States get over 100 proposal for bulk drugs/API production after MoEF decentralises process for green nod

Amid the coronavirus outbreak in the country, more than 100 proposals seeking green clearance for production of bulk drugs oractive pharmaceutical ingredients (API) have been received by states in the last two weeks after the Centre amended rules to expedite the process of giving environmental approval.

To address the unprecedented situation arising from the global outbreak of COVID-19and to ramp up availability or production of various drugs, the environment ministry (MoEF) had last month amended Environment Impact Assessment (EIA) notification for expediting the environmental clearance for API related projects saying they will get the approval at state level itself.

"To ensure expeditious disposal of the proposals within a given time-line, the Ministry has 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.

"Within a period of about 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 ministry said on Wednesday.

According to World Health Organisation, API is any substance or combination of substances used in a finished pharmaceutical product (FPP), intended to furnish pharmacological activity or to otherwise have direct effect in the diagnosis, cure, mitigation, treatment or prevention of disease, or to have direct effect in restoring, correcting or modifying physiological functions in human beings.

In itsMarch 27, 2020 notification, the ministry had made an amendment to EIA Notification 2006 sayingallprojects or activities in respect of bulk drugs and intermediates, manufactured for addressing various ailments, have beenre-categorizedfrom the existing Category 'A' to 'B2'category.

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 sevelso as to fast track the process," it had said, adding that thestepiswith a view to help in increasing the availability of the important medicines/ drugs in the country within a short span of time.

This amendment is applicable to all proposals received up toSeptember 30, 2020 with the states being directed to expeditiously process such proposals.