After its move to grant “out of turn” clearances to bulk drug projects against the backdrop of surging Covid-19 cases, the Centre has gone a step further to ramp up the availability of drugs by making an amendment to Environment Impact Assessment (EIA) Notification 2006.
“All projects or activities in respect of bulk drugs and intermediates, manufactured for addressing various ailments, have been re-categorised from the existing Category ‘A’ to ‘B2’ category. Projects falling under Category B2 are exempted from requirement of collection of Base line data, EIA Studies and public consultation,” the Ministry of Environment, Forest and Climate Change said in a statement.
The move is aimed at addressing the unprecedented situation arising from global outbreak of COVID-19. Within two weeks, more than 100 proposals have been received under this category, which are at different levels of decision making by the concerned regulatory authorities in the states.
“The re-categorization of such proposals has been done to facilitate decentralization of appraisal to State Level so as to fast track the process. This step is with a view to help in increasing the availability of the important medicines/ drugs in the country within short span of time. This amendment is applicable to all proposals received up to 30th September 2020. The states have also been issued advisories to expeditiously process such proposals.
“Further, to ensure expeditious disposal of the proposals within given time-line, Ministry has also advised states to use information technology e.g. video conference, considering the fact that in view of the prevailing situation on ground, appraisal of proposals may not be possible through physical meetings, the MoEF stated.
Earlier, the Centre had decided to expedite clearances to bulk drug projects by considering them ‘out of turn’ ensure overall preparedness and availability of drugs to reduce the impact of the outbreak.