Drug schedule v1 dated 27 6-2014

Drug Schedules
By Dr Sonali More.
JR-2, Dept. of Pharmacology
Guide-Dr B.B. Ghongane.

History
 POSITIN 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 control.
 The Drug Enquiry Committee submitted its report in 1931,the government
of India could not give effect to its recommendation till 1937.
 After passing of the Government of India Act,1935, drug became
provincial subject & therefore center could pass law in respect of only
imports.
 The Drug Import Bill was prepared & placed for consideration before the
assembly in 1939. This was not acceptable to the public & provinces for
uniform & comprehensive legislation. This led to the introduction of the
Indian Drug Bill in the Central Legislative assembly. It was passed &
received assent of Governor General in Council & became Drug And
Cosmetic Act in 1940.

Drug and Cosmetic Act,1940
• The quality of the drugs imported, manufactured and sold in the
country is regulated under the provisions of Drugs and Cosmetics
Act, 1940 and Rules made there under.
• The Act visualizes the regulatory control over the drugs imported in
to the country by the Central Government while the manufacture,
sale and distribution of drugs is primarily regulated by the State
Drug Control Authorities appointed by the 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 Control Organization (CDSCO), headed
by the Drugs Controller General (India) is concerned with the
regulatory control over the quality of drugs &cosmetics.
• The organization has its head quarters at New Delhi and has six
zonal offices, two sub zonal offices, seven seaports/Airports offices
and six laboratories under its control.

OBJECTIVES
To prevent substandard in drugs, maintaining high standards of medical
To regulate the import, manufacture, distribution and sale of drugs & cosmetics
through licensing.
Manufacture, distribution and sale of drugs and cosmetics by qualified persons
only.
To regulate the manufacture and sale of Ayurvedic, Siddha and Unani drugs.
To establish Drugs Technical Advisory Board(DTAB) and Drugs Consultative
Committees(DCC) for Allopathic and allied drugs and cosmetics.
4

• CHAPTER I
INTRODUCTION
Short title, extent and commencement and Definitions
• CHAPTER II
THE DRUGS TECHNICAL ADVISORY BOARD, THE CENTRAL DRUGS LABORTORY
AND THE DRUGS CONSULTATIVE COMMITTEE
• CHAPTER III
IMPORT OF DRUGS AND COSMETICS, Standards of quality, Misbranded drugs,
Adulterated drugs ,Spurious drugs., Misbranded cosmetics., Spurious
cosmetics etc.
• CHAPTER IV
MANUFACTURE, SALE AND DISTRIBUTION OF DRUGS AND COSMETICS
Chapters in the
“Drugs and Cosmetics Act and Rules”

• CHAPTER IVA
PROVISIONS RELATING TO AYURVEDIC SIDDHA AND UNANI DRUGS
• CHAPTER V
MISCELLANEOUS like Publication of sentences passed under this Act,
Magistrate’s power to impose enhanced penalties

Provisions
of Act
Import Manufacturing Sales
Labeling &
Packaging
Drug & Cosmetics Act,1945

 The Repealing and Amending Act, 1949.
 The Adoption of Laws Order, 1950
 The part B States (Laws) Act, 1951.
 The Drugs (Amendment) Act, 1955 .
 The Drugs (Amendment) Act, 1960.
 The Drugs (Amendment) Act, 1962 .
 The Drugs and Cosmetics (Amendment) Act, 1964 .
 The Drugs and Cosmetics (Amendment) Act, 1986.
 The Drugs and Cosmetics (Amendment) Act, 1995
 The Drugs and Cosmetics (Amendment) Act,2003
 The Drugs and Cosmetics (Amendment) Act,2008
 The drugs and cosmetics (Amendment) Act,2013
List Of Amending Acts And Adaptation
Orders

• According to the Drug & Cosmetic Act 1940 (along with the Drugs
and Cosmetic Rules 1945) the schedules for the drugs are as
follows
Schedule A
 Gives the specimens of prescribed forms necessary for obtaining
licenses, permits, certificates, intimations and so on.( about 50 in
no)
• Form 2-Certificate of test or analysis by the Central Drugs
Laboratory
• Form 8- Application for license to import drugs (excluding those
specified in Schedule X) to the Drugs and Cosmetics Rules 1945.
• Form 8 A- Application for license to import drugs specified in
Schedule X to the Drugs and Cosmetic Rules 1945.
• Form no 46-Permission / Approval for manufacture of new drug
formulation.

