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Drug and cosmetic act 1940 & Rules 1945
Objective
 The D&C Act was passed in 1940 (10th April 1940), with the main object to
import, manufacture, distribution, sale of drug & osmetics.
 The act regulates the import of drugs in India, so that no substandard or spurious
drug will enter into our country.
 The act prohibits the manufacture of substandard or spurious drug in the country.
 The act provide for the control over the sale & distribution of drugs by only
trained & qualified persons.
 The act also provide for the control over the manufacture, sale & distribution of
Ayurvedic, Siddha, Unani & Homeopathic drugs.
 Certain provisions of the act regulates the import, manufacture, sale &
distribution of cosmetics.
 To have regular inspection of licensed premises by drug inspectors.
 To have control over the standards of drugs & cosmetics by taking samples &
analyzing them at approved laboratories.
 To provide special provisions to regulate the preparation, standardization &
storage of biological & special products.
 To prescribe the manner of labeling & packing of the various classes of drugs &
cosmetics.
Definitions
Drug
“Drug” 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 gelatin
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,
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.
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.
Standards of quality:
Standards of quality in relation to a drug means that the drug complies with the standard
set out in the Second Schedule and in relation to a cosmetic that the cosmetic complies
with such standards as may be prescribed.
Misbranded drugs:
A drug shall be deemed to be misbranded—
(a) if it is so coloured, coated, powdered or polished that damage is concealed or if it is
made to appear of better or greater therapeutic value than it really is; or
(b) if it is not labelled in the prescribed manner; or
(c) if its label or container or anything accompanying the drug bears any statement,
design or device which makes any false claim for the drug or which is false or misleading
in any particular.
Misbranded cosmetic:
A cosmetic shall be deemed to be misbranded—
If it contains a colour which is not prescribed; or
If it is not labelled in a prescribed manner; or
If the label or container or anything accompanying the cosmetic bears any statement
which is false or misleading in any particular.
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 instead of olive oil
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;
or
 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
Spurious cosmetic:
A cosmetic shall be deemed to be spurious if
If it is imported under the name which belongs to another cosmetic; or
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 individual or company 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.
New drug:
Shall mean and include :-
 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) and route of administration.
 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
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
Inspector:
Means
 In relation to a Ayurvedic, Siddha or Unani drug, an Inspector appointed by the Central
Government or a 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
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;
Patent or proprietary medicine:
Means
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.
Homeopathic medicines:
Include
 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 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.
Schedules to the Act & Rules
Schedules to the Act
First Schedule: List of Ayurvedic, Siddha & Unani books
Ayurvedic books
 Charak Samhita,
 Sushrut Samhita,
 Vaidya Chintamani
 Ayurveda Chintamani,
 Arya Bhishak
 Ark Prakasha
 Siddha Books
 Siddha vaidya Thiratu,
 Nagmuni (700),
 Brahma muni Karukkadai (300),
 Pulippani (500),
 Bhogar (700)
 Unani books
 Karabadin Quadri,
 Karabadin Kabir,
 Karabadin Azam
 Karabadin Jaddid,
 Al Karabadin
Second Schedule
Standards to be complied with by imported drugs & by drugs manufactured for sale, sold,
stocked or exhibited for sale or distributed.
Schedules to the Rule
A: List of forms for making applications for issuing licences, granting licences, sending
memorandum
B: Fees for test or analysis by the Central Drugs Laboratory
C: Deals with biological products such as sera antigens, toxin, antitoxin, Vaccines for
parenteral injections, solution of serum proteins intended for injection, Insulin etc
C1: Special products such as fish liver oil, ergot preparations, drugs belonging to digitalis
groups, adrenaline, Liver extract, vitamines, hormones
D: Classes of exempted drugs which are exempted from certain provisions applicable to
import of drugs E.g. Skimmed milk, powdered milk fortified with vitamins, farex, oats,
ginger, pepper, cummins etc Schedules to the Rule
Schedule K
 K: List of drugs exempted from certain provisions applicable to manufacture of drugs
and sale of drugs
 Class of Drugs is not sold for medicinal use and that each container is labelled
conspicuously with the words “NOT FOR MEDICINAL USE”.
 The medicines that continue to be under the 'household remedy' category include
Paracetamol tablets, Analgesic Balms, Antacid Preparations, Calcium preparations with
or without Vitamin D, Gripe Water for use of infants, Inhalers (containing drugs for
treatment of cold and nasal congestion), Syrups lozenges, pills and tablets for cough, cold
or sore throat.
 However, these drugs should not contain any substance specified in Schedules G, H or
X of D&C Act and Rules. The shopkeepers are also to ensure that the drugs are sold in
the original unopened containers of the licensed manufacturers.
 Note- Aspirin and Quinine Sulphate have been removed from this schedule
Mashelkar Committee recommendations
 The Committee on Drug Regulatory System headed by the Chief Dr. Mashelkar.
 suggested to expand the scope of Schedule K to include OTC drugs.
 The ultimate objective is to enhance public access to commonly required medicines but
at the same time ensuring quality of delivery.
OTC Drugs
 The phrase “OTC” has no legal recognition in India, all the drugs not included in the list
of prescription-only drugs” are considered to be non- prescription drugs (or OTC drugs).
 OTC Drugs means drugs legally allowed to be sold “Over The Counter” by
pharmacists, i.e. without the prescription of a Registered Medical Practitioner.
 Prescription-only drugs are those medicines that are listed in Schedule H and X and
Schedule G
Ayurvedic (OTC) Medicines
 OTC drugs registered as “Ayurvedic Medicines” containing natural / herbal ingredients
 Ayurvedic drugs are manufactured under a manufacturing license issued by the
Ayurvedic State Licensing Authorities. However, they do not require a drug sale license
and can be sold freely by non- chemists.
 Largest OTC brands in India are registered as “Ayurvedic Medicines because of their
plant-based‟ natural active ingredients
Categories with OTC potential
 Vitamins and minerals;
 Health tonics,
 Cough suppressants likes vicks 44
 Gastrointestinal drugs like Gas X
 Analgesics
 Dermatological preparations
 Herbal / Ayurvedic medicines
SCHEDULE E & E1
[Omitted as per GOI Notification No.G.S.R. 462(E) dt 22-6-1982]
SCHEDULE E(1): List of Ayurvedic, Siddha, and Unani poisons
Ex- Snake poison, arsenic,mercury,CuSo4, Dhatura, Bhang, Ganja etc
Schedule F and F (I)
 F: Provisions applicable to blood banks (Requirements and licencing process)
 F (I) : Provisions applicable to other biological and special products such as vaccines,
antigens, diagnostic antigens, tuberculin, etc. regarding their production, testing, storage,
packing, etc.
