Application Forms: Drugs, Cosmetics, Medical Devices and Clinical Trial

Application Forms: Drugs, Cosmetics, Medical Devices and Clinical Trial

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Regulation Law Act
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Last Updated on June 15, 2021 by The Health Master

Application Forms: Drugs

Applications Forms: Drugs and Cosmetics Act 1940 and Rules 1945

Rules Law
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As per Drugs and Cosmetics Act 1940 and Rules 1945 we have provided Application Forms relevant to the above said topic, Click below links for more information:

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 24: Application for the grant of or renewal of a licence to manufacture for sale or for distribution of drugs other than those specified in [Schedule C, C (1) and X]
Form-24

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

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

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 C

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

Form 27: Application for grant of a licence to manufacture for sale [or for distribution of] drugs specified in Schedules C and C(1) 2[excluding those specified in 3(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 Schedule C and C (1) excluding those specified in part XB and Schedule X
Form-27 A

Form 27-B: Application for grant of a licence to manufacture for sale or for distribution of drugs specified in Schedules C, C (1) and X
Form-27 B

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

Form 27-D: Application for grant of a licence to manufacture for sale or for distribution of Large Volume Parenterals / Sera and Vaccines excluding those specified in Schedule X
Form-27 D

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

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

Form 31: Application for grant of a licence to manufacture cosmetics for sale or for distribution (Obsolete)
Form 31

Form 31-A: Application for grant of a loan licence to manufacture cosmetics for sale [or for distribution] (Obsolete)
Form 31 A

Form 36: Application for grant or renewal of approval for carrying out tests drugs / cosmetics or raw materials used in the manufacture thereof on behalf of licensees for manufacture for sale of drugs / cosmetics
Form-36

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

How to obtain retail drug license, click here

How to obtain Jan Aushadhi License, click here

How to change pharmacist at medical store, click here

Good storage practice of medicines at Medical Store, click here

Record keeping for Medical Store / Pharmacy, click here

Self inspection of Medical Store :105 points, click here

Licensing procedure for manufacturing of Drugs

Latest Notifications: D&C Rules 1945Latest Notifications: D&C Act 1940

Application Forms: Cosmetics

Applications Forms: Cosmetics Rules 2020

Rules Law
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As per Cosmetics Rules 2020 we have provided Application 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

Application Forms: Medical Devices

Applications Forms: Medical Devices Rules 2017

Rules Law
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As per Medical Devices Rules 2017 we have provided Application 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

For more details on licensing process of Medical devices, click here

For notifications of Medical Devices, click here

Application Forms: Clinical Trial

Applications Forms: New Drugs and Clinical Trials Rules 2019

Rules Law
Picture: Pixabay

As per New Drugs and Clinical Trials Rules 2019 we have provided Application 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


Notifications: New Drugs, FDC, Clinical Trial

Other details about New Drugs, FDCs, Clinical trial


Compiled by:
Rakesh DahiyaSDCO cum Licensing Authority, FDA Haryana

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