ANALYSIS OF COMPLETENESS OF DRUG PACKAGE INSERTS AVAILABLE IN PHARMACIES OF CENTRAL INDIA

Manali M. Mahajan*, Sujata Dudhgaonkar, Swapnil N. Deshmukh, Mohini S. Mahatme, Sachin K. Hiware.

ABSTRACT

Accurate and reliable drug information is essential for safe and effective use of marketed products. Incomplete and incorrect product information may promote irrational prescribing and may have serious consequences, including disability and death .The primary source of drug information is a Package Insert (PI). Drug package insert is the bedrock of methods used to inform people about their medicines. It is a printed leaflet that contains information based on regulatory guidelines for the safe and effective use of a drug. It is also known as prescription drug label or prescribing information. A good PI contains the approved, essential and accurate information about a drug. It is written in a language that is not promotional, false or misleading. It is evidence-based and is updated time to time as relevant pre-clinical and clinical data becomes available.[1] In India, the concept of package insert is governed by the ‘Drugs and Cosmetics Act (1940) and Rules (1945). The section 6 of Schedule D (II) of the rules lists the headings according to which information should be provided in the PIs. The ‘Section 6.2’ mandates that the PIs must be in ‘English’ and provides information regarding therapeutic indications; posology and methods 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; and antidote for overdosing. The ‘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; and instruction for use / handling.[2]

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