D & C Act 1940

Prepared by:
Ms. Chevale S. L.
Assistant professor.
Dept. of Pharmaceutical Chemistry
VDF School of Pharmacy Latur. Maharashtra, India.
Drugs & Cosmetic
Act 1940, Rules 1945.

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Contents:
Introduction & Objectives
Schedules of the Act.
Schedules of the Rule
Definitions
Administrative bodies
Import & Registration.
Manufacture of drugs
Sale of drugs
Labeling & packaging of drugs
Conditions for grant of licenses
Detailed study of schedules.

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Introduction & Objective
•The D & C Act was passed in 1940 (10th April 1940), with
the main object to regulate:
•Import,
•Manufacture,
•Distribution &
•Sale of drug & cosmetics.
•Regulates the import of drugs in India, no substandard
or spurious drug will enter into our country.
•Prohibits the manufacture of substandard or spurious
drug in the country.
•Provide for the control over the sale & distribution of
drugs by only trained & qualified persons.

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Introduction & Objective
•Provide for control over manufacture, sale & distribution
of Ayurvedic, Siddha, Unani & Homeopathic drugs.
•Regulates the import, manufacture, sale & distribution of
cosmetics.
•Regular inspection of licensed premises by drug
inspectors.
•Control over the standards of drugs & cosmetics by
taking samples & analyzing them at approved
laboratories.
•Regulate the preparation, standardization & storage of
biological & special products.
•To prescribe the manner of labeling & packing of the
various classes of drugs & cosmetics.
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Chapters of the act:
Chapter I: Introduction & Definitions
Chapter II: DTAB, DCC, CDL
Chapter III: Import of drugs & Cosmetics
Chapter IV: Manufacture, Sale & distribution of drugs & cosmetics
Chapter V: A Provisions relating to Ayurvedic, Siddha & Unani drugs.
Chapter VI: Miscellaneous

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The rules of act divided into 23 different parts as follows:
PART I: Preliminary
PART II : The Central Drugs Laboratory
PART III: (Rules 9 To 20)
PART IV : Import [And Registration]
PART V: Government Analysts, Inspectors, Licensing Authorities And Controlling Authorities
PART VI : Sale Of Drugs Other Than Homoeopathic Medicines
PART VI- A : Sale Of Homeopathic Medicines
PART VII : Manufacture For Sale Or For Distribution Of Drugs Other Than Homoeopathic
Medicines
PART VIII : Manufacture for examination, test or analysis
PART IX : Labelling and packing of drugs other than homoeopathic medicines
PART X : Special provisions relating to biological and other special products
PART XA : Import of manufacture of new drug for clinical trials or marketing

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The rules of act divided into 23 different parts as follows:
PART XA : Import of manufacture of new drug for clinical trials or marketing
PART XB : Requirements for the collection, storage, processing and distribution of whole human
blood, human blood Components by blood banks & manufacture of blood products.
PART XI : Exemptions
PART XII : Standards
PART XIII : Import of cosmetics
PART XIV : Manufacture of cosmetic for sale or for distribution
PART XV : Labelling, packing and standards of cosmetics
PART XV : Manufacture for sale of Ayurvedic (including Siddha) or Unani drugs
PART XVII : Labelling, packing and limit of alcohol in Ayurvedic (including Siddha) or Unani drugs
PART XVIII: Government analysis and inspectors for Ayurvedic (including Siddha) or Unani drugs
PART XIX : Standards of Ayurvedic, Siddha and Unani drugs

Schedules To The Act:
• First Schedules: List of Ayurvedic, Siddha, Unani
books.
• Second Schedules: Standards to be complied with
by imported drugs & drugs manufacture for sale,
sold, stocked or exhibited for sale or distribution.

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Schedules To The Rule:
SCHEDULES THE RULES
A List of forms used for application for issuing licenses, & granting licenses, for sending memoranda.
B Rates of fee for test or analysis by the Central Drugs Laboratory or the Government analysist.
C List of biological & other special products whose import, sale, distribution and manufacturing are a
governed by special provision.
C1 List of other special products whose import, sale, distribution and manufacturing are governed by
special provision.
D List of drugs exempted from the provisions of import of drugs.
E1 List of poisonous substances under the Ayurvedic, Siddha & Unani systems of medicine.
F & F1 Provisions applicable to the production, testing, storage, packing and labeling of biological & other
Special products.
F2 Standards for surgical dressings.

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F3 Standards for sterilized umbilical tapes.
FF Standards of ophthalmic preparations.
G List of substances that are required to be used only under medical supervision and which are to
be labeled accordingly.
H List of prescription drugs.
I Calculation of proportion of poison in certain cases.
J Disease or ailments which a drug may not purport to prevent or cure.
K Drugs exempted from certain provision relating to manufacture of drugs.
M GMP requirement of factory premises, plants and equipment.
M1 Requirement of factory premises etc. for manufacture of homoeopathic preparation.
M2 Requirement of factory premises etc. for manufacture of cosmetics.
N List of minimum equipment for efficient running of a pharmacy.
O Standard for disinfectant fluid.

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P Life period of drug.
Q List of coals tar color permitted to be used in cosmetics.
R Standard for medical devices .
S Standard for cosmetics.
T Requirement of factory premises and hygienic condition for Ayurvedic, Siddha & Unani drugs.
U Particulars to be shown in manufacturing, raw material and analytical records of drug.
U1 Particulars to be shown in manufacturing, raw material and analytical records of cosmetics.
V Standard for patent or proprietary medicines. (Containing vitamins.)
W List of drug which is to be marketed under generic names only.
X List of habit forming psychotropic & other such drugs
Y Requirement and guideline on clinical trials for import and manufacture of new drug.

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Definitions:
1. Drug :
It includes:
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, including
preparations applied on human body for the purpose of repelling insects like mosquitoes;
Such substances (other than food) intended to affect the structure or any function of human body or intended to be
used for the destruction of (vermin) or insects which cause disease in human beings or animals,
All substances intended for use as components of a drug including empty gelatine capsules; and
Such devices intended for internal or external use in the diagnosis, treatment, mitigation or prevention of disease or
disorder in human beings or animals,

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2. Ayurvedic, Siddha, or Unani drug:
Includes all medicines intended for internal or external use for or
in the diagnosis, treatment, mitigation or prevention of disease
or disorder in human beings or animals, and manufactured
exclusively in accordance with the formulae described in, the
authoritative books of Ayurvedic, Siddha and Unani systems of
medicine, specified in the First Schedule.

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3. Misbranded Drugs:
A drug shall be deemed to be misbranded:
•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
•if it is not labelled in the prescribed manner; or
•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.

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4. Adulterated Drugs:
A drug shall be deemed to be adulterated
If it consists, in whole or in part, of any filthy, putrid or decomposed substance; or
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
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
If it bears or contains, for purposes of colouring only, a colour other than one
which is prescribed; or
If it contains any harmful or toxic substance which may render it injurious to health;
or
If any substance has been mixed therewith so as to reduce its quality or strength.
e.g. supply of cheap cottonseed oil in stead of olive oil

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5. Spurious Drugs:
A drug shall be deemed to be spurious:
If it is imported under a name which belongs to another drug; or
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
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;
If it has been substituted wholly or in part by another drug or substance; or
If it purports to be the product of a manufacturer of whom it is not truly a product. e.g. when methamphetamine is
sold as cocaine.

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6. New drug:
•A new substance of chemical, biological or biotechnological origin, in bulk or prepared dosage form; used for
prevention, diagnosis, or treatment of disease in man or animals; which except during local clinical, trials, has not
been used in the country to any significant extent and which has not been recognized in the country as effective and
safe for the proposed claims.
•A drug already approved by the licensing authority for certain claims which is now proposed to be marketed with
modified or new claims, namely indications, dosage form(including sustained release dosage form) & route of admin.
•A fixed dose combination of two or more drugs, individually approved earlier for certain claims, which are now
proposed to be combined for the first time in a fixed ratio, or if the ratio of ingredients in an already marketed
combination is proposed to be changed, with certain claims, viz indications, dosage, form (including sustained release
dosage form) and route of admin. For the purpose of this rule :-
•All vaccines shall be new drugs unless certified otherwise by the licensing authority
•A new drug shall continue to be considered as new drug for a period of 4 yrs from the date of its first approval or
inclusion in the I. P. whichever is earlier.

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7. Inspector:
Means:
1. In relation to a Ayurvedic, Siddha or Unani drug, an
Inspector appointed by the Central Government or a
State Government under section 33G; and
2. In relation to any other drug or cosmetics, an
State Government under section 21

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8. Cosmetic:
• Cosmetic means any article intended to be
rubbed, poured, sprinkled or sprayed on,
or introduced into, or otherwise applied
to, the human body or any part thereof for
cleansing, beautifying, promoting
attractiveness, or altering the appearance,
and includes any article intended for use
as a component of cosmetic.

9. Misbranded cosmetic:
A cosmetic shall be deemed to be misbranded:
1.If it contains a colour which is not prescribed;
2. If it is not labelled in a prescribed manner;
3.If the label or container or anything accompanying the cosmetic
bears any statement which is false or misleading in any particular

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10. Spurious cosmetic:
If it is imported under the name which belongs to another
cosmetic;
If it is an imitation of, or is a substitute for, another cosmetic or
resembles another cosmetic in a manner likely to deceive or
bears upon it or upon its label or container the name of
another cosmetic, unless it is plainly or conspicuously marked
so as to reveal its true character and its lack of identity with
such other cosmetic; or
If the label or the container bears the name of an individual or
company purporting to be the manufacturer of the cosmetic,
which is fictitious or does not exist; or
If it purports to be the product of a manufacturer of whom it is
not truly a product
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11. Drug store:
•A description drug store shall be displayed by
licensees who do not require the services of
registered pharmacists.
12. Chemist & Druggist :
•A description Chemist & Druggist shall be displayed by
licensees who employed service of registered
pharmacists but where the drugs are not
compounded against prescription.

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13. Registered Pharmacists:
• Means a person who is registered
pharmacists as defined in clause (i) of section
2 of the pharmacy Act 1948.
14. Qualified Person:
• A person who are already approved as
qualified person by licensing authorities on or
before 31st Dec. 1969.

