In a bid to ramp up production of various drugs amid the looming threat of the third wave of Covid-19 pandemic, the Central government has extended the exemption of strict environmental clearance procedures for drug manufacturers till December 31, 2021.

The drug firms have been exempted from strict environmental process since March 27, 2020 when Union ministry of environment, forest and climate change (MoEFCC) had reclassified bulk drugs and intermediates from category A to category B2 through a notification amending Environment Impact Assessment (EIA) Notification 2006. Projects falling under category B2 are exempted from requirement of collection of baseline data, EIA studies and public consultation.

The re-categorization of such proposals has been done to facilitate decentralization of appraisal to state level so as to fast track the process in view of the Covid-19 pandemic and the requirement to expedite drug manufacturing. As per the notification issued by the MoEFCC on March 27, 2020, all proposals for projects or activities in respect of active pharmaceutical ingredients (API), received up to September 30, 2020, shall be appraised as Category ‘B2’ projects. Subsequently, this was extended by six months from September 30, 2020 to March 30, 2021 vide notification no. S.O. 3636(E) dated October 15, 2020.

The central government received requests for further extension of the time period beyond March, 30, 2021 as there was a continued requirement to expedite drug manufacturing in view of the outbreak of the second wave of Covid-19 pandemic. With the fear of third wave of Covid-19 looming large and continued requirement of expeditious drug manufacturing, the MoEFCC on July 16, 2021 came out with a notification stating that all proposals for projects or activities in respect of active pharmaceutical ingredients (API), received from July 16, 2021 to December 31, 2021, shall be appraised, as category ‘B2’ projects.