Act

1. Dr. Shubhankur Bhardwaj
BDS, MHA
Hospital Administration
SGPGIMS, Lucknow

2. History and Objectives
Definitions
Administration of the act and rules
Provisions related toImport
Provisions related toManufacture
Schedules to the act and rules

3. •The act was prepared in accordance to the recommendations of the
Chopra Committee formed in 1930.
•British misrule-Providing poor healthcare system to Indian
citizens, Observations made by-Drugs Enquiry Committee,
Indian MedicalAssociation
•Reports in- Indian Medical Gazette during 1920-30
•1940 – Drugs and CosmeticsAct
• The related Drugs Rules was passed in 1945
•Since 1940, the act has undergone several amendments and is now
known as the Drugs and Cosmetics Act, 1940

4. The primary objective of the act is to ensure that the drugs and
cosmetics sold in India are safe, effective and conform to state
quality standards.
To regulate the import, manufacture, distribution and sale of drugs
and cosmetics through licensing.
To provide guidelines for the storage, sale, display and prescription
of each schedule
Manufacture , distribution and sale of drugs and cosmetics by
qualified persons only.
To establish Drugs Consultative Committees(DCC).

5. •Drug- as defined in the act includes a wide variety of substance,
diagnostic and medical devices.
•Cosmetic- as any product that is meant to be applied to the human
body for the purpose of beautifying or cleansing. The definition
however excludes soaps. In 1964, the act was amended to
include Ayurveda and Unani drugs.

6. Adulterated Drug-Section 27 deals fake and adulterated drugs. The act
requires that ingredients of the drugs should be printed on the label
• 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
Spurious drugs.
(a) if it is imported under a name which belongs to another drug; or
(b) if it is an imitation of, or a substitute for, another drug or resembles
another drug in a manner likely to deceive or bears upon it or upon its
label or container the name of another drug unless it is plainly and
conspicuously marked so as to reveal its true character and its lack of
identity with such other drug; or

7. (c) if the label or the container bears the name of an individual
or company purporting to be the manufacturer of the drug,
which individual or company is fictitious or does not exist; or
Misbranded cosmetics —
(a) if it contains a color which is not prescribed; or
(b) if it is not labeled in a prescribed manner; or
(c) if the label or container or anything accompanying the
cosmetic bears any statement which is false or misleading in
any particular

8. Spurious cosmetics.—
(a) if it is imported under the name which belongs to another cosmetic;
or
(b) 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
(c) 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
(d) if it purports to be the product of a manufacturer of whom it is not
truly a product.

9. A) Advisory :
1)Drugs Technical Advisory Board-DTAB
2)Drugs Consultative Committee-DCC
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

10. (i) the Director General of Health Services, who shall be Chairman;
(ii) the Drugs Controller, India
(iii) the Director of the Central Drugs Laboratory, Calcutta
(iv) the Director of the Central Research Institute, Kasauli
(v) the Director of Indian Veterinary Research Institute, Izatnagar
(vi) the President of Medical Council of India
(vii) the President of the Pharmacy Council of India
(viii) the Director of Central Drug Research Institute, Lucknow
(ix) two persons to be nominated by the Central Government from
among persons who are in charge of drugs control in the States

11. 1) Two persons by the Central Government
2) One person by the Central Government from the pharmaceutical
industry
3) Two persons holding the appointment of Government Analyst
under this Act

12. -one person to be nominated by the Central Government from the
pharmaceutical industry;
-one pharmacologist to be elected by the Governing Body of the Indian
Council of Medical Research;
-one person to be elected by the Central Council of the Indian Medical
Association;
-one person to be elected by the Council of the Indian Pharmaceutical
Association;
The nominated and elected members of the Board shall hold office for
three years, but shall be eligible for renomination and re-election
Functions
•To advise the Central Government and the State Governments on
technical matters
•To carry out the other functions assigned to it by this Act

13. The Central Government shall, as soon as may be, established a
Central Drugs Laboratory under the control of a Director to be
appointed by the Central Government, to carry out the functions
entrusted to it by this Act .
-It is also an advisory body constituted by central government.
-Constitution: Two representatives of the Central Government & One
representative of each State Government

14. -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.
-The Drugs Consultative Committee shall meet when required
- Has power to regulate its own procedure.

15. (1) 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.
(2) The Drugs Consultative Committee shall consist of two
representatives of the Central Government to be nominated by that
Government and one representative of each State Government to be
nominated by the State Government concerned.
(3) The Drugs Consultative Committee shall meet when required to do so
by the Central Government and shall have power to regulate its own
procedure.

16. -Testing of drug sample
-Analysis of food sample
-Analysis of excise sample

17. Duties:
• Analyze or tested such sample or drugs and cosmetics may be
sent to him by Inspectors
• Timely forward reports to the Government giving the results
of analytics work.

18. Duties:
• To inspect all establishments licensed for the sale of drugs within the
area assigned to him
• To send for test or analysis.
•To investigate any complaint.
•To maintain a record of all inspections made by him.
• To maintain a record of action taking by him in the performance of his
duties.