FORM 8
(See Rule 24)
Application for licence to import drugs (excluding those specified in Schedule X) to the Drugs
and Cosmetics Rules 1945.
I/We* ………………………………………….. (full address with telephone number, fax
number and e-mail address) hereby apply for a licence to import drugs specified below
manufactured by M/s ………………………………(full address with telephone no, fax and email
no.).
2. Names of the drugs to be imported:
(1)
(2)
(3)
3. I/We* …………………………………. enclose herewith an undertaking in Form 9
dated………. signed by the manufacturer as required by rule 24 of the Drugs and Cosmetics
Rules, 1945.
4. I/We …………………………………. enclose herewith a copy of Registration
Certificate concerning the drugs to be imported in India, issued under Form 41 of the rules,
vide Registration Certificate No. …………dated ………….. issued through M/s.
.………………….(name and full address)……………………valid up to …………………..
I/We* ……………………………….. hold a valid wholesale licence for sale or
distribution of drugs or valid licence to manufacture drugs, under the provisions of the Act and
rules made thereunder. A copy of the said licence is enclosed.
6. A fee of ………….. has been credited to Government under the Head of Account “0210
– Medical and Public Health, 04-Public Health, 104-Fees and Fines” under the Drugs and
Cosmetics Rules 1945 – Central vide Challan No. ……………… dated ……….. (attached in
original)
Signature ………………..
Name ………………..
Designation …………
Seal/Stamp of Manufacturer’s agent in India
Place ……..
Date ………..
___________________________________________________________________________

FORM 8-A
Application for licence to import drugs specified in Schedule X to the Drugs and Cosmetic
Rules 1945.
I/We* ……………………………(full address with telephone number, fax number and e-mail
address) hereby apply for a licence to import drugs specified below manufactured by
M/s………………………… (full address with telephone No, fax and e-mail No.).
2. Name of the drugs to be imported.
(1)
(2)
(3)
3. I/We* ………………………… enclose herewith an undertaking in Form 9 dated
………… signed by the manufacturer as required by rule 24 of the Drugs and
Cosmetics Rules, 1945.
4. I/We* ………………………….. enclose herewith a copy of Registration Certificate
concerning the drugs to be imported in India, issued under Form 41 of the rules, vide
Registration Certificate No. …………. dated ………………. issued through M/s.
……………………….(name and full address) ………..……….. valid upto ……
5 I/We* ………………. Hold a valid wholesale licence for sale or distribution of drugs
or licence to manufacture drugs, under the provisions of the Act and rules made
thereunder. A copy of the said licence is enclosed.
6. A fee of ……………….. has been credited to Government under the Head of Account
“0210 – Medical and Public Health, 04- Public Health, 104- Fees and Fines” under the
Drugs and Cosmetics Rules 1945 – Central vide Challan No. ……. dated ……….. (
attached in original).
Signature ………………..
Name ………………..
Designation …………
Seal/Stamp of Manufacturer’s agent in India
Place ……..
Date ………..

Schedule B
 States fees for test or analysis by the Central Drug
Laboratory or the Government Analyst.
Under this schedule fees of for tests are mentioned :
• 1. Test and assay of Drugs requiring use of animals
• 2. Microbiological tests and assays
• 3. Identification tests like chemical,microscopical, UV
spectroscopy, Chromatography, Electrophoresis
• 4. Physical tests- Optical rotation, Specific gravity,
Solubility,pH, Refractive index, Disintegration and
dissolution test.

