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Drugs and magic remedies act

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Drugs and magic remedies act

  1. 1. Presented by:Mr. Amit S. SatputeM.Pharm I (Pharmaceutics)
  2. 2. The Drugs and Magic Remedies (ObjectionableAdvertisements) Act is an Act No. 21 of 1954,which came in force on 1st of April 1955.The Drugs and Magic Remedies (ObjectionableAdvertisements) Rules, 1955.
  3. 3. The Drugs and Magic Remedies(Objectionable Advertisements)Act, 1954
  4. 4. Structure of the actSection Contents1 Short title, extent &Commencement2 Definitions3,4,5,6 Prohibitions7 Power of entry, search etc88 AOffences by companiesOffences to be cognizable9 Jurisdiction to try offences10 Officers to be deemed to bepublic servants
  5. 5. Structure of the actSection Contents11 Indemnity12 Other laws not affected13 Savings14 Power to exempt fromapplication of act15 Power to make rules16 Penalty
  6. 6. The Drugs and Magic Remedies (ObjectionableAdvertisements) Act, 1954 is an Act No. 21 of1954(Section 1)It extends to the whole of India, except the stateof Jammu & Kashmir.It was came into force by Gazette notificationon 1st April, 1955.
  7. 7. Definitions‘drug’ includes –(¡) A medicine for the internal or external useof human beings or animals;(¡ ¡) Any substance intended to be used for or inthe diagnostic, cure, mitigation , treatment orprevention of disease in human beings oranimals;
  8. 8. Definitions‘drug’ includes –(¡¡¡) Any article, other than food, intended toaffect or influence in any way the structure orany organic function of the body of humanbeings or animals;(¡v)Any article intended for use as a componentof any medicine, substance or article, referredto in sub-clauses (i), (i) and (iii);
  9. 9. Definitions- D & C act“drug” includes—(i) all medicines for internal or external use of human beings oranimals and all substances intended to be used for or in thediagnosis, treatment, mitigation or prevention of any disease ordisorder in human beings or animals, including preparationsapplied on human body for the purpose of repelling insects likemosquitoes;(ii) such substances (other than food) intended to affect thestructure or any function of human body or intended to beused for the destruction of vermin or insects which causedisease in human beings or animals, as may be specified fromtime to time by the Central Government by notification in theOfficial Gazette;]
  10. 10. Definitions- D & C act(iii) all substances intended for use as components of a drugincluding empty gelatin capsules; and(iv) such devices intended for internal or external use in thediagnosis, treatment, mitigation or prevention of disease ordisorder in human beings or animals, as may be specifiedfrom time to time by the Central Government by notificationin the Official Gazette, after consultation with the Board
  11. 11. Definitions‘magic remedy’ includesA talisman, mantra, kavacha and any othercharm of any kind which is alleged to possessmiraculous powers for or in the diagnosis,cure, mitigation, treatment or prevention ofany disease in human beings or animals or foraffecting or influencing in any way thestructure or any organic function of the bodyof human beings or animals;
  12. 12. Definitions‘Advertisement’‘Advertisement’ includes any notice, circular,label, wrapper, or other document, and anyannouncement made orally or by any meansof producing or transmitting light, sound orsmoke;
  13. 13. Definitions‘Taking any part in the publication of anyadvertisement’ includes -(i) the printing of the advertisement;(ii) the publication of any advertisementoutside the territories to which this Actextends by or at the instance of a personresiding within the said territories;
  14. 14. PROHIBITIONS -Section 3Subject to the provisions of this Act, no personshall take any part in the publication of anyadvertisement referring to any drug in termswhich suggest or are calculated to lead to theuse of that drug for –(a) the procurement of miscarriage in women orprevention of conception in women; or(b) the maintenance or improvement of thecapacity of human beings for sexual pleasure; or(c) the correction of menstrual disorder inwomen; or
  15. 15. (d) the diagnosis, cure, mitigation, treatment orprevention of any disease, disorder or conditionspecified in the Schedule, or any other disease,disorder or condition (by whatsoever namecalled) which may be specified in the rules madeunder this Act.PROHIBITIONS -Section 3
  16. 16. Provided that no such rules shall be made except –(i) in respect of any disease, disorder or condition whichrequires timely treatment in consultation with aregistered medical practitioner or for which there arenormally no accepted remedies, and(ii) after consultation with the Drug Technical AdvisoryBoard constituted under the Drugs and Cosmetics Act,1940 and, if the Central Government considersnecessary, with such order persons having specialknowledge or practical experience in respect ofAyurvedic or Unani systems of medicines as thatGovernment deems fit.
  17. 17. PROHIBITION OF MISLEADING ADVERTISEMENTS RELATING TODRUGSSubject to the provisions of this Act, no person shall take any partin the publication of any advertisement relating to a drug if theadvertisement contains any matter which –(a) directly or indirectly gives a false impressionregarding the true character of the drug; or(b) make a false claim for the drug; or(c) is otherwise false or misleading in any materialparticular.
