MoEF amendment brings APIs and intermediates under single category

The Ministry of Environment, Forest and Climate Change (MoEF) has issued a letter with an amendment that clubs APIs and intermediates as a single category instead of individual products. The move has been appreciated by industry stakeholders as it will provide them with the flexibility to change the raw material mix/or product mix within the sanctioned pollution load.

The Ministry has taken the decision based on the several presentations made by the industry representatives requesting for issuance of Prior Environmental Clearance under the provisions of EIA notification 2006. 

According to issued communication by the MoEF, the matter has been examined in the Ministry and henceforth all the Expert Appraisal Committees of Environment Ministry/ SEAc (State Expert Appraisal Committee) should appraise the proposal for prior Environmental Clearance under the provisions of EIA notification 2006 and subsequent amendments under the Environmental Impact Assessment (EIA) notification 2006 for APIs and intermediates as a single category instead of individual products. 

Accordingly, the EAC/SEAC should recommend the permissible pollution load i.e.quantity and quality including the composition of emissions, discharge and solid waste generation from such activity for inclusion in the prior Environmental Clearance.

Mahesh Doshi, National President, IDMA, expressed, “It is a long pending demand from the IDMA. On behalf of the Indian pharma industry, we acknowledge the initiated efforts taken by the DoP Secretary, S Aparna. After understanding the industry’s concerns she ably managed to lead a high delegation from the Ministry of Environment, Foreign and Climate Change and managed to deliberate in favour of the industry. Certainly, this step will help the industry to further flourish the Indian pharma industry’s image in the competitive global pharma market.”

BR Sikri, VP, BDMA and Chairman, FOPE, commented, “It is a welcome step. The industry has been pursuing this issue with GoI for several years and it is a very positive step on behalf of the Environment Ministry because it will increase production since within the load sanctioned we will be able to switch over to other product ranges. I wish it would have been done long back but there is a saying “Der aye durust aye,” i.e. better late than never. It will have far-reaching, positive consequences for the nation provided State Pollution Control Boards do not find fault in implementing this great change in the system. Atma Nirbhar Bharat is now achievable since the Government’s way of working has changed and it has started listening to the industry.”