Schedule C & C1
C: Deals with biological products such as sera
antigens, toxin, antitoxin, Vaccines for
parenteral injections, solution of serum proteins
intended for injection, Insulin etc
C1: Special products such as fish liver oil, ergot
preparations, drugs belonging to digitalis groups,
adrenaline, Liver extract,vitamines, hormones

Labelling special
Class of
drugs
Nature of medicines Specific particulars appeared on label
Schedule
C/C1
In original form 1) Proper name in addition to patent name
2) Potency in units
3) Name & address of manufacturer
4) Licence No. under which manufacturer
5) Date of manufacture
6) Date of expiry
7) Precaution for preparation

Schedule D
 Devoted to exemption regarding import of drugs. Substances
not intended for medicinal use
 According to provisions of Chapter III of this Act and Rules ,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,
farex, oats, ginger, pepper, cummins etc

Schedule D(I)
• Following information and undertaking required to be
submitted by the manufacturer or his authorized agent
with the Application Form for a Registration Certificate.
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 D (II)
• Following information required to be submitted by the
manufacturer or his authorized agent with the
Application Form for the registration of a bulk
drug/formulation/special product for its import into
India.
 General
 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 & E1
[Omitted as per GOI Notification
No.G.S.R. 462(E)
dt 22-6-1982]
 SCHEDULE E (I)-Gives the list of
poisonous substances under
Ayurvedic, Siddha & Unani systems
of medicine.
 Ex- Snake poison,
arsenic,mercury,CuSo4
Dhatura, Bhang, Gunj etc

Schedule F and F (I)
F states requirements for functioning of blood
bank & preparation of blood component.
F (I) : Give details of the standards of bacterial
vaccines made from any microorganism
pathogenic to man or other animals and also
the vaccines made from other microorganisms
which have any antigenic value.

Schedule FF
 Gives details of standards for ophthalmic preparations.
Part A
 Ophthalmic Solutions and Suspensions
 a)should be sterile when dispensed or when sold in the unopened
container of the manufacturer.
 b)contain one or more of the following suitable substances to prevent
the growth of micro -organisms.
• Benzalkonium Chloride, 0.01 per cent
• Phenyl mercuric nitrate, 0.001 per cent.
• Chlorbutanol 0.5 per cent.
• Phenyl ethyl alcohol 0.5 per cent
 (c) free from foreign matter.
 d) contained in bottles made of either neutral glass or soda glass
specially treated to reduce the amount of alkali released when in
contact of aqueous liquids, or in suitable plastic containers which
would not in any way be incompatible with the solutions.

 e)following particulars should also be shown on the label:-
(1) containers
(i) The statement ‘Use the solution within one month after
opening the container’.
(ii) Name and concentration of the preservative, if used.
(iii) The words ‘NOT FOR INJECTION’.
(2) carton or package leaflet
(i) Special instructions regarding storage, wherever applicable.
(iii) WARNING.
“ Do not touch the dropper tip or other dispensing tip to any
surface since this may contaminate solutions”.

Part-B. Ophthalmic Ointments
Ophthalmic Ointments should-
(a) be sterile when dispensed or when sold in the unopened
container of the manufacturer.
(b) be free from foreign matter.
(c) following particulars should be shown on the container or
carton or package leaflet-
(i) Special instructions regarding storage wherever applicable.
(ii) “Warning :- If irritation persists or increases discontinue the
use and consult physicians”

Schedule F (II)
• Gives details of standards for
Surgical dressings and bandage
cloth.
Schedule F (III)
 Gives standard for umbilical tapes.

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”. 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: L asperginase,Bleomycin, Busulphan, chlorambucil,
chlorthiazide, chlorpropamide, doxorubicin, ethosuximide,
Metformin, Insilin all types,Hydroxyurea, Mercaptopurines etc

Schedule H ((Drugs & cosmetics (2nd amendment)
Rules 2006)
• Deals with drugs and medicines which must be sold by retail only
when a prescription by Registered Medical Practitioner is
produced.
• Drugs come under Schedule H should be labelled with the symbol
Rx and conspicuously displayed on the left top corner of the label.
• Drugs specified in Schedule H, and comes within [Narcotic Drugs
and Psychotropic Substances Act, 1985 labelled with the symbol
NRx which shall be in red and conspicuously displayed on the left
top corner of the label.
• Examples-Alprazolam, Allopurinol, Amikacin, Atenolol
,Acyclovir, Buspirone, Azathioprine, Captopril, Carbidopa,
Clindamycin, Cimetidine, Ciprofloxacin,Cefuroxime,DiclofenaC,
• Glimepiride, diazepam etc.

