Drugs & Cosmetics Act 1940

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Drugs and Cosmetics Act 1940 and Rules 1945 :

Drugs and Cosmetics Act 1940 and Rules 1945 Prepared by : Vinod V. Maheshwari M.Pharm. Sem -II Guided By: Mrs. Riddhi Madhu M.Pharm (Ph D) Mts. V. B. Manvar College of Pharmacy, Dumiyani 4/2/2012 1

Contents:

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 4/2/2012 2

History:

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…… 4/2/2012 3

LIST OF AMENDING ACTS AND ADAPTATION ORDERS:

LIST OF AMENDING ACTS AND ADAPTATION ORDERS 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 4/2/2012 4

Objectives:

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, presumably for maintaining high standards of medical treatment. 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. 4/2/2012 5

Definitions:

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 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. 4/2/2012 6

Definitions:

Definitions 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. 4/2/2012 7

Definitions:

Definitions Misbranded drugs : 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 if it is not labelled in the prescribed manner; or if its label or container or anything accompanying the drug bears any statement, design or device which makes any false claim for the drug or which is false or misleading in any particular. Ex. 4/2/2012 8 Xental 400, Pentoxiphylline , Targof Pure Drug Ltd. Zentel 400, Albendazole , Glaxo Smithklilne

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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; or 4/2/2012 9

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(d) if it bears or contains, for purposes of colouring only, a colour other than one which is prescribed; or (e) if it contains any harmful or toxic substance which may render it injurious to health; or (f) if any substance has been mixed therewith so as to reduce its quality or strength. 4/2/2012 10 e.g . supply of cheap cottonseed oil in place of olive oil.

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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 unless it is plainly and conspicuously marked so as to reveal its true character and its lack of identity with such other drug; or 4/2/2012 11

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(c) if the label or the container bears the name of an individual or company purporting to be the manufacturer of the drug, which individual or company is fictitious or does not exist ; or (d) if it has been substituted wholly or in part by another drug or substance; (e) if it purports to be the product of a manufacturer of whom it is not truly a product. 4/2/2012 12 e.g., when methamphetamine  is sold as cocaine

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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 . 4/2/2012 13

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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. 4/2/2012 14

Administration of the act and rules:

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 4/2/2012 15

Drugs Technical Advisory Board(DTAB):

Drugs Technical Advisory Board(DTAB) Ex-Officio: ( 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 4/2/2012 16

Drugs Technical Advisory Board(DTAB):

Drugs Technical Advisory Board(DTAB) Nominated: Two persons by the Central Government from among persons who are in charge of drugs control in the States One person by the Central Government from the pharmaceutical industry Two persons holding the appointment of Government Analyst under this Act, to be nominated by the Central Government 4/2/2012 17

Drugs Technical Advisory Board(DTAB):

Drugs Technical Advisory Board(DTAB) Elected: 1)one person, to be elected by the Executive Committee of the Pharmacy Council of India , from among teachers in pharmacy or pharmaceutical chemistry or pharmacognosy on the staff of an Indian university or a college affiliated thereto; 2)one person, to be elected by the Executive Committee of the Medical Council of India , from among teachers in medicine or therapeutics on the staff of an Indian university or a college affiliated thereto; 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 ; 4/2/2012 18

Drugs Technical Advisory Board(DTAB):

Drugs Technical Advisory Board(DTAB) Functions: To advise the Central Government and the State Governments on technical matters arising out of the administration of this Act. To carry out the other functions assigned to it by this Act. (The nominated and elected members of the Board shall hold office for three years , but shall be eligible for re-nomination and re-election) 4/2/2012 19

Drugs Consultative Committee(DCC):

Drugs Consultative Committee(DCC) It is also an advisory body constituted by central government. Constitution: Two representatives of the Central Government One representative of each State Government 4/2/2012 20

Drugs Consultative Committee(DCC):

Drugs Consultative Committee(DCC) 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. 4/2/2012 21

Central Drug Laboratory(CDL):

Central Drug Laboratory(CDL) Established in Calcutta , under the control of a director appointed by the Central Government 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. 4/2/2012 22

