• Schedule

    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 plz attache specimen sample 2. For How many years the Schedule H1 Medicines Record To Be Kept Stored? 3. Is only purchase bill of schedule h1 drugs is to be maintained/stored or the sale bill of their is also? Response: Name and address of prescriber with patients name, name of drug, quantity dispensed shall be maintained in a separate register.Check reference/specimen copy by clicking at link of Drug Authority website Record should be kept for 3 years. All sale and purchase record…

  • Schedule

    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 Capsules Parenteral Preparations For other Drugs Raw Materials Container, Packing Material Etc  Schedule U(I): Schedule U(I) describes the particulars to be shown in the manufacturing record for cosmetics For detail analysis refer drug and cosmetic act and rules

  • Schedule

    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 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 pharmacy shall be separated from rooms for private use. The premises shall be well built, dry, well lit and ventilated and, of sufficient dimensions to allow the goods in stock, especially medicaments and poisons to be kept in a clearly visible and appropriate manner. The areas of the section to be used as dispensing department shall be not less than 6 square meters for one pharmacist working therein with additional 2 square meters for…

  • Schedule

    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 of drugs. Part 1: Describes Good Manufacturing Practices For Premises and Material Part 1A: Describes the Specific requirement for manufacture of sterile products. Parenteral preparations (Small Volumn Injections and Large Volumn Parenterals) and Sterile Ophthalmic Preparations Part 1B: Describes the Specific requirements for manufacture of oral solid forms (Capsule and Teblets) Part 1C: Describes the Specific…

  • Schedule

    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 thereunder subject to the conditions. The drugs specified in Schedule K shall be exempted from the provisions of Chapter IV of the Act and the Rules made thereunder to the extent and subject to the conditions specified in that Schedule. Exemption is provided only against fulfillment of conditions specified in Schedule.  Few Exempted Drugs are as follow:  Drugs Labelled as ‘Not for medicinal Use’  Quinine and other antimalarial drugs as per conditioned mention in Schedule Drugs supplied by a registered medical practitioner to…

  • Schedule

    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 purport or claim to procure or assist to procure, or may convey to the intending user thereof any idea that it may procure or assist to procure, miscarriage in women. Explanation. Diseases and ailments (by whatever name described) which a drug may not purport to prevent or cure or make claims to prevent or cure.…

  • Schedule

    Schedule H : List of Prescription Drugs

    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 H: Schedule H includes drugs that shall be sold by retailer on prescription of the registered medical practitioners. If product contains a substance specified in Schedule H be labelled with the symbol Rx and conspicuously displayed on the left top corner of the label and be also labelled with the following words: ‘Schedule H drug –  Warning: To be sold by retail on the prescription of a Registered Medical Practitioner only’ If product contains a substance specified in Schedule H and comes within the purview of the Narcotic Drugs and Psychotropic Substances Act, 1985 (61 of 1985) be labelled with the symbol NRx which shall be in red…

  • Schedule

    Schedule G: List of substances included

    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 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 a line within which there shall be no other words; List substances included in Schedule G is as below: Aminopterin  L-Asparaginase  Bleomycin  Busulphan; its salts  Carbutamide  Chlorambucil;its salts  Chlorothiazide and other derivatives of 1, 2, 4 benzothiadiazine  Chlorpropamide; its salts  Chlorthalidone and other derivatives of Chlorobenzene compound.  Cis-Platin Cyclophosphamide; its salts  Cytarabine Daunorubicin  Di-Isopropyl Eluorophosphate  Disodium Stilboestrol Diphosphate  Doxorubicin Hydrochloride  Ethacrynic Acid, its salts  Ethosuximide  Glibenclamide  Hydantoin; its salts; its derivatives, their salts  Hydroxyurea …

  • Schedule

    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 bulk, the importer shall certify that the substance is imported for non-medicinal uses, and if imported otherwise than in bulk, each container shall bear a label indicating that the substance is not intended for medicinal use or or is of commercial quality. Entry 2,3,4 has been omitted 5. The following substances, which are used both as…

  • Schedule

    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. Br. ex. Ait.  Bhallataka (Semecarpus anacardium Linn. F. ) Bhanga (Cannabis sativa Linn.)  Danti (Baliospermum montanum Mull. Arg.)  Dhattura (Datura metal Linn.)  Gunj (Abrus precatorium Linn.)  Jaipala (Jayapala) (Croton tiglium Linn.)  Karaveera (Rerium indicum Mill.)  Langali (Gloriosa superba Linn.)  Parasika Yavani (Hyoscyamus inibar Linn.)  Snuhi (Euphorbia neriifolia Linn.)  Vatsanabha  (Acontium chasmanthum Stapfex Holm.) Vishamushti (Strychnox…