Ministry of Environment, Forest and Climate Change vide a notification dated 16th July, 2021 has directed that 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 to ‘B2’ category. 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.
The projects categorized as ‘B2’ are to be appraised based on the application accompanied with pre-feasibility report and other relevant documents. There is no requirement for environment Impact Assessment (EIA) report or public consultation process for such projects.
The new decision is in the view of the second wave of COVID-19 pandemic and continued requirement of expeditious drug manufacturing.
