Last Updated on October 10, 2024 by The Health Master
The Indian Pharmacopoeia Commission (IPC) has clarified that the General Chapter on ‘Uniformity of Dosage Units’ recently added to Indian Pharmacopoeia (IP) 2022 is not mentioned in individual monographs and hence it is not mandatory for the drug industry to adhere to the requirement.
The IPC has recently introduced a General Chapter on ‘Uniformity of Dosage Units’ in harmonization with other pharmacopoeias under section 2.5.4. (i) on page 361, Volume I of IP 2022.
This chapter is presently introduced in IP for information and awareness of the stakeholders and is not referred to in individual monographs and therefore remains a non-mandatory requirement, said Dr. Rajeev Singh Raghuvanshi, secretary-cum-scientific director, IPC.
However, stakeholders may adopt this chapter before its implementation is made mandatory by the IPC, added Dr. Raghuvanshi.
Dosage units are defined as dosage forms containing a single dose or a part of a dose of a drug substance in each unit. IP 2022 contains 33 dosage forms.
The term “uniformity of dosage unit” is defined as the degree of uniformity in the amount of the drug substance among dosage units.
To ensure the consistency of dosage units, each unit in a batch should have a drug substance contained within a narrow range around the label claim.
The IP 2022 released by the IPC last month contains a total of 92 new monographs including:
- 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,
- 7 phytopharmaceutical ingredients.
This has led to the total number of 3,152 monographs in the current edition of IP.
In addition, 12 new general chapters have also been introduced. 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.
The standards of the IP are authoritative and legally enforceable. It intends to help in the licensing of manufacturing, inspection, and distribution of medicines in our country.
Drugs manufactured and marketed in India are required to adhere to the standards prescribed in the IP.
Failure to adhere to the standards specified under IP may render the drug, not of standard quality and may result in penalties under the Drugs and Cosmetics Act.
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