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DRUG SCHEDULES
PG Guide- Dr. Shyamal Sinha
Presenter- Dr. Shivesh Gupta
JR 1, Dept of Pharmacology,
GGMC, Mumbai
Throughout the seminar……
■ Introduction
■ History
■ Drugs and Cosmetics Act, 1940
■ Chapters
■ Drugs and Cosmetics rules, ...
Introduction
Pharmaceutical Company
• After carrying out
R&D, in compliance
with government
laws and policies
Manufacturin...
Contd….
Contd….
• Inaccurate Diagnosis
• Using inappropriate medications
• Masking the symptoms of a serious condition
• Delaying medical ...
Regulation
■ Here is where, the role of regulatory bodies of therapeutic goods, i.e.
drugs and therapeutic devices, comes ...
History
■ Up until the 20th century, there were few federal laws regulating the contents and sale of
domestically produced...
History
 TILL 1930 : India was largely dependent on import of modern medicines until after first word war.
 In August 19...
Regulations inVarious countries
 Therapeutic goods in the United States are regulated by the U.S. Food and Drug
Administr...
Contd….
■ Each of the controlled substances is identified under one of five Controlled Substances
Schedules.
■ Schedule I
...
Contd….
■ Schedule I Drugs
– High potential for abuse.
– No accepted medical use in the U.S. or lacks accepted safety for ...
Contd….
■ Schedule II Drugs
– High potential for abuse.
– Has a currently accepted medical use in the U.S.
– Abuse of subs...
Contd….
■ Schedule III Drugs
– Abuse potential less than substances in schedule I or schedule II.
– Has a currently accept...
Contd….
■ Schedule IV Drugs
– Abuse potential less than substances in schedule III.
– Has a currently accepted medical use...
Contd….
■ ScheduleV Drugs
– Low potential for abuse relative to schedule IV.
– Has a currently accepted medical use in the...
Contd….
In Canada,
 Regulation of therapeutic goods are governed by the Food and
Drug Act and associated regulations.
■ I...
Contd….
 Medicines for Human Use in the United Kingdom are regulated by the Medicines and
Healthcare products RegulatoryA...
Contd….
Australia
■ Therapeutic goods in Australia are regulated by the Therapeutic Goods Administration (TGA).
■ The avai...
Drugs and Cosmetics Act, 1940
■ The Drugs and Cosmetics Bill was passed by the Central LegislativeAssembly
and it received...
Contd….
 The Act visualizes the regulatory control over the drugs imported in to the country by the
Central Government wh...
Role of Drugs and CosmeticsAct, 1940
■ To prevent substandard in drugs, maintaining high standards of medical care.
■ To r...
LIST OF AMENDING ACTS AND
ADAPTATION ORDERS
1. The Repealing and Amending Act, 1949 (40 of 1949).
2. The Adoption of Laws ...
Chapters in D&C Act, 1940
■ Chapter I- Introduction
Short title, extent and commencement and definitions
■ Chapter II- Var...
Contd….
■ Chapter IV- Manufacture, Sale and Distribution Of Drugs And Cosmetics
Standards of quality, misbranded drugs, ad...
Definitions in D&C Act, 1940
Drug:-
 All medicines for internal or external use of human beings or animals and
 All subs...
Contd….
■ Spurious drugs:-
(a) if it is imported under a name which belongs to another drug; or
(b) if it is an imitation ...
Contd….
■ Adulterated drugs:-
(a) if it consists, in whole or in part, of any filthy, putrid or decomposed substance; or
(...
Contd….
■ Misbranded drugs:-
(a) if it is so coloured, coated, powdered or polished that damage is concealed or if it is m...
Schedules in D&C Act
■ First schedule – Names of books under Ayurvedic, Siddha and Unani systems.
– A.—Ayurvedic system bo...
Drugs and Cosmetics Rules, 1945
■ The Drugs and Cosmetics Rules, 1945 is an Act of the Parliament of India which
contains ...
ScheduleA
Gives the specimens of prescribed forms necessary for obtaining licenses, permits, certificates,
intimations and...
Schedule B
This Schedule includes fees for test or analysis by the Central Drug
Laboratory or the Government Analyst.
1. F...
Contd….
• Fees for Sera andVaccine , Cosmetics , Homoeopathic medicines, etc.
are also included in Schedule B.
• Schedule ...
Schedule C
 Schedule C:-
Includes biological and special products such as Sera,Vaccines,
Antigens,Toxin,Antitoxin, Insuli...
Schedule D
Provides extent and conditions of exemption regarding import of drugs.
Eg:-
1. Class of drugs which are substan...
Contd….
2. Drugs and cosmetics imported for manufacture and export:-
– Exempted under the provisions of Chapter III of the...
