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Whole Human Blood collected and transfused by Centres r un by Armed Forces Medical Services in border areas, small mid- zonal hospitals including peripheral hospitals, Field Ambulances, Mobile medical units and other field medical units including blood supply units in border, sensitive and field areas. All the provisions of Chapter IV of the Act and rules made thereunder which require them to be covered by a licence to operate a Blood Bank for collection, storage and processing of whole human blood for sale or distribution subject to the following conditions:- (i) These Centres shall collect, process and transfuse blood in emergent situations which require lifesaving emergency surgeries/or transfusion. (ii) These Centres shall be under the active direction and personal supervision of a qualified Medical Officer, possessing the Drugs and Cosmetics Rules 1945 417 qualifications and experiences specified in condition (i) of rule 122-G. (iii) Each blood unit shall be tested before use for freedom from HIV I and II antibodies, Hepatitis B surface antigen, malarial parasites and other tests specified under the monograph ―Whole Human Blood‖ in current edition of Indian Pharmacopoeia (iv) These Centres shall have adequate infrastructure facilities for storage and transportation of blood. (v) The blood collected and tested by such Centres shall be transfused by the Centre itself and may be made available for use of other peripheral Armed Forces hospitals or Centres during operational circumstances.] 48[31. The following Homoeopathic Medicines, namely: - 49[(a) *** (b) Homoeopathic Ointments, each 50[in 25gm. Tube]: (i) Arnica Montana (ii) Calendula Officinalis (iii) Cantharis (iv) Rhus Toxicodendron (c) Biochemic tissue remedies in tablet forms, in generic names only, each in 20gm. Packing in 3X and 6X trituration- (i) Calcarea Phosphorica (ii) Calcarea Sulphurica (iii) Ferum Phosphoricum (iv) Kali Muriaticum (v) Kali Phosphoricum (vi) Kali Sulphuricum (vii) Magnesium Phophoricum (viii) Magnesia Sulphurica (ix) Natrum Muriaticum (x) Natrum Phophoricum (xi) Natrum Sulphuricum (xii) Silica (d) Homoeopathic medicines, mentioned below, in pills, each in 30C potency, in sealed original packing of manufacturer of 8 gms: (i) Arnica Montana (ii) Aconitum Napellus (iii) Arsenicum Album The provisions of Chapter IV of the Act and the rules made thereunder which require them to be covered with a sale licence in Form 20- C, subject to the following conditions: - (i) These homoeopathic medicines shall be sold in the original sealed small quantity packings of the licensed manufacturers. (ii) These medicines may be stocked and sold by retail of medicines licensed under rule 61. (iii) These medicines shall be stored separately from other allopathic drugs. (iv) These medicines shall be purchased from a manufacturer or a dealer licensed under these rules. (v) The purchase and sale records of these medicines shall be maintained by the dealer for minimum period of three years. (vi) These medicines shall be labelled in generic / pharmacopoeial names only. Drugs and Cosmetics Rules 1945 418 (iv) Aloe Socotrina (v) Apis Mellifica (vi) Allium Cepa (vii) Bryonia Alba (viii) Borax (ix) Belladonna (x) Cantharis (xi) Carbo Vegatabilis (xii) Cina (xiii) Colocythis (xiv) Calendula Officinalis (xv) Caulophyllum Thalictroides (xvi) Cocculus Indicus (xvii) Chamomilla (xviii) Drosera Rotundifolia (xix) Hypeicum Perforatum (xx) Hepar Sulphur (xxi) Ipecacuanha (xxii) Ledum Palustre (xxiii) Millefolium (xxiv) Mercurius Solubilis (xxv) Nux Vomica (xxvi) Pulsatilla Nigricans (xxvii) Podophyllum Peltatum (xxviii) Plantago Major (xxix) Rhus Toxicodendron (xxx) Ruta Graveolens (xxxi) Symphytum Officinalis (xxxii) Veratrum Album 51[(e) All biochemic and its combinations (1 to 28), in tablet forms, in sealed original packing of the manufacture.] 52[32. First Aid kit supplied along with motor vehicle by the manufacturer or its distributors at the time of first sale of vehicle. The provisions of Chapter IV of the Act and rules made thereunder which require them to be covered by a sale licence, subject to the condition that the drug items are procured from a manufacturer or a dealer licensed under the rules.] 53[33. Nicotine gum 54[and Lozenges] containing upto 2 mg of nicotine The provisions of Chapter IV of the Act and the Rules made thereunder which require them to be covered by a sale license subject to the condition that such a product has been manufactured under a valid drug manufacturing license.] 55[34. Production of Oxygen 93 per cent USP, produced from air by the molecular sieve process, by a hospital or Medical Institute for their captive consumption. The provisions of Chapter IV of the Act and the Rules made thereunder which require them to be covered by manufacturing licence under the rules, provided that the production facilities shall be open to inspection by an Inspector appointed under the Act, who can, if necessary, take samples For test‖.] Drugs and Cosmetics Rules 1945 419 56[35. Homoeopathic hair oils having active ingredients up to 3X potency only The provisions of Chapter IV of the Act and the rules made thereunder which require them to be covered with a sale licence 57[***] subject to the condition that such a product has been manufactured under a valid manufacturing licence and sold in the original sealed packing of the licensed manufacturers.] 58[36. Custom made devices All provisions of Chapter IV of the Act and the rules made thereunder, subject to the condition that the device being specifically made in accordance with a duly qualified medical practitioner‘s written prescription under his responsibility, in accordance with specific design characteristics and is intended for the sole use of a particular patient and the label should bear the word ―custom made device.‖ Explanation.–– Mass produced devices which only need adoption to meet the specific requirements of the medical practitioner or any other professional user shall not be considered to be custom made devices.]