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 ministry of environment and forests (MoEF) had last month amended the Environmental Impact Assessment (EIA) notification for expediting the environmental clearance for API-related projects, saying they will get the approval at the state level itself.

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.

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

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.

Environmental Impact Assessment

Environmental Impact Assessment (EIA) is a process, used to identify the environmental, social and economic impacts of a project. It is a decision-making tool, which guides the decision makers in taking appropriate decisions for proposed projects. 

It aims to predict environmental impacts at an early stage of project planning and design, find ways and means to reduce adverse impacts, shape projects to suit the local environment and present the predictions and options to decision makers.

By using EIA, both environmental and economic benefits can be achieved. EIA systematically examines both beneficial and adverse consequences of the proposed project and ensures that these impacts are taken into account during the project design. 

By considering environmental effects and mitigation early in the project planning cycle, there are many benefits, such as protection of the environment, optimum utilization of resources and saving overall time and cost of the project.

Properly conducted EIA also lessens conflicts by promoting community participation.

EIA in India

EIA was first used in India as early as 1978 with river valley projects, and was subsequently extended to large public sector projects requiring Public Investment Board (PIB) clearance. 

These practices were formally codified for the first time in the EIA Notification, 1994, which came into effect from January 27, 1994. 

The notification made the requirement of environmental clearance mandatory for 29 categories of projects/processes, listed therein. The criterion of investment was the basis for the projects requiring environmental clearance in different sectors. 

Subsequently, EIA Notification, 2006 was issued with an objective of National Environmental policy as approved by the Union Cabinet. This notification made the requirement of prior environmental clearance mandatory for 39 categories of projects/ activities, listed therein based on the pollution potential.

The EIA Notification, 2006 have been amended from time to time to further streamline the clearance process. The amendments have also been done to address emerging concerns stemming from the need to integrate environmental concerns into the developmental process for achieving the goal of sustainable development.

Environmental clearance

It has been made mandatory to obtain environmental clearance for different kinds of developmental projects. The notification has classified projects under two categories - A and B. 

Category-A projects (including expansion and modernisation of existing projects) require clearance from central government while category-B projects should be considered by State Level Environmental Impact Assessment Authority (SEIAA), constituted with the approval of MoEF.

The B category is further categorized as ‘B1’ and ‘B2’. B1 projects will require preparation of EIA reports. Projects falling under Category B2 are exempted from the requirement of collection of baseline data, EIA studies and public consultation.

Different stages for obtaining clearance

The environmental clearance process for new projects consists of four stages, some of which may not be required for all projects. 

1) Screening

At the screening stage, which only applies for Category B projects, the State level Expert Appraisal Committee (SEAC) reviews the application to determine whether the project requires further environmental studies for preparation of an EIA report. This decision also depends on the nature and location of the project. Projects are then further categorised according to whether they require an EIA (Category B1) or not (Category B2).

2) Scoping

At the scoping stage, detailed and comprehensive Terms of Reference (TOR) addressing all relevant environmental concerns for the preparation of an EIA report are determined. This is carried out by the Expert Appraisal Committee (EAC) for Category A projects and by the State-level Expert Appraisal Committee (SEAC) for Category B1 projects. Scoping is not required for B2 projects.

3) Public Consultation

This stage involves consultation with project affected persons on the effects of the project. Public consultation is required for all Category A and Category B1 projects, with some exceptions including projects involving the expansion of roads and highways which do not involve any further acquisition of land. The concerns heard during the public consultation process must be addressed in the EIA report and in the Environmental Management Plan.

4) Appraisal 

This stage sees the overall and detailed scrutiny of the final EIA report, which will have been presented to EAC or SEAC. The EAC or SEAC considers the environmental aspects of the project and makes a recommendation to the Regulatory Authority on whether prior EC should be granted or not.

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