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D & c act

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Drug & Cosmatics Act 1940

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D & c act

  1. 1. 1 MR. VINOD GANGADHAR TONDE
  2. 2. Contents  History and Objectives  Definitions  Administration of the act and rules  Provisions related to Import  Provisions related to Manufacture  Provisions related to Sale  Labeling and Packaging  Schedules to the act and rules  Recent amendment act, 2008  List of forms 2
  3. 3. History  British misrule-Providing poor healthcare system to Indian citizens  Observations made by-Drugs Enquiry Committee, Indian Medical Association  Reports in- Indian Medical Gazette during 1920-30  1940 – Drugs and Cosmetics Act  1945 – Rules under the Act Extended to whole of India…… 3
  4. 4. LIST OF AMENDING ACTS AND ADAPTATION ORDERS-------- (correct, improve) 1. The Drugs (Amendment) Act, 1955 2. The Drugs (Amendment) Act, 1960 3. The Drugs (Amendment) Act, 1962 4. The Drugs and Cosmetics (Amendment) Act, 1964 5. The Drugs and Cosmetics (Amendment) Act, 1972 6. The Drugs and Cosmetics (Amendment) Act, 1982 7. The Drugs and Cosmetics (Amendment) Act, 1995 8. The Drugs and cosmetics (Amendment) Act, 2008 4
  5. 5. Objectives  To regulate the import, manufacture, distribution and sale of drugs & cosmetics through licensing.  Manufacture, distribution and sale of drugs and cosmetics by qualified persons only.  To prevent substandard in drugs.  To regulate the manufacture and sale of Ayurvedic, Siddha and Unani drugs.  To establish Drugs Technical Advisory Board(DTAB) and Drugs Consultative Committees(DCC) for Allopathic and allied drugs and cosmetics. 5
  6. 6. Definitions  Drug  Cosmetics  Misbranded Drug  Adulterated Drug  Spurious Drug  Manufacture 6
  7. 7. Definitions Drugs : All medicines for internal or external use of human beings or animals and all substances intended to be used for or in the diagnosis, treatment, mitigation (suppression) or prevention of any disease or disorder in human beings or animals, including preparations applied on human body for the purpose of repelling insects like mosquitoes. 7
  8. 8.  Such substance (other than food) intended to affect the structure or any other function of the human body or intended to be used for destruction of vermin or insects which cause disease in the human beings or animals.  All the substances intended for use as components of drug including empty gelatin capsule and,  Such devices intended for internal or external use in diagnosis, treatment, mitigation or prevention of disease or disorder in human beings or animals. 8
  9. 9. Cosmetic : Any article intended to be rubbed, poured, sprinkled or sprayed on, or introduced into, or otherwise applied to, the human body or any part thereof for cleansing, beautifying, promoting attractiveness, or altering the appearance, and includes any article intended for use as a component of cosmetic. 9
  10. 10.  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. 10
  11. 11.  Adulterated drug : (a) if it consists, in whole or in part, of any filthy, putrid (dirty) 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. 11
  12. 12.  If it bears or contains, a colour other than prescribed which may be used for the purpose of colouring only or  If any subsatance mixed with it so as to reduce its quality or strength. 12
  13. 13.  Spurious drugs : (fake) (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 c) If the label or container of which bears the name of an individual or company purporting to be the manufacturing of drug, which individual or company is fictitious or does not exists. 13
  14. 14. Manufacture : In relation to any drug or cosmetic, it includes any process or part of a process for making, altering, ornamenting, finishing, packing, labelling, breaking up or otherwise treating or adopting any drug or cosmetic with a view to its sale or distribution but does not include the compounding or dispensing of any drug, or the packing of any drug or cosmetic, in the ordinary course of retail business. 14
  15. 15. Patent or Proprietary medicine : A drug which is a remedy or prescription presented in a form ready for internal or external administration of human beings or animals and which is not included in the edition of the Indian Pharmacopoeia for the time being or any other Pharmacopoeia authorized in this behalf by the Central Government. 15
