Last Updated on October 2, 2024 by The Health Master
The Indian Pharmacopoeia Commission (IPC) is set to digitize the Indian Pharmacopoeia (IP) to increase its coverage and facilitate its simple use.
The ninth edition of IP, launched on July 1 this year by Union Minister of Health and Family Welfare Dr Mansukh Mandaviya, contains four heavy volumes.
Digitization will help stakeholders access IP from anywhere, saving them time and money.
IPC, on November 23, 2022, invited tenders on the government e-marketplace (GeM portal) from eligible and qualified IT firms related to online portal development, application development, data digitization, online content management, etc. for the project “Digitization of Indian Pharmacopoeia.”
The bid is open from November 22, 2022. The last date for submission of the bid is December 13, 2022.
IP 2022 is quite bulky. It contains:
- 92 new monographs for drugs,
- 12 new general chapters,
- 1,245 monographs for formulations,
- 930 monographs for active pharmaceutical ingredients (APIs),
- as well as dissolution specifications for all prolonged-release formulations.
To date, there are no such specifications for prolonged-release formulations. It will impact public health in the long term.
Of the 92 new monographs, there are:
- 60 chemicals,
- 21 vitamins, minerals, amino acids, fatty acids, etc.,
- 3 biotechnology-derived therapeutic products,
- 4 human vaccines,
- 2 blood and blood-related products,
- 2 herbs and herbal-related products, and
- 7 phytopharmaceutical ingredient category monographs.
Besides this, IP 2022 also contains 652 pharma reference substances covering 70 per cent requirement of reference materials used for quality control in the country.
Currently, there are 300 impurity standards in IP which are crucial for managing pharmaceutical quality.
It also includes remdesivir API and injection monographs, favipiravir API and tablets monographs, 2DG API & powder & sachet monographs, and Rapid microbiological testing—draft chapter.
This has led to a total number of 3,152 monographs in the current edition of IP.
Several monographs and general chapters have also been revised to update them as per current global requirements and to harmonize with other pharmacopoeias like USP, BP, EP, etc.
The harmonization of standards with global standards is expected to help IP get recognized and accepted in foreign countries.
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