Drugs and Cosmetics Act – Lesson 3 – Schedules G-Y

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Drugs and Cosmetics Act – Lesson 3 – Schedules G – Y

The Drugs and Cosmetics Act, 1940 is an Act of the Parliament of India which regulates the import, manufacture and distribution of drugs in India.

Schedules of Drugs  and Cosmetics Act

Schedule H: Prescription Drugs

Schedule I: Omitted

Schedule J: Disease and ailment (by whatever name described ) which a drug not purport to prevent or cure.

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

Schedule L1 : Good Laboratory Practice

Schedule M: Good manufacturing practices and requirements of premises,  plant and equipment for Pharmaceutica

Part I: Good manufacturing practices for premises and materials.

Part I-A:  Specific requirements for manufacture of sterile products,  parenteral preparation (small volume injectables 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, 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 ingredient

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 cosmetic.

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,
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 ingredient

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, colours and Pigments permitted to be used in Cosmetics and Soaps as given under IS : 470 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: Narcotic Drugs & Psychotropic Substances

Schedule Y: Requirements and guidelines for permission to import and/or manufacture New Chemical Entities (the schedule that gives you complete information regarding guidelines and processes for Clinical Trials and Functioning of Ethics Committees.

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