  16. 16. Ayurvedic, Siddha or Unani Drug  I t includes all medicine intended for internal or external use for, or in the diagnosis, treatment, mitigation or prevention of disease or disorder in human beings or animals and manufactured in accordance with the formula describe in the authoritative books of Ayurvedic, Siddha or Unani system of medicine. 16
  17. 17. New Drug  a) a new substance of chemical, biological or biotechnological origin; in bulk or prepared dosage form; used for prevention, diagnosis, or treatment of disease in man or animal; which, except during local clinical trials, has not been used in the country to any significant extent; and which, except during local clinical trials, has not been recognized in the country as effective and safe for the proposed claims;  (b) a drug already approved by the licensing authority mentioned in certain claims, which is now proposed to be marketed with modified or new claims, namely, indications, dosage forms (including sustained release dosage form) and route of administration; 17
  18. 18.  (c) A fixed dose combination of two or more drugs, individually approved earlier for certain claims, which are now proposed to be combined for the first time in a fixed ratio, or if the ratio of ingredients in an already marketed combination is proposed to be changed, with certain claims, viz. indications, dosage form (including sustained release dosage form) and route of administration 18
  19. 19. ADMINISTRATIVE BODIES  The central government and state government establish or appoint following bodies for efficient running of the act. 19
  20. 20. Administration of the act and rules A) Advisory : 1)Drugs Technical Advisory Board-DTAB 2)Drugs Consultative Committee-D.C.C. B) Analytical : 1)Central Drugs Laboratory - CDL 2)Drug Control Laboratory in states 3)Government Analysts C) Executives : 1)Licensing authorities 2)Controlling authorities 3)Drug Inspectors 20
  21. 21.  Under the provision of the act the central Government appoints the drugs Technical Advisory Board to advice the central and state Government on technical matters arising out of the administration of this act, and to carry out the other function assigned to it by this act. 21
  22. 22. Drugs Technical Advisory Board(DTAB)- The board consisting of the following members.  Ex-Officio – members (i) Director General of Health Services (Chairman) (ii) Drugs Controller, India (iii)Director of the Central Drugs Laboratory, Calcutta (iv) Director of the Central Research Institute, Kasauli (v)Director of Indian Veterinary Research Institute, Izatnagar (vi) President of Medical Council of India (vii) President of the Pharmacy Council of India (viii)Director of Central Drug Research Institute, Lucknow 22
  23. 23. Nominated: 1) Two persons by the Central Government. 2) One person by the Central Government from the pharmaceutical industry 3) Two persons holding the appointment of Government Analyst under this Act, 23
  24. 24.  Elected: 1)one person, to be elected by the Executive Committee of the Pharmacy Council of India, 2)one person, to be elected by the Executive Committee of the Medical Council of India, 3)one pharmacologist to be elected by the Governing Body of the Indian Council of Medical Research; 4)one person to be elected by the Central Council of the Indian Medical Association; 5)one person to be elected by the Council of the Indian Pharmaceutical Association; 24
  25. 25. Functions: To advise the Central Government and the State Governments on technical matters. To carry out the other functions assigned to it by this Act. 25
  26. 26. Drugs Consultative Committee(DCC)  It is also an advisory body constituted by central government.-  to advice the central and state governments and the Drug Technical Advisory Board on any matter to secure uniformity throughout India in the administration of this act.  Constitution: Two representatives of the Central Government nominated by central government One representative of each State Government nominated by concerned Government 26
  27. 27.  There is separate ‘ The ayurvedic, siddha and unani drugs consultative committee constituted under the act. 27
  28. 28. Functions:  To advise the Central Government, the State Governments and the Drugs Technical Advisory Board on any other matter tending to secure uniformity throughout India in the administration of this Act.  The Drugs Consultative Committee shall meet when required  Has power to regulate its own procedure. 28
