Drug and cosmetic act
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Drug and cosmetic act Presentation Transcript

  • 1. DRUG AND COSMETIC ACT 1940 (only schedules) by RAHUL challarahul77@gmail.com
  • 2. FIRST SCHEDULE;“Ayurvedic, Siddha or Unani drug” includes all medicines intended for internalor external use for or in the diagnosis, treatment, mitigation or prevention.SECOND SCHEDULE. Standards of qualitystandards to be complied with by imported drugs and by drugsmanufactured for sale, vold, stocked or exhibited for sale or distributedSCHEDULE ‘E’. Poisonous substanceList of poisonous substances under the Ayurvedic (including Siddha) and UnaniSystemsSCHEDULE ‘B’The fees for test and analysis shall be those specified in Schedule B.
  • 3. SCHEDULE ‘X ‘: symbol XRX“import licence” means a licence in Form 10A to import drugs ; excludingthose specifiedSCHEDULE ‘C ‘OR ‘C ‘(1): Prohibition of import after expiry of potencyNo biological or other special product specified shall be imported after the dateshown on the label, wrapper or container of the drug as the date up to which thedrug may be expected to retain a potency not less than, or not to acquire a toxicitygreater than, that required, or as the case may be, permitted by the prescribedtest.SCHEDULE ‘F’ (1) :standard for certain imported drugsNo drug shall be imported unless it complies with the standard of strength, qualityand purity
  • 4. SCHEDULE ‘M’ AND SCHEDULE ‘M-III’Every application in Form 24 shall be made up to ten items for each category ofdrugs categorised in and shall be accompanied by a licence fee of rupees sixthousand and an inspection fee of one thousand and five hundred for everyinspection or for the purpose of renewal of the licenceSCHEDULE ‘U’.lot of the raw material used by him for the manufacture of his products and alsoeach batch of the final product and shall maintain records.The records or registers shall be retained for a period of 5 years from the date ofmanufacture
  • 5. SCHEDULE ‘F’The licence shall provided and maintain an adequate staff and adequate premisesand plant for the proper manufacture and storage of the substances in respect ofwhich the licence is issued.SCHEDULE ‘R’.The date of manufacture.The date up to which the contraceptive is expected to retain its properties.The storage conditions necessary for preserving the properties of thecontraceptive up to the date indicated in sub-clause (b) .SCHEDULE ‘G’ :LABELLING OF MEDICINESlabelled with the words ‘Caution: it is dangerous to take this preparation exceptunder medical supervision’ – conspicuously printed and surrounded by a line withinwhich there shall be no other words
  • 6. SCHEDULE ‘H’ :LABELLING OF MEDICINESLabelled with the symbol Rx and conspicuously displayed on the left top corner of thelabel .Labelled with the following words To be sold by retail on the prescription of a RegisteredMedical Practitioner only.SCHEDULE ‘P-1’: PACKING OF DRUGSThe pack sizes of drugs meant for retail sale shall be as prescribed.Eg; The pack sizes for liquid Oral preparations shall be 30ml (paediatric only) 60 ml/100 ml/200 ml/450 ml.SCHEDULE ‘Y’,Provided further that any application received after one year of the grant of approval forthe import and sale of new drug.A fee of fifteen thousand rupees and such information and data as required by Appendix Ior Appendix I-A.
  • 7. SCHEDULE ‘A’For the purpose of this rule, “Blood Bank” means a place or organizational unit or aninstitution or other arrangement made by such organizational unit or institution forcarrying our all or any of the operations of manufacture of human blood components,or blood products or whole human blood for its collection, storage, processing,distribution from selected human donors.SCHEDULE ‘K’; EXEMPTIONThe drugs specified in shall be exempted from the provisions of Chapter IV of the Actand the Rules made there under to the extent and subject to theconditions specified in that Schedule.SCHEDULE ‘V’; STANDARDS FOR PATENT OR PROPRIETARYMEDICINESThe standards for patent or proprietary medicines shall be those laid down in ScheduleV and such medicines shall also comply with the standards laid down in the SecondSchedule to the Act.
