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IDMA urges DoP to relax environmental norms for better utilisation of surplus capacity of brownfield units to boost API production

Shardul Nautiyal, Mumbai
Monday, November 9, 2020, 08:00 Hrs  [IST]

The Indian Drug Manufacturers Association (IDMA) has urged the Department of Pharmaceuticals (DoP) to give flexibility in the present environmental regulations for better utilisation of surplus capacity of the existing brownfield manufacturing units for self-reliance in domestic production of active pharmaceutical ingredients (APIs).

This comes close on the heels of Centre’s recent move to remove minimum investment criteria and the condition of domestic sales from the production linked incentive (PLI) scheme to boost bulk drugs production in the country.

In a representation to the DoP recently, the IDMA has recommended that reasonable time limits for grant of various permissions for additional production from pollution control authorities is needed for timely implementation of the projects and ultimate success of the PLI scheme. Many of the eligible products are intermediates or require intermediates to achieve value addition.

Although para 5(f) of Environment Impact Assessment (EIA) 2006 notification mentions APIs and intermediates, the recent relaxation in environment clearance (EC) rules by union environment ministry with reference to notification dated October 15, 2020 for treating all bulk drug projects as B2 category has omitted the word “intermediates”. Even the draft 2020 EIA notification, which is yet to be notified, also mentions under para 5 (f) for API and intermediates. Unless included, intermediates production under PLI scheme will get delayed as EC will be insisted upon.

Besides this, baseline is not defined in the revised PLI scheme. It has therefore been recommended to offer clarity on the matter. It has also been recommended that change of location may be permitted as long as the committed investment is achieved. It is also recommended to rethink carrying forward an unused incentive amount from the first year as it may not be possible to achieve 100% production due to certain problems.

Finally, since the criteria of minimum investment is now removed in the revised guidelines, some of the clauses are no longer relevant or need minor alterations, which need to be relooked at as there is no longer an investment criteria.

The clauses which are no longer relevant are with reference to that however the investment already made in the ancillary facilities shall not qualify for the purpose of the committed investment to be made under the scheme.

Expenditure on land shall not be considered. Similarly guest house, recreation, building, office building, residential accommodation etc shall not be considered as threshold investment. Investment as defined in the guidelines shall be considered for determining the eligibility. The applicant shall submit a certificate by chartered engineer by Project Management Agency (PMA) for committed investment by the applicant and shall be relied upon by PMA.


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