Last Updated on December 30, 2023 by The Health Master
The drug industry has appealed to Indian Pharmacopoeia Commission (IPC) to defer the implementation of Indian Pharmacopoeia 2018 Addendum 2021 by six months in the wake of current situation of C-19 pandemic making it extremely difficult for the industry to release products in market complying with monographs of IP 2018 Addendum 2021.
The Addendum 2021 to IP 2018 is slated to be implemented from October 1, 2021. It contains a total of 66 new drug monographs (including 59 chemical, 5 herbal products, and 2 blood-related products) and 4 new general chapters.
In addition, a total of 260 monograph amendments have also been included in IP Addendum 2021 that would further upgrade the quality of drug standards included in the IP.
Accordingly, there is a huge impact on pharma industry with need of evaluation or reformulation for number of products which cannot be completed within the current timeline of October 1, 2021, said Indian Drug Manufacturers’ Association (IDMA).
IDMA has recently submitted a representation to the Secretary-Cum-Scientific Director, IPC, the Drugs Controller General of India (DCGI), Directorate General of Health Services (DGHS) urging them to provide additional transition time of six months for implementation of Indian Pharmacopoeia 2018 Addendum 2021, that is March 1, 2022, as launch of products in market in compliance with monographs of IP 2018 Addendum 2021 is very challenging due to C-19 pandemic.
Before releasing a product in market with IP claim, lot of work is done by manufacturers within the organization and outside of it. Starting from procurement of required materials or equipments, testing as per monograph and in case needed, reformulation of product to make it compliant to monograph of IP.
Then, printing of label which takes minimum 20 days. Also, in these struggling days, there will also be destruction of packaging inventory for products requiring revision in label claim, which will have financial and environmental impact and is not in national interest, stated Mahesh Doshi, national president, IDMA.
A number of drugmakers have already initiated the evaluation of monographs as appeared in this new edition. However, to evaluate, understand and then to implement the monographs of Indian Pharmacopoeia, will definitely take more efforts and time than usual in this difficult times.
Accordingly, extension is very much required for smooth transition by pharma manufactures to maintain business continuity, ensure availability of safe and essential medicines in India market, he said.
India has been among the worst hit countries in terms of absolute C-19 numbers. All the companies are putting their efforts to fight and provide the medicines to save lives from C-19. While having the goal of providing sufficient quality medicines in market, all pharma companies are also facing the practical issue of working with limited manpower.
To overcome shortage of medicines in market, all pharma companies have shifted their focus to develop C-19 specific medicines at the earliest to meet the market demands. Additionally, the industry also needs to be prepared enough with medicines and supplies in case the next wave strikes the country.
Hence in the interest of continuous availability of life-saving medicines to the Indian patients, the industry body appealed to IPC and DCGI to issue a notice with change in effective date of IP 2018 addendum 2021 as March 1, 2022 i.e., granting extension of at least another six months.
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