One of the easily available sources of drug information is package insert (PI). The PI is the primary source of drug information. These package inserts were analyzed for the content of clinically important information in various sections. After detailed deliberation the committee recommended that CDSCO should request the State Drugs Controllers to direct the manufacturers of Proton Pump Inhibitors to incorporate Acute Kidney Injury as an Adverse Drug Reaction in the package insert leaflet of the drugs. Around 130 package inserts were collected from pharmacies located at different areas of Bangalore. Vaccine Trade Name: MenAfriVac Vaccine Type: Meningococcal A conjugate Manufacturer: Serum Institute of India Ltd, India Country of Manufacture: India Date of prequalification: 23 June 2010 NRA of Record: CDSCO Product Description. Culture of the scraping of the lesional skin yielded Trichophyton rubrum in two cases and Epidermophyton floccosum in the other two. Additionally, only one (5%) imported and no (0%) local PIs mentioned the duration of therapy. Thus, there is a need for revising and improving the traditional concept of package inserts in India, to make it more effective in serving its purpose. Stages involved in Drug importation: 1. Package inserts are printed leaflets accompanying marketed drug products and contain information approved by the regulatory agencies.

The purpose of this study was to evaluate the completeness of PIs supplied with the 100 top-selling medications in Iran. Often unread they have potential educational and legal implications. PIs oriented toward educating the patient are the need of the hour.Percentage of package inserts by Indian and Multinational Companies.Percentage of various classes of package inserts (n=159).Package inserts that followed criteria lay down by Drug and Cosmetic Rules, 1945.All figure content in this area was uploaded by Roslin JoseMedication package inserts: how far do they adhere to the guidelines?.pdfAll content in this area was uploaded by Roslin Jose on May 06, 2019 Medication package inserts: how far do they adhere to the guideMedication package inserts: how far do they adhere to the guidelines?.pdfNeha D et al. The mass media were accorded little prominence. To assess the presentation and completeness of clinically important information provided in the currently available package inserts in India. Small font size was a common problem. subject to censure and international abolition campaigns. Public users are able to search the site without a subscription. All of them included the brand name, active ingredients, indications, directions for use, adverse drug reactions, drug–drug interactions, pregnancy and lactation considerations, and storage.
Package inserts (PIs) provide information for the safe and effective use of medication. The application for import of new drugs including their fixed dose period of time are to be regarded as new drug.Permission for the import of new drugs This study was undertaken to assess the presentation and completeness of clinical information provided in the currently available package inserts for anti-diabetic, anti-hypertensive and hypolipedemic drugs in India. of medicine has to be imported from other countries.

Aims and Objectives: The aim of this study is to evaluate the completeness of the presently available PIs and grade them. Results were expressed as percentage of total responses for that question. sale or to undertake clinical trials:No New drugs are allowed to be The first part was the criteria required by the IFDA, mentioned in Chapter 16 of the Pharmaceutical Regulations and Instructions provided by the IFDA.

It was observed that the PIs were inadequate in many aspects. The results were expressed as absolute numbers and percentages. Conclusions The new drug is a medication or therapy that has not been used earlier in clinical practice to treat a disease. & Guidelines for permission to import and/or manufacture of new drugs for
Preliminary analyses revealed that most package inserts did contain information under headings, such as, therapeutic indications, contraindications, undesirable effects, etc., listed in the Drugs and Cosmetics Rules 1945. The inserts available today are mostly physician oriented. CDSCO requested its state counterparts to direct the manufacturers of SGLT2 inhibitor class drugs such as Canagliflozin, Dapagliflozin, Empagliflozin, etc. 2017 Jan;6(1):133-136Neha D et al. They were analysed based on the criteria mentioned in Schedule D of Drug and Cosmetic act 1945.Results: Out of 192 PIs, 33 were repeated and so were not taken into account. safety, efficacy or tolerance of such new drug or Package inserts (PIs) as a reliable reference for patients and health care providers should provide accurate, complete and up-to-date information. A total of 310 drugs were checked for package inserts (PI) and 192 PI’s were collected. Great emphasis was placed on the adequate provision of information, and this appears to be a crucial function in an adequate doctor-patient relationship. The best approach going forward would be further research utilizing networks of DSD teams where all stakeholders, including advocacy groups, are included in the research process. Furthermore, the maximum dose was not indicated in 90% of imported and 86.7% of local PIs.

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