  29. 29. Central Drug Laboratory(CDL)  The central government Establishes a central drug laboratory (calcutta) under the control of Director. Functions:  Analysis or test of samples of drugs/cosmetics sent by the custom collectors or courts.  Analytical Q.C. of the imported samples.  Collection, storage and distribution of internal standards.  Preparation of reference standards and their maintenance.  Maintenance of microbial cultures.  Any other duties entrusted by Central Government.  Acting as an appellate authority in matter of disputes. 29
  30. 30.  The functions of the Laboratory in respect of the following drugs or classes of drugs shall be carried out at the Central Research Institute, Kasauli,  The functions of the Director in respect of the said drugs or classes of drugs shall be exercised by the Director of the said  Institute :___ (1) Sera (2) Solution of serum proteins intended for injection (3) Vaccines (4) Toxins (5) Antigens (6) Anti-toxins (7) Sterilized surgical ligature and sterilized surgical suture. (8) Bacteriophages 30
  31. 31.  The functions of the Laboratory in respect of Oral Polio Vaccine shall be carried out by the following Institutes – (a)Pasteur Institute of India, Coonoor. (b) Enterovirus Research Centre (Indian Council of Medical Research), Haffkin Institute Compound, Parel, Bombay-400012.] [(c) The National Institute of Biologicals, NOIDA.] 31
  32. 32.  The functions of the Laboratory in respect of the following drugs or classes of drugs shall be carried out at the Indian Veterinary Research Institute, Izatnagar or Mukteshwar and the functions of the Director in respect of the said drugs or classes of drugs shall be exercised by the Director of either of the said institutes. (1) Anti-sera for veterinary use. (2) Vaccines for veterinary use. (3) Toxoids for veterinary use. (4) Diagnostic Antigens for veterinary use 32
  33. 33.  The functions of the Laboratory in respect of human blood and human blood products including components  to test for freedom of HIV antibodies, shall be carried out by the following Institutes- (a) National Institutes of Communicable Disease, Department of Microbiology, Delhi. (b) National Institute of Virology, Pune (c) Centre of Advanced Research in Virology, Christian Medical College, Vellore 33
  34. 34.  The functions of the Laboratory in respect of Homoeopathy shall be carried out at the Homoeopathy Pharmacopoeia Laboratory, Ghaziabad. 34
  35. 35.  The functions of the Laboratory in respect of Blood Grouping reagent and diagnostic kits for Human Immunodeficiency Virus, Hepatitis B Surface Antigen and Hepatitis C Virus shall be carried out at the National Institute of Biologicals, NOIDA. 35
  36. 36. Dispatch of samples for test or analysis. (1) Samples for test or analysis under subsection (4) of Section 25 of the Act shall be sent by registered post in a sealed packet, enclosed, together with a memorandum in Form 1, in an outer cover addressed to the Director. (2)The packet as well as the outer cover, shall be marked with a distinguishing number. (3)A copy of the memorandum in Form 1 and a specimen impression of the seal used to seal the packet shall be sent separately by registered post to the Director. 36
  37. 37. Recording of condition of seals.  On receipt of the packet, it shall be opened by an officer authorized in writing in that behalf by the Director who shall record the condition of the seal on the packet. 37
  38. 38.  Report of result of test or analysis. __ After test or analysis the result of the test or analysis, together with full protocols of the tests applied, shall be supplied forthwith to the sender in Form 2.  Fees. __ The fees for test and analysis shall be those specified in Schedule B.  Signature of certificates. __ Certificates issued under these Rules by the Laboratory shall be signed by the Director or by an officer authorized by the Central Government by notification in the official Gazette to sign such certificates. 38
  39. 39. Drug control laboratories in state In Gujarat three laboratories established which collect, analyzed and report the various sample of the drugs and food. 1) Baroda: Established in 1959. 2) Bhuj: Established in 1979. 3) Rajkot: Established in 1983 The laboratory has the following devision:-  Pharmaceutical Chemistry Division  Immunology Division  Pharmacology Division  Pharmacognocy Division  Food Division  Ayurvedic Division 39
  40. 40. Function:  Testing of drug sample  Analysis of food sample  Analysis of excise sample 40
  41. 41. Government analyst  These officers are appointed by the central or state government and perform the duties. Qualification of government analysist 1 Persons having qualification for appointment as government as governmental Analysis for allopathic drugs ; 2 having a degree in medicine, ayurved, sidha or unani system and not less than three year post graduate experience in the analysis of drugs in a laboratory under control of a government analyst. 41
