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The Commerce Ministry has granted an extension to pharma major Lupin to set up its state-of-the-art formulation manufacturing unit at the MIHAN Special Economic Zone (SEZ) in Nagpur. However, a final call on the matter is yet to be taken by the Board of Approval (BoA) for SEZs.
Lupin had sought the extension on the grounds that it is yet to receive approvals from the US Food and Drug Administration (USFDA) for drugs that are to be produced at the unit.
“The BoA will take up Lupin’s application for extension of letter-of-permission (LoP) for the unit beyond the expiry date of April 22, 2015, at its meeting on Tuesday. The Commerce Ministry has granted it an extension on file, but it needs to be ratified by the BoA,” a government official told BusinessLine . The BoA decides on the functioning of SEZs, and includes officials from the ministries of commerce, finance, industry and home.
Lupin received the LoP for setting up its unit in the MIHAN SEZ in April 2012, but has not been able to start commercial operations.
The company said this was because of the delay in obtaining approvals from drug regulatory authorities in various countries.
“Only after receipt of final approval from the authorities, which generally takes 24 to 48 months, can commercial production commence at the unit,” the company said. A part of the unit in the SEZ has already been set up and certain exhibit batches of three products — Ethambutol, Rousvastatin and Lurasodine — have been produced and sent to the USFDA for marketing approval, the application added.
The unit is also filing applications to regulatory authorities of various other countries for 50 products.
The unit has invested ₹89.11 crore in the project so far and spent ₹20.86 crore on civil construction since it got its last extension, according to government records.
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