Govt issues environmental clearance for Bulk Drugs

The industry had also urged the Department of Pharmaceuticals (DoP) to give flexibility in the present environmental regulations

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Govt India
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Last Updated on February 2, 2021 by The Health Master

The Union environment ministry has finally issued environmental clearance for active pharmaceutical ingredients (APIs) and intermediates as single category instead of individual products to provide flexibility to the industry to change the raw material mix and / or product mix within the sanctioned pollution load following representations from the industry.

The industry had also urged the Department of Pharmaceuticals (DoP) to give flexibility in the present environmental regulations for better utilisation of surplus capacity of the existing brownfield manufacturing units for self-reliance in domestic production of active pharmaceutical ingredients (APIs).

According to official sources, the Union environment ministry is in receipt of representations for issuance of prior environmental clearance under the provisions of Environment Impact Assessment (EIA) notification, 2006 and subsequent amendments, for the ‘API and Intermediates’ as single category instead of individual products has been considered in order to provide flexibility to the industry to change the raw material mix and/ or product mix within the sanctioned pollution load.


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“It is hereby directed that henceforth all the Expert Appraisal Committees (EACs) or State Expert Appraisal Committees (SEACs) shall appraise the proposals for prior environmental clearance under the provisions of EIA Notification 2006 and subsequent amendments under the category of the Schedule EIA Notification 2006, for the API and Intermediates as single category instead of individual products,” according to a note shared by the environment ministry.

Accordingly, the EAC/SEAC shall clearly recommend the permissible pollution load, i.e., quantity and quality including composition of emissions, discharges and solid waste generation for such activity for inclusion in the prior environmental clearance.

In a representation to the DoP last year, industry had recommended that reasonable time limits for grant of various permissions for additional production from pollution control authorities is needed for timely implementation of the projects and ultimate success of the production linked incentive (PLI) scheme.


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