For monitoring use and misuse of
antibiotics
• Schedule H of the drug and cosmetics act contains a list of 536
drugs which are required to be dispensed on the prescriptions of a
registered medical practitioner.
• In order to have separate regulation to check unauthorized sale of
antibiotics, a separate schedule as Schedule H1 may be introduced
under the Drugs and Cosmetics (4th amendment ) rules 2013 to
regulate sale of antibiotics exclusively.
• Under schedule H1, drug formulations should 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-
It is dangerous to take this preparation except in accordance with the
medical advice.
Not to be sold by retail without the prescription of a RMP.

Drugs under schedule H
are omitted
Drugs under Schedule H1
Alprazolam Thiacetazone Alprazolam Diazepam
Cefdinir zolpidem Cefdinir Codein
Cefepime Ethambutol HCl Cefepime Cycloserine
Clofazamine Meropenem Cefixime Ertapenem
Codein Ethionamide Cefoperazone Doripenem
Diazepam Nitrazepam Imipenem Ethambutol HCl
Cefpirone Pentazocine Midazolam Gemifloxacin
Midazolam Sparfloxacine Cefpirome Rifampicin
Tramadol Chlordaizepoxide Ceftriaxone Tramadol

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
 Schedule J specifies the disease and ailments, for which no
drug should claim prevention or cure.
 Some of the diseases and ailments under this schedule are
1. AIDS
2. Angina Pectoris
3. Appendicitis
4. Arteriosclerosis
5. Baldness
6. Blindness
7. Bronchial Asthma
8. Cancer and Benign tumour
9. Cataract
10. Change in colour of the hair and growth of new hair.
11. Change of Foetal sex by drugs.
(almost 51 ailments mentioned on Schedule J)

Schedule K
 Schedule K specifies the extent and conditions of exemption for
certain class of drugs from the provisions of the Chapter IV of this
act.
 Class of Drugs is not sold for medicinal use and that each container
is labelled conspicuously with the words “NOT FOR MEDICINAL
USE”.
 The medicines that continue to be under the 'household remedy'
category include 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.
 However, these drugs should not contain any substance specified in
Schedules G, H or X of D&C Act and Rules. The shopkeepers are also
to ensure that the drugs are sold in the original unopened
containers of the licensed manufacturers.
 Note- Aspirin and Quinine Sulphate have been removed from this
schedule

Mashelkar Committee recommendations
• The Committee on Drug Regulatory System headed by the Chief Dr
Mashelkar.
• suggested to expand the scope of Schedule K to include OTC
drugs.
• The ultimate objective is to enhance public access to commonly
required medicines but at the same time ensuring quality of
delivery.
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).
• 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 Schedule

Ayurvedic (OTC) Medicines
• OTC drugs registered as “Ayurvedic Medicines”
containing natural / herbal ingredients
• Ayurvedic drugs are manufactured under a
manufacturing license issued by the Ayurvedic State
Licensing Authorities. However, they do not require a
drug sale license and can be sold freely by non-
chemists.
• Largest OTC brands in India are registered as
“Ayurvedic Medicines‟ because of their plant-based
natural active ingredients

Categories with OTC potential
• Vitamins and minerals;
• Health tonics,
• Cough suppressants likes vicks 44
• Gastrointestinal drugs like Gas X
• Analgesics
• Dermatological preparations
• Herbal / Ayurvedic medicines

Schedule L
 Omitted
Schedule L-I ( Drugs and cosmetics (3rd
amendment) Rules 2008)
 “Good Laboratory Practices and requirement
of premises and equipments as laid down in
Schedule L-I
Schedule M
 Deals with the Good Manufacturing Practices
(GMP) and requirements of premises , plant
and equipment.
 Part I deals with GMP & Factory premises.
 Part II deals with plant and equipment.

