Categories of drugs and Drug schedule

1. DRUG SCHEDULES
Dr (Maj) Pankaj N Surange
MBBS,MD, FIPP
Director, IPSC India
Hon Secretary, ISSP-Chapter IASP
Founder, Neuromodulation Spine Society
Past Chairman, World Institute of Pain

2. 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

3. · 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.

4. 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 .

5. 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 Enquiry Committee 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.

6. Scheduling in Various 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 Pharmacopoeia Vol. XXII and by
National Formulary.

7. Contd ….
■ Each of the controlled substances is identified under one of five Controlled Substances
Schedules.
■ Schedule I
■ Schedule II
■ Schedule III
■ Schedule IV
■ Schedule V

8. 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.

9. 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

10. 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

11. 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
Tramadol was included in 2014

12. Contd ….
■ Schedule V Drugs
– Low potential for abuse relative to schedule IV.
– Has a currently accepted medical use in the U.S.
– Some schedule V 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

13. 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 .

14. Contd ….
! Medicines for Human Use in the United Kingdom are regulated by the Medicines and
Healthcare products Regulatory Agency (MHRA).
! The United Kingdom has a three - tier classification system :
1. General Sale List (GSL)
2. Pharmacy medicines (P)
3. Prescription Only Medicines (POM)
Tramadol: U.K., where it is now a class C schedule 3 drug,

15. 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) - Prescription Only Medicines
■ Schedule 8 (S8) - Controlled Drugs

16. Drugs and Cosmetics Act, 1940
■ The Drugs and Cosmetics Bill was passed by the Central Legislative Assembly
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.

17. 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.

18. 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.

19. 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 .

20. 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

21. 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.

22. Schedule A
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.

23. 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.

24. 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 O ther 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.

25. 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 a ccording 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
! I f 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.

26. 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 of Vegetable 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.

27. 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.

28. Schedule FF
It lays down Standards for O phthalmic 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 ”

29. 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.
■ Eg : Aminopterin , L - Asparaginase, Bleomycin , Busulphan ,
Chlorambucil , Chlorthiazide, Glibenclamide, Hydantoin ,
Hydroxyurea , Insulin, Metformin, etc.

30. 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 drug Warning prominently.
· Contains a list of 536 drugs.
· Eg : - Abxicimab, Acyclovir, Diclofenac, Baclofen, Carbidopa ,
Terazosin, etc.

31. Schedule H1
■ Schedule H1:- Introduced under the Drugs and Cosmetics (4 th
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
Tramadol in 2014

32. 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.

33. 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&C Act and Rules.
! The Mashelkar Recommendation Committee on Drug
Regulatory System suggested to expand the scope of Schedule
K to include OTC drugs.

34. 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 ‘Over The 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.

35. 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
without Vitamin D, Gripe Water 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.

36. Schedule L
Schedule L:
Schedule L (I) :-
Good Laboratory Practices and requirements of premises and equipments ,
Chemicals & Reagents, etc.

37. Schedule M
This Schedule includes Good Manufacturing Practices and requirements of premises, plant
and equipment for manufacture of pharmaceutical products.
■ P art 1 : - Good Manufacturing P ractices for premises and materials
– 1A - Specific requirements for manufacture of sterile products , parenteral
preparations (small volume injectables and 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- specific requirements of premises, plant and materials for manufacture of
active pharmaceutial ingredients (bulk drugs)
■ Part 2 : - Requirements of Plant and e quipments

38. Schedule N
o List of minimum equipment for the efficient running of a
pharmacy
o G ives 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

39. 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.

40. 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
Ampicillin Trihydrate 30 In a Cool place

41. 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, Black Oxide of iron
(2) Artificial Colours: - Caramel
(3) Coal Tar Colours

42. 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

43. 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

44. Schedule T
# 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.

45. 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
Schedule V
! Give details of standards for patent and proprietary medicines .

46. Schedule W
" 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

47. 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.
# The drugs must be kept under lock and key.
# Examples of few drugs under schedule X : - Phencyclidine, Secobarbital ,
Amobarbital, Amphetamines, Glutethimide , Methylphenidate, etc .

48. 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
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

50. References
■ Drugs and Cosmetics Act, 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 of THERAPEUTICS; 12 th Edition. New York:
McGraw Hill Medical; 2011.
■ H L Sharma, K K Sharma: Principles of Medical Pharmacology; 3 rd 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 Family Welfare , 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 Family Welfare, G.S.R . 103 (E) dated 02nd February, 2017.

51. Online survey on use of Tramadol in India

52. Practicing pain physicians of India
ISSP Members

53. Do you use Tramadol in your practice?

54. How many percentage of your patients needs Tramadol as part of treatment to control pain?

55. Do you have easy access to other opioids for pain management?

56. What is the level of dependence you have noticed in your clinical practice

57. Where do you use Tramadol in your clinical practice

58. Do you see better safety and better results with combination of Tramadol with PCM than Tramadol alone?

59. Has NDPS act impacted your practice in terms of availability and access