ee CHAPTER 8 The Drugs and Magic Remedies (Objectionable Advertisements) Act introduction ‘ Advertising has become a part of our life and hence the modern age may be called the ‘advertisement era’. Advertisements have occupied such a position in our life that it has become impossible to imagine living without them. The media for advertisement has made enormous progress and newer methods are being evolved continuously. Advertising one’s own merits, about fifty years ago was never appreciated but now the position is quite different. Modern methods of advertising like TV, internet, cell phones (mobiles) ete have proved to be very effective. Drugs and cosmetics’ manufacturers are often blamed for spending exorbitantly on advertising their products. This however has become necessary for their existence and further growth, although drugs are essential commodities which one has to take without option. Ethical advertising is never objectionable but when the advertising is misused it may cause harm to the user of the advertised goods or materials. This is the point which serves as a line of demarcation between the advertising for promoting the sale of drugs vis a vis other commodities. For instance, if one purchases a pen relying on a beautiful and exaggerated advertisement, he may simply repent for wasting the money. However if the same person relying on similar advertisement consumes a drug for any disease condition, he may not be cured and his condition may become even worse. This is also the reason why the advertisements for drugs are not for the public directly but for the qualified Persons like physicians, pharmacists and nurses etc. In India it is a common practice that in the streets in any city some Persons might be selling some magic remedies like kavachas, mantras, talismans etc. which are claimed to be universal cure for any disease ete. nay one may find advertisements in the magazines, newspapers and on eee of certain doctors, hakims or vaids (so called) claiming cure of tea 4 4 which no drug or no treatment is yet available. Innocent people money Be in the trap of such unsocial elements and waste their time, this nd worse of all, spoil their health and sometimes forced to leave World prematurely. 271272 \ TEXTBOOK OF FORENSIC PHARMACY tment of Act stated: “In recent years he number of objectionable advertise. ments published in newspapers and magazines, TV and internet or otherwise relating to alleged cures for venereal diseases, sexual stimulants and about diseases and conditions peculiar to woman. These advertisements tend to to self medication with harmful cause the ignorant and the unwary to resort drugs and appliances, or to resort to quacks who indulge in such adver. tisements for treatments which cause great harm. It is necessary in the public interest to put a stop to such uridesirable advertisements.” The Drugs and Magic Remedies Act, 1954 was passed with the object to control the advertisements of drugs in certain cases, to prohibit the adver. tisements for certain purposes for remedies alleged to possess magic qualities and to provide for related matter The scope and object of the Act is to prevent self-medication or self- treatment and for that purpose advertisements commending certain drugs and medicines have been prohibited. It cannot be said that this is an abridgement of the petitioners’ right to free speech." As held by their Lordships in Hamdard Dawakhana v. The Union of India the Drugs and Magic Remedies Act read as a whole does not merely prohibit advertisements relating to drugs and medicines connected with the diseases expressly mentioned in Section 3 of the Act but they cover all advertisements which are objectionable or unethical and are used to promote self-medication or self treatment. The Act came into force on Ist April, 1955 and was amended in 1963 and extends to the whole of India except the state of Jammu and Kashmir. The Drugs and Magic Remedies (Objectionable Advertisements) Rules came into effect from April 1, 1955. Remedies provided for health, sociality or developing beauty are not hit by Section 3.3 Objects and reasons for the ena: there has been a great increase in U Definitions “ ‘Advertisement’ includes any notice, circular, label, wrapper, or other docu- \—— ments, and any announcement made orally or by means of producing or transmitting light, sound or smoke; The target for any advertisement or publicity or sale or promotion of prescription