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4/2/2012 23

IMPORT:

IMPORT 4/2/2012 24

IMPORT of drugs:

IMPORT of drugs Classes of drugs prohibited to import Import of drug under license 1)Specified in Schedule-C/C 1 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 4/2/2012 25

Classes of drugs prohibited to import:

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. 4/2/2012 26

Classes of drugs prohibited to import:

Classes of drugs prohibited to import Drugs not labelled /packed in prescribed manner. Drugs of biological poducts (C/C 1 ) after the date of expiry Drugs not claiming therapeutic values. Drugs which is risky to human beings or animals. Any new drug except with express permission of Lic.authority . 4/2/2012 27

Import of the biological drugs(C/C1):

Import of the biological drugs(C/C 1 ) Conditions to be fulfillled : Licensee must have adequate facility for the storage . Licensee must maintain a record of the sale , showing the particulars of the names of drugs and of the persons to whom they have been sold. 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. 4/2/2012 28

Import of the Schedule-X drugs (Narcotic & Psychotropic drugs):

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 ever 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. 4/2/2012 29

Drugs Imported for examination, test or analysis:

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. 4/2/2012 30

Drugs imported for personal use:

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. 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. 4/2/2012 31

Import of drugs without license:

Import of drugs without license Substances not used for medicinal pupose Drugs in Sch-C 1 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 4/2/2012 32

Penalties related to Import:

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 3 years imprisonment and 5000 Rs. fine on first conviction 5 years imprisonment OR 1000 Rs. fine OR both for subsequent conviction Contravention of the provision 6 months imprisonment OR 500 Rs. fine OR both for first conviction 1 year imprisonment OR 1000 Rs. fine for subsequent offence 4/2/2012 33

Import of cosmetics:

Import of cosmetics 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 4/2/2012 34

Cont….:

Cont…. Cosmetics meant for eye and containing coal tar dyes Cosmetics coloured with lead OR arsenic compounds Cosmetics containing Hexachlorophene OR Mercury Risky to user 4/2/2012 35

MANUFACTURE:

MANUFACTURE 4/2/2012 36

Manufacture:

Manufacture Prohibition of manufacture Manufacture of other than in Sch -C/C 1 Manufacture of those in Sch -C/C 1 Manufacture of Sch -X drugs Loan license Repackaging license Offences & Penalties 4/2/2012 37

Prohibition of manufacture:

Prohibition of manufacture Drug not of standard quality or misbranded, adulterated or spurious . Patent or Proprietary medicine Drugs which claims to cure diseases specified in Sch -J Drugs which Risky to human beings or animals Drugs without therapeutic value Preparation containing cyclamates 4/2/2012 38

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4/2/2012 39 Types of manufacturing licences Allopathic Drugs Other than Sch.- C/C1 & X Sch.- C/C1 But not -X Sch.-X Sch.-C/C1 & X Drugs for the purpose of examination test or analysis Own Premises Own Premises Own Premises Loan Licence Repacking licence

Manuf. of drugs other than in Sch-C/C1:

Manuf. of drugs other than in Sch -C/C 1 Conditions: Premises should comply with schedule ‘M’ Adequate facility for testing , separate from manufacturing Adequate storage facility Records of mfg. & testing-maintained for at least 2 years from date of Exp. Licence should provide sample to authority Furnish data of stability Maintain the inspection book Maintain reference samples from each batch Accounts of production recorded & maintained for 5 years or 1 year after Expiry. 4/2/2012 40

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4/2/2012 41

Manuf. of drugs those in Schedule-C/C1(Biological):

Manuf. of drugs those in Schedule-C/C 1 (Biological) Conditions: Drugs must be issued in previously sterilized sealed glass or suitable container Containers should comply with req. of Sch -F/F1 Drug must comply with std. (quality, purity, strength) specified in sch.-F Serum tested for freedom from abnormal toxicity Parenteral 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. 4/2/2012 42

Manufacture Of Sch-X drugs:

