Forms: All types of Drugs

Applications Forms for all types of Drugs under Drugs and Cosmetics Act 1940 and Rules 1945

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Forms for Allopathic drugs Medical Devices Homoeopathy Cosmetics Clinical trial
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Rakesh Dahiya

Last Updated on November 6, 2024 by The Health Master

Forms: All types of Drugs

Forms for all types of Drugs under Drugs and Cosmetics Act 1940 and Rules 1945

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We have provided all Forms relevant to the above-mentioned topic in accordance with the Drugs and Cosmetics Act 1940 and Rules 1945; click on the links below for more information:

Form 1: Memorandum to the Central Drugs Laboratory

Form-1

Form 2: Certificate of test or analysis by the Central Drugs Laboratory

Form-2

Form 3 to Form 7: (Omitted)

Form 8: Application for licence to import drugs (excluding those specified in Schedule X) to the Drugs and Cosmetics Rules, 1945

Form-8

Form 8A: Application for licence to import drugs specified in Schedule X to the Drugs and Cosmetics Rules, 1945

Form-8A

Form 9: Form of undertaking to accompany an application for an import licence

Form-9

Form 10: Licence to import drugs (excluding those specified in Schedule X) to the Drugs and Cosmetic Rules, 1945

Form-10

Form 10A: Licence to import drugs specified in Schedule X to the Drugs and Cosmetics Rules, 1945

Form-10A

Form 11: Licence to import drugs for the purposes of examination, test or analysis

Form-11

Form 11A: Licence to import drugs by a Government Hospital or Autonomous Medical Institution for the treatment of patients

Form-11A

Form 12: Application for licence to import drugs for purpose of examination, test or analysis

Form-12

Form 12A: Application for the issue of a permit to import small quantities of drugs for personal use

Form-12A

Form 2AA: Application for licence to import small quantities of new drugs by a Government Hospital or Autonomous Medical Institution for the treatment of patients.

Form-12AA

Form 12B: Permit for the import of small quantities of drugs for personal use

Form-12B

Form 13: Certificate of test or analysis by Government Analyst under section 25 (1) of the Drugs and Cosmetics Act, 1940

Form-13

Form 14A: Application from a purchaser for test or analysis of a drug under Section 26 of the Drugs and Cosmetics Act, 1940

Form-14A

Form 14B: Certificate of test or analysis by Government Analyst under Section 26 of the Drugs and Cosmetics Act, 1940

Form-14B

Form 15: Order under section 22 (1)(c) of the Drugs and 1[***) Act, 1940 requiring a person not to dispose of stock in his possession

Form-15

Form 16: Receipt for stock of drugs for record, register, document or material object seized under section 22 (1) (c) or (cc) of the Drugs and 1[***] Act, 1940.

Form-16

Form 17: Intimation to person from whom sample is taken

Form-17

Form 17A: Receipt for samples of drugs taken where fair price tendered thereof under sub- section (I) of Section 23 of the Drugs and 1[***] Act, 1940 is refused

Form-17A

Form 18: Memorandum to Government Analyst

Form-18

Form 19: Application for grant licence to sell, stock, exhibit or offer for sale, or distribute drugs other than those specified in Schedule X

Form 19

Form 19-A: Application for the grant of a restricted licence to sell, stock or exhibit or offer for sale, or distribute drugs by retail by dealers who do not engage the service of a qualified person

Form 19-A

Form 19-AA: Application for grant of a licence to sell, stock or exhibit or offer for sale by wholesale or distribute] drugs from a motor vehicle

Form 19 AA

Form 19-B: Application for licence to sell, stock or exhibit or offer for sale, or distribute Homoeopathic Medicines

Form 19-B

Form 19-C: Application for grant of a licence to sell, stock, exhibit or offer for sale, or distribute] drugs specified in Schedule X

Form 19C

Form 20: Licence to sell, stock or exhibit or offer for sale, or distribute drugs by retail other than those specified in Schedules C, C(1) and X

Form-20

Form 20A: Restricted Licence to sell, stock or exhibit or offer for sale, or distribute] drugs by retail other than those specified in Schedules C, C (1) and X for dealers who do not engage the services of a registered pharmacist

Form-20A

Form 20B: 1[Licence to sell, stock or exhibit or offer for sale, or distribute] by wholesale, drugs other than those specified in 2[Schedules C, C(I) and X]

Form-20B

Form 20BB: Licence to sell, stock or exhibit or offer for sale by wholesale, or distribute drugs other than those specified in Schedule C and Schedule C (1) to the Drugs and Cosmetics Rules, 1945 from a motor vehicle

Form-20BB

Form 20C: 2[Licence to sell, stock or exhibit or offer for sale, or distribute] Homoeopathic medicines by retail

Form-20C

Form 20D: 2[Licence to sell, stock or exhibit or offer for sale, or distribute] Homoeopathic medicines by wholesale