Schedule DI
■ Contains Information and undertaking required to be submitted by the manufacturer
or his authorized agent wi...
Schedule DII
■ Here, the information is required to be submitted by the manufacturer for registration of a
bulk drug/formu...
Schedule E
Schedule E- Omitted as per GOI Notification No.G.S.R. 462(E) dt 22-6-1982.
Schedule E (I):- List of poisonous s...
Schedule F
 It includes requirements for the Functioning and operation of a blood
bank and / or for preparation of blood ...
Contd….
 F (I) :- Give details of the standards of bacterial vaccines, antisera
and diagnostic antigens made from any mic...
Schedule FF
It lays down Standards for Ophthalmic preparations.
■ Part-A. Ophthalmic Solutions and suspensions.
1. sterile...
Schedule G
Medicines listed as schedule G medicines carry on the label a caution
■ Caution – “it is dangerous to take this...
Schedule H
• This Schedule includes PRESCRIPTION DRUGS i.e. Drugs and
Medicines which must be sold by retail only when a p...
Schedule H1
■ Schedule H1:- Introduced under the Drugs and Cosmetics (4th
amendment ) rules 2013, by MOHFW on 30 Aug, 2013...
Schedule I
 Particulars as to proportion of poison in certain cases.
 Omitted by GOI Notification No. G.S.R 462(E) dt 22...
Schedule K
 The drugs specified in Schedule K shall be exempted from the
provisions of Chapter IV of the Act and the Rule...
OTC Drugs
 The phrase ‘OTC’ has no legal recognition in India, all the drugs not included in the list of
‘prescription-on...
Contd….
 The Schedule K include:-
 Quinine Sulphate and other antimalarial drugs
 Drugs supplied by RMP to his own pati...
Schedule L
Schedule L:- Omitted
Schedule L (I) :-
Good Laboratory Practices and requirements of premises and equipments,
C...
Schedule M
This Schedule includes Good Manufacturing Practices and requirements of premises, plant
and equipment for manuf...
Good Manufacturing Practices (GMP)
 General requirements:-
 Location and surroundings- Free from open sewage,public lava...
Contd….
■ Quality control area- Lab independent of production area with separate and adequate
space for each type of testi...
Contd….
Schedule M- I:- Prescribes in detail requirements of factory
premises for the manufacture of Homeopathic drugs.
Sc...
Schedule N
o List of minimum equipment for the efficient running of a
pharmacy
o Gives directions to Pharmacies regarding:...
Schedule O
Deals with the provisions applicable to disinfectant fluids.
• Part 1:- Provisions applicable to black and whit...
Schedule P
 It deals with life period of drug and the conditions of the storage of drugs.
 Period in months (unless othe...
Schedule P1
 Schedule P1 – specifies the pack size of certain drugs.
 It gives the names of drugs, along with the dosage...
Schedule Q
 Gives the list of dyes, colors and pigments permitted to be used
in cosmetics and soaps.
 No drug should con...
Schedule R
 Standards for condoms made of rubber latex intended for single use and other
mechanical contraceptives.
 Eg....
Schedule S
 Prescribes Standard for Cosmetics
 The following cosmetics in finished form should conform to the specificat...
ScheduleT
 Lays down the Good Manufacturing Practices for Ayurvedic, Siddha
and Unani Medicines
 PART I:- GOOD MANUFACTU...
Schedule U & U1
 Gives the particulars to be shown in manufacturing records.
 Gives the particulars to be recorded of ra...
ScheduleW
 Inserted as per G.O.I. Notificiation No. GSR 27(E) dt 17.1.1981 and
deleted as per G.O.I. Notification No. GSR...
Schedule X
 Contains list of narcotic drugs and psychotropic substance.
 Have a warning mentioned on a label ‘Schedule X...
ScheduleY
This Schedule includes requirements and guidelines for permission
to import and / or manufacture of new drugs fo...
Data required to be submitted with application for permission
to market a New Drug
1. Introduction
2. Chemical And Pharmac...
ClinicalTrials
 Nature of trials. -The clinical trials required to be carried out in the country before a
new drug is app...
ScheduleY1
■ Amended under Rule 122- DAB
■ This Schedule includes Registration of Clinical Research Organization (CRO) for...
RecentAmendments
 In the Drugs and Cosmetics Rules, 1945, in Rule 3A, in sub-rule (8), in clause (b), after
item (5) and ...
Summary
 The Drug & Cosmetics Act and Rules controls how medicines and chemicals
are made available to the public.
 They...
References
■ Drugs and CosmeticsAct, 1940. Available at
https://en.wikipedia.org/wiki/Drugs_and_Cosmetics_Act,_1940#Amendm...