  42. 42.  A post graduated degree in medicine or science or pharmacy or pharmaceutical chemistry of a recognized university or has an equivalent qualification recognized and notified by central government for such purpose. Associated Diploma of the Institution of chemists (India) with Analysis of Drug and pharmaceuticals as one of the subjects and had not less than 3years experience in the testing of drug in labrotary under the control of, a) A government analyst b) Head of an Institution or testing laboratory approved for the purpose by the appointing authority or has completed two years training or testing of drugs, including items stated in schedule C in Central Drug Laboratory. 42
  43. 43. Duties:  1) The Government Analyst shall cause to be analysed or tested such samples or drugs and cosmetics as may be sent to him by Drug Inspectors.  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. 43
  44. 44. Licencing authority Qualification: (i) Graduate in Pharmacy on Pharmaceutical Chemistry or in Medicine with specialization in clinical pharmacology or microbiology from a University established in India by law; and (ii)Experience in the manufacture or testing of drugs a minimum period of five years, Provided that the requirements as to the academic qualification shall not apply to those inspectors . 44
  45. 45. Duties: (1) to inspect all establishments licensed for the sale of drugs within the area assigned to him; (2) to satisfy himself that the conditions of the licences are being observed; (3) to procure and send for test or analysis, if necessary, imported packages. (4) to investigate any complaint. 45
  46. 46. (5) to maintain a record of all inspections made and action taken by him in the performance of his duties, (6) to make such enquiries and inspections as may be necessary to detect the sale of drugs in contravention to the Act; 46
  47. 47. Procedure on receipt of Sample  On receipt of a package of a sample from drug Inspector, the government analyst compares the seal on the package or on portion of sample or container with specimen impression of the seal received separately and notes condition of seal on the pack or on the portion of sample or container.  On completion of test or analysis he supplied to the inspector a report of analysis in triplicate , together with full protocols of the test applied. 47
  48. 48.  If purchaser wants to analyze or test drug or cosmetic he has to make an application for test or analysis in form accompanied with prescribed fees and the report of test or analysis of such drug or cosmetic is to be supplied in form by government analyst. 48
  49. 49. Drug Inspector  A person to be appointed as a Drug Inspector should have no financial interest in the import, manufacture or sale of the drug or cosmetics,  Drug Inspector is a Public Servant under sec 21 of Indian panel code. 49
  50. 50.  A person who is appointed an Inspector under the Act shall be a person who has a degree in Pharmacy or Pharmaceutical Sciences or Medicine with specialization in clinical Pharmacology or Microbiology from a University established in India by law- 50
  51. 51. Provided that only those Inspectors: --  (i) Who have not less than 18 months’ experience in the manufacture of atleast one of the substances specified in Schedule C, or  (ii) Who have not less than 18 months’ experience in testing of atleast one of the substances in Schedule C in a Laboratory approved for this purpose by the licensing authority, or  (iii) Who have gained experiences of not less than three years in the inspection of firms manufacturing any of the substances specified in Schedule C during the tenure of their services as Drugs Inspector; shall be authorized to inspect the manufacture of the substances mentioned in Schedule C. 51
  52. 52. Qualification of a Licensing Authority  No person shall be qualified to be a Licensing Authority under the Act unless:--  (i) he is a graduate in Pharmacy on Pharmaceutical Chemistry or in Medicine with specialization in clinical pharmacology or microbiology from a University established in India by law; and  (ii) he has experience in the manufacture or testing of drugs or enforcement of the provisions of the Act for a minimum period of five years: 52
