Schedule

Schedule A: Forms, applications and Licenses

(Last Updated On: March 8, 2018)
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Schedule A:

Schedule A describes the format of form used for various licenses and approvals under Drug and Cosmetic Act & Rules.

FORM 1: Memorandum to the Central Drugs Laboratory

FORM 2: Certificate of test or analysis by the Central Drugs Laboratory
FORM 3-7: 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 12AA : 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 13A : Certificates of tests or analysis by Government Analyst under section 33H 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 14-B : 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 Cosmetics Act, 1940 requiring a person not to dispose of stock in his possession

FORM 16 : Receipt for stock of drugs or cosmetics for record, register, document or material object seized under section 22 (1) (c) or (cc) of the Drugs and Cosmetics Act, 1940

FORM 17 : Intimation to person from whom sample is taken

FORM 17A : Receipt for samples of drugs or cosmetics taken where fair price tendered thereof under sub-section (I) of Section 23 of the Drugs and Cosmetics Act, 1940 is refused

FORM 18 : Memorandum to Government Analyst

FORM 18A : Memorandum to Government Analyst

FORM 19 : Application for grant or renewal of a [licence to sell, stock or exhibit or offer for sale, or distribute] of drugs other than those specified in Schedule

FORM 19A : Application for the grant or renewal of a restricted 1[licence to sell, stock or exhibit or offer for sale, or distribute] drugs by retail by dealers who do not engage the services of a registered pharmacist

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

FORM 19B : Application for [licence to sell, stock or exhibit or offer for sale, or distribute] Homoeopathic medicines

FORM 19C : Application for grant or renewal of a [licence to sell, stock, exhibit or offer for sale, or distribute] of drugs specified in Schedule

FORM 20 : [Licence to sell, stock or exhibit or offer for sale, or distribute] drugs by retail other than those specified in 2[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 : [Licence to sell, stock or exhibit or offer for sale, or distribute] by wholesale, drugs other than those specified in [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 20-C : [Licence to sell, stock or exhibit or offer for sale, or distribute] Homoeopathic medicines by retail

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

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

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

FORM 21B : [Licence to sell, stock or exhibit or offer for sale, or distribute] by wholesale drugs specified in Schedules C and C (1) [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 : Certificate of renewal of [licence to sell, stock or exhibit or offer for sale, or distribute] drugs

FORM 21CC : Certificate of renewal of [licence to sell, stock or exhibit or offer for sale by wholesale, or distribute] drugs from a motor vehicle

FORM 22-23: Omitted

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

FORM 24A : Application for grant or renewal of a loan 1[licence to manufacture for sale or for distribution] of drugs other than those specified in [Schedules C and C (I) and X]

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

FORM 24C : Application for the grant or renewal of a 2[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 24D : Application for the grant / renewal of a licence to manufacture for sale of Ayurvedic/ Siddha or Unani drugs

FORM 24E : Application for grant or renewal of a loan licence to manufacture for sale Ayurvedic (including Siddha) or Unani Drugs

FORM 24F : Application for the grant or renewal 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 : [Licence to manufacture for sale or for distribution of] drugs other than those specified in [Schedules C and C(1) and X]

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

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

FORM 25C : [Licence to manufacture for sale or for distribution of] Homoeopathic medicines

FORM 25D : Licence to manufacture for sale of Ayurvedic (including Siddha) or Unani drugs

FORM 25E : Loan Licence to manufacture for sale Ayurvedic (including Siddha) or Unani Drugs

FORM 25F : [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 : Certificate of renewal of licence to manufacture for sale of drugs other than those specified in Schedule X

FORM 26A : Certificate of renewal of loan licence to manufacture for sale of drugs other than those specified in Schedule X

FORM 26B : Certificate of renewal of licence to repack for sale or distribution of drugs being drugs other than those specified in Schedules C and C (1) [excluding those specified in Schedule X]

FORM 26C : Certificate of renewal of licence to manufacture for sale of Homoeopathic medicines

FORM 26D : Certificate of renewal of licence to manufacture for sale of Ayurvedic / Siddha or Unani drugs

FORM 26E : Certificate of renewal of loan licence to manufacture for sale of Ayurvedic / Siddha or Unani Drugs

FORM 26E1 : Certificate of Good Manufacturing Practices (GMP) to manufacture of Ayurveda, Siddha or Unani drugs

FORM 26F : Certificate of renewal of licence to manufacture for sale of drugs specified in Schedule X

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 component

FORM 26H : Certificate of renewal of licence to manufacture for sale of Large Volume Parenterals/Sera and Vaccines specified in Schedules C and C(I) excluding those specified in Schedule X

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

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

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

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

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

FORM 27E : Application for grant/renewal* of licence to manufacture blood products for sale or distribution

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

FORM 28B : [Licence to manufacture for sale or for distribution of] drugs specified in Schedules C, CI 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 Large Volume Parenterals/Sera and Vaccines specified in Schedules C and C(I) excluding those specified in Schedule X

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

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

FORM 30 : Application for licence to manufacture drugs for purposes of examination, test or analysis

FORM 31 : Application for grant or renewal of a [licence to manufacture cosmetics for sale or for Distribution]

FORM 31A : Application for grant or renewal of loan [ licence to manufacture cosmetics  for sale or for distribution]

FORM 32 : [Licence to manufacture cosmetics for sale or for distribution]

FORM 32A : Loan [licence to manufacture cosmetics for sale or for distribution]

FORM 33 : Certificate of renewal of licence to manufacture cosmetics for sale

FORM 34 : Certificate of test or analysis of cosmetic by the Central Drugs Laboratory or  the Government Analyst

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

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

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 : Certificate of renewal of approval for carrying out tests on drugs / cosmetics and raw materials used in the manufacture thereof on behalf of licensees for manufacture for sale of drugs / cosmetics

FORM 39 : Report of test or analysis by approved institution

Forms 40 to 43 : (Pertaining to Ayurveda, Siddha and Unani drugs replaced by Forms Nos .47 to 50.)

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

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 the 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 : Application for grant or renewal of approval for carrying out tests on Ayurvedic, Siddha and Unani drugs or raw materials used in the manufacture thereof on behalf of licensees for manufacture for sale of Ayurvedic, Siddha and Unani drugs

FORM 48 : Approval for carrying out tests or analysis on Ayurvedic, Siddha and Unani drugs or raw materials used in the manufacture thereof on behalf of licensees for manufacture for sale of Ayurvedic, Siddha and Unani drugs

Form 49 : Certificate of renewal for carrying out tests or analysis on Ayurvedic, Siddha or Unani drugs or raw materials used in the manufacture thereof on behalf of licensees for manufacture for sale of Ayurvedic, Siddha or Unani drugs

FORM 50 : Report of test analysis by approved Laboratory

Hope above information is useful to you…

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