• GENERAL REQUIREMENTS
 Location and surroundings.- The factory building(s) for manufacture of
drugs should be so situated and should have such measures as to avoid
risk of contamination from external environmental including open sewage,
drain, public lavatory or any factory which product disagreeable or
obnoxious odour, fumes, excessive soot, dust, smoke, chemical or
biological emissions.
 Building and premises.- The building(s) used for the factory should be
designed, constructed, adapted and maintained to suit the manufacturing
operations so as to permit production of drugs under hygienic conditions.
They should conform to the conditions laid down in the Factories Act,
1948
 Water Supply. –
There should be validated system for treatment of water drawn from own
or any other source to render it potable in accordance with standards
specified by the Bureau of Indian Standards or Local Municipality.
Purified Water conforming to Pharmacopoeial specification. Purified
Water so produced should only be used for all operations except washing
and cleaning operations where potable water may be used. Water should
be stored in tanks, which do not adversely affect quality of water and
ensure freedom from microbiological growth. The tank should be cleaned
periodically and records maintained by the licensee in this behalf.
GOOD MANUFACTURING PRACTICES FOR PREMISES AND
MATERIALS.

• Disposal of waste. -
 The disposal of sewage and effluents (solid, liquid and gas) from the
factory should be in conformity with the requirements of Environment
Pollution Control Board.
 All bio-medical waste should be destroyed as per the provisions of the
Bio-Medical Waste (Management and Handling) Rules, 1996.
 Additional precautions should be taken for the storage and disposal of
rejected drugs. Records should be maintained for all disposal of waste.
 Provisions should be made for the proper and safe storage of waste
materials awaiting disposal. Hazardous, toxic substances and
flammable materials should be stored in suitably designed and
segregated, enclosed areas in conformity with Central and State
Legislations.
• Personnel.-
 The manufacture should be conducted under the direct supervision of
competent technical staff with prescribed qualifications and practical
experience in the relevant dosage and / or active pharmaceutical
products.

Schedule M1
 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
 Deals with the minimum equipment of a pharmacy & gives
directions regarding
a) Entrance of Pharmacy
b) Premises
c) Furniture & Apparatus
d) General Provisions.

Schedule O (Drugs & Cosmetics (8th amendment)
Rules 2005)
 Deals with the provisions applicable to disinfectant
fluids.

Schedule P
 It deals with life period of drug.
 Period in months (unless otherwise specified)
between date of manufacture and date of expiry which the labelled potency
period of the drug should not exceed under the conditions of storage
Specified.
 The schedule includes antibiotics,vitamins,insulin preparation, normal
human plasma, sera toxins, toxoids , other toxins , anti-toxins,
miscellaneous drugs
Schedule P Life period of drugs
Name of Drug Period in Month Conditions of storage
Adriamycin 30 In a cool place
Ampicillin Na 36 In cool place
Carbenicillin
Sodium
Powder
24 At temperature not
exceeding 5°C

Schedule P 1
 Schedule P I – 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.
 Examples of a few drugs under this schedule:
Schedule P- I pack size of the drug
Name of Drug Dosage form Pack size
Albendazole suspension 10ml
Atenolol Tablet 14 tabs
Piperazine Granules 5 gm

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 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

Schedule R
 Describes the standards for mechanical contraceptive.
Eg. Condom, Cu- T
Schedule R-1
 Prescribes standards for medical devices.
The following medical device shall conform to the Indian
Standards specification laiddown 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
Indian Standards specifications laid down from time to time by the
Bureau of Indian Standards (BIS)].
1. Skin Powders
2. Skin Powder for infant
3. Tooth Powder
4. Toothpaste
5. Skin Creams
6. Hair Oils

Schedule T
• Lays down the requirements of factory premises and
hygienic conditions for Ayurvedic and Unani drugs.
• The Good Manufacturing Practices (GMP) are
prescribed as follows in Part I and Part II :
PART I
• GOOD MANUFACTURING PRACTICES
PART II
• List of machinery, equipment and minimum
manufacturing remises required for the manufacture
of various categories of ayurvedic, siddha system of
medicines

Schedule T –A
( Drug & Cosmetics (1st amendment)
2008)
• Contains form for record of utilisation of raw
material by Ayurveda, Siddha,Unani licensed
manufacturing units during the financial year.

