The small and medium scale bulk drug units across the country are finding it difficult to go ahead with their expansion or modernization plans with several State Pollution Control Boards are deciding to enforce the central regulations with regard to the clearance of bulk pharmaceuticals and intermediates projects in most stringent manner.

The bulk drug units in states like Haryana and Gujarat are known to have been taken by surprise by the insistence of the state PCBs to go for central clearance for every such expansion or modernization proposals. The drug manufacturers complain that the time consuming process of central clearance and a subsequent state level public scrutiny as mandated by the regulations put in place by the Ministry of Environment and Forests would create indefinite delays in commencing and completion of their projects.

They also point out that the central clearance is not necessary for all kinds of expansions but is needed only for the ones that result in increased pollution. Andhra Pradesh is another state where the industry is in trouble due to the blanket instructions put forth by the state PCB.

The decisions of the state PCBs are based on the Environment Impact Assessment (EIA) Notification S.O.60 (E), dated 27/01/1994 which states that the expansion or modernization of any activity if pollution load is to exceed the existing one, or new project listed in Schedule I to this notification, shall not be undertaken in any part of India unless it has been accorded environmental clearance by the Central Government in accordance with the procedure specified in the notification.

Interestingly, 'bulk drugs and pharmaceuticals' is included in the Schedule 1 of this notification as item no 8. In the wake of this notification, the state PCBs are known to have asked the bulk drug manufacturers to go for EIA clearance from the central government for all future expansion programmes.

The notification however, exempts any item reserved for Small Scale Industrial Sector with investment less than Rs 1 crore from these requirements. Similar exemptions have also been given to the manufacture of certain specific drugs.

The companies feel that the state PCBs have now made it compulsory for the entire industry to go for central clearance, without any consideration to the status of the unit.

When enquired, Central PCB sources pointed out that there have been no fresh central instructions to include SSI units under the purview of central PCB. The CPCB was however critical about the capability of small scale bulk drug units to comply with the central regulations. "We are not in favour of small investments in the bulk drugs and intermediates segment. Future approvals would be given only to large scale projects as only they would be capable of initiating effective pollution control measures."

What worries the industry most is the public hearing that is mandatory as per the notification. They complain that the "involvement of NGOs who do not understand chemistry" would result in unnecessary delays in the clearance of the projects. As per the notification, all persons including bona fide residents, environmental groups and others located at the project site/sites of displacement/sites likely to be affected can participate in the public hearing.

They can also make oral/written suggestions to the State Pollution Control Board. The Public Hearing Panel would consist of a representative of the state PCB, District Collector or his nominee, representative of State Government dealing with the subject, representative of Department of the State Government dealing with Environment, representatives of the local bodies such as Municipalities or panchayats and senior citizens of the area nominated by the District Collector.

Though the notification calls for the completion of the hearing within six months, bulk drug manufacturers feel that the NGO would oppose the project without duly considering the merit of the programme.