Drug schedules
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Drug schedules

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A brief description of history,drugs and cosmetics acts and rules, various drug schedules included in the act and rules, brief description of drug schedules, Recent amendments, etc.

Published in: Health & Medicine
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Drug schedules

  1. 1. DRUG SCHEDULES PG Guide- Dr. Shyamal Sinha Presenter- Dr. Shivesh Gupta JR 1, Dept of Pharmacology, GGMC, Mumbai
  2. 2. Throughout the seminar…… ■ Introduction ■ History ■ Drugs and Cosmetics Act, 1940 ■ Chapters ■ Drugs and Cosmetics rules, 1945 ■ Drug Schedules ■ Recent Amendments ■ Summary ■ References
  3. 3. Introduction Pharmaceutical Company • After carrying out R&D, in compliance with government laws and policies Manufacturing, Marketing and distribution of drugs • In compliance with regulatory bodies (National/ International) Drugs reach retailer shops and consumers for medication use
  4. 4. Contd….
  5. 5. Contd….
  6. 6. • Inaccurate Diagnosis • Using inappropriate medications • Masking the symptoms of a serious condition • Delaying medical advice • Inaccurate dosage that leads to accidental overdose • Mixing medications that are not safe to mix • Risk of abuse • Risk of developing an addiction • In the worst-case scenario, self-medicating can lead to severe health conditions or even death.
  7. 7. Regulation ■ Here is where, the role of regulatory bodies of therapeutic goods, i.e. drugs and therapeutic devices, comes into play, to regulate this illegal trade and sale of drugs across the country and Globe. ■ The role of therapeutic goods regulation is designed mainly to protect the health and safety of the population. ■ Regulation is aimed at ensuring the safety, quality, and efficacy of the therapeutic goods.
  8. 8. History ■ Up until the 20th century, there were few federal laws regulating the contents and sale of domestically produced food and pharmaceuticals. ■ In June 1906, US signed into law the Food and Drug Act which prohibited the interstate transport and marketing of food that had been "adulterated." ■ President Franklin Roosevelt signed the new Food, Drug, and Cosmetic Act (FD&CAct) into law on June 24, 1938. ■ Soon after passage of the 1938Act, the FDA began to designate certain drugs as safe for use only under the supervision of a medical professional, and the category of "prescription-only" drugs was securely codified into law by 1951.
  9. 9. History  TILL 1930 : India was largely dependent on import of modern medicines until after first word war.  In August 1930 the government of India appointed a Drug Enquiry Committee under the chairmanship of R.N. Chopra, to go in to the question of adulterated & substandard drugs sold in country & to recommend steps by which this menace could be controlled.  In 1937 a Bill was introduced in the Central Legislative Assembly to give effect to the recommendations of the Drugs EnquiryCommittee to regulate the import of drugs into British India.  The Committee expressed the opinion that a more comprehensive measure for the uniform control of import, manufacture, distribution and sale of drugs was desirable.  The Drug Import Bill was prepared & placed for consideration before the Central Legislative assembly in 1939. It was passed & received assent of Governor General in Council & became Drug And Cosmetic Act in 1940.
  10. 10. Regulations inVarious countries  Therapeutic goods in the United States are regulated by the U.S. Food and Drug Administration (FDA), which makes some drugs available over the counter at retail outlets and others by prescription only.  Under the jurisdiction of controlled substance act of the United States of America ,drugs are categorized according to their potential abuse and are divided in 5 schedules.  These schedules have been detailed by United states PharmacopoeiaVol. XXII and by National Formulary.
  11. 11. Contd…. ■ Each of the controlled substances is identified under one of five Controlled Substances Schedules. ■ Schedule I ■ Schedule II ■ Schedule III ■ Schedule IV ■ ScheduleV
  12. 12. Contd…. ■ Schedule I Drugs – High potential for abuse. – No accepted medical use in the U.S. or lacks accepted safety for use in treatment in the U.S. – May be used for research purposes by properly registered individuals. • Examples: heroin, methylene dioxymethamphetamine, lysergic acid diethylamide, mescaline, and all salts and isomers thereof.
