Description
Drugs And Cosmetics Act,1940
And Its Rules 1945
•Introduction
• History and Objectives
• Definitions
• Administration of the act and rules
• Provisions related to Import
• Provisions related to Manufacture
• Provisions related to Sale
• Labeling and Packaging
• Schedules to the act and rules
British mis rule-Providing poor healthcare system to Indian citizens
• Observations made by-Drugs Enquiry Committee, Indian Medical
Association
• Reports in- Indian Medical Gazette during 1920-30
• 1940 – Drugs and CosmeticsAct
•1945 – Rules under the Act
Extended to whole of India
To regulate the import, manufacture, distribution and sale of drugs &
cosmetics through licensing.
• Manufacture, distribution and sale of drugs and cosmetics by qualified
persons only.
• To prevent substandard in drugs, presumably for maintaining high
standards of medical treatment.
• To regulate the manufacture and sale of Ayurvedic, Siddha and Unani drugs.
• To establish Drugs Technical Advisory Board(DTAB) and Drugs Consultative Committees(DCC) for Allopathic and allied drugs and cosmetics.
- Subject:- pharmaceutical Jurisprudence
- Course:- B.pharm (pharmacy),
- Semester:- 4th sem , sem :- 4
DRUGS AND COSMETICS ACT,1940
AND ITS RULES 1945
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• Introduction
• History and Objectives
• Definitions
• Administration of the act and rules
• Provisions related to Import
• Provisions related to Manufacture
• Provisions related to Sale
• Labeling and Packaging
• Schedules to the act and rules
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• British mis rule-Providing poor healthcare system to Indian citizens
• Observations made by-Drugs Enquiry Committee, Indian Medical
Association
• Reports in- Indian Medical Gazette during 1920-30
• 1940 – Drugs and CosmeticsAct
•1945 – Rules under the Act
Extended to whole of India…
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• To regulate the import, manufacture, distribution and sale of drugs &
cosmetics through licensing.
• Manufacture, distribution and sale of drugs and cosmetics by qualified
persons only.
• To prevent substandard in drugs, presumably for maintaining high
standards of medical treatment.
• To regulate the manufacture and sale of Ayurvedic, Siddha and Unani
drugs.
• To establish Drugs Technical Advisory Board(DTAB) and Drugs
Consultative Committees(DCC) for Allopathic and allied drugs and
cosmetics.
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a) Maximum penalty life imprisonment and fine of Rs. 10 lakhs or 3 times
the value of the confiscated goods, whichever is more.
b) Besides officers from the Drug Controller’s Office, other gazette officers
also authorized to launch prosecution under theAct;
b) Specially designated courts for trial of offences covered under theAct;
c) Provision for compounding of minor offences.
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Drugs :
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.
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COSMETIC :
Any article intended to be rubbed, poured, sprinkled or sprayed
on, 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.
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MISBRANDED DRUGS :
a) if it is so coloured, coated, powdered or polished that damage is
concealed
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.
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ADULTERATED DRUG :
(a) if it consists, in whole or in part, of any filthy, putrid or decomposed
substance;or
(b) if it has been prepared, packed or stored under insanitary conditions
whereby it may have been contaminated with filth or whereby it may have
been rendered injurious to health; or
(C) if its container is composed in whole or in part, of any poisonous or
deleterious substance which may render the contents injurious to health.
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SPURIOUS DRUGS :
(a) if it is imported under a name which belongs to another drug; or
(b) if it is an imitation of, or a substitute for, another drug or resembles
another drug in a manner likely to deceive or bears upon it or upon its label
or container the name of another drug.or
(c) if it has been substituted wholly or in part by another drug or
substance.
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MANUFACTURE :
In relation to any drug or cosmetic, it 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.
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PATENT OR PROPRIETARY 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 authorized in this behalf
by the Central Government.
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A)Advisory :
1) Drugs Technical Advisory Board-DTAB
2) Drugs Consultative Committee-D.C.C.
