This PPT Covers Sale of Drugs – Wholesale, Retail sale and Restricted license. Offences and penalties Labeling & Packing of drugs- General labeling requirements and specimen labels for drugs and cosmetics, List of permitted colors. Offences and penalties. Administration of the Act and Rules – Drugs Technical Advisory Board, Central drugs Laboratory, Drugs Consultative Committee, Government drug analysts, Licensing authorities, controlling authorities, Drugs Inspectors

1. Sale of Drugs Wholesale, Retail, and Restricted Sale
Licenses

2. Wholesale
Drug License
Issued to wholesalers for drug
distribution.
From stockists to shopkeepers.

3. Retail Sale
Drug License
Issued for retail sale to patients.
From shopkeepers (chemists,
druggists) to patients.

4. License Types
Retail Drug License
Requires pharmacy degree/diploma.
Wholesale Drug License
For wholesale drug business.
Conditions apply.

5. Wholesale
License
Conditions
Minimum area: 10 sq. m.
Storage: Refrigerator & air conditioner.
Competent Staff: Pharmacist or qualified person.
Display license prominently.
Purchase from a licensed dealer/manufacturer.
Maintain purchase records for 3 years.
Maintain records for 2 years.
Maintain Inspection book (Form 35).
Do not stock/sell expired or physician's sample drugs.
A separate record for Schedule X drugs.
Only sale for resale with proper license.

6. Restricted
License
Conditions
Retail sale of specific drugs.
Forms 20A and 21A.
(a) For drugs not needing qualified supervision.
(b) Licenses for itinerant vendors in exceptional cases.
(c) License for travelling agents for specific distribution
purposes.
(d) Adequate premises with storage facilities.
(e) Display license in public area or on demand.
(f) Comply with Drugs and Cosmetics Act.
(g) Purchase from licensed dealers/manufacturers.
(h) Deal with drugs not requiring qualified supervision.
(i) Sell drugs in original containers.

7. Obtaining
Drug
License
Application Form.
Cover letter with applicant's details.
Copy of fees deposit challan.
Declaration as prescribed.
Kite plan and site plan.
Proof of premises possession.
Ownership proof for rented property.
Business constitution documents.
Affidavit of non-conviction of director/partner
/proprietor.
Testimony and appointment of a pharmacist or
competent person.

8. Offences and
Penalties

9. General Labelling
Requirements
Particulars are to be printed/written on drug labels.
Innermost container & every covering.

10. Drug Name and
Net Content
Drug name: Proper name >
Trade name (if any).
Net content: Weight/volume in
metric system.

11. Content of
Active
Ingredients
Oral liquids: Per single dose or per ml.
Liquid parenterals: Per ml/percentage/dose.
Solid parenterals: Per mg/gm/units.
Tablets, capsules, pills: Per tablet/capsule/pill.
Other preparations: Percentage or units per gm/ml.

12. Manufacturer
Details
Name and address of manufacturer.
Manufacturing license number: Mfg. Lic. No. or ML
No.

13. Batch
Details and
Dates
Batch number: Batch No. or Lot No.
Date of manufacturing: Mfg. Date.
Date of expiry: Exp. Date.

14. Additional
Labelling
Requirements
Free samples: "Physician’s Sample - Not To Be Sold".
Alcoholic preparations: Mention alcohol content.
Handling, use, distribution, storage info.
Maximum Retail Price: M.R.P.

15. Special
Labelling -
Schedule C1
Date of manufacture and expiry.
Import license number.

16. Special
Labelling -
Schedule G
Dangerous to take without medical supervision

17. Special
Labelling -
Schedule H
RX symbol, "To be sold by prescription only".
NRX symbol for Narcotic/Psychotropic drugs.

18. Special
Labelling -
Schedule X
XRX symbol, "To be sold by prescription only

19. External Use
Preparations
"FOR EXTERNAL USE ONLY".
e.g., lotion, liniment, ointment, liquid antiseptics.

20. Pharmacopoeial
Preparations
I.P.', 'B.P.', 'B.P.C', 'U.S.P', 'N.F.' etc.

21. Patents and
Proprietary
Medicines
Quantities of active ingredients

22. Ophthalmic
Preparations
(Schedule FF)
"Use within one month after opening".
Name and concentration of preservative.
'Not for Injection'.
Storage instructions.
Warnings for use.

