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

PHARMD GURU Page 1 INTRODUCTION: The Central Legislative Assembly passed the Drugs and Cosmetics Act 1940 and rules 1945 with an objective to regulate the import, manufacture and distribution and sale of drugs and cosmetics. It is applicable on Allopathic, Homeopathic, Unani and Siddha drugs as well on contraceptives, mosquito repellents, creams, lotions, cosmetics and devices used for internal and external use for diagnosis. Under this Act, the regulation of manufacture, sale and distribution of Drugs is primarily the concern of the State authorities while the Central authorities are responsible for approval of New Drugs, Clinical trials in the country, laying down standards for Drugs, control over the quality of imported drugs, co-ordination of the activities of Drug Control Organization and providing expert advice with a view of bringing about uniformity in the enforcement of Drug and Cosmetic Act. OBJECTIVES: 1) The Drugs and Cosmetics Act 1940 provides the Central legislation, which regulates import, manufacture, distribution and sale of drugs and cosmetics in the country. 2) The main objective of the Act is to ensure that the drugs available to the people are safe and efficacious and the cosmetics marketed are safe for use. 3) The D and C Act regulates the manufacture and import of drugs into India so that no substandard or spurious drugs get manufactured and imported in and into India respectively. 4) This provides the regulation of sale and distribution of drugs and cosmetics whereby only qualified and trained persons can undertake their handling, compounding and distribution. 5) This Act also provides the constitution of two boards namely, the Drug Technical Advisory Board (DTAB) and Ayurvedic and Unani Drugs Technical Advisory Board to advise the Central and State governments on technical matters arising out of the administration of this act. DRUGS AND COSMETICS ACT, 1940, AND ITS RULES 1945
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.
PHARMD GURU Page 4 COSMETIC: Any article intended to be rubbed, poured, sprinkled or sprayed on, or introduced into, or otherwise applied to, the human body or any part thereof for cleansing, beautifying, promoting attractiveness, or altering the appearance, and includes any article intended for use as a component of cosmetic. MISBRANDED COSMETICS: A cosmetic shall be deemed to be misbranded: 1) If it contains a color which is not prescribed; or 2) If it is not labeled in the prescribed manner; or 3) If the label or container or anything accompanying the cosmetic bears any statement which is false or misleading in any particular. SPURIOUS COSMETICS: A cosmetic shall be deemed to be spurious: 1) If it is imported under a name which belongs to another cosmetic; or 2) If it is an imitation of, or is a substitute for, another cosmetic or resembles another cosmetic in a manner likely to deceive or bears upon it or upon its label or container the name of another cosmetic, unless it is plainly and conspicuously marked so as to reveal its true character and its lack of identity with such other cosmetic; or 3) If the label or container bears the name of an individual or a company purporting to be the manufacturer of the cosmetic which individual or company is fictitious or does not exist; or 4) If it is an imitation of, or is a substitute for, another drug or re-not truly a product. DRUG STORE: Licensed premises for the sale of drugs, a retail store which do not require the services of a qualified person and sells both prescription and non-prescription drugs. PHARMACY: Licensed premises for the sale of drugs, which require the services of a qualified person but where the drugs are not compounded against prescriptions.