Amendment status not verified — confirm the current text below against the official source.
In the case of medicine containing a substance specified in 6[Schedule G, H or X] of the following additional conditions shall be complied with:- a. the medicine shall be labelled with the Drugs and Cosmetics Rules 1945 410 name and address of the registered medical practitioner by whom it is supplied; b. if the medicine is for external application it shall be labelled with the words 7[***] ―For external use only‖ or, if it is for internal use with the dose; c. the name of the medicine or ingredients of the preparation and the quantities thereof, the dose prescribed, the name of the patient & the date of supply and the name of the person who gave the prescription shall be entered at the time of supply in register to be maintained for the purpose; d. the entry in the register shall be given a number and that number shall be entered on the label of the container; e. the register and the prescription, if any, on which the medicines are issued shall be preserved for not less than two years from the date of the last entry in the register or the date of the prescription, as the case may be. 8[3. The drug will be stored under proper storage conditions as directed on the label.] 9[4. No drug shall be supplied or dispensed after the date of expiration of potency recorded on its container, label or wrapper or in violation of any statement or direction recorded on such container, label or wrapper.] 10[5A. Drugs supplied by a hospital or dispensary maintained or supported by Government or local body 11[***] The provisions of Chapter IV of the Act and the Rules thereunder which require them to be covered by a sale licence, subject to the following conditions : (1) The dispensing and supply of drugs shall be carried out by or under the supervision of a qualified person; (2) The premises where drugs are supplied or stocked shall be open to inspection by an Inspector appointed under the Drugs and Cosmetics Act who can, if necessary, take samples for test; (3) The drugs shall be stored under proper storage conditions. (4) 12[The drugs shall be purchased from a manufacturer or a dealer licensed under these rules or received as transferred stocks from hospital stores for distribution. Records of such purchases or receipts shall be maintained.] (5) 13[No drug shall be supplied or dispensed after the date of expiration of potency recorded on its container, label or wrapper Drugs and Cosmetics Rules 1945 411 or in violation of any statement or direction recorded on such container, label or wrapper.] 14[5B. Whole Human Blood IP and / or its components stored for transfusion by a First Referral Unit, Community Health Centre, Primary Health Centre and a Hospital. The provisions of Chapter IV of the Act and the rules made thereunder which require obtaining of a licence for operation of a Blood Ban k or processing Whole Human Blood and / or its components, subject to the following conditions, namely: - (1) The First Referral Unit, Community Health Centre, Primary Health Centre and / or any Hospital shall be approved by the State / Union Territory Licensing Authority after satisfying the conditions and facilities through inspection. (2) The captive consumption of Whole Human Blood IP or its components in the First Referral Unit, Community Health Centre, Primary Health Centre and / or any Hospital shall not be more than 2000 units annually. (3) The Whole Human Blood an d / or its components shall be procured only from Government Blood Bank and / or Indian Red Cross Society Blood Bank and / or Regional Blood Transfusion Centre duly licensed. (4) The approval shall be valid for a period of two years from the date of issue unless sooner suspended or cancelled and First Referral Unit, Community Health Centre, Primary Health Centre and / or any Hospital shall apply for renewal to the State Licensing Authority three months prior to the date of expiry of the approval. (5) The First Referral Unit, Community Health Centre, Primary Health Centre and / or any Hospital shall have the following technical staff for storage of blood or its components: (a) A trained Medical Officer for proper procurement, storage and cross matching of blood and / or its components. He / she shall also be responsible for identifying haemolysed blood and ensure non-supply of date expired blood or its components. (b) A blood bank Technician with the qualification and experience as specified in Part XII B of Schedule F or an experienced laboratory technician trained in blood grouping and cross matching. Drugs and Cosmetics Rules 1945 412 (6) The First Referral Unit, Community Health Centre, Primary Health Centre and / or any Hospital shall have an area of 10 sq. metres. It shall be well lighted, clean and preferably air- conditioned. Blood bank refrigerator of appropriate capacity fitted with alarm device and temperature indicator with regular temperature monitoring shall be provided to store blood units between 2° C to 8° C and if the components are proposed to be stored, specialized equipment‘s as specified in Part XII B of Schedule F shall also be provided. (7) The First Referral Unit, Community Health Centre, Primary Health Centre and / or any Hospital shall maintain records and registers including details of procurements of Whole Human Blood IP and / or blood components, as required under Part XII B Schedule F. (8) (8) The First Referral Unit, Community Health Centre, Primary Health Centre and / or any Hospital shall store samples of donors blood as well as patients sera for a period seven days after transfusion. 