The Central Pollution Control Board (CPCB) will exempt tablets and capsule manufacturers in the small scale sector from obtaining mandatory clearance from the PCBs, and may consider to exempt liquid formulators up to 1000 liters capacity after a soon to be conducted random inspection in ten units to assess the effluent levels.
Further, the CPCB has agreed to do away with the periodic Environmental Impact Assessment (EIA) done by the PCB officials at the tablets and capsule-manufacturing units. With this, the SSI pharmaceutical units into capsule, tablets and liquid formulation manufacturing is likely to be reclassified as non-polluting 'green category industries' from the present 'orange category'.
The decision comes in the wake of a recent memorandum on this submitted to the union minister of Environment and Forest A Raja by the Confederation of Indian Pharmaceutical Industries (CIPI) and a subsequent discussion with CPCB top officials in Delhi, this week.
The seven-member CIPI delegation, which met the union minister and top level CPCB officials, had demanded to review the present norms on classification of SSIs which come under the Orange category, since the level of effluents and chances of atmospheric pollution were nil in the case of tablets and capsule manufacturers, and was minimum in the case of liquid formulation manufacturers, though basic chemicals and pharmaceuticals are classified in the high polluting 'red category'.
Though the PCB officials were convinced about the case of tablets and capsule manufacturers, they felt it necessary to assess the situation in the case of liquid formulation manufacturers. The CPCB directed the delegation to suggest ten units in different parts of India for conducting a random sample study by a team of CPCB officials to assess the level of effluents and its chances of atmospheric pollution. Based on their report, the CPCB will take a decision on exempting formulators up to 1000-liter capacity from the mandatory pollution clearances.
T S Jaishankar, chairman of CIPI told Pharmabiz that the decision would be a boon for numerous SSI manufacturers in the country. The decision to do away the mandatory PCB clearances would help in speedy implementation of projects, besides saving time and cost. Further, the decision to remove these units from periodic Environmental Impact Assessment (EIA) would benefit the SSIs in saving annual fees due to the PCBs besides official harassment.
The CIPI delegation included various state level SSI industry leaders from different part of India, including the Tamilnadu Pharmaceutical Manufacturers Association president B Sethuraman and S Lakshminarayanan, TN IPA president and secretary of Tamilnadu PMA.