Indian pharmaceutical GMP guidelines are given in Drugs & Cosmetics Act 1940. Rules are given for pharmaceuticals and schedules are there to comply with those rules.
MINISTRY OF HEALTH AND FAMILY WELFARE (Department of Health) updates this time to time. Pharmaceutical industries in India those are manufacturing the drug products for domestic market have to follow the Drugs & Cosmetics Act.
It contains 168 rules from 1 to 168 and 25 Schedules from Schedule A to Schedule Y.
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:
MINISTRY OF HEALTH AND FAMILY WELFARE (Department of Health) updates this time to time. Pharmaceutical industries in India those are manufacturing the drug products for domestic market have to follow the Drugs & Cosmetics Act.
It contains 168 rules from 1 to 168 and 25 Schedules from Schedule A to Schedule Y.
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
(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 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 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.
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.
Click here to read: Drugs and Cosmetics Act, 1940
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
(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 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 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.
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.
Click here to read: Drugs and Cosmetics Act, 1940
Haloo,
ReplyDeleteI want to read the e-book of Drug and Cosmetics Act but the link couldn't opened.
If you don't mind, can you give me another link or the pdf file ?
Thank you.
New link changed, you can read now.
Delete