Labeling & Packaging of Drugs as per Drugs and cosmetic act

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.

Labeling in India

All labels of a drug should conform as per the
specifications under the Drugs and Cosmetics Rules 1945.

Ø  That
no person sell or distribute any drug unless it is labeled in accordance with
the Rules (Rule 95 of D&C Act).

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.

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.

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.

Components of Labeling

The prescription drug labeling consists of following

Ø      Container/ Carton Label

Ø      Package Insert

  1.   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

  • 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 :- 

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

  • for
    drugs included in the National Formulary of India, the name or synonym
    specified therein followed by the letters ‘N.F.I.’

  1. Net
    Quantity of contents

  1. The
    content of active ingredients

  1. Name
    and Address of manufacturer

  2. Batch
    or lot number(Batch No.)

  1. Manufacturing
    license number (“Mfg. Lic. No.”)

  1. Import
    License No.
    (if applicable):- the no. of license under which the drug
    is imported, preceded by words “Import Lic. No.”

  1. Manufacturing
    date, Expiry date and Storage conditions

  1. Other
    Specific Requirements

  1. Physician
    Sample – ‘Not to be sold’.

  2. Alcohol

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
    )’ .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

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”.

For Allopathy

For Ayurvedic, Siddha, Unani, Homoepathy and Cosmetics

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