  53. 53. Controlling authority  authority.__(1) All Inspectors appointed by the Central Government shall be under the control of an officer appointed in this behalf by the Central government and State Government  (2) For the purposes of these rules an officer appointed by the Central Government under sub-rule (1), or as the case may be, an officer appointed by the State Government under sub-rule (2), shall be a controlling authority. 53
  54. 54. Power: a) Inspect, -- (i) any premises where in any drug or cosmetic is being manufactured. (ii) any premises where in any drug or cosmetic is being sold, or stocked or exhibited or offered for sale, or distributed ; (b) Take samples of any drug or cosmetic,-- (i) which is being manufactured or being sold or is stocked or exhibited or offered for sale, or is being distributed; (ii) from any person who is in the course of conveying, delivering or preparing to deliver such drug or cosmetic to a purchaser. 54
  55. 55.  Search any person in connection with the offence (fault)  Enter and search at all reasonable times any place or premises in which he has reasoned to believe that an offence is being committed or has been committed  Stop and Search any vehicle or other conveyance which he has reason to believe, used for carrying any drug or cosmetic in respect of which offence has been or has being committed.  Give order in writing to the person in possession of drug or cosmetic in respect of which offence has been committed or is being committed, not to dispose stock of such drug or cosmetic for a specified period not exceeding twenty days or unless the defect may be removed by the possessor of the drug or cosmetic, and may size the stock of such drug or cosmetic or any substance or article employed for commission of offence. 55
  56. 56.  Examine any record, register, document or any other material object found while exercising above powers and sieze (Catch,hold)) the same if he has reason to believe that it is an evidence of the commission of an offence under the act. 56
  57. 57. Penalty for obstructing Inspector  If any person willfully obstruct an Inspector in the exercise of the powers conformed upon him or refuse to produce any record, register or any other document when required or any document when required, he shall be punishable with imprisonment (jail) upto 3 year or with fine or with both. 57
  58. 58. Provision of Act Import Manufacturi ng Sales Labeling & Packaging 58
  59. 59. IMPORT 59
  60. 60. For the purpose of import, which is deemed to be the process of a bringing a material from a place outside India to a place in India, a drug are classified below: A) Drug whose import is prohibited B) Drug which may be imported under license or permit C) Drug which can be imported without license 60
  61. 61. IMPORT of drugs  Classes of drugs prohibited to import  Import of drug under license 1)Specified in Schedule-C/C1 2)Specified in Schedule-X 3)Imported for Test/Analysis 4)Imported for personal use 5)Any new drugs  Drugs exempted from provisions of import  Offences and Penalties 61
  62. 62. A) 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. 62
  63. 63. B) Drug which may be imported under license or permit UNDER LICENCE/PERMIT schedule C/C1 Drugs Schedule-X drugs Drugs Imported for examination, test or analysis Without license 63
  64. 64. Import of the biological drugs(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. 64
  65. 65. Import of the Schedule-X drugs (Narcotic & Psychotropic drugs) Conditions to be fulfilled:  Licensee must have adequate storage facility.  Applicant must be reputable in the occupation, trade or business.  The license granted even before should not be suspended or cancelled.  The licensee has not been convicted any offence under the Drugs and Cosmetics Act or Narcotic and Psychotropic Substances Act. 65
  66. 66. Drugs Imported for examination, test or analysis Conditions to be fulfilled:  License is necessary under form-11  Must use imported drugs only for said purpose and 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 and check the records. 66
  67. 67. Drugs imported for personal use Conditions to be fulfilled:  Up to 100 average doses may be imported without any permit, provided it is part of passenger’s luggage.(articles)  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. 67
  68. 68. Import of drugs without license  Substances not used for medicinal purpose  Drugs in Sch-C1 required for manufacturing and not for medicinal use.  Substances which are both drugs and foods such as: Condensed/Powdered Milk Malt Lactose Farex/Cereal Oats  Predigested foods  Ginger, Pepper, Cumin, Cinnamon 68
