Drugs And Cosmetics Act,1940
And Its Rules 1945
• History and Objectives
• 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
British mis rule-Providing poor healthcare system to Indian citizens
• Observations made by-Drugs Enquiry Committee, Indian Medical
• Reports in- Indian Medical Gazette during 1920-30
• 1940 – Drugs and CosmeticsAct
•1945 – Rules under the Act
Extended to whole of India
To regulate the import, manufacture, distribution and sale of drugs &
cosmetics through licensing.
• Manufacture, distribution and sale of drugs and cosmetics by qualified
• 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.
- Subject:- pharmaceutical Jurisprudence
- Course:- B.pharm (pharmacy),
- Semester:- 4th sem , sem :- 4
DRUGS AND COSMETICS ACT,1940 AND ITS RULES 1945 â€¢ www.remixeducation.in 1 â€¢ Introduction â€¢ History and Objectives â€¢ Definitions â€¢ Administration of the act and rules â€¢ Provisions related to Import â€¢ Provisions related to Manufacture â€¢ Provisions related to Sale â€¢ Labeling and Packaging â€¢ Schedules to the act and rules www.remixeducation.in â€¢ British mis rule-Providing poor healthcare system to Indian citizens â€¢ Observations made by-Drugs Enquiry Committee, Indian Medical Association â€¢ Reports in- Indian Medical Gazette during 1920-30 â€¢ 1940 â€“ Drugs and CosmeticsAct â€¢1945 â€“ Rules under the Act Extended to whole of Indiaâ€¦ www.remixeducation.in 3 â€¢ To regulate the import, manufacture, distribution and sale of drugs & cosmetics through licensing. â€¢ Manufacture, distribution and sale of drugs and cosmetics by qualified persons only. â€¢ To prevent substandard in drugs, presumably for maintaining high standards of medical treatment. â€¢ To regulate the manufacture and sale of Ayurvedic, Siddha and Unani drugs. â€¢ To establish Drugs Technical Advisory Board(DTAB) and Drugs Consultative Committees(DCC) for Allopathic and allied drugs and cosmetics. www.remixeducation.in 4 a) Maximum penalty life imprisonment and fine of Rs. 10 lakhs or 3 times the value of the confiscated goods, whichever is more. b) Besides officers from the Drug Controllerâ€™s Office, other gazette officers also authorized to launch prosecution under theAct; b) Specially designated courts for trial of offences covered under theAct; c) Provision for compounding of minor offences. www.remixeducation.in 7 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. www.remixeducation.in 6 COSMETIC : Any article intended to be rubbed, poured, sprinkled or sprayed on, 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. www.remixeducation.in 7 MISBRANDED DRUGS : a) if it is so coloured, coated, powdered or polished that damage is concealed b) if it is not labelled in the prescribed manner; or c) 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. www.remixeducation.in 8 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. www.remixeducation.in 9 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.or (c) if it has been substituted wholly or in part by another drug or substance. 10 www.remixeducation.in 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. 11 www.remixeducation.in 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. 12 www.remixeducation.in 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 13 www.remixeducation.in 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) (v) Director of Indian Veterinary Research Institute, Izatnagar (vi) President of Medical Council of India (vii) President of the Pharmacy Council of India (viii) (viii) Director of Central Drug Research Institute, Lucknow 14 www.remixeducation.in NOMINATED: 1) Two persons by the Central Government from among persons who are in charge of drugs control in the States 2) One person by the Central Government from the pharmaceutical industry 3) Two persons holding the appointment of Government Analyst under this Act, to be nominated by the Central Government 15 www.remixeducation.in 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. 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. 3) One pharmacologist to be elected by the Governing Body of the Indian Council of Medical Research. www.remixeducation.in 1 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. www.remixeducation.in To advise the Central Governmentand the State Governments on technical matters arising out of the administration of thisAct. To carry out the other functions assigned to it by thisAct. (The nominated and elected members of the Board shall hold office for three years, but shall be eligible for re-nomination and re-election) 18 www.remixeducation.in â€¢ It is also an advisory body constituted by central government. Constitution: Two representatives of the Central Government One representative of each State Government 19 www.remixeducation.in FUNCTIONS: ï‚§ 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 thisAct. ï‚§ The Drugs Consultative Committee shall meet when required ï‚§ Has power to regulate its own procedure. 