The draft, Environment Impact Assessment (EIA) Rules, notified by the union ministry of environment and forests has invited widespread criticism from the industry including the chemical and bulk drugs manufacturing sectors. The industry has complained that the process of public hearing is too complex and counter productive and wanted a total review including the composition of the committee for public hearing. The industry felt that the new rules can work against the modernisation and expansion plans of the existing units which comes under Category A. It also questioned the rationale behind the categorisation of various industrial sectors.

Interestingly, the draft has eased the EIA requirements for bulk drug units that come up in notified areas like industrial zones and special economic zones. The problems highlighted by the industry are to affect only those bulk drug units that remain in Category A. With most of the new bulk drug units coming up in designated areas with built in EIA clearance, the majority of the pharmaceutical units may escape the rigorous requirements.

The industry has also called for specific checklists for specific industries. The idea is to have a list of legal requirements that "A" category units would have to comply for EIA clearance. Sighting the case of chemicals and bulk drug sectors, industrialists said that the EIA draft should have clearly mentioned that expansion, product mix change, product change, unless it involves generation of substantial extra pollution load, should be automatically permitted. On the decision of the ministry to do away with the requirement of central EIA clearance for new bulk drug units coming up in notified areas, the industrialists asked whether the rule would hold good if no EIA assessment has taken place in the government allotted area before. The industry, under the leadership of Federation of Indian Chambers of Commerce and Industry (FICCI), is to submit a sector wise memorandum before the Union Ministry soon.

As pharmabiz had reported earlier, the government proposes the setting up of Environment Impact Assessment Authority, both at the central level as well as state level to clear new projects in various sectors including the bulk drug and intermediate manufacturing sector. The draft notification says that all projects falling under Category A would need clearance both at the central and state level from Central Environment Impact Assessment Authority as well as State Impact Assessment Authority before any construction work, or preparation of land by the project management, is started on the project or activity.

As per the current draft, all new projects or activities, expansion and modernisation of existing projects or activities, any change in product mix in an existing manufacturing unit, in projects included as Category 'A' shall require prior environmental clearance from the Central Government in the Ministry of Environment and Forests (MoEF) on the recommendations of an Expert Appraisal Committee (EAC) to be constituted by the Central Government for the purpose. All projects or activities included as Category 'B' including expansion and modernisation of existing projects, will require prior environmental clearance from the State/Union Territory Environment Impact Assessment Authority (SEIAA). The SEIAA will base its decision on the recommendations of a State/Union Territory level Expert Appraisal Committee (SEAC) to be constituted by the State Government /Union Territory Administration concerned.