Since projects under ‘B2’ category do not require environment impact assessment (EIA) and public hearings, drug manufacturers can get speedy green clearance. The flexibility is believed will help domestic drug manufacturers self-reliant in the manufacture of APIs which are used as raw materials for producing medicines.
“All proposals for projects or activities in respect of API, received from 16th July, 2021 to 31st December, 2021, shall be appraised as Category ‘B2’ projects,” said the ministry’s notification under the Environment (Protection) Act, 1986.
It, at the same time, clarified that all projects/activities after December 31 would be considered as per the provisions in force at that time.
The ministry in its notification justified the liberal approach in granting green clearance. It said, “The central government deems it necessary to provide another window (of exemption) in view of the second wave of Covid-19 pandemic and continued requirement of expeditious drug manufacturing.”
It noted the ministry had received requests for extension of the time period beyond the earlier one which expired on March 30 as “there is a continued requirement to expedite drug manufacturing”.
Rules notified under the 1986 Act classify projects into three categories – category ‘A’ which needs to be appraised by the ministry, category ‘B’ where states need to give clearance and category ‘B2’ which exempts projects from EIA and public hearing.
Though the ministry had earlier issued notification twice while granting the exemption to drug manufacturers, there was no such specific order beyond March 30.