The absence of a non-uniform stand on the eco-friendly status of drug formulation manufacturing units taken by several state pollution control boards are posing serious trouble to the formulation units in most parts of the country, it is feared.
The small-scale drug units, who are at the receiving end due to the insistence of NOCs from state PCBs for expansion or modernization of their units, have sought the intervention of union SSI ministry to issue a directive to all states to comply with the same central norms which exempts drug formulation SSIs from the need for PCB clearances.
According to sources, only states like Tamil Nadu, Gujarat and Karnataka have exempted formulation units from environmental clearance requirements. Even among these states, the exemption is not complete and has several riders attached. The formulation industry complains that the insistence of NOCs by state PCBs is not in tune with the central PCB instructions which allows formulation drug units in all eco-sensitive states like Himachal Pradesh or North Eastern States. "The control over bulk drug units, the effluents of which are bound to have an impact on the environment is understandable. But what is the rationale behind such bureaucratic hurdles on formulation units," they ask.
The drug formulators feel that the problem lies with the lack of uniform implementation of existing rules and wanted the centre to issue a directive to all state PCBs clarifying the eco-friendly nature of formulation units.
The state level associations of the drug makers have already brought up the matter before respective state PCBs also. Pharmabiz had recently reported the plans of Hyderabad-based Organisation of Pharmaceutical Manufacturers (OPM) to approach the State Government with a request to exempt pharmaceutical formulation units from obtaining NOC from the PCB.