  18. 18. PROHIBITION OF ADVERTISEMENT OF MAGIC REMEDIESFOR TREATMENT OF CERTAIN DISEASES AND DISORDERSNo person carrying on or purporting to carry onthe profession of administering magic remediesshall take any part in the publication of anyadvertisement referring to any magic remedywhich directly or indirectly claims to beefficacious for any of the purpose specified inSection 3.
  19. 19. PROHIBITION OF IMPORT INTO, AND EXPORT FROMINDIA OF CERTAIN ADVERTISEMENTSNo person shall import into, or export from, theterritories to which this Act extends any documentcontaining an advertisement of the nature referred to inSection 3, or Section 4, or Section 5, and any documentscontaining any such advertisement shall be deemed tobe goods of which the import or export has beenprohibited under Section 19 of the Sea Customs Act,1878 and all the provisions of that Act shall have effectaccordingly.
  20. 20. Powers Of Entry, Search etc(1) Subject to the provisions of any rules made in this behalf, anyGazetted officer authorised by the state Government may, withinthe local limits of the area for which he is so authorised –a) enter and search at all reasonable times, with suchassistants, if any, as he considers necessary, any place inwhich he has reason to believe that an offence under thisact has been or is being commited;b) seize any advertisement which he has reason to believecontravenes any of provisions of this act;
  21. 21. Powers Of Entry, Search etcc) Examine any record, register, document or any othermaterial object found in any place mentioned in clause(a) and seize the same if he has reason to believe that itmay furnish evidence of the commission of an offencepunishable under this act.(2) Provisions of the code of criminal procedure, 1898 shallmay apply to any search under this act.(3) Where any person seizes anything under clause (b) orclause (c) of sub section (1), he shall, as soon as may beinform a Magistrate and take his orders as to the custodythereof.
  22. 22. Offences By Companies(1)If the person contravening any of the provisions of this Act is acompany, every person who, at the time the offence wascommitted, was in charge of, and was responsible to, thecompany for the conduct of the business of the company as wellas the company shall be deemed to be guilty of thecontravention and shall be liable to be proceeded against andpunished accordingly:(2) Not withstanding anything contained in sub-section (1) wherean offence under this act has been committed by a company andit is proved that the offence was committed with the consent orconnivance of, or is attributable to any neglect on the part of, anydirector or manager, secretary or other officer of the company,such director manager, secretary or other officer of the companyshall also be deemed to be guilty of that offence and shall beliable to be proceeded against and punished accordingly.
  23. 23. Jurisdiction To Try OffencesNo court inferior to that of a Presidency Magistrate or aMagistrate of first class shall try any offence punishableunder this Act.ForfeitureWhere a person has been convicted by any court forcontravening any provision of this Act or any rule madethere under, the court may direct that any document(including all copies thereof), article or thing, in respectof which the contravention is made, including thecontents thereof where such contents are seized underclause (b) of sub-section (1) of section 8, shall beforfeited to the Government.
  24. 24. Officers to be deemed to be public servantsEvery person authorized under section 8, shall bedeemed to be a public servant within the meaning ofsection 21 of Indian Penal Code.IndemnityNo suit, persecution or other legal proceeding shall lieagainst any person for anything which is in good faithdone or intended to be done under this Act.Other laws not affectedThe provisions of this Act in addition to, and not inderogation of, the provisions of any other law for thetime being in force.
  25. 25. SAVINGS – NOTHING IN THIS ACT SHALL APPLY TO :(a) any signboard or notice displayed by a registeredmedical practitioner on his premises indicating thattreatment for any disease, disorder or conditionspecified in Section 3, the Schedule or the rules madeunder this Act, is undertaken in those premises; or(b) any treatise or book dealing with any of the mattersspecified in Section 3 from a bonafide scientific orsocial standpoint; or(c) any advertisement relating to any drug sentconfidentially in the manner prescribed under Section16 only to a registered medical practitioner; or
  26. 26. SAVINGS – NOTHING IN THIS ACT SHALL APPLY TO :(d) any advertisement relating to a drug printed orpublished by the Government; or(e) any advertisement relating to a drug printed orpublished by any person with the previous sanction ofthe Government granted prior to the commencementof the Drugs and Magic Remedies (ObjectionableAdvertisement) Amendment Act, 1963 (42 of 1963);
  27. 27. POWER TO EXEMPT FROM APPLICATION OF ACTIf in the opinion of the Central Government publicinterest requires that the advertisement of any specifieddrug or class of drugs 1[or any specified class ofadvertisements relating to drugs] should be permitted; itmay, by notification in the Official Gazzette, direct thatthe provisions of sections 3, 4, 5 and 6 or any one ofsuch provisions shall not apply or shall apply subject tosuch conditions as may be specified in the notification toor in relation to the advertisement of any such drug orclass of drugs 1[or any specified class of advertisementrelating to drugs].
