Express Pharma

Industry maange more

Recently, the Ministry of Environment, Forest and Climate Change (MoEF) brought an amendment by bringing API and intermediates under a single category for environmental clearance. This move is expected to benefit the industry by speeding up the manufacturing process of pharma formulations. Now, industry experts opine that relaxation of certain other norms and approval process can accelerate the industry's further growth and enable it to become a self-sufficient industry

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There is increased flexibility for API manufacturers to change product mix as per
market requirements

This is indeed a welcome move from the Government. Earlier the new environmental clearances were given product-wise and it was causing inordinate delays. As a result, manufacturing progressive new molecules in place of obsolete ones was not easy and opportunities were lost on this count. Now, by agreeing to provide environmental clearances under a single category for APIs and intermediates, there is increased flexibility on the part of API manufacturers to change their product mix as per market requirements. We hope that the Government will implement this without any delay. The new rule has been formed by MoEF due to DoP’s initiative and we hope that they will ensure its implementation. Besides, the PLI schemes mooted by DoP encourages the production of API and intermediates import substitutes, which can be carried out by industry with quicker environmental clearances. On the part of MoEF, we hope that they will provide clearance without any delay.

This initiative, along with PLI scheme, will increase investments in this sector and
make India Atmanirbhar

We welcome this move from MoEF. This move will have a far-reaching positive impact on how the bulk drug and intermediate industry works in India and will go a long way in improving the ease of doing business. The KDPMA had been pursuing this demand at every forum for about a decade. Hopefully, this initiative, along with the PLI scheme, will increase investment in this important sector and make India Atmanirbhar. We