IMA WHITE PAPER ON NON PRESCRIPTION DRUGS The import, manufacture, distribution and sale of drugs and cosmetics in India is regulated by the Drugs and Cosmetics Act, 1940 (hereinafter referred to as ―DCA‖) and Drugs and Cosmetics Rules, 1945 (hereinafter referred to as ―DCR‖). The profession and practice of pharmacy and constitution of pharmacy council is being regulated by The Pharmacy Act, 1948. DEFINITION OF DRUG The term ―drug‖ has been defined in Section 3(b) of the DCA which is an inclusive definition. According to Section 3(b) of DCA ―drug‖ includes— (i) all medicines for internal or external use of human beings or animals and all substances intended to be used for or in the diagnosis, treatment, mitigation or prevention of any disease or disorder in human beings or animals, including preparations applied on human body for the purpose of repelling insects like mosquitoes; (ii) such substances (other than food) intended to affect the structure or any function of the human body or intended to be used for the destruction of vermin or insects which cause disease in human beings or animals, as may be specified from time to time by the Central Government by notification in the Official Gazette; (iii) all substances intended for use as components of a drug including empty gelatin capsules; and (iv) such devices intended for internal or external use in the diagnosis, treatment, mitigation or prevention of disease or disorder in human beings or animals, as may be specified from time to time by the Central Government by notification in the Official Gazette, after consultation with the Board; According to Section 2 of the Pharmacy Act, the term drug means any substance or mixture of substances manufactured, sold or represented for use in- (a) The diagnosis, treatment; mitigation or prevention of a-disease, disorder, abnormal physical state or the symptoms thereof in man or animal; (b) Restoring, correcting or modifying organic functions in man or.anima1; (c) disinfection in premises in which food is manufactured, prepared, preserved, packaged or stored for sale or sold or for the control of vermin or insects in such premises; According to Section 2(b) of The Drugs And Magic Remedies (Objectionable Advertisements) Act, 1954, the term drug‘ includes: (i) A medicine for the internal or external use of human beings or animals (ii) Any substance intended to be used for or in the diagnosis, cure, mitigation, treatment or prevention of disease in human beings or animals (iii) Any article, other than food, intended to affect or influence in any way the structure or any organic function of the body of human beings or animals; (iv) Any article intended for use as a component of any medicine, substance or article, referred to in sub-clauses (i), (ii) and (iii). According to Section 2(f) of Drugs (Prices Control) Order, 1995, the definition of term drugs includes: (i) all medicines for internal or external use of human beings or animals and all substances intended to be used for, or in the diagnosis treatment, mitigation, or prevention of any disease or disorder in human beings or animals, including preparations applied on human body for the purpose of repelling insects like mosquitoes (ii) such substances, intended to affect the structure or any function of the human or animal body or intended to be used for the destruction of vermin or insects which cause disease in human beings or animals, as may be specified from time to time by the Government by notification in the Official Gazette (iii) bulk drugs and formulations The definition of the term drug as mentioned above in various acts neither classify / divide the drugs into allopathic drugs, ayurvedic, siddha or unani drug or homeopathic drug nor does it discriminate between prescribed drugs or non prescribed drugs. Further, the definition of drug does not define the term over the counter drugs (OTC) as commonly known in USA which can be sold or purchased by any person over the counter. CLASSIFICATION OF DRUG EXCLUDING HOMEOPATHIC DRUGS Allopathic Drugs / Medicines The provisions of Drugs & Cosmetics Act, does not define the term allopathic drug or modern medicine. Indian Medical Council Act, 1956 (hereinafter referred to as IMC Act) is an act to provide for the reconstitution of the Medical Council of India and the maintenance of a Medical Register for India and for matters connected therewith. According to Section 2 (g) of Indian Medical Council Act, 1956, "medicine" means modern scientific medicine in all its branches and includes surgery and obstetrics, but does not include veterinary medicine and surgery. Indian Medical Degrees Act, 1916 was enacted to regulate the grant of titles implying qualifications in Western medical science and the assumption and use by unqualified persons of such titles. According to Section 2 of the Indian Medical Degrees Act, 1916, ―Western Medical Science‖ means the Western methods of Allopathic medicine, Obstetrics and Surgery, but does not include the Homeoptahic