Title 4. DRUGS AND COSMETICS ACT, 1940, AND ITS RULES 1945.pdf ✅

PHARMD GURU Page 2 6) It also provides the establishment of two Drugs Consultative Committees (DCC), one for allopathic and the other for Ayurvedic, Siddha, Unani drugs to advise the various Governments and Boards on matters tending to secure uniformity throughout the country in the administration of the act. DEFINITIONS: DRUG: 1) 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. 2) Such substances (other than food) intend 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. 3) All substances intended for use as components of a drug including empty gelatin capsules; and 4) Such devices intended for internal or external use in the diagnosis, treatment, mitigation or prevention of disease or disorder in human beings or animals. AYURVEDIC, SIDDHA (OR) UNANI DRUG: It includes all medicines intended for internal or external use of human beings or animals for diagnosis, treatment, mitigation or prevention of disease or disorder in accordance with the formulae described in the authoritative books of Ayurvedic, Siddha and Unani Tibb system of medicine, specified in first schedule. MISBRANDED DRUGS: A drug shall be deemed to be misbranded: 1) If it is so colored, coated, powdered or polished that damage is concealed or if it is made to appear of better or greater therapeutic value than it really is; or 2) If it is not labeled in the prescribed manner; or 3) If its label or container or anything accompanying the drug bears any statement, design or device which makes any false claim for the drug or which is false or misleading in any particular.
PHARMD GURU Page 3 ADULTERATED DRUGS: A drug shall be deemed to be adulterated: 1) If it consists, in whole or in part, of any filthy, putrid or decomposed substance; or 2) If it has been prepared, packed or stored under insanitary conditions whereby it may have been contaminated with filthy or whereby it may have been rendered injurious to health; or 3) If its container is composed in whole or in part, of any poisonous or deleterious substance which may render the contents injurious to health; or 4) If it bears or contains, for purposes of coloring only, a color other than one which is prescribed; or 5) If it contains any harmful or toxic substance which may render it injurious to health; or 6) If any substance has been mixed therewith so as to reduce its quality or strength. SPURIOUS DRUGS: A drug shall be deemed to be spurious: 1) If it is manufactured under a name which belongs to another drug; or 2) If it is an imitation of, or is a substitute for, another drug or resembles another drug in a manner likely to deceive or bears upon it or upon its label or container the name of another drug unless it is plainly or conspicuously marked so as to reveal its true character and its lack of identity with such other drug; or 3) If the label or container bears the name of an individual or company purporting to be the manufacturer of the drug, which individual or company is fictitious or does not exist; or 4) If it has been substituted wholly or in part by another drug or substance., or 5) If it purports to be the product of a manufacturer of whom it is not truly a product. DRUG INSPECTOR: A Drug Inspector appointed by the Central Government or a State Government who is an expert and qualified to monitor the safety, utility, efficacy and quality of a drug from its manufacturing till its sale at the retail shop.