  13. 13. Contd…. ■ Schedule II Drugs – High potential for abuse. – Has a currently accepted medical use in the U.S. – Abuse of substance may lead to severe psychological or physical dependence. • Examples: morphine, oxycodone, fentanyl, meperidine, dextroamphetamine, cocaine, amobarbital
  14. 14. Contd…. ■ Schedule III Drugs – Abuse potential less than substances in schedule I or schedule II. – Has a currently accepted medical use in the U.S. – Abuse of substance may lead to moderate to low physical dependence or high psychological dependence. • Examples: anabolic steroids, nalorphine, ketamine, certain schedule II substances in suppositories, mixtures, or limited amounts per dosage unit
  15. 15. Contd…. ■ Schedule IV Drugs – Abuse potential less than substances in schedule III. – Has a currently accepted medical use in the U.S. – Abuse of substance may lead to limited physical or psychological dependence relative to substances in schedule III. • Examples: alprazolam, phenobarbital, meprobamate, modafinil
  16. 16. Contd…. ■ ScheduleV Drugs – Low potential for abuse relative to schedule IV. – Has a currently accepted medical use in the U.S. – Some scheduleV products may be sold in limited amounts without a prescription at the discretion of the pharmacist; however, if a physician wishes a patient to receive one of these products, it is preferable to provide a prescription. • Examples: buprenorphine, products containing a low dose of an opioid plus a non- narcotic ingredient such as cough syrup with codeine and guaifenesin, antidiarrheal tablets with diphenoxylate and atropine sulphate.
  17. 17. Contd…. In Canada,  Regulation of therapeutic goods are governed by the Food and Drug Act and associated regulations. ■ In addition, the Controlled Drugs and Substance Act requires additional regulatory requirements for controlled drugs and drug precursors In China:-  The regulation of drugs in China is governed by the State Food and Drug Administration.
  18. 18. Contd….  Medicines for Human Use in the United Kingdom are regulated by the Medicines and Healthcare products RegulatoryAgency (MHRA).  The United Kingdom has a three-tier classification system: 1. General Sale List (GSL) 2. Pharmacy medicines (P) 3. Prescription Only Medicines (POM)
  19. 19. Contd…. Australia ■ Therapeutic goods in Australia are regulated by the Therapeutic Goods Administration (TGA). ■ The availability of drugs and poisons is regulated by scheduling under individual state legislation, but is generally under the guidance of the National Standard for the Uniform Scheduling of Drugs and Poisons (SUSDP). Under the SUSDP, medicinal agents generally belong to one of five categories: ■ Unscheduled/Exempt ■ Schedule 2 (S2) - Pharmacy Medicines ■ Schedule 3 (S3) - Pharmacist Only Medicines ■ Schedule 4 (S4) - PrescriptionOnly Medicines ■ Schedule 8 (S8) - Controlled Drugs
  20. 20. Drugs and Cosmetics Act, 1940 ■ The Drugs and Cosmetics Bill was passed by the Central LegislativeAssembly and it received the assent of the Governor General on 10th April, 1940 and thus became the Drugs and Cosmetics Act, 1940 (23 of 1940). ■ The quality of the drugs imported, manufactured and sold in the country are regulated under the provisions of Drugs and Cosmetics Act, 1940 and Rules made there under. ■ 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.
  21. 21. Contd….  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 ControlAuthorities appointed by the State Governments.  The manufacture and sale of the drugs is regulated through a system of licensing and inspection by the Licensing Authorities.  The Central Drugs Standard ControlOrganization (CDSCO), headed by the Drugs Controller General (India) is concerned with the regulatory control over the quality of drugs & cosmetics.
  22. 22. Role of Drugs and CosmeticsAct, 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 DrugsTechnicalAdvisory Board(DTAB) and Drugs Consultative Committees(DCC) for Allopathic and allied drugs & cosmetics.
  23. 23. LIST OF AMENDING ACTS AND ADAPTATION 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
  24. 24. 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.
  25. 25. Contd…. ■ 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 IVA- Provisions relating to Ayurvedic, Siddha and Unani drugs ■ ChapterV- 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.
  26. 26. 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.
  27. 27. Contd…. ■ 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.
  28. 28. Contd…. ■ 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.
  29. 29. Contd…. ■ 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 claim for the drug or which is false or misleading in any particular
  30. 30. Schedules in D&C Act ■ First schedule – Names of books under Ayurvedic, Siddha and Unani systems. – A.—Ayurvedic system books like Arogya Kalpadruma,Arka Prakasha, etc. and Siddha systems books like VaidyaThirattu,Therayar Maha Karisal, etc. – B.—Unani system books like KarabadinQadri, 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.
  31. 31. Drugs and Cosmetics Rules, 1945 ■ The Drugs and Cosmetics Rules, 1945 is an Act of the Parliament of India which contains provisions for classification of drugs under given schedules and there are guidelines for the storage, sale, display and prescription of each schedule.
  32. 32. ScheduleA Gives the specimens of prescribed forms necessary for obtaining licenses, permits, certificates, intimations and so on. ■ FORM 2A- Certificate of test or analysis from the Pharmacopoeial Laboratory for Indian Medicine or Government Analyst ■ FORMS 3-7- (Omitted) ■ FORM 8 -Application for licence to import drugs (excluding those specified in Schedule X) to the Drugs and Cosmetics Rules, 1945 ■ FORM 8A - Application for licence to import drugs specified in Schedule X to the Drugs and Cosmetics Rules, 1945 ■ FORM 9 - Form of undertaking to accompany an application for an import licence ■ FORM 46- Permission / Approval for manufacture of new drug formulation ■ There are in total upto 50 forms.