Schedule F (II): Standards for Surgical dressings and bandage cloth.
Schedule F (III): Standard for umbilical tapes.
Schedule FF: Standards for ophthalmic preparations.
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, chlorthiazide, chlorpropamide,
doxorubicin, ethosuximide, Metformin, Insilin all types,Hydroxyurea, Mercaptopurines
etc
Schedule H [Drugs & cosmetics (2nd amendment) Rules 2006]
 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 labelled with the symbol NRx which shall be in red and
conspicuously displayed on the left top corner of the label.
 Examples-Alprazolam, Allopurinol, Amikacin, Atenolol, Acyclovir, Buspirone,
Azathioprine, Captopril, Carbidopa, Clindamycin, Cimetidine, Ciprofloxacin,
Cefuroxime, Diclofenac, Glimepiride, diazepam etc.
For monitoring use and misuse of antibiotics
 Schedule H of the drug and cosmetics act contains a list of 536 drugs which are required
to be dispensed on the prescriptions of a registered medical practitioner.
 In order to have separate regulation to check unauthorized sale of antibiotics, a separate
schedule as Schedule H1 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.
Schedule J
List of diseases and ailments which a drug may not claim to prevent or cure.
Some of the diseases and ailments under this schedule are
1. AIDS
2. Angina Pectoris
3. Appendicitis
4. Arteriosclerosis
5. Baldness
6. Blindness
7. Bronchial Asthma
8. Cancer and Benign tumour
9. Cataract
10. Change in colour of the hair and growth of new hair.
11. Change of foetal sex by drugs. (almost 51 ailments mentioned on Schedule J)
Schedule M
Deals with the Good Manufacturing Practices (GMP) and requirements of premises,
plant and equipment.
Part I deals with GMP & Factory premises.
Part II deals with plant and equipment.
Schedule M1: Prescribes in detail requirements of factory premises for the manufacture
of Homeopathic drugs.
Schedule M- II: Prescribes requirements of factory premises for manufacture of
cosmetics.
Schedule M- III: Prescribes requirements of factory premises for manufacture of medical
devices.
Schedule T: Requirements of factory premises and hygienic conditions for Ayurvedic
and Unani drugs.
Schedule N: List of minimum equipment for efficient running of pharmacy
Schedule O: Standards for disinfectant fluids
Schedule P:
 Life period of drug.
 Period in months (unless otherwise specified) between date of manufacture and date of
expiry which the labelled potency period of the drug should not exceed under the
conditions of storage Specified.
 The schedule includes antibiotics, vitamins, insulin preparation, normal human plasma,
sera toxins, toxoids, other toxins, anti-toxins, miscellaneous drugs
Schedule P 1
Pack size of certain drugs.
It gives the names of drugs, along with the dosage form and the pack size.
No other pack size than the one listed is allowed to be marketed.
Examples of a few drugs under this schedule:
Schedule Q
 List of coaltar colours permitted to be used in drug and cosmetics
 No drug should contain a colours other than specified below :
 Natural Colours
 Carotene, Chlorophyll, Red Oxide of Iron, Yellow Oxide of Iron, Titanium Di-oxide,
Black Oxide of iron
 Artificial Colours Caramel
 Coal Tar Colours
Schedule R: R- Standards for condoms made up of rubber latex intended for single use
and other mechanical contraceptives Eg. Condom, Cu- T
Schedule R-1: standards for medical devices.
Schedule S
 Standards for cosmetics
 The following cosmetics in finished form should conform to the Indian Standards
specifications laid down from time to time by the Bureau of Indian Standards (BIS)].
1.Skin Powders
2. Skin Powder for infant
3. Tooth Powder
4. Toothpaste
5. Skin Creams
6. Hair Oils
Schedule U & U1
U- Particulars to be shown in manufacturing and analytical records of drugs.
U (I)- Particulars to be shown in manufacturing records of cosmetics.
Schedule V: Standards for patent and proprietary medicines and for patent and
proprietary medicines containing vitamins.
Schedule W
 List of drugs which shall be marketed under generic name only
 This includes only five drugs that shall be marketed under generic names only:
 Analgin
 Aspirin and its salt
 Chlorpromazine and its salt
 Ferrous sulfate
 Piperazine and its salts
 (Schedule W) – Inserted as per G.O.I. Notificiation No. GSR 27(E) dt 17.1.1981 and
deleted as per G.O.I. Notification No. GSR 94(E) dt 8.2.2000.
Schedule X: List of habit forming, psychotropic, and other such drugs.
Schedule X contains list of drugs which:
Need discretion while dispending and pharmacist should ensure that this drugs are not
sold without prescription
Have a waning mentioned on a label ‘Schedule X drug’ – Warning : to be sold on retail
on prescription of a registered medical practitioner only. The label will also have a
symbol ‘XRx’ in red & conspicuously displayed on the top left corner of the table
After dispending the drug the pharmacist must Stamp & retain the prescription
Maintain & record purchase & sale of the drug and Preserve it for a period of 2 years
from the date of transactions
Examples of few drugs under schedule X
1)Amobarbital
2)Amphetamines
3)Dexamphetamines
4) Glutethimide
5)Methylphenidate etc.
Schedule Y: Requirements and Guidelines for clinical trials, import, and manufacture of
new drugs.
The schedule covers details like :
Chemical and pharmaceutical information
Animal tests, toxicology and pharmacology
Clinical Trails
 Nature of trials
 Permission for trials
 Responsibility of sponsor / Investigator
Administrative Bodies
 Advisory
 Drug Technical Advisory Board (DTAB)
 Drug Consultative Committee (DCC)
 Analytical
 The Central Drug Laboratory (CDL)
 Drug Control Laboratories in the state (DCL)
Government Analyst
 Executive
 Licensing Authorities (central & state)
 Drug Inspectors
 Custom Collector
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.
Constitution of DTAB
Ex-officio members
1. Director General of Health Services (chairman of the board)
2. Drug Controller of India
3. President, Pharmacy Council of India
4. President, Medical Council of India
5. Director, Central Drug Laboratories, Kolkata
6. Director, Central Drug Research Institute, Lucknow
7. Director, Central Research Institute, Kasuali.
8. Director, Indian Veterinary Research Institute, Izzatnagar
Nominated Members
1. One person from pharmaceutical Industry
2. Two Govt. Analyst
3. Two persons from among the persons who are in-charge of the drug control
organization in the state.