  69. 69. Penalties related to Import OFFENCES PENALTIES Import of spurious OR adulterated drug OR drug which involves risk to human beings or animals OR drug not having therapeutic values a) 3 years imprisonment and 5000 Rs. fine on first conviction b) 5 years imprisonment OR 1000 Rs. fine OR both for subsequent conviction Contravention of the provision a) 6 months imprisonment OR 500 Rs. fine OR both for first conviction b) 1 year imprisonment OR 1000 Rs. fine for subsequent offence 69
  70. 70. Cosmetics prohibited to import  Misbranded cosmetics  Spurious cosmetics  Cosmetic containing harmful ingredients  Cosmetics not of standard quality  which contains more than-2 ppm Arsenic, 20 ppm lead, 100 ppm heavy metals 70
  71. 71. MANUFACTURE 71
  72. 72. Manufacture --------- ?  Manufacture of drug is a totally controlled process and drug can be manufactured and under license subject to following : i) Infrastructure facilities ii) Technical Manpower iii) Analytical Labrotaries iv) Records v) Inspection and sampling of drug 72
  73. 73. Manufacture  Kind of License – For the manufacturing of drugs the following categories of licenses can be granted. Licence for  Manufacture of Sch-C and C1 drug Manufacture of Sch-X drugs Manufacture of other than in Sch X and Sch-C/C1 Loan license  Drug meant for examination , test or analysis Repackaging license 73
  74. 74. Manuf. of drugs those in Schedule- C/C1(Biological) Conditions:  Drugs must be issued in previously sterilized sealed glass or suitable container  Containers should comply with Sch-F  Some classes tested for aerobic & anaerobic micro-organism. eg. Sera ,Insulin, Pituitary hormones.  Serum tested for abnormal toxicity  Parentral in doses of 10 ml or more should be tested for freedom from Pyrogens  Separate lab. for culture & manipulation of spore bearing Pathogens  Test for sterility should be carried out. 74
  75. 75. Manufacture Of Sch-X drugs Conditions:  Accounts of all transactions regarding manuf. should be maintained in serially.(Preserved for 5 years)  Have to sent invoice of sale to licensing authority every 3 months  Store drugs in direct custody of responsible person.  Marketed in packings not exceeding  100 unit dose –Tablets/Capsules  300 ml- Oral liquid  5 ml - Injection 75
  76. 76. Manuf. of drugs other than in Sch- C/C1 Conditions:  Premises should comply with schedule ‘M’  Adequate facility for testing, separate from manufacturing  Adequate storage facility  Records maintained for at least 2 years from date of Exp.  Should provide sample to authority  Furnish data of stability  Maintain the inspection book  Maintain reference samples from each batch 76
  77. 77. Loan License Definition: A person(applicant) who does not have his own arrangements(factory) for manufacture but who wish to manufacturing facilities owned by another licensee. Such licenses are called Loan licenses. Loan licenses are issued for: 1) Drugs other than specified in C/C1 & X. 2) Drugs specified in Schedule-C/C1 77
  78. 78. Drug meant for examination , test or analysis  Adequate space , well lighted and ventilated or if the need be air-conditioned should be provided commensurate with the nature and number of samples  Where animals are used for testing an adequate well lighted and ventilated animal house should be provided and the animal housed hygienically, proper arrangement should be made for quarantining and periodic examination of animals and preparation of animal feeds.  In general, compliance with the provision of the prevention of cruelty of animals should be ensured 78
  79. 79.  The test should be done by or under the supervision of qualified and experience person  Books of standards and reference literature needed for testing and analysis should be provided.  Adequate facilities should be provided for proper storage of samples.  Record of analysis should be maintained for at least 2 years for drugs with expiry dates and at least for 6 yr for other.  Report of analysis should be furnished in prescribed form. 79
  80. 80. Repackaging license Definition: Process of breaking up any drug from a bulk container into small packages and labeling with a view to their sale and distribution. Repackaging of drugs is granted of drugs other than Schdule-C/C1 and X. 80
  81. 81. Prohibition of manufacture  Drug not of standard quality or misbranded, adulterated or spurious.  Patent or Proprietary medicine  Drugs in Sch-J  Risky to human beings or animals  Drugs without therapeutic value  Preparation containing cyclamates(artificial sweetener ) 81