  33. 33. Schedule B This Schedule includes fees for test or analysis by the Central Drug Laboratory or the Government Analyst. 1. Fees for test and assay of Drugs requiring use of animals – Eg:- Adrenocorticotrophic hormone assay- 1000 Rs 2. Microbiological tests and assays – Eg:- Microbiological assay of vitamins - 300 Rs 3. Identification tests – Eg:- Electrophoresis - Polyacrylamide Gel- 300 Rs 4. Physical tests- Optical rotation, Specific gravity,Viscosity, Solubility, pH, Refractive index, Solubility, Absorbancy, Disintegration and dissolution test.
  34. 34. Contd…. • Fees for Sera andVaccine , Cosmetics , Homoeopathic medicines, etc. are also included in Schedule B. • Schedule B(1) Fees for the test or analysis by the Pharmacopoeial Laboratory for Indian Medicine (PLIM) or the Government analyst Eg:- Determination of lethal does LD 50 to 10 on mice – 2500 Rupees
  35. 35. Schedule C  Schedule C:- Includes biological and special products such as Sera,Vaccines, Antigens,Toxin,Antitoxin, Insulin, Bacteriophages, solution of serum proteins intended for injection, etc.  Schedule C1:- Includes Other Special products such as Digitalis Preparations, fish liver oil, ergot preparations, Liver extract, vitamins, hormones, etc. ■ Labelled with the words-- ‘Caution: It is dangerous to take this preparation except under medical supervision’. ■ Prohibition of import of these products after expiry of potency.
  36. 36. Schedule D Provides extent and conditions of exemption regarding import of drugs. Eg:- 1. Class of drugs which are substances not intended for medicinal use  Exempted according to provisions of Chapter III of this Act and Rules, thereunder subject to the condition:-  If the substance is imported in bulk, the importer should certify that the substance is imported for non-medicinal uses, and  If imported otherwise than in bulk, each container should bear a label indicating that the substance is not intended for medicinal use or is intended for some purposes other than medicinal use. E.g. Skimmed milk, powdered milk fortified with vitamins, Lactose, cereal products, oats, ginger, pepper, cummins, etc. come under this class of drugs.
  37. 37. Contd…. 2. Drugs and cosmetics imported for manufacture and export:- – Exempted under the provisions of Chapter III of the Act and rules, provided:- ■ they are covered under an import licence, import registration and import through notified port of entry. ■ Subject to the conditions that these drugs and cosmetics shall not be diverted for sale in the country.
  38. 38. Schedule DI ■ Contains Information and undertaking required to be submitted by the manufacturer or his authorized agent with the Application Form for a Registration Certificate. ■ The details required are: 1. Particulars of the manufacturer and manufacturing premises 2. Particulars of the manufactured drugs to be registered under Registration Certificate 3.Undertaking to declare that manufacturer should comply with all the conditions imposed on the Registration Certificate.
  39. 39. Schedule DII ■ Here, the information is required to be submitted by the manufacturer for registration of a bulk drug/formulation/special product for its import into India. ■ The details required are: – General like name, regulatory status of drug, etc. – Chemical and pharmaceutical information of drugs. – Biological and biopharmaceutical information – Pharmacological and toxicological information of Drugs. – Clinical documentation – Labelling and packing information of drug – Specified information required for special products.
  40. 40. Schedule E Schedule E- Omitted as per GOI Notification No.G.S.R. 462(E) dt 22-6-1982. Schedule E (I):- List of poisonous substances under the Ayurvedic (including Siddha) and Unani Systems of Medicine : Ayurvedic System:- ■ Drugs ofVegetable origin :- Bhang, Dhatura, Jaiphala, etc ■ Drugs of Animal origin :- Snake Poison ■ Drugs of Mineral origin :- Hartala (arsenic), Parada (mercury), etc. ■ The container of a medicine for internal use should be labelled conspicuously with the words ‘Caution: To be taken under medical supervision’ both in English and Hindi language.
  41. 41. Schedule F  It includes requirements for the Functioning and operation of a blood bank and / or for preparation of blood components.  General :- Blood bank location, infrastructure requirements, Staff and equipments required, etc.  Minimum requirement for grant of license to procure blood components from whole human blood.
  42. 42. Contd….  F (I) :- Give details of the standards of bacterial vaccines, antisera and diagnostic antigens made from any microorganism pathogenic to man or other animals. ■ F (II):- Standards for Surgical Dressings that include bandage cloth, absorbent gauze, rolled bandage,etc ■ F (III):- Standards For UmbilicalTapes like umbilical polyester tape, cotton tape, etc.