Manufacture Of Sch - X drugs Conditions: Accounts of all transactions regarding manuf. should be maintained in serially bound & paged register. (Preserved for 5 years) Have to sent invoice of sale to licensing authority every 3 months Store drugs in direct custody of responsible person . Preparation must be labeled with XRx Marketed in packings not exceeding 100 unit dose –Tablets/Capsules 300 ml- Oral liquid 5 ml - Injection 4/2/2012 43

Loan license:

Loan license Definition : A person(applicant) who does not have his own arrangements(factory) for manufacture but who wish to avail the manufacturing facilities owned by another licensee . Such licenses are called Loan licenses. Procedure: Licence is obtained from licensing authority (FDA) on application in prescribed forms (24-A , 27-A) with prescribed fees (Rs. 6000, 1500). Loan licenses are issued for: 1) Drugs other than specified in C/C 1 & X. 2) Drugs specified in Schedule-C/C 1 4/2/2012 44

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4/2/2012 45 FORM 27-A (See Rule 75-A) Application for grant or renewal of a loan license to manufacture for sale 8a(or for distribution of) drugs specified in Schedules C and C(1)8b(excluding those specified in 8c(Part XB and) Sch. X) 1.I/We *………………………….. of……………………….hereby apply for the grant/renewal of loan license to manufacture on the premises situated at…………C/o………… the under mentioned drugs, being drugs specified in Schedules C and C(1) 8b(excluding those specified in 8c(Part XB and) Sch .X) to the Drugs and Cosmetics Rules, 1945. Names of drugs (each substance to be separately specified). The names, qualifications and experience of the expert staff actually connected with the manufacture and testing of the specified products in the manufacturing premises. a)Name(s) of expert staff responsible for manufacture…………….. b)Name(s) of expert staff responsible for testing…………… I/We enclose:- a)A true copy of a letter from me/us to the manufacturing concern whose manufacturing capacity is intended to be utilized by me/us. b) A true copy of a letter from the manufacturing concern that they agree to lend the services of their

Repackaging license:

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 Schedule-C/C 1 and X. Procedure: Licence is obtained from licensing authority (FDA) on application in prescribed forms (24-B) with prescribed fees (Rs. 500, 200). 4/2/2012 46

Penalties related to Manufacture:

Penalties related to Manufacture OFFENCES PENALTIES Manufacture of any spurious drugs 1-3 years imprisonment and Rs.5000 fine 2-6 years imprisonment & Rs.10000 fine on subsequent conviction Manufacture of adulterated drugs 1 year imprisonment & Rs.2000 fine 2 years imprisonment & Rs.2000 fine for subsequent conviction Manuf. of drugs in contravention of the provisions Imprisonment up to 3 months & Rs.500 fine Imprisonment up to 6 months & Rs.1000 fine on subsequent conviction 4/2/2012 47

Manufacture of cosmetics:

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 4/2/2012 48

SALE:

SALE 4/2/2012 49

Sale of Drugs:

Sale of Drugs Classes of drugs prohibited to be sold Wholesale of biological (C/C 1 ) Wholesale of other than those specified in C/C 1 and X Wholesale of Sch -X drugs Retail sale 4/2/2012 50

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4/2/2012 51 TYPES OF SALES LICENCES Allopathic Drugs Whole Sale Retail Sale Sales From Motor Vehicle ( Vender) General Licence Restricted Licence Drugs other than sch.-C/C1 & X Drugs in Sch.- C/C1 Drugs in Sch.- X For Sch.- C/C1

Classes of drugs prohibited to be sold:

Classes of drugs prohibited to be sold 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 E.S.I.S., Armed force. Physician’s samples 4/2/2012 52

