Amid Covid-19, govt relaxes green norms for drug firms till December 31 | India News
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NEW DELHI: Amid continued threat of Covid-19 pandemic and possibility of its third wave, the Centre has exempted drug manufacturers from stringent environmental clearance processes till December 31.
Under the exemption, notified by the environment ministry on Friday, all such proposals will be appraised for speedy green clearances by putting activities relating to ‘active pharmaceutical ingredients’ (API) under ‘B2’ category projects.
Since projects under ‘B2’ category do not require environment impact assessment and public hearings, drug manufacturers can get speedy green clearance. The flexibility may help domestic drug manufacturers become 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 Active Pharmaceutical Ingredients, received from 16th July, 2021 to 31st December, 2021, shall be appraised as Category ‘B2’ projects,” said the notification under the Environment (Protection) Act, 1986. At the same time, it clarified that all such projects/activities after December 31 would be considered as per provisions in force at that time.
The ministry in its notification justified the liberal approach in granting green clearance due to the existing Covid-19 threat. It said, “The Centre 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 further extension of the time period beyond the earlier one which expired on March 30 as “there is a continued requirement to expedite drug manufacturing” in view of the outbreak of the second wave of the pandemic.
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.
Under the exemption, notified by the environment ministry on Friday, all such proposals will be appraised for speedy green clearances by putting activities relating to ‘active pharmaceutical ingredients’ (API) under ‘B2’ category projects.
Since projects under ‘B2’ category do not require environment impact assessment and public hearings, drug manufacturers can get speedy green clearance. The flexibility may help domestic drug manufacturers become 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 Active Pharmaceutical Ingredients, received from 16th July, 2021 to 31st December, 2021, shall be appraised as Category ‘B2’ projects,” said the notification under the Environment (Protection) Act, 1986. At the same time, it clarified that all such projects/activities after December 31 would be considered as per provisions in force at that time.
The ministry in its notification justified the liberal approach in granting green clearance due to the existing Covid-19 threat. It said, “The Centre 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 further extension of the time period beyond the earlier one which expired on March 30 as “there is a continued requirement to expedite drug manufacturing” in view of the outbreak of the second wave of the pandemic.
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.
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