Food and Drugs Administration, (FDA) Haryana, India. |
Email ID: dahiya19@yahoo.com
- Key Notes on Revised Schedule M: Point No. 14 – Materials - December 25, 2024
- Key Notes on Revised Schedule M: Point No. 13 – Equipment - December 24, 2024
- Forms: For Homoeopathy Medicines - December 22, 2024
Last Updated on November 27, 2024 by The Health Master
Forms: Drugs
Forms: Drugs and Cosmetics Act 1940 and Rules 1945
As per Drugs and Cosmetics Act 1940 and Rules 1945 we have provided all Forms relevant to the above said topic, Click below links 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: (Omitted)
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 24C-1: Application for the grant of a loan licence to manufacture for sale or for distribution of homoeopathic medicines
Form 24C-2: Application for the certificate of Good manufacturing Practices for homoeopathic medicines manufacturing units
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: Licence to manufacture for sale or for distribution of Homoeopathic medicines
Form 25C-1: Loan 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: (Omitted)
Form 26C-1: Certificate of Good Manufacturing Practices (GMP) to manufacture 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
How to obtain retail drug license
How to obtain Jan Aushadhi License
How to change pharmacist at medical store
Good storage practice of medicines at Medical Store
Record keeping for Medical Store / Pharmacy
Forms: Cosmetics
Forms: Cosmetics Rules 2020
As per Cosmetics Rules 2020 we have provided all Forms relevant to the above said topic, Click below links for more information:
Form Cos-1: Application for issue of registration certificate for import of cosmetics into India
Form-Cos-1
Form Cos-2: Import registration certificate to be issued for import of cosmetics into India
Form-Cos-2
Form Cos-3: Permission to import or manufacture new cosmetics in India
Form-Cos-3
Form Cos-4: Application for issue of Import Registration Number for Import of already registered cosmetics
Form-Cos-4
Form Cos-4A: Import Registration Number to be issued for import of already registered cosmetics into India
Form-Cos-4A
Form Cos-5: Application for grant of a license to manufacture cosmetics for sale or for distribution
Form-Cos-5
Form Cos-6: Application for grant of a loan license to manufacture cosmetics for sale or for distribution
Form-Cos-6
Form Cos-7: Self-certificate of compliance of Good Manufacturing Practices (GMP) for manufacture of cosmetics
(To be given by the applicant along with Form COS- 5 or Form COS- 6 at the time of application for manufacturing licence or loan licence)
Form-Cos-7
Form Cos-8: License to manufacture cosmetics for sale or for distribution
Form-Cos-8
Form Cos-9: Loan license to manufacture cosmetics for sale or for distribution
Form-Cos-9
Form Cos-10: Intimation to person from whom sample is taken
Form-Cos-10
Form Cos-11: Form in which the inspection book shall be maintained
Form-Cos-11
Form Cos-12: Application for grant of permission for new cosmetics for obtaining import registration certificate or manufacturing license
Form-Cos-12
Form Cos-13: Application from a purchaser for test or analysis of a cosmetic under Section 2 6 of the Drugs and Cosmetics Act, 1940
Form-Cos-13
Form Cos-14: Report of test or analysis by Government Analyst under Section 26 of the Drugs and Cosmetics Act, 1940
Form-Cos-14
Form Cos-15: Receipt for stock of cosmetics for record, register, document or material object seized under section 22 (1) (c) or (cc) of the Drugs and Cosmetics Act, 1940
Form-Cos-15
Form Cos-16: Receipt for samples of cosmetics taken where fair price tendered thereof under sub – section (1) of section 23 of the Drugs and Cosmetics Act, 1940 is refused
Form-Cos-16
Form Cos-17: Memorandum to Government Analyst
Form-Cos-17
Form Cos-18: Order under section 22 (1)(c) of the Drugs and Cosmetics Act, 1940 requiring a person not to dispose of stock in his possession
Form-Cos-18
Form Cos-19: Report of tests or analysis of cosmetics by the Government Analyst
Form-Cos-19
Form Cos-20: Memorandum to the Director, Central Cosmetic Laboratory
Form-Cos-20
Form Cos-21: Report of test or analysis by the Central cosmetic laboratory
Form-Cos-21
Form Cos-22: Application for grant of approval for carrying out tests on cosmetics or raw materials used in the manufacture thereof on behalf of licensees for manufacture for sale of cosmetics
Form-Cos-22
Form Cos-23: Approval for carrying out tests on cosmetics and raw materials used in their manufacture on behalf of licensees for manufacture for sale of cosmetics
Form-Cos-23
Form Cos-24: Report of test or analysis by approved institution
Form-Cos-24
Cosmetics – Manufacturing License
Latest Notifications: Cosmetics
FAQs on – Cosmetics Rules 2020
FAQs – on Cosmetics (Series-1)
FAQs on Pollution in Drug, Cosmetics & Homeopathic Industries
Forms: Medical Devices
Forms: Medical Devices Rules 2017
