Schedules of Drugs & Cosmetics Act (1940), Rules(1945)

All the schedules of Drugs & Cosmetics Act ,1940 as well the Rules,1945 are detailed described. Also the history, objectives, role, all the amendments & orders of the D & C Act are described in most simplified way.

1. SCHEDULES OF DRUGS & COSMETICS ACT (1940), RULES (1945) 1

2. Mr. Shaktiprasad Pradhan M.Pharm, Ph.D* Research Scholar & SRF-ICMR, UDPS [email protected] Utkal University, Bhubaneswar Odisha, India 2

3. DRUGS & COSMETICS ACT, 1940 History: The modern medicines have been imported by India till after the first word war which made India mostly dependent. In August 1930 , the Government of India, under the chairmanship of R.N. Chopra appointed a Drug Enquiry Committee for the quality & standard of drugs sold and recommendation for control measure. In 1937 , a bill was introduced to give effect to the recommendations of the Drugs Enquiry Committee in the Central Legislative Assembly for a more comprehensive measure for the uniform control of import, manufacture, distribution and sale of drugs was desirable. In 1939 , the Drug Import Bill was prepared & placed for consideration before the Central Legislative Assembly. In 10th April, 1940 the bill was passed & received assent of the Governor General in Council & became the Drugs and Cosmetics Act. In 1945 , the related Drugs Rules were passed & since 1940, a number of amendments have been done in the Act and is currently known as the Drugs and Cosmetics Act, 1940. 3

4. Objectives of D & C Act, 1940 The Act visualizes the regulatory control over the drugs imported in to the country by the Central Government while the manufacture, sale and distribution of drugs is primarily regulated by the State Drug Control Authorities appointed by the respective State Governments. The primary objective of the Act is to ensure that the drugs & cosmetics sold in India are safe, effective and conform to state quality standards and to make available Standard Quality drug/ cosmetic to consumer. The manufacture and sale of the drugs is regulated through a system of licensing and inspection by the Licensing Authorities. The Central Drugs Standard Control Organization (CDSCO), headed by the Drugs Controller General, India is concerned with the regulatory control over the quality of drugs & cosmetics. 4

5. Role of D & C Act, 1940 To prevent substandard in drugs & maintaining high standards of medical care. To regulate the import, manufacture, distribution and sale of drugs & cosmetics through licensing. 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 & cosmetics. 5

6. Amendments in the Act and adaptation of orders 1. The Repealing and Amending Act, 1949 (40 of 1949) 2. The Adoption of Laws Order, 1950 3. The part B States (Laws) Act, 1951 (3 of 1951) 4. The Drugs (Amendment) Act, 1955 (11 of 1955) 5. The Drugs (Amendment) Act, 1960 (35 of 1960) 6. The Drugs (Amendment) Act, 1962 (21 of 1962) 7. The Drugs and Cosmetics (Amendment) Act, 1964 8. The Drugs and Cosmetics (Amendment) Act, 1972 9. The Drugs and Cosmetics (Amendment) Act, 1982 10. The Drugs and Cosmetics (Amendment) Act, 1986 11. The Drugs and Cosmetics (Amendment) Act, 1995 12. The Drugs and Cosmetics (Amendment) Act,2003 13. The Drugs and Cosmetics (Amendment) Act,2008 14. The Drugs and Cosmetics (Amendment) Act,2013 15. The Drugs and Cosmetics (Amendment) Act,2015 16. The Drugs and Cosmetics (Amendment) Act,2016   6

7. Chapters in D & C Act, 1940 Chapter I - Introduction Short title, extent and commencement and definitions. Chapter II- Various Boards The drugs technical advisory board, the central drugs laboratory and the drugs consultative committee and its constitution. Chapter III- Import of Drugs and Cosmetics Standards of quality, misbranded drugs, adulterated drugs ,spurious drugs & cosmetics, and prohibition of import of certain drugs or cosmetics. (Cont.) 7

8. Chapters in D & C Act, 1940 Chapter IV- Manufacture, Sale and Distribution of Drugs and Cosmetics. Standards of quality, misbranded drugs, adulterated drugs, spurious drugs & cosmetics, and prohibition of manufacture, sale and distribution of certain drugs or cosmetics. Chapter IV(A)- Provisions relating to Ayurvedic, Siddha and Unani drugs. Chapter V- Miscellaneous Power to give directions, offences by companies, government departments, penalties and sentences passed under this Act, Magistrate’s power to impose enhanced penalties, etc. 8