19. Function:
1. Inspection of all area where the drug and cosmetics are
being manufactured/sold/stocked
2. Take sample of any drug and cosmetic are being
manufactured/sold/stocked

20. Provision
of Act
Import
Manufacturi
ng
Sales Labeling
&
Packaging

21. IMPORTofdrugs
Classes of drugs prohibited to import
Import of drug under license
1)Specified in Schedule-C/C1
2)Specified in Schedule-X
3)Imported forTest/Analysis
4)Imported for personal use
5)Any new drugs
Drugs exempted from provisions of import
Offences and Penalties

22. Classesof drugsprohibitedto
import
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.

23. Import of drugswithoutlicense
Substances not used for medicinal pupose
Drugs in Sch-C1 required for manufacturing and not for
medicinal use.
Substances which are both drugs and foods such as:
Condensed/Powdered Milk
Malt
Lactose
Farex/Cereal
Oats
Predigested foods
Ginger, Pepper, Cumin, Cinnamon

24. Cosmeticsprohibited toimport
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 heavymetals

25. • From the date notified by the State Government, no person shall himself
manufacture for sale or distribution or sell or distribute-
o Any drug which is not of standard quality or is misbranded, adulterated
or spurious;
o Any cosmetic which not of standard quality or is misbranded,
adulterated or spurious;
o Any patent or proprietary medicine whose formulae is not disclosed on
label or the container;
o Any drug which purports to cure, mitigate or prevent any disease
specified in Schedule J;
o Any cosmetic containing any ingredient which may render it unsafe or
harmful for use;
o Any drug or cosmetic in contravention of this act or rules there under;
o Any drug or cosmetic which has been imported or manufactured in
contravention of the provisions of this Act or Rules there under or in
contravention of the conditions of a license.

26. Schedulesto theact
underFirst schedule – Names of books
Ayurvedic and Siddha systems
Second schedule – Standard to be complied
with by imported drugs and by drugs
manufactured for sale, sold, stocked or exhibited
for sale or distribution

27. Schedulesto therules
SJTPC 27
TYPE CONTENT
“A” Performa for forms( 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 specialprovisions.
“C1” List of Biological and special products (nonparenteral)
applicable tospecial provisions.
“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

28. Schedulesto therules
TYPE CONTENT
“F1” Special provision applicable to biological and special products, eg.
Bacterial and viral vaccines, sera from living animals, bacterial
origin diagnosticagents
“F2” Standards for surgicaldressings
“F3” Standards for umbilicaltapes
“FF” Standards for ophthalmicpreparations
“G” List of substances required to be used under medical
supervision andlabelled accordingly
“H” List of substances (prescription) that should be sold by retail only
on prescriptionsof R.M.P.

29. Schedulesto therules
TYPE CONTENT
“J” List of diseases and ailments that drug should not claim to cure
“K” List of drugs that are exempted from certain provisions regarding
manufacture
“M” Requirements of manufacturing premises, GMP requirements of factory
premises, plants andequipments
“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

30. TYPE CONTENT
“P” Life period(expiry) ofdrugs
“Q” Coal tar colors permitted to be used in cosmetics
“R” Standards for mechanicalcontraceptives
“R1” Standards for medicaldevices
“S” Standards forcosmetics
“T” Requirements (GMP) of factory premises for Ayurvedic, Siddha,
Unani drugs
“U” Manufacturing and analytical records of drugs

31. Schedulesto therules
SJTPC 31
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
“Y” Requirement and guidelines on clinical trials for import and
manufacture of newdrugs

32. Penaltiesrelatedto Manufacture
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 contraventionof
the provisions
a) Imprisonment up to 3 months &
Rs.500 fine
b) Imprisonment up to 6 months
& Rs.1000 fine on subsequent
conviction

33. THETHIRD SCHEDULE
(See sub-section (6) of section 18)
CATEGORIES OF DRUGS FOR WHICH THE CENTRAL LICENSING
AUTHORITY IS EMPOWERED TO ISSUELICENCE AND PERMISSION.
1. antigens and anti-toxins;
2. blood products;
3. cytotoxic substances (anti-cancer drugs);
4. drug products containing modified living organisms;
5. fixed dose combination.
6. gene therapeutic products;
7. hormones and preparations containing hormones;
8. large volume parenterals;
9. monoclonal anti-bodies;
10. recombinant-deoxyribo nucleic acid derived drugs;
11. ribo nucleic acid derived drugs;
12. sera;
13. solution of serum proteins intended for injection;
14. stem cells and cell based drug products;
15. toxins;
16. vaccines;

34. -If the Central Government is satisfied that the use of any drug or
cosmetic is likely to involve any risk to human beings or animals
or that any drug does not have the therapeutic value claimed for it
or contains ingredients and in such quantity for which there is no
therapeutic justification and that in the public interest it is
necessary or expedient so to do then, that Government may, by
notification in the Official Gazette, prohibit the import of such
drug or cosmetic