  • 8. SCHEDULE ‘F (II)’ ;Standards for Surgical DressingsThe standards for Surgical Dressing shall be such as are laid downSCHEDULE ‘F(III)’ ;Standards for Sterilised Umbilical tapesThe standards for Sterilised Umbilical tapes shall be as laid downSCHEDULE ‘R-1’.Standards for Medical Devices.- the standards for the Medical Devices shallbe such as are laid down
  • 9. SCHEDULE ‘D’; EXEMPTION OF COSMETICSCosmetics specified shall be exempted from the provisions of Chapter III ofthe Act and the Rules made there under to the extent and subject to theconditions specified .SCHEDULE ‘Q’. COSMETIC TO CONTAIN DYES, COLOURSAND PIGMENTSNo Cosmetic shall contain Dyes, Colours and Pigments other than thosespecified by the Bureau of Indian Standards (IS:4707 Part 1 as amended)SCHEDULE ‘U(1)’the licensee shall keep records of the details of each batch of cosmeticmanufactured by him and of raw materials used therein as per particularsspecified in Schedule U(1) and such records shall be retained for a period ofthree years.
  • 10. SCHEDULE ‘T’For getting a certificate of ‘Good Manufacturing Practices of Ayurveda Siddha-Unani drugs, the applicant shall made application on plain paper, providing theinformation on existing infrastructure of the manufacturing unit, and the licensingauthority shall after verification of the requirements as per Schedule ‘T’ issue thecertificate within a period of 3 months in form 26-ESCHEDULE ‘E’ (1),The container of a medicine for internal use made up ready for the treatment ofhuman ailments shall, if it is made up from a substance specified in Schedule E (1), belabelled conspicuously with the words ‘Caution: To be taken under medicalsupervision’ both in English and Hindi language.
  • 11. SCHEDULE ‘D (II)’Information required to be submitted by the manufacturer or his authorized agent withthe Application Form for the registration of a bulk drug/formulation/special product forits import into India. The format shall be properly filled in and the detailed information, secret in nature,may be furnished on a Computer Floppy.SCHEDULE ‘FF’. STANDARDS FOR OPHTHALMIC PREPARATIONSbe sterile when dispensed or when sold in the unopened container of themanufacturer, except in case of those ophthalmic solutions and suspensions which arenot specifically required to comply with the test for ‘Sterility’ in the Pharmacopoeia
  • 12. SCHEDULE. ‘I’particulars as to proportion of poison in certain casesSCHEDULE ‘J’Diseases and ailments (by whatever name described) which a drug may not purportto prevent or cure or make claims to prevent or cure.SCHEDULE ‘L’
  • 13. SCHEDULE ‘N’list of minimum equipment for the efficient running of a pharmacySCHEDULE ‘O’standard for disinfectant fluidsthe disinfectants shall be classified as follows:(A)black fluids ; coal tar acid or similar acids(b)white fluids; without hydrocarbons, and/or other phenolic compounds, and their derivatives.SCHEDULE ‘P’; LIFE PERIOD OF DRUGSperiod in months (unless otherwise specified) between date of manufacture anddate of expiry which the labelled potency period of the drug shall not exceed underthe conditions of storage specified
  • 14. SCHEDULE ‘S’ ; STANDARDS FOR COSMETICS IN FINISHED FORMShall conform to the Indian Standards specifications laid down from time to time by the3[Bureau of Indian Standards (BIS)].SCHEDULE ‘W’;INSERTED AS PER G.O.I. NOTIFICIATION NO. GSR 27(E) DT 17.1.1981 AND DELETEDAS PER G.O.I. NOTIFICATION NO. GSR 94(E) DT 8.2.2000.
  • 15. .