Schedule K:Exempted Drugs, Conditions and extent of exemption

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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 his own patient or any drug specified in Schedule C supplied by a registered medical practitioner at the request of another such practitioner if it is specially prepared with reference to the condition and for the use of an individual patient provided the registered 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
  • All the provisions of Chapter IV of the Act and the Rules made thereunder, subject to the conditions mention in schedule
  • Drugs supplied by a hospital or dispensary maintained or supported by Government or local body as per conditions mentioned in schedule
  • Whole Human Blood I.P. and/or its components stored for transfusion by a First Referral Unit Community Health Centre, Primary Health Centre and Hospital as per conditions mentioned in schedule
  • Quinine Sulphate as per conditions mentioned in schedule
  • Magnesium Sulphate as per conditions mentioned in schedule
  • Some substances which are used both as articles of food as well as drugs as per conditions mentioned in schedule
  • Substances intended to be used for destruction of vermin or insects as per conditions mentioned in schedule
  • Mechanical and Chemical Contraceptives as per conditions mentioned in Schedule
  • Some household Asprin Tablets, Paracetamol Tablets, Analgesic Balms, Antacid Preparations, Gripe Water for use of infants, Inhalers, containing drugs for treatment of cold and nasal congestion, Syrups, lozenges, pills and tablets for cough, Liniments for external use, Skin ointments and ointments for burns, Absorbent cotton wool, bandages, absorbent gauze and adhesive
  • plaster, Castor Oil, liquid Paraffin and Epsom Salt, Eucalyptus Oil, Tincture Iodine, Tincture Benzoin Co.and Mercurochrome solution in containers not exceeding 100 ml, Tablets of Quinine Sulphate I.P., Tablets of Iodochlorohydroxy quinoline – 250 mg as per conditions mentioned in schedule
  • Cosmetics as per conditions mention in schedule
  • Ophthalmic ointments of the Tetracycline group of drugs as per conditions mention in schedule
  • Hair Fixers, namely mucilagenous preparations containing gums, used by men for fixing beard as per conditions mention in schedule
  • Radio Pharmaceuticals as per conditions mentioned in schedule
  • Tablets of Chloroquine Salts as per conditions mentioned in schedule
  • and Many more

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Ajay Kamboj

Full Time Blogger, Part Time Entrepreneur and Partial Time Helper for New Start-UP's in Pharmaceutical, Ayurvedic and Nutraceutical Sector. Contact him at pharmafranchiseehelp@gmail.com

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