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15. Government Analyst:
Means:
• In relation to Ayurvedic, Siddha or Unani
drugs a person appointed by central or state
govt. under section 33-F
• In relation to any other drugs or cosmetics a
person appointed by central or state govt.
under section 20

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16. Manufacture:
Manufacture in relation to any drug or cosmetic includes:
•Any process or part of a process for making, altering, ornamenting,
finishing, packing, labelling, breaking up or otherwise treating or
adopting any drug or cosmetic with a view to its sale or distribution but
does not include the compounding or dispensing of any drug, or the
packing of any drug or cosmetic, in the ordinary course of retail
business; and “to manufacture” shall be construed accordingly;

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17. Patent or proprietary medicine:
In relation to Ayurvedic, Siddha or Unani systems of medicine all formulations containing only such
ingredients mentioned in the formulae described in the authoritative books of Ayurveda, Siddha or
Unani systems of medicine specified in the First Schedule, but does not include a medicine which is
administered by parenteral route and also a formulation included in the authoritative books as listed in
the First Schedule;
In relation to any other systems of medicine, a drug which is a remedy or prescription presented in a
form ready for internal or external administration of human beings or animals and which is not included
in the edition of the Indian Pharmacopoeia for the time being or any other Pharmacopoeia authorised in
this behalf by the Central Government after consultation with the Drugs Technical Advisory Board
constituted under section 5.

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18. Homeopathic medicines:
Any drug which is recorded in Homeopathic provings or
therapeutic efficacy of which has been established through long
clinical experience as recorded in authoritative homeopathic
literature of India and abroad and which is prepared according to
the techniques of Homeopathic Pharmacy and covers combination
of ingredients of such homeopathic medicines but does not
include a medicine which is administered by parenteral route.

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19. Registered medical practitioner:
Holding a qualification granted by an authority specified in sec. 3 of the Indian Medical Degrees Act, 1916 specified to
schedule of the Indian Medical council Act 1956 . Or
Registered or eligible for registration in a medical register of the state meant for the registration of persons practicing the
modern scientific system of medicine excluding the homeopathic system of medicine. Or
Registered in medical register (other than homeopathic practitioner) of a state who although not failing in sub clause i) or
ii) is declared by general or special order made by state government to be practicing modern scientific system of medicine
Registered or eligible for registration in the register of Dentist for a state under Dentist Act 1948. or
Who is engaged in the practice of veterinary medicine & who passes qualification approved by state government.

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20. Registered Homeopathic Medical Practitioner:
A person who is Registered in the central or state Register of Homeopathy.
21. Sale by way of wholesale dealing:
It means sale to tho a person for the purpose of selling again & also includes the sale to hospitals, dispensaries, or
medical or educational or research institutes.
22. Retail sale:
It means a sale whether to hospital or dispensaries, or medical or educational or research institutes or to any other
person other tan a sale by way of wholesale dealing.
23. Repacking of Drugs:
Process of breaking any drug from bulk container to small packages & labeling of such each packages wit a view to its sale
& distribution. But it does not include compounding, dispensing/packing of any drug in ordinary course of retail business.
24. Loan license:
It means a license issued by authority to a person who does not ave is own arrangements for manufacture but wo intends
to avail himself of manufacture facilities owned by another manufacturer.

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25. Import:
Means to bring into India.
26. Central License Approving Authority:
Means drug controller India appointed by central govt.
27. Large Volume Parenterals:
means sterile solution intended for parenteral
administration wit a volume of 100 ml or more in one
container of finished dosage form intended for single use.
28. Blood Bank:
Means a place or organization unit or an institution for
carrying out all or any of operation of manufacture of
human blood components/products or whole human
blood for its collection storage, processing, distribution,
from selected human donors.

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29. Pharmacy :
Where drugs are dispensed, that is measured or weighted or made up &
supplied ; or
Where prescription are composed ; or
Where drugs are prepared; or
Which has upon it or displayed with it or affixed to or used in connection with
it a sign bearing the word or pharmacy, pharmacist , dispensing chemist, or
pharmaceutical chemist.
Which by sign or symbol or indication within or upon it gives the impression
that the operations mentioned at i), ii), & iii) are carried out in the premises;
Which is advertised in terms referred to in iv) above.

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Administrative Bodies:
I. Advisory :
• Drug Technical Advisory Board (DTAB)
• Drug Consultative Committee (DCC)
II. Analytical :
• The Central Drug Laboratory (CDL)
• Drug Control Laboratories in the state (DCL)
• Government Analyst
III. Executive :
• Licensing Authorities (central & state)
• Drug Inspectors
• Custom Collector

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Drug Technical Advisory Board
(DTAB) :
Central govt. appoints DTAB to advice the central &
state govt. on technical matters arising out of the
administration of this act & to carry out the other
functions assigned to it by this act.

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Constitution of DTAB:
• I. Ex-officio members
• Director General of Health Services (chairman of the board)
• Drug Controller of India
• President, Pharmacy Council of India
• President, Medical Council of India
• Director, Central Drug Laboratories, Kolkata
• Director, Central Drug Research Institute, Lucknow
• Director, Central Research Institute, Kasuali.
• Director, Indian Veterinary Research Institute, Izzatnagar
• II. Nominated Members
• One person from pharmaceutical Industry
• Two Govt Analyst
• Two persons from among the persons who are in-charge of the DCO in the state.

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III. Elected Members:
•One teacher in pharmacy, pharmaceutical chemistry or Pharmacognosy from the staff of University or
affiliated college elected by the executive Committee of Pharmacy Council of India
•One teacher in medicine or therapeutics from the staff of University or affiliated college elected by
the executive Committee of Medical Council of India
•One person elected by the central council of Indian Pharmaceutical Association.
•One person elected by the central council of Indian Medical Association.
•One Pharmacologist, elected by the governing body of the Indian Council of Medical Research.
The nominated & elected members hold office for 3 years & are eligible for re-nomination or re-election.
The central govt. appoints a Secretary of the board & other clerical staff.

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Drugs Consultative Committee (DCC):
The Central Government may constitute an advisory committee to be called “the Drugs Consultative Committee” to
advise the Central Government, the State Governments and the Drugs Technical Advisory Board on any other matter
tending to secure uniformity throughout India in the administration of this Act.
Constitution of DCC:
The Drugs Consultative Committee shall consist of
•Two representatives of the central government to be nominated by that government and
•One representative of each state government to be nominated by the state government
concerned.
The Drugs Consultative Committee shall meet when required to do so by the Central Government and shall have
power to regulate its own procedure.

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Functions of Central Drug Laboratory (CDL)
•To analyze the samples of drugs or cosmetics sent to it by:
•Custom Collector or any authorized officer
•by Court
•To carry out such other duties as may be assigned to it by Central govt. or state
govt. with the permission of central govt. after consultation with DTAB.
•In case of some drugs like biological & microbiological tests are not carried out in
the CDL at Kolkata hence the test or analysis of such samples or functions of CDL is
carried out at other labs or institution.

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Products Lab
Sera, vaccines, toxins, antigen, antitoxins,
sterilized surgical sutures & ligatures etc
Central research institute, Kasuali
Sera, vaccines, toxins, antigen, antitoxins
for veterinary use
Indian veterinary research institute, Izzatnagar
Oral polio vaccines
1. Vaccine testing laboratory of CRI Kasuali.
2. National inst. of communicable diseases
3. National inst. of vaccines, pune
VDRL antigen
Laboratory of serologist & chemical examiner to the govt.
of India Kolkata
Condoms Indian Pharmacopoeial Laboratory, Ghaziabad
IUD & Felopian rings Dept. of Biochemical Engg. IIT, New Delhi

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Dispatch of samples.
Recording conditions of seal.
Report of test or analysis.
Fees.
Signature of certificate.
Dispatch of samples for test or analysis to CDL.

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Drug Control Laboratories in the State:
• Every state has a laboratory for the analysis &
testing of the drugs & cosmetics
manufactured or sold in that particular area.
• Samples sent by D.I. are analyzed by such
laboratories.
• Also analyzed the drugs sent by any person or
purchaser on payment of necessary fee.

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Government Analyst:
Means:
• In relation to Ayurvedic, Siddha or Unani
drugs a person appointed by central or
state govt. under section 33-F.
• In relation to any other drugs or
cosmetics a person appointed by central
or state govt. under section 20.

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Qualification of
Govt. Analyst
•A graduate in medicine or science or pharmacy or pharmaceutical
chemistry of a recognized University, with at least 5 years of
experience in the testing of drugs in a laboratory under the control of
•1. Govt. Analyst
•2. Head of an institution or approved testing laboratory
•A Postgraduate in medicine or science or pharmacy or pharmaceutical
chemistry of a recognized University, with at least 3 years of
experience in the testing of drugs in a laboratory under the control of
•1. Govt. Analyst
•2. Head of an institution or approved testing laboratory
•Associate ship diploma of the Institution of Chemist, India, with
“Analysis of drugs & Pharmaceuticals” as one of the subject with not
less than 3 years of experience, in the testing of drugs in a laboratory
under the control of as mentioned in 1 & 2.

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Duties of Government
Analyst:
•To analyse or test samples of drugs or cosmetics
sent to him by Drug Inspectors or other persons
under the provisions of the Act for manufacture
or sale or distribution and furnish reports as per
rules.
•To forward reports giving the results of analysis
work and research with a view to their
publication at the discretion of the Govt.