As per Medical Devices Rules 2017 we have provided all Forms relevant to the above said topic, Click below links for more information:
Form MD 1: Application for grant of Certificate of Registration of a Notified Body
Form-MD-1
Form MD 2: Certificate of Registration for a Notified Body under the Medical Devices Rules, 2017
Form-MD-2
Form MD 3: Application for Grant of Licence to Manufacture for Sale and Distribution of Class A or Class B medical device
Form-MD-3
Form MD 4: Application for Grant of Loan Licence to Manufacture for Sale or for Distribution of Class A or Class B medical device
Form-MD-4
Form MD 5: Licence to Manufacture for Sale or for Distribution of Class A or Class B Medical Device
Form-MD-5
Form MD 6: Loan Licence to Manufacture for Sale or for Distribution of Class A or Class B medical device
Form-MD-6
Form MD 7: Application for Grant of Licence to Manufacture for Sale or for Distribution of Class C or Class D
Form-MD-7
Form MD 8: Application for Grant of Loan Licence to Manufacture for Sale or for Distribution of Class C or Class D
Form-MD-8
Form MD 9: Licence to Manufacture for Sale or for Distribution of Class C or Class D
Form-MD-9
Form MD 10: Loan Licence to Manufacture for Sale or for Distribution of Class C or Class D medical device
Form-MD-10
Form MD 11: Form in which the Audit or Inspection Book shall be maintained
Form-MD-11
Form MD 12: Application for licence to manufacture medical device for purpose of clinical investigations, test, evaluation, examination, demonstration or training
Form-MD-12
Form MD 13: Licence to Manufacture Medical Devices for the Purposes of Clinical Investigations or Test or Evaluation or Demonstration or Training
Form-MD-13
Form MD 14: Application for issue of import licence to import medical device
Form-MD-14
Form MD 15: Licence to Import Medical Device
Form-MD-15
Form MD 16: Application for Licence to Import Medical Devices for the Purposes of Clinical Investigations or Test or Evaluation or Demonstration or Training
Form-MD-16
Form MD 17: Licence to Import Medical Devices for the Purposes of Clinical Investigations or Test or Evaluation or Demonstration or Training
Form-MD-17
Form MD 18: Application for licence to import investigational medical devices for the purposes by a government hospital or statutory medical institution for the treatment of patients
Form-MD-18
Form MD 19: Licence to import investigational medical device by a government hospital or statutory medical institution for the treatment of patients
Form-MD-19
Form MD 20: Application for permission to import small quantity of medical devices for personal use
Form-MD-20
Form MD 21: Permission to import of small quantity of medical devices for personal use
Form-MD-21
Form MD 22: Application for Grant of permission to conduct clinical investigation of an investigational medical device
Form-MD-22
Form MD 23: Permission to conduct Clinical Investigation
Form-MD-23
Form MD 24: Application for grant of permission to conduct clinical performance evaluation of new in vitro diagnostic medical device
Form-MD-24
Form MD 25: Permission to conduct clinical performance evaluation of new in vitro diagnostic medical device
Form-MD-25
Form MD 26: Application for grant of permission to import / manufacture for sale or for distribution of medical device which does not have predicate medical device
Form-MD-26
Form MD 27: Permission to import or manufacture for sale or for distribution of medical device which does not have predicate medical device
Form-MD-27
Form MD 28: Application for grant of permission to Import or Manufacture for sale or for distribution of new in vitro diagnostic medical device
Form-MD-28
Form MD 29: Permission to Import or Manufacture New In Vitro Diagnostic Medical Device
Form-MD-29
Form MD 30: Memorandum to the Central Medical Device Testing Laboratory
Form-MD-30
Form MD 31: Certificate of test or evaluation by the Central Medical Device Testing Laboratory
Form-MD-31
Form MD 32: Report of Test or Evaluation of Medical Devices by Medical Device Testing Officer
Form-MD-32
Form MD 33: Application from a purchaser for test or evaluation of a Medical Device under section 26 of the Drugs and Cosmetics Act, 1940 (23 of 1940)
Form-MD-33
Form MD 34: Order under clause (c) of sub-section (1) of section of the Drugs and Cosmetics Act, 1940, (23 of 1940) requiring a person not to dispose of stock in his possession
Form-MD-34
Form MD 35: Receipt for stock of medical devices for record, register, document or material object seized under clause (c) or clause (cc) of sub-section (1) of Section 22 of the Drugs and Cosmetics Act (23 of 1940)
Form-MD-35
Form MD 36: Intimation of Person from Whom Sample is taken
Form-MD-36
Form MD 37: Receipt for Sample of medical device(s) taken where fair price tendered thereof under sub-section (1) of Section 23 of the Drugs and Cosmetics Act, 1940 is refused
Form-MD-37
Form MD 38: Memorandum to Medical Device Testing Officer
Form-MD-38