B)Analytical :
1) Central Drugs Laboratory - CDL
2) Drug Control Laboratory in states
3) Government Analysts
C) Executives :
1) Licensing authorities
2) Controlling authorities
3) Drug Inspectors
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Ex-Officio:
(i) Director General of Health Services (Chairman)
(ii) Drugs Controller, India
(iii) Director of the Central Drugs Laboratory, Calcutta
(iv) Director of the Central Research Institute, Kasauli (v)
(v) Director of Indian Veterinary Research Institute, Izatnagar
(vi) President of Medical Council of India
(vii) President of the Pharmacy Council of India (viii)
(viii) Director of Central Drug Research Institute, Lucknow
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NOMINATED:
1) Two persons by the Central Government from among persons who are
in charge of drugs control in the States
2) One person by the Central Government from the pharmaceutical
industry
3) Two persons holding the appointment of Government Analyst under
this Act, to be nominated by the Central Government
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ELECTED:
1) One person, to be elected by the Executive Committee of the Pharmacy
Council of India, from among teachers in pharmacy or pharmaceutical
chemistry or pharmacognosy on the staff of an Indian university or a
college affiliated.
2) One person, to be elected by the Executive Committee of the Medical
Council of India, from among teachers in medicine or therapeutics on
the staff of an Indian university or a college affiliated.
3) One pharmacologist to be elected by the Governing Body of the
Indian Council of Medical Research.
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4) One person to be elected by the Central Council of the
Indian Medical Association.
5) One person to be elected by the Council of the Indian
Pharmaceutical Association.
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To advise the Central Governmentand the State Governments on
technical matters arising out of the administration of thisAct.
To carry out the other functions assigned to it by thisAct.
(The nominated and elected members of the Board shall hold office for
three years, but shall be eligible for re-nomination and re-election)
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• It is also an advisory body constituted by central government.
Constitution:
Two representatives of the Central Government
One representative of each State Government
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FUNCTIONS:
 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 thisAct.
 The Drugs Consultative Committee shall meet when required
 Has power to regulate its own procedure.
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• Established in Calcutta, under the control of a director appointed by the
Central Government
Functions:
• Analysis or test of samples of drugs/cosmetics sent by the custom collectors
or courts.
• Analytical Q.C. of the imported samples.
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• Collection, storage and distribution of internal standards.
• Preparation of reference standards and their maintenance.
• Maintenance of microbial cultures.
• Any other duties entrusted by Central Government.
• Acting as an appellate authority in matter of disputes.
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IMPORT OF DRUGS AND COSMETICS
Classes of drugs and cosmetics prohibited to import
• Import of drug under license
1)Specified in Schedule-X
2)Any new drugs
• Drugs exempted from provisions of import
• Offences and Penalties
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• Misbranded drugs
• Drugs of substandard quality
• Drugs claiming to cure diseases specified in Sch-J
• Adulterated drugs
• Spurious drugs
• Drugs whose manufacture, sale/distribution are prohibited in original
country, except for the purpose of test, examination and analysis.
• Patent/Proprietary medicines whose true formula is not disclosed.
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Conditions to be fulfilled :
• Licensee must have adequate facility for the storage.
• Licensee must maintain a record of the sale, showing the particulars of
the names of drugs and of the persons to whom they have been sold.
• Licensee must allow an inspector to inspect premises and to check the
records.
• Licensee must furnish the sample to the authority.
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Conditions to be fulfilled:
• Licensee must have,adequate storage facility.
• Applicant must be reputable in the occupation, trade or business.
• The license granted ever before should not be suspended or
cancelled.
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Conditions to be fulfilled:
• License is necessary under form-11
• Must use imported drugs only for said purpose and at the place
specified in the license.
• Must keep the record with respect to quantities, name of the
manufacturer and date of import.
• Must allow an inspector to inspect the premises and check the records.
