 11-02-2022
Checklist for Application of Site Verification and Layout Plan ApprovalChecklist 11-02-2022
Checklist for Application of Revised Layout Plan and Additional SectionChecklist 11-02-2022
Checklist for Applications of Enlistment of Firm as Manufacturer of Alternative Medicines and Health ProductsChecklist 11-02-2022
Checklist for Applications of Enlistment of Firm as Importer of Alternative Medicines and Health ProductsChecklist 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 ManufacturingChecklist 11-02-2022
Checklist for Application for issuance of GMP certificateChecklist 11-02-2022
Checklist for application of Change in Shelf Life of an Enlisted ProductChecklist 11-02-2022
Checklist for Application of Post Enlistment VariationsChecklist 11-02-2022
5. Controlled Substances
TitleTypePublished 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 HospitalForm11-02-2022
Performa to Submit Manufacturing Record for an YearForm 11-02-2022
Performa to submit Primary Sale Record for an YearForm 11-02-2022
Performa to submit Secondary Sale Record for an YearForm 11-02-2022
Undertaking for Fulfillment of Conditions of Previous Allocation of Controlled SubstanceTemplate 11-02-2022
Undertaking for Licit Manufacturing of Controlled SubstanceTemplate 11-02-2022
Performa to Submit Detail of Quantity of Controlled Substance(s) to be Destroyed/Disposed OffForm 11-02-2022
Check List For Application of Allocation Of Quota Of Controlled Substances For Export PurposeChecklist 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 ManufacturersChecklist 11-02-2022
6. Licensing and Inspections
TitleTypePublished Date
Application (Form 1) for Grant of Drug Manufacturing LicenseForm11-02-2022
Application (Form 1-A) of Renewal of DMLForm 11-02-2022
Undertaking for application of change in technical staffTemplate 11-02-2022
Application (Form 3) for Grant of Drug Manufacturing License for Experimental PurposesForm 11-02-2022
Checklist for application of Site VerificationChecklist 11-02-2022
Checklist for application of approval of layout planChecklist 11-02-2022
Checklist for Application of Grant of APIsChecklist 11-02-2022
Checklist for Application of approval of technical staffChecklist 11-02-2022
Checklist for Application of issuance of new or duplicate inspection bookChecklist 11-02-2022
Checklist for Application of Attestation of DMLChecklist 11-02-2022
Checklist for Application of Change in Management/ Title of the Pharmaceutical FirmChecklist 11-02-2022
Checklist for Application of Grant of Repacking ProductsChecklist 11-02-2022
Check List for application of cGMP Certificate issuanceChecklist 11-02-2022
Form 7; Statement Showing Quarterly ProductionForm 11-02-2022
7. Product Recalls
TitleTypePublished Date
Form for Recall Assessment Form11-02-2022
Logbook Template for RecallTemplate 11-02-2022
Template for Recall Letters Notice to Distributors/ Marketing Company/ Stockists  / RetailersTemplate 11-02-2022
8. Costing & Pricing
TitleTypePublished Date
Application for Price Revision of Locally Manufactured DrugsForm11-02-2022
Application for Price Revision of Imported Finished DrugsForm 11-02-2022
Application for Price Revision of Imported Drugs for RepackingForm 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 categoryChecklist 11-02-2022
Check list for  application of verification of Maximum Retail Price (MRP) of additional pack or changed of pack sizeChecklist 11-02-2022
Check list for  application of verification of Annual Increase in MRPs of drugsChecklist 11-02-2022
9. Clinical Trials, Bioavailability and Bioequivalence Studies
TitleTypePublished Date
Application(Form 2)  for Approval and Registration of Clinical TrialForm11-02-2022
Application (Form 2-A) for approval and registration of bio-equivalence or bio-availability studyForm 11-02-2022
Application (Form 1) for license to act as center, clinical trial site, CRO or laboratoryForm 11-02-2022
Application (Form 3) for renewal of license to act as center, clinical trial site, CRO or laboratoryForm 11-02-2022
Checklist for Application for Approval of Clinical Trials and Bio-availability/ Bio-equivalence StudiesChecklist 11-02-2022
Checklist for Applications for Grant of License to BABE Studies Centre, CRO, Clinical Trial Site or Bio-analytical Laboratory for Clinical ResearchChecklist 11-02-2022
TitleTypePublished Date
Application (Form 8) for Approval of Advertisement of Therapeutic GoodsForm11-02-2022
Form for complaint (against advertisement of therapeutic goods remedy treatment offer of treatment)Form 11-02-2022
11. Import & Export
TitleTypePublished Date
Check List for Application of Clearance of Import Cases Checklist11-02-2022
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
TitleTypePublished Date
Central Research Fund Receipt Voucher Form11-02-2022
Checklist for Application for Deposition of Central Research Fund Checklist 11-02-2022