60. Elected Members
1.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
2.One teacher in medicine or therapeutics from the staff of University or affiliated college
elected by the executive Committee of Medical Council of India
3. One person elected by the central council of Indian Pharmaceutical Association.
4.One person elected by the central council of Indian Medical Association.
5.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.
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
 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.
Functions of Central Drug Laboratory (CDL)
 To analyze the samples of drugs or cosmetics sent to it by
a) Custom Collector or any authorized officer
b) 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.
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.
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
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
a) Govt. Analyst
b) 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
a) Govt. Analyst
b) 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.
Duties of Government Analyst:
 To cause analysis or testing of samples of drugs / cosmetics sent to him by Drug
Inspectors or other persons under the provisions of the Act for mfg/sale/distribution and
furnish reports as per rules.
 To forward from time to time reports giving the results of analysis work and research
with a view to their publication at the discretion of the Govt.
Drug Inspector:
Means
 In relation to a Ayurvedic, Siddha or Unani drug, an Inspector appointed by the Central
Government or a 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
Qualifications for Drug Inspectors
1) 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,
(i) Not less than 18 months experience in the manufacture of atleast one of the
substances specified in Schedule C; or
(ii) Not less than 18 months experience in testing of atleast one of the substances
specified in Schedule C in a approved laboratory; or
(iii) Not less than 3 years experience in the inspection of firms manufacturing any of the
substances specified in Schedule C during the course of their services as the Drug
Inspectors
Powers Of Drug Inspectors
Within the local limits for which the inspector is appointed, he may
i) 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
ii) 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
iii) Search any person in connection with the offence under this chapter at all reasonable
times
(iv) 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
(v) 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
(vi) 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
(vii) 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
(viii) Exercise any other powers as may be necessary, for carrying out the purpose of this
Act and the rules made thereunder
Duties of Drug Inspectors
In relation to sale of drugs and cosmetics:
(a) To inspect atleast 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
(b) 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
(c) To investigate any complaint made in writing to him
(d) To institute prosecutions in case of the breach of the Act and Rules
(e) To maintain the records relating to all inspections and actions taken by him and to
submit copies of such records to the controlling authority
(f) To make inquiries and inspections regarding the sale of drugs in contravention of the
Act
(g) To detain the imported packages, if he suspects to contain drugs the import of which
is prohibited.
In relation to manufacture of drugs and cosmetics:
(a)To inspect atleast 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
(b) 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.
(c) 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.
(d) To take samples of drugs manufactured on premises and send them for test or
analysis
(e) To check all records and registers required to be maintained under rules.
(f) To institute prosecutions for breaches of Act Duties of Drug Inspectors
Procedure Of Inspectors
For taking samples of drug and dispatching them to laboratory :
1. 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.
2. Where the price is refused, he shall tender a receipt thereof in the prescribed form.
3. 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.
4. 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
5. 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.
6. 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 :—
(i) one portion or container he shall forthwith send to the Government Analyst for test or
analysis;
(ii) the second he shall produce to the Court before which proceedings, if any, are
instituted in respect of the drug or cosmetic;
(iii) 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
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
Controlling Authority
 All inspectors at central and state level are under their control.
 Qualifications :
1. He is a graduate in Pharmacy / Pharmaceutical chemistry / Medicine with
specialization in Clinical pharmacology or Microbiology from a University established in
India
2. 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.
Licensing Authority
 State Govt.: Each State Govt. employs Licensing Authority to issue license for
manufacture, sale, distribution of drugs / cosmetics within the state. They can Issue /
refuse license/Cancel or suspend license
 Central Govt. appoints licensing authority to issue license for import of drugs
 DRUGS CONTROLLER OF INDIA IS CENTRAL LICENSE APPROVING
AUTHORITY
Qualifications:
1. He is a graduate in Pharmacy / Pharmaceutical chemistry / Medicine with
specialization in Clinical pharmacology or Microbiology from a University established in
India
2. 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.
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.
Import of Drugs
Import means to bring into India
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.
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
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.
Import of schedule X drugs
The license for the import of schedule X 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.
 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 ie 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 small quantities of drug for examination, test or analysis
 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 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 bonafide 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 bonafide personal luggage if
 The drug is for bonafide personal use.
 The quantity to be imported is reasonable & is covered by prescription of RMP.
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.
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.
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)
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 predigested food.
 Cinnamon, pepper, zinger & other condiment & spices.
Offences & Penalty related to import of drug
 Anyone who,
1. Imports adulterated or spurious drug or cosmetic or cosmetic unsafe for use
 Punishable with imprisonment upto 3 years or with fine upto 5,000 or both on first
conviction
 & 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.
 Punishable with imprisonment upto six months or with fine upto 500 or both on first
conviction
 & 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.
 Punishable with imprisonment upto 3 years or with fine upto 5,000 or both on first
conviction
 & punishable with imprisonment upto 5 years or with fine upto 10,000 or both on
subsequent conviction
Manufacture of drugs
Definition
Manufacture in relation to any drug or cosmetics includes any process or part of process
for making, altering, ornamenting, finishing, packing, labeling, breaking up or otherwise
treating or adopting any drug or cosmetic for sale or distribution but does not include
compounding or dispensing of any drug or the packing of any drug or cosmetic in the
ordinary course of retail business.
Kinds of manufacturing licenses
 License for manufacture of schedule C & C1 drugs
 License for manufacture of schedule X drugs
 License for manufacture of drugs other than those specified in schedule C & C1, X.
 License for manufacture of drugs meant for examination, test or analysis.
 Loan license
 Repacking license
Manufacture of biological & other special products specified in schedule C&C1 A
person licensed to manufacture schedule C & C1 drugs, is required to observe the
following conditions (General Condition)
 Licensed premises must conform to the requirements of GMP specified in schedule M.
 The licensee must provide adequate arrangement for testing the strength & quality of
drugs.
 The manufacture of drugs must be carried out under active direction & personal
supervision of technically qualified staff (who should be either
a) graduate in pharmacy or pharmaceutical chemistry with at least 18 months experience
in the manufacture of drugs or
b) a graduate in medicine with at least 3 years experience in the manufacture & testing of
drugs or
c) 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
d) Any other equivalent foreign qualification.
 Licensee must have adequate facilities for the storage of imported drugs, so that the
properties of drugs are preserved.
 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.)
 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 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.
 Licensee on request, shall supply the samples of drugs from all the batches to the
licensing authority for test or analysis.
 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.
Manufacture of drugs specified in schedule X
In addition to general conditions as mentioned before 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 should be stored in bulk & if needed for manufacture 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.
