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Pharmaceutical major Wockhardt has sought a one-year extension of approval for its proposed inhaler and nasal dosage manufacturing unit at the Wockhardt Infrastructure Development SEZ in Aurangabad due to a delay in regulatory approvals from agencies such as the US Food and Drug Administration (USFDA), on account of the Covid-19 pandemic, as per the agenda of the Board of Approval (BoA) meeting for SEZs scheduled on March 18 .
The BoA will also take up a proposal for a two-year extension of approval to Mundra Solar Ltd – a SEZ unit for manufacture of solar cells and modules in Adani Ports and SEZ (APSEZ) at Mundra – up to April 18, 2022, as it now no longer wants to exit from the SEZ, the agenda noted.
‘Inspection soon’
The Wockhardt unit has applied to USFDA for product approval – with renewal fee up to December 31, 2021 – is expecting surprise inspection anytime. “The unit is hopeful that once the situation is back to normal, the Regulatory Authority shall visit their plant and they shall start their commercial production in due course,” the note added.
The company has also been trying to obtain other regulatory approvals for markets like Europe. There is no change with regards to physical progress as the construction activities of the unit have already been completed and the plant and machinery has been fully installed to its capacity.
The proposed capital investment of ₹88.9 crore has already been made. The Wockhardt SEZ unit, which got its LoA in February 2013, has got seven extensions till now. “Development Commissioner SEEPZ-SEZ has recommended the request of extension of LoA... up to February 24, 2022. The request is placed before BoA for consideration,” the agenda stated.
Mundra Solar
In the case of Mundra Solar Ltd, the DC of the APSEZ noted that the agenda is being forwarded to BoA, in spite of the fact that though four extensions were granted to the unit, apart from obtaining environment clearance they had not initiated any physical construction activity on ground.
“It is pertinent to note that the unit vide letter dated October 16, 2019, had applied for exit from SEZ and subsequently withdrew their proposal for exit from SEZ vide letter dated January 8, 2021, thereby willing to continue in SEZ formation,” the agenda stated. The proposed investment in the unit is estimated at ₹2,860.85 crore.
The unit explained that their technical team is now working on advanced direct wafering technology which will help them improve the operational cost of wafer manufacturing, thereby making project more viable in terms of finance and reliability, it said.
The DC observed that given all the stated considerations and the fact that it was an environment friendly project, it recommended the request of the unit for extension of the LoA for a period of two years, up to April 18, 2022, for consideration of the BoA.
India is set to impose a basic customs duty of 25 per cent on imported solar PV cells and 40 per cent on imported solar PV modules, with effect from April 1, 2022, in a bid to boost domestic manufacturing.
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