  28. 28. POWER TO MAKE RULES(1) The Central Government may, by notification in theOfficial Gazzette, make rules for carrying out thepurposes of this Act.(2) In particular and without prejudice to the generality ofthe foregoing power, such rules may-(a) specify any [disease, disorder or condition] to whichthe provisions of section 3 shall apply;(b) prescribe the manner in which advertisements ofarticles or things referred to in clause (c) of section 14may be sent confidentially.
  29. 29. POWER TO MAKE RULES(3)Every rule made under this Act shall be laid as soon asmay be after it is made, before each House of Parliamentwhile it is in session for a total period of thirty days whichmay be comprised in one session or in two or moresuccessive sessions and if before the expiry of session inwhich it is so laid or the successive sessions aforesaid,both Houses agree in making any modification in the ruleor both Houses agree that the rule should not be made,the rule shall thereafter have effect only in such modifiedform or be of no effect, as the case may be; so, however,that any such modification or annulment shall be withoutprejudice to the validity of anything previously doneunder that rule.
  30. 30. PENALTYWhoever contravenes any of the provisions of this Act [orthe rules made there under] shall, on conviction, bepunishable –a) in the case of a first conviction, withimprisonment which may extend to six months orwith fine, or with both;b) in the case of a subsequent conviction, withimprisonment which may extend to one year, orwith fine, or with both.
  31. 31. The Drugs and Magic Remedies(Objectionable Advertisements)Rules, 1955.
  32. 32. Structure of the ruleRule Content1 Short title & Commencement2 Definitions3 Scrutiny of misleading misleading advertisements relatingto drugs4 Procedure to be followed in prohibiting import into &export from, India of certain advertisements5 Manner in which advertisements may be sentconfidentially6 Prohibition of advertisement of drugs for treatment ofdisease, etc
  33. 33. SCRUTINY OF MISLEADING ADVERTISEMENTSRELATING TO DRUGSAny person authorised by the state Government in thisbehalf may, if satisfied, that an advertisement relating toa drug contravenes the provisions of section 1 by order,require the manufacturer , packer, distributer or seller ofthe drug to furnish within such time as may be allowedin this behalf by the person so authorised informationregarding the composition of the drug or the ingredientsthereof or any other information in regard to that drugas he deems necessary for holding the scrutiny of theadvertisement, and where any such the drug to whichthe advertisement relates to comply with the order.
  34. 34. SCRUTINY OF MISLEADING ADVERTISEMENTSRELATING TO DRUGSProvided that no publisher or advertising agency of anymedium for the dissemination of an advertisementelating to a drug shall be deemed to have made anysuch contravention merely by reason of thedissemination by him or it of any such advertisement,unless such publisher or advertising agency has failedto comply with any direction made by the authorisedperson in this behalf calling upon him or it to furnishthe name and address of the manufacturer,packer,distributer, seller or advertising agency, as thecase may be, who or which caused such advertisementto be disseminated.
  35. 35. PROCEDURE TO BE FOLLOWED IN PROHIBITING IMPORT INTO &EXPORT FROM, INDIA OF CERTAIN ADVERTISEMENTS(1)If the customs collector has reasons to believe that anyconsignment contains documents of the nature referredto in section 6, he may , and if requested by an officerappointed for the purposes by the Central Government,shall detain the consignment and dispose it of inaccordance with the provisions of the Sea Customs Act1878 and shall also inform the importer or exporter ofthe order so passed.
  36. 36. MANNER IN WHICH ADVERTISEMENTS MAY BE SENTCONFIDENTIALLYAll documents containing advertisements relating todrugs referred to in clause (c) of sub –section (1) ofsection 14, shall be sent by post to a registered medicalpractitioner by name, or to a wholesale or retail chemist,the address of such registered medical practitioner orwholesaler or retail chemist being given. Such documentshall be at the top, printed in indelible ink in aconspicuous manner, the words “For the use only ofregistered medical practitioners or a hospital or alaboratory.
  37. 37. PROHIBITION OF ADVERTISEMENT OF DRUGSFOR TREATMENT OF DISEASE, ETCNo person shall also take part in the publication ofany advertisement referring to any drug in termswhich suggest or are calculated to lead to the use ofthat drug for the diagnosis,cure,mitigation,treatmentor prevention of any disease, disorder or conditionspecified in the Schedule annexed to these rule.
  38. 38. REFERENCES• A Textbook of Forensic Pharmacy, by B.M.Mithal, Vallabh Prakashan, page no.144-156• Pharmaceutical Jurisprudence, by B.S.Kuchekar, Nirali Prakashan, page no.171-176

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