Unit I Balanced diet Presented by Hezil Reema
Unit I Balanced diet Presented by Hezil Reema Barboza
THE DRUGS AND COSMETICS ACT 1940 AND RULES 1945
Learning objectives • At the end of class learner will be able to • Objectives of drug and cosmetic act • explain about functioning of drug and cosmetic act
Introduction • The Drugs and Cosmetics Act, 1940 is an act of the Parliament of India which regulates the import, manufacture and distribution of drugs in India.
• THE DRUGS AND COSMETICS ACT, 1940 as amended by the • Drugs (Amendment) Act, 1955, the Drugs (Amendment) Act, 1960, the Drugs (Amendment) Act, 1962, the Drugs and Cosmetics (Amendments) Act, 1964, the Drugs and Cosmetics (Amendments) Act, 1972, the Drugs and Cosmetics (Amendments) Act, 1986 and the Drugs and Cosmetics (Amendments) Act, 1995.
History and objectives • The original act was prepared in accordance to the recommendations of the Chopra Committee formed in 1930. • The related Drugs Rules was passed in 1945. Since 1940, the act has undergone several amendments and is now known as the Drugs and Cosmetics Act, 1940 • To regulate the import, manufacture, distribution • and sale of drugs & cosmetics through licensing. • Manufacture, distribution and sale of drugs and cosmetics by qualified persons only. • To prevent substandard in drugs. • To regulate the manufacture and sale of Ayurvedic, Siddha and Unani drugs.
Definitions • Drugs: -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;
Definition cont… • such substances (other than food) intended to affect the structure or any function of 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.
Definitions … • All substances intended for use as components of a drug including empty gelatin capsules; and • 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
Drug cont… • Government analyst: -in relation to Ayurvedic, Siddha 2 or Unani drug, a Government Analyst appointed by Central Government or a State Government under section 33 F; and • In relation to any other drug or cosmetic , a Government Analyst appointed by the Central Government or a State Government under section 20
“Inspector”: - (i) in relation to Ayurvedic, Siddha 3 or Unani drug, an Inspector appointed by the Central Government or a State Government under section 33 G; and
Misbranded drugs • For the purposes of this Chapter a drug shall be deemed to be misbranded • 1. (a) if it is so coloured, 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 • (b) if it is not labelled in the prescribed manner; or • (c) 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
Adulterated drugs • For the purposes of this Chapter, a drug shall be deemed to be adulterated • (a) if it consists, in whole or in part, of any filthy, putrid or decomposed substance. • (b) if it has been prepared, packed or stored under insanitary conditions whereby it may have been contaminated with filth or whereby it may have been rendered injurious to health. • (c) if its container is composed in whole or in part, of any poisonous or deleterious substance which may render the contents injurious to health. • (d) if it bears or contains, for purposes of colouring only, a colour other than one which is prescribed.
Spurious drugs • (a) if it is imported under a name which belongs to another drug. • (b) if it is an imitation of , or 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 and conspicuously marked so as to reveal its true character and its lack of identity with such other drug. • (c) if the label or the 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
Misbranded cosmetics • For the purposes of this Chapter, a cosmetic shall be deemed to be misbranded – • (a) If it contains a colour which is not prescribed ; or • (b) If it is not labeled in the prescribed manner ; or • (c) If the label or container or anything accompanying the cosmetic bears any statement, which is false or misleading in any particular.
Spurious cosmetics • For the purposes of this Chapter, a cosmetic shall be deemed to be spurious, – • (a) If it is imported under a name which belongs to another cosmetic • (b) 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 • (c) 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 • (d) If it purports to be the product of a manufacturer of whom it is
Licencing authority • Qualification: • (i) Graduate in Pharmacy on Pharmaceutical Chemistry or in Medicine with specialization in clinical pharmacology or microbiology from a University established in India by law; and • (ii)Experience in the manufacture or testing of drugs a minimum period of five years, Provided that the requirements as to the academic qualification shall not apply to those inspectors.
• Duties: (1)to inspect all establishments licensed for the sale of drugs within the area assigned to him; (2)to satisfy himself that the conditions of the licences are being observed; (3)to procure and send for test or analysis, if necessary, imported packages. (4) to investigate any complaint. (5)to maintain a record of all inspections made and action taken by him in the performance of his duties, (6)to make such enquiries and inspections as may be necessary to detect the sale of drugs in contravention to the Act;
Controlling authority • Qualification: • graduate in Pharmacy or Pharmaceutical Chemistry or in Medicine with specialization in clinical Pharmacology or microbiology from a University established in India by law and • experience in the manufacture or testing of drugs or enforcement of the provisions of the Act for a minimum period of five years:
Drug Inspector • Qualification • Persons having qualification for appointment as government as govermental Analysis for allopathic drugs ; or • having a degree in ayurved, sidha or unani system and not less than three year post graduate experience in the analysis of drugs in a laboratory under control of (a) a government analyst, or (b) a chemical examinar, or (c) head of an institution specially approved for this purpose.
Power of inspectors a) Inspect (i)any premises where in any drug or cosmetic is being manufactured. (ii)any premises where in any drug or cosmetic is being sold, or stocked or exhibited or offered for sale, or distributed ; (b) Take samples of any drug or cosmetic, -(i)which is being manufactured or being sold or is stocked or exhibited or offered for sale, or is being distributed; (ii)from any person who is in the course of conveying, delivering or preparing to deliver such drug or cosmetic to a purchaser or a consignee.
Penalty for manufacture, sale, etc. , of drugs in contravention of this Chapter (section 27) • (i) any cosmetic deemed to be spurious under section 17 D or adulterated under section 17 E shall be punishable with imprisonment for a term which may extend to three years and with fine which shall not be less than fifty thousand rupees or three times to value of the cosmetics confiscated.
Summary • The primary objective of the act is to ensure that the drugs and cosmetics sold in India are safe, effective and conform to state quality standards. • The related Drugs and Cosmetics Rules, 1945 contains provisions for classification of drugs under given schedules and there are guidelines for the storage, sale, display and prescription of each schedule
Evaluation • What is drug and cosmetic act? • What are the objectives of drug and cosmetic act?
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