Incoming and Outgoing Shipments in 1 STEP Using Odoo 17
Package Insert
1. Package Insert
Dr. Pankaj Kumar Gupta,
Assistant Professor,
Department of Pharmacology,
ESIC Medical College & Hospital, Faridabad
2. Concept of Package Insert
• Package insert is a document, approved by the
administrative licensing authority, which is
provided with the package of a drug.
• A package insert, primarily directed at the
prescribers, is intended to provide information
for the safe and effective use of the respective
drug. It is also known as Prescription drug
label, Prescribing information, etc
3. Regulatory Requirement
• In India, the concept of package insert is
governed by the ‘Drugs and Cosmetics Act
(1940) and Rules (1945)’.
• Section 6 of Schedule D (II) of the Rules lists
the headings according to which information
should be provided in the package inserts.
4. Schedule D
• ‘Section 6.2’ mandates that the package insert must be
in ‘English’ and must include information on
Therapeutic indications
Posology (dosage)
Method of administration
Contraindications
Special warnings and precautions
Drug interactions
Contra-indications
In pregnancy and lactation
Effects on ability to drive and use machines
Undesirable effects
Antidote for overdosing
5. Schedule D
• ‘Section 6.3’ mandates pharmaceutical
information on
List of excipients
Incompatibilities
Shelf life as packaged, after dilution or reconstitution, or
after first opening the container
Special precautions for storage
Nature and specification of container
Instruction for use/handling
6. Significance of package insert
• To provide information for the safe and effective use
of the prescription drug:
– For the Patients (*Patient Information Leaflet)
– For the Healthcare professionals (Doctor, nurses,
pharmacists etc.)
*Patient Information Leaflet- a separate document written in nontechnical language
and intended for the patient