Form-20D

Form 20E: (Omitted)

Form 20F: Licence to sell, stock or exhibit for sale or distribute by retail drugs specified in Schedule X

Form-20F

Form 20G: 2[Licence to sell, stock or exhibit or offer for sale, or distribute] by wholesale drugs specified in Schedule X

Form-20G

Form 21: 1[Licence to sell, stock or exhibit or offer for sale,or distribute] by retail drugs specified in Schedules C and C (1) 2[excluding those specified in Schedule X]

Form-21

Form 21A: 1[Licence to sell, stock or exhibit or offer for sale, or distribute] by retail drugs specified in 2[Schedule C (1)] 3[excluding those specified in Schedule X] 4[***] for dealers who do not engage the services of a registered pharmacist

Form-21A

Form 21B: 1[Licence to sell, stock or exhibit or offer for sale, or distribute] by wholesale drugs specified in Schedules C and C (1) 2[excluding those specified in Schedule X

Form-21B

Form 21BB: Licence to sell by wholesale or to distribute drugs specified in Schedule C and Schedule C (1) to the Drugs and Cosmetics Rules, 1945 from a motor vehicle.

Form-21BB

Form 21C: (Omitted)

Form 21CC: (Omitted)

Form 22: (Omitted)

Form 23: (Omitted)

Form 24: Application for the grant of a licence to manufacture for sale or for distribution of drugs other than those specified in Schedules C and C (1) and X

Form-24

Form 24-A: Application for grant of a loan licence to manufacture for sale or for distribution of drugs other than those specified in Schedules C and C (I) and X

Form-24A

Form 24-B: Application for grant of licence to repack for sale or distribution of drugs, being drugs other than those specified in Schedules C and C (1) 2[excluding those specified in Schedule X]

Form-24B

Form 24-C: Application for the grant of a licence to manufacture for sale [or for distribution] of Homoeopathic medicines or a licence to manufacture potentised preparations from back potencies by licensees holding licence in Form 20-C

Form-24C

Form 24C-1: Application for the grant of a loan licence to manufacture for sale or for distribution of homoeopathic medicines

Form-24C-1

Form 24C-2: Application for the certificate of Good manufacturing Practices for homoeopathic medicines manufacturing units

Form-24C-2

Form 24-F: Application for the grant of a licence to manufacture for sale or for distribution of] drugs specified in Schedule X and not specified in Schedules C and C(1)

Form-24F

Form 25: 1[Licence to manufacture for sale or for distribution of] drugs other than those specified in 2[Schedules C and C(1) and X]

Form-25

Form 25A: Loan 1[licence to manufacture for sale or for distribution of] drugs other than those specified In 2[Schedules C and C (1) and X]

Form-25A

Form 25B: Licence to repack for sale or distribution of drugs being drugs other than those specified inSchedules C and C (1) 2[excluding those specified in Schedule X]

Form-25B

Form 25C: Licence to manufacture for sale or for distribution of Homoeopathic medicines

Form-25C

Form 25C-1: Loan Licence to manufacture for sale or for distribution of Homoeopathic medicines

Form-25C-1

Form 25F: 2[Licence to manufacture for sale or for distribution of] drugs specified in Schedule X and not specified in Schedules C and C(I)

Form-25F

Form 26: (Omitted)

Form 26A: (Omitted)

Form 26B: (Omitted)

Form 26C: (Omitted)

Form 26C-1: Certificate of Good Manufacturing Practices (GMP) to manufacture of homoeopathic medicines

Form-26C-1

Form 26F: (Omitted)

Form 26G: Certificate of renewal of licence to operate a Blood Bank for processing of whole human blood and/or* for preparation for sale or distribution of its components

Form-26G

Form 26H: (Omitted)

Form 26-I: Certificate of renewal of licence for manufacture of blood product

Form-26-I

Form 26J: Certificate of renewal of licence for collection, processing, testing, storage, banking and release of umblical cord blood stem cells.

Form-26J

Form 27: Application for grant of a licence to manufacture for sale or for distribution of drugs specified in Schedules C and C (1) excluding those specified in Part XB and Schedule X

Form-27

Form 27-A: Application for grant of a loan licence to manufacture for sale or for distribution of drugs specified in Schedules C and C(1) excluding those specified in Part XB and Schedule X

Form-27A

Form 27-B: Application for grant of a licence to manufacture for sale or for distribution of drugs specified in Schedules C, C(I) and X

Form-27B

Form 27-C: Application for grant/renewal of licence for the operation of a Blood Centre for processing of whole blood and/or preparation of Blood Components

Form-27C

Form 27-D: Application for grant of a licence to manufacture for sale or for distribution of [Large Volume Parenterals/Sera and Vaccines/recombinant DNA (r-DNA) derived drugs] excluding those specified in Schedule X

