Company : Sol Infotech Pvt. Ltd. Website : www.courtkutchehry.com MERCHANT SHIPPING (MEDICINES, MEDICAL STORES AND APPLIANCES) RULES, 1966 CONTENTS 1. Short title, commencement and application 2. Definitions 3. Definitions 4. Standards of Medicines, Instruments, Appliances, Dressings and General Medical Equipments 5. Labels 6. Poisons 7. Inspection of Medicines, etc., by Port Health Officer 8. Substitutes 9. Exemptions SCHEDULE :- SCHEDULE SCHEDULE 2 :- Schdule-2 SCHEDULE 3 :- Schdule-3 SCHEDULE 4 :- Schdule-4 SCHEDULE 5 :- Schdule-5 MERCHANT SHIPPING (MEDICINES, MEDICAL STORES AND APPLIANCES) RULES, 1966 11. Published in the Gazette of India, 1966, Pt. II, Sec. 3 (ii), p. 1746. I n exercise of the powers conferred by Sec. 172 read with Sec. 457 of the Merchant Shipping Act, 1958 (44 of 1958) and in supersession of all the existing rules on the subject the Central Government hereby makes the following rules, namely 1. Short title, commencement and application :- (1) These rules may be called the Merchant Shipping (Medicines, Medical Stores and Appliances) Rules, 1966. (2) They shall come into force at once. (3) They shall apply to all foreign-going Indian ships and all home- trade Indian ships of two hundred tons gross or more but shall not apply to unberthed passenger ships or pilgrim ships. 2. Definitions :- In these rules, unless the context otherwise requires: (a) "Act" means the Merchant Shipping Act, 1958 (44 of 1958); (b) "Medical Officer" means a person possessing a degree in medicine and surgery of any recognised University and enrolled as a Medical Practitioner on the register of the Medical Council of any State and also holds a valid licence issued by the Health Officer of the port of departure of the ship in the form prescribed under the Merchant Shipping (Carriage of Medical Officers) Rules, 1961; (c) "Official pharmacopoeia" means the Indian Pharmacopoeia (I.P.), the National Formulary of India (N.F.I.), or the British Pharmaceutic Code ' (B.P.C.); (d) "Port health officer" means any person appointed by the Central Government either by name or by virtue of his office, to be the Health Officer of a port and includes (i) an additional, deputy or assistant port health officer, or any officer appointed by the Central Government, either by name or by virtue of his office, to perform any of the duties of a health officer of a port; (ii) a person appointed by the Central Government under sub- section (3) of Sec. 172 of the Act to inspect the medicines, medical stores and appliances with which a ship is required to be provided; (e) "Schedule" means a Schedule to these rules. 3. Definitions :- 4. Standards of Medicines, Instruments, Appliances, Dressings and General Medical Equipments :- 1 All such medicines, instruments, appliances, dressings and general medical equipments shall conform to the special requirements relating to labelling packaging, storage, etc., specified in Schedule I or, as the case may be, in column (5) of Schedule II] 1. Subs, by G.S.R. 1384, dated 9th October, 1972. 5. Labels :- (1) All labels on containers or wrapping shall be rendered resistant to moisture by the use of an efficient label varnish or by some other suitable means. (2) All labels shall indicate (a) both the English and the full Latin name of the preparation as given in the official pharmacopoeias; and (b) the prescribed maximum and minimum doses. (3) Each preparation shall also have a label showing thereon the name and address of the supplier. (4) The articles to be used externally only, shall have on the container or wrapping, a label bearing the words "for external use only". 6. Poisons :- 1 [(1) Every medicine indicated by the symbol (P) in Schedule I or indicated as "poison" in column (5) of Schedule II, shall have on its container or wrapping a label with the word "POISON" printed thereon in capital letters either in red lettering or on a red background.] (2) All such medicines shall be kept under lock and key in a separate cabinet and the key of the cabinet shall be kept in the charge of the Medical Officer, where such officer is on board, or otherwise in the charge of the master of the ship. 1. Ibid. 7. Inspection of Medicines, etc., by Port Health Officer :- (1) The medicines, medical stores and appliances on board a ship shall be inspected at least once in twelve months by the Port Health Officer. (2) If the Port Health Officer is satisfied that the provisions of these rules have been complied with, he shall give to the master of the ship a certificate in the form set out in 1 [Schedule III]. 