Hailing ministry of environment, forest and climate change (MoEF&CC)'s initiative to amend their November 2018 notification, which permitted product change without fresh environment clearance (EC) as long as there was no increase in pollution load, the Indian Drug Manufacturers’ Association (IDMA) has urged the ministry to further simplify procedure for product change for bulk drug by removing need to obtain a ‘no increase in pollution load’ certificate from the concerned state pollution control board (PCB) for any expansion.
It is learnt that MoEF&CC is considering further amending their November 2018 notification allowing product change without fresh EC as long as there was no rise in pollution load.
Unfortunately, industry has not been able to take full advantage of this notification, as amendment to “consent to operate” from state pollution control boards is still necessary, which takes anywhere from six to 12 months, said IDMA in a representation to CK Mishra, secretary, MoEF&CC on January 2, 2020.
Once MoEF&CC does away with need to get further approval from State Boards while changing product without increasing pollution load, it will lead to avoidance of bureaucratic delays and allow freedom to manufacturers to change product mix as per market demand. In order to achieve this, the notification should spell out time limit, such as 30 days, beyond which “no increase in pollution load” certificate would have been deeded to be issued. This is necessary so as to pass on the benefit of the notification at the ground level and ensure state boards act in timely manner.
IDMA has come out with three suggestions for consideration of MoEF&CC while drafting the notification on simplifying procedure for product change for APIs.
The industry body said the increase in quantity of production will lead to increase in pollution load only where increase is for the same product and there is no change in process or stage of manufacture. In a multistage manufacture, if for economic reasons, the manufacturer decides to start from an advanced stage by outsourcing it, the pollution load may in fact decrease. Similarly, when the product mix is changed, the new product may require less number of chemical steps or generate less effluent. In that case the pollution load may again decrease. Thus, pollution load has no bearing on quantity being manufactured and needs to be delinked from it.
However, in case MoEF&CC wants to introduce the linkage with production, IDMA suggested that 50% is insignificant and should be at least 5 times of existing capacity.
It is noted that the ministry will clear a proposal to allow drug manufacturers to tweak their product mix or raw materials used without a fresh EC, provided there is no increase in pollution load and the increase in production capacity is not more than 50 per cent of the production capacity permitted in the earlier environmental clearance.
Further, the concept of EC was first introduced in 2006, and hence, all industrial estates prior to that did not have EC. Same is the case for units situated in those estates. Hence instead of linking expansion to EC same may be linked to “consent to manufacture”. Otherwise all these units will have to apply for fresh EC, said IDMA.
EC is taken under a specific project category like 5(f) for bulk drugs and intermediates. Hence products manufacturing consent to be given under broad category of “bulk drugs and intermediates” and not individual product names within this category. Thus change of bulk drug production made within the same general category to be freely allowed without seeking fresh EC or any application to be made for “change in product mix.” This is very much needed for bulk drug industry as the products keep changing very frequently as they become obsolete or new drugs with better efficacy are introduced regularly and globally. Based on the market demand there is need for quick product changeovers in pharma business, the industry body suggested.
The above suggestions can be implemented by amending zero draft of EIA 2019 notification, Section 6(ii), page 12, 13 of 129, Prior EC process for modernization or any change in product mix or any change in process.
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