Form-27D

Form 27DA: Application for grant or of a loan licence to manufacture for sale or for distribution of Large Volume Parenterals/Sera and Vaccines/recombinant DNA (r-DNA) derived drugs excluding those specified in Schedule X

Form-27DA

Form 27-E: Application for grant /renewal* of licence to manufacture Blood products for sale or distribution

Form-27E

Form 27F: Application for grant/renewal* of licence for collection, processing, testing, storage, banking and release of umbilical cord blood stem cells

Form-27F

Form 28: 1[Licence to manufacture for sale or for distribution of] drugs specified in Schedules C and C (1) 2[excluding those specified in Schedule X]

Form-28

Form 28A: Loan 1[Licence to manufacture for sale or for distribution of] drugs specified in Schedules C and C (1) 2[excluding those specified in Schedule X]

Form-28A

Form 28B: 2[Licence to manufacture for sale or for distribution of] drugs specified in
Schedules C, C(I) and X

Form-28B

Form 28C: Licence to operate a Blood Bank for collection, storage and processing of whole human blood and/or* its components for sale or distribution

Form-28C

Form 28D:

Licence to manufacture for saleor for distribution of 2[Large Volume Parenterals/Sera and Vaccines/recombinant DNA (r-DNA) derived drugs] specified in Schedules C and C(I) excluding those specified in Schedule X

Form-28D

Form 28DA: Loan licence to manufacture for sale or for distribution of Large Volume Parenterals/Sera and Vaccines/recombinant DNA (r-DNA) derived drugs excluding those specified in Schedule X

Form-28DA

Form 28E: Licence to manufacture and store blood products for sale or distribution

Form-28E

Form 28F: Licence To Collect, Process, Test, Store, Banking And Release Of Umbilical Cord Blood Stem Cells.

Form-28F

Form 29: Licence to manufacture drugs for purposes of examination, test or analysis

Form-29

Form 30: Application for licence to manufacture drugs for purpose of examination, test or analysis

Form-30

Form 31: (Omitted)

Form 31-A: (Omitted)

Form 32: (Omitted)

Form 32-A: (Omitted)

Form 33: (Omitted)

Form 33-A: (Omitted)

Form 34: (Omitted)

Form 35: Form in which the Inspection Book shall be maintained

Form-35

Form 36: Application for grant of approval for carrying out tests on drugs or raw materials used in the manufacture thereof on behalf of licensees for manufacture for sale of drugs or for an Individual or Organizaion or Procurement Agency

Form-36

Form 37: Approval for carrying out tests on drugs / cosmetics and raw materials used in their manufacture on behalf of licensees for manufacture for sale of drugs /cosmetics

Form-37

Form 38: (Omitted)

Form 39: Report of test or analysis by approved institution

Form-39

Form 39A: Report of test or analysis by approved institution for an Individual or Organisation or Procurement agency

Form-39A

Form 40: Application for issue of Registration Certificate for import of drugs into India under the Drugs and Cosmetics Rules 1945

Form-40

Form 41: Registration Certificate to be issued for import of drugs into India under Drugs and Cosmetics Rules, 1945

Form-41

Form 42: Application for issue of Registration Certificate for import of cosmetics into India under the Drugs and Cosmetics Rules, 1945

Form-42

Form 43: (Omitted)

Form 44: Application for grant of permission to import or manufacture a New Drug or to undertake clinical trial

Form-44

Form 45: Permission to import Finished Formulation of a New Drug

Form-45

Form 45A: Permission to import raw material (new bulk drug substance)

Form-45A

Form 46: Permission / Approval for manufacture of new drug formulation

Form-46

Form 46A: Permission/ Approval for manufacture of raw material (new bulk drug substance)

Form-46A

Form 47 to Form 50: Pertaining to Ayurveda, Siddha and Unani drugs 

Form-51: Form of undertaking to the licensing authority for marketing a drug under a brand name or trade name — to be submitted by the manufacturer or on behalf of the manufacturer

FORM-51

Compiled by:
Rakesh DahiyaSDCO cum Licensing Authority, FDA Haryana


Forms: Drugs

Forms: Cosmetics

Forms: Medical Devices

Forms: Clinical Trial

Licensing procedure for manufacturing of Drugs

Procedure to obtain license for manufacturing of Cosmetics

Procedure to obtain license for manufacturing of Homoeopathic Medicines

Procedure to obtain license for manufacturing of Medical Devices

Procedure to obtain License to Manufacture drugs for testing and analysis purposes

Procedure to obtain license for Blood Centre (Blood Bank)

Procedure to obtain license for Commercial Testing Laboratories

Procedure to obtain license for Medical Store / PharmacyHow to start Jan Aushadhi Store: Procedure

Latest Notifications: D&C Rules 1945

Latest Notifications: D&C Act 1940

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