PHARMACEUTICAL Part JURISPRUDENCE 1 Study of Salient Features of Drugs and Magic Remedies Act and its rules r yT er PTY TN rl 4 WW aT TCL me aw SS SW CORO ME CBSO ACC eae elyCHAPTER - 6 THE DRUGS AND MAGIC REMEDIES (OBJECTIONABLE ADVERTISEMENTS) ACT AND ITS RULES > 1. INTRODUCTION —»> 2. OBJECTIVES 3. DEFINITION 4. PROHIBITED ADVERTISEMENTS 5. EXEMPTED > ADVERTISEMENTS —> 6. OFFENCES AND PENALTIES bel Tiel Te) one naINTRODUCTION * In India is advertisement of magic remedies like Kavachas, mantras, talismans which are believed to be curative remedies for diseases for which no cure or treatment is available. To control and inhibit all these issues, the Drugs and Magic Remedies Act was passed in the year 1954. The Act came into effect from April 1** 1955 and was implemented in 1963. * Act extends to whole of India except the state of Jammu and Kashmir. * The Act was also referred as Objectionable Advertisements Act. O OBJECTIVES i. To control some of the drug related advertisements which can mislead the public. ii. To prohibit certain kind of advertisements related to magic remedies which make false claims and are likely to mislead the public. O DEFINITIONS 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 diseases in human beings or animals Any article, other than food, intended to affect the body of human beings. Any article intended for use as a component of any medicine, substance or article referred to above. It includes all the notices, labels, circulars, wrappers or other documents and all the announcements made orally or by means of producing or transmitting light, sound or smoke. Advertise -ment Lh = & a 4 be Tle) eae coe mE STE ere tats)It includes talismans, mantras, Kavachas and any other charm of any kind which is alleged to possess miraculous powers for or in the diagnosis, cure, mitigation, treatment or prevention of any diseases in human beings or animals or for PROHIBITED ADVERTISEMENTS 1. Advertisements, relating to drugs, which are likely to lead to their use in the following ailments or conditions: a) Procurement of miscarriage or prevention of conception in women. b) The correction of menstrual disorders in women. c) The maintenance or improvement of the capacity of human beings for sexual pleasure. d) The diagnosis, cure, mitigation, treatment or prevention of any disease, disorder or condition specified in Schedule J. Advertisements which: a) Directly or indirectly gives a false impression regarding the true character of the drug. b) Makea false claim for the drug. Import and export of all documents containing an advertisement of nature referred to above is prohibited. Any documents containing any such advertisements are deemed to be goods of which import or export has been prohibited under the Sea Customs Act, 1878. Se TT ers ic8 ea Nh ee UNSC es Ure ean a=)CJ EXEMPTED ADVERTISEMENTS Following classes exempted from the purview and hence can be made without any prohil 1. Any sign boards or notices displayed by Registered Medical Practitioner (RMP) indicating that treatment of disease or disorder. Books or treaties relating to the diseases or ailments are otherwise advertised published from bonafide scientific or social standing. Drug related advertisements sent confidentially, in the prescribed manner, to RMP's. Such advertisements should bear the following words on top, in a conspicuous manner “For the use only of RMP or a Hospital or a Laboratory.” Advertisement relating to a drug printed or published by the Govt or by any person with the prior permission of the Govt. Advertisements, labels or set of instructions which are permitted under the Drugs and Cosmetics Act or Rules made there under. The Central Govt may also permit the advertisement of any drug which it feels shall be in the interest of the public. CLASS OF ADVERTISEMENT CONDITIONS Leaflets or literature | Advertisement contains only information as accompanying packing of| it is required for registered medical drugs. practitioner in respect of matters relating to: a) Therapeuticindications of the drug. b) Administration and dosage of the drug. ©) Side effects of the drug. d) The precautions to be observed in the treatment with the drug. Sa ict ce a0 \--a( eene UNSC es Ure ean a=)Advertisements of drugs in medical, pharmaceutical, scientific and technical journals. Responsibility to prove that any claim of advertisement is not false or misleading shall lie on the advertiser. Price lists or therapeutic indexes published by manufacturers, distributors of importers or drugs duly licensed * Advertisement contains information as is required for RMP in regard to therapeutic indications of drugs, dosage, administration, side affects and the precautions to be observed in the treatment. The responsibility to prove that any claim made in the advertisement is not false or misleading shall lie on the advertiser. Medical literature distributed by medical or distributors of drugs, duly licensed The distribution of such literature is confined only to the RMP hospitals, research dispensaries, medical and institutions, chemists and druggists or pharmacies duly licensed O) OFFENCES AND PENALTIES S. NO. OFFENCES PENALTIES First conviction | Second conviction On contravention any of the provisions of act and rules upto six months upto one year or or with fine or fine or both both See TT er ic)8 NS) aM Cassa Ghul ital a =a)If the person contravening any of the provisions of this Act isa company * Every person who, at tl me ence mmitted, was in charge of, and was responsible for the conduct of its business, as well as the company, shall be deemed to be guilty and punished accordingly Unless it is proved that the offence was committed without his kr or that he had exercised due diligence to prevent the commission of that offence. | QUESTIONS FROM THE ABOVE TOPIC | Extra short answer type question (2-marks) What are the objectives of Drugs and Magic Remedies Act? Define Drug under Drugs and Magic Remedies Act. Define the following terms in relation to Drugs and Magic Remedies Act: (a) Advertisement (c) Magic remedy Short answer question (4-marks) Write the classes of advertisements prohibited under D&MR Act. SPST LMU LM MUCMey eco eactwe- THC oooCT LW (cme MUN cm DUN -ee-Voe MET Cm Cortera Act Long answer type questions (8-marks) Py eaTeee eC inaT CRO EeRCOR SECM rra renter e meter tsicel conditionally under D&MR Act. i) DI eC ict eal Cee ee rece(53 B.Pharma at rupees(@J=J= =] (each) Cee baer Med) STUDY MATERIAL De Reta eed re Rt aed oR CS oT CTS : Cie SORE CHEE ftcazerraantsr vores Rupees. spin Py Store toOowniot oo | a Sree ee LDS Fa Coe) 9 1 eer) IN PLAY STORE TO DOWNLOAD THE APP TO GET B.PHARM SEMESTER COURSE