1. Subs, by G.S.R. 1384, dated 9th October, 1972. 8. Substitutes :- If any particular item of medicine or medical store in Schedule I, II or III is not available, a substance having closely similar pharmacological action or, in the case of prescribed preparations of formulations, similar preparations or formulations which comply with the standards laid down therefor in official pharmacopoeia may be substituted after obtaining the sanction of the Port Health Officer. 9. Exemptions :- (1) The Central Government may, by order in writing and upon such conditions, if any, as it may think fit to impose and for reasons to be recorded, exempt any ship from carrying on board any particular item required by these rules to be carried thereon. (2) The exemption order shall be in the form set out in 1[Schedule IV]. SCHEDULE SCHEDULE SCHEDULE 2 Schdule-2 SCHEDULE 3 Schdule-3 SCHEDULE 4 Schdule-4 SCHEDULE IV [See rule 7 (2)] Certificate of Inspection of Medicines, Medical Stores, etc. Certified that I have this day.................inspected the medicines, medical stores and appliances onboard S.S./M.V...................and I am satisfied that they comply with the requirements laid down in the Merchant Shipping (Medicines, Medical Stores and Appliances) Rules, 1966. (Name of Port) (Signature) Dated the..............day of............19................ .......................... (Designation) NOTE.This certificate shall be valid for a period of one year unless revoked at some earlier date by the Issuing Authority. National Emblem SCHEDULE 5 Schdule-5 SCHEDULE V [See rule 9 (2)] GOVERNMENT OF INDIA MINISTRY OF................. Certificate of Exemption The S.S./M.V......................is hereby exempted from the requirements of the Merchant Shipping (Medicines, Medical Stores and Appliances) Rules, 1966, to the extent and subject to the conditions indicated below: This certificate shall remain in force until the...........day of..................19.............. (Name of Port) (Signature) Dated the....................day of..............19............ (Designation) APPENDIX 'A' Specification of Disinfectants and Antiseptics for Ships 1. DISINFECTANTS The disinfectant shall conform to the following specification: (1) General description.The disinfectant shall be a white fluid and shall be a finally dispersed, stabilized emulsion containing coal-tar acid or other phenolic bodies, with or without hydrocarbons. (2) Germicidal value and the method of its determination.The germicidal value shall be not less than 1.7 when determined by the modified Chick-Martin method as laid down by the British Standards Specification No. 808 of 1938. (3) Stability before dilution.On standing for three months at ordinary temperatures (5C to 30C) the disinfectant fluid shall not precipitate nor show separation of more than traces of oil. A creamed fluid, which can be rendered homogeneous by gentle mixing, is permissible. (4) Stability after dilution.The disinfectant fluid shall be miscible with distilled water and artificial seawater [27 grammes of sodium chloride and 5 grammes of crystalline magnesium sulphate (Mg SO4 7H2O) dissolved in and made up to 1,000 ml. with distilled water and filtered before use] in all proportions from one to five per cent., inclusive, to give a stable emulsion which shall not break nor show more than traces of separation of either top or bottom oil, when maintained at 1822C for six hours. When examining the disinfectant under this sub-paragraph, the sample and diluent shall each be brought to the specified temperatures before mixing, which shall be performed by pouring the former into the latter from a cylinder. (5) Odour and corrosive action.The fluid shall be free from objectionable smell and, when used as directed, shall have no more corrosive action on metals than that occasioned by the water employed as a diluent. (6) Packaging, where no container is specified on the tender form, the fluid shall be packaged in containers capable of being stored under normal conditions f o r six months without deleterious interaction between the fluid and the container. (7) Labeling.The containers shall be labeled to show the name and nature of the contents and with full instructions for use for various purposes. The dilutions recommended in the instructions shall be suitable for the purposes specified. The labels shall be rendered resistant to moisture either by the use of an efficient label varnish, which must cover the label and overlap the edges or by some alternative method the effect of which is not inferior to varnishing. 