23. Medicines
for Animals
"NOT FOR HUMAN USE, FOR ANIMAL TREATMENT
ONLY".
Symbol of domestic animal's head.

24. Specimen Labels

25. Specimen Labels

26. LIST OF
PERMITTED
COLOURS
No drug shall contain a color other than that specified below:
(1) Natural Colours: Annatto, Carotene, Chlorophyll, Cochineal,
Curcumin, Red oxide of iron, Yellow oxide of iron, Titanium
dioxide, Black oxide of iron.
(2) Artificial Colours: Caramel, Riboflavin.
(3) Coal Tar Colours: Quinazarine Green SS, Alizarin Cyanine
Green F, Fast Green FCF, Tartrazine, RED (Erythrosine), Eosin
YS or Eosine G, Toney Red or Sudan III, Indigo Carmine,
Brilliant Blue FCF, Orange G, Resorcin Brown, Naphthol Blue-
Black.
(4) Lakes the aluminum or calcium salts (lakes) of any of the
water-soluble colors listed above.
(5) The label on the container of a drug containing a permitted
color shall indicate the common name of the colour.

27. OFFENCES AND
PENALTIES
Same as offenses and penalties under the sale of drugs

28. Administration
of the Drugs
and Cosmetics
Act

29. Drugs Technical Advisory Board (DTAB)
Constituted by the
Central
Government
Advises Central
and State
Governments on
technical matters
Carries out
functions assigned
by the Act

30. A. Composition of DTAB
A. Ex-Officio Members:
1. Chairman: Director General of Health Services
2. Drugs Controller, India
3. Director of the Central Drugs Laboratory, Calcutta
4. Director of the Central Research Institute, Kasauli
5. Director of the Indian Veterinary Research Institute, Izatnagar
6. President of the Medical Council of India
7. President of the Pharmacy Council of India
8. Director of the Central Drug Research Institute, Lucknow

31. B. Nominated Members
1. Two representatives from State drugs control
authorities
2. One representative from the Pharmaceutical
Industry
3. Two Government analysts nominated by the
Central Government

32. C. Elected Members
1. Representative elected by the Executive Committee of the Pharmacy Council of India from
pharmacy/chemistry/pharmacognosy teachers in universities or colleges
2. Representative elected by the Executive Committee of the Medical Council of India from
medicine/therapeutics teachers in universities or colleges
3. Pharmacologist elected by the Governing Body of the Indian Council of Medical Research
4. Representative elected by the Central Council of the Indian Medical Association
5. Representative elected by the Council of the Indian Pharmaceutical Association

33. • Nominated and elected members serve for
three years
• Eligible for re-nomination and re-election
• Secretary and staff appointed by the Central
Government
• Office duration tied to the individual's current
appointment
• DTAB can form sub-committees
• Sub-committee members can be non-Board
members
• Sub-committees for specific matters or up to
three years

34. Central Drugs
Laboratory (CDL)

35. Establishment and
Purpose
Central Government established CDL
Under the control of a Director appointed by the
Central Government
Purpose: Carry out functions as per the Act and rules

36. CDL Functions
Sample Analysis and Testing
CDL analyzes/test samples of drugs
Sent by Custom Collectors or Courts
Collaborative Functions
CDL is not equipped to test all products
Other Government labs and Institutes perform CDL functions

37. Collaborative Functions (Examples)
Central Research
Institute, Kasauli
Pasteur Institute of
India, Conoor, and
Enterovirus Research
Centre, Mumbai
Indian Veterinary
Research Institute,
Izatnagar/Mukteshwar
Central Indian
Pharmacopoeia
Laboratory, Ghaziabad
Laboratory of the
Serologist and Chemist
examiner to the
Government of India,
Calcutta
Department of
Biomedical Engineering
of the Indian Institute
of Technology, New
Delhi
Homeopathic
Pharmacopoeia
Laboratory, Ghaziabad

38. Procedure for Sending Samples
1. Registered Post:
Samples sent in sealed
packet
2. Memorandum:
Enclosed in prescribed
form, addressed to the
Director

39. Sample Handling and Testing
1. Packet Receipt:
Opened by
authorized officer
appointed by Director
2. Testing: CDL
conducts necessary
tests

