April 4, 2020 2:30:57 am
TO EXPEDITE clearances to manufacturers of bulk drugs and intermediates meant for treating COVID-19, the Environment Ministry has exempted such projects from Environment Impact Assessment (EIA) till September 30 as an interim measure.
“All proposals for projects or activities in respect of Active Pharmaceutical Ingredients (API), received up to the 30th September 2020, shall be appraised as Category ‘B2’ projects, provided that any subsequent amendment or expansion or change in product mix, after the 30th September 2020, shall be considered as per the provisions in force at that time,” the Ministry said in a notification dated March 27.
Rules notified under the Environment Protection Act (1986) classify projects into three categories. Projects under Category A are appraised by the Ministry, and those under category B by states. Projects exempted from EIA and public hearings are classified under Category B2.
Underlining that the Ministry “deems it necessary to expedite the prior Environmental Clearances to the projects or activities in respect of bulk drugs and intermediates,” the notification said that drug production and availability “to reduce the impact of the Novel Corona Virus (COVID-19) are to be ensured” as part of a “comprehensive and robust system” to handle the outbreak.
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