Manufacture of drugs other than those specified in schedule C, C1 & X
In addition to general conditions as mentioned before the licensee should observe the
following conditions.
The licensee should maintain an inspection book in which the inspector may record their
inferences.
If the licensee desires to undertake the manufacture of any additional categories of drugs
he should pay a fee of Rs. 10 for each such additional category.
Licensee must comply with such additional requirements of which he has been given at
least 4 months notice by the licensing authority.
Manufacture of drugs for examination, test or analysis
The following conditions must be observed by the licensee.
Licensee must use manufactured drug exclusively for the purpose for which they are
manufactured.
Licensee must maintain the records of the manufactured drugs, showing particular of
their quantities & names of the persons to whom they have been supplied.
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.
Licensee must comply with such additional requirements of which he has been given at
least 1 month notice by the licensing authority.
Loan License
 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.
 Application for grant of loan license should be supported by documentary consent of
the licensee whose facilities he is going to use.
 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.
 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.
 The licensee must test each batch of raw material & finished product.
 Licensee should maintain manufacturing & analytical records of drugs.
 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.
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.
Person licensed to repack drug should observe the following condition.
 Licensed premises must conform to the requirements of GMP specified in schedule M.
 Licensee must provide adequate arrangements for testing the strength & quality of
drugs.
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.
Licensee must have adequate facilities for the storage of drugs, so that the properties of
drugs are preserved.
 Licensee must maintain the records for the repacking of drugs.
 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.
 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.
 Licensee on request, shall supply the samples of drugs from all the batches to the
licensing authority for test or analysis.
 In addition to other particulars, the repacked drug should bear the no. of license with
words “Rpg. Lic. No.” on its label.
 The license should be kept on the licensed premises & should produce before an
inspector on demand.
 Licensee should comply with the provisions of the act.
0fenses & Penalties for manufacture of drugs
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
Sale of Drugs
 Sale may be defined as the process of passage of articles from the manufacturer to the
consumer.
 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: (sale by way of wholesale dealing) 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, or research institute
 Drug store: It means a licensed premises for the sale of drug who do not require the
services of a qualified person.
 Chemist & druggist: It means a licensed premises for the sale of drug who requires the
services of a qualified person but where the drugs are not compounded against
prescription.
 Pharmacy: It means a licensed premises for the sale of drug who requires the services
of a qualified person but where the drugs are compounded against prescription.
Drug and cosmetic act 1940
Wholesale of schedule C&C1 drugs
 Following conditions are to be satisfied by the licensee having wholesale of schedule
C&C1 drugs
 The license should be displaced in a prominent part of premises opened to the public.
 The licensee must have adequate premises which should not be less than 10 sq. meters,
equipped with facilities for the proper storage of drugs.
 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
 Drug should be purchased from dully signed manufacturer.
 Drug should be sold only to those persons who are licensed to retail them.
 The licensee should comply with all the provisions as per the act.
Wholesale of drugs other than those specified in schedule C&C1
 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.
 The general conditions as mentioned in previous slide.
Wholesale from motor vehicle
 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
 The license should be displaced in the prominent place in the vehicle.
 Drugs may also be distributed to govt. hospital or institutions.
Retail sale from shops
 Facilities as per schedule N.
 Purchased only from licensed wholesalers.
 No sale of specified drugs
 Separate license for sch. C, C1 & X drugs.
 Sale under qualified supervision.
 Records
 Inspection
 Sale of specified households drugs from drug stores.
Licenses for chemist & druggist shops & pharmacy
 The license granted subject to the following conditions.
 The licensee must have adequate premises & facilities for proper storage of drugs &
under the supervision of competent person for sale & distribution of drugs.
 Must fulfill the requirements as per sch. N.
 Must obtain the permission to sale additional categories of drugs.
 Licensee must maintain records of drugs.
 Licensee must allow an inspector to inspect the premises & to check the records.
 Licensee must inform to the licensing authority about any change in qualified staff.
 Precaution must be taken during storage of sch C & C1 drugs.
Sale of sch X & sch X drugs
 Drugs specified in schedule H & X should be sold only on prescription of RMP.
 In case of sch. X drugs, the prescription should be in duplicate & should be retained for
2 years.
 The cash or credit bill should bear a signature of customer with his address.
 Separate bound & paged registers should be maintained for supply in which separate
sheets should be allotted for each drug.
 The following particulars should be enter at the time of supply
a) date of supply
b) opening & closing stocks of drugs on that day & relevant bill number.
c) name of the drug, its manufacturers name & batch no.
d) name & address of the purchaser
e) date of prescription & name & address of RMP
f) signature of Registered pharmacist under whose supervision supply is made.
 Supply of drugs to medical practioner & other institution should be preserve for at least
3 years from the date of supply.
 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.
Classes of drugs prohibited for wholesale
 Misbranded, spurious & adulterated drugs & drugs not of standard quality
 Any patent or proprietary medicine
 Any drug which claims to cure or prevent any disease or ailments as described in sch J.
 Any drug manufactured or imported in contravention to the act.
 Drugs whose date of expiry has expired.
 Drugs intended for supply to central govt. health scheme or govt hospital or institution.
 Physician samples.
 Drugs not intended for sale.
Offenses & penalty for sale of drugs
 Sale, stocking, exhibition or offer for sale of drugs likely to cause death or grievous hurt
as per sec. 320
 5 years----life imprisonment & not less than Rs. 10,000 fine.
 Sale, stocking, exhibition or offer for sale of adulterated drug
 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
 3-5 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
129.  Sale of drug in contravention of any other provision
 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
 Imprisonment upto 1 year & or fine upto Rs. 1000
 False warranty to purchaser
 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
 Fine upto Rs.500 on first conviction & imprisonment upto 10 years or fine or both on
subsequent conviction.
Labeling & Packing of drug as per D&C Act 1940
Legal requirements for labeling of drugs are as follows
Name of drug (official name, trade name)
Name of manufacturer & his address along with license no. & batch no.
Potency, standard, grade, dose etc expressed as ML, grains, units etc.
Net contents by volume/weight/number
Manufacturing & expiry dates (schedule P & C drugs only)
Precautions for handling, storage, sale or usage etc.
Special instructions may be there such as for veterinary use, physician sample etc.
Special labeling for, “drug for export”, “dispensed drug”.
For schedule G drugs
 “Caution: It is dangerous to take this preparation except under the medical supervision”.
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.
Schedule X drugs
 Schedule X drug Warning: To be sold on prescription of RMP only.
 Symbol XRx in red on left hand top corner.
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.
Veterinary drugs
 Not for human use
 For animal treatment only
 Head of any domestic animal
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.
