Schedule A: Forms, Licenses, Certificates, Applications


Schedule A under Drug and Cosmetic Act & rules defines the different types of Forms i.e. Memorandum, certificates, application form, licenses, renewal forms etc. This schedule provides complete information about different types of forms and their formats. Here we are going to give you brief information about form, applicable rule under drug and cosmetic rule and its purpose.

Forms are as follow:

Form 1 (Rule 4): Memorandum to the Central Drugs Laboratory

Form 1 (Rule 163C): Memorandum to the Pharmacopoeial Laboratory for Indian Medicine (PLIM)

Form 2 (Rule 6): Certificate of test or analysis by the Central Drugs Laboratory

Form 2A (Rule 163E): Certificate of test or analysis from the Pharmacopoeial Laboratory for Indian Medicine or Governmen Analyst

Form 3-7 has been omitted

Form 8 (Rule 24): Application for licence to import drugs (excluding those specified in Schedule X) to the Drugs and Cosmetics Rules, 1945

Form 8A (Rule 24): Application for licence to import drugs specified in Schedule X to the Drugs and Cosmetics Rules, 1945

Form 9 (Rule 24): Omitted

Form 10 (Rule 23 and 27): Licence to import drugs (excluding those specified in Schedule X) to the Drugs and Cosmetic Rules, 1945

Form 10A (Rule 23 and 27): Licence to import drugs specified in Schedule X to the Drugs and Cosmetics Rules, 1945

Form 11 (Rule 33): Licence to import drugs for the purposes of examination, test or analysis

Form 11A (Rule 33A): Licence to import drugs by a Government Hospital or Autonomous Medical Institution for the treatment of patients

Form 12 (Rule 34): Application for licence to import drugs for purpose of examination, test or analysis

Form 12A (Rule 36, second provision): Application for the issue of a permit to import small quantities of drugs for personal use

Form 12AA (Rule 34A): 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 (Rule 36, second provision): Permit for the import of small quantities of drugs for personal use

Form 13 (Rule 46): Certificate of test or analysis by Government Analyst under section 25 (1) of the Drugs and Cosmetics Act, 1940

Form 13A (Rule 163(5)): Certificates of tests or analysis by Government Analyst under section 33H of the Drugs and Cosmetics Act, 1940

Form 14A (Rule 47): Application from a purchaser for test or analysis of a drug under Section 26 of the Drugs and Cosmetics Act, 1940

Form 14B (Rule 47): Certificate of test or analysis by Government Analyst under Section 26 of the Drugs and Cosmetics Act, 1940

Form 15 (Rule 54 and 145C): 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 (Rule 55 and 145-B): 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 (Rule 56 and 145A): Intimation to person from whom sample is taken

Form 17A (Rule 56A and 145AA): 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 (Rule 57): Memorandum to Government Analyst

Form 18A (Rule 163 (1)): Memorandum to Government Analyst

Form 19 (Rule 59 (2)): 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 (Rule 59 (2)): Application for the grant or renewal 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 services of a registered pharmacist

Form 19AA (Rule 62C): 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 (Rule 67A): Application for licence to sell, stock or exhibit or offer for sale, or distribute Homoeopathic medicines

Form 19C (Rule 59 (2)): 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 (Rule 61 (1)): 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 (Rule 61 (1)): 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 (Rule 61 (1)): 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 (Rule 62-D): 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 (Rule 67-C): Licence to sell, stock or exhibit or offer for sale, or distribute Homoeopathic medicines by retail

Form 20D (Rule 67C): Licence to sell, stock or exhibit or offer for sale, or distribute Homoeopathic medicines by wholesale

Form 20E (Rule 67EE): Certificate of renewal of Licence to sell, stock or exhibit or offer for sale, or distribute Homoeopathic medicines

Form 20F (Rule 61 (3)): Licence to sell, stock or exhibit for sale or distribute by retail drugs specified in Schedule

Form 20G (Rule 63 (3)): Licence to sell, stock or exhibit or offer for sale, or distribute by wholesale drugs specified in Schedule X

Form 21 (Rule 61 (2)): 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 (Rule 61 (2)): 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 (Rule 61 (2)): 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 (Rule 62D): 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 (Rule 63A): Omitted

Form 21CC (Rule 63B): Omitted

Form 22 (Rule 67): Omitted

Form 23 (Rule 67): Omitted

Form 24 (Rule 69): Application for the grant of or renewal 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 24A (Rule 69A): Application for grant or renewal 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 24B (Rule 69A): 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

Form 24C (Rule 85B): Application for the grant or renewal 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 20C

Form 24D (Rule 153): Application for the grant / renewal of a licence to manufacture for sale of Ayurvedic/ Siddha or Unani drugs

Form 24E (Rule 154A): Application for grant or renewal of a loan licence to manufacture for sale Ayurvedic (including Siddha) or Unani Drugs

Form 24F (Rule 69): 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 (Rule 70): Licence to manufacture for sale or for distribution of drugs other than those specified in Schedules C and C(1) and X

Form 25A (Rule 70A): 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 (Rule 70): 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 (Rule 85D): Licence to manufacture for sale or for distribution of] Homoeopathic medicines

Form 25D (Rule 154): Licence to manufacture for sale of Ayurvedic (including Siddha) or Unani drug

Form 25E (Rule 154A): Loan Licence to manufacture for sale Ayurvedic (including Siddha) or Unani Drugs

Form 25F (Rule 70): 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 (Rule 73 and 83): Omiited