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4/2/2012 53 S.No . Category Type Sale Application Form Licence Form Fees for Grant/Renewal Renewal Certificate Form No. Fee+ Penalty after expiry but within six months Fees for duplicate copy of Org. Lic. 1 Drugs other than those specified in Schedule C&C (1)&X Whole Sale 19 20-B Rs.1500 21 -C Rs.1500+Rs.500 p.m. or part there of Rs.150 Retail Sale 19 20 Rs.1500 21 -C Rs.1500+Rs.500 p.m. or part there of Rs.150 Restricted(Gen.Store) 19-A 20-A R-61 (1) Rs.500 R-59 (2) 21 -C Rs.500+Rs.250 p.m. or part thereof R-59 (4) Rs.150 R- 59 (3) 2 Drugs specified in Schedule C&C (1) but excluding those specified in Schedule ‘X’ Whole Sale 19 21B Rs.1500 21 -C Rs.1500+Rs.500 p.m. or part there of Rs.150 Retail Sale 19 21 Rs.1500 21 -C Rs.1500+Rs.500 p.m. or part there of Rs.150 Restricted(Gen.Store) 19-A 21-A R-61 (1) Rs.500 R-59 (2) 21 -C Rs.500+Rs.250 p.m. or part thereof R-59 (4) Rs.150 R- 59 (3) 3 Drugs specified in Schedule ‘X’ Whole Sale 19-C 20-G Rs.500 21-C Rs.500+Rs.250 p.m. or part there of Rs.150 Retail Sale 19-C 20-F R-61(1) Rs.500 R-59(2) 21-C Rs.500+Rs.250 p.m. or part there of R-59(4) Rs.150 R- 59 (3) 4 Sale of Drugs from motor vehicles (1) Drugs other than those specified in Schedule C&C (1) Whole Sale 19-AA 20-BB Rs.500 21-CC Rs.500+Rs.250 p.m. or part there of Rs.150 (2) Drugs specified in Schedule C&C (1) Whole Sale 19-AA 21-BB R-62-D Rs.500 21-CC Rs.500+Rs.250 p.m. or part there of Rs.150 5 Homoeopathic Medicines Whole Sale 19-B 20-D Rs.250 20-E Rs.250+Rs.50p.m. or part there of Rs. 50 Retail Sale 19-B 20-C R-67-C Rs. 250 R-67-A(2) 20-E Rs.250+Rs.50p.m. or part there of R-67-A(2) Rs. 50 R-67-A(2) *GSR No. 421 dated 24/08/2001 Forms

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4/2/2012 54 FORM 19-C {See Rule 59(2)} Application for grant or renewal of a { licence to sell, stock, exhibit or offer for sale, or distribute} drugs specified in Schedule X I/We ……………………….. of …………..hereby apply for a licence to sell by Wholesale/retail drugs specified in Schedule-X to the Drugs and Cosmetics Rules, 1945. We operate a pharmacy on the premises, situated at…………. The sale and dispensing of drugs will be made under the personal supervision of the qualified persons mentioned below:- Name………………….(Qualification) Name………………….(Qualification) Name of drugs to be sold . Particulars of storage accommodation. A fee of rupees…………………….. has been credited to Government account under the head of account…………………………………. Date…………………………. Signature……………………

Wholesale of biological (C/C1):

Wholesale of biological (C/C 1 ) Adequate premises, with greater than 10 M 2 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 4/2/2012 55

Wholesale of other than those specified in C/C1 and X:

Wholesale of other than those specified in C/C 1 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. 4/2/2012 56

Retail sale:

Retail sale For retail sale, two types of licenses are issued: i ) General licenses ii) Restricted licenses Restricted license: Granted to those dealers who do not engage the services of a qualified person and only deal with such classes of drugs whose sales can be effected without qualified person and vendors who do not have fixed premises. 4/2/2012 57

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4/2/2012 58 FORM 19-A {(See Rule 59(2)} Application for the grant or renewal of a restricted licence to sell, stock or exhibit {or offer} for sale or distribute drugs by retail by dealers Who do not engage the service of a qualified person. 1. I/We …………………………….. of ………………………..hereby apply for a licence to sell by retail ( i ) {Drugs other than those specified in Schedule C, C(1) and X on the premises situated at ……………………….or (ii) Drugs specified in {Schedule C(1) on the premises situated drugs specified in {Schedule C(1) as vendor in the at…………………….. are……………………………….. Sales shall be restricted to such drugs as can be sold without the supervision of a qualified person under the Drugs and Cosmetics Rules. Names or classes of drugs proposed to be sold………………………………….. Particulars of the storage accommodation for the storage of {Schedule C(1) drugs on the premises referred to above. The drugs for sale will be purchased from the following dealers and such other dealers as may be endorsed on the licence by the licensing authority from time to time. A fee of rupees __________ has been credited to Government under the head of account ……………………… Date…………………….. Signature……………………….