9. Important definitions in D & C Act, 1940 Drug: 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 Preparations applied on human body for the purpose of repelling insects like mosquitoes. 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 for cleansing, beautifying, promoting attractiveness, or altering the appearance Includes any article intended for use as a component of cosmetic. (Cont.) 9

10. 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 (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; or (e) if it purports to be the product of a manufacturer of whom it is not truly a product. (Cont.) 10

11. Adulterated drugs: (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 (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. (Cont.) 11

12. 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; or (c) if its label or container or anything accompanying the drug bears any statement, design or device which makes any false claiming for the drug or which is false or misleading. 12

13. Schedules in D & C Act, 1940 There are two Schedules in the Drugs & Cosmetics Act, 1940. First Schedule : Names of books under Ayurvedic, Siddha and Unani systems. A. Ayurvedic system books like Arogya Kalpadruma , Arka Prakasha , etc. & Siddha systems books like Vaidya Thirattu , Therayar Maha Karisal , etc. B. Unani system books like Karabadin Qadri , Karabadin Kabir , etc. Second Schedule : Various Standards to be Complied with by Imported Drugs and by Drugs Manufactured for Sale, Sold, Stocked or Exhibited for Sale or Distributed.       13

14. Schedules in D & C Rules, 1945 Schedule-A Gives the specimens of prescribed forms necessary for obtaining licenses, permits, certificates, intimations and so on. There are in about 50 forms in this Schedule. Schedule-B This Schedule includes fees for test or analysis by the Central Drug Laboratory or the Government Analyst . Schedule-B(I) This Schedule includes fees for the test or analysis by the Pharmacopoeial Laboratory for Indian Medicine (PLIM) or the Government analyst. (Cont.)   14

15. Schedule-C Includes biological and special products (Parenteral/ Injectable) such as Sera, Vaccines, Antigens, Toxin, Antitoxin, Insulin, Bacteriophages, solution of serum proteins intended for injection etc. Schedule-C(I) Includes other special products (Non Parenteral) such as Digitalis Preparations, Fish liver oil, Ergot preparations, Liver extract, Vitamins, Hormones, In-vitro devices for HIV, HCV etc. Schedule-D This Schedule includes Provides extent and conditions of exemption regarding import of drugs such as Pre-digested food, Condensed or powdered milk, Cereal preparations, Chicken essence, Spices and condiments, Drugs and cosmetics imported for manufacture and export in Special Economic Zone. (Cont.)   15

16. Schedule-D(I) Contains information and undertaking required to be submitted by the manufacturer or his authorized agent with the Application Form for a Registration Certificate . The format shall be properly filled in and the detailed information, secret in nature. Schedule-D(II) Includes the information required to be submitted by the manufacturer for registration of a bulk drug/ formulation/ special product for its import into India. The format shall be properly filled in and the detailed information, secret in nature. Schedule-E Omitted (Cont.)   16

17. Schedule-E(I) List of poisonous substances under the Ayurvedic (including Siddha) and Unani Systems of Medicine. Drugs of Vegetable origin- Bhang, Dhatura , Jaiphala Drugs of Animal origin- Snake poison Drugs of Mineral origin- Hartala (Arsenic), Parada (Mercury) Schedule-F It includes requirements for the functioning and operation like Space, equipment and supplies required for a blood bank and/ or minimum requirement for grant of license for preparation of blood components from whole human blood. (Cont.)   17

18. Schedule-F(I) Part I - Provision applicable to the production of bacterial and viral vaccines. Part II- Provision applicable to the production of all sera from living animals. Part III- Provision applicable to the production and standardization of diagnostic agents of bacterial origin . Schedule-F(II) Standards for Surgical dressings that include bandage cloth, absorbent gauze, rolled bandage etc. Schedule-F(III) Standards for sterilized Umbilical tapes like umbilical polyester tape, cotton tape etc. (Cont.)   18

