IPC extends implementation of IP 2018 Addendum 2021

The Addendum 2021 to IP 2018 was slated to be implemented from October 1, 2021.

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Last Updated on July 30, 2021 by The Health Master

Considering the impact of ongoing C-19 pandemic, the Indian Pharmacopoeia Commission (IPC) has extended implementation of Indian Pharmacopoeia 2018 Addendum 2021 by three months.

This comes after the drug industry’s appeal to IPC to defer the implementation of IP 2018 Addendum 2021 by six months in the wake of current situation of C-19 pandemic making it extremely difficult for the industry to launch products in market complying with monographs of IP 2018 Addendum 2021.

“Considering the impact of the current C-19 pandemic, a one time extension of three months in the effective date of Addendum 2021 to the IP 2018 is being provided to the stakeholders for implementation of the standards included therein. IP Addendum 2021 shall be effective from December 31, 2021,” said Dr Rajeev Singh Raghuvanshi, secretary cum scientific director, IPC in a notification on July 26, 2021.

IPC sent a notice to concerned stakeholders in this regard which included Drugs Controller General of India, all zonal offices and port offices of CDSCO, all state drug controllers, directors of central drugs laboratories, members of scientific body of IPC, government analysts, industry associations—IDMA, BDMA, OPPI, FSSAI, small scale industry associations.

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The Addendum 2021 to IP 2018 was slated to be implemented from October 1, 2021.

It comprises 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.

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Last month IDMA submitted a representation to IPC, DCGI, Directorate General of Health Services (DGHS) requesting 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.

In a bid to launch a product in market with IP claim, a lot of work needs to be done by drug makers ranging from procurement of required materials or equipment, testing as per monograph to reformulation of product to make it compliant to monograph of IP. Subsequently, printing of labels takes a 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.

Several drug firms have already started 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 effort and time than usual in these difficult times. Hence, extension is needed for smooth transition by pharma manufactures to maintain business continuity, ensure availability of safe and essential medicines in India market, stated Doshi.

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