Sale of Drugs – Licensing, Labeling, Offenses & Regulatory Authorities Under Drugs and Cosmetics Act, 1940

 Sale may be defined as the process of passage of articles from
the manufacturer to the consumer.
 There are two general types of sale: Wholesale and Retail sale.
 Wholesale: (sale by way of wholesale dealing) It means a sale to
a person for the purpose of selling again & also includes hospital
or a dispensary or medical
 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.
SALE OF DRUGS

Type of License Forms
Other than
Schedule C, C1
and X Drugs
Schedule C
and C1
Drugs
Schedule X
Drugs
Retail 20 21 20-F
Restricted 20-A 21-A -
Wholesale 20-B 21-B 20-G
Wholesale or
Distribution from
motor vehicle
20-BB 21-BB -

LAYOUT OF RETAIL & WHOLE SALE DRUG STORE

 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.
WHOLESALE LICENSE CONDITIONS

 Retail sale of specific drugs.
 Forms 20A and 21A.
a.Sales are limited to drugs that can be sold without
supervision.
b.The license holder must comply with the Drugs and Cosmetics
Act and Rules.
c. The license holder must allow inspections.
d.The license holder must display the license prominently.
e.The license holder must only purchase drugs from licensed
manufacturers.
RESTRICTED LICENSE CONDITIONS

OFFENCES
PENALTIES
FIRST CONVICTION SUBSEQUENT CONVICTION
Sale or distribution of
 Any adulterated or spurious
drugs or drug not of standard
quality
 Imprisonment upto 5 years and
extending upto lifetime and fine
of not less than 10,000
 Imprisonment upto 10 years or
fine upto 20.000 or both
 Any adulterated but not
containing toxic or harmful
substances injurious to health
 Imprisonment from 1-3 and fine
of not less than 5,000
 Imprisonment for 2-4 years or
fine upto 10000
 Without a license
 Imprisonment of less than a year
and a lesser fine
 Imprisonment for not less than 2
years or fee upto 10.000
 Spurious drugs but not
manufactured under the name
of any other drug
 Imprisonment for 3-5 years and
fine of not less than 5,000
 Imprisonment for not less than 6-
10 years of fine upto 10,000
 Any other  Imprisonment for 1 year. -
 Contravention of this act
 Imprisonment from 1-2 years and
fine
 Imprisonment for 2-4 years or
fine upto 5,000 or both.
Not keeping records of sale in the  Imprisonment upto 3 years or
 Same as First conviction

 Drug Name and Net Content: Proper name, trade name (if any).
Net content: Weight/volume in metric system.
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.
DRUG INFORMATION AND LABELLING REQUIREMENTS

 Manufacturer Details: Name and address of manufacturer.
Manufacturing license number: Mfg. Lic. No. or ML No.
 Batch Details and Dates: Batch number: Batch No. or Lot No.
Date of manufacturing: Mfg. Date. Date of expiry: Exp. Date.
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.
DRUG INFORMATION AND LABELLING REQUIREMENTS

 Schedule C1: Date of manufacture and expiry. Import license
number.
 Special Labelling - Schedule G: Dangerous to take without medical
supervision.
 Schedule H: RX symbol, "To be sold by prescription only". NRX
symbol for Narcotic/Psychotropic drugs.
 Schedule X: XRX symbol, "To be sold by prescription only".
 External Use Preparations: "For external use only". e.g., lotion,
liniment, ointment, liquid antiseptics.
 Pharmacopoeial Preparations: I.P., B.P., B.P.C., U.S.P., N.F., etc.
 Patents and Proprietary Medicines: Quantities of active ingredients.
SPECIAL LABELLING

Ophthalmic Preparations (Schedule FF):
 "Use within one month after opening". Name and
concentration of preservative. 'Not for Injection'. Storage
instructions. Warnings for use.
Medicines for Animals:
 "Not for human use, for animal treatment only". Symbol of
domestic animal's head.
SPECIAL LABELLING

No drug shall contain a color other than that specified below:
 Natural Colours: Amatto, Carotene, Chlorophyll, Cochineal, Curcumin,
Red oxide of iron, Yellow oxide of iron, Titanium dioxide, Black oxide
of iron.
 Artificial Colours: Caramel, Riboflavin.
 Coal Tar Colours: Quinoline Yellow SS, Alizarin Cyanine Green F, Fast
Green FCF, Tartrazine, Ponceau 4R, Erythrosine, Eosin YS or Eosine G,
Amaranth, Sudan III, Indigo Carmine, Brilliant Blue FCF, Orange G,
Resorcin Brown, Naphthol Blue-Black.
 Lakes: The aluminum or calcium salts (lakes) of any of the water-
soluble colors listed above.
Offences and Penalties Same as the sale of drugs.
LIST OF PERMITTED COLOURS

DRUGS TECHNICAL ADVISORY BOARD
(DTAB)