Labeling of cosmetics
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.
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.
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
blindeness.
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

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Drug and cosmetic act 1940

  • 1. Drug and cosmetic act 1940 & Rules 1945 Objective  The D&C Act was passed in 1940 (10th April 1940), with the main object to import, manufacture, distribution, sale of drug & osmetics.  The act regulates the import of drugs in India, so that no substandard or spurious drug will enter into our country.  The act prohibits the manufacture of substandard or spurious drug in the country.  The act provide for the control over the sale & distribution of drugs by only trained & qualified persons.  The act also provide for the control over the manufacture, sale & distribution of Ayurvedic, Siddha, Unani & Homeopathic drugs.  Certain provisions of the act regulates the import, manufacture, sale & distribution of cosmetics.  To have regular inspection of licensed premises by drug inspectors.  To have control over the standards of drugs & cosmetics by taking samples & analyzing them at approved laboratories.  To provide special provisions to regulate the preparation, standardization & storage of biological & special products.  To prescribe the manner of labeling & packing of the various classes of drugs & cosmetics. Definitions Drug “Drug” 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 gelatin 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, 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. 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
  • 2. books of Ayurvedic, Siddha and Unani systems of medicine, specified in the First Schedule. Standards of quality: Standards of quality in relation to a drug means that the drug complies with the standard set out in the Second Schedule and in relation to a cosmetic that the cosmetic complies with such standards as may be prescribed. Misbranded drugs: A drug shall be deemed to be misbranded— (a) if it is so coloured, coated, powdered or polished that damage is concealed or if it is made to appear of better or greater therapeutic value than it really is; or (b) if it is not labelled in the prescribed manner; or (c) if its label or container or anything accompanying the drug bears any statement, design or device which makes any false claim for the drug or which is false or misleading in any particular. Misbranded cosmetic: A cosmetic shall be deemed to be misbranded— If it contains a colour which is not prescribed; or If it is not labelled in a prescribed manner; or If the label or container or anything accompanying the cosmetic bears any statement which is false or misleading in any particular. 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 instead of olive oil 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; or  If it has been substituted wholly or in part by another drug or substance; or
  • 3.  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 Spurious cosmetic: A cosmetic shall be deemed to be spurious if If it is imported under the name which belongs to another cosmetic; or 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 individual or company 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. New drug: Shall mean and include :-  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) and route of administration.  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 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 Inspector: Means  In relation to a Ayurvedic, Siddha or Unani drug, an Inspector appointed by the Central Government or a 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
  • 4. 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; Patent or proprietary medicine: Means 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. Homeopathic medicines: Include  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 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. Schedules to the Act & Rules Schedules to the Act First Schedule: List of Ayurvedic, Siddha & Unani books Ayurvedic books  Charak Samhita,  Sushrut Samhita,  Vaidya Chintamani  Ayurveda Chintamani,  Arya Bhishak  Ark Prakasha  Siddha Books  Siddha vaidya Thiratu,  Nagmuni (700),  Brahma muni Karukkadai (300),  Pulippani (500),  Bhogar (700)  Unani books  Karabadin Quadri,
  • 5.  Karabadin Kabir,  Karabadin Azam  Karabadin Jaddid,  Al Karabadin Second Schedule Standards to be complied with by imported drugs & by drugs manufactured for sale, sold, stocked or exhibited for sale or distributed. Schedules to the Rule A: List of forms for making applications for issuing licences, granting licences, sending memorandum B: Fees for test or analysis by the Central Drugs Laboratory C: Deals with biological products such as sera antigens, toxin, antitoxin, Vaccines for parenteral injections, solution of serum proteins intended for injection, Insulin etc C1: Special products such as fish liver oil, ergot preparations, drugs belonging to digitalis groups, adrenaline, Liver extract, vitamines, hormones D: Classes of exempted drugs which are exempted from certain provisions applicable to import of drugs E.g. Skimmed milk, powdered milk fortified with vitamins, farex, oats, ginger, pepper, cummins etc Schedules to the Rule Schedule K  K: List of drugs exempted from certain provisions applicable to manufacture of drugs and sale of drugs  Class of Drugs is not sold for medicinal use and that each container is labelled conspicuously with the words “NOT FOR MEDICINAL USE”.  The medicines that continue to be under the 'household remedy' category include Paracetamol tablets, Analgesic Balms, Antacid Preparations, Calcium preparations with or without Vitamin D, Gripe Water for use of infants, Inhalers (containing drugs for treatment of cold and nasal congestion), Syrups lozenges, pills and tablets for cough, cold or sore throat.  However, these drugs should not contain any substance specified in Schedules G, H or X of D&C Act and Rules. The shopkeepers are also to ensure that the drugs are sold in the original unopened containers of the licensed manufacturers.  Note- Aspirin and Quinine Sulphate have been removed from this schedule Mashelkar Committee recommendations  The Committee on Drug Regulatory System headed by the Chief Dr. Mashelkar.  suggested to expand the scope of Schedule K to include OTC drugs.  The ultimate objective is to enhance public access to commonly required medicines but at the same time ensuring quality of delivery. OTC Drugs  The phrase “OTC” has no legal recognition in India, all the drugs not included in the list of prescription-only drugs” are considered to be non- prescription drugs (or OTC drugs).  OTC Drugs means drugs legally allowed to be sold “Over The Counter” by pharmacists, i.e. without the prescription of a Registered Medical Practitioner.  Prescription-only drugs are those medicines that are listed in Schedule H and X and Schedule G
