Time extension for B2 category product - reg.

July 16, 2021

Notification S.O. 2859 (E)

Whereas, the Central Government, in exercise of its powers by sub-section (1) and clause (v) of sub-section (2) of section 3 of the Environment (Protection) Act, 1986 has published the Environment Impact Assessment Notification, 2006 vide number S.O. 1533(E), dated the 14th September, 2006, (hereinafter referred to as the said notification) making the requirement of prior environmental clearance from the concerned regulatory authority mandatory for all new projects or activities listed in the Schedule to the said notification, their expansion and modernisation and/or change in product mix, as the case may be, before any construction work or preparation of land by the project management except for securing the land;

And Whereas, in view of the CoVID-19 pandemic and the requirement to expedite drug manufacturing the ‘said notification’ was amended vide notification no. S.O. 1223(E), dated 27th March, 2020 wherein it was notified that all proposals for projects or activities in respect of Active Pharmaceutical Ingredients (API), received up to 30th September, 2020, shall be appraised as Category ‘B2’ projects. Subsequently, the above mentioned period was extended by six months from 30th September, 2020 to 30th March, 2021 vide notification no. S.O. 3636(E) dated 15th October, 2020;

And Whereas, in view of the outbreak of the second wave of COVID-19 pandemic, the Central Government has received requests for further extension of the time period beyond 30th March, 2021 as there is a continued requirement to expedite drug manufacturing;

And Whereas, the Central Government deems it necessary to provide another window in view of the second wave of COVID-19 pandemic and continued requirement of expeditious drug manufacturing;

Now, Therefore, in exercise of powers conferred by sub-section (1) and clause (v) of sub-section (2) of section 3 of the Environment (Protection) Act, 1986 (29 of 1986), the Central Government, hereby makes following further amendments in the said notification, namely:-

In the said notification, in the Schedule, against item 5(f), in column (5), for the third paragraph the following paragraph shall be substituted, namely:-

“All proposals for projects or activities in respect of Active Pharmaceutical Ingredients (API), received from 16th July, 2021 to 31st December, 2021, shall be appraised, as Category ‘B2’ projects, provided that any subsequent amendment or expansion or change in product mix, after the 31st December, 2021, shall be considered as per the provisions in force at that time.”

F.No. 22-25/2020-IA .II

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