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.
 The Drugs Technical Advisory Board (DTAB) consists of 8 ex-
officio members, including the Chairman (Director General of
Health Services), Drugs Controller of India, Director of the
Central Drugs Laboratory (Calcutta), Director of the Central
Research Institute (Kasauli), Director of the Indian Veterinary
Research Institute (Izatnagar), President of the Medical Council
of India, President of the Pharmacy Council of India, and Director
of the Central Drug Research Institute (Lucknow).
COMPOSITION OF DTAB

Additionally, there are 4 elected members: one representative
elected by the Executive Committee of the Pharmacy Council of India(from
pharmacy/chemistry/pharmacognosy teachers in universities or colleges),
one representative elected by the Executive Committee of the
Medical Council of India (from medicine/therapeutics teachers in
universities or colleges).
one pharmacologist elected by the Governing Body of the Indian
Council of Medical Research, and one representative elected by the Central
Council of the Indian Medical Association.
The board also includes nominated members: two representatives
from State drugs control authorities, one representative from the
Pharmaceutical Industry, and two Government analysts nominated by the
Central Government.
COMPOSITION OF DTAB

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.
CENTRAL DRUGS LABORATORY (CDL)

Composition of DCC:
Two representatives nominated by central government one
representative nominated by each state government.
Functions of DCC:
Provides advice on matters achieving uniformity in drug
related to act administration regulation across india.
Importance of DCC:
Collaboration: central and state government expertise
facilitates informed decision-making uniformity: aims for
consistent drug administration practices.
DRUGS CONSULTATIVE COMMITTEE (DCC)

Appointment of Government Analysts:
Central and State Governments appoint Government Analysts.
Notification in Official Gazette. Specifics areas, drugs, or cosmetics for
analysis.
Qualifications of Government Analysts:
Graduate in medicine, science, pharmacy, or pharmaceutical
chemistry with 5+ years of post-graduate testing experience.
Post-graduate degree in medicine, science, pharmacy, or
pharmaceutical chemistry with 3+ years experience.
Associateship Diploma of the institution of chemists with 'Analysis
of Drugs and Pharmaceuticals' specialization and 3+ years experience
in approved laboratories.
GOVERNMENT DRUG ANALYSTS

DUTIES OF GOVERNMENT ANALYSTS
Package Inspection:
Verify seals against specimen impression. Note seal
condition.
Sample Analysis:
Analyze drugs and cosmetics sent by Drug Inspectors.
Furnish reports on analysis.
Importance of Government Analysts:
Ensures drug and cosmetic quality. Independent verification
of products. Supports drug regulatory authorities.
GOVERNMENT DRUG ANALYSTS

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.
License Validity:
Licenses remain valid unless suspended or canceled. Ensures
adherence to regulations and standards.
Designation of Licensing Authorities:
Many designated as Drug Controllers.
Central License Approving Authority:
Drug Controller India.
LICENSING AUTHORITIES

Role of Controlling Authorities:
Drug inspectors under control of controlling authority.
Oversight and coordination of regulatory activities.
Qualifications of Controlling Authorities:
Graduate in Pharmacy, Pharmacology, Chemistry, or Medicine.
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).
CONTROLLING AUTHORITIES

National Regulatory Authority (NRA) of India. Headquarters:
FDA Bhawan, New Delhi.
Functions:
Approvals, Clinical Trials, Standards, Quality Control.
CDSCO Objectives:
Uniform implementation of Act and Rules. Patient safety, rights,
and well-being. Transparency, accountability, and uniformity.
CDSCO Responsibilities:
Approval of Drugs. Clinical Trial Oversight. Standards Setting.
Quality Control of Imports. Coordination with State Drug Control
Orgs.
CENTRAL DRUGS STANDARD CONTROL ORGANISATION (CDSCO)

Role of Drug Inspectors:
Appointed by the Central or State Government. Required qualifications:
B.Pharma/M.Pharm with 18 months experience in manufacturing substances
in Schedule C or 3 years experience inspecting firms.
Duties of Drug Inspectors:
 Inspection of Manufacturing Premises.
 Inspection of Sales Premises.
 Sample Collection: From Manufacturers or Sellers. From Conveyors.
 Search and Seizure Authority: Entering and Searching Places, Persons,
Vehicles. Stopping and Searching Vehicles.
DRUG INSPECTORS

Duties of Drug Inspectors:
 Seizure of Stocks and Materials:
 Temporarily Preventing Disposal. Seizing Materials Used for Offences.
 Record Examination and Production: Examining Records, Registers,
Documents. Requiring Production of Records.
 Legal Provisions: Code of Criminal Procedure, 1973, applies to search or
seizure. Obstruction or refusal to produce records punishable with
imprisonment or fine.
 Importance of Drug Inspectors: Ensure compliance with regulations.
Safeguard patient safety and well-being. Uphold drug and cosmetic quality
standards.
DRUG INSPECTORS

Sale of Drugs – Licensing, Labeling, Offenses & Regulatory Authorities Under Drugs and Cosmetics Act, 1940

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