Form 26A (Rule 73A and 83A): Omitted

Form 26B (Rule 73B): Omitted

Form 26C (Rule 85G): Certificate of renewal of licence to manufacture for sale of Homoeopathic medicines

Form 26D (Rule 155): Certificate of renewal of licence to manufacture for sale of Ayurvedic / Siddha or Unani drugs

Form 26E (Rule 155A): Certificate of renewal of loan licence to manufacture for sale of Ayurvedic / Siddha or Unani Drugs

Form 26 E-I (Rule 157B): Certificate of Good Manufacturing Practices (GMP) to manufacture of Ayurveda, Siddha or Unani drugs

Form26E2-I (Rule 158C): State Drug Controller or Licensing Authority for Ayurveda, Siddha and Unani Medicines-Free sale certificate

Form 26E2-II (Rule 158C): State Drug Controller or Licensing Authority for Ayurveda, Siddha and Unani Medicines-free sale certificate

Form 26E3 (Rule 158C): State Drug Controller or Licensing Authority for Ayurveda, Siddha and Unani Medicines- Non-Conviction Certificate

Form 26F (Rule 73 and 83): Omitted

Form 26G (Rule 122F): 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 (Rule 68A, 76,77, 78): Omitted

Form 26-I (Rule 122-I): Certificate of renewal of licence for manufacture of blood product.

Form 26-J (Rule 122G, 122H, 122I, 122P): Certificate of renewal of licence for collection, processing, testing, storage, banking and release of umblical cord blood stem cells.

Form 26J (Rule 83A and 83AA): Omitted

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 Part XB and Schedule X

Form 27A (Rule 75A): 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 Part 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 (Rule 122-F): 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 (Rule 75): Application for grant or renewal 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 (Rule 75A): Application for grant or renewal 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 27E (Rule 122F): Application for grant/renewal of licence to manufacture blood products for sale or distribution

Form 27F (Rule 122F): Application for grant/renewal of licence for collection, processing, testing, storage, banking and release of umblical cord blood stem cell

Form 28 (Rule 76): Licence to manufacture for sale or for distribution of drugs specified in Schedules C and C (1) excluding those specified in Schedule X

Form 28A (Rule 76-A): 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 (Rule 76): Licence to manufacture for sale or for distribution of drugs specified in Schedules C, C(I) and X

Form 28C (Rule 122-G): 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 (Rule 76): 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 (Rule 76A, 78A, 83AA): 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 (Rule 122G): Licence to manufacture and store blood products for sale or distribution

Form 28F (Rule 122F- 122I, 122K,122P): Licence To Collect, Process, Test, Store, Banking And Release Of Umbilical Cord Blood Stem Cells.

Form 29 (Rule 89): Licence to manufacture drugs for purposes of examination, test or analysis

Form 30 (Rule 90): Application for licence to manufacture drugs for purposes of examination, test or analysis

Form 31 (Rule 139): Application for grant or renewal of a licence to manufacture cosmetics for sale or for Distribution

Form 31A (Rule 138A): Application for grant or renewal of loan licence to manufacture cosmetics for sale or for distribution

Form 32 (Rule 140): Licence to manufacture cosmetics for sale or for distribution

Form 32A (Rule 139B): Loan licence to manufacture cosmetics for sale or for distribution

Form 33 (Rule 141): Omitted

Form 33A (Rule 141-A): Omitted

Form 34 (Rule 131 and 150): Certificate of test or analysis of cosmetic by the Central Drugs Laboratory or the Government Analyst

Form 35 (Rule 65, 67-G, 74, 74A, 74B, 78, 78A, 85H, 122P, 142, 142-B, 150E, 158 and 158A): Form in which the Inspection Book shall be maintained

Form 36 (Rule 150B): 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 (Rule 150C): 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 (Rule 150J): 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 (Rule 150E(f)): Report of test or analysis by approved institution

Form 39A (Rule 150E(f)): Report of test or analysis by approved institution

Form 40 (Rule 24-A): Application for issue of Registration Certificate for import of drugs into India under the Drugs and Cosmetics Rules 1945

Form 41 (Rule 27A): Registration Certificate to be issued for import of drugs into India under Drugs and Cosmetics Rules, 1945

Form 42 (Rule 129A): Application for issue of Registration Certificate for import of cosmetics into India under the Drugs and Cosmetics Rules, 1945

Form 43 (Rule 129C): Registration Certificate to be issued for import of cosmetics into India under Drugs and Cosmetics Rules, 1945

Form 44 (Rule 122A, 122B, 122D and 122 D): Application for grant of permission to import or manufacture a New Drug or to undertake clinical trial

Form 45 (Rule 122 A, 122 D and 122 D): Permission to import Finished Formulation of a New Drug

Form 45A (Rule 122A and 122DA): Permission to import raw material (new bulk drug substance)

Form 46 (Rule 122 B, 122 D and 122 DA): Permission / Approval for manufacture of new drug formulation

Form 46A (Rule 122B and 122DA): Permission/ Approval for manufacture of raw material (new bulk drug substance)

Form 47 (Rule 160A): 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 (Rule 160B): 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 (Rule 160-I): 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 (Rule 160D(f): Report of test or analysis by approved Laboratory

Form 51 (Rule rules 71(9), 71A(5), 71B(v), 76(11) and 76A(v)): Form of undertaking to the licensing authority for marketing a drug under a brand name or trade name

For more detail refer Drug and Cosmetic Act

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