drugs could only be the doctors who would prescribe them, The object of distribution of the samples of the drugs to the doctors is to make them aware that such drugs are available in the market in relation to the cure of a particular affliction and, therefore, to persuade them to prescribe the same in appropriate cases. So doing is tantamount to publicity and sales promotion.4 asii DRUGS AND MAGIC REMEDIES. qcp dicines for i . jncludes (a) me the internal “pris. os of animals; () any substance inten OF external use of ‘sis, Cure, Mitigation, treatmen ded to be rT : ment or i Sed for or in the oe For animals; Suan article, other am a dis in - . Inte ence in any Way the structure or any organ ee tended (6 affect oe rien ings; (d) any article intended fore funtion Of the body of oy of jcine, substarice or article referred to in (a), ( 6) component of wNew Life, New Vigour, New Spiri 6 ee » well known world famous ex; tiene a If you want a cure, see Sect such as oldness in youth, all aot ot defects et ehsician, Special jaziness are treated with full Tesponsibility with new tnethovia oF weakness, of science and electric treatment and are cured Permanentl " ee machines ment was published in a Hindi newspaper in 1967. tt ads ta advertise. aiticle, other than food, which is intended to affect or influence Id that any any organic function of the body of a human being, is a rod in a way meaning of that provision. The so called “machines of i within the selectric treatment” whose magically curative Properties were aida i of the appellant_are articles intended to influenc by 273 € the organic function of the human body. A drug unless it is intended as Preventive or curative, it . _un , itself has no meaning.° Sari ————__— “Magic remedy” includes a_talisman, mantra, kavacha and any other charm of any kind which is alleged to possess miraculous powers for or in the diagnosis, cure, mitigation, treatment or influencing in any way the structure or any organic function of the body of human beings or animals, Section 3 of the Act does not refer to any magic cure. But in view of the aims and objects of the Act mentioned in the preamble it is clear view that the main purpose of the Act is to prohibit such magic remedies and so restrictions will have to be made on such advertisements containing reference to magic cure. Remedies provided for health, sociability or developing beauty are not hit by the section. The remedies referred for immediate and forthwith cure giving hopes to the customers in a magic fashion are prohibited. Therefore it 18 Not correct to say that particular paragraph in regard to Breast Beauty Bust Development is objectionable within the meaning of the Act.” The main object of the Act is to prohibit advertisement on such Drugs and Magic Remedies, which can be construed a medicine or remedy for the Weatment of diseases and ailments indicated ws 3 or 4 of the Act. The Spiritual, supernatural or astrological powers are not prohibited in this coun- tty. Advertisement of Astrology or an Astrologer cannot be construed to be an offence under the ...Act. Discussion in T.V, is not an advertisement but a discussion.’ —ea 274 A TEXTBOOK OF FORENSIC PHARMACY “Taking part in the publication of any advertisement’ includes (a) the printing of the advertisement; (b) the publication of any advertisement outside the territories to which this Act extends by or at the instance of q person residing within the said territories. i Prohibition of Certain Advertisements 1. No person can take part in te publication of any advertisement referring to any drug in terms which suggest or are calculated to lead to the use of that drug for— (a) the procurement of miscarriage in woman, or prevention of conception in woman; or (b) the maintenance or improvement of the capacity of human beings for sexual pleasure, or (c) the correction of menstrual disorder in woman; or (@ the diagnosis, cure, mitigation, treatment or prevention of any disease, disorder or condition specified in the Schedule, or any other disease, disorder or condition which may be specified in the rules made under this Act. Whereas the advertisement in effect only means that chloroquine is recommended in case of malaria fever and not chloroquine should be taken for all types of fever and the advertisement was neither false nor misleading in any particular, it must be held that there is no violation of Section 4(c) of the Act. 2. No person shall take part in the publication of any advertisement relating to a drug if the advertisement contains any matter which— (a) directly gives a false impression regarding the true character of the drug; or (b) makes a false claim for the drug; or (c) is otherwise false or misleading in any material particular. 