  82. 82. Penalties related to Manufacture OFFENCES PENALTIES Manufacture of any spurious drugs a) 1-3 years imprisonment and Rs.5000 fine b) 2-6 years imprisonment & Rs.10000 fine on subsequent conviction Manufacture of adulterated drugs a) 1 year imprisonment & Rs.2000 fine b) 2 years imprisonment & Rs.2000 fine for subsequent conviction Manuf. of drugs in contravention of the provisions a) Imprisonment up to 3 months & Rs.500 fine b) Imprisonment up to 6 months & Rs.1000 fine on subsequent conviction 82
  83. 83. Manufacture of cosmetics Prohibited for the following classes of drug:  Misbranded or spurious cosmetics and of substandard quality  Cosmetics containing hexachlorophene or mercury compounds  Cosmetics containing color which contain more than- - 2 ppm of arsenic - 20 ppm of lead - 100 ppm of heavy metals  Eye preparations containing coal-tar color 83
  84. 84. SALE 84
  85. 85. Sale of Drugs  Classes of drugs prohibited to be sold  Wholesale of biological (C/C1)  Wholesale of other than those specified in C/C1 and X 85
  86. 86. Class of drug prohibited to sale  Misbranded, spurious, adulterated and drugs not of standard quality  Patent/Proprietary drugs with undisclosed formula  Sch-J drugs  Expired drugs.  Drugs used for consumption by government schemes such as, Armed force.  Physician’s samples 86
  87. 87. Wholesale of biological (C/C1)  Adequate premises, with greater than 10 M2 area, with proper storage facility  Drugs sold only to retailer having license  Premises should be in charge of competent person who is Reg. Pharmacist.  Records of purchase & sale  Records preserved for 3 years from date of sale  License should displayed on premises 87
  88. 88. whole sale from other than specified in c/c1 and x  All the conditions as discussed in for biological.  Compounding is made by or under the direct and personal supervision of a qualified person. 88
  89. 89. Labeling & Packaging All the general and specific labeling and packaging specified to all classes of drugs and cosmetics should be as per the provisions made under the act. 89
  90. 90. Labelling  Name of drug  Net content  Content of API  Name & address of the manufacturing  Batch no.  License no.  Date of mfg  Date Exp  % Alcohol 90
  91. 91. For allopathy  Label ?  Ophthalmic  Animal  Disinfectant  Colored medicine  Vaccines  Oral  External 91
  92. 92. For ayurvedic, siddha, unani homoepathy and cosmetics LABEL 92
  93. 93. Export  According to the country of Export 93
  94. 94. Schedules to the act  First schedule – Names of books under Ayurvedic and Siddha systems  Second schedule – Standard to be complied with by imported drugs and by drugs manufactured for sale, sold, stocked or exhibited for sale or distribution 94
  95. 95. Schedules to the rules TYPE CONTENT “A” Performa for forms( Application, issue, renewal, etc.) “B” Rates of fee for test or analysis by CDL 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 “F” Provisions applicable to blood bank 95
  96. 96. Schedules to the rules TYPE CONTENT “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. 96
  97. 97. Schedules to the rules TYPE CONTENT “J” List of diseases and ailments that drug should not claimto 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 “M1” Requirements of factory premises for manufacture of Homeopathic medicines “M2” Requirements of factory premises for manufacture of cosmetics “M3” Requirements of factory premises for manufacture of medical devices “N” List of equipment to run a Pharmacy “O” Standards for disinfectant fluids 97
  98. 98. TYPE CONTENT “P” Life period(expiry) of drugs “Q” Coal tar colors permitted to be used in cosmetics “R” Standards for mechanical contraceptives “R1” Standards for medical devices “S” Standards for cosmetics “T” Requirements (GMP) of factory premises for Ayurvedic, Siddha, Unani drugs “U” Manufacturing and analytical records of drugs 98
  99. 99. Schedules to the rules TYPE CONTENT “U1” Manufacturing and analytical records of cosmetics “V” Standards for patent or proprietary medicines “W” List of drugs marketed under generic names- Omitted “X” List of narcotic drugs and psychotropic substances “Y” Requirement and guidelines on clinical trials for import and manufacture of new drugs 99
  100. 100. Drugs and Cosmetics (Amendment) Act, 2008 Salient features of the Act:-  Substantial enhancement in punishment  Life imprisonment for offenders involved in manufacture, sale and distribution of spurious and adulterated drug likely to cause grievous hurt  Minimum punishment of seven years which may extend to life imprisonment  Provision for compensation to affected person 100
  101. 101. References 101
  102. 102. 102

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