20 www.remixeducation.in â€¢ Established in Calcutta, under the control of a director appointed by the Central Government Functions: â€¢ Analysis or test of samples of drugs/cosmetics sent by the custom collectors or courts. â€¢ Analytical Q.C. of the imported samples. 21 www.remixeducation.in â€¢ Collection, storage and distribution of internal standards. â€¢ Preparation of reference standards and their maintenance. â€¢ Maintenance of microbial cultures. â€¢ Any other duties entrusted by Central Government. â€¢ Acting as an appellate authority in matter of disputes. www.remixeducation.in IMPORT OF DRUGS AND COSMETICS Classes of drugs and cosmetics prohibited to import â€¢ Import of drug under license 1)Specified in Schedule-X 2)Any new drugs â€¢ Drugs exempted from provisions of import â€¢ Offences and Penalties 23 www.remixeducation.in â€¢ Misbranded drugs â€¢ Drugs of substandard quality â€¢ Drugs claiming to cure diseases specified in Sch-J â€¢ Adulterated drugs â€¢ Spurious drugs â€¢ Drugs whose manufacture, sale/distribution are prohibited in original country, except for the purpose of test, examination and analysis. â€¢ Patent/Proprietary medicines whose true formula is not disclosed. 24 www.remixeducation.in Conditions to be fulfilled : â€¢ Licensee must have adequate facility for the storage. â€¢ 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. â€¢ Licensee must allow an inspector to inspect premises and to check the records. â€¢ Licensee must furnish the sample to the authority. 25 www.remixeducation.in Conditions to be fulfilled: â€¢ Licensee must have,adequate storage facility. â€¢ Applicant must be reputable in the occupation, trade or business. â€¢ The license granted ever before should not be suspended or cancelled. 26 www.remixeducation.in Conditions to be fulfilled: â€¢ License is necessary under form-11 â€¢ Must use imported drugs only for said purpose and at the place specified in the license. â€¢ Must keep the record with respect to quantities, name of the manufacturer and date of import. â€¢ Must allow an inspector to inspect the premises and check the records. 27 www.remixeducation.in Cosmetics prohibited to import: â€¢ Misbranded cosmetics â€¢ Spurious cosmetics â€¢ Cosmetic containing harmful ingredients â€¢ Cosmetics not of standard quality â€¢ which contains more than-2 ppm Arsenic, 20 ppm lead, 100 ppm heavy metals 28 www.remixeducation.in OFFENCES (an illegal act) PENALTIES Import of spurious OR adulterated drug a) 3 years imprisonment and 5000 Rs. OR drug which involves risk to human fine on first conviction beings or animals OR drug not having b) 5 years imprisonment OR 1000 Rs. fine therapeutic values 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 29 www.remixeducation.in â€¢ Drug not of standard quality or misbranded, adulterated or spurious. â€¢ Patent or Proprietary medicine. â€¢ Drugs which claims to cure diseases specified in Sch-J. â€¢ Drugs which Risky to human beings or animals. â€¢ Drugs without therapeutic value. 30 www.remixeducation.in TYPES OF MANUFACTURING LICENSE Allopathic Drugs Other than Sch.- Sch.-X Sch.-C/C1 & Drugs for the Sch.- C/C1 & C/C1 But X purpose of X not -X examination test oranalysis Own Own Premises Premises Own Premises Loan License Repacking license www.remixeducation.in 31 ï‚§ Conditions: â€¢ Premises should comply with schedule â€˜Mâ€™. â€¢ Adequate facility for testing, separate from manufacturing. â€¢ Adequate storage facility. â€¢ Records of mfg. & testing-maintained for at least 2 years from date of Exp. 32 www.remixeducation.in â€¢ License should provide sample to authority. â€¢ Furnish data of stability. â€¢ Maintain the inspection book. â€¢ Maintain reference samples from each batch. â€¢ Accounts of production recorded & maintained for 5 years or 1 year after Expiry. www.remixeducation.in Conditions: â€¢ Have to sent invoice of sale to licensing authority every 3 months â€¢ Store drugs in direct custody of responsible person. â€¢ Preparation must be labeled with XRx â€¢ Marketed in packing not exceeding â€¢ 100 unit dose â€“Tablets/Capsules â€¢ 300 ml- Oral liquid â€¢ 5 ml - Injection 34 www.remixeducation.in Conditions: â€¢ Drugs must be issued in previously sterilized sealed glass or suitable container â€¢ Containers should comply with req. of Sch-F/F1 â€¢ Drug must comply with std. (quality, purity, strength) specified in sch.