DRUGS AND
COSMETICS ACT
Contents of this chapter
•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
www.DuloMix.com
Learning Objectives
• At the end of this lecture, student will be able to
– Explain the provisions for sale of drugs
– Describe the types of sale licenses
– Discuss the Class of drug prohibited to sale
– Discuss the Drugs and Cosmetics (Amendment) Act, 2008
– Describe the labeling aspects of drugs and cosmetics
www.DuloMix.com
SALE OF DRUGS
▪Classes of drugs prohibited to be sold
▪Wholesale of biological (C/C1)
▪Wholesale of other than those specified in C/C1 and X
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
www.DuloMix.com
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 be displayed on premises
All the conditions as discussed in for biological.
Compounding is made by or under the direct and personal supervision of a qualified
person.
www.DuloMix.com
Retail Sale
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
www.DuloMix.com
Labeling & Packaging
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.
www.DuloMix.com
Labeling in India
All labels of a drug should conform as per the specifications under the
Drugs and Cosmetics Rules 1945.
➢That no person sell or distribute any drug unless it is labeled in
accordance with the Rules (Rule 95 of D&C Act).
www.DuloMix.com
Labeling – is the norm in this context that provide comprehensive and
concise statement of a drug’s Quality Safety and Efficacy.
-it includes information regarding indications, effects, dosage form,
frequency and duration of administration, warnings, hazards,
contraindications, side effects, precautions and other relevant
information.
www.DuloMix.com
Importance of labeling
The safe use of all medicines depends on users reading the labeling and packaging
carefully and accurately and being able to assimilate and act on the information
presented.
All labels must be clear and concise and must bear all necessary information regarding
the safe use of a product.
www.DuloMix.com
Prescription Drug Labeling
▪These cannot be used safely by consumers without the diagnosis and
supervision of a physician.
▪These have unavoidably adverse effects, but the benefits of using such drugs
outweigh the accompanying risks.
▪It is the expert judgment of a practitioner to decide the use of a drugs for a
particular patient.
▪Thus, the manufacturer of a prescription drug is required to provide adequate
labeling for practitioners to be able to administer or dispense the drug safely
and for the purposes for which it is intended.
www.DuloMix.com
Components of Labeling
The prescription drug labeling consists of following components:-
➢ Container/ Carton Label
➢ Package Insert
A. Regulatory Requirements for Label :-
Rule 96 of the Drug and Cosmetic Rules (manner of labelling) mandates the minimum
information which needs to be put on the label of all medicines.
www.DuloMix.com
▪Misbranded drug if it is not labelled in the prescribed manner
as in drug and cosmetic rules(chapter 3 section 9(b) of D&C act).
▪The following particulars shall be either printed or written in
indelible ink and shall appear in a conspicuous manner on the
label of the innermost container of any drug and on every other
covering which the container is packed, namely :-
www.DuloMix.com
1) Name of the drug:-
▪ For drug included in the schedule F /F(1), the name given therein.
▪ For drugs included in the Indian Pharmacopoeia or the official pharmacopoeia and
official compendia of drug standards prescribed in the rule 124, the name or
synonym specified in the respective followed by letters ‘I.P.’
▪ It entered on the label of the drug only for the purpose of indicating that the drug is
in accordance with standards set out in the Indian Pharmacopoeia.
▪ for drugs included in the National Formulary of India, the name or synonym
specified therein followed by the letters ‘N.F.I.’
www.DuloMix.com
2. Net Quantity of contents
3. The content of active ingredients
4. Name and Address of manufacturer
5. Batch or lot number(Batch No.)
6. Manufacturing license number (“Mfg. Lic. No.”)
7. Import License No. (if applicable):- the no. of license under which
the drug is imported, preceded by words “Import Lic. No.”
8. Manufacturing date, Expiry date and Storage conditions
www.DuloMix.com
9. Other Specific Requirements
i. Physician Sample – ‘Not to be sold’.
ii. Alcohol content
Package Inserts
▪The Package insert is considered “adequate direction for use”.
▪It is also directed to healthcare professional and help him in making correct decision
regarding the prescribing of drug to a particular patient.
▪In India, it is governed by the ‘Drugs and Cosmetics Act(1940) and Rules(1945)’
.Schedule D 11 (section 6) of the rules including the heading to which information to be
provided in the Package Inserts.
▪It is divided into two parts:
-Therapeutic indications
-Pharmaceutical information
www.DuloMix.com
Drug Labeling Regulation in India
Rule 97 requires specific caution statements to be present on label for the different
drug schedules.
Prescription drugs in India are those that fall under two schedules of the Drug and
Cosmetics Rules, 1945 :
– Schedule H
– Schedule X
But drugs falling under Schedule G require the following mandatory text on the label:
“Caution: It is dangerous to take this preparation except under medical supervision”.
www.DuloMix.com
For Allopathy
www.DuloMix.com
For Ayurvedic, Siddha, Unani, Homoepathy and Cosmetics
www.DuloMix.com
Drugs and Cosmetics (Amendment) Act, 2008
Salient features of the Act:-
➢ Substantial enhancement in punishment
➢ Life imprisonment for offenders involved in manufacture, sale and distribution of
spurious and adulterated drug likely to cause grievous hurt
➢ Minimum punishment of seven years which may extend to life imprisonment
➢ Provision for compensation to affected person
www.DuloMix.com
Drugs Manufacturing License
Own License (Form) • Loan License (Form)
Drugs (25 & 28) – Drugs (25A & 28A)
Cosmetics (32) – Cosmetics (32A)
Homeopathic (25C) – Ayurvedic (25E)
Ayurvedic (25D)
Blood Bank (28C)
www.DuloMix.com
Allopathic License (25, 28, 28C)
▪Condition of License
❑Premises
❑Technical Staff
❑Plant & Machinery
❑Documents
www.DuloMix.com
Trading License
Allopathic
Retailer – Form 20, 21 & 20C (Homeopathic)
Wholesaler – Form 20B, 21B & 20D (Homo.)
Note –
No trading license for sale of Ayurvedic Drugs as per Drugs & Cosmetics Act.
No trading license required for sale of cosmetics.
Documents
Requisite Drugs Trading License
Premises/ ownership document of premises
Pharmacist or Competent person.
Partnership deed/Memorandum of Article etc
Pharmacist appointment & acceptance letter
Refrigerator purchase receipt www.DuloMix.com
Summary
•Classes of drugs prohibited to be sold includes wholesale of biological (C/C1)
•Wholesale of other than those specified in C/C1 and X
•Restricted license is 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
•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