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 have repeatedly stressed the fact that we cannot have such a strategically important, world-class formulation industry depending on imports of bulk drugs. Having said that, we need to gear up our research capabilities with a multidisciplinary approach like Artificial Intelligence and Machine learning.

Hopefully, with the impending launch of 5G, our expertise in IT will be added advantage. We expect the government to firmly handhold this sector. In the long run, if we have to globally competitive, we need to build up large global scale capacities, process improvements to cut cost, obtain regulatory approvals.

The notification is still silent on capacity enhancement within the approved pollution loads

The Environmental Clearance (EC) is taken under a specific project category like 5(f) for bulk drugs and intermediates. Change of product mix within the same category is now allowed without seeking fresh EC. This is very much needed for the 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.

EC is given for specific pollution discharge loads. Hence seeking fresh EC for modernisation, change in process technology and capacity enhancement is not logical when there is no increase in pollution load. Though the notification allows for a change of product mix, it is still silent on capacity enhancement within the approved pollution loads. As far as environmental compliance is concerned it is the quantum of pollution load to be addressed and not the quantity of products produced as long as they are from the same category for which EC has been given. With the improvement in technologies and process changes, there is a possibility to increase production and reduce the pollution generated. If capacity enhancement is also allowed it would lead to process innovations and make our industry globally competitive.

The following initiatives should be taken up by the government to encourage the drug industry:

  • The government should facilitate providing world-class environment control systems by involving expert agencies like CPCB, NEERI and charge the industry for the services provided rather than always punishing the industry for any default.
  • Develop large scale pharma clusters with world-class infrastructure, plug and play facilities and environment control facilities which can reduce the quantum of investment and operation costs due to the economy of scale.
  • Encourage R&D and skill development

There is a need for establishing ‘API monitoring cell’