Schedule U & U1
 Gives the particulars to be shown in manufacturing records.
1. Serial number
2. Name of the product
3. Reference of Master Formula Records.
4. Lot/Batch Size.
5. Lot/Batch Number
6. Date of commencement of manufacture and date of
completion of manufacture and
7)assigned date of expiry.
 Gives the particulars to be recorded of raw materials
 Gives the particulars to be recorded in analytical records.

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

Schedule W
 Gives the name of the drugs which shall be marketed under
generic names only.
 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 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.

Schedule X
Schedule X contains list of drugs which:
 Need discretion while dispending and pharmacist should ensure
that this drugs are not sold without prescription
 Have a waning mentioned on a label ‘Schedule X drug’ – Warning :
to be sold on retail on prescription of a registered medical
practitioner only. The label will also have a symbol ‘XRx’ in red &
conspicuously displayed on the top left corner of the table
 After dispending the drug the pharmacist must Stamp & retain the
prescription
 Maintain & record purchase & sale of the drug and Preserve it for a
period of 2 years from the date of transactions
 Examples of few drugs under schedule X
1)Amobarbital 2)Amphetamines 3)Dexamphetamines 4) Glutethimide
5)Methylphenidate etc.

Schedule Y ( Drugs & Cosmetics ( 2nd
amendment) 2005)
 Requirement And Guidelines On Clinical Trials For
Import And Manufacture Of New Drug or To
Undertake Clinical Trials.
 The schedule covers details like :
– Chemical and pharmaceutical information
– Animal tests, toxicology and pharmacology
– Clinical Trails
• Nature of trails
• Permission for trials
• Responsibility of sponsor / Investigator

 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.
 If the drug is already approved/marketed, Phase III trials are usually required.
 If the drug is not approved / marketed trials are generally allowed to be
initiated at one phase earlier to the phase of trials in other countries.
 For 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.
 However, such trials may be permitted even in the absence of Phase I data
from other countries if the drug is of special relevance to the health problem
of India.
 For new drug substances discovered in India, clinical trials are required to be
carried out in India right from phase I.
 Though Phase III permission to carry out these trials is generally given in
stages, considering the data emerging from earlier phase.
Clinical Trials

Permission for trials –
 Permission to initiate clinical trials with a new drug may be
obtained by applying in Form 12 for a test license (TL) to import or
manufacture the drug under the Rules.
 In addition, the protocol for proposed trials, case report forms to be
used, and the names of investigators and institutions should also be
submitted for approval.
 The investigators selected should possess appropriate
qualifications and experience and should have such investigations
facilities as are required to the proposed trials protocol.
 It is desirable that protocols for clinical trials be reviewed and
approved by the institution’s ethical committee.
 For new drugs having potential for use in children, permission for
clinical trials in the pediatric age group is normally given after phase
III trials in adults are completed.

Responsibilities of Sponsor –
Sponsors are required to submit to the
 licensing authority as given under Rule 21 an annual status report
on each clinical trial, namely ongoing, completed, or terminated.
In case a trial is terminated, reason for this should be stated.
 Any unusual, unexpected or serious adverse drug reaction (ADR)
detected during a trial should be promptly communicated by the
sponsor to the licensing authority and the other investigators.
 To implement & maintain quality assurance system.
Investigator
 In all trials an informal, written consent required to be
obtained from each volunteer/patient in the prescribed
Forms which must be signed by the patient/volunteer
and the chief investigator.
 Conduct of trial according to protocol & Good Clinical Practice.
 Standard Operating Procedure (SOP) should be followed.