or Ayurvedic or Unani System of medicine. Thus, Indian Medical Degrees Act does not grant degrees of Ayurvedic, Unani system of medicines. Ayurvedic, Siddha And Unani Drug According to Section 3(a) of Drugs and Cosmetics Act, 1940, Ayurvedic, Siddha or Unani drug‖ includes all medicines intended for internal or external use for or in the diagnosis, treatment, mitigation or prevention of disease or disorder in human beings or animals, and manufactured exclusively in accordance with the formulae described in, the authoritative books of Ayurvedic, Siddha and Unani Tibb systems of medicine, specified in the First Schedule. The Indian Medicine Central Council Act, 1970 (hereinafter referred to as ―IMCC Act) has been framed to provide for the constitution of a Central Council of Indian Medicine and the maintenance of a Central Register of Indian Medicine and for matters connected therewith. According to Section 2(e) of the Indian Medicine Central Council Act, "Indian Medicine" means the system of Indian medicine commonly known as Ashtang Ayurveda, Siddha or Unani Tibb whether supplemented or not by such modern advances as the Central Council may declare by notification from time to time. DEFINITION OF FOOD The Food Safety and Standards Act, 2006 has been framed to consolidate the laws relating to food and to establish the Food Safety and Standards Authority of India for laying down science based standards for articles of food and to regulate their manufacture, storage, distribution, sale and import, to ensure availability of safe and wholesome food for human consumption and for matters connected therewith or incidental thereto. According to Section 3(j) of Food Safety and standards Act, 2006, ―Food‖ means any substance, whether processed, partially processed or unprocessed, which is intended for human consumption and includes primary food to the extent defined in clause (zk), genetically modified or engineered food or food containing such ingredients, infant food, packaged drinking water, alcoholic drink, chewing gum, and any substance, including water used into the food during its manufacture, preparation or treatment but does not include any animal feed, live animals unless they are prepared or processed for placing on the market for human consumption, plants, prior to harvesting, drugs and medicinal products, cosmetics, narcotic or psychotropic substances : Provided that the Central Government may declare, by notification in the Official Gazette, any other article as food for the purposes of this Act having regards to its use, nature, substance or quality POISONOUS SUBSTANCES According to Section 4 of DCA, any substance specified as poisonous by rule made under Chapter III or Chapter IV or Chapter IVA shall be deemed to be a poisonous substance for the purposes of Chapter III or Chapter IV or Chapter IVA, as the case may be. SCHEDULE DRUGS and NON SCHEDULE DRUGS According to the provisions of Drugs & Cosmetics Act, 1940 and Drugs & Cosmetics Rules, 1945 certain restriction has been imposed on the manufacture, sale, advertisement, labeling, packing, etc. of certain drugs. Thus, the allopathic drugs and ayurvedic, siddha and unani drgs can further be classified as i) Schedule Drugs / Prescription Drugs: The List of schedule / prescription drugs of allopathic and ayurvedic, siddha and unani drugs is mentioned in Schedules appended to the Drugs and Cosmetics Rules, 1945. The drugs mentioned in Schedule E1, G, H, H1 and X appended to the Drugs and Cosmetics Rules, 1945 can be termed as Schedule Drugs / Prescription drugs. ii) Non Schedule / Non Prescription Drugs: There are certain drugs as mentioned in Schedule K of Drugs & Cosmetics Rules, 1945 which are exempted from the various restrictions as imposed in case of schedule drugs. iii) Non Schedule / Non Prescription Drugs not mentioned in Schedule K: There are certain drugs other than those as mentioned in Schedule K which are exempted from various restrictions as imposed in case of schedule drugs / prescription drugs. These are those drugs which are not mentioned in any of the Schedule appended to the Drugs and Cosmetics Rules, 1945. However, there is no exhaustive list of non schedule drugs. SCHEDULE / PRESCRIPTION DRUGS The drugs mentioned in Schedule E1, G, H, H1 and X appended to the Drugs and Cosmetics Rules, 1945 can be termed as Schedule Drugs / Prescription drugs. The drugs mentioned in Schedule E1, G, H, H1 and X along with various restrictions as imposed on these drugs are discussed hereinunder: SCHEDULE E(I) - List of poisonous substances under the ayurvedic (including Siddha) and Unani Systems of Medicine Restriction on Labeling According to Rule 161(2) of Drugs and Cosmetics Rules, 1945, the container of medicines for internal use made up ready for the treatment of human ailments shall, if it is made up from a substance specified in Schedule E(1) be labeled conspicuously with the words: Caution: To be taken under medical supervision‘ both in English and Hindi language.