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Drug Inspector:
In relation to a Ayurvedic, Siddha or Unani drug, an
State Government under section 33G; and
In relation to any other drug or cosmetics, an Inspector
appointed by the Central Government or a State
Government under section 21

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Qualification for D. I.:
•A graduate in pharmacy or pharmaceutical sciences or medicine with specialization in Clinical
Pharmacology or Microbiology of a recognized university; Provided that for the purpose of
Inspection of Manufacture of substances specified in Schedule C, a person appointed as a Drug
Inspector should have,
•1. Not less than 18 months experience in manufacture of at least one of the substances
specified in Schedule C; or
•2. Not less than 18 months experience in testing of at least one of the substances specified in
Schedule C in a approved laboratory; or
•3. Not less than 3 years experience in inspection of firms manufacturing any of the
substances specified in Schedule C during the course of their services as the Drug Inspectors

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Powers of D.I. :
Within the local limits for which the inspector is appointed, he may
•Inspect:
•a) Any premises wherein any drug or cosmetic is being manufactured. And also he may inspect the means
employed for standardizing and testing the drug or cosmetic
•b) Any premises wherein any drug or cosmetic is being sold or stocked or exhibited or offered for sale or
distributed
•Take samples of any drug or cosmetic:
•a) which is being manufactured or being sold or is stocked or offered for sale or exhibited or being distributed
•b) from any person conveying, delivering or preparing to deliver any drug or cosmetic to a purchaser or a
consignee.
•Search any person in connection with the offence under this chapter at all reasonable times

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4. Enter and search at all reasonable times, any place or premises in which he has reason to
believe that an offence is being committed or has been committed
5. Stop and search any vehicle or conveyance which he has reason to believe, used for
carrying any drug or cosmetic in respect of which offence has been or is being committed
6. Give order in writing to the person in possession of drug or cosmetic in respect of which
offence has been committed not to dispose stock of such drug or cosmetic for a specified
period not exceeding twenty days or unless the defect may be removed by the possessor
of the drug or cosmetic, and may seize the stock of such drug or cosmetic or any substance
/article employed for commission of offence.
7. Examine any record, register, document, or any other material object found while
exercising above powers and seize the same if he has reason to believe that it is an
evidence of commission of an offence under the Act
8. Exercise any other powers as may be necessary, for carrying out the purpose of this Act
and the rules made thereunder.

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Duties of D. I. :
In relation to sale of drugs and cosmetics:
•To inspect at least once a year all establishments licensed for sale of drugs in the area assigned to him and
to satisfy himself whether the conditions of the licences are observed or not
•If he thinks necessary to obtain and send samples of imported drugs and cosmetics for test or analysis,
which are being sold or stocked in contravention of the provisions of this Act
•To investigate any complaint made in writing to him
•To institute prosecutions in case of the breach of the Act and Rules
•To maintain the records relating to all inspections and actions taken by him and to submit copies of such
records to the controlling authority
•To make inquiries and inspections regarding the sale of drugs in contravention of the Act
•To detain the imported packages, if he suspects to contain drugs the import of which is prohibited.

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Duties of D. I. :
In relation to manufacture of drugs and cosmetics:
•To inspect at least once a year all premises licensed for manufacture of drugs in the area assigned to him and to
satisfy himself whether the conditions of the licences and provisions of the Act and Rules are observed or not
•To inspect premises licensed for mfg of drugs specified in Schedule C and C (1) and to observe process of
manufacture, means employed for standardization and testing of drugs, storage conditions, qualifications of
technical staff employed and all other details of construction, location, administration of establishment etc.
which are likely to affect potency or purity of product.
•To send after each inspection, a detailed report of inspection to controlling authority with details of conditions
of licence and provisions of the Act and Rules being observed and those not observed.
•To take samples of drugs manufactured on premises and send them for test or analysis
•To check all records and registers required to be maintained under rules.
•To institute prosecutions for breaches of Act.

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Procedure of Inspector:
For taking samples of drug and dispatching them to laboratory :
•Where an Inspector takes any sample of a drug or cosmetic, he shall tender the fair price thereof and
may require a written acknowledgment thereof.
•Where the price is refused, he shall tender a receipt thereof in the prescribed form.
•Where an Inspector takes a sample of a drug or cosmetic for the purpose of test or analysis, he shall
intimate such purpose in writing in the prescribed form to the person from whom he takes it and, in the
presence of such person unless he wilfully absents himself, shall divide the sample into four portions and
effectively seal and suitably mark the same and permit such person to add his own seal and mark to all or
any of the portions so sealed and marked.
•Where the sample is taken from premises whereon the drug or cosmetic is being manufactured, it shall
be necessary to divide the sample into three portions only.

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•Where the drug or cosmetic is made up in containers of small volume, instead of dividing a sample as
aforesaid, the Inspector may, and if the drug or cosmetic be such that it is likely to deteriorate or be
otherwise damaged by exposure shall, take three or four, as the case may be, of the said containers after
suitably marking the same and, where necessary, sealing them.
•The Inspector shall restore one portion of a sample so divided or one container, as the case may be, to the
person from whom he takes it, and shall retain the remainder and dispose of the same as follows:
•One portion or container he shall forthwith send to the government analyst for test or analysis;
•The second he shall produce to the court before which proceedings, if any, are instituted in respect of
the drug or cosmetic;
•The third, where taken, he shall send to the person, if any, whose name, address and other particulars
have been disclosed as manufacturer or his agent.

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• For seizure of stocks:
• Whenever inspector suspects contravention he may seize any stock of such drug or records,
registers, documents which are believed to be evidence of commission of offence, he should
at the earliest inform a judicial magistrate and take his order for custody.
• Or He may order not to dispose off stock in prescribed format (form 15)
• If he takes above action. he should Use all means to ascertain if there is contravention, if not
return stock
• If defect can be remedied, allow to do so and after satisfaction, revoke order.

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Licensing Authority:
Central License Approving Authority :
• Central govt. may appoint C.L.A.A. from commencement of D & C Amendment Rule 1992
to issue license for manufacture or sale or distribution of drugs in specified from time to
time by notification in official gazette for grant or renewal of licenses.
• Following categories of drugs presently notified for this purpose:
• Large volume parenterals, Sera & vaccines
• Operation of blood bank processing of human blood & manufacture of blood products.
• Drug controller India is appointed as central approving authority for this purpose.

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Qualifications of Licensing Authority:
He is a graduate in Pharmacy / Pharmaceutical chemistry /
Medicine with specialization in Clinical pharmacology or
Microbiology from a University established in India
He has experience in manufacturing or testing of drugs or
enforcement of the provisions of the Act for a minimum period of
5 yrs.
The requirement of academic qualification is not applicable to
inspectors and Government Analysts appointed before 12th Apr
1989.

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Controlling Authority:
Central and state government may appoint controlling authority having prescribed qualifications
All inspectors at central and state level are under their control
Qualifications :
•He is a graduate in Pharmacy / Pharmaceutical chemistry / Medicine with specialization in Clinical
pharmacology or Microbiology from a University established in India
•He has experience in mfg or testing of drugs or enforcement of the provisions of the Act for a
minimum period of 5 yrs.
•(The requirement of academic qualification is not applicable to inspectors and Government Analysts
appointed before 12th Apr 1989.

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Customs Collectors :
• The customs collectors or person on his behalf
may detain imported package which he
suspects to contain drug / cosmetic import of
which is prohibited, report detention to Drugs
Controller and if required forward sample to
CDL.
• Laws relating to Sea Customs Act are
applicable.

57
Import And Registration of Drugs
Import means to bring into India

58
Classes of drugs prohibited to Import :
• Any drug which is not of standard quality.
• Any misbranded, spurious or adulterated drug
• Any misbranded or spurious cosmetic
• Any drug or cosmetics which require import license & if imported without such license.
• Any patent or proprietary medicine, the true formula or list of active ingredients with their true
quantities, is not displayed on the label or container in a prescribed manner.
• Any cosmetics containing any such ingredient which may render it unsafe or harmful for use.
• Any drug which claim to cure or prevent any disease or ailment described in schedule J.
• Any drug or cosmetic the import of which is prohibited by rules.

59
Import Of Drug & Cosmetics Permitted Under License Only:
Drugs specified in
schedule C & C1
Drugs specified in
schedule X
Drugs for
examination, test or
analysis.
Drugs for personal
use
Any new drug

60
Import of schedule C & C1 drugs:
The license for the import of schedule C & C1 drug is granted subject to the following condition.
• Licensee must have adequate facilities for the storage of imported drugs so that the properties of drugs are preserved.
• Licensee must maintain the records of sale of drugs showing particulars of the names of the drugs & of the persons to whom
they have been sold.
• Licensee must allow the inspector to inspect the premises where imported drugs are stored & to check the record & to take the
samples for test or analysis.
• Licensee on request, shall supply the samples of drugs from all batches to the licensing authority for test or analysis.
• Licensee must not sell the drugs from any batch from which samples have been supplied to the licensing authority, except
under the advise of the licensing authority.
• The licensee must comply with the undertaking given in form 9.
• The import license may be cancelled or suspended, if conditions are not satisfied.

61
The license for the import of schedule X drug is granted subject to following condition.
Licensee must have adequate facilities for the storage of imported drugs, so that the
properties of drugs are preserved.
Licensing authority may also refuse to grant the license if the license granted to the
applicant previously was suspended or cancelled. Or in case if the applicant failed to
comply with any provision of the act i.e. drug & cosmetics act or NDPS
However if the applicant is not satisfied with the decision may appeal to central
government within 30 days.
Import of Schedule X Drugs:

62
•Small quantities of drugs, the import of which is prohibited under the act may
be imported for the purpose of examination, test or analysis, subject to the
following conditions.
•The licensee must use imported drug exclusively for the purpose for which
they are imported & specified in the license.
•Licensee must maintain the records of imported drugs, showing particulars of
their quantities, names of manufacturer & date of import.
•Licensee must allow the inspector to inspect the premises where imported
drugs are kept & to check the record & to take the samples for test or analysis.
•Licensee must comply with other conditions as prescribed.
Import
of
small
quantities
of
drug
for
examination,
test
or
analysis:

“
63
Import of drugs for personal use:
Small quantities of drugs, the import of which is otherwise prohibited may be imported for
personal use without any license subject to the following conditions.
The drug shall form the passenger’s bonafied luggage & shall exclusively be for personal use
of the passenger.
The drug shall be declared to the customs authority, if they direct so.
The quantity of any single drug so imported shall not exceed 100 doses.
The licensing authority may in an exceptional case, sanction the import of large quantity.
Drug is not forming a part of bonafied personal luggage if
The drug is for bonafied personal use.
The quantity to be imported is reasonable & is covered by prescription of RMP.

