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DRUG AND COSMETIC ACT,1940 AND ITS RULES 1945.pptx

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DRUG AND COSMETIC ACT,1940 AND ITS RULES 1945.pptx

  1. 1. DRUG AND COSMETIC ACT,1940 AND ITS RULES 1945
  2. 2. CONTENTS • OBJECTIVES • DEFINATION • SCHEDULE TO THE RULES • SALES • IMPORT • LABELLING AND PACKAGING • QUALIFICATION AND DUTIES OF GOVERMENT ANALYSTS • QUALIFICATION AND DUTIES OF DRUG INSPECTOR
  3. 3. OBJECTIVES • An Act to regulate the import, manufacture, distribution and sale of drugs • It was passed in 1940(10th April 1940) with main objective to regulate the imoprt,manufacture,distribution and sale of drugs and cosmetics • The Act regulates the manufacture by making provisions and rules which provides control over manufacture of spurious or substandard drugs in the country Also provides control over the distribution and sale of drugs (ayurvedic,siddha,unani,homeopathic) by only trained and qualified person’s and Cosmetics are widely used in country becomes necessary to control their quality.Hence the act was passes to regulate its import, manufacture, sale &distribution
  4. 4. DEFINATION **DRUG-all medicines for internal or external use of animals and human beings & intended to be used for in the diagnosis, treatment, mitigation or prevention of any disease or disorder in human beings or animals, including preparation applied on human body for the purpose of repelling insects like mosquito -such substances other than food intend to affect the structure and function of human body or intend to cause destruction of vermin or insects which cause disease in human beings and animals. Substances which temporarily suspends normal physiological functions e.g. contraceptives **COSMETICS-it means any article intended to be rubbed,poured,sprinkled or sprayed or introduce into or applied to any part of the human body for cleansing,beautifying,promoting attractiveness or altering the appearance and includes any article intended for used as a component in cosmetic
  5. 5. Misbranded drugs : (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 Adulterated drug : (a) if it consists, in whole or in part, of any filthy, putrid or decomposed substance; or (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; or (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. Spurious drugs : (a) if it is imported under a name which belongs to another drug; or (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
  6. 6. SCHEDULES TO THE RULES B Rates of fee for test or analysis by CDL(central drug laboratories) or Govt. analysts C List of Biological and special products (Injectable) applicable to special provisions. C1 List of Biological and special products (nonparenteral) applicable to special provisions. D List of drugs that are exempted from provisions of import E1 List of poisonous substances under the Ayurvedic , Siddha and Unani systems TYPE CONTENT
  7. 7. TYPE CONTENT F Provisions applicable to blood bank F1 Special provision applicable to biological and special products, eg. Bacterial and viral vaccines, sera from living animals, bacterial origin diagnostic agents F2 Standards for surgical dressings F3 Standards for umbilical tapes FF Standards for ophthalmic preparations G List of substances required to be used under medical supervision and labelled accordingly H List of substances (prescription) that should be sold by retail only on prescriptions of R.M.P.
  8. 8. TYPE CONTENT J List of diseases and ailments that drug should not claim to cure K List of drugs that are exempted from certain provisions regarding manufacture M Requirements of manufacturing premises, GMP requirements of factory premises, plants and equipments N List of equipment to run a Pharmacy P Life period(expiry) of drugs R Standards for mechanical contraceptives V Standards for patent or proprietary medicines W List of drugs marketed under generic namesOmitted X List of narcotic drugs and psychotropic substances Y Requirement and guidelines on clinical trials for import and manufacture of new drugs
  9. 9. SALES • The act issued a licence for the selling of drugs • Granted licence to be renewed within six months of its expiry TYPES OF LICENCE 1)RETAIL SALE-For drugs other than those specified in schedule C, C1 and x: Form 20 -For drugs specified in schedule C,C1:Form 21 -For schedule X drugs :Form 20 F 2)Restricted LICENCE-For drugs other than those specified in schedule C, C1 and x: Form 20 A - For drugs specified in schedule C,C1:Form 21 A - -No licence issued for schedule X drugs 3)WHOLESALE -For drugs other than those specified in schedule C, C1 and x: Form 20 B - For schedule X drugs :Form 20 G
  10. 10. IMPORT • No licence is required for import of drugs • Import of drug under license 1)Specified in Schedule-C/C1 • Conditions to be fulfillled: • Licensee must have adequate facility for the storage. • Licensee must maintain a record of the sale. • Licensee must allow an inspector to inspect premises and to check the records. • Licensee must furnish the sample to the authority. • Licensee must not sell drugs from which sample is withdrawn and he is advised not to sale, and recall the batch from the market.
