Does Small quantity require Ayurvedic manufacturing license?

Query:   If I want to manufacture Ayurvedic product according to Ayurvedic doctor for dispense purpose only, not for sale. Does it require manufacturing license ? Please guide me. Response: An Ayurvedic doctor has permission to manufacture Ayurvedic product as per his need, not for sale without any manufacturing license. If you are doctor or […]

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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 N: List of Minimum Equipment for the Efficient Running of Pharmacy

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 Documents and procedure to Start Pharmacy Business read here Documents and procedure to Start Online Pharmacy Business read here Schedule N: Schedule N Describes the Equipment for efficient running of a Pharmacy: 1. Entrance. – The front of a pharmacy shall bear an inscription “Pharmacy” in front. 2. Premises. – The premises of a […]

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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 […]

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Schedule G: List of substances included

This article covers name of active pharmaceutical ingredients (api) come under Schedule G, Warning, pdf download link etc. 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 G Warning: Products or Substances that are included in this list should mention below lines at label: ‘Caution: It is dangerous to take this preparation except under medical supervision’ – conspicuously printed and surrounded by […]

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Schedule D, D(I) and D(II): Import of medicinal substances in India

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 D:   Schedule D describe the requirement and formalities to import medicinal substances in India. Some Highlights of details covered under Schedule D is: 1. Substances not intended for medicinal use All provisions of Chapter III of the Act and rules thereunder subject to the condition that if the substance is imported in […]

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Schedule E and Schedule E(1): Poisonous Substances under Ayush System

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 E was omitted in 1982. Schedule E(1) contains the list of poisonous substances under Ayurvedic (including Siddha) and Unani System of Medicines. Schedule-E (Omitted) Schedule-E(1) List of poisonous substances under the Ayurvedic (including Siddha)  and Unani Systems of Medicine Ayurvedic System:  Drugs of vegetable origin: Ahipena (Papaver somniferum Linn.)  Arka  (Calotropis gigantea (linn.)R. […]

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Schedule B : Fees Required to Pay for test or analysis by CDL/SDL

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 B: Schedule B Describe the Fees required to pay for test or analysis by the Central Drugs Laboratories or State Drugs Laboratories. Few Tests that are covered under Schedule B are as Follow: Section 1:  Drugs Required for use of Animals Microbiological Tests and Assays Identification Tests Physical Tests Assay Polymorph Tests Drugs […]

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