19. Schedule-FF It lays down Standards for ophthalmic preparations. Part-A: Ophthalmic solutions and suspensions . Part-B: Ophthalmic ointments. Labelled with words use within 1month of opening, not for injection, name and concentration of preservatives. Schedule-G List of substances required to be used under medical supervision and accordingly labelled with the words “Caution: It is dangerous to take this preparation except under medical supervision ”. Examples are Aminopterin , L- Asparaginase , Bleomycin , Busulphan , Chlorambucil , Chlorthiazide , Glibenclamide , Hydantoin , Hydroxyurea , Insulin, Metformin etc. (Cont.)   19

20. Schedule-H List of substances (prescription) that should be sold by retail only on the prescriptions of Registered Medical Practitioner ( R.M.P). Labelled with the symbol Rx and conspicuously displayed on the left top corner of the label, labelled with the following words “To be sold by retail on the prescription of a Registered Medical Practitioner only”. Contains a list of 536 drugs. Schedule-H(I) Regulates sale of antibiotics . Labelled Rx in red & displayed on left corner of the label with red border warnings (1)It is dangerous to take this preparation except in accordance with the medical advice, (2)Not to be sold by retail without the prescription of a RMP. Examples are Alprazolam , Gemifloxacin , Isoniazid , Cefixime , Levofloxacin , Cefpodoxime , Clofazimine , Zolpidem , etc. Contains a list of 46 drugs . (Cont.)   20

21. Schedule-I Particulars as to proportion of poison in certain cases currently not in existence as omitted by the Govt. Schedule-J Contains a list of various diseases and conditions which a drug may not purport to prevent or cure or make claims to prevent or cure. No drug may legally claim to treat these diseases. Examples are AIDS, Blindness, Deafness, Encephalitis, Diabetes, Fairness of skin, Improvement in height of children/adults, Obesity, Cancer, Paralysis etc. (Cont.)   21

22. Schedule-K Specified drugs are exempted from the provisions of Chapter IV of the Act & the Rules made there under to the extent and subject to the conditions specified in that Schedule. It include Quinine and other antimalarial drugs, Drugs supplied by RMP to his own patient, Drugs supplied by hospital or supported by government or local body, Substances which are used both as articles of food as well as drugs, Household remedies like Aspirine tab, Paracetamol tab, Analgesic balm, Gripe water for infants etc.(OTC drugs) Schedule-L Omitted Schedule-L(I) This Schedule includes Good Laboratory Practices and requirements of premises and equipments, Chemicals & Reagents, etc. (Cont.)   22

23. Schedule-M Includes Good Manufacturing Practices and requirements of premises, plant and equipment for manufacture of pharmaceutical products. Part 1 : Good Manufacturing Practices for premises and materials 1A -Specific requirements for manufacture of sterile products , parenteral preparations(small volume injectables & large volume parenterals ) and sterile ophthalmi c preparations. 1B -Oral solid dosage forms (Tablets and Capsules) 1C -Oral liquids (Syrups, Elixirs, Emulsions and Suspensions) 1D -Topical products (Creams, Ointments, Pastes, Emulsions, Lotions, etc.) 1E - Metered-dose-inhalers (MDI) 1F -S pecific requirements of premises, plant and materials for manufacture of Active Pharmaceutical Ingredients (bulk drugs) Part 2 : Requirements of Plant and equipments. (Cont.) 23

24. Schedule-M(I) Prescribes in detail requirements of factory premises for the manufacture of homeopathic drugs . Schedule-M(II) Prescribes requirements of factory premises for manufacture of cosmetics . Schedule-M(III) Prescribes requirements of factory premises for manufacture of medical devices . Schedule-N List of minimum equipments for the efficient running of a Pharmacy. Entrance shall bear an inscription “Pharmacy” in front. (Cont.) 24

25. Schedule-O Deals with the provisions applicable to disinfectant fluids . • Part 1 : Provisions applicable to black and white fluids • Part 2 : Provisions applicable to other disinfectants Black fluids are homogeneous dark brown solution of coal tar acid or similar acids. White fluids are finely dispersed homogeneous emulsion of coal tar acid or similar acids. Schedule-P It deals with life period of drug and the conditions of the storage of drugs, period in months (unless otherwise specified) between date of manufacture and date of expiry. This schedule includes antibiotics, vitamins, insulin preparation, normal human plasma, sera toxins, toxoids , other toxins, anti-toxins, miscellaneous drugs. (Cont.) 25