  11. 11. -Licensee must have adequate storage facility. -Applicant must be reputable in theoccupation, trade or business. -The license granted even before should not be suspended or cancelled. -The licensee has not been convicted anyoffence under the Drugs and Cosmetics Act or Narcotic and Psychotropic Substances Act 3) Drugs Imported forexamination, test • License is necessary under form-11 • Must use imported drugs only for said purposeand at the place specified in the license. • Must keep the record with respect to • quantities, name of the manufacturer and date of • import. • Must allow an inspector to inspect the premises 2)Import of the Schedule-X drugs (Narcotic & Psychotropic drugs)
  12. 12. 4)Drugs imported for personal use • Up to 100 average doses may be importedwithout any permit, provided it is part ofpassenger’s luggage. • More than 100 doses imported with license.Apply on form no.-12-A,12-B • Drugs must be bonafide personal use. • Drugs must be declared to the custom collectors if so directed. 5) Import of drugs without license • Substances not used for medicinal pupose • Drugs in Sch-C1 required for manufacturing and not formedicinal use. • Substances which are both drugs and foods such as: • Condensed/Powdered Milk • Malt • Lactose • Farex/Cereal • Oats • Predigested foods • Ginger, Pepper, Cumin, Cinnamon
  13. 13. Classes of drugs prohibited to import • Misbranded drugs • Drugs of substandard quality • Drugs claiming to cure diseases specified in Sch-J • Adulterated drugs • Spurious drugs • Drugs whose manufacture, sale/distribution are prohibited in original country, except for the purpose of test, examination and analysis. • Patent/Proprietary medicines whose true formula is not disclosed.
  14. 14. LABELING AND PACKAGING The rules under this act provides for the particulars to be shown on the containers of the drugs.No person shall sell or distribute any drug unless it is labelled according to the rules MANNER OF LABELLING 1}identifying particulars such as name of drug,batch number,manufacturer’s name etc. 2)Date of expiry of potency(expiry date) 3)Particulars related to potency,official standard.etc 4)Precautionary information related to care in handling,use,distribution.etc 5)Particular’s related to storage,manner of use,etc 6)Genearal information such as physicians sample,not to be sold,etc
  15. 15. • General requirements of labelling 1)NAME OF THE DRUG STATEMENT OF NET CONTENT THE CONTENT OF ACTIVE INGREDIENTS EXPRESSED IN TERMS OF Oral liquids Liquid parentals Drugs in solid form For tabltes,capsules,pills For othert preparations THE NAME AND ADDRESS OF THE MANUFACTURER DISTINCTIVE BATCH NUMBER MANUFACTURING LICENCE NUMBER DATE OF EXPIRY OF POTENCY LABELING OF MECHANICAL CONTRACEPTIVE DISTRIBUTED AS FREE SAMPLE TO MEDICAL PRACTIONERS BEARING THE LABLE ‘NOT TO BE SOLD’ ALCOHOLIC PREPARTIONS CONTAINING MORE THAN 3 % BY VOLUME OF ALCOHOL
  16. 16. PACKAGING 1}The pack size of drugs for retail sale shall be as prescribed in Schedule P 1 If no of capsules tablets is less than 10,the pack size should be integral For no above 10 size be multiple of 5 2}liguid oral preparations-30 mlfor pediatric preparations 3}Paediatric oral drops-5ml/10ml/15 ml 4}Eye/ear/nasal drops-3ml/5ml/10ml 5}Eye ointement-3 gm/5 gm/10 gm
  17. 17. QUALIFICATION OF DRUG ANALYST • These officers are appointed by the central or state government and perform the duties. 1}Persons having qualification for appointment asgovernment as govermental Analysis for allopathicdrugs ; 2} having a degree in medicine, ayurved, sidha orunani system and not less than three year post graduate experience in the analysis of drugs in alaboratory under control of a government analyst. Duties: 1) The Government Analyst shall cause to beanalysed or tested such samples or drugs and cosmetics as may be sent to him byInspectors. 2) A Government Analyst shall from time to time forward reports to the Government giving the result of analytical work and research with a view to their publication.
  18. 18. Drug inspector is a ‘PUBLIC SERVANT’ should have no finacial interest in the import,manufacture or sale of the drugs or cosmetics A graduate in Pharmacy or Pharmaceuticals Sciences or Medicine with specialization in clinical Pharmacology or Microbiology from recognised university 1} not less than 18 months experience in the manufacture of atleast one of the substances specified in Schedule C 2} not less than 18 months experience in testing of at least one of the substances specified in Schedule C in approved laboratory 3} not less than 3 years experience in the inspection of firms manufacturing any of the substances specified in Schedule C QUALIFICATION OF DRUG INSPECTOR
  19. 19. DUTIES
  20. 20. • Seizing procedure
  21. 21. • Details regarding import and export of drugs • duties of customs officer
  22. 22. • Ayurvedic Unani and Siddha drugs : Section 3(a)
  23. 23. • Misbranded drugs Section: 17 • Adulterated Drugs Section 17A • Spurious drugs Section 17B • New drug rule -122E
  24. 24. • Inspector Section 3 (e) • Cosmetic Section 3(aaa) • Misbranded Cometics Section 17-C • Spurious Cosmetics Section 17-D
  25. 25. • Drug Store : Rule 65 (15a) • Chmeists & Druggist Rule 65(15b) • Pharmacy : Rule 65 (15c) • Regd Pharmacist Rule 15 • Qualified person Rule 65(15I) • Govt Analyst :Section 3©
  26. 26. • Manufacture Section 3(f) • Patent & proprietary Medicine
  27. 27. THANK YOU

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