  43. 43. Schedule FF It lays down Standards for Ophthalmic preparations. ■ Part-A. Ophthalmic Solutions and suspensions. 1. sterile when dispensed 2. contain suitable substances to prevent the growth of micro-organisms 3. free from foreign matter & in bottles made of either neutral glass or soda glass Label Contains:- o The statement ‘Use the solution within one month after opening the container’. o The words ‘NOT FOR INJECTION’. o WARNING:- “ Do not touch the dropper tip or other dispensing tip to any surface since this may contaminate solutions”. ■ Part B: Ophthalmic Ointments 1. sterile when dispensed 2. free from foreign matter 3. Label contains:- “Warning :- If irritation persists or increases discontinue the use and consult physicians”
  44. 44. Schedule G Medicines listed as schedule G medicines carry on the label a caution ■ Caution – “it is dangerous to take this preparation except under medical supervision” ■ The Caution is conspicuously printed and surrounded by a line within which there should be no other words.  It is necessary to make proper bill of sale.  Records of purchase and sale of these medicines must be maintained for a period of 2 years. ■ Eg:Aminopterin, L-Asparaginase, Bleomycin, Busulphan, Chlorambucil,Chlorthiazide,Glibenclamide, Hydantoin, Hydroxyurea, Insulin, Metformin, etc.
  45. 45. Schedule H • This Schedule includes PRESCRIPTION DRUGS i.e. Drugs and Medicines which must be sold by retail only when a prescription by RMP is produced. • The time and date of prescription must be noted. • The drug label must display the texts "Rx" and "Schedule H drug. Warning :To be sold by retail on the prescription of a Registered Medical practitioner only" prominently. • Drugs specified in Schedule H, and comes within {Narcotic Drugs and Psychotropic Substances Act, 1985} labelled with the symbol “NRx” & Schedule H drugWarning prominently. • Contains a list of 536 drugs. • Eg:- Abxicimab, Acyclovir, Diclofenac, Baclofen, Carbidopa, Terazosin, etc.
  46. 46. Schedule H1 ■ Schedule H1:- Introduced under the Drugs and Cosmetics (4th amendment ) rules 2013, by MOHFW on 30 Aug, 2013 vide GSR 588 (E) to regulate sale of antibiotics. ■ To have separate regulation to check unauthorized sale of antibiotics, thus monitoring use and abuse of these antibiotics. ■ Here, the drug has to be labelled with symbol “Rx” in red and conspicuously displayed on left corner of the label with the following words in box with red border  Warning- 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. ■ Eg:-Alprazolam, Gemifloxacin, Isoniazid, Cefixime, Levofloxacin, Cefpodoxime, Clofazimine, Zolpidem, etc
  47. 47. Schedule I  Particulars as to proportion of poison in certain cases.  Omitted by GOI Notification No. G.S.R 462(E) dt 22.6.1982 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.  Eg :-AIDS, Blindness, Deafness, Encephalitis, Diabetes, Leukemia, Paralysis, etc.
  48. 48. Schedule K  The drugs specified in Schedule K shall be exempted from the provisions of Chapter IV of the Act and the Rules to the extent and subject to the conditions specified in that Schedule.  Class of Drugs which is not sold for medicinal use should be labelled conspicuously with the words “NOT FOR MEDICINAL USE”.  However, these drugs should not contain any substance specified in Schedules G, H or X of D&CAct and Rules.  The Mashelkar Recommendation Committee on Drug Regulatory System suggested to expand the scope of Schedule K to include OTC drugs.
  49. 49. OTC Drugs  The phrase ‘OTC’ has no legal recognition in India, all the drugs not included in the list of ‘prescription-only drugs’ are considered to be non-prescription drugs (or OTC drugs).  Hence ‘OTC Drugs’ means drugs legally allowed to be sold ‘OverThe Counter’ by pharmacists, i.e. without the prescription of a Registered Medical Practitioner.  Prescription-only drugs are those medicines that are listed in Schedules H and X and G of the Drug and Cosmetics Rules.  Currently, non drug-licensed stores (e.g. non-pharmacists) can sell a few medicines classified as ‘Household Remedies’ listed in Schedule K.
  50. 50. Contd….  The Schedule K include:-  Quinine Sulphate 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.  The medicines that continue to be under 'household remedy' category:-  Paracetamol tablets, Analgesic Balms, Antacid Preparations, Calcium preparations with or withoutVitamin D, GripeWater for use of infants, Inhalers (containing drugs for treatment of cold and nasal congestion), Syrups lozenges, pills and tablets for cough, cold or sore throat.
  51. 51. Schedule L Schedule L:- Omitted Schedule L (I) :- Good Laboratory Practices and requirements of premises and equipments, Chemicals & Reagents, etc.