3. No person carrying on or purporting to carry on the profession of advertising magic remedies should take part in the publication of any advertisement referring to any magic remedy which directly or indirectly claims to be efficacious for any of the purposes specified in (1) above. 4. No person shall take part in the publication of any advertisement referrting to any drug in terms which suggest or are calculated to lead to the use of that drug for the diagnosis, cure, mitigation, treatment or prevention of any disease, disorder or condition in Asthma and AIDS. Their Lordships were of the opinion that the words “or in any other disease or condition which may be specified in the rules under this Act” confer unchannalised and uncontrolled power to the executive and are there- fore ultra vires (beyond the power delegated). However this does not affect275 the 59 ‘Para- ple: : ertisement of chloroquin by short The Fassel by Government of Ind ds j ia in order to ine use of chloroquin is not objectionable |! aes ising in a booklet an arti ed advertising in a an article knows cou! to be used for proper development of bret of wom ate mi st Advertise. Ments as mentioned in 8. 2¢by(i), (ii) known ag Bust De: eee vel a drug under the Act. yer cation be ‘O84N printed on cards. and Malaria and to yent Fe ins a having any reference to any ail men jij) Pamphlet and the instrument n objectionable article or iements Whose Brae and Export Prohibited A nd export of all advertisements teferred to j i ‘ pn reatent of certain diseases and dikordets), section tay —— jsements relating to drugs), and section 5 (magic remedies for treat- t of certain diseases and disorders) js Prohibited, Any documents raining any such adverti ‘Sements are deemed to be g00ds of which import expo rt has been prohibited under the Sea Customs Act, 1878, The Customs Collector is empowered to detain such Consignment and dispose it in accordance with the provisions of the Sea Customs Act, 1878. Entry, Search and Seizure Subject to the provisions of any rules made Officer authorised by the State Government ma the area for which he is so authorised— in this behalf, any Gazetted Y, within the local limits of (a) enter and search at all reasonable times, with such assistants as necessary, any place in which he has reason to believe that an offence under this Act has been or is being committed; (b) seize any advertisement which he has reason to believe, contra- venes any of the provisions of the Act. Power of seizure under this clause may be exercised in respect of any document, article or thing which contains any record, register, document or any other material object found in any place mentioned under (a) above and Stize the same if it is likely to furnish the evidence of the commission of an Offence punishable under this Act. Search and seizure should be made under the authority of a warrant as Povided in the Code of Criminal Procedure, 1898. An offence punishable Under this Act shall be cognizable. A magistrate should be informed of any Stizure and his order should be taken as to the custody of seized material. Every person authorised for entry and search etc. under this Act shall be deemed to be public servant within the meaning of Section 21 of the Indian Penal Code, —Jin 276 A TEXTBOOK OF FORENSIC PHARMACY ‘Advertisements in the below mentioned manner can be made without any prohibition— (a) Any sign board or notice displayed by a registered medical practi- tioner on his premises indicating that treatment for any disease, disorder or condition is undertaken relating to which advertisements otherwise are prohibited; or . (b) Any treatise or book dealing with any of the matters relating to the diseases or conditions which are otherwise prohibited to be advertised, provided published from a bona fide scientific or social standing; or (c) Any advertisement relating to any drug sent confidentially in the prescribed manner only to a registered medical practitioner; or (@ Any advertisement relating to a drug printed or published by the Government, or by any person with the previous sanction of the Govern- ment granted prior to the commencement