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
components:-
Ø Container/ Carton Label
Ø Package Insert
- 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.
- 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
Pharmacopoeia. - for
drugs included in the National Formulary of India, the name or synonym
specified therein followed by the letters ‘N.F.I.’
- Net
Quantity of contents
- The
content of active ingredients
- Name
and Address of manufacturer - Batch
or lot number(Batch No.)
- Manufacturing
license number (“Mfg. Lic. No.”)
- Import
License No. (if applicable):- the no. of license under which the drug
is imported, preceded by words “Import Lic. No.”
- Manufacturing
date, Expiry date and Storage conditions
- Other
Specific Requirements
- Physician
Sample – ‘Not to be sold’. - 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
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