  52. 52. Schedule M This Schedule 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 and large volume parenterals) and sterile ophthalmic 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- specific requirements of premises, plant and materials for manufacture of active pharmaceutial ingredients (bulk drugs) ■ Part 2 :- Requirements of Plant and equipments
  53. 53. Good Manufacturing Practices (GMP)  General requirements:-  Location and surroundings- Free from open sewage,public lavatory, dust, smoke, excessive soot, obnoxious odour, chemical or biological emission  Buildings and premises- Designs suitable for manufacturing operation and maintain hygiene.  Water system-Validated system for water treatment to make it usable and free from microbial growth.  Disposal of wastes- Disposal shall be according to Environment Pollution Control Board and as per provision. ■ Warehousing area- Designs allow sufficient and orderly warehousing of various categories of materials and products. ■ Production area-Area shall be designed to allow the production preferably in uniflow with logical sequence of operation and avoiding the risk of cross contamination.
  54. 54. Contd…. ■ Quality control area- Lab independent of production area with separate and adequate space for each type of testing. ■ Manufacturing operation-All operations shall be carried out under supervision of technical staff approved by LicensingAuthority. ■ Documentation and record- It shall specify the title, nature and purpose and laid out in orderly fashion.
  55. 55. Contd…. 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.
  56. 56. Schedule N o List of minimum equipment for the efficient running of a pharmacy o Gives directions to Pharmacies regarding:- a) Entrance of Pharmacy b) Premises c) Furniture & Apparatus d) General Provisions. o Entrance shall bear an inscription “Pharmacy” in front
  57. 57. 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. (A)Black fluids- Homogeneous dark brown solution of coal tar acid or similar acids. (B)White fluids- Finely dispersed homogeneous emulsion of coal tar acid or similar acids.
  58. 58. 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.  The schedule includes antibiotics, vitamins, insulin preparation, normal human plasma, sera toxins, toxoids , other toxins , anti-toxins, miscellaneous drugs. Drug Life Period (months) Storage Adramycin 30 In a Cool place Ampicillin 36 In a Cool place Ampicillin Sodium 36 In a Cool place AmpicillinTrihydrate 30 In a Cool place
  59. 59. Schedule P1  Schedule P1 – specifies the pack size of certain drugs.  It gives the names of drugs, along with the dosage form and the pack size.  No other pack size than the one listed is allowed to be marketed. Drug Dosage form Pack Size Aspirin (Low Dose) Tablets 14Tabs Cholecalciferol Granules 1gm Sachet Famotidine Tablets 14Tabs GlycerylTrinitrate Spansules 25 Spansules
  60. 60. Schedule Q  Gives the list of dyes, colors and pigments permitted to be used in cosmetics and soaps.  No drug should contain a colours other than specified specified by the Bureau of Indian Standards below : (1) Natural Colours:- Carotene, Chlorophyll, Red Oxide of Iron, Yellow Oxide of Iron,Titanium Di-oxide, BlackOxide of iron (2) Artificial Colours:-Caramel (3) CoalTar Colours
  61. 61. Schedule R  Standards for condoms made of rubber latex intended for single use and other mechanical contraceptives.  Eg.Condom, Cu-T, etc  Label contain:- – The date of manufacture. – The date up to which the contraceptive is expected to retain its properties. Schedule R1  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
  62. 62. Schedule S  Prescribes Standard 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). 1. Skin Powders 2. Tooth Powder 3. Toothpaste 4. Shaving Creams 5. Hair Creams 6. Shampoo 7. Nail Polish
  63. 63. ScheduleT  Lays down the Good Manufacturing Practices for Ayurvedic, Siddha and Unani Medicines  PART I:- GOOD MANUFACTURING PRACTICES  PART II:- List of recommended machinery, equipment and minimum manufacturing premises required for the manufacture of various categories of ayurvedic, siddha system of medicines.
  64. 64. Schedule U & U1  Gives the particulars to be shown in manufacturing records.  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 & 3 years for Cosmetics from the date of manufacture ScheduleV  Give details of standards for patent and proprietary medicines.
  65. 65. ScheduleW  Inserted as per G.O.I. Notificiation No. GSR 27(E) dt 17.1.1981 and deleted as per G.O.I. Notification No. GSR 94(E) dt 8.2.2000.  Gives the name of the drugs which shall be marketed under generic names only.  Its label contain the Names and quantities of active ingredients.  This includes only five drugs that shall be marketed under generic names only: 1. Analgin 2. Aspirin and its salt 3. Chlorpromazine and its salt 4. Ferrous sulfate 5. Piperazine and its salts
  66. 66. Schedule X  Contains list of narcotic drugs and psychotropic substance.  Have a warning mentioned on a label ‘Schedule X drug’ -Warning : to be sold on retail on prescription of a RMP only.  The label will also have a symbol ‘NRx’ in red & conspicuously displayed on the top left corner.  After dispending the drug the pharmacist must Stamp & retain the prescription for 2 years.  Maintain & record purchase & sale of the drug and preserve it for a period of 2 years from the date of transactions.  All the regulations of Schedule H apply.The drugs must be kept under lock and key.  Examples of few drugs under schedule X :- Phencyclidine, Secobarbital, Amobarbital, Amphetamines, Glutethimide, Methylphenidate, etc.
