Food and Drugs Administration, (FDA) Haryana, India. |
Email ID: dahiya19@yahoo.com
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Last Updated on January 21, 2024 by The Health Master
Forms for all types of Drugs under Drugs and Cosmetics Act 1940 and Rules 1945
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 2: Certificate of test or analysis by the Central Drugs Laboratory
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 8A: Application for licence to import drugs specified in Schedule X to the Drugs and Cosmetics Rules, 1945
Form 9: Form of undertaking to accompany an application for an import licence
Form 10: Licence to import drugs (excluding those specified in Schedule X) to the Drugs and Cosmetic Rules, 1945
Form 10A: Licence to import drugs specified in Schedule X to the Drugs and Cosmetics Rules, 1945
Form 11: Licence to import drugs for the purposes of examination, test or analysis
Form 11A: Licence to import drugs by a Government Hospital or Autonomous Medical Institution for the treatment of patients
Form 12: Application for licence to import drugs for purpose of examination, test or analysis
Form 12A: Application for the issue of a permit to import small quantities of drugs for personal use
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 12B: Permit for the import of small quantities of drugs for personal use
Form 13: Certificate of test or analysis by Government Analyst under section 25 (1) of the Drugs and Cosmetics Act, 1940
Form 14A: Application from a purchaser for test or analysis of a drug under Section 26 of the Drugs and Cosmetics Act, 1940
Form 14B: Certificate of test or analysis by Government Analyst under Section 26 of the Drugs and Cosmetics Act, 1940
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 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 17: Intimation to person from whom sample is taken
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 18: Memorandum to Government Analyst
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-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-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-B: Application for licence to sell, stock or exhibit or offer for sale, or distribute Homoeopathic Medicines
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 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 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 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 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 20C: 2[Licence to sell, stock or exhibit or offer for sale, or distribute] Homoeopathic medicines by retail
Form 20D: 2[Licence to sell, stock or exhibit or offer for sale, or distribute] Homoeopathic medicines by wholesale
Form 20E: Certificate of renewal of 2[Licence to sell, stock or exhibit or offer for sale, or distribute] Homoeopathic medicines
Form 20F: Licence to sell, stock or exhibit for sale or distribute by retail drugs specified in Schedule X
Form 20G: 2[Licence to sell, stock or exhibit or offer for sale, or distribute] by wholesale drugs specified in Schedule X
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 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 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 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 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-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 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 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 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 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 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 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 25C: 2[Licence to manufacture for sale or for distribution of] Homoeopathic medicines
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 26: (Omitted)
Form 26A: (Omitted)
Form 26B: (Omitted)
Form 26C: Certificate of renewal of licence to manufacture for sale of Homoeopathic medicines
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 26H: (Omitted)
Form 26-I: Certificate of renewal of licence for manufacture of blood product
Form 26J: Certificate of renewal of licence for collection, processing, testing, storage, banking and release of umblical cord blood stem cells.
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-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 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 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 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 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 27-E: Application for grant /renewal* of licence to manufacture Blood products for sale or distribution
Form 27F: Application for grant/renewal* of licence for collection, processing, testing, storage, banking and release of umbilical cord blood stem cells
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 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 28B: 2[Licence to manufacture for sale or for distribution of] drugs specified in
Schedules C, C(I) and X
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 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 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 28E: Licence to manufacture and store blood products for sale or distribution
Form 28F: Licence To Collect, Process, Test, Store, Banking And Release Of Umbilical Cord Blood Stem Cells.
Form 29: Licence to manufacture drugs for purposes of examination, test or analysis
Form 30: Application for licence to manufacture drugs for purpose of examination, test or analysis
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 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 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 38: (Omitted)
Form 39: Report of test or analysis by approved institution
Form 39A: Report of test or analysis by approved institution for an Individual or Organisation or Procurement agency
Form 40: Application for issue of Registration Certificate for import of drugs into India under the Drugs and Cosmetics Rules 1945
Form 41: Registration Certificate to be issued for import of drugs into India under Drugs and Cosmetics Rules, 1945
Form 42: Application for issue of Registration Certificate for import of cosmetics into India under the Drugs and Cosmetics Rules, 1945
Form 43: (Omitted)
Form 44: Application for grant of permission to import or manufacture a New Drug or to undertake clinical trial
Form 45: Permission to import Finished Formulation of a New Drug
Form 45A: Permission to import raw material (new bulk drug substance)
Form 46: Permission / Approval for manufacture of new drug formulation
Form 46A: Permission/ Approval for manufacture of raw material (new bulk drug substance)
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
Compiled by:
Rakesh Dahiya, SDCO cum Licensing Authority, FDA Haryana
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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