Salient features of Indian Pharmacopoeia
The actual process of publishing the first Pharmacopoeia started in the year 1944 under the chairmanship of Col. R. N. Chopra. The I. P. list was first published in the year 1946 and was put forth for approval. The titles are suffixed with the respective years of publication, e.g. IP 1996.
Salient features of Indian Pharmacopoeia 2018 include
- General Chemical tests and TLC for identification of an article have been almost eliminated and more specific infrared, ultraviolet spectrophotometer and HPLC tests have been given emphasis.
- The use of chromatographic methods has been greatly extended to cope with the need for more specificity in assays and in particular, in assessing the nature and extent of impurities in ingredients and products.
- Most of the existing Assays and Related Substances Test methods are upgraded by liquid chromatographic technique in view to harmonizing with other International Pharmacopoeia.
- Pyrogen tests have been replaced by Bacterial Endotoxin tests (BET) in parenteral preparations and other monographs
- 53 New Fixed-Dose Combination (FDC) combination monographs have been included, out of which 25 FDC monographs are not available in any Pharmacopoeia.
- General Chapters on Volumetric Glassware, Conductivity, Dissolution test, Disintegration test, Dimensions of Hard Gelatin Capsule Shells etc. have been revised.
- For Controlling the Microbial quality of all the medicinal products general chapter on
- Maintenance, Identification, Preservation and Disposal of Microorganism have been revised.
New Additions
• 170 Chemical Monographs
15 Herbal Monographs
Blood and Blood-related products: 10 Monographs
6 Monographs on Biotechnology derived therapeutic products
Radiopharmaceuticals: 3 Monographs
2 Monographs on Vaccines and Immunosera for Human use
14 Monographs on Veterinary Non Biologicals
The Indian Pharmacopoeia (IP) is the official document that defines the standards for drugs in India. It contains detailed information on the quality, purity, and potency of medicines available in the country. Some of the salient features of the Indian Pharmacopoeia are:
- Comprehensive Monographs: The IP contains monographs on various drugs, including their chemical structure, physical characteristics, and methods of analysis.
- Quality Standards: The IP sets the quality standards for medicines, including their active ingredient content, impurities, and packaging requirements.
- Evidence-based Approach: The IP uses the latest scientific data and research to establish its standards and guidelines.
- User-friendly Format: The IP is designed to be user-friendly, with clear and concise information presented in an easy-to-read format.
- Regular Updation: The IP is regularly updated to ensure that it reflects the latest scientific advancements and changes in the industry.
- Legal Recognition: The IP is legally recognized in India and its standards are enforced by the regulatory authorities.
- Essential for Licensing: The IP is an essential reference for manufacturers, suppliers, and regulators of medicines, as compliance with its standards is a requirement for licensing and selling drugs in India.
In conclusion, the Indian Pharmacopoeia plays a crucial role in ensuring the quality, safety, and efficacy of drugs in India, and is an important tool for the pharmaceutical industry, regulatory authorities, and healthcare professionals.
Editions of Indian Pharmacopoeia
| Edition | Year | Volumes | Addendum/Supplement |
|---|---|---|---|
| 1st Edition | 1955 | – | Supplement 1960 |
| 2nd Edition | 1966 | – | Supplement 1975 |
| 3rd Edition | 1985 | 2 | Addendum 1989 |
| Addendum 1991 | |||
| 4th Edition | 1996 | 2 | Addendum 2000 |
| Vet Supplement 2000 | |||
| Addendum 2002 | |||
| Addendum 2005 | |||
| 5th Edition | 2007 | 3 | Addendum 2008 |
| 6th Edition | 2010 | 3 | Addendum 2012 |
| 7th Edition | 2014 | 4 | Addendum 2015 |
| Addendum 2016 | |||
| 8th Edition | 2018 | 4 | Addendum 2019 |
| Addendum 2021 |
Read more about What is Pharmacopoeia? What is International Pharmacopoeia?
Suggested readings:
Recommended readings:
First Year B Pharmacy Syllabus
B Pharmacy Subjects List for F Y B Pharm include following Theory and Lab