64
Import of new drug:
No new drugs are allowed to imported without the
sanction of the licensing authority.
The importer of new drug when applying for
permission, shall produce all documentary evidence &
other evidences relating to its standards, standards of
quality & purity, strength, and such other information
including the clinical trials; to the licensing authority.

65
Import of drug without license or
permit :
Drugs other than those discussed above, may be
imported without any permit or license.
However before such drugs are imported into the
country, the importer should submit a declaration to
the custom collector that they comply with all the
provisions of chapter III of D & C Act.

66
Places through which the drugs are imported:
• The import of drug in India is allowed only through following places.
• By Sea: Mumbai, Chennai, Kolkata, Cochin, Vishakhapattanam & Nhava sheva
• By Air: Delhi, Mumbai, Chennai, Kolkatta, Ahmedabad & Hyderabad
• By Rail:
• Ferozpure cantt & Amritsar Rly station (for drugs coming from pakistan)
• Ranaghat, Bongaon & Mahiassan (for drugs coming from Bangladesh)
• Raxaul (for drugs coming from Nepal)

67
Drugs exempted from provisions regulating imports of drug:
• Substances not intended for medical use(condition: label should bear that not for medicinal use.)
• Following substance which are used both as article of foods & drugs. (Condition: Exempted from
all provisions of chapter III)
• All condensed or powdered milk.
• Farex, oats, lactose, cerelac except for parenteral use.
• Virol, Bovril, Chicken essence & other similar pre-digested food.
• Cinnamon, pepper, zinger & other condiment & spices.

68
Any one who,
1. Imports adulterated or spurious drug or cosmetic or cosmetic unsafe for use
i. Punishable with imprisonment upto 3 years or with fine upto 5,000 or both on first conviction
ii. & punishable with imprisonment upto 5 years or with fine upto 10,000 or both on subsequent conviction
2. Imports any drug or cosmetic the import of which is prohibited under section 10.
i. Punishable with imprisonment upto six months or with fine upto 500 or both on first conviction
ii. & punishable with imprisonment upto 1 year or with fine upto 1,000 or both on subsequent conviction
3. Imports any drug or cosmetics, the import of which is prohibited in the public interest.
i. Punishable with imprisonment upto 3 years or with fine upto 5,000 or both on first conviction
ii. & punishable with imprisonment upto 5 years or with fine upto 10,000 or both on subsequent conviction
Offences & Penalty related to import of drug

“
69
Manufacture Of Drugs:
Definition: Manufacture in relation to any drug includes any
process or part of a process for making, altering, finishing,
packing, labelling, breaking up or otherwise treating or
adopting any drug with a view to its sale and distribution, but
does not include compounding or dispensing of any drug or
packing of any drug in ordinary course of retail business.
Types of licences granted for manufacture & sale of drugs:
1) Licences for the manufacturing of drugs.
2) Loan licences for the manufacturing of drugs.
3) Licence for repacking.

70
Licences are required for the manufacturing of following categories of drugs.
1. Manufacturing of drugs belonging to Schedules C and C (I).
2. Manufacturing of drugs belonging to Schedule X.
3. Manufacturing of drugs belonging to Schedules C, C (I) and X.
4. Manufacturing of drugs other than Schedule C, C (I), and X.
5. Manufacturing of drugs for examination, test or analysis.
I. Licences For The Manufacturing Of Drugs:

71
A person licensed to manufacture schedule C & C1 drugs, is required to observe following conditions:
1) Licensed premises must conform to the requirements of GMP specified in schedule M.
2) The licensee must provide adequate arrangement for testing the strength & quality of drugs.
3) The manufacture of drugs must be carried out under active direction & personal supervision of technically
qualified staff who should be either:
i. Graduate in pharmacy or pharmaceutical chemistry with at least 18 months experience in the mfg of drugs
ii. Graduate in medicine with at least 3 years experience in the manufacture & testing of drugs or
iii. Graduate in science with chemistry or microbiology as the principal subject or graduate in chemical engineering
with at least 3 years experience in the manufacture & testing of drugs or
iv. Any other equivalent foreign qualification.

72
4) Licensee must have adequate facilities for the storage of imported drugs, so that the properties of drugs are
preserved.
5) Licensee must maintain the manufacturing & analytical records of the drugs (records should be preserved for at
lest 2 years after the expiry of date for drugs with expiry & 5 years from the date of manufacture for other drugs.)
6) Licensee must allow the inspector to inspect the premises where imported drugs are kept & to check the record &
to take the samples for test or analysis.
7) Licensee must inform to the licensing authority about any changes in the technical staff or any material changes
in the plant or premises since the date of last inspection.
8) Licensee on request, shall supply the samples of drugs from all the batches to the licensing authority for test or
analysis.

73
The following special provision related to biological or other special product must comply.
All schedule C drugs must be issued in a previously sterilized glass containers sealed so as to prevent entry of
bacteria.
Drugs must comply with the standards of strength, quality & purity as specified in schedule F.
Biological products such as sera, vaccine, antigen, antitoxin, insulin etc. should be tested for the absence of
living & anaerobic microorganism.
The test for sterility must be carried out.

74
2. Manufacture of drugs specified in schedule X
In addition to
general conditions
the licensee should
observe the
following conditions:
Accounts of all
transactions relating
to the manufacture
should be
maintained in a
serially bound &
paged register.
Drugs stored in bulk
& if needed for mfg
outside storage
place they should be
kept in a separate
place in the custody
of responsible
person.
Licensee must
submit a report to
the licensing
authority every 3
months regarding
manufacture & sale
of drugs.
No schedule X drugs
should be supplied
by way of physician
sample.

75
Application for grant of licence or renewal is made in form 24. The Licence is issued by licensing authority in form 25.
I - Conditions for grant of licence are as follows:
1. Competent staff :
•A graduate in pharmacy/pharmaceutical chemistry with a minimum of 18 months of experience after graduation.
The duration may be reduced by 6 months, if the applicant has undergone training during graduation. Or
•A graduate in science with chemistry as a principal subject and with 3 years of mfg experience after graduation or
•A graduate in chemical engineering or chemical technology or medicine with 3 years of mfg experience after
graduation or
•Holding equivalent foreign qualification as mentioned in i), ii) & iii)
3. Manufacturing of Drugs other than Schedules C, C (I) and X :

76
2. Factory premises: As per Schedule' M' with regard to premises, space, plant and equipment.
3. Separate facilities for analysis of raw materials and finished formulations. Separate HOD for analysis & mfg sections.
Head of the testing and analytical department should be a graduate in Medicine/Pharmacy/Pharmaceutical
Chemistry/Science with adequate experience in analysis.
4. There should be adequate arrangement of storage of raw materials and finished products.
5. While applying for licence to manufacture patent or proprietary medicines, it is required to submit evidence justifying
therapeutic claims of the product, its stability and safety.

77
II - Conditions to be fulfilled after getting a licence:
1) The manufacturer should always maintain adequate staff, sufficient premises and equipment.
2) The manufacturing records, records for raw material and analysis and other operational records should be
maintained as per Schedule 'U'.
3) The licensee should own an analytical laboratory or get tested the samples analysed in an approved analytical
laboratory.
4) The manufacturer should allow the Inspector to inspect the premises, manufacturing process, analytical
procedures, and withdraw the samples. The manufacturer should also withdraw the batch manufactured by him
if directed to do so by the Controlling Authority.

78
II - Conditions to be fulfilled after getting a licence:
5) The manufacturer should comply with all the requirements of the Act and Rules thereunder.
6) The manufacturer should maintain the Inspection Book.
7) Samples with expiry date should be maintained for 6 months after expiry date. For other categories, the
samples should be maintained for 3 years from the date of manufacturing. Twice the lot of reference samples
should be maintained. The quantity maintained should be sufficiently available for analysis.
8) Any change in the staff structure especially, technical staff should be reported to Licencing Authority.
9) Any major structural change in the premises should be done with the permission of Licencing Authority
10) The manufacturer should forward all the sales records to the Controlling Authority.

79
4. Manufacture of drugs for examination, test or analysis:
The following conditions must be observed by the licensee.
1) Licensee must use manufactured drug exclusively for the purpose for which they are
manufactured.
2) Licensee must maintain the records of the manufactured drugs, showing particular of their
quantities & names of the persons to whom they have been supplied.
3) Licensee must allow the inspector to inspect the premises where drugs are kept & to check the
record & to take the samples for test or analysis.
4) Licensee must comply with such additional requirements of which he has been given at least 1
month notice by the licensing authority.

“
80
II. Loan licences for the manufacturing of drugs:
It means a license issued by the licensing
authority to a applicant who does not have his
own arrangements for manufacture but who
intends to avail himself of the manufacturing
facilities owned by another licensee.

81
The following conditions must be observed by the licensee.
1) Application for grant of loan license should be supported by documentary consent of the licensee whose
facilities he is going to use.
2) Before granting a license the authority may satisfy himself that the person, whose facilities applicant
wishes to use must possess necessary staff, equipment & space for manufacture of drugs.
3) The loan license shall be deemed to be cancelled or suspended, if the license owned by licensee whose
manufacturing facilities have been availed by the licensee is cancelled or suspended.
4) The licensee must test each batch of raw material & finished product.
5) Licensee should maintain manufacturing & analytical records of drugs.
6) Licensee must allow the inspector to inspect the premises where drugs are kept & to check the record &
to take the samples for test or analysis.
II. Loan licences for the manufacturing of drugs:

“
82
III. Repacking License:
It means the process of breaking up any drug from a
bulk container into small packages & the labeling of
such package with a view to its sale & distribution,
but does not include the compounding or dispensing
or the packing of any drug in the ordinary course of
retail business.