  • 6. Ayurvedic (OTC) Medicines  OTC drugs registered as “Ayurvedic Medicines” containing natural / herbal ingredients  Ayurvedic drugs are manufactured under a manufacturing license issued by the Ayurvedic State Licensing Authorities. However, they do not require a drug sale license and can be sold freely by non- chemists.  Largest OTC brands in India are registered as “Ayurvedic Medicines because of their plant-based‟ natural active ingredients Categories with OTC potential  Vitamins and minerals;  Health tonics,  Cough suppressants likes vicks 44  Gastrointestinal drugs like Gas X  Analgesics  Dermatological preparations  Herbal / Ayurvedic medicines SCHEDULE E & E1 [Omitted as per GOI Notification No.G.S.R. 462(E) dt 22-6-1982] SCHEDULE E(1): List of Ayurvedic, Siddha, and Unani poisons Ex- Snake poison, arsenic,mercury,CuSo4, Dhatura, Bhang, Ganja etc Schedule F and F (I)  F: Provisions applicable to blood banks (Requirements and licencing process)  F (I) : Provisions applicable to other biological and special products such as vaccines, antigens, diagnostic antigens, tuberculin, etc. regarding their production, testing, storage, packing, etc. Schedule F (II): Standards for Surgical dressings and bandage cloth. Schedule F (III): Standard for umbilical tapes. Schedule FF: Standards for ophthalmic preparations. 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, chlorthiazide, chlorpropamide, doxorubicin, ethosuximide, Metformin, Insilin all types,Hydroxyurea, Mercaptopurines etc Schedule H [Drugs & cosmetics (2nd amendment) Rules 2006]  Prescription drugs which are required to be sold by retail only when a prescription by RMP
  • 7.  Drugs come under Schedule H should be labelled with the symbol Rx and conspicuously displayed on the left top corner of the label.  Drugs specified in Schedule H, and comes within [Narcotic Drugs and Psychotropic Substances Act, 1985 labelled with the symbol NRx which shall be in red and conspicuously displayed on the left top corner of the label.  Examples-Alprazolam, Allopurinol, Amikacin, Atenolol, Acyclovir, Buspirone, Azathioprine, Captopril, Carbidopa, Clindamycin, Cimetidine, Ciprofloxacin, Cefuroxime, Diclofenac, Glimepiride, diazepam etc. For monitoring use and misuse of antibiotics  Schedule H of the drug and cosmetics act contains a list of 536 drugs which are required to be dispensed on the prescriptions of a registered medical practitioner.  In order to have separate regulation to check unauthorized sale of antibiotics, a separate schedule as Schedule H1 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. Schedule J List of diseases and ailments which a drug may not claim to prevent or cure. Some of the diseases and ailments under this schedule are 1. AIDS 2. Angina Pectoris 3. Appendicitis 4. Arteriosclerosis
  • 8. 5. Baldness 6. Blindness 7. Bronchial Asthma 8. Cancer and Benign tumour 9. Cataract 10. Change in colour of the hair and growth of new hair. 11. Change of foetal sex by drugs. (almost 51 ailments mentioned on Schedule J) Schedule M Deals with the Good Manufacturing Practices (GMP) and requirements of premises, plant and equipment. Part I deals with GMP & Factory premises. Part II deals with plant and equipment. Schedule M1: Prescribes in detail requirements of factory premises for the manufacture of Homeopathic drugs. Schedule M- II: Prescribes requirements of factory premises for manufacture of cosmetics. Schedule M- III: Prescribes requirements of factory premises for manufacture of medical devices. Schedule T: Requirements of factory premises and hygienic conditions for Ayurvedic and Unani drugs. Schedule N: List of minimum equipment for efficient running of pharmacy Schedule O: Standards for disinfectant fluids Schedule P:  Life period of drug.  Period in months (unless otherwise specified) between date of manufacture and date of expiry which the labelled potency period of the drug should not exceed under the conditions of storage Specified.  The schedule includes antibiotics, vitamins, insulin preparation, normal human plasma, sera toxins, toxoids, other toxins, anti-toxins, miscellaneous drugs Schedule P 1 Pack size of certain drugs. It gives the names of drugs, along with the dosage form and the pack size. No other pack size than the one listed is allowed to be marketed.
  • 9. Examples of a few drugs under this schedule: Schedule Q  List of coaltar colours permitted to be used in drug and cosmetics  No drug should contain a colours other than specified below :  Natural Colours  Carotene, Chlorophyll, Red Oxide of Iron, Yellow Oxide of Iron, Titanium Di-oxide, Black Oxide of iron  Artificial Colours Caramel  Coal Tar Colours Schedule R: R- Standards for condoms made up of rubber latex intended for single use and other mechanical contraceptives Eg. Condom, Cu- T Schedule R-1: standards for medical devices. Schedule S  Standards for cosmetics  The following cosmetics in finished form should conform to the Indian Standards specifications laid down from time to time by the Bureau of Indian Standards (BIS)]. 1.Skin Powders 2. Skin Powder for infant 3. Tooth Powder 4. Toothpaste 5. Skin Creams 6. Hair Oils Schedule U & U1 U- Particulars to be shown in manufacturing and analytical records of drugs. U (I)- Particulars to be shown in manufacturing records of cosmetics. Schedule V: Standards for patent and proprietary medicines and for patent and proprietary medicines containing vitamins. Schedule W  List of drugs which shall be marketed under generic name only  This includes only five drugs that shall be marketed under generic names only:  Analgin  Aspirin and its salt  Chlorpromazine and its salt  Ferrous sulfate  Piperazine and its salts
  • 10.  (Schedule W) – Inserted as per G.O.I. Notificiation No. GSR 27(E) dt 17.1.1981 and deleted as per G.O.I. Notification No. GSR 94(E) dt 8.2.2000. Schedule X: List of habit forming, psychotropic, and other such drugs. Schedule X contains list of drugs which: Need discretion while dispending and pharmacist should ensure that this drugs are not sold without prescription Have a waning mentioned on a label ‘Schedule X drug’ – Warning : to be sold on retail on prescription of a registered medical practitioner only. The label will also have a symbol ‘XRx’ in red & conspicuously displayed on the top left corner of the table After dispending the drug the pharmacist must Stamp & retain the prescription Maintain & record purchase & sale of the drug and Preserve it for a period of 2 years from the date of transactions Examples of few drugs under schedule X 1)Amobarbital 2)Amphetamines 3)Dexamphetamines 4) Glutethimide 5)Methylphenidate etc. Schedule Y: Requirements and Guidelines for clinical trials, import, and manufacture of new drugs. The schedule covers details like : Chemical and pharmaceutical information Animal tests, toxicology and pharmacology Clinical Trails  Nature of trials  Permission for trials  Responsibility of sponsor / Investigator Administrative Bodies  Advisory  Drug Technical Advisory Board (DTAB)  Drug Consultative Committee (DCC)  Analytical  The Central Drug Laboratory (CDL)  Drug Control Laboratories in the state (DCL) Government Analyst  Executive  Licensing Authorities (central & state)  Drug Inspectors  Custom Collector 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. Constitution of DTAB
  • 11. Ex-officio members 1. Director General of Health Services (chairman of the board) 2. Drug Controller of India 3. President, Pharmacy Council of India 4. President, Medical Council of India 5. Director, Central Drug Laboratories, Kolkata 6. Director, Central Drug Research Institute, Lucknow 7. Director, Central Research Institute, Kasuali. 8. Director, Indian Veterinary Research Institute, Izzatnagar Nominated Members 1. One person from pharmaceutical Industry 2. Two Govt. Analyst 3. Two persons from among the persons who are in-charge of the drug control organization in the state. 60. Elected Members 1.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 2.One teacher in medicine or therapeutics from the staff of University or affiliated college elected by the executive Committee of Medical Council of India 3. One person elected by the central council of Indian Pharmaceutical Association. 4.One person elected by the central council of Indian Medical Association. 5.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. 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  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. Functions of Central Drug Laboratory (CDL)  To analyze the samples of drugs or cosmetics sent to it by a) Custom Collector or any authorized officer b) 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.
