Maha FDA Join Talks Hands with APIs to Develop Bulk Drugs Park

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

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

This as per the state drug regulator will complement the much awaited Center’s policy on bulk drugs and medicinal devices park. Plans to set up a therapeutic device park like what has been developed in Visakhapatnam was additionally examined in the meet held in Mumbai two months ago.

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

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

For Dr. Babasaheb Ambedkar, MIHAN is an airport project International Airport Nagpur expected to exploit the central location of Nagpur and convert over the present airport into a major cargo center with incorporated road and rail connectivity. It comprises of two sections, to be specific an International airport to go about as a cargo center point and an SEZ on the southern end of Nagpur.

This comes when the government plans an exclusive policy on developing bulk drug parks, medicinal device parks, and formulation parks to decrease its dependence on different nations for the supply of APIs and faulty therapeutic devices.

The park is stipulated to have common manufacturing facilities and will decrease capital expenditure for projects by offering minimal cost rentals and revenue support services, thus allowing these units to be competitive. The park will allow the companies with all the most recent technical support required for R&D.

This will also improve medication and medical device testing and certification abilities of the industry which has been a neglected area. Andhra MedTech Zone (AMTZ) which is India’s first Government-funded medicinal device park is today serving in as a one-stop- solution for not just diminishing the cost of manufacturing up to 40% and to improve end-to-end operations but also decreasing import dependency, which is presently around 75%.

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

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