40. Reporting Results
CDL sends results and complete test
protocols to the sender
Certificate Issuance
Certificates issued by CDL under the rules
Signed by the Director or authorized Central
Government officer

42. Drugs
Consultative
Committee
(DCC)

43. Establishment and Purpose
DCC: Advisory body
by the Central
Government
Aims to advise
Central and State
Governments, and
DTAB
Goal: Secure
uniformity in
administering the
Act nationwide

44. Composition of DCC
TWO REPRESENTATIVES NOMINATED
BY CENTRAL GOVERNMENT
ONE REPRESENTATIVE NOMINATED BY
EACH STATE GOVERNMENT

45. Functions of DCC
PROVIDES ADVICE ON MATTERS
RELATED TO ACT ADMINISTRATION
ACHIEVING UNIFORMITY IN DRUG
REGULATION ACROSS INDIA

46. Meeting and Procedure
DCC Meetings:
Convened when
required by Central
Government
Autonomy:
Empowered to
regulate its own
procedures

47. Importance of DCC
COLLABORATION: CENTRAL AND
STATE GOVERNMENT
REPRESENTATIVES
EXPERTISE: FACILITATES INFORMED
DECISION-MAKING
UNIFORMITY: AIMS FOR
CONSISTENT DRUG
ADMINISTRATION PRACTICES

48. Benefits of Uniformity
CLARITY: CLEAR REGULATIONS
AND STANDARDS
EFFICIENCY: STREAMLINED DRUG
ADMINISTRATION PROCESSES
SAFETY: ENHANCED DRUG
QUALITY AND PATIENT SAFETY

49. DCC established by the Central
Government
Composed of Central and State
government representatives
Advisory role in achieving uniform drug
administration
Autonomous in regulating its own
procedures

50. Government
Drug
Analysts

51. Appointment of
Government Analysts
• Central and State Governments appoint
Government Analysts
• Notification in Official Gazette
• Specifies areas, drugs, or cosmetics for
analysis

52. Qualifications of
Government
Analysts
1. Graduate in medicine, science, pharmacy, or pharmaceutical
chemistry
5+ years of post-graduate testing experience
2. Post-graduate degree in medicine, science, pharmacy, or
pharmaceutical chemistry
3+ years experience
3. Associateship Diploma of the institution of chemists
'Analysis of Drugs and Pharmaceuticals' specialization
3+ years experience in approved laboratories

53. Financial
Interest
Restriction
Government Analysts should not have
financial interest in drugs or cosmetics
import, manufacture, or sale

54. Duties of
Government
Analysts
1. Package Inspection
- Verify seals against specimen impression
- Note seal condition
2. Sample Analysis
- Analyze drugs and cosmetics sent by Drug Inspectors
- Furnish reports on analysis

55. Reporting
Analysis
Reports submitted in Form 13
Includes test protocols applied

56. Analysis Requests by
Purchaser
Purchaser's Application: Form 14-A
Prescribed fee required
Analysis Report: Form 14-B, issued by Government Analyst

57. Importance of
Government
Analysts
Ensures drug and cosmetic
quality
Independent verification of
products
Supports drug regulatory
authorities

58. Government Analysts appointed by
Central and State Governments
Qualified individuals with
experience
Duties include package inspection
and sample analysis
Reports submitted in specified
forms

59. Licensing
Authorities

60. Role of Licensing
Authorities
Appointed by Central and State governments
Responsibilities: Grant, renewal, and oversight
of licenses
Pertains to import, manufacture, sale,
distribution of drugs and cosmetics.

61. License Validity
Licenses remain valid unless
suspended or canceled
Ensures adherence to regulations and
standards

62. Designation of Licensing Authorities
Many designated as Drug
Controllers
Central License Approving
Authority: Drug Controller, India

63. Qualifications of Licensing Authorities
EDUCATION: GRADUATE IN
PHARMACY, PHARMACEUTICAL
CHEMISTRY, OR MEDICINE
SPECIALIZATION IN CLINICAL
PHARMACOLOGY OR
MICROBIOLOGY
EXPERIENCE: MINIMUM 5 YEARS
IN DRUG MANUFACTURE OR
TESTING

64. Role Significance
Crucial role in drug and
cosmetic regulation
Ensures products meet
safety and quality standards
Balances public health and
industry interests