Data required to be submitted with application for
permission
to market a New Drug
• 1. INTRODUCTION
A brief description of the drug and the therapeutic class to which it
belongs.
• 2.CHEMICAL AND PHARMACEUTICAL INFORMATION.
2.1. Chemical name, code name or number, if any, non-proprietary or
generic name, if any, structure, physio-chemical proportion.
2.2 Dosage form and its composition.
2.3 Specifications of active and inactive ingredients.
2.4. Tests for identification of the active ingredient and method of its
assay.
2.5. Outline of the method of manufacture of the active ingredient.
2.6 Stability data

3)ANIMAL PHARMACOLOGY
3.1) Specific pharmacological actions.
3.2) General pharmacological actions.
3.3). Pharmacokinetics, absorption, distribution, metabolism, excretion.
4)ANIMAL TOXICOLOGY
4.1 )Acute Toxicity
4.2) Long Term Toxicity
4.3)Reproduction Studies.
4.4) Local Toxicity
4.5) Mutagenicity and Carcinogenicity.
5)HUMAN/CLINICAL PHARMACOLOGY (PHASE I).
5.1) Specific Pharmacological effects.
5.2) General Pharmacological effects.
5.3)Pharmacokinetics, absorption, distribution, metabolism, excretion.
6)EXPLANATORY CLINICAL TRIALS (PHASE II).
6.1) Investigator wise reports.

7.CONFIRMATORY CLINICAL TRIALS (PHASE III)
7.1)Investigator reports
8)SPECIAL STUDIES
8.1)Bioavailability and dissolution studies.
8.2)Studies in specific population like pediatric age group, pregnant
women)
9)REGULATORY STATUS IN OTHER COUNTRIES.
• Countries where –
a)Marketed
b)Approved.
c) Under trial, with phase.
d)Withdrawn, if any, with reasons.
• Restrictions on use, if any, in countries where marketed/approved.
• Free sale certificate from country of origin.
10)PRESCRIPTION INFORMATION.
10.1)Proposed full prescribing information
10.2)Drafts of labels and cartons.
10.3)Sample of pure drug substance, with testing protocol.

Submission of Reports
The reports of completed clinical trials shall be submitted by the
applicant duly signed by the investigator with a stipulated period of
time.
Marketing information.
The product monograph should comprise the full prescribing
information necessary to enable a physician to use the drug properly.
It should include description, actions, indications, dosage precaution,
drug interactions, warnings and adverse reactions.
Post-marketing surveillance study.
On approval of a new drug, the importer or the manufacturer should
conduct post-marketing surveillance study of that new drug after
getting the protocols and the names of the investigators approved by
the Licensing Authority during the initial period of two years of
marketing.

Format for submission of clinical Trial Reports.
• ___ Title of the trial
• ___ Name of investigator and institution
• ___ Objectives of the trial
• ___ Design of study: Open, single-blind or double blind, non-comparative or comparative,
• parallel group or crossover.
• ___ Number of patients, with criteria selection and exclusion, whether written, informed
• consent, was obtained.
• ___ Treatments given – drugs and dosage forms, dosage regimens, method of allocation
of
• patients to treatments, method of verifying compliance, if any
• ___ Observations made before, during and at the end of treatment, for efficacy and
safety, with methods used.
• ___ Results : exclusions and dropouts, if any, with reasons, description of patients with
initial comparability of groups where appropriate, clinical patients with initial
comparability of groups where appropriate, clinical and laboratory observations on
efficacy and safety, adverse drug reactions.
• ___ Discussion of results ; relevance to objectives, correlation with other reports/data, if
any,
• guidance for further study, if necessary.
• ___ Summary and conclusion.

 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.
 The possession of some substances is prohibited by scheduling
under the Controlled Substances Act, under the joint control of
FDA and the Drug Enforcement Administration (DEA).
 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.
In United States

 Schedule I category of drugs not considered legitimate for medical
use. Included are heroin, lysergic acid diethylamide (LSD), and
marijuana.
 Schedule II, category of drugs considered to have a strong potential
for abuse or addiction but that also have legitimate medical use.
Included are opium, morphine, and cocaine.
 Schedule III, category of drugs that have less potential for abuse or
addiction than Schedule I or II drugs and have a useful medical
purpose. Included are short-acting barbiturates and amphetamines.
 Schedule IV, medically useful category of drugs that have less
potential for abuse or addiction than those of Schedules I, II, and III.
Included are diazepam and chloral hydrate.
 Schedule V medically useful category of drugs that have less
potential for abuse or addiction than those of Schedules I to IV.
Included are antidiarrheal and antitussives with opioid derivatives.