Labeling & Packaging:

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 . 4/2/2012 59

Schedules to the act:

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 4/2/2012 60

Schedules to the rules:

Schedules to the rules TYPE CONTENT “A” Performa for forms no. 1 to 50 ( 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. Ex. Sera, Vaccines, Penicillin…..etc “C 1 ” List of Biological and special products ( nonparenteral ) applicable to special provisions. Ex. Digitalis, Hormones , Ergot “D” List of drugs that are exempted from provisions of import “E 1 ” List of poisonous substances under the Ayurvedic , Siddha and Unani systems “F” Provisions applicable to blood bank 4/2/2012 61

Schedules to the rules:

Schedules to the rules TYPE CONTENT “F 1 ” Special provision applicable to biological and special products, eg . Bacterial and viral vaccines, sera from living animals, bacterial origin diagnostic agents “F 2 ” Standards for surgical dressings “F 3 ” Standards for umbilical tapes “FF” Standards for ophthalmic preparations “G” List of substances required to be used under medical supervision and labelled accordingly Ex. Metformin , Anti Histaminic, …etc “H” List of substances (prescription ) that should be sold by retail only on prescriptions of R.M.P. Ex. Atenolol , Lorazepam , Dapson …etc 4/2/2012 62

Schedules to the rules:

Schedules to the rules TYPE CONTENT “J” List of diseases and ailments that drug should not claim to cure Ex. Cancer, AIDS, Cataract, Diabetes…etc “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 “M 1 ” Requirements of factory premises for manufacture of Homeopathic medicines “M 2 ” Requirements of factory premises for manufacture of cosmetics “M 3 ” Requirements of factory premises for manufacture of medical device s “N” List of equipment to run a Pharmacy “O” Standards for disinfectant flui ds Ex… Phenol, H2O2, alcohol…. 4/2/2012 63

Schedules to the rules:

Schedules to the rules TYPE CONTENT “P” Life period(expiry) of drugs Ex. Insuline Inj. – 24 months “Q” Coal tar colors permitted to be used in cosmetics Ex. Caramel, TiO2, Toney red….. “R” Standards for mechanical contraceptives “R 1 ” 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 4/2/2012 64

Schedules to the rules:

Schedules to the rules TYPE CONTENT “U 1 ” Manufacturing and analytical records of cosmetics “V” Standards for patent or proprietary medicine s “W” List of drugs marketed under generic names- Omitted “X” List of narcotic drugs and psychotropic substances EX. Opium, Morphine, Barbital…… “Y” Requirement and guidelines on clinical trials for import and manufacture of new drugs 4/2/2012 65

Drugs and Cosmetics (Amendment) Act, 2008:

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 4/2/2012 66

Drugs and Cosmetics (Amendment) Act, 2008:

Drugs and Cosmetics (Amendment) Act, 2008 Salient features of the Act:- Corresponding enhancement in punishment for repeated offenders Cognizance can be taken on the complaint of any gazetted officer authorized by Central or State Government Cases to be tried by Sessions Court 4/2/2012 67

Drugs and Cosmetics (Amendment) Act, 2008:

Drugs and Cosmetics (Amendment) Act, 2008 Salient features of the Act:- Designation of special courts for trial of offences in respect of adulterated and spurious drugs All offences relating to adulterated and spurious drugs made cognizable and non bailable Restrictions on bail – Bail cannot be granted unless public prosecutor is heard Certain offences made compoundable 4/2/2012 68

References:

References Available on www.cdsco.nic.in “Pharmaceutical Jurisprudence” by Dr.G.K.Jani ; Atul prakashan ; Fifth edition(2005-06); 28-133. Forensic Pharmacy by C.K. Kokate and S.B. Gokhle ; Published by Pharma Book Syndicate; 152. 4/2/2012 69

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4/2/2012 70

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4/2/2012 71 (a) Describe the functions of Central Drug Laboratory. (b) Sale of drugs according to drugs and cosmetic Act.

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