Amendment status not verified — confirm the current text below against the official source.
(c) Biochemic tissue remedies in tablets forms, in generic names only, each in 20 gm. Packing in 3x and 6x trituration : (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. (i) Calcarea Phosphorical (ii) Calcarea Sulphurica (iii) Ferum Phosphoricum (iv) Kali Muriaticum (v) Kali Phosphoricum Drugs and Cosmetics Rules, 1945 384 Class of Drugs Extent and Conditions of Exemptions ___________________________________________________________________________________ 1 Ins. by . Notification No. G.S.R. 218(E) , dt. 28.3.2001. (vi) Kali Sulphuricum (vii)Magnesium Phosphoricum (v) The purchase and sale records of these medicines shall be maintained by the dealer for a minimum period of three years. (vi) These medicines shall be labelled in generic/pharmacopoeial names only.] (viii) Megnesia Sulphurica (ix) Natrum Muriaticum (x) Natrum Phosphoricum (xi) Natrum Sulphuricum (xii) Silicea (d) Homoeopathic medicines, mentioned below, in pills, each in 30 C potency, in sealed original packing of manufacturer of 8 gms:– (i) Arnica Montana (ii) Aconitum Napellus (iii) Arsenicum Album (iv) Aloe Socotrina (v) Apis Mellifica (vi) Allium Cepa (vii) Bryonia alba (viii) Borax (ix) Belladonna (x) Cantharis (xi) Carbo Vegetabilis (xii) Cina (xiii) Colocynthis (xiv) Calendula Officinalis (xv) Caulophyllum Thalictroides (xvi) Cocculus Indicus (xvii) Drosera Rotundifolia (xix) Hypericum Perforatum (xx) Hepar Sulphur (xxi) Ipecacuanha (xxii) Ledum Palustre (xxiii) Millefolium (xxiv) Mercurius Solubillis (xxv) Nux Vomica (xxvi) Pulsatilla Nigricans (xxvii) Podophyllum Peltatum Drugs and Cosmetics Rules, 1945 385 Class of Drugs Extent and Conditions of Exemptions (xxviii) Plantago Major (xxix) Rhus Toxicodendron (xxx) Ruta Graveolens (xxxi) Symphytum Officinalis (xxxii) Veratrum Album 1[32. 2[33. First Aid Kit supplied along with motor vehicle by the manufacturer or its distributor at the time of first sale of vehicle. Nicotine gum containing up to 2 mg. of nicotine. 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 dealer licensed under the rules.] The provisions of Chapter IV of the Act and the rules made thereunder which require them to covered by a sale licence subject to the condition that such a product has been manufactured under a valid drug manufacturing licence.] __________________________________________________________________ _____________________________________________________________________ 1 Ins. by G.S.R. 648 (E) , dt. 16.9.2002. 2 Ins. by G.S.R. 549(E), dt. 16.67.2005. Drugs and Cosmetics Rules, 1945 386 1SCHEDULE L (Omitted) 2 [SCHEDULE M [See Rules 71, 74, 76 and 78] GOOD MANUFACTURING PRACTICES AND REQUIREMENTS OF PREMISES, PLANT AND EQUIPMENT FOR PHARMACEUTICAL PRODUCTS Note: To achieve the objectives listed below, each licensee shall evolve appropriate methodology, systems and procedures which shall be documented and maintained for inspection and reference; and the manufacturing premises shall be used exclusively for production of drugs 3[and no other manufacturing activity shall be undertaken therein except in respect of units licensed prior to 11th December, 2001]. PART 1 GOOD MANUFACTURING PRACTICES FOR PREMISES AND MATERIALS 1 GENERAL REQUIREMENTS: 1.1. Location and surroundings.- The factory building(s) for manufacture of drugs shall be so situated and shall have such measures as to avoid risk of contamination from external environment including open sewage, drain, public lavatory or any factory which produce disagreeable or obnoxious odour or fumes, excessive soot, dust, smoke, chemical or biological emissions. 1.2. Buildings and premises.- The building(s) used for the factory shall be designed, constructed, adapted and maintained to suit the manufacturing operations so as to permit production of drugs under hygienic conditions. They shall conform to the conditions laid down in the Factories Act, 1948 (63 of 1948). The premises used for manufacturing, processing, warehousing, packaging, labelling and testing purposes shall be – (i) compatible with other drug manufacturing operations that may be carried out in the same or adjacent area / section; (ii) adequately provided with working space to allow orderly and logical placement of equipment, materials and movement of personnel so as to: (a) avoid the risk of mix-up between different categories of drugs or with raw materials, intermediates and in-process material; (b) avoid the possibilities of contamination and cross- contamination by providing suitable mechanism; (iii) designed / constructed / maintained to prevent entry of insects, pests, birds, vermins and rodents. Interior surface (walls, floors and ceilings) shall be smooth and free from cracks, and permit easy cleaning, painting and disinfection; _________________________________________________________________________