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Maha FDA initiate talks with API manufacturers to develop bulk drugs park in Nagpur

Shardul Nautiyal, MumbaiTuesday, December 26, 2017, 08:00 Hrs  [IST]

The Maharashtra Food & Drug Administration (FDA) has initiated talks with API manufacturers to develop a bulk drugs park in Nagpur. The state regulator had earlier spoken to the Multi-Modal International Air Cargo and Hub (MIHAN), Nagpur management on the modalities of setting up a bulk drugs park with focus on drug quality in line with global regulatory harmonisation process.

Following which the MIHAN team gave a presentation on the implementation of guidelines, approvals and clearances required for the companies for setting up the units. The MIHAN team also apprised the state regulator and manufacturers of the various opportunities available to pharma players globally and domestically.

This according to the state drug regulator will complement the much awaited Centre’s policy on bulk drugs and medical devices park.  Plans to set up a medical device park similar to what has been developed in Visakhapatnam was also discussed in the meet held in Mumbai two months ago.  

Maharashtra FDA Commissioner Dr Pallavi Darade had earlier met pharmaceutical companies at Nashik, Pune, Aurangabad and Thane to explore investment opportunities in special economic zones (SEZ) in MIHAN to pave way for development of pharma hub in the state.  

Maharashtra Chief Minister Devendra Fadnavis and Union Minister for Road Transport & Highways Nitin Gadkari are also scheduled to meet the pharmaceutical manufacturers towards exploring prospects of developing Nagpur as a pharmaceutical hub and make India a favourable investment destination.

MIHAN is an airport project for Dr. Babasaheb Ambedkar International Airport, Nagpur aimed to exploit the central location of Nagpur and convert the present airport into a major cargo hub with integrated road and rail connectivity. It consists of two parts, namely an International airport to act as a cargo hub and an SEZ on the southern end of Nagpur.

This comes at a time when the government plans an exclusive policy on developing bulk drug parks, medical device parks and formulation parks to reduce its dependence on other countries for supply of APIs and faulty medical devices.

The park is stipulated to have common manufacturing facilities and will reduce capital expenditure for projects by offering low cost rentals and revenue support services, thus enabling these units to be competitive. The park will enable the companies with all the latest technological support required for R&D.

This will also enhance drug and medical device testing and certification capabilities of the industry which has been a neglected area.

Andhra MedTech Zone (AMTZ) which is India’s first Government funded medical device park is today serving as a one-stop- solution for not only reducing cost of manufacturing up to 40% and to simplify end-to- end operations but also reducing import dependency, which is presently around 75%.

Gujarat has also demarcated 25 such locations under the Gujarat Industrial Development Corporation (GIDC) to attract investment from pharma players.

 
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