Last Updated on December 26, 2023 by The Health Master
Indian Pharmacopoeia Commission
The Indian Pharmacopoeia Commission (IPC) has added seven new veterinary monographs and eight new chemical monographs to the Indian Pharmacopoeia (IP) 2022 with the aim of promoting animal health and public health in the country.
The newly released veterinary monographs include:
- Carprofen tablets,
- Pimobendan,
- Pimobendan capsules,
- Selamectin,
- Tilmicosin,
- Tilmicosin injection,
- Triclabendazole.
The IPC has sought feedback from stakeholders on the same within 45 days.
Besides this, there are new monographs of veterinary chemicals referred to from volume II and volume III of the Indian Pharmacopoeia, which include:
- Aspirin tablets/Bolus,
- Carboprost tromethamine,
- Carboprost tromethamine injection,
- Clopidogrel bisulphate,
- Diclofenac injection,
- Ketamine hydrochloride,
- Ketamine injection,
- Propofol,
- Propofol injection,
- Quiniodochlor.
Stakeholders have also been asked by the commission to share their feedback on these veterinary monographs.
Furthermore, the IPC also sought stakeholders’ suggestions on eight new chemical monographs, which include:
- Aceclofenac and paracetamol tablets,
- Azacitidine for injection,
- Ethamsylate,
- Lactulose solution,
- Atropine ophthalmic solution,
- Moxifloxacin tablets,
- Remogliflozin,
- Remogliflozin tablets.
A pharmacopoeial monograph provides a reliable basis for making an independent and objective judgement as to the quality of a pharmaceutical substance.
The IP 2022 has:
- 265 chemical monographs,
- 47 vaccine monographs,
- 17 vitamins, minerals, amino acids, fatty acids monographs,
- 7 phytopharmaceutical monographs,
- 43 monographs of herbs and herbal products,
- 14 monographs of blood and blood-related products,
- 6 biotechnology-derived therapeutic product monographs,
- 14 veterinary monographs.
There are 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. 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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