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Wednesday, December 29, 2010

Gujarat Food and Drugs Control Administration (FDCA) is flooded with enquiries from US companies

If one goes by the number of enquiries that Gujarat Food and Drugs Control Administration (FDCA) is getting everyday, pharmaceutical sector is likely to shine in this year's Vibrant Gujarat Global Investors' Summit (VGGIS). Two US based companies, Amneal Pharmaceuticals and Apicore LLC have sent proposals to the Gujarat FDCA to set up units in the state. FDCA is hoping that investments this year could nearly be around four times that of 2009 VGGIS which had seen investments worth Rs 2,700 crore.


H G Koshia, commissioner, FDCA said "We are expecting investments worth Rs 10,000 crore in the sector this year" He confirmed that Amneal and Apicore have evinced interest in setting up units here. "Amneal has sent a proposal to set up a formulations unit and a research and development center here, while Apicore plans to set up an active pharmaceutical ingredients (API) unit in the state", Koshia said adding that Amneal is one among the ten largest generic companies in the US. Apicore is a limited liability company incorporated in New Jersey, US that is a developer and manufacturer of specialty Active Pharmaceutical Ingredients (APIs) and cGMP advanced intermediates. Amneal, on the other hand is a manufacturer of generic pharmaceuticals that works on the entire product lifecycle-from the early stages of R&D and API development through FDA approval.
Both the companies already have presence in India. Koshia said "Roughly around Rs 50 crore investment can be expected from these two US based companies, who would require small land parcels of around 10,000-20,000 square yards. The memorandums of understanding can be signed during the VGGIS."
Among the other proposals the FDCA is receiving, there is a mix of both domestic companies and export oriented units (EOU) in special economic zones (SEZ). "We have received 70 proposals in all so far, and it includes a mix of both domestic companies and EOUs. Most proposals are for formualtions and active pharmaceutical ingredients (API) manufacturing units, besides research and development (R&D) outfits", Koshia said.
In 2009, the Gujarat government had signed 26 MoUs with pharma companies for investments worth Rs 2,700 crore. Of the 26, around eight projects have taken off, with plants that are already operational, and the others are in various stages of implementation, Koshia informed.
Gujarat currently enjoys a 42 per cent share in India's pharmaceutical production, while its share in the medical devices segment is around 50 cent. The state has over 2,300 pharma manufacturing units, and 115 medical devices manufacturing units.
Koshia clarified that the 70 proposals that it has on its table are all pharma manufacturing units, adding that this year there is a slight dip in the applications for clinical research organisations (CRO).
As for the medical devices sector, the state government is working closely with the Centre to develop a medical devices cluster over 100 acres in the area that has shot to fame after the Tata Nano project parked in. The state government has committed around Rs 30 crore investment in the project that can house 30-40 small and medium sized companies making syringes, intra-venous (IV) packs, cardiac stents among other devices.
National Institute of Pharmaceutical Education & Research (NIPER) is going to co-execute the project. Gujarat has around 150 medical device manufacturing units, of which around 30 odd have the European Union CE Certification.

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