83
1) Licensed premises must conform to the requirements of GMP specified in schedule M.
2) Licensee must provide adequate arrangements for testing the strength & quality of drugs.
3) The manufacture of drugs must be carried out under active direction & personal supervision of
competent person.
a. person who either holds diploma in pharmacy or Registered pharmacist under pharmacy act. OR
b. Have passed the intermediate examination with chemistry as principal subject. OR
c. Have passed matriculation examination & have not less than 4 years of experience in manufacturing or
dispensing or repacking of drugs.
4) Licensee must have adequate facilities for the storage of drugs, so that the properties of drugs are
preserved.
Person licensed to repack drug should observe the following
condition:

84
5) Licensee must maintain the records for the repacking of drugs.
6) Licensee must allow the inspector to inspect the premises where drugs are repacked & to check the records & to
take the samples for test or analysis.
7) Licensee must inform to the licensing authority about any changes in the technical staff or any material changes in
the plant or premises since the date of last inspection.
8) Licensee on request, shall supply the samples of drugs from all the batches to the licensing authority for test or
analysis.
9) In addition to other particulars, the repacked drug should bear the no. of license with words “Rpg. Lic. No.” on its
label.
10) The license should be kept on the licensed premises & should produce before an inspector on demand.
11) Licensee should comply with the provisions of the act.
Person licensed to repack drug should observe the following
condition:

85
Manufacturing of New Drugs
In addition to provisions for manufacture of
drugs, there should be documentary evidence
for quality, purity, therapeutic trials of new
drugs and evidence for approval under
schedule 'V' (Clinical trials).

86
1. Manufacture of drug/ adulterated drug/ spurious drug likely to cause death or grievous body
hurt as per sec. 320 of IPC.:- 5 years----life imprisonment & not less than Rs. 10,000 fine.
2. Manufacture drugs without license or adulterated drug not likely to cause death or grievous
body hurt:- 1-3 years imprisonment & not less than Rs. 5,000 fine.
3. Manufacture of drug in contravention of any other provision:- 1-2 years imprisonment & with
fine.
4. Failure to keep records or disclose required information:- 1 year imprisonment & or fine Rs.
1,000
5. False warranty by manufacturer to a purchaser:- imprisonment or fine upto Rs. 500 or both.
6. Use of Govt. analyst report for advertising:- Fine upto Rs.500
0fenses & Penalties For Manufacture Of Drugs

87
The following categories of drugs and cosmetics are prohibited to be manufactured or sold in our country.
1) Any drug or cosmetic which is substandard, misbranded, adulterated or spurious.
2) Any patent or proprietary medicine without clear indication of ingredients.
3) Any drug claiming for accurate cure or prevention of diseases listed in Schedule J.
4) Any manufacturing of formulation containing drug or cosmetic which has been imported into our
country in contravention to the provisions of the Act and Rules.
5) Manufacturing for sale of any drug or cosmetic containing any harmful ingredient.
6) Manufacturing for sale of any drug or cosmetic in contravention to the provisions of the Act and Rules,
provided that manufacture of small quantities of any drug for the purpose of examination, test or
analysis is permitted, subject to prescribed conditions
Prohibition Of Manufacture & Sale Of Drugs:

“
88
Sale of Drugs:
1) The ultimate objective of pharmaceutical manufacture is to sell
quality drug formulations to the consumers or patients.
2) Sale may be defined as the process of passage of articles from the
manufacturer to the consumer.
3) Pharmaceutical marketing today, is a glittering and challenging
professional activity.
4) The distribution channel in pharmaceutical marketing is :
Manufacturer Distributor Wholesaler Retailer Consumer
Manufacturer Wholesaler Retailer Consumer

89
Types Of Sale:
There are two general types of sale
•Retail sale
•Wholesale
•Retail Sale: It means a sale whether to a hospital or a
dispensary or medical, educational, or research institute
or to any other person other than a sale by way of
wholesale dealing.
•Wholesale: It means a sale to a person for the purpose
of selling again & also includes a sale to hospital or a
dispensary or medical, educational/research institute.

90
Types of sales Licences:
Sales Licences
Retail sale
Licences
Wholesale
Licences
Restricted
Licences

91
Licences
issued
Forms
Drugs other than sch. C,
C1 & X.
Drugs specified in sch. C,
C1.
Drugs specified in sch. X.
Retail 20 21 20F
Restricted 20A 21A -
Wholesale 20B 21B 20G
Wholesale or Distribution
by motor vehicle.
20BB 21BB -
Form no. in which licenses are issued for the sale, stock, exhibit for sale or
distribution of drugs License issued

92
Kinds of licenses for Retail sale:
Retail
From Shop
Drug store
Chemist &
druggist
pharmacy
vendors
Only specified
drugs in specified
area

93
The retail trade is solely in hands of Registered Pharmacists or Qualified persons.
The licensee should maintain registers with following particulars:
A. Drugs Other than Schedule X on a prescription of RMP:
1. Serial number of entry,
2. Date of supply
3. Name of the prescriber
4. Name and address of the patient/owner of animal in case of veterinary drug.
5. Name and quantity of drug,
6. For Schedules H and X drugs - name of the manufacturer, its batch number and expiry date.
7. Signature of the qualified person under whose supervision the drug is supplied.
1. Retail Sale:

94
B. Drugs belonging to Schedules C and C (1):
1. The requirement given under 1,2,4,5, 7. as
given above under (A) are also for this
category of drugs.
2. In addition, name of the manufacturer,
Batch No., date of expiry are required to be
mentioned.
3. All above entries are required to be made
in cash or credit memo book

95
C. Drugs under Schedules H and X :
1. Schedule H prescription drugs- These drugs should not be sold except on prescription of RMP.
2. For sale of Schedule X drugs, the prescription should be accepted in duplicate. One copy of this prescription is
required to be retained by the licensee for 2 years.
3. The prescription should be accepted be in clear writing and signed by the prescriber/doctor with date. The name of
the patient or owner of the animal if it is veterinary drug, should also be indicated by the doctor.
4. The information in prescription should also cover the total amount of medicine to be supplied and the dose to be
given.
5. The instructions only in writing by the superintendent of hospital or RMP should be honored provided, they are in
accordance with the Rules.
6. The records and the copy of the prescription should be retained by the licensee for a period of at least 2 years.

96
Schedules H and X drugs be kept under lock and key in a separate cupboard. The pharmacist should not supply any substitute to
these drugs. Schedule X drugs are recorded serially in the register. Separate page for each drug should be maintained in the
register with following details.
(i) Date of purchase by the retailer,
(ii) quantity received,
(iii) name and address of supplier or wholesaler,
(iv) name and quantity of drug supplied to the patient on prescription of RMP,
(v) manufacture's name,
(vi) Batch Number,
(vii) Lot No.,
(viii) name and address of patient to whom it is supplied,
(ix) reference No. of prescription against which it is prescribed,
(x) name of doctor,
(xi) bill number issued,
(xii) date of receipt issued, and
(xiii) signature of qualified person.

97
Kinds of licenses for wholesale:
Wholesale
From Shop
License for
wholesale of Sch
C & C1
License for Drugs
other Than Sch.
C & C1
From motor
Vehicle
License for C & C1
drugs
License for Drugs
other Than Sch.
C & C1

98
Wholesale of Drug
Wholesale trade is permitted to be carried out by one of the following categories of persons under
Rule 64, Sub-Rule (ii).
The wholesaler who is qualified is called a competent persons, which is either
(a) registered pharmacist
(b) matriculate with 4 years experience in handling or sale of drugs, and
(c) any graduate with one year experience in sale of drugs.
In addition to the requirements already mentioned, specific requirements are as follows:
1. For drugs of Schedules C and C (1), the licence for wholesale is issued in From 21-B
2. For Schedule X drugs, the licence for wholesale is issued in Form 20-G.
3. For drugs other than Schedules C, C (I) and X, the licence for wholesale is issued in Form 20-B.

99
Following conditions are to be satisfied by the licensee having wholesale of schedule C & C1 drugs:
1. The license should be displaced in a prominent part of premises opened to the public.
2. The licensee must have adequate premises which should not be less than 10 sq. meters, equipped with facilities for
the proper storage of drugs.
3. Licensee should maintain records related to all purchase & sale of drugs, with particular such as
a) date of purchase & sale
b) name & addresses of the person from whom purchased & to whom sold.
c) names & quantities of drugs & their batch no.
d) names of manufacturers of drugs.
4. Drug should be purchased from dully signed manufacturer.
5. Drug should be sold only to those persons who are licensed to retail them.
6. The licensee should comply with all the provisions as per the act.
Wholesale of schedule C & C1 drugs:

100
Wholesale of drugs other than those specified in
schedule C & C1:
1. Drugs should not be sold to any person who
do not hold the license for the retail sale or
distribution of drugs of these class.
2. The general conditions as mentioned in
previous slide

“
101
Wholesale from motor vehicle:
1. The general conditions as mentioned in previous
slide. Separate license is necessary for schedule C &
C1 drugs & other than those specified in schedule C
& C1.
2. The license should be displaced in the prominent
place in the vehicle.
3. Drugs may also be distributed to govt. hospital or
institutions.

102
General license:
General license is granted to a person who have
premises for business & who have engage the services
of qualified person to supervise the sale of drug & do
the compounding & dispensing.
Restricted license:
Restricted license is granted to those dealer who do
not engage the services of qualified person.