of the Drugs and Magic Remedies (Amendment) Act, 1963. Such sanction could be obtained by making an application to the officer authorised in this behalf by the Central or the State Government, mentioning the registered name and the trade mark of the drug, its detailed composition and any special reasons justifying the sane- tion of the Government. This section covers advertisement relating to a disease and its treatment made by the Government.!? Such sanction can be withdrawn by the Government after giving the person an opportunity of showing cause against such withdrawal. The Central Government may, in the public interest, permit the adver- tisement of any specified drug or classes of drugs which is otherwise prohibited under the Act. (e) Any advertisement, labels or sets of instructions which are permit- ted under the Drugs and Cosmetics Act or Rules thereunder. The Central Government through a notification issued in 1967 has further exempted from the provisions of the Act the following classes of the advertisements with the conditions against them: lass of Advertisement Conditions 4 ~ 1. Leaflets or literature accompa- 1. The advertisement contains only such in- nying packing of drugs; and formation as is required for the guidance 2. Advertisements of drugs in medi- of registered medical practitioner in re- cal, pharmaceutical, scientific spect of matters relating to— and technical journals, (a) therapeutic indications of the drug: ——_____ its siminraions ...continuedor therapeutic indexes. 3. PF ned by manufacturers, im- publishes gistributors of drugs ‘oensed under the Drugs etics Act, 1940 and the under; and Medical literature distributed by jical retailers appointed by manufacturers, importers, or dis- ributors of drugs, duly licensed under the Drugs and Cosmetics tat, 1940 and Rules thereunder. sce lists ih c cost ules there! §, Advertisement of chemical con- traceptives for oral use mugs AND MAGIC REMEDIES ACT D » The responsibilit . The respo! the precautions lo be obs i treatment with the drug, erved in the 'y to prove that any claim tne in the advertisement in ‘epee of ' ie drug is not false, exaggerated or mis- leading; lies on the advertiser. . The advertisement contains only such technical information as is required for the guidance of tegistered medical practi- tioners in regard to therapeutic indications of drugs, the manner of their administra- tion, their dosage, side effects and the precautions to be observed in the treat- ment. . The distribution of such literature is con- fined only to the registered medical practitioners, hospitals, dispensaries, medical and research institutions, and chemists and druggists or pharmacies duly licensed under the provisions of the Drugs and Cosmetics Rules. _ The responsibility to prove that any claim made in the advertisement in respect of the drug is not false, exaggerated or mis- leading; lies on the advertiser. . Advertisement relates to chemical contra- ceptives for oral use having the following composition per tablet— (a) DL-Norgestral-0.30 mg. Ethinyl Estradil-0.30 mg. Or (b) Levo-norgestral-0.15 mg. Ethinyl Estradil-0.03 mg- Or (c) Centehroman-30 mg: nsibility to prove that any oe ade in the advertisement in respect ¢ a is not false, exaggerated or mis- leading; lies on the advertiser [.oan 278 A TEXTBOOK OF FORENSIC PHARMACY Manner in which Advertisements may be sent confidentially All documents containing advertisements relating to drugs to be sent confidentially shall be sent by post to a RMP by name, or to a wholesaler or retail chemist, the address of such RMP or wholesaler or retail chemist at given address. Such documents shall bear at the top, printed in indelible ink in a conspicuous manner, the words “For the use of registered medical practitioner or a hospital or a laboratory”. Scrutiny of misleading advertisements relating to drugs : Any person authorised by the State Government in this behalf, if satisfied that a particular advertisement has been made in contravention of the provisions of the Act, may require the manufacturer, packer, distributor or seller in question to furnish, within the specified time, information regarding the composition of the drug or its ingredients or any other information he deems necessary for scrutinising the advertisement. Such manufacturer, packer, distributor or seller shall be duty bound to comply with this order: Provided that no publisher or advertising agency taking part