Form MD 39: Application for grant of registration to Medical Device Testing Laboratory for carry out Test or Evaluation of a medical device on behalf of manufacturer
Form-MD-39
Form MD 40: Certificate of registration to Medical Device Testing Laboratory for carry out Test or Evaluation of a medical device on behalf of manufacturer
Form-MD-40
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Forms: Clinical Trial
Forms: New Drugs and Clinical Trials Rules 2019
As per New Drugs and Clinical Trials Rules 2019 we have provided all Forms relevant to the above said topic, Click below links for more information:
Form CT-1: Application for registration / renewal of ethics committee relating to clinical trial or bioavailability and bioequivalence study or biomedical health research
Form-CT-1
Form CT-2: Grant of registration of ethics committee relating to clinical trial or bioavailability and bioequivalence study
Form-CT-2
Form CT-3: Grant of registration of ethics committee relating to biomedical health research
Form-CT-3
Form CT-4: Application for grant of permission to conduct clinical trial of new drug or investigational new drug
Form-CT-4
Form CT-4A: Information to initiate clinical trial of new drug or investigational new drug as part of discovery, research and manufacture in India
Form-CT-4A
Form CT-5: Application for grant of permission to conduct bioavailability or bioequivalence study
Form-CT-5
Form CT-6: Permission to conduct clinical trial of new drug or investigational new drug
Form-CT-6
Form CT-7: Permission to conduct bioavailability or bioequivalence study of new drug or investigational new drug
Form-CT-7
Form CT-8: Application for registration / renewal of bioavailability or bioequivalence study centre
Form-CT-8
Form CT-9: Grant of registration of bioavailability or bioequivalence study centre
Form-CT-9
Form CT-10: To manufacture new drug or investigational new drug for clinical trial or bioavailability or bioequivalence study or for examination, test and analysis
Form-CT-10
Form CT-11: Permission to manufacture new drug or investigational new drug for clinical trial, bioavailability or bioequivalence study or for examination, test and analysis
Form-CT-11
Form CT-12: Application for grant of permission to manufacture formulation of unapproved active pharmaceutical ingredient for test or analysis or clinical trial or bioavailability or bioequivalence study
Form-CT-12
Form CT-13: Application for grant of permission to manufacture unapproved active pharmaceutical ingredient for development of formulation for test or analysis or clinical trial or bioavailability or bioequivalence study
Form-CT-13
Form CT-14: Permission to manufacture formulation of unapproved active pharmaceutical ingredient for test or analysis or clinical trial or bioavailability or bioequivalence study
Form-CT-14
Form CT-15: Permission to manufacture unapproved active pharmaceutical ingredient for the development of formulation for test or analysis or clinical trial or bioavailability or bioequivalence study
Form-CT-15
Form CT-16: Application for grant of licence to import new drug or investigational new drug for clinical trial or bioavailability or bioequivalence study or for examination, test and analysis
Form-CT-16
Form CT-17: Licence to import new drug or investigational new drug for the purpose of clinical trial or bioavailability or bioequivalence study or for examination, test and analysis
Form-CT-17
Form CT-18: Application for grant of permission to import new drug for sale or for distribution
Form-CT-18
Form CT-19: Permission to import new active pharmaceutical ingredient for sale or for distribution
Form-CT-19
Form CT-20: Permission to import pharmaceutical formulations of new drug for sale or for distribution
Form-CT-20
Form CT-21: Application for grant of permission to manufacture new drug formulation for sale or for distribution
Form-CT-21
Form CT-22: Permission to manufacture new active pharmaceutical ingredient for sale or for distribution
Form-CT-22
Form CT-23: Permission to manufacture pharmaceutical formulation of new drug for sale or for distribution
Form-CT-23
Form CT-24: Application for licence to import of unapproved new drug for treatment of patients of life threatening disease in a government hospital or government medical institution
Form-CT-24
Form CT-25:Licence to import unapproved new drug for treatment of patients of life threatening disease in a government hospital or medical institution
Form-CT-25
Form CT-26: Application for grant of permission to manufacture unapproved new drug but under clinical trial for treatment of patients of life threatening disease in a government hospital or medical institution
Form-CT-26
Form CT-27: Permission to manufacture unapproved new drug but under clinical trial for treatment of patients of life threatening disease in a government hospital or medical institution
Form-CT-27
Compiled by:
Rakesh Dahiya, SDCO cum Licensing Authority, FDA Haryana
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