-F â€¢ Parenteral in doses of 10 ml or more should be tested for freedom from Pyrogens â€¢ Separate lab. for culture & manipulation of spore bearing Pathogens â€¢ Test for sterility should be carried out. 35 www.remixeducation.in 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 a) Imprisonment up to 3 months & Rs.500 provisions fine b) Imprisonment up to 6 months & Rs.1000 fine on subsequent conviction www.remixeducation.in3 5 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). 37 www.remixeducation.in 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/C1 and X. Procedure: Licence is obtained from licensing authority (FDA) on application in prescribed forms (24-B) with prescribed fees (Rs. 500, 200). 38 www.remixeducation.in TYPES OF SALES LICENCES Allopathic Drugs www.remixeducation.in Whole Sale Retail Sale Sales From Motor Vehicle ( Vender) General Licence Restricted Licence Drugs in Drugs in Drugs For Sch.- X Sch.- Sch.- other than C/C1 sch.-C/C1 C/3C81 â€¢ Misbranded, spurious, adulterated and drugs not of standard quality â€¢ Patent/Proprietary drugs with undisclosed formula â€¢ Sch-J drugs â€¢ Expired drugs. 40 www.remixeducation.in â€¢ Adequate premises, with greater than 10 M2 area, with proper storage facility â€¢ Drugs sold only to retailer having license â€¢ Premises should be in charge of competent person who is Reg. Pharmacist. â€¢ Records of purchase & sale â€¢ Records preserved for 3 years from date of sale â€¢ License should displayed on premises 41 www.remixeducation.in â€¢ All the conditions as discussed in for biological. â€¢ Compounding is made by or under the direct and personal supervision of a qualified person. 42 www.remixeducation.in â€¢ 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. 43 www.remixeducation.in â€¢ 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. 44 www.remixeducation.in TYPE CONTENT â€œAâ€� Performa for forms no. 1 to 50( Application, issue, renewal, etc.) â€œBâ€� Rates of fee for test or analysis by CDL or Govt. analysts â€œCâ€� List of Biological and special products (Injectable) applicable to special provisions. Ex. Sera, Vaccines, Penicillinâ€¦..etc â€œC1â€� List of Biological and special products (nonparenteral) applicable to special provisions. Ex. Digitalis, Hormones , Ergot â€œDâ€� List of drugs that are exempted from provisions of import â€œE1â€� List of poisonous substances under the Ayurvedic , Siddha and Unani systems â€œFâ€� Provisions applicable to blood bank www.remixeducation.in4 4 TYPE CONTENT â€œF1â€� Special provision applicable to biological and special products, e.g. Bacterial and viral vaccines, sera from living animals, bacterial origin diagnostic agents â€œF2â€� Standards for surgical dressings â€œF3â€� Standards for umbilical tapes â€œFFâ€� Standards for ophthalmic preparations www.remixeducation.in â€œGâ€� List of substances required to be used under medical supervision and labelled accordingly Ex. Metformin, Anti Histaminic, â€¦etc. â€œHâ€� List of substances (prescription) that should be sold by retail only on prescriptions of R.M.P. Ex. Atenolol, Lorazepam, Dapson â€¦etc. 4 5 TYPE CONTENT â€œJâ€� List of diseases and ailments that drug should not claim to cure Ex. Cancer, AIDS, Cataract, Diabetesâ€¦etc â€œKâ€� List of drugs that are exempted from certain provisions regarding manufacture â€œMâ€� Requirements of manufacturing premises, GMP requirements of factory premises, plants and equipments â€œM1â€� Requirements of factory premises for manufacture of Homeopathic medicines â€œM2â€� Requirements of factory premises for manufacture of cosmetics â€œM3â€� Requirements of factory premises for manufacture of medical devices â€œNâ€� List of equipment to run a Pharmacy â€œOâ€� Standards for disinfectant fluids Exâ€¦ Phenol, H2O2, alcoholâ€¦. www.remixeducation.in4 6 TYPE CONTENT â€œPâ€� Life period(expiry) of drugs Ex. Insulin Inj. â€“ 24 months â€œQâ€� Coal tar colors permitted to be used in cosmetics Ex. Caramel, TiO2, Toney redâ€¦.. â€œRâ€� Standards for mechanical contraceptives â€œR1â€� Standards for medical devices â€œSâ€� Standards for cosmetics â€œTâ€� Requirements (GMP) of factory premises for Ayurvedic, Siddha, Unani drugs â€œUâ€� Manufacturing and analytical records of drugs 48 www.remixeducation.in TYPE CONTENT â€œU1â€� Manufacturing and analytical records of cosmetics â€œVâ€� Standards for patent or proprietary medicines â€œWâ€� List of drugs marketed under generic names- Omitted â€œXâ€� List of narcotic drugs and psychotropic substances EX. Opium, Morphine, Barbitalâ€¦â€¦ â€œYâ€� Requirement and guidelines on clinical trials for import and manufacture of new drugs 49 www.remixeducation.in www.remixeducation.in