in the publication of a prohibited advertisement shall be deemed guilty, unless he has failed to comply with any direction made by the authorised person in this behalf calling upon him to furnish the name and address of the manufacturer, packer, distributor or seller of advertising agency, who/which caused the publication of such advertisement. Other laws not affected : The provisions of this Act are in addition to, and not in derogation of the provisions of any other law for the time being in force. Power to exempt in public interest : The Central Government may permit advertisements which are otherwise prohibited under the Act or tules; in public interest. OFFENCES AND PENALTIES Whoever contravenes any of the provision of this Act or Rules made thereunder shall be punishable with imprisonment upto six months or with fine or both on first conviction, and imprisonment upto one year or fine or both on any subsequent conviction. If the person contravening any of the provisions of this Act is a company, every person who, at the time the offence was committed, 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 knowledge or that he had exercised due diligence to prevent the commission of that offence. If it is proved that the offence by a company was committed with the consent or connivance of, or is attributable to any neglect on the part of, any director,pRUGS AND MAGIC REMEDIES acy é 279 as retary etc. of the company, such of that offence and shall be Punished ola be deemed to oil rson has been convicted under thig A w ; See of any document, article oF thing, pe bende oe ae fe ion is made including the contents thereof, beads Pelee vel nce punishable under this Act shall be copnj a court inferior to that of a Presidency higmteee pe be tt class. suit, prosecution or other legal Proceedin, No for anything done in good faith of intende Act 2 shall fie against any d to be done under this to be laid before both the houses of under this Act should be laid before each He te th the Houses agree hot to make a rule or to modify it, the rule shall shor be NOt made or modified accordingly, However any such modifica van or annulment should be without Prejudice to the validity of anything previowsly done under that rule. + All rules ‘Ouse of Parliament and in THE SCHEDULE Prohibition of advertisement of certain drugs for treatment of certain diseases and disorders AIDs, Appendicitis, Arteriosclerosis, Asthama, Blindness, Blood Ppoison- ing, Bright’s disease, Cancer, Cataract, Deafness, Diabetes, Diseases and disorders of brain, optical system and uterus; Disorders of menstrual flow, nervous system and prostatic gland; Dropsy, Epilepsy, Female diseases (in general), Fevers (in general), Fits, Form and structure of female bust; Gall stones, kidney stones and bladder stones; Gangrene, Glaucoma, Goitre, Heart diseases, High or low blood Pressure, Hydrocele, Hysteria, Infantile paralysis, Insanity, Leprosy, Leucoderma, Lockjaw, Locomotor ataxia, Lu- pus, Nervous debility, Obesity, Paralysis, Plague, Pleurisy, Pneumonia, Rheumatism, Ruptures, Sexual impotence, Smallpox, Stature of persons, Sterility in women, Trachoma, Tuberculosis, Typhoid fever, Ulcers of S4astrointestinal tract, Venereal diseases including syphilis, gonorrhoea, soft chanere, venereal granuloma and lympho granuloma. CASES CITED |; Hamdard Dawakhana v. The Union of India AIR 1960 2 SCR 671: 1960 Cx LI 735: (1960) 1 KLR 746. * Hamdard Dawakhana y, The Union of India, AIR 1960 SC 554: 1960 MLI (Cr) 358 : (1960) 1 SCA 314, —280 A TEXTBOOK OF FORENSIC PHARMAcy © 3. Kantirani Jayaraman y. State of Maharashtra, 1982, Mh LJ 822. 4, Eskayef v. CIT, (2000) 6 SCC 35. 5.. Zafar Mohd, vy, State of West Bengal, AIR 1976 SC 171 (171, 172 and 173). (1976) 1 Cr LJ 1790; (1975) 2 PAC 321; 1975 Cr App R 435: 1980 Fay 9% sc. 6. A.S.P. Kurup v, Union of India, 1984 FAI 36 (Ker). 7. Smt. Kantirani Jaynarayan Mangal y, State of Maharashtra, 1983 (1) Bom, GR. 429 at p 434: 182 Cr LJ 1454 FA. 237 at p. 244 (Bom.). bs 8. Prabir Ghosh v. Jaya Ganguli, (2003) | CHN/68. 9. ASP. Kurup v. Union of India, AIR, 198% Ker, 259 at p. 261: 1983 PLAY, 355 : 1983 (1) F.ALC. 262. 10. Hamdard Dawakhana v. The Union of India, AIR 1960 SC 554 (566, 567 & 568): (1960) 1 SCA 314; (1960) 2 Andh WR (SC) 1: 1960 Dr LJ 735 11. AS.P. Kurup y. Union of India, 1983 (Ker 259: 1983 Ker LT 186). 12. A.S.P. Kurup y. Union of India, 1984 FAJ 36 (Ker). o- prices ¢ drug m: Prices o The the DP