15[6.* * *] 7.Quinine Sulphate The provisions of sub-section (a) (i) of Section 18 of the Act to the following extent- (i) the colour of the drug may be pink, owing to its being coloured with an edible pink colouring matter; (ii) the B. P. tests for readily carbonisable substances produce a yellow colour of an intensity about four times the colour produced with quinine sulphate conforming to the B.P. standard; (iii) other Cinchona alkaloids present shall not exceed six per cent; and (iv) the residue on incineration shall not exceed 0.14 per cent. 16[8.* * *] 17[9. Magnesium Sulphate The provisions of sub-clause (i) of clause (a) of Section 18 of the Act to the following extent:- Chlorides present in the salt shall not exceed 0.12 per cent in the case of the produce prepared from sea water.] 18[10. The following substances which are used both as articles of food as well as drugs - (i) all condensed or powdered milk whether All provisions of Chapter IV of the Act and the Rules thereunder Drugs and Cosmetics Rules 1945 413 pure, skimmed or malted, fortified with vitamins and minerals or otherwise. (ii) Farex, Oats, 19[***] and all other similar cereal preparations whether fortified with vitamins or otherwise excepting those for parenteral use. (iii) Virol, Bovril, Chicken essence and all other similar predigested foods. (iv) 20[Ginger, Pepper, Cumin, Cinnamon and all other similar spices and condiments unless they are specially labelled as conforming to the standards in the Indian Pharmacopoeia or the Official Pharmacopoeia and official compendia of drug standards prescribed under the Act and Rules made thereunder.] 21[11.* * *] 22[12. Substances intended to be used for destruction of vermin or insects which cause disease in human beings or animals, viz. Insecticides and Disinfectants.] The provision of Chapter IV of the Act and Rules thereunder, which require them to be covered by a sale licence 23[subject to the condition that provision of condition (17) of Rule 65 of the Drugs and Cosmetics Rules, 1945 are complied with by the person stocking or selling such substances.] 24[13. The following household remedies, namely- (1) 25[Aspirin tablets.] (2) 26[Paracetamol Tablets.] (3) Analgesic Balms. (4) Antacid preparations. (5) Gripe Water for use of infants. (6) Inhalers, containing drugs for treatment of cold and nasal congestion. (7) Syrups, lozenges, pills and tablets for cough. (8) Liniments for external use. (9) Skin ointments and ointments for burns. (10) Absorbent cotton wool, bandages absorbent guaze and adhesive plaster. (11) Castor Oil, liquid Paraffin and Epsom Salt. (12) Eucalyptus Oil (13) Tincture Iodine, Tincture Benzoi n C o. and Mercurochrome in containers not exceeding 100 ml. (14) Tablets of Quinine Sulphate I.P. (15) Tablets of Iodochlorohydroxy quinoline-250 mg. The provisions of Chapter IV of the Act and the Rules thereunder which require them to be covered with a sales licence in Form 20-A subject to the following conditions— (a) The drugs are sold only in a village having population of not more than one thousand persons and where there is no licensed dealer under the Drugs and Cosmetics Act; (b) The drugs do not contain any substance specified in 27[Schedules G, H or X]; (c) The drugs are sold in the original unopened containers of the licensed manufacturers; (d) When the drugs are sold under clause (a) condition 3 under ―Conditions of licence‖ of Form 20-B shall not apply. 28[14. Mechanical Contraceptives The provisions of Chapter IV of the Act and Rules thereunder, which require them to be Drugs and Cosmetics Rules 1945 414 covered by a sale licence 29[subject to the condition that the provisions of condition (17) of Rule 65 of the Drugs and Cosmetics Rules, 1945, are complied with by the person stocking or selling mechanical contraceptives.] 30[14A. Vaginal contraceptive pessaries containing Nonoxynol. The provisions of Chapter IV of the Act and the Rules made thereunder which require them to be covered by a sale licence subject to the condition that the provisions of clause (17) of Rule 65 of the Drugs and Cosmetics Rules, 1945 are complied with by the person stocking or selling this contraceptive.] 31[15. Chemical contraceptive having the following composition per tablet : (1) DL-Norgestrel-0.30 mg. Ethinyloestradiol-0.03 mg. (2) Levonorgestrel-0.15 mg. Ethinyloestradiol-0.03 mg. (3) Centchroman-30mg. (4) 32[Desogestrel -0.150mg. Ethinyloestradiol 0.030mg. (5) Levonorgestrel 0.1mg. Ethinyloestradiol 0.02mg The provisions of Chapter IV of the Act and the rules made thereunder which required them to be covered by a sale licence.] 33[16. Cosmetics The provisions of Chapter IV of the Act and the Rules made thereunder, which require them to be covered by a licence for sale provided that the cosmetics sold, if of Indian origin, are manufactured by licensed manufacturers.] 34[17. Ophthalmic ointments of the Tetracycline group of drugs Persons authorised by the Government to distribute or sell the drugs under the National Trachoma Control Programme shall be exempted from the provisions of Chapter IV of the Act and the Rules made thereunder, which require the drugs to be covered by a sale licence.] 