Last Updated on March 17, 2021 by The Health Master
The Indian Pharmacopoeia Commission (IPC) has issued notices to the Drug Controller General of India (DCGI), State Licensing Authorities (SLAs), government analysts and drug testing laboratories towards omission of monographs of lorcaserin hydrochloride hemihydrate and lorcaserin tablets from the Indian Pharmacopoeia (IP).
To read or download the notice from IPC, click here
The Commission has urged all stakeholders in the country to bring the same to the notice of all authorities under their control for compliance on the same.
In the notice, IPC secretary-cum-scientific director Dr Rajeev Singh Raghuvanshi stated, “Based on the safety clinical trial and possible risk of cancer associated with lorcaserin, manufacturers have voluntarily withdrawn the said product from the US Market.
Subsequently to safeguard the public health, the manufacturer has also voluntarily withdrawn the distributed product from the Indian market. In view of the same, monographs of lorcaserin hydrochloride hemihydrate and lorcaserin tablets are omitted from the IP 2018.”
IPC recently released the Guidance Document for Drafting and Formatting of Monographs for IP to guide the stakeholders including drug manufacturers, analysts and academicians on drafting of drug monographs before their inclusion in the Indian Pharmacopoeia.
In this Guidance Document, emphasis has been given to elaborate IP monographs under the categories of active pharmaceutical ingredients (APIs), dosage forms and pharmaceutics.
IP is a compilation of official standards for drugs manufactured and/or marketed in India. A monograph states the quality or test parameters, the acceptance criteria and details of the tests that are to be performed to determine compliance with the criteria.
In other words, a pharmacopoeial monograph provides a reliable basis for making an independent and objective judgement as to the quality of a pharmaceutical substance.
As IP standards are statutory, it is important that the contents of monographs are unambiguous, acceptance criteria are clearly spelt out and the methods of evaluation provide all the details for carrying out the tests and assays, including the equipment, reagents and other ancillary materials that are to be used.
The guidance document is a guide for drafting and elaboration of the monographs to the stakeholders of the IP especially industries, testing laboratories and academicians. The aim is to provide guidance for drafting clear unambiguous texts, with similar requirements presented in the same way in each monograph.
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