Drugs & Cosmetics Act 1940

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Different type of forms is also given for the different type of approvals from drug
authorities.
Following are the schedules:
Schedule A: Forms and applications
Schedule B: Fees for test or analysis by the Central Drugs Laboratories or State Drugs
Laboratories
Schedule C: Biological and Special Products
Schedule C(1): Other Special Products
Schedule D: Class of Drugs: Extent and conditions of the exemption
Schedule D(I): Information and undertaking required to be submitted by the
manufacturer of his authorized agent with the application form for a Registration
Certificate. The format shall be properly filled in for each application in Form 40. The
detailed information, secret in nature, may be furnished on a computer floppy.
Schedule D(II): Information required to be submitted by
the manufacturer or his authorized agent with the
application form for the registration of a bulk
drug/formulation/special product for its import into India.
The format shall be properly filled in and the detailed
information, secret in nature, may be furnished on a
computer floppy.
Schedule E: Omitted
Schedule E(1): List of Poisonous Substances under the
Ayurvedic (including Siddha) and Unani Systems of
Medicine
Schedule F:

Part I to Part XII-A: Omitted

Part XII-B: Requirements for the functioning and
operation of a Blood Bank and/ or for preparation of Blood
Components
(I) Blood Banks/ Blood Components
(II) Blood Donation Camps
(III) Processing of Blood Components from whole blood by a Blood Bank
Part XII-C:
(I) Requirements for manufacture of Blood Products

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(II) Requirements for manufacture of Blood products from bulk finished products
Part XIII: General
Schedule F(I):
Part I: Vaccines
(A) Provisions applicable to the production of Bacterial Vaccines
(B) Provisions applicable to the production of Viral Vaccines
Part II: Antisera
Provisions applicable to the production of all sera from living animals
Part II: Diagnostic Antigens
Provisions applicable to the manufacture and standardization of Diagnostic Agents
(Bacterial Origin)
Part IV: General
Schedule F(II): Standards for Surgical Dressings
Schedule F(III): Standards for umbilical Tapes
Schedule FF: Standards for Ophthalmic Preparations
Schedule G:
Schedule H: Prescription Drugs
Schedule I: Omitted
Schedule J: Disease and ailment (by whatever name described ) which a drug does not
purport to prevent or cure.

Schedule K: Class of drug: Extent and conditions of the exemption

Schedule L1:Good Laboratory Practice
Schedule M:Good manufacturing practices and requirements of premises, plant and
equipment for Pharmaceutical product.
Part I: Good manufacturing practices for premises and materials.
Part I-A: Specific requirements for manufacture of sterile products, parenteral
preparation (small volume injectables and large volume parenterals ) and sterile
ophthalmic preparation.
Part I-B: Specific requirement for manufacturing of oral solid dosage forms (Tablet and
Capsules).
Part I-C: Specific requirement for manufacture of oral liquids (Syrups, elixirs, emulsions
and suspensions).
Part I-D: Specific requirements for manufacture of topical products i.e. external
preparation (creams, ointments, pastes, emulsions, lotions, solutions, dusting powders
and identical products)
Part I-E: Specific requirements for manufacture of metered-dose-inhalers (MDI)
Part I-F: Specific requirements of premises, plant and materials for manufacture of
active pharmaceutical ingredients ( Bulk Drugs ).
Part II: Requirements of plant and equipment.
Schedule M-I: 1. Requirements of factory premises for manufacture of homoeopathic
preparations.
2. Requirements of plants and equipments.
Schedule M-II: Requirements of factory premises for manufacture of cosmetics.
Schedule M-III: Requirements of factory premises for manufacture of medical devices.
Part I-B: Specific requirement for manufacturing of oral solid dosage forms (Tablet and

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Capsules).
Part I-C: Specific requirement for manufacture of oral liquids ( Syrup, elixirs, emulsions
and suspensions).
Part I-D: Specific requirements for manufacture of topical products i.e. external
preparation ( creams, ointments, pastes, emulsions, lotions, solutions, dusting powders
and identical products )
Part I-E: Specific requirements for manufacture of metered-dose-inhalers (MDI)
Part I-F: Specific requirements of premises, plant and materials for manufacture of
active pharmaceutical ingredients (Bulk Drugs).
Part II: Requirements of plant and equipment.
Schedule N: List of Minimum Equipment for the Efficient Running of a Pharmacy
Schedule O: Standard for Disinfectant Fluids
Schedule P: Life Period of Drugs
Schedule P1: Pack Sizes of Drugs
Schedule Q: List of Dyes, colors and Pigments permitted to be used in Cosmetics and
Soaps as given under IS: 4707 (Part I)-1988 as amended by the Bureau of Indian
Standards
Schedule R: Standards for condoms made of rubber latex intended for single use and
other mechanical contraceptives
Schedule S: Standard for cosmetics.
Schedule T: Good manufacturing practices for Ayurvedic, Siddha and all Unani
medicines.

Schedule U: I – Particulars to be shown in the manufacturing records.

II – Records of Raw Materials.
III – Particulars to be recorded in the analytical records.
Schedule U(I): I – Particulars to be shown in manufacturing records.
II – Records of Raw Material.
Schedule V: Standards for patent or proprietary medicines.
Schedule W: Omitted
Schedule X
Schedule Y: Requirements and guidelines for permission to import and/or manufacture
of New Drug for sale or to undertake clinical Trials.

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