2. ANTISEPTICS The antiseptic shall conform to the following specification: (1) General description.The antiseptic shall consist of a homogeneous solution or emulsion of a phenol, chlorocresol, p-chloro-m-xylenol or any other germicidal substance that maybe approved by the Central Government, dissolved in a suitable solvent. (2) Germicidal value.The germicidal value shall be not less than 3 when determined by the Rideal Walker method as laid down by the British Standards specification No. 541 of 1934. (3) Stability of dilution.The antiseptic shall not show any separation after six hours when mixed, in all proportion from one to four per cent., inclusive, in waters of all degrees of hardness up to the equivalent of 300 parts calcium carbonate per million. These mixtures shall not break or precipitate in less than 6 hours at 22C and 37C. (4) Labeling.The containers shall be labeled to show the name and nature of the contents and with full instructions for use for various purposes. The dilutions recommended in the instructions shall be suitable for the purposes specified. The labels shall be rendered resistant to moisture either by the use of an efficient label varnish that must cover the label and overlap the edges or by some alternative method the effect of which is not inferior to varnishing. APPENDIX 'B' Specification of Anti-V.D. Outfit 1. The Anti-V.D. Outfit shall comprise a tube of prophylactic ointment and a washing cloth to the following specifications: Anti-V.D. Ointment. Formula: Mercurous chloride 30 grammes Sulphathiazole 15 grammes White soft paraffin 40 grammes Light liquid paraffin 14 grammes Cetyl alcohol 1 grammes Oil of Lavender 0.01 milliliter The ointment shall be supplied in collapsible tubes, with elongated nozzles and screw caps, each containing 4 g., and labelled Prophylactic Ointment. The length of the nozzle shall not be less than 12.7 mm. nor more than 16 mm. 2. Washing cloth This cloth shall be of coarse weave soft cotton washcloth free from size or dressing, or white lint, and not less than 7.5 cm. square impregnated with soap to a total weight of approximately 300 g. per square meter. Soap shall be of the type that will lather in either hard or soft water. As an alternative to soap a suitable synthetic detergent, to give a washing cloth not inferior in any respect to a washing cloth prepared with soap may be used, provided that the detergent employed is not an irritant to the skin. 3. Each kit to be in a separate sealed waterproof envelope bearing the following instructions: Anti-V.D. Outfit Instructions for use after exposure 1. Pass water. 2. Wet the washcloth and thoroughly wash the penis, purse and surrounding skin. 3. Squeeze about 1/4 of the contents of the tube into the canal of the penis. Massage gently with thumb and forefinger for a few seconds after injeting the ointment. 4. Rub the rest of the ointment over the entire length of the penis, purse and adjacent-abdomen and thigh for at least 3 minutes paying particular attention to the foreskin, head and neck of penis. 5. Do not pass water for two hours after using the kit if you can avoid it. APPENDIX 'C' Specification of Insecticides and Spray 1. An insecticide suitable after appropriate dilution for spraying infested living quarters; galleys, etc. (1) The insecticide used shall contain as the active ingredient either 2:2-di (pchlorophenyl)-l: 1:1-trichloroethan (DDT) of the gamma isomer of benzene hexachord (gamma BHC) or both with the addition of pyrethrums, if desired. It may be supplied in the form of a concentrate, such that, after the addition of water in accordance with the instructions printed on the label of the container the product suitable for spraying contains: (a) If no pyrethrums are present, either 5 per cent DDT or 0.5 per cent of gamma BHC, or both, or (b) If pyrethrums are present, either 3 per cent. DDT with 0.2 per cent, pyrethrums of the equivalent in synergies pyrethrums; or 0.3 per cent, gamma BHC with 0.1 per cent, pyrethrums or the equivalent in synergies pyrethrums; or both. (2) The DDT and gamma BHC used for the formulation of the products shall contain not less than 70 per cent of the p.p.