103
Sale, stocking, exhibition or offer for sale of drugs likely to cause death or grievous hurt as per
sec. 320.
1. 5 years of life imprisonment & not less than Rs. 10,000 fine. Sale, stocking, exhibition or
offer for sale of adulterated drug.
2. 1-3 years imprisonment & not less than Rs. 5,000 fine on first conviction & 2-6years
imprisonment & not less than Rs. 10,000 fine on subsequent conviction Sale, stocking,
exhibition or offer for sale of spurious drugs.
3. 3-5 years imprisonment & not less than Rs. 5,000 fine on first conviction & 6-10 years
imprisonment & not less than Rs. 10,000 fine on subsequent conviction
Offenses & penalty for sale of drugs:

104
Sale of drug in contravention of any other provision:
1. 1-2 years imprisonment & fine on first conviction & 2-4 years imprisonment & not less than
Rs. 5,000 fine on subsequent conviction Failure to keep records or disclosed required
information.
2. Imprisonment upto 1 year & or fine upto Rs. 1000 False warranty to purchaser
3. Imprisonment upto 1 year & or fine upto Rs. 5000 on first conviction & 2 years
imprisonment or fine or both on subsequent conviction. Use of govt. analyst report or CDL
report for advertising
4. Fine upto Rs.500 on first conviction & imprisonment upto 10 years or fine or both on
subsequent conviction.
Offenses & penalty for sale of drugs:

105
Labeling & Packaging of Drugs:
Labeling & Packing of drug as per D&C Act 1940 Legal requirements for labeling of drugs are as follows:
The label should be printed or written in indelible ink and should clearly appear on label of inner most container and
every other covering of the container. The details of labelling include:
1. Name of drug (official name, trade name)
2. Statement of net content.
3. Content of active ingredient.
4. Name of manufacturer & his address along with license no. & batch no.
5. Potency, standard, grade, dose etc. expressed as ML, grains, units etc.
6. Manufacturing & expiry dates
7. Precautions for handling, storage, sale or usage etc.
8. Special instructions may be there such as for veterinary use, physician sample etc. Special labeling for, “drug for
export”, “dispensed drug”

106
Particulars of Label:
1. For schedule G drugs:
 “Caution: It is dangerous to take this preparation
except under the medical supervision”.
2. For schedule H drugs:
 Warning: To be sold by retail on the prescription
of a registered medical practitioner only”.
 Symbol Rx prominently on left hand top corner of
the label.
 Symbol NRx prominently on left hand top corner
for narcotic & psychotropic substances.

107
3. Schedule X drugs:
 “schedule X drug Warning: To be sold on prescription of RMP only” .
 Symbol XRx in red on left hand top corner.
4. Ophthalmic solution/suspension/ointment:
 Use within one month after opening the container.
 FOR OPTHALMIC USE ONLY
 NOT FOR INJECTION
 Name & concentration of preservatives if used.
 Special instructions regarding storage wherever applicable.
 Warning: If irritation persist or increases, discontinue the use & consult the physician.
 Do not touch the dropper tip or other dispensing tip to any surface since this may contaminate the solutions.

108
5. Veterinary drugs:
Not for human use
For animal treatment only
Head of any domestic animal
6. Packing of drugs specified in Sch. X:
The drugs specified in sch. X can be marketed in packing
not exceeding
i) 100 unit doses in case of tablet/capsules
ii) 300 ml in case of liquid preparation
iii) 5 ml in case of injection.

109
7. Schedule C drug:
(i) Proper name of the drug in addition to patent or proprietary name
(ii) Licence number
(iii) Batch/Lot number
(iv) Statement of potency in units
(v) Manufacturer's name and address
(vi) Date of manufacturing
(vii) Statement for test for maximum toxicity
(viii) Date of expiry
(ix) Nature and percent of antiseptic or preservative added.
(x) Precautions for preservation.

110
8. Patent & Proprietary medicine:
Should have on its label words: containing vitamins for "For prophylactic use" or "For prophylactic or therapeutic use".
therapeutic use.
9. Non-sterile ligatures:
"Non sterile surgical ligature or and sutures suture - Not to be used for operation upon human body unless effectively
sterilized" and this part of label should be in red ink.
10. Pharmacopoeial and other drugs:
(i) It should have on label words printed as J.P., U.S.P., and B. P.
(ii) Net amount of drug in metric system
(iii) Amount of active ingredient and all other particulars.

111
11. Medicines containing methylated spirit:
It should have words "For external use only "
12. Disinfectants:
Name of the disinfectant, grade, type, potency, quantity in container, indications for mode of use and address of
manufacturer.
13. Oral contraceptives:
Date of manufacturing and instructions for usage.
14. Coloured medicament or formulation:
Common name of the colour used and its percentage (only permitted colours are required to be used)

112
1. Biological and other specific products of Schedules C and C (1) advertised and sold as proprietary medicine,
proper name of the substance should appear on label of every ampoule or container.
2. Proper name, Manufacturing Licence Number, Batch Number, statement of potency in units, expiry date,
storage requirement, etc., should be mentioned.
3. For ophthalmic solutions and suspensions, the additional requirement on label is: "Use within one month if
opening and not for injection."
4. The standard reference books are J.P, U.S.P, B.P, B.P.C, National Formulary of U.S., State Formulary of U.S.A,
International Pharmacopoeia and Pharmacopoeia of Soviet Socialist Republic.
Specific Requirements:

113
Mechanical Contraceptives:
The label should contain:
1. Particulars specified in Schedule R,
2. Date of manufacturing,
3. Date upto which it retains its property,
4. Storage, in addition to other information.
Oral Contraceptives:
1. In addition to general information, label should depict - date of manufacture and usage.
2. Drugs for export should be labelled as per rules prevailing in country of export or importing country.
3. In Schedule E (1) drugs, label in red printing or printed against red background.

114
1. On both inner & outer label it should indicate
 Name of the cosmetic.
 The name & address of the manufacturer.
2. On the outer label, it should indicate the net content of the
package.
 Such statement need not appear on the label if the net
content does not exceeds 60 ml/30 grams.
3. On the inner label, it should indicate, the proper direction of
safe use, warning, caution, or the ‘special direction’ & the names
& contents of ingredients that are poisons or hazardous.
Labeling of cosmetics:

115
4. The label in addition should indicate.
 batch no., only if the content of cosmetics is more
than 10 gms or 25 ml, in case of soap instead of
batch no. the month & year of manufacture of soap
shall be given on the label.
 Mfg. lic no. Preceded by letter M.
5. If the package or container of the cosmetic has only
one label, it should contain all the information required
to be shown on both inner & outer label.

116
Labeling of hair dyes:
 Hair dyes containing coal tar color should label
(inner & outer)
 “Caution: This product contains ingredients which
may cause skin irritation in certain cases & so a
preliminary test according to directions should first
be made.
 The product should not be used for dyeing eye
lashes or eye brows, as such as use may cause
blindness.

117
Labeling of toothpaste containing
fluorides:
 Fluoride content in tooth paste shall not be more
than 1000 ppm & the content of fluoride in terms
of ppm shall be mentioned on tube & carton
 Date of expiry shall be mentioned on tube &
carton.

118
List of permitted colours:
Sr. No. Type of Colour Examples
1 Natural colours Annatto, carotene chlorophyll, cochineal, curcumin, red oxide or iron, yellow oxide or iron, titanium oxide,
black oxide of iron.
2 Artificial colours Caramel, riboflavin.
3 Coaltar colours Green
Quinazine
Green SS,
Alzarin
Cyanine
Green,
Fast Green
FCF,
Green S.
Yellow
Tartrazine,
Sunset Yellow FCF,
Quinoline Yellow
WS.
Red
Amarnath,
Erythrosine,
Eosin YS or
Eosin G, Tony
red or Sudan
III, Carmosine,
Fast red E.
Blue
Indio
carmine,
Brilliant blue
FCF.
Orange
Orange
G.
Brown
Resocin
brown.
Black
Naphthol
blue
black.
4 Lakes Aluminum or calcium salts,

119
Offences & Penalties:
Offences by government Department:
Chapter IV in relation to manufacture, sale,
distribution etc of the drug, the head of dept. shall be
deemed guilty of that offences punishable with
following :
1. Penalty for vexatious search or seizure:
By any inspector punishable with Rs. 1000
2. Protection of action taken in good faith:
No suit, prosecution or other legal process shall lie
against any person for any thing which is done in good
faith.

120
Study of Schedules:
Schedule G:
 List of substances required to be taken only under supervision of RMP.
 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, chlorothiazide, chlorpropamide,
doxorubicin, ethosuximide, Metformin, Insulin all types, Hydroxyurea, Mercaptopurines etc.

121
Study of Schedules:
Schedule H:
 Prescription drugs which are required to be sold by retail only when a prescription by RMP.
 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 (NDPS) 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.

122
Study of Schedules:
Schedule H:
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 was 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.

123
Drugs under schedule H are omitted Drugs under Schedule H1
Alprazolam, Thioacetazone Alprazolam, Diazepam
Cefdinir, Zolpidem Cefdinir, Codeine
Cefepime, Ethambutol HCl Cefepime, Cycloserine
Clofazimine, Meropenem Cefixime, Ertapenem
Codeine, Ethionamide Cefoperazone, Doripenem
Diazepam, Nitrazepam Imipenem, Ethambutol HCl
Cefpirome, Pentazocine Midazolam, Gemifloxacin
Midazolam, Sparfloxacine Cefpirome, Rifampicin
Tramadol, Chlordiazepoxide Ceftriaxone, Tramadol

124
Schedule M:
 Deals with the Good Manufacturing Practices
(GMP) & requirements of premises, plant and
equipment.
 Part I deals with GMP & Factory premises.
 Part II deals with plant and equipment.
 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.

125
PART I: Factory Premises and Materials (Salient Features)
1. General Requirements
2. Warehousing Area
3. Sterile Products
4. Working Space
5. Health Clothing Sanitation of Workers
6. Medical Services
7. Sanitation in Manufacturing Premises
8. Equipment
9. Raw Materials
10. Personnel
11. Master Formula Records (MFR)
12. Batch Packaging Records
13. Batch Processing Records (BPR)
14. Standard Operating Procedures & Records
15. Manufacturing Operations and Controls
16. Reprocessing and Recovery
17. Product Containers
18. Labels and Other Printed Materials
19. Distribution Records
20. Quality Control System

126
PART II Plant and Equipment (Salient Features)
1. External Preparations:
It covers ointments, emulsions, lotions, solutions, pastes, creams, dusting powders and other identical preparations.
•Minimum area: 30 square meters for basic installation and 10 square meters for ancillary area.
•Requirements: Mixing and storage tanks, jacketed kettles of different types, electric mixer, planetary mixer, colloid
mill, triple roller mill, liquid and tube filling equipment's, etc.
2. Oral Liquid Preparations:
It covers syrups, elixirs, emulsions and suspensions.
•Minimum area: 30 square meters for basic installation and 10 square meters for ancillary area;
•Requirements: SS mixing and storage tanks, jacketed kettles of different types, electric stirrer, electric colloidal mill,
emulsifier, filtration equipment, bottle filling machine, cap sealing machine, de-ioniser or water distillation unit,
clarity testing unit, etc.