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Cosmetics prohibited to import:
• Misbranded cosmetics
• Spurious cosmetics
• Cosmetic containing harmful ingredients
• Cosmetics not of standard quality
• which contains more than-2 ppm Arsenic, 20 ppm lead, 100 ppm heavy
metals
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OFFENCES (an illegal act) PENALTIES
Import of spurious OR adulterated drug a) 3 years imprisonment and 5000 Rs.
OR drug which involves risk to human fine on first conviction
beings or animals OR drug not having b) 5 years imprisonment OR 1000 Rs. fine
therapeutic values OR both for subsequent conviction
Contravention of the provision a) 6 months imprisonment OR 500 Rs.
fine OR both for first conviction
b) 1 year imprisonment OR 1000 Rs. fine
for subsequent offence
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• Drug not of standard quality or misbranded, adulterated or
spurious.
• Patent or Proprietary medicine.
• Drugs which claims to cure diseases specified in Sch-J.
• Drugs which Risky to human beings or animals.
• Drugs without therapeutic value.
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TYPES OF MANUFACTURING LICENSE
Allopathic Drugs
Other than Sch.- Sch.-X Sch.-C/C1 & Drugs for the
Sch.- C/C1 & C/C1 But X purpose of
X not -X examination test
oranalysis
Own Own
Premises Premises
Own Premises Loan License
Repacking
license
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 Conditions:
• Premises should comply with schedule ‘M’.
• Adequate facility for testing, separate from manufacturing.
• Adequate storage facility.
• Records of mfg. & testing-maintained for at least 2 years from date of
Exp.
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• License should provide sample to authority.
• Furnish data of stability.
• Maintain the inspection book.
• Maintain reference samples from each batch.
• Accounts of production recorded & maintained for 5 years or
1 year after Expiry.
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Conditions:
• Have to sent invoice of sale to licensing authority every 3 months
• Store drugs in direct custody of responsible person.
• Preparation must be labeled with XRx
• Marketed in packing not exceeding
• 100 unit dose –Tablets/Capsules
• 300 ml- Oral liquid
• 5 ml - Injection
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Conditions:
• Drugs must be issued in previously sterilized sealed glass or suitable
container
• Containers should comply with req. of Sch-F/F1
• Drug must comply with std. (quality, purity, strength) specified in sch.-F
• Parenteral in doses of 10 ml or more should be tested for freedom
from Pyrogens
• Separate lab. for culture & manipulation of spore bearing Pathogens
• Test for sterility should be carried out.
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OFFENCES PENALTIES
Manufacture of any spurious drugs a) 1-3 years imprisonment and Rs.5000
fine
b) 2-6 years imprisonment & Rs.10000
fine on subsequent conviction
Manufacture of adulterated drugs a) 1 year imprisonment & Rs.2000 fine
b) 2 years imprisonment & Rs.2000 fine
for subsequent conviction
Manuf. of drugs in contravention of the a) Imprisonment up to 3 months & Rs.500
provisions fine
b) Imprisonment up to 6 months &
Rs.1000 fine on subsequent conviction
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Definition:
A person(applicant) who does not have his own arrangements(factory) for
manufacture but who wish to avail the manufacturing facilities owned by
another licensee. Such licenses are called Loan licenses.
Procedure:
Licence is obtained from licensing authority (FDA) on application in
prescribed forms (24-A , 27-A) with prescribed fees (Rs. 6000, 1500).
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Definition:
Process of breaking up any drug from a bulk container into small
packages and labeling with a view to their sale and distribution.
Repackaging of drugs is granted of drugs other than Schedule-C/C1 and
X.
Procedure:
Licence is obtained from licensing authority (FDA) on application in
prescribed forms (24-B) with prescribed fees (Rs. 500, 200).
