analysis of completeness of drug package inserts available in india

Doctors often prescribe some introduction drugs to treat diseases.
Most of these drugs are manufactured by pharmaceutical companies according to industry standards in the manufacturing industry.
These drugs produced by pharmaceutical companies contain information about the drugs in the form of packaging inserts (PI)
According to the provisions of the Drug and Cosmetic rules (1945). [1]
PIs is a major source of information on medicines for doctors, pharmacists and patients.
These PIs are also known by different names, such as packaging, labeling of prescription drugs, prescription information ,[2]
Prescription drug instructions, professional labels, etc.
PI was introduced for the first time in the 1960 and 1970 s for iso adrenaline inhaler after oral contraceptives and other drugs. [3]
The word PI should not be fused with the word drug labeling, and the word drug labeling means all the printed information that comes with the drug, including labels, packaging, and PI. [4]
The packaging flyer is a leaflet containing information about the end user of the drug. [5,6]
Other definitions of the Pi include that it is a document that is provided in the form of printed leaflets approved by the drug regulatory authority and provided in conjunction with drug packaging.
PIs in India are regulated by Drug and Cosmetic rules (1945)section 6. 2 and 6. 3 of Schedule D. Section 6.
2 it is required that PIs should be in English and must include information on treatment indications, administration methods, taboos, special warnings and preventive measures, drug interactions, pregnancy and lactation taboos, the ability to drive and use the machine, the adverse effects, and the antidote to excessive use. Section 6.
3 include information on medicines for excipients labeling. [1]
If the PI contains approval, correct and basic information about the drug and is regularly updated before and when clinical data are available, the PI is considered complete. [2]
In addition, it should be written in an easy-to-understand language, containing essential information related to the drug, is based on evidence and does not falsely promote the drug based on false statements and commitments. [2]
The Drug and Cosmetic rule fails to specify the end user of the PI, however, it appears to be for health
Nursing Practitioners
By providing reliable, accurate and necessary information about drugs, PIs is an important source of information about drugs for health
Thus reducing and avoiding medical errors.
They bridge the gap between the prescribing and the patient [7-9]
Improve Medication and patient compliance. [10,11]
According to a study by Joubert and Skene, the various reasons for consulting PI are information about adverse effects (64%)
, Instructions and mechanisms of action (33%). [11]
Different countries have developed their own guidelines on the information that should be included in the PIs, and the terms for the name of the PIs are slightly different.
S.  Food and Drug Administration calls them \"patient PI\", while in the EU they are called \"patient information leaflets \". \" [2]
PIs has received due attention in developed countries, but still does not receive full attention in developing countries such as India, and these PIs still have room for improvement. [12]
In developing countries, PIs remains an important source of drug information, even if doctors prescribe it, as they sometimes have limited access to drug informationto-
Date details of the new drug.
Even from the patient\'s point of view, PIs is an important source of drug information, because many patients tend to use it on counter drugs, and PIs helps to provide patients with the correct information about the drug.
Although many attempts have been made to make authoritative people aware of the current lack of PI information available at the national and international levels, there are still many deficiencies in the current PI design regulations available, especially in developing countries such as India. [13-17]
Therefore, this studywas further emphasizes the integrity of these differential presentlyavailable PIs measurements (
Availability of key information)
PIs in India scored based on a set of standard criteria and scored based on the score obtained.
Collection of materials and methods for PIs this study is a cross-study
Segmentation, observation, and prospective studies.
In the months of January, a total of 55 PIs were collected from various pharmacies-February 2017.
5 of them were duplicated and therefore not included in the study.
Analysis of PIs content these PIs analyze the presentation and completeness of clinical and pharmaceutical preparations in accordance with the standards set out in section 6 of Indian Drug and Cosmetics Rule 1945. 2 and 6. 3 of Schedule D.
The following survey was conducted on each of these PIs :[18]
Easy generic of active ingredients, approved generic name, active ingredient content of each dosage form, List of excipients, indications for treatment, possibilities and methods of administration, taboos, special warnings and pregnancy and lactation, pediatric and elderly indications, special circumstances and taboos, effects on the ability to drive and use machines, adverse effects, excessive antidote, drug information, storage information, instructions for use and handling, shelf life, the date of the last update of the information, the name and address of the manufacturer/distributor, should emphasize the provision of complete information on the requirements, retail price of the drug and references.
PIs scores and scores are assigned 24 points for each of these PIs based on the criteria set out in Drug and Cosmetic rule 1945.