127
3. Tablets:
For effective production, tablet production department is divided into four sections:
•Mixing, granulation and drying section
•Tablet compression section
•Packaging section (strip/blister)
•Coating section
Minimum area: A minimum of 60 square meters for basic installation and 20 square meters for ancillary area for
un-coated tablets. For coated tablet, additional area of 30 square meters for coating section and 10 square
meters for ancillary area.
Requirements: Disintegrator, sifter, powder mixer, rapid mixer granulator, granulator, hot air oven, weighing machines, compression
machine, punches and dies, storage cabinets, table de-duster, table inspection unit/belt, dissolution test apparatus, single pan
balance, hardness tester, friability and disintegration test apparatus, strip/blister packaging machine, leak test apparatus, tablet
counter, jacketed kettles of different types, SS coating pan, polishing pan, weighing balance, exhaust system and vacuum dust
collector, air-conditioning system (wherever applicable), etc.

128
4. Powders:
•Area: Minimum 30 square meters; additional room for actual blending
•Requirements: Disintegrator, electric mixer, sifter, SS vessels and scoops of suitable sizes, filling equipment,
weighing balance, etc.
5. Capsules:
•Area: A separate enclosed area, suitably air-conditioned and dehumidified. A minimum area of 25 square
meters for basic installation and 10 square meters for ancillary area each for penicillin and non-penicillin
section.
•Requirements: Electrical mixing and blending equipment, capsule filling units (semiautomatic and automatic),
capsules counters, weighing balance, disintegration test apparatus, capsule polishing equipment, etc.

129
6. Surgical Dressings:
•Area: Minimum 30 square meters for basic installation; for medicated dressing additional room required.
•Requirements: Rolling, staining, cutting, folding and pressing machines; mixing tanks, hot air oven, steam
sterilizer, work tables, etc.
7. Opthalmic Preparations:
It includes eye-ointment, eye lotions and other preparations for external use. Separate enclosed areas with air-
lock arrangements required.
•Area: Minimum 25 square meters for basic installation and 10 square meters for ancillary area;
•Requirements: Hot air ovens, jacketed kettles of different types, colloid mill, ointment mill, SS-mixing and
storage tanks; tube washing, drying, cleaning and filling machines; automatic vial washing machine, vial
drying machines, sintered glass funnels, autoclave, liquid filling equipment, laminar flow units, air
conditioning and dehumidification arrangement. rubber bung washing machine, etc.

130
8. Pessaries and Suppositories :
•Area: Minimum 25 square meters for basic installation
•Requirements: Mixing, pouring and moulding equipment's; weighing devices. For pessaries manufactured
by granulation and compression, requirements shall be as given under "tablet".
9. Inhalers:
•Area: Minimum 25 square meters for basic installation
•Requirements: Mixing, graduated delivery and sealing equipment's
10. Repacking of Drugs and Pharmaceuticals:
•Area: Minimum 30 square meters for basic installation. Exhaust system be provided in case of operations
involving floating particles.
•Requirements: Weighing, measuring and filling equipments; powder disintegrator, electrically operated
powder sifter, electric sealing machine, SS scoops and vessels, etc.

131
11. Parenteral Preparations:
1. Parenteral Preparations in glass containers: It includes areas for water management, containers, closures
preparation, solution preparation, filling, capping, sealing, sterilization, quarantine, visual inspection and
packaging.
• Area: Minimum 150 square meters for basic installation and 100 square meters for ancillary area for small volume
injectables.
• Requirements: Distillation unit, de-ionised water unit, thermostatically controlled water storage tank, transfer pumps,
SS service lines for carrying water, automatic rotary ampoule/ vial/bottle washing machine, automatic closures,
washing machine, dryer, double ended sterilizer; storage equipment for ampoules, vials, bottles and closures, SS
benches/stools, dust proof storage cabinets, mixing SS tanks, portable stirrer, filtration equipment, transfer pumps,
automatic ampoule/vial/bottle filling, capping, sealing machines under laminar air flow work station; gas lines for
nitrogen, oxygen and carbon dioxide; steam sterilizer, hot air sterilizer, storage cabinets, visual inspection units, batch
coding, machine labelling unit, pressure leak test apparatus, etc.

132
2. Parenteral Preparations in Plastic Containers:
The operational activities are in separate areas for water management, solution preparation, container-
moulding-cum-filling, sealing, sterilization, quarantine, visual inspection and packaging.
•Area: Minimum 250 square meters for basic installation and 150 square meters for ancillary area. Areas for
formulations meant for external and internal uses shall be separately provided. A minimum of 100 squares
meters be provided for packaging materials for large volume parenterals.
•Requirements: De-ionised water treatment unit, distillation unit (multi-column with heat exchangers),
thermostatically controlled water storage tank, transfer pumps, SS service lines for carrying water, storage
tanks, solution preparation tanks, transfer pumps, cartridge and membrane filters, sterile form fill-seal
machine, plastic granules feeding device, super-heated steam sterilizer, adequate number of platforms,
racks for storage, visual inspection unit, pressure leak test apparatus, batch coding machine, labelling unit,
etc

133
 List Of Minimum Equipments For The Efficient Running Of A Pharmacy.
 Entrance: shall bear an inscription “Pharmacy” in front.
 Premises: shall be separated from rooms for private use, shall be well lighted & ventilated & sufficient dimensions
to allow goods stock. Specially medicament & poison kept clearly visible.
 Area of dispensing : NLT 6 square meter for 1 pharmacist & additional 2 square meter for each additional
pharmacist, height of premises at least 2.5 meter. Floor smoot & washable surface.
 Water supply: good quality.
 Furniture & apparatus: As per requirement of establishment. Drawers, glasses, cabinets & containers used for
storage should be closed tightly to avoid entry of dust. Containers bear label of appropriate size & easily readable.
 Separate cupboard for storage of poison with lock & key & marked with word POISON in red on white background.
 General provisions: Pharmacy shall be conducted under continuous supervision of registered pharmacist.
Schedule-N

134
Schedule-P
 It deals with life period of drug and the conditions of the storage of drugs, period in months
(unless otherwise specified) between date of manufacture and date of expiry.
 This schedule includes antibiotics, vitamins, insulin preparation, normal human plasma, sera
toxins, toxoids, other toxins, antitoxins, miscellaneous drugs.
Schedule-P(I)
 Specifies the pack size of certain drugs.
 The pack sizes for liquid Oral preparations shall be 30ml (Pediatric only) 60 ml/100 ml/200
ml/450 ml.

135
Good Manufacturing Practices for Ayurvedic, Siddha & Unani medicines.
• Raw materials used in the manufacture of drugs are authentic, of prescribed quality & free from contamination.
• The manufacturing process is as has been prescribed to maintain the standards.
• Adequate quality control measures are adopted.
• The manufactured drug which is released for sale is of acceptable quality.
PART-I: Good Manufacturing Practices
• Factory Premises General requirements
• Location and surroundings
• Buildings
• Water supply
• Disposal of waste
• Containers cleaning
Schedule- T

136
PART-I: Good Manufacturing Practices
• Stores (Raw materials, Packing material, Finished Goods Stores)
• Working space
• Health, Clothing Sanitation and Hygiene of Workers
• Medical Services
• Equipment’s
• Batch manufacturing Record
• Distribution Record
• Record of market complaints
• Quality control
Requirements for Sterile product
• Manufacturing area
• Precautions against contaminations and mix

137
Schedule-T
PART-II:
•List of recommended machinery, equipment & minimum manufacturing premises required for the manufacture
of various categories of Ayurvedic, Siddha system of medicines.
•List of recommended machinery, equipment & minimum manufacturing premises required for the manufacture
of various categories of Unani system of medicines.
•Machinery and equipments should be according to the size of operation and nature of product.
•Manufacturing process could be manual, semi-automatic or automatic.
•These equipments have to be properly installed and maintained with proper cleaning.
•There should be adequate space between machines to facilitate the cleaning and maintenance operation.
•Proper Standard Operational Procedures (SOPs) for cleaning, maintaining & performance of every machine
should be laid down.

138
Sr. No. Category of medicine Machinery and Equipments
1 Anjana/Pisti Kharel-machanized/motorized, kharel, end runner/ballmill.
Sieves/shifter
2 Churna, Manjan/lepa Grinder, disintegrator, pulverize, powder mixer, sieves/shifter
3 Pills/vatti/Gutika Ball mill, mass mixer, vati cutting machine, stainless steel
trays/containers for storage
4 Tablets Ball mill, mass mixer/powder mixer granulator, drier, compressing
machine and sugar coating
5 Kupi/kasra/Parpati/lavana,
bhashma, satva/sidura,
karpu/uppu/Param
Bhatti , karahi/stainless steel vessels/patila flask, multani matti/plaster
of paris, coper rod, earthen container, gaj put bhatti, muffle furnace
end/edge runner

139
Sr. No. Category of medicine Machinery and Equipments
6 Capsule Air conditioner, dehumidifier, hygrometer, thermometer, capsule
feeling machime
7 Ointments/Marham pasai Tube feeling machine, crimping machine/ointments mixer, end
runner/ mill
8 Pak/Avaleh/khand/
Modak/lakayam
Bhatti section fitted with exhaust fan and should be fly proof, iron
kadahi/ SS patila and SS storage container
9 Asava/Arishtha Tincture press, exhaust fan fitted and fly proof, bhatti section , bottle
washing machine, liquid feeling machine, PP capping machine
10 Tail , Ghrit, ney Bhatti, kadahi/SS patila SS storage container, filtration equipment
filtration with tap/liquid feeling machine

140
Gives the particulars to be shown in manufacturing records of Drugs.
• Gives the particulars to be recorded of raw materials & gives the particulars to be recorded in analytical records.
• The records or registers shall be retained for a period of 5 years for Drugs from the date of manufacture.
A. Substances other than parenteral preparations in general.
• Serial number.
• Name of the product.
• Reference of master formula records.
• Batch size.
• Batch number.
• Date of commencement of manufacture & date of completion of manufacture & the assigned date of expiry.
• Name of all ingredients , specifications quantities required for the lot /batch size and quantities actually used.
Schedule-U

141
A. Substances other than parenteral preparations in general
•All weighing's & measurements shall be carried out by a responsible personal, shall be counter-checked &
signed by the competent technical staff under whose personal supervision the ingredients are used for
manufacture.
•The theoretical yield and actual productions yield and packing particulars indicating the size and quantity of
finished packings.
•Specimen of label or strip, carton with batch coding information like batch number ,date of manufacture ,date
of expiry, retail price as applicable, stamped thereon and inserts used in the finished packings.
•Signature with the date of component technical staff responsible for the manufacture
•Counter-signature of the head of the testing units for other approved person in charge of testing for having
verified the batch records and for having released the batch for sale and distribution , the quantity released
and date of release.

