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Industry urges IPC to defer implementation of monograph of Ferrous Ascorbate IP 2018 addendum 2021 till June 2022
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Laxmi Yadav, Mumbai
January 27 , 2022
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In a bid to ensure availability and supply of Ferrous Ascorbate API and its formulation in domestic market amid rising cases of Covid-19 and its Omicron variant, the drug industry has urged the Indian Pharmacopoeia Commission (IPC) to defer the implementation of 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 not been able to successfully upgrade and validate their manufacturing to produce API that could comply to 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 request 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 surge in Covid-19 cases which has slowed down their operation.
This could lead to shortage of Ferrous Ascorbate API and its formulation in the domestic market, said the industry body.
IDMA therefore requested secretary-cum-scientific director, IPC to postpone the implementation of monograph for Ferrous Ascorbate – IP 2018 Addendum 2021 for a period of six months i.e. upto June 30, 2022.
This will give a little more time to the API manufacturers to complete their development and validation part and also enable the formulation manufacturers to upgrade their formulation based on the revised API specifications, said the industry body.
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