Category: Schedule
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What are Drug and Cosmetic Act, 1940 & Rules, 1945?
The Drug and cosmetic Act, 1940 is an act to regulate import, manufacture, distribution & sale of drug and cosmetics. The Drug and Cosmetic rules, 1945 made under the act prescribe statuary requirements for grant of license to manufacture for sale and distribution of drug to ensure safety, efficacy and quality of drugs manufactured and…
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How many years the Schedule H1 Medicines Record To Be Kept Stored
Query: I have some queries 1. What are the details of a patient and doctors has to be noted and to be keep in record ? If possible please attache specimen sample2. For How many years the Schedule H1 Medicines Record To Be Kept Stored?3. Is only purchase bill of schedule H1 drugs is to…
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Schedule U: Manufacturing records
Schedule A B C D E F G H H1 I J K L M N O P Q R S T U V W X Y Z Schedule U: Schedule U describes the particulars to be shown in manufacturing record. Following details are included in Schedule U: 1. Particulars to be shown in Manufacturing Records: Substances other than Parenteral Preparation in General Parenteral Preparations 2. Records of Raw Materials 3. Particulars to be recorded in the Analytical Records Tablet and…
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Schedule M: Good Manufacturing Practice
Schedule A B C D E F G H H1 I J K L M N O P Q R S T U V W X Y Z Schedule M: Schedule M describes Good Manufacturing Practices and Requirements of Premises. Schedule M provides the insights to achieve the objectives listed in schedule, each licensee shall evolve appropriate methodology, system and procedures which shall be documented and maintained for inspection and reference; and the manufacturing premises shall be used exclusively for production…
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Schedule K:Exempted Drugs, Conditions and extent of exemption
Schedule A B C D E F G H H1 I J K L M N O P Q R S T U V W X Y Z Schedule K: Schedule K describe the exempted drugs, conditions and extent of exemption from all the provisions of Chapter IV of the Act and the Rules there under subject to the conditions. The drugs specified in Schedule K shall be exempted from the provisions of Chapter IV of the Act and the…
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Schedule J: Diseases which a drug may not purport to prevent or cure
Schedule A B C D E F G H H1 I J K L M N O P Q R S T U V W X Y Z Schedule J: Diseases which a drug may not purport to prevent or cure.- No drug may purport or claim to prevent or cure or may convey to the intending user thereof any idea that it may prevent or cure, one or more of the diseases or ailments specified in Schedule J. No drug may…