142
B . Parenteral preparations:
•Serial number.
•Name of the product.
•Reference of master formula records.
•Batch size.
•Batch number.
•Date of commencement of manufacture & date of completion of manufacture & the assigned date of expiry.
•Name of all ingredients , specifications quantities required for the batch size and quantities actually used.
•All weighings & measurements shall be carried out by a responsible personal & shall be counter-checked & signed
by the competent technical staff under whose personal supervision the ingredients are used for manufacture.
•Control numbers of raw materials used in the formulation.
•Date, time and duration of mixing.
•Details of environmental controls like room temperature, relative humidity.

143
12. Records of in-processes controls.
13. Reference to analytical report number stating the results of test and analysis.
14. Separate records of the disposal of the rejected batches and of batches withdrawn from the
market
15. The theoretical yield, actual productions yield, packing particulars indicating the size &
quantity of finished packings.
16. Specimen of label or strip, carton with batch coding information like batch number, date of
manufacture, date of expiry, retail price as applicable, stamped thereon and inserts used in
the finished packings.
17. Signature with the date of component technical staff responsible for the manufacture
18. Counter-signature of the head of the testing units for other approved person in charge of
testing for having verified the batch records and for having released the batch for sale &
distribution , the quantity released and date of release.

144
Records of Raw Material:
• Records in respect of each raw materials shall be maintained Indicating…
• The quantity received
• Control reference number
• Quantity issued from time to time
• The names and batch numbers of the products for the manufacture of which the said quantity of raw materials has been
issued and the particulars relating to the proper disposal of the stocks.
A . Tablets And Capsules:
• Analytical report number.
• Name of the sample
• Date of receipt of sample.
• Batch or lot number
• Protocols of tests applied.
• Signature of analyst.

145
B . Parenteral preparations:
1. Protocols of tests applied
2. Clarity
3. pH
4. Volume In Container
5. Sterility
6. Pyrogen Test
7. Toxicity Test
8. Results Of Assay.
C . For other drugs:
1. Analytical report number.
2. Name of the sample
3. Date of receipt of sample.
4. Batch or lot number
5. Protocols of tests applied.
6. Signature of analyst
7. Opinion and signature of the approved

146
Schedule-U(I)
Gives the particulars to be shown in manufacturing records of Cosmetics.
 The records or registers shall be retained for a period of 3 years for Cosmetics from the date of manufacture.
Schedule-V
 Give details of standards for patent and proprietary medicines, containing vitamins.
 General standards for patent & proprietary medicines.
 Patent and proprietary medicines shall comply with the dosage form under which it falls given in IP.
1. Tablet
2. Capsule
3. Liquid oral dosage form
4. Injections
5. Ointments

147
Schedule-X
Contains a list of 15 narcotic drugs and psychotropic substance.
• A label ‘Schedule X drug’ warning: To be sold on retail on prescription of a RMP only.
• It also have ‘NRx’ in red & conspicuously displayed on the top left corner.
• Examples: Barbital, Dexamphetamine, Methaquinoline, Phencyclidine, Secobarbital,
Amobarbital, Amphetamines, Glutethimide, Methylphenidate, etc.
• These drugs may be imported under license or permit

148
This Schedule includes requirements and guidelines for permission to import and/ or manufacture of new drugs
for sale or to undertake clinical trials.
It Includes:
•Application for permission
•Clinical trial (approval for trial, responsibilities of sponsor, investigator, ethical committee, phases I, II, III, IV)
•Studies in special population (like geriatric, pediatric & pregnant women, Post Marketing Surveillance etc.)
•Post Marketing surveillance
•Special Studies: BA/BE studies
Schedule-Y

149
1. Application for permission:
It shall made in FORM 44 accompanied with following data in accordance with appendices , namely Chemical and
pharmaceutical Information.
•Animal pharmacology data
•Animal toxicology data
•Human clinical pharmacology data
•Regulatory status in other countries
•Prescribing Information
•FORM 12- To import Study drug for examination, test or analysis
Schedule-Y

150
2. Clinical Trial:
1) Approval for clinical trials
•CT on a new drug shall be initiated only after permission by licensing authority and approval from EC
2) Responsibilities of sponsor
•Implementing and Maintaining QA
•Submit status report to the licensing authority periodically
•SAE should be reported to the licensing authority within 14 calendar days.
3) Responsibilities of Investigator
•Ensure adequate medical care is provided to the subject.
•SAE and unexpected AE should be reported to the sponsor within 24hours and to the EC within 7 working days.
4) Informed Consent
•freely given informed written consent
•Provide information about the study verbally

151
5.Responsibilities of Ethics Committee
•Approval trial protocol to safeguard RSW of all trial subject and to protect RSW of all vulnerable subjects
•Conduct ongoing review of the trials.
6) Human Pharmacology (Phase l)
•Safety and tolerability – Objective
7) Therapeutic Exploratory Trials (Phase ll)
•To evaluate the effectiveness of a drug for particular indication.
•To determine the short term side effects and risk associated with the drug
•To determine the dose and regimen for phase lll trials.
8) Therapeutic confirmatory Trials (Phase lll)
•Demonstration of therapeutic benefit
•Drug is safe and effective for use and Provide and adequate basis for marketing approval
9) Post Marketing Trials (lV)
•Performed after drug approval and related to the approved indication
•Includes drug-drug interaction, dose-response or safety studies, mortality/morbidity studies

152
3.Studies in Special Population:
•Geriatrics
•Pediatrics
•Pregnant or Nursing Women
4.Post Marketing Surveillance
•Closely monitored new drugs
clinical safety
•PSUR- to report all relevant
new information
•PSUR shall be submitted every
6 months for the first 2 years
5.Special Studies-BA/BE
studies
•Conducted according to the
guidelines for BA and BE
studies.
•Evaluation of the effect of
food on absorption following
oral administration

153
Schedule-Y(I)
 This Schedule includes Registration of Clinical Research Organization (CRO) for conducting clinical trials.
 It also deals with compensation in case of Injury/ Death during clinical trial study

154
Form 1 Memorandum to the Central Drugs Laboratory (CDL).
Form 2 Certificate of CDL for test or analysis.
Form 8 Application for licence to import drugs except, schedule X (Roman X) and Licence for this is
issues in Form 10.
Form 8-A Application for licence to import schedule X drugs & licence for this is issues in Form -10A.
Form 9 Undertaking accompanying application for import licence.
Form 11 Licence for import of drugs of examination, test or analysis; while the application for this
licence is made in Form 12.
Form 11-A Licence to import drugs by a Government hospital or Autonomous medical institution;
while the application for this is made in Form 12-AA.
Form 12-A Application for permit to import small quantities of drugs for personal use while, permit is
issued in Form 12-B.
Different Forms used for variety of operations pertaining to D & C Act 1940:

155
Form 13 Certificate of test or analysis by Government Analyst under section 25 (1) of DCA,
1940.
Form 13-A Certificate of test or analysis by Government Analyst under Section 33 H of DCA, 1940.
Form 14-A Application for test or analysis of a drug from purchaser under section 26 of DCA, 1940
and the certificate for the same is issued in Form 14-B.
Form 15 Order requiring a person not to dispose of stock in his possession.
Form 16 Receipt for seized stock of drugs or cosmetics, records, register, documents or
material.
Form 17 Intimation to person for taking sample.
Form 17-A Receipt for samples of drugs or cosmetics taken where fair price is tendered.
Form 18 & 18-A Memorandum to Government Analyst.

156
Form 19 Application for grant or renewal of a licence to sell, stock, exhibit or distribute drugs
other than schedule X.
Form 19-A Application for grant or renewal of a restricted licence to sell, stock, exhibit or distribute
drugs by retail by dealer who does not engage qualified person. The Licence for this is
issued in Form 20-A.
Form 19-AA Application for grant or renewal of licence to sell, stock, exhibit or distribute drugs from
a motor vehicle. The licence for this is issued in Form 20-BB.
Form 19-B Application for a licence to sale, stock, exhibit, sale or distribute Homoeopathic
medicine. The I licence for retail is issued in Form 20-C, while the licence for wholesale is
given in Form 20-D. The certificate for renewal of licence is issued in Form 20- E.
Form 19-C Application for grant or renewal of a licence to sell, stock, exhibit or distribute schedule
X drugs. The licence this by retail sale is issued in Form 20-F while, the licence for the
same by wholesale is given in Form 20-G

157
Form 20 Licence for retail sale of drugs other than Schedules C, C (1) and X.
Form 20-A Restricted retail licence for drugs other than Schedules C, C (1) and X
Form 20-B Wholesale licence for drugs other than Schedules C, C (I) and X.
Form 20-F Retail licence for Schedules X drugs.
Form 20-G Wholesale licence for Schedule X drugs.
Form 20-BB Wholesale licence for drugs other than Schedules C and C (I) from motor vehicle.
Form 21 Retail licence for Schedules C and C (1) drugs, excluding Schedule X.
Form 21-A Restricted retail licence for Schedule C and C (1) drugs, excluding Schedule X.
Form 21-B Wholesale licence for Schedule C and C (I) drugs.
Form 21-BB Wholesale licence from motors vehicle for Schedules C and C (1) drugs.

D & C Act 1940

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