-isomer and not less than 90 per cent of the pure gamma isomer, respectively. (3) The concentrated form of the insecticide shall have a flash point above 26.7C, and when prepared in a form suitable for spraying, it shall be non- inflammable and leave no residual odour or unsightly deposit. It shall have no undue deleterious effect upon metal finishes, fabrics and plastics with which it may come into contact. Full instructions for dilution to give the appropriate concentration stated above shall be printed on the label of the container. The insecticide shall be carried in containers of a capacity not greater than 500 ml. effectively sealed so that they will remain airtight and watertight under all conditions. The containers shall be packed in sawdust or thick corrugated paper in wooden cases. Storage shall be away from living accommodation. 2. Spray for use with the liquid insecticide.A soundly constructed all brass atomiser of a type suitable for spraying walls and other surfaces, the body being made from 22 G brass with a capacity of approximately 1 litre. The nozzle, which shall have an aperture of 0.8 mms. diameter, shall be of an uncloggable type or alternatively, a type which, when clogged, is rapidly cleared by a needle or some other method. The atomiser should be of the continuous pressure type and no parts coming into contact with the solution should be made of rubber or leather. 3. Insecticide Powder. (1) This shall be suitable for application to the body of clothing of infested persons but capable of being used also as a general insecticide. It shall consist of a fine powder containing not less than 5 per cent, of 2 : 2-di-(p-chloroprene)-! : 1 : 1-trichloroethance (DDT) or not less than 0.5 per cent of the gamma isomer of benzene hex chloride (gamma BHC) in a neutral non-hygroscopic inter base. (2) The DDT and gamma BHC used for the formulation of the products must contain not less than 70 per cent of the p-p-isomer and not less than 90 per cent of the pure gamma isomer, respectively. APPENDIX 'D' Specification of oxygen therapy equipment for use on Board Ships 1. Three disposable oxygen inhalers of plastic material. 2. One manometer type oxygen Flow meter. 3. One fine adjustment valve with oxygen pressure gauge, bull nosed fitting. 4. 2 m. Rubber tubing. 5. One Oxygen Universal cylinder key which provides a lever for tightening fly-nut of bull nosed valve unions and spanners for the union nuts of fine adjustment valves, also gland nuts of bull nose type oxygen cylinder valves, chromium finish. 6. The above equipment shall be contained in a hardwood carrying case including simple instructions in use of equipment. APPENDIX 'E' Specification of chloride of lime for the treatment of drinking water in ship 1. The chloride of lime shall contain not less than 24 per cent and not more than 26 per cent available chlorine. It shall also contain not less than 14 per cent of free quick lime (caO). 2. The total water existing in all forms, consisting largely if not entirely, of the water in combination in the form of calcium hydroxide, shall not exceed 7.5 per cent. 3. The chloride of lime shall be of such stability that after passing four weeks in an oven kept at 60C (+_ 1C) the percentage of available chlorine shall not decrease more than 2. 4. The chloride of lime shall be put up in 100 g. tins, the date of issue by the manufacturer being stamped on the base of each tin. 5. Each tin shall contain a measure, made of a material resistant to chlorine, to contain 5 g. of the powder, when full, i.e., sufficient to chlorinate approximately 1136 liters of water. 6. Each tin and contents (except the measure, which may be used again) whether partially used or not, shall be renewed within one year following the date stamped on the tin. APPENDIX 'F Specification of burns and wound dressing paraffin gauze dressing (BPC) Each dressing shall measure approximately 8.5 cm. x 8.5 cm. and shall be packed in an individual envelope (the dimensions of which shall be not greater than 14 cm. square) in such a manner as to allow it to retain its even impregnation. The envelope shall be made of a suitable material, preferably not more than 20 thousand of a cm. thick shall be impermeable to moisture, free from pin holes and also be grease-proof. The envelope shall be hermetically sealed and remain so under all conditions of sea transport. Thirty-six envelopes shall be packed in a suitable carton appropriately labelled, giving detailed instructions for use.