  • 12.  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. 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. 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 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 a) Govt. Analyst b) 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 a) Govt. Analyst b) 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.
  • 13. Duties of Government Analyst:  To cause analysis or testing of samples of drugs / cosmetics sent to him by Drug Inspectors or other persons under the provisions of the Act for mfg/sale/distribution and furnish reports as per rules.  To forward from time to time reports giving the results of analysis work and research with a view to their publication at the discretion of the Govt. Drug Inspector: Means  In relation to a Ayurvedic, Siddha or Unani drug, an Inspector appointed by the Central Government or a 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 Qualifications for Drug Inspectors 1) 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, (i) Not less than 18 months experience in the manufacture of atleast one of the substances specified in Schedule C; or (ii) Not less than 18 months experience in testing of atleast one of the substances specified in Schedule C in a approved laboratory; or (iii) Not less than 3 years experience in the inspection of firms manufacturing any of the substances specified in Schedule C during the course of their services as the Drug Inspectors
  • 14. Powers Of Drug Inspectors Within the local limits for which the inspector is appointed, he may i) 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 ii) 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 iii) Search any person in connection with the offence under this chapter at all reasonable times (iv) 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 (v) 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 (vi) 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 (vii) 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 (viii) Exercise any other powers as may be necessary, for carrying out the purpose of this Act and the rules made thereunder Duties of Drug Inspectors In relation to sale of drugs and cosmetics: (a) To inspect atleast 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 (b) 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 (c) To investigate any complaint made in writing to him (d) To institute prosecutions in case of the breach of the Act and Rules (e) To maintain the records relating to all inspections and actions taken by him and to submit copies of such records to the controlling authority (f) To make inquiries and inspections regarding the sale of drugs in contravention of the Act (g) To detain the imported packages, if he suspects to contain drugs the import of which is prohibited. In relation to manufacture of drugs and cosmetics: (a)To inspect atleast 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
  • 15. (b) 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. (c) 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. (d) To take samples of drugs manufactured on premises and send them for test or analysis (e) To check all records and registers required to be maintained under rules. (f) To institute prosecutions for breaches of Act Duties of Drug Inspectors Procedure Of Inspectors For taking samples of drug and dispatching them to laboratory : 1. 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. 2. Where the price is refused, he shall tender a receipt thereof in the prescribed form. 3. 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. 4. 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 5. 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. 6. 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 :— (i) one portion or container he shall forthwith send to the Government Analyst for test or analysis; (ii) the second he shall produce to the Court before which proceedings, if any, are instituted in respect of the drug or cosmetic; (iii) 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 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
  • 16. Controlling Authority  All inspectors at central and state level are under their control.  Qualifications : 1. He is a graduate in Pharmacy / Pharmaceutical chemistry / Medicine with specialization in Clinical pharmacology or Microbiology from a University established in India 2. 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. Licensing Authority  State Govt.: Each State Govt. employs Licensing Authority to issue license for manufacture, sale, distribution of drugs / cosmetics within the state. They can Issue / refuse license/Cancel or suspend license  Central Govt. appoints licensing authority to issue license for import of drugs  DRUGS CONTROLLER OF INDIA IS CENTRAL LICENSE APPROVING AUTHORITY Qualifications: 1. He is a graduate in Pharmacy / Pharmaceutical chemistry / Medicine with specialization in Clinical pharmacology or Microbiology from a University established in India 2. 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. 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. Import of Drugs Import means to bring into India 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.
  • 17. 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 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. Import of schedule X drugs The license for the import of schedule X 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.  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 ie 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 small quantities of drug for examination, test or analysis  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 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.
  • 18.  The drug shall form the passenger’s bonafide 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 bonafide personal luggage if  The drug is for bonafide personal use.  The quantity to be imported is reasonable & is covered by prescription of RMP. 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. 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. 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) 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 predigested food.  Cinnamon, pepper, zinger & other condiment & spices. Offences & Penalty related to import of drug  Anyone who, 1. Imports adulterated or spurious drug or cosmetic or cosmetic unsafe for use  Punishable with imprisonment upto 3 years or with fine upto 5,000 or both on first conviction  & punishable with imprisonment upto 5 years or with fine upto 10,000 or both on subsequent conviction
  • 19. 2. Imports any drug or cosmetic the import of which is prohibited under section 10.  Punishable with imprisonment upto six months or with fine upto 500 or both on first conviction  & 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.  Punishable with imprisonment upto 3 years or with fine upto 5,000 or both on first conviction  & punishable with imprisonment upto 5 years or with fine upto 10,000 or both on subsequent conviction Manufacture of drugs Definition Manufacture in relation to any drug or cosmetics includes any process or part of process for making, altering, ornamenting, finishing, packing, labeling, breaking up or otherwise treating or adopting any drug or cosmetic for sale or distribution but does not include compounding or dispensing of any drug or the packing of any drug or cosmetic in the ordinary course of retail business. Kinds of manufacturing licenses  License for manufacture of schedule C & C1 drugs  License for manufacture of schedule X drugs  License for manufacture of drugs other than those specified in schedule C & C1, X.  License for manufacture of drugs meant for examination, test or analysis.  Loan license  Repacking license Manufacture of biological & other special products specified in schedule C&C1 A person licensed to manufacture schedule C & C1 drugs, is required to observe the following conditions (General Condition)  Licensed premises must conform to the requirements of GMP specified in schedule M.  The licensee must provide adequate arrangement for testing the strength & quality of drugs.  The manufacture of drugs must be carried out under active direction & personal supervision of technically qualified staff (who should be either a) graduate in pharmacy or pharmaceutical chemistry with at least 18 months experience in the manufacture of drugs or b) a graduate in medicine with at least 3 years experience in the manufacture & testing of drugs or c) 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 d) Any other equivalent foreign qualification.  Licensee must have adequate facilities for the storage of imported drugs, so that the properties of drugs are preserved.