65. Responsibilities of Licensing Authorities
Granting licenses for various
activities
Renewing licenses Monitoring
compliance with regulations

66. Central License Approving
Authority
Drug Controller, India
Recent designation for central approvals
Centralizes decision-making for licenses

67. Licensing Authorities
appointed by Central
and State
governments
Core role: Granting,
renewing, and
monitoring licenses
Qualifications:
Pharmacy,
Pharmaceutical
Chemistry, or Medical
background
Ensures adherence to
safety and quality
standards

68. Controlling Authorities

69. Role of Controlling Authorities
DRUG INSPECTORS UNDER CONTROL
OF CONTROLLING AUTHORITY
OVERSIGHT AND COORDINATION OF
REGULATORY ACTIVITIES

70. Qualifications of Controlling Authorities
Education: Graduate in
Pharmacy,
Pharmaceutical
Chemistry, or Medicine
Specialization in Clinical
Pharmacology or
Microbiology
Experience: Minimum 5
years in drug
manufacture or testing

71. Drug Control Department (DCD)
Responsible for licensing
manufacturing and sales
premises
Focus on ensuring the supply
of quality drugs
Comprises Enforcement Wing,
Educational Wing, and Drugs
Testing Laboratory (DTL)

72. Central Drugs Standard Control Organisation
(CDSCO)
National Regulatory
Authority (NRA) of India
Headquarters: FDA
Bhawan, New Delhi
Functions: Approvals,
Clinical Trials, Standards,
Quality Control

73. CDSCO Objectives
Uniform
implementation of Act
and Rules
Patient safety, rights,
and well-being
Transparency,
accountability, and
uniformity

74. CDSCO Responsibilities
Approval of
Drugs
Clinical Trial
Oversight
Standards
Setting
Quality
Control of
Imports
Coordination
with State
Drug Control
Orgs

75. CDSCO and State Regulators
Joint responsibility for specialized
drug licenses
Examples: Blood products, I.V.
fluids, Vaccines

76. CDSCO: National
Regulatory
Authority,
diverse
responsibilities
DCD: Ensures
quality drug
supply, consists
of multiple
wings
Qualifications:
Pharmacy,
Pharmaceutical
Chemistry, or
Medical
background
Controlling
Authorities
oversee Drug
Inspectors

77. Role of Drug
Inspectors

78. Qualifications
for Drug
Inspectors
Appointed by the Central or State
Government
Required qualifications-B.Pharma/M.Pharm
18 months experience in manufacturing
substances in Schedule C
18 months experience in testing substances
in Schedule C
3 years experience inspecting firms
manufacturing substances in Schedule C

79. Duties of
Drug
Inspectors
1. Inspection of Manufacturing Premises
Standardization and testing methods
2. Inspection of Sales Premises
Selling, stocking, exhibiting, offering, or
distributing drugs or cosmetics

80. Sample
Collection
1. From Manufacturers or Sellers
Manufacturing, sale, stocking,
exhibition, or distribution
2. From Conveyors
While conveying, delivering, or
preparing to deliver to purchaser or
consignee

81. Search
and
Seizure
Authority
1. Entering and Searching Places, Persons, Vehicles
Suspected offences
2. Stopping and Searching Vehicles
Suspected transportation of drugs or cosmetics
for offenses

82. Seizure
of Stocks
and
Materials
1. Temporarily Preventing Disposal
Not exceeding 20 days
If the defect can be rectified, seize the stock
2. Seizing Materials Used for Offences
Substances, articles facilitating offenses

83. Record
Examination
and
Production
1. Examining Records, Registers, Documents
To gather evidence of offenses
2. Requiring Production of Records
Relating to manufacturing, stocking, selling,
distribution

84. Legal
Provisions
Code of Criminal
Procedure, 1973, applies
to search or seizure
Obstruction or refusal to
produce records
punishable with
imprisonment or fine

85. Importance of Drug Inspectors
Ensure compliance with regulations
Ensure
Safeguard patient safety and well-being
Safeguard
Uphold drug and cosmetic quality standards
Uphold

86. Drug Inspectors
appointed by Central or
State Governments
Manufacturing, testing,
or inspection
experience
Inspection, sample
collection, search,
seizure, record
examination
Essential role in
upholding drug and
cosmetic safety