• In U.S. ,drug products are also coded under the National Drug
Code (NDC).
• In U.S.,NDC serves as a universal product identifier for drugs
used in humans.
• The current edition of the National Drug code Directory is
limited to prescription drugs and few selected over-the-
counter products.
• Each drug product listed under the Federal Food, Drug and
Cosmetic act is assigned a unique 10 digit, 3 segment number.
• This number, known as NDC number identifies the
labeller/vendor, product, and package size.
• The labeller/vender code is assigned by FDA.
• The second segment, product code identifies specific
strength, dosage form, formulations for particular drug
company.
• The third segment , package code identifies package size.
• Both package and product codes are assigned by
manufacturer.

 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
In China
 The regulation of drugs in China is governed by the State Food
and Drug Administration.
In Canada

 Medicines for Human Use in the United Kingdom are regulated
by the Medicines and Healthcare products Regulatory
Agency (MHRA).
 The availability of drugs is regulated by classification by the
MHRA
 The United Kingdom has a three-tiered classification system:
1. General Sale List (GSL)
2. Pharmacy medicines (P)
3. Prescription Only Medicines (POM)
In United Kingdom

 Medicines in Norway are divided into five groups:
 Class A Narcotics, sedative-hypnotics, and amphetamines in this class
require a special prescription form: morphine and its immediate
family, heroin, desomorphine, nicomorphine; codeine and its immediate
family, dihydrocodeine, ethylmorphine, nicocodeine;
 Class B Restricted substances which easily lead to addiction like
diazepam, nitrazepam, and all other benzodiazepines(with the exception
of temazepam and flunitrazepam), phentermine;
 Class C - All prescription-only substances
 Class F - Substances and package-sizes not requiring a prescription
 Unclassifieds - Brands and packages not actively marketed in Norway
In Norway

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
• Schedule 2 (S2) - Pharmacy Medicines
• Schedule 3 (S3) - Pharmacist Only Medicines
• Schedule 4 (S4) - Prescription Only Medicines
• Schedule 8 (S8) - Controlled Drugs
In other countries…………….

References
• Drugs and Cosmetics Act. (Internet) 1940[cited 2014 Jun 23]Available from:
http://www.drugscontrol.org/.
• Drug and cosmetics rules. (Internet) 1945 corrected on 30th Nov 2004 [cited 2014 Jun 23]
Available from: http://www.drugscontrol.org
• Drug and cosmetics (amendment) bill (Internet) 2013 [ Cited 2014 Jun 23] Available from:
http://www.drugscontrol.org
• Drug and cosmetics (amendment) act( Internet) 2010 [ Cited 2014 Jun 23] Available from:
http://www.drugscontrol.o
• Drug and cosmetics (amendment) act (Internet) 2008 [ Cited 2014 Jun 23] Available from:
http://www.drugscontrol.org
• Controlled substance act : Regulatory requirements (Internet) 2012[Cited 2014 Jun 24]
available from:http://fas.org/sgp/crs/misc/RL34635.pdf
• New york state controlled substances act (Internet) 2012 [ Cited 2014 Jun 23] Available
from:http://www.health.ny.gov/regulations/public_health_law/article/33/docs/33.pdf
• Narcotic bill. (1985). THE NARCOTIC DRUGS AND PSYCHOTROPIC SUBSTANCES ACT,
1985. [cited 2014 jun 23] Available from
http://narcoticsindia.nic.in/upload/download/document_id08b2dbdc9ca941d237893bd425af8
bfa.pdf.
• Bernard P. Schimmer L., Goodman and Gilman’s The pharmaceutical basis of Therapeutics;
Principles of prescription order writing and patient.; chapter 66, 1882-1884; 12th ed., 2011,
New York: Mc Graw Hill.
• H.L.Sharma. (2013)General principles of pharmacology:Introduction. In: H.L Sharma, K K
Sharma Principles of Medical Pharmacology. 2nd ed.5-6 New Delhi: Paras publisher.

Drug schedule v1 dated 27 6-2014

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