  • 20.  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.)  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 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.  Licensee on request, shall supply the samples of drugs from all the batches to the licensing authority for test or analysis.  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. Manufacture of drugs specified in schedule X In addition to general conditions as mentioned before 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 should be stored in bulk & if needed for manufacture 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. Manufacture of drugs other than those specified in schedule C, C1 & X In addition to general conditions as mentioned before the licensee should observe the following conditions. The licensee should maintain an inspection book in which the inspector may record their inferences. If the licensee desires to undertake the manufacture of any additional categories of drugs he should pay a fee of Rs. 10 for each such additional category. Licensee must comply with such additional requirements of which he has been given at least 4 months notice by the licensing authority. Manufacture of drugs for examination, test or analysis The following conditions must be observed by the licensee. Licensee must use manufactured drug exclusively for the purpose for which they are manufactured. Licensee must maintain the records of the manufactured drugs, showing particular of their quantities & names of the persons to whom they have been supplied. 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.
  • 21. Licensee must comply with such additional requirements of which he has been given at least 1 month notice by the licensing authority. Loan License  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.  Application for grant of loan license should be supported by documentary consent of the licensee whose facilities he is going to use.  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.  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.  The licensee must test each batch of raw material & finished product.  Licensee should maintain manufacturing & analytical records of drugs.  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. 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. Person licensed to repack drug should observe the following condition.  Licensed premises must conform to the requirements of GMP specified in schedule M.  Licensee must provide adequate arrangements for testing the strength & quality of drugs. 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. Licensee must have adequate facilities for the storage of drugs, so that the properties of drugs are preserved.  Licensee must maintain the records for the repacking of drugs.  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.  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.  Licensee on request, shall supply the samples of drugs from all the batches to the licensing authority for test or analysis.  In addition to other particulars, the repacked drug should bear the no. of license with words “Rpg. Lic. No.” on its label.
  • 22.  The license should be kept on the licensed premises & should produce before an inspector on demand.  Licensee should comply with the provisions of the act. 0fenses & Penalties for manufacture of drugs 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 Sale of Drugs  Sale may be defined as the process of passage of articles from the manufacturer to the consumer.  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: (sale by way of wholesale dealing) 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, or research institute  Drug store: It means a licensed premises for the sale of drug who do not require the services of a qualified person.  Chemist & druggist: It means a licensed premises for the sale of drug who requires the services of a qualified person but where the drugs are not compounded against prescription.  Pharmacy: It means a licensed premises for the sale of drug who requires the services of a qualified person but where the drugs are compounded against prescription.
  • 24. Wholesale of schedule C&C1 drugs  Following conditions are to be satisfied by the licensee having wholesale of schedule C&C1 drugs  The license should be displaced in a prominent part of premises opened to the public.  The licensee must have adequate premises which should not be less than 10 sq. meters, equipped with facilities for the proper storage of drugs.  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  Drug should be purchased from dully signed manufacturer.  Drug should be sold only to those persons who are licensed to retail them.  The licensee should comply with all the provisions as per the act. Wholesale of drugs other than those specified in schedule C&C1  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.  The general conditions as mentioned in previous slide. Wholesale from motor vehicle  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  The license should be displaced in the prominent place in the vehicle.  Drugs may also be distributed to govt. hospital or institutions. Retail sale from shops  Facilities as per schedule N.  Purchased only from licensed wholesalers.  No sale of specified drugs  Separate license for sch. C, C1 & X drugs.  Sale under qualified supervision.  Records  Inspection  Sale of specified households drugs from drug stores. Licenses for chemist & druggist shops & pharmacy  The license granted subject to the following conditions.  The licensee must have adequate premises & facilities for proper storage of drugs & under the supervision of competent person for sale & distribution of drugs.  Must fulfill the requirements as per sch. N.  Must obtain the permission to sale additional categories of drugs.  Licensee must maintain records of drugs.  Licensee must allow an inspector to inspect the premises & to check the records.  Licensee must inform to the licensing authority about any change in qualified staff.  Precaution must be taken during storage of sch C & C1 drugs.
  • 25. Sale of sch X & sch X drugs  Drugs specified in schedule H & X should be sold only on prescription of RMP.  In case of sch. X drugs, the prescription should be in duplicate & should be retained for 2 years.  The cash or credit bill should bear a signature of customer with his address.  Separate bound & paged registers should be maintained for supply in which separate sheets should be allotted for each drug.  The following particulars should be enter at the time of supply a) date of supply b) opening & closing stocks of drugs on that day & relevant bill number. c) name of the drug, its manufacturers name & batch no. d) name & address of the purchaser e) date of prescription & name & address of RMP f) signature of Registered pharmacist under whose supervision supply is made.  Supply of drugs to medical practioner & other institution should be preserve for at least 3 years from the date of supply.  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. Classes of drugs prohibited for wholesale  Misbranded, spurious & adulterated drugs & drugs not of standard quality  Any patent or proprietary medicine  Any drug which claims to cure or prevent any disease or ailments as described in sch J.  Any drug manufactured or imported in contravention to the act.  Drugs whose date of expiry has expired.  Drugs intended for supply to central govt. health scheme or govt hospital or institution.  Physician samples.  Drugs not intended for sale. Offenses & penalty for sale of drugs  Sale, stocking, exhibition or offer for sale of drugs likely to cause death or grievous hurt as per sec. 320  5 years----life imprisonment & not less than Rs. 10,000 fine.  Sale, stocking, exhibition or offer for sale of adulterated drug  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  3-5 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 129.  Sale of drug in contravention of any other provision  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
  • 26.  Imprisonment upto 1 year & or fine upto Rs. 1000  False warranty to purchaser  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  Fine upto Rs.500 on first conviction & imprisonment upto 10 years or fine or both on subsequent conviction. Labeling & Packing of drug as per D&C Act 1940 Legal requirements for labeling of drugs are as follows Name of drug (official name, trade name) Name of manufacturer & his address along with license no. & batch no. Potency, standard, grade, dose etc expressed as ML, grains, units etc. Net contents by volume/weight/number Manufacturing & expiry dates (schedule P & C drugs only) Precautions for handling, storage, sale or usage etc. Special instructions may be there such as for veterinary use, physician sample etc. Special labeling for, “drug for export”, “dispensed drug”. For schedule G drugs  “Caution: It is dangerous to take this preparation except under the medical supervision”. 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. Schedule X drugs  Schedule X drug Warning: To be sold on prescription of RMP only.  Symbol XRx in red on left hand top corner. 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. Veterinary drugs  Not for human use  For animal treatment only  Head of any domestic animal 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
  • 27. ii) 300 ml in case of liquid preparation iii) 5 ml in case of injection. Labeling of cosmetics 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. 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. 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 blindeness. 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