  67. 67. ScheduleY This Schedule includes requirements and guidelines for permission to import and / or manufacture of new drugs for sale or to undertake clinical trials It include:  Application for permission  Clinical trial:-  Approval for trial  Responsibilities of sponsor, investigator, Ethics Committee  Phases I, II, III, IV  Studies in special population like Geriatric, Paediatric and Pregnant/ Nursing women  Post Marketing Surveillance
  68. 68. Data required to be submitted with application for permission to market a New Drug 1. Introduction 2. Chemical And Pharmaceutical Information 3. Animal Pharmacology 4. AnimalToxicology 5. Human/Clinical Pharmacology (Phase I). 6. Exploratory ClinicalTrials (Phase II). 7. Confirmatory ClinicalTrials (Phase III) 8. Special Studies 9.Regulatory Status In Other Countries. 10. Prescription Information.
  69. 69. ClinicalTrials  Nature of trials. -The clinical trials required to be carried out in the country before a new drug is approved for marketing depend on the status of the drug in other countries.  Drug already approved/marketed--- Phase III trials required.  Drug not approved / marketed--- trials started one phase earlier to the phase of trials in other countries.  New drug substances discovered in other countries--- phase I trials are not usually allowed to be initiated in India unless Phase I from other countries are available.  New drug substances discovered in India, clinical trials carried out in India right from phase I.
  70. 70. ScheduleY1 ■ Amended under Rule 122- DAB ■ This Schedule includes Registration of Clinical Research Organization (CRO) for conducting clinical trials. ■ It also deals with compensation in case of Injury / Death duringTrial.
  71. 71. RecentAmendments  In the Drugs and Cosmetics Rules, 1945, in Rule 3A, in sub-rule (8), in clause (b), after item (5) and the entries relating thereto, the following shall be inserted, namely:- (6) Enzyme and Hormones such as- Streptokinase, HCG, etc. (7) Bacterial vaccine such as- (BCG) vaccine (8) Viral vaccines such as- Live Attenuated Measles & RubellaVaccine, Cell culture Rabies vaccine  Serial No. "537. Etizolam" is added in Schedule H, after serial number 536 wef from 30.3.2017.  In the Drugs and Cosmetics Rules, 1945, Rule 135A and 145D substituted with new Regulation for cosmetics containing Mercury.
  72. 72. Summary  The Drug & Cosmetics Act and Rules controls how medicines and chemicals are made available to the public.  They ensure that good quality medicines and cosmetics are made available to consumers from the manufacturers.  The growing impact of regulations on the economy has led the administration to search for new ways of reforming and amending the regulatory process to make it more feasible.  These regulatory processes thus play a key role in protecting public health and safety.
  73. 73. References ■ Drugs and CosmeticsAct, 1940. Available at https://en.wikipedia.org/wiki/Drugs_and_Cosmetics_Act,_1940#Amendments ■ Drugs and Cosmetics Rules, 1945. Available at https://en.wikipedia.org/wiki/Drugs_and_Cosmetics_Rules,_1945 ■ Goodman, Gilman, L.Bruton:The Pharmacological Basis ofTHERAPEUTICS; 12th Edition. NewYork: McGraw Hill Medical; 2011. ■ H L Sharma, K K Sharma: Principles of Medical Pharmacology; 3rd Edition .New Delhi: Paras publisher; 2017. ■ Dr. B. S. Kuchekar (8 January 2008). Pharmaceutical Jurisprudence. Pragati Books Pvt. Ltd. pp. 5.0–5.2 ■ Dr. Lily Srivastava. Law & Medicine. Universal Law Publishing. pp. 216–. ISBN 978-81-7534-949-0. ■ http://www.medindia.net/indian_health_act/drugs-and-cosmetics-act-1940-introduction.htm ( history of D&C act) ■ Ministry of Health and FamilyWelfare, GSR 588 (E) dated 30 Aug, 2013. Available at http://www.drugscontrol.org/amendments.asp?act=Drugs%20and%20Cosmetics%20Rules,%201945 ■ Ministry of Health and FamilyWelfare, G.S.R. 103 (E) dated 02nd February, 2017.

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