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’
It is a welcome move as now API manufacturers are free to manufacture desired molecules as per market requirements and do not need to knock PCB clearances for every alteration as per permissible pollutions limits as both, excipients and APIs, are treated now as a single category.
It was a long pending demand of bulk drug manufacturers and it will be a booster dose for upcoming PLI schemes and bulk drug parks.
Besides this, we expect from the DoP that Section 33 P guidelines should become Rules, to protect genuine manufacturers and punish spurious drugs manufacturers. Several prosecution cases/litigations are pending all over India’s lower and session courts, on hand holding procedures and decriminalisation for genuine manufacturers is the need of the hour.
There is a need to establish an ‘API monitoring cell’ as price fluctuations during this pandemic has affected the entire formulations market, for e.g. Paracetamol price has shot up from Rs 300 to Rs 585, but prices of the final product which is controlled by the NPPA remained the same.
Therefore, a mechanism required to support the bulk drug industry and importers to get the final product from formulators at a reasonable price.
There is also a need to protect the MSME industry for better participation of Jan Aushadhi to various State Government’s tender which needs to remove clause of Rs 25 crore turnover for last four consecutive years, and should not make it mandatory the requirements of WHO-GMP as it is needed for the Export purpose and not required for the domestic market. Wherein, our own Schedule-M and GMP compliance requirements are enough and across the country primarily licences are granted by State FDA on such basis.
The Government should also allow new plants, manufacturing units for Government tender participation to promote ‘Make in India‘, which is lacking in the present scenario.
Inspector raj to be disbanded
- Speedy clearance of PLI Awardees in 1/2 months facilitated by DOP if data is completed in all respects.
- In case of the commitment of Zero Discharge all PLI Awardees to be allowed to fast-track their projects with periodic review with state and central agencies by self-declarations.
- Inspector raj to be disbanded. Online monitoring to be a faceless assessment.
- NGT to have SMEs on board with extensive knowledge.
If these above-raised points by industry stakeholders are analysed in consultation with government bodies, technocrats and stakeholders then it is likely that the API, intermediates manufacturing activities will get a further boost in the country