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TYPES OF SALES LICENCES
Allopathic Drugs
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Whole Sale Retail Sale Sales From
Motor Vehicle
( Vender)
General Licence Restricted
Licence
Drugs in Drugs in Drugs For
Sch.- X Sch.- Sch.-
other than
C/C1 sch.-C/C1 C/3C81
• Misbranded, spurious, adulterated and drugs not of standard
quality
• Patent/Proprietary drugs with undisclosed formula
• Sch-J drugs
• Expired drugs.
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• Adequate premises, with greater than 10 M2 area, with proper storage
facility
• Drugs sold only to retailer having license
• Premises should be in charge of competent person who is Reg.
Pharmacist.
• Records of purchase & sale
• Records preserved for 3 years from date of sale
• License should displayed on premises
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• All the conditions as discussed in for biological.
• Compounding is made by or under the direct and personal
supervision of a qualified person.
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• For retail sale, two types of licenses are issued:
i) General licenses
ii) Restricted licenses
Restricted license:
Granted to those dealers who do not engage the services of a
qualified person and only deal with such classes of drugs whose sales
can be effected without qualified person and vendors who do not have
fixed premises. 43
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• All the general and specific labeling and packaging specified to all
classes of drugs and cosmetics should be as per the provisions made
under the act.
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TYPE CONTENT
“A� Performa for forms no. 1 to 50( Application, issue, renewal, etc.)
“B� Rates of fee for test or analysis by CDL or Govt. analysts
“C� List of Biological and special products (Injectable) applicable to special
provisions.
Ex. Sera, Vaccines, Penicillin…..etc
“C1� List of Biological and special products (nonparenteral) applicable to
special provisions.
Ex. Digitalis, Hormones , Ergot
“D� List of drugs that are exempted from provisions of import
“E1� List of poisonous substances under the Ayurvedic , Siddha and Unani
systems
“F� Provisions applicable to blood bank
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TYPE CONTENT
“F1� Special provision applicable to biological and special products, e.g.
Bacterial and viral vaccines, sera from living animals, bacterial origin
diagnostic agents
“F2� Standards for surgical dressings
“F3� Standards for umbilical tapes
“FF� Standards for ophthalmic preparations www.remixeducation.in
“G� List of substances required to be used under medical supervision and
labelled accordingly Ex. Metformin, Anti Histaminic, …etc.
“H� List of substances (prescription) that should be sold by retail only on
prescriptions of R.M.P. Ex. Atenolol, Lorazepam, Dapson …etc. 4
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TYPE CONTENT
“J� List of diseases and ailments that drug should not claim to cure
Ex. Cancer, AIDS, Cataract, Diabetes…etc
“K� List of drugs that are exempted from certain provisions regarding
manufacture
“M� Requirements of manufacturing premises, GMP requirements of factory
premises, plants and equipments
“M1� Requirements of factory premises for manufacture of Homeopathic
medicines
“M2� Requirements of factory premises for manufacture of cosmetics
“M3� Requirements of factory premises for manufacture of medical devices
“N� List of equipment to run a Pharmacy
“O� Standards for disinfectant fluids Ex… Phenol, H2O2, alcohol….
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TYPE CONTENT
“P� Life period(expiry) of drugs Ex. Insulin Inj. – 24 months
“Q� Coal tar colors permitted to be used in cosmetics Ex. Caramel, TiO2,
Toney red…..
“R� Standards for mechanical contraceptives
“R1� Standards for medical devices
“S� Standards for cosmetics
“T� Requirements (GMP) of factory premises for Ayurvedic, Siddha, Unani
drugs
“U� Manufacturing and analytical records of drugs
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TYPE CONTENT
“U1� Manufacturing and analytical records of cosmetics
“V� Standards for patent or proprietary medicines
“W� List of drugs marketed under generic names- Omitted
“X� List of narcotic drugs and psychotropic substances
EX. Opium, Morphine, Barbital……
“Y� Requirement and guidelines on clinical trials for import and manufacture
of new drugs
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