Drug schedules

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, 1945
■ Drug Schedules
■ Recent Amendments
■ Summary
■ References

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

• 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.

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.

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.

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.

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.

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

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.

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

Contd….
■ Schedule III Drugs
– Abuse potential less than substances in schedule I or schedule II.
– 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

Contd….
■ Schedule IV Drugs
– Abuse potential less than substances in schedule III.
– Abuse of substance may lead to limited physical or psychological dependence
relative to substances in schedule III.
• Examples: alprazolam, phenobarbital, meprobamate, modafinil

Contd….
■ ScheduleV Drugs
– Low potential for abuse relative to schedule IV.
– 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.

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.

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)

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

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.

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.

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.

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).
7. The Drugs and Cosmetics (Amendment) Act, 1964
12. The Drugs and Cosmetics (Amendment) Act,2003

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.

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.

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.

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.

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.

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

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.

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.

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.

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.

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

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.

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.

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.

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.

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.

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.

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.

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.

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”

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.

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.

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

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.

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.

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.

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.

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

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

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.

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.

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.

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

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.

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

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

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

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

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

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.

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.

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

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.

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

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.

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.

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.

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.

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.

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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