States get over 100 proposals for bulk drugs production after MoEF decentralises green nod process

New Delhi: Amid the coronavirus outbreak in the country, more than 100 proposals seeking green clearance for production of bulk drugs or active 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-19 and to ramp up availability or production of various drugs, the environment ministry (MoEF) had last month amended the Environment Impact Assessment (EIA) notification for expediting the environmental clearance for API-related projects, saying they will get the approval at the 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 the World Health Organisation, API is any substance or combination of substances used in a finished pharmaceutical product (FPP), intended to furnish pharmacological activity or otherwise have a direct effect in the diagnosis, cure, mitigation, treatment or prevention of disease, or have a direct effect in restoring, correcting or modifying physiological functions in human beings.

In its March 27, 2020 notification, the ministry had made an amendment to the EIA Notification 2006, saying 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 the ‘B2’ category.

Projects falling under Category B2 are exempted from the requirement of collection of baseline data, EIA studies and public consultation.

“The re-categorisation of such proposals has been done to facilitate decentralisation of appraisal to state sevel so as to fast-track the process,” it had said, adding that the step was taken with a view to help in increasing the availability of important medicines/drugs in the country within a short span of time.

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