Last Updated on December 30, 2023 by The Health Master
In a bid to ensure availability and supply of Ferrous Ascorbate API and its formulation in the domestic market amid rising cases of C-19 and its Omicron variant, the drug industry has urged the Indian Pharmacopeia Commission (IPC) to defer the implementation of the monograph of Ferrous Ascorbate IP 2018 Addendum 2021 till June 30, 2022.
Ferrous Ascorbate is used to treat iron deficiencies in the body. Thus, it acts as a health supplement for those with low iron content in their diet.
Iron increases the production of red blood cells and haemoglobin. Vitamin C present in Ferrous Ascorbate aids in the effective and maximum absorption of dietary iron.
The recent disruption in pharmaceutical industry’s operations due to the pandemic has slowed down a lot of activities and it is trying to focus on manufacturing and maintaining the supply chain for essential medicines for India and the world.
Active pharmaceutical ingredient (API) manufacturers have yet to be able to successfully upgrade and validate their manufacturing to produce API that could comply with the newly published monograph of ferrous ascorbate listed in IP 2018 addendum 2021, with respect to the requirements for content of iron and ascorbic acid.
In this context, it might cause a temporary disruption in the availability of this API in the market, and this might disrupt availability of its formulations too.
The Indian Drug Manufacturers’ Association (IDMA) has received requests from some API manufacturers, showing incapability to upgrade and validate their facility to manufacture Ferrous Ascorbate API in compliance with its newly published monograph, which is listed in IP 2018 Addendum 2021, in the wake of a surge in C-19 cases which has slowed down their operation.
The industry body said this could lead to a shortage of ferrous ascorbate API and its formulation in the domestic market.
IDMA therefore requested the secretary-cum-scientific director, IPC to postpone the implementation of the monograph for ferrous ascorbate– IP 2018 Addendum 2021 for a period of six months, i.e., up to June 30, 2022.
This will give a little more time to the API manufacturers to complete their development and validation parts and also enable the formulation manufacturers to upgrade their formulations based on the revised API specifications, said the industry body.
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