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Laxmi Yadav, Mumbai July 09 , 2020
In order to increase production of active pharmaceutical ingredients (APIs) in the country, the pharmaceutical industry in the country has urged the Union ministry of environment, forest and climate change (MoEFCC) to simplify guidelines of draft Environment Impact Assessment (EIA) Notification, 2020 to remove numerous layers of permissions as presently required before being able to produce bulk drugs.

At least for API manufacturing, a simplified version is the need of the hour. Consent as broad category of “API and Intermediates” with no control over quantity of production is the need of the hour, said Indian Drug Manufacturers’ Association (IDMA) in a representation to the secretary, MoEFCC and Mohammed Farhan, technical consultant (Pharma), Pharma Bureau, Department of Pharmaceuticals (DoP) on draft EIA Notification, 2020.

EIA Notification 2020 continues with the cumbersome procedures and highly technical guidelines which can be understood by very few. Most MSMEs (which comprise bulk of API manufacturers in the country) cannot understand the fine print of the 83 pages document. What we need is simplified guidelines which eliminate various approvals as currently required to manufacture the API, and which still continue to be part of the new document, stated IDMA.

To boost API production, it is absolutely necessary that the government does away with the cumbersome archaic guidelines of environmental controls which presently also control manufacturing activities of API producers along with the effluent characteristics, said the industry body.

Nobody disputes the need to ensure environment is not polluted. But that can be achieved simply by ensuring adequate common effluent treatment plants (CETPs) are installed so that all discharges from API units are fed to them. Then all that is needed is to just monitor functioning of CETPs and discharge from them, leaving API units to concentrate on manufacturing of drugs, it added.

For grant of prior-environmental clearance to bulk drug and drug intermediate projects, IDMA suggested more liberal exemption criteria, adding that declaration of ‘no increase in pollution load’ should suffice instead of prior permission.

In order to ensure time bound clearances of all applications, wherever timelines are specified, it should be added that “if no decision is taken within that stipulated period then the application will be deemed to have been approved,” it concluded.

MoEFCC in its March 27, 2020 notification had made an amendment to EIA Notification 2006 saying all projects or activities in respect of bulk drugs and intermediates, manufactured for addressing various ailments, have been re-categorized from the existing category 'A' to 'B2' category. Projects falling under B2 category 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 level so as to fast track the process of giving environmental approval.

The compliance monitoring of conditions prescribed in respect of prior-environmental permissions for category ‘B2’ projects, shall be carried out by the State Pollution Control Boards (SPCB) or Union Territory Pollution Control Committee (UTPCC).

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