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Laxmi Yadav, Mumbai December 27 , 2021
The Indian Drug Manufacturers’ Association (IDMA) has urged Gujarat Pollution Control Board (GPCB) to make amendment to Consent to Establish (CE) and Consent to Operate (CO) requirements in line with March 2, 2021 notification issued by the ministry of environment, forest and climate change so that the manufacturing units do not have to come to the board for increase in production quantity/modernisations/change of product mix/change of equipment, as long as there is no increase in pollution load.

As per the March 2 notification issued by the ministry, all fresh environmental clearances (EC) are to be issued as single category of “active pharmaceutical ingredients (APIs) & intermediates” and all manufacturing units are exempted from requirement of prior environmental clearance for increase in production quantity/modernizations /change of product mix/change of equipment as long as pollution load remains the same as certified by competent designated authority.

The notification exempted units from requirement of prior EC as long as pollution load remains the same.

The ministry came out with the notification following its office memorandum on January 28, 2021 regarding issuance of environmental clearance for the APIs and intermediates as a single category instead of individual products.

The ministry had come out with this memorandum following representation from the drug industry seeking issuance of prior environmental clearance under the provisions of Environmental Impact Assessment (EIA) Notification, 2006 and subsequent amendments for the API and intermediates as single category instead of individual products in order to provide flexibility to the industry to change the raw material mix and product mix within the sanctioned pollution load.

The memorandum stated that henceforth all the Expert Appraisal Committees (EACs) or State Expert Appraisal Committees (SEACs) shall appraise the proposals for prior environmental clearance under the provisions of EIA Notification, 2006 and subsequent amendments under the category of the schedule of EIA Notification, 2006 for the API and intermediates as single category instead of individual products. Accordingly, the EAC/SEAC shall clearly recommend the permissible pollution load i.e. quantity, quality and composition of emissions, discharges and solid waste generation from such activity for inclusion in the prior environmental clearance.

“Similar amendments are needed in case of Consent to Establish (CE) and Consent to Operate (CO), both of which are issued by the states. EC is just the first stage in the prior requirements before a manufacturer is able to make any “changes” in the unit. Unless similar exemptions are also forthcoming as regards to CTE & CTO, the intended benefit of providing flexibility to manufacturers to quickly adapt to the changing needs of the market will remain only on paper, stated IDMA.

The industry body has recently made a representation to GSPB appealing to it to make appropriate changes to CE and CO so the consents can also be issued in the same way as EC in the common terminology of “API & intermediates” so as to provide Gujarat API manufacturers much needed flexibility once again.

“EC is just the first step in the various permissions needed for a unit to operate and discharge treated effluent. Without back up of similar legislation allowing consents to be issued as “API & intermediates”, at the state level the concept of immediate change over will remain only on paper, as the consents will still continue to be issued in names of individual products. For change of product mix, the laborious task of amendment to the consents will defeat the purpose of allowing just the EC to be issued in the general name of API & intermediates,” it stated.

India has been overly dependent on China for bulk drugs (APIs) and key intermediates, which has been rightly identified by the central government as a threat to national medicine security. Lately, there have been conscious efforts at various levels in the government to support the national sector to indigenise production of and reduce the country’s dependence on imports of APIs from China. The Department of Pharmaceuticals (DoP) has come out with production-linked incentive schemes for just such a reason, said Mahesh Doshi, IDMA national president.

In order for the domestic industry to take up this challenge, flexibility is needed for it to quickly change product mix as per the changing requirement of market demand. Also, there are times when in order to meet urgent export opportunities, manufacturers need to make a quick product change. After being duly sensitized by both industry and DoP, MoEF came out with above OM in January this year, which permits issue of EC as a single category “API & intermediate”. This provides complete flexibility to the manufacturers to change the product within this group without waiting for cumbersome procedure for amendment to the EC, he said.

“What MoEF has done at the central level for EC, needs to be emulated at the state level for CE and CO. Then onlythe real benefit of the intention of MoEF will percolate to the ground level,” said Doshi.

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