26. Schedule-P(I) Specifies the pack size of certain drugs. The pack sizes for liquid Oral preparations shall be 30ml (Paediatric only) 60 ml/100 ml/200 ml/450 ml. Schedule-Q Gives the list of dyes, colours and pigments permitted to be used in cosmetics and soaps . Part1 : List of dyes, colours and pigments permitted in cosmetics and soaps. Part 2 : List of colours permitted in soaps. Natural colours: Carotene, Chlorophyll, Red Oxide of Iron, Yellow Oxide of Iron, Titanium Di-oxide, Black Oxide of iron Artificial Colours: Caramel Coal Tar Colours (Cont.) 26

27. Schedule-R Standards for mechanical contraceptives containing label of the date of manufacture & the date up to which the contraceptive is expected to retain its properties. Examples are Condom, Cu-T, etc. Schedule-R(I) Standards for medical devices & the following medical device shall conform to the Indian Standards specification laid down from time to time by the Bureau of Indian Standards: - 1. Sterile Disposable Perfusion sets for single use only 2. Sterile Disposable Hypodermic Syringes for single use only 3. Sterile Disposable Hypodermic Needles for single use only (Cont.) 27

28. Schedule-S Prescribes S tandard for Cosmetics & the following cosmetics in finished form should conform to the specifications laid down from time to time by the Bureau of Indian Standards (BIS). Skin Powders, Tooth Powder, Toothpaste, Shaving Creams, Hair Creams, Shampoo, Nail Polish etc. Schedule-T Lays down the Good Manufacturing Practices for Ayurvedic, Siddha & Unani medicines. PART-I: Good Manufacturing Practices PART-II: List of recommended machinery, equipment & minimum manufacturing premises required for the manufacture of various categories of Ayurvedic, Siddha system of medicines. (Cont.) 28

29. Schedule-U Gives the particulars to be shown in manufacturing records of Drugs. Gives the particulars to be recorded of raw materials & gives the particulars to be recorded in analytical records . The records or registers shall be retained for a period of 5 years for Drugs from the date of manufacture . Schedule-U(I) Gives the particulars to be shown in manufacturing records of Cosmetics. The records or registers shall be retained for a period of 3 years for Cosmetics from the date of manufacture.  Schedule-V Give details of standards for patent and proprietary medicines . (Cont.) 29

30. Schedule-W Contains the drugs which shall be marketed under generic names only & the label contains the names and quantities of active ingredients. This includes only five drugs marketed under generic names only Analgin , Aspirin and its salt, Chlorpromazine and its salt, Ferrous sulphate, Piperazine and its salts. Schedule-X Contains a list of 15 narcotic drugs and psychotropic substance . A label ‘Schedule X drug’ warning : to be sold on retail on prescription of a RMP only, having ‘ NRx ’ in red & conspicuously displayed on the top left corner. Examples are Phencyclidine, Secobarbital , Amobarbital , Amphetamines, Glutethimide , Methylphenidate, etc. (Cont.) These drugs may be imported under license or permit. 30

31. Schedule-Y This Schedule includes requirements and guidelines for permission to import and/ or manufacture of new drugs for sale or to undertake clinical trials. Includes application for permission of Clinical trial, approval for trial, responsibilities of sponsor, investigator, ethical committee, phases I, II, III, IV Studies in special population like geriatric, paediatric & pregnant women, Post Marketing Surveillance etc.   Schedule-Y(I) This Schedule includes Registration of Clinical Research Organization (CRO) for conducting clinical trials. It also deals with compensation in case of Injury/ Death during clinical trial study. 31

32. References History of D&C Act, 1940. http://www.medindia.net/indian_health_act/drugs-and-cosmetics-act-1940 introduction.htm  Drugs and Cosmetics Act, 1940. https://en.wikipedia.org/wiki/Drugs_and_Cosmetics_Act,_1940#Amendments Drugs and Cosmetics Rules, 1945. https://en.wikipedia.org/wiki/Drugs_and_Cosmetics_Rules,_1945 Ministry of Health and Family Welfare, GSR 588 (E) dated 30 Aug,2013. Ministry of Health and Family Welfare, GSR 103 (E) dated 02nd February, 2017. Dr. B. S. Kuchekar . Pharmaceutical Jurisprudence. Pragati Books Pvt. Ltd. pp. 5.0–5.2. 32

33. Thank You 33