The drugs specified in Schedule K shall be exempted from the provisions of Chapter IV of the Act and the Rules to the extent and subject to the conditions specified in that Schedule.
Class of Drugs which is not sold for medicinal use should be labelled conspicuously with the words "NOT FOR MEDICINAL USE".
However, these drugs should not contain any substance specified in Schedules G, H or X of D&C Act and Rules.
The Mashelkar Recommendation Committee on Drug Regulatory System suggested to expand the scope of Schedule K to include OTC drugs.
The phrase 'OTC' has no legal recognition in India, all the drugs not included in the list of 'prescription-only drugs' are considered to be non-prescription drugs (or OTC drugs).
Hence 'OTC Drugs' means drugs legally allowed to be sold 'Over The Counter' by pharmacists, i.e. without the prescription of a Registered Medical Practitioner.
Prescription-only drugs are those medicines that are listed in Schedules Hand X and G of the Drug and Cosmetics Rules.
Currently, non drug-licensed stores (e.g. non-pharmacists) can sell a few medicines classified as 'Household Remedies' listed in Schedule K.
The Schedule K include ;
► Quinine Sulphate and other antimalarial drugs
► Drugs supplied by RMP to his own patient
► Drugs supplied by hospital or supported by government or local body
► Substances which are used both as articles of food as well as drugs
► Household remedies.
E.g - Paracetamol tablets, Analgesic Balms, Antacid Preparations, Calcium preparations with or without Vitamin D, Gripe Water for use of infants, Inhalers (containing drugs for treatment of cold and nasal congestion), Syrups lozenges, pills and tablets for cough, cold or sore throat.