Objectives, Definitions, Legal definitions of schedules to the Act and Rules Import of drugs Classes of drugs and cosmetics prohibited from import ,Import under license or permit. Offences and penalties. Manufacture of drugs Prohibition of manufacture and sale of certain drugs Conditions for grant of license and conditions of license for manufacture of drugs, Manufacture of drugs for test, examination and analysis ,manufacture of new drug, loan license and repacking license.

1. Drugs and Cosmetics Act
1940 &Rules 1945
Guided By -
Mr.Chandraprakash Dwivedi
M.Pharma (Pharmaceutics)
ACP Durg ,C .G
Submitted by –
Tameshwar Kamariya
B.pharmacy(5th sem)
Apollo college of Pharmacy,
Durg

2. Topic to be Discuss……..
Objectives, Definitions, Legal definitions of schedules to the Act and Rules
Import of drugs Classes of drugs and cosmetics prohibited from import
,Import under license or permit. Offences and penalties.
Manufacture of drugs Prohibition of manufacture and sale of certain drugs
Conditions for grant of license and conditions of license for manufacture of
drugs, Manufacture of drugs for test, examination and analysis
,manufacture of new drug, loan license and repacking license.

3. Short History
British misrule-Providing poor healthcare system
to Indian citizens
Use of filthy drugs in the market
Observations made by- Drugs Enquiry
Committee and Indian Medical Association
Reports in- Indian Medical Gazette during 1920-
30
1940 – Drugs and Cosmetics Act
1945 – Rules under the Act
Extended to whole of India……

4. LIST OF AMENDING ACTS AND ADAPTATION
ORDERS
1. The Drugs (Amendment) Act, 1955
2. The Drugs (Amendment) Act, 1960
3. The Drugs (Amendment) Act, 1962
4. The Drugs and Cosmetics (Amendment) Act, 1964
5. The Drugs and Cosmetics (Amendment) Act, 1972
6. The Drugs and Cosmetics (Amendment) Act, 1982
7. The Drugs and Cosmetics (Amendment) Act, 1995
8. The Drugs and cosmetics (Amendment) Act, 2008
9. The Drugs and cosmetics (Amendment) Act, 2017
10. The Drugs and cosmetics (Amendment) Act,2018
-Duration of licence
-Inspection for grant of license and verification of compliance
-Inspection for verification of compliance
11.The Drugs and cosmetics (Amendment) Act, 2019
https://www.scconline.com/blog/post/2019/01/11/drugs-and-cosmetics-
second-amendment-rules-2019-notified/

5. Objectives
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.
Toprevent substandard in drugs.
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.

6. Definitions
• 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, including preparations
applied on human body for the purpose of repelling insects like
mosquitoes.
• Cosmetic: 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.

7. Misbranded drugs
 (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 prescribedmanner.
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.

8. 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 anotherdrug
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.

9. Administration of the act and rules
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

10. A) Advisory
Drugs Technical Advisory Board (DTAB)
 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) Director of Indian Veterinary ResearchInstitute,
Izatnagar
(vi) President of Medical Council of India
(vii) President of the Pharmacy Council of India
(viii) Director of Central Drug Research Institute, Lucknow

11.  Nominated:
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 thisAct.
Elected:
1) One person, to be elected by the Executive Committee of
the Pharmacy Council of India
2) One person, to be elected by the Executive Committee of
the Medical Council of India
3) One pharmacologist to be elected by the Governing
Body of the Indian Council of Medical Research
4) One person to be elected by the Central Council of the
Indian MedicalAssociation
5) One person to be elected by the Council of the
Indian Pharmaceutical Association

12. Functions:
Toadvise the Central Government and
the State Governments on technical
matters.
Tocarry out the other functions assigned
to it by thisAct.

13. Drugs Consultative Committee (DCC)
• It is also an advisory body constituted
by central government.
• Constitution:
• Two representatives of the Central
Government
• One representative of each State
Government

14. 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.

15. Central Drug Laboratory(CDL)
• 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.
• 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.

16. Drug control laboratories in state
• In Gujarat, three laboratories established which collect, analysed
and report the various sample of the drugs and food.
1) Baroda: Established in 1959.
2) Bhuj: Established in 1979.
3) Rajkot: Established in 1983
The laboratory has the following division:-
• Pharmaceutical Chemistry Division
• Immunology Division
• Pharmacology Division
• Pharmacognosy Division
• Food Division
• Ayurvedic Division

17. Function:
Testing of drug sample
Analysis of food sample
Analysis of excise sample
LINK:

18. Government analyst
• These officers are appointed by the central or state
government and perform the duties.
• Qualification of government analysist
• 1 Persons having qualification for appointment as
government as governmental Analysis for allopathic
drugs;
• 2 having a degree in medicine, ayurved, sidha or
unani system and not less than three year post
graduate experience in the analysis of drugs in a
laboratory under control of a government analyst.