35[18.* * *] 36[19. Hair Fixers, namely mucilaginous preparations containing gums, used by men for fixing beard. The provisions of Chapter IV of the Act and the rules thereunder.] 37[20. Radio Pharmaceuticals. All the provisions of Chapter IV of the Act and the rules made thereunder.] 38[21. Tablets of Chloroquine Salts. The provisions of Chapter IV of the Act and Rules thereunder, which require them to be covered by a sale licence, provided the drug in strip pack is sold under the Commercial Distribution Scheme of the National Malaria Eradication Programme and duly labelled as Drugs and Cosmetics Rules 1945 415 ―National Malaria Eradication Programme- Ministry of Health and Family Welfare, Government of India.‖] 39[22. Sales from restaurant cars of trains and from coastal ships of household remedies, which do not require the supervision of a qualified person for their sale. The provisions of Chapter IV of the Act and the rules thereunder which require them to be covered by a sale licence, subject to the following conditions, namely - (a) the records of purchase and sale of drugs shall be maintained by the person in charge of sale of such drugs, which shall be available for inspection by an Inspector appointed under the Act; (b) the place where such drugs are stocked shall be open to inspection by a n Inspector appointed under the Act who can, if necessary, takes samples for test.] 40[23. Drugs supplied by ( i ) Multipurpose Workers attached to Primary Health Centres/Sub- Centres, (ii) Community Health Volunteers under the Rural Health Scheme, (iii) Nurses, Auxiliary Nurses, Midwives an d Lady Health Visitors attached to Urban Family Welfare Centres/Primary Health Centres/Sub- Centres and 41[(iv) Anganwadi Workers]. All The provisions of Chapter IV of the Act and Rules thereunder, which require them to be covered by a sale licence, provided the drugs are supplied under the Health or Family Welfare Programme of the Central or State Government.] 42[24. Homoeopathic medicines supplied by a registered Homoeopathic medical practitioner to his own patient or Homoeopathic medicines supplied by a registered Homoeopathic medical practitioner at the request of another such practitioner provided the registered Homoeopathic medical practitioner is not (a) keeping an open shop, or (b) selling across the counter or, (c) engaged in the importation, manufacture, distribution or sale of Homoeopathic medicines in India to a degree which renders him liable to the provisions of Chapter IV of the Act and the rules made thereunder All the provisions of Chapter IV of the Act and the rules made thereunder subject to the following conditions:— (1) The Homoeopathic medicines shall be purchased only from a dealer or a manufacturer licensed under the Drugs and Cosmetics Rules, 1945. (2) The premises where the Homoeopathic Medicines are stocked shall be open to inspection by an Inspector appointed under the Act, who may, if necessary, ―take samples for test.]‖ 43[25. Preparations applied to human body for the purpose of repelling insects like mosquitoes. The provisions of Chapter IV of the Act and Rules thereunder which require them to be covered by a sale licence subject to the conditions that such a product has been manufactured under a valid drug manufacturing licence. 44[26. Medicated Dressing and Bandages for First Aid. The provisions of Chapter IV of the Act and Rules thereunder which require them to be covered by a sale licence subject to the conditions that such a product has been manufactured under a valid drug manufacturing licence.] Drugs and Cosmetics Rules 1945 416 45[27. Oral Rehydration Salts (Manufactured as per the following formula) : o Sodium chloride 3.5 g/litre. o Trisodium citrate dehydrate 2.9 g/litre o Potassium Chloride 1.5 g/ litre. May be replaced by Sodium bicarbonate(Sodium hydrogen Carbonate) 2.5 g/ litre, when citrate salt is not available. The provisions of Chapter IV of the Act and Rules thereunder which required them to be covered by a sale licence, subject to the conditions that such a product has been manufactured under a valid drug manufacturing Licence.] 46[28. White or Yellow Petroleum Jelly I.P. (Non-perfumed). The provisions of Chapter IV of the Act and Rules thereunder which required them to be covered by a sale licence, subject to the condition that such a product has been manufactured under a valid drug manufacturing Licence. 47[29. Morphine Tablets The provisions of Chapter IV of the Act and the rules made thereunder which require them to be covered by a sale licence, subject to the following conditions, namely: - (i) The drug shall be supplied by the Palliative Care Centres approved by the State Government to terminally ill cancer patients (ii) The drug shall be kept under the custody of the Medical Officer in charge of the said Centre. (iii) The drug shall be purchased from a dealer or a manufacturer who holds licence under these rules and records of such purchases showing the names and quantities together with their batch numbers and names and addresses of the manufacturers or dealers and the names and addresses of the patients to whom supplies have been made shall be maintained. Such records shall be open to inspection by an inspector appointed under the Act, who may also take samples for test.