19. Duties:
• 1) The Government Analyst shall cause to be
analysed or tested such samples or drugs and
cosmetics as may be sent to him by Inspectors.
• 2) A Government Analyst shall from time to
time forward reports to the Government
giving the result of analytical work and
research with a view to their publication.

20. Licensing authority
• Qualification:
(i)Graduate in Pharmacy on Pharmaceutical
Chemistry or in Medicine with specialization in
clinical pharmacology or microbiology from a
University established in India by law; and
(ii)Experience in the manufacture or testing of
drugs a minimum period of five years

21. Duties:
(1)Toinspect all establishments licensed for the sale
of drugs within the area assigned to him;
(2)Tosatisfy himself that the conditions of the licences
are being observed;
(3) Toprocure and send for test or analysis, if
necessary, imported packages.
(4) Toinvestigate any complaint.
(5)To maintain a record of all inspections made and
action taken by him in the performance of his duties,
(6)To make such enquiries and inspections as may be
necessary to detect the sale of drugs in contravention
to theAct;

22. Controlling authority
Qualification:
• Graduate in Pharmacy or Pharmaceutical
Chemistry or in Medicine with specialization in
clinical
• Pharmacology or microbiology from a University
established in India by law and
• Experience in the manufacture or testing of drugs
or enforcement of the provisions of the Act for a
minimum period of five years:

23. Drug Inspector
Qualification
1 Persons having qualification for appointment as
government as governmental Analysis for
allopathic drugs; or
2 Having a degree in ayurveda, siddha or unani
system and not less than three year post graduate
experience in the analysis of drugs in a laboratory
under control of
(a) A government analyst,or
(b) A chemical examiner,or
(c) Head of an institution specially approved for this
purpose.

24. Power:
A) Inspect:
(i)Any premises where in any drug or cosmetic is being
manufactured.
(ii)Any premises where in any drug or cosmetic is being
sold, or stocked or exhibited or offered for sale, or
distributed ;
(B) Take samples of any drug orcosmetic:
(i)Which is being manufactured or being sold or is stocked
or exhibited or offered for sale, or is being distributed;
(ii)From any person who is in the course of conveying,
delivering or preparing to deliver such drug or cosmetic to
a purchaser or a consignee.

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

27. Classes of drugs prohibited to
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.

28. Import of the biological drugs(C/C1)
Conditions to be fulfillled:
• Licensee must have adequate facility for the
storage.
• Licensee must maintain a record of the sale.
• Licensee must allow an inspector to inspect
premises and to check the records.
• Licensee must furnish the sample to the authority.
• Licensee must not sell drugs from which sample is
withdrawn and he is advised not to sale, and recall
the batch from the market.

29. Import of the Schedule-X drugs
(Narcotic & Psychotropic drugs)
Conditions to be fulfilled:
• Licensee must have adequate storage facility.
• Applicant must be reputable in the occupation,
trade or business.
• The license granted even before should not be
suspended or cancelled.
• The licensee has not been convicted any offence
under the Drugs and Cosmetics Act or Narcotic
and Psychotropic Substances Act.

30. Drugs Imported for
examination, test or analysis
Conditions to be fulfilled:
• License is necessary underform-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 ofimport.
• Must allow an inspector to inspect
the premises and check the
records.

31. Drugs imported for personal use
Conditions to be fulfilled:
• Up to 100 average doses may be imported
without any permit, provided it is part of
passenger’s luggage.
• More than 100 doses imported with license.
Apply on form no.-12-A,12-B
• Drugs must be bonafide personal use.
• Drugs must be declared to the custom
collectors if so directed.

32. Import of drugs without license
• Substances not used for medicinal purpose
• Substances which are both drugs and foods
such as: Condensed/Powdered Milk, Malt
Lactose, Farex/Cereal, Oats, Predigested foods,
Ginger, Pepper, Cumin, Cinnamon

33. Penalties related to Import

34. 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

35. MANUFACTURE
Prohibition of manufacture
• Manufacture of other
than in Sch-C/C1
• Manufacture of those in
Sch-C/C1
• Manufacture of Sch-X
drugs
• Loan license
• Repackaging license
• Offences & Penalties

36. Prohibition of manufacture
• Drug not of standard quality or misbranded,
adulterated or spurious.
• Patent or Proprietary medicine or drugs in
Sch-J
• Risky to human beings or animals
• Drugs without therapeutic value
• Preparation containing cyclamates

37. Manufacture of drugs other than in Schedule-
C/C1
Conditions:
• Premises should comply with schedule ‘M’
• Adequate facility for testing, separate from
manufacturing
• Adequate storage facility
• Records maintained for at least 2 years from date
of Exp.
• Should provide sample to authority
• Furnish data of stability
• Maintain the inspection book
• Maintain reference samples from each batch

38. Manuf. of drugs those in Schedule-
C/C1(Biological)
Conditions:
• Drugs must be issued in previously sterilized sealed glass
or suitable container
• Containers should comply with Sch-F
• Some classes tested for aerobic & anaerobic
microorganism. eg. Sera ,Insulin, Pituitary hormones.
• Serum tested for abnormal toxicity
• Parenteral in doses of 10 ml or more should be testedfor
freedom from Pyrogens
• Separate lab. for culture & manipulation of spore bearing
Pathogens
• Testfor sterility should be carried out.

39. Manufacture Of Sch-X drugs
Conditions:
• Accounts of all transactions regarding manuf. Should be
maintained in serially.(Preserved for 5 years)
• Have to sent invoice of sale to licensing authority every 3
months
• Store drugs in direct custody of responsible person.
• Preparation must be labelled withX-Rx
• Marketed in packing not exceeding
• 100 unit dose–Tablets/Capsules
• 300 ml- Oral liquid
• 5 ml - Injection

40. Manufacture of cosmetics
Prohibited for the following classes of drug:
• Misbranded or spurious cosmetics and of
substandard quality
• Cosmetics containing hexachlorophene or
mercury compounds
• Cosmetics containing color which containmore
than-
• 2 ppm of arsenic
• 20 ppm of lead
• 100 ppm of heavy metals
• Eye preparations containing coal-tar color

41. Penalties related to Manufacture

42. Loan License
Definition:
• A person(applicant) who does not have his own
arrangements(factory) for manufacture but who
wish to manufacturing facilities owned by
another licensee such licenses are called Loan
licenses.
• Loan licenses are issued for:
1) Drugs other than specified in C/C1 & X.
2) Drugs specified in Schedule-C/C1

43. Repackaging license
Definition:
• Process of breaking up any drug from a bulk
container into small packages and labelling
with a view to their sale and distribution.
• Repackaging of drugs is granted of drugs other
than Schdule-C/C1 and X.

44. SALE
Classes of drugs prohibited to be sold
• Wholesale of biological (C/C1)
• Wholesale of other than those specified in
C/C1 and X

45. Class of drug prohibited to sale
• Misbranded, spurious, adulterated and drugs
not of standard quality
• Patent/Proprietary drugs with undisclosed
formula
• Sch-J drugs
• Expired drugs.
• Drugs used for consumption by government
schemes such as, Armed force.
• Physician’s samples

46. Wholesale of biological (C/C1)
• 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

47. whole sale from other than
specified in C/C1 and X
• All the conditions as discussed in for
biological.
• Compounding is made by or under the direct
and personal supervision of a qualified
person.

48. Labelling & Packaging
• All the general and specific labelling and
packaging specified to all classes of
drugs and cosmetics should be as per
the provisions made under the act.
Link:
• https://www.slideshare.net/SaloniAmbasana/labeling-and-
packaging-of-drugs-as-per-drugs-and-cosmetic-act
• https://www.slideshare.net/BiNduXtrEiy/labelling-of-drugs-
cosmetics-nd-biotech
• http://www.mcrhrdi.gov.in/drugs/week2/Labels%20&%20labelling2
.pdf

51. IMPORTANT LINKS
• http://ijpsr.com/bft-article/regulatory-process-for-import-and-export-of-
drugs-in-india/?view=fulltext
• http://apps.who.int/medicinedocs/documents/s17098e/s17098e.pdf
• https://www.healthcarelawinsights.com/2019/01/recent-developments-
in-state-pharmacy-law-regulation-looking-back-at-2018-and-what-to-
expect-in-2019/
• http://epilepsyns.com/buying-medicines-online-advantages-and-
disadvantages/
• https://blog.soliant.com/pharmacy/local-pharmacy-vs-online-pharmacy/