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Government to frame new rules on medical devices to draw investments

Government to frame new rules on medical devices to draw investments

New Delhi : Government said it will amend the Drugs and Cosmetics Rules to ensure availability of medicines at reasonable prices and also formulate new norms for the medical devices sector to bring in investments.

“We propose to amend the Drugs and Cosmetic Rules to ensure availability of drugs at reasonable prices to ensure use of generic medicines.

“New rules regarding medical devices will be formulated. These rules will be internationally harmonised and attract investments into this sector. This will reduce the cost of such devices,” Finance Minister Arun Jaitley said.

India is the largest provider of generic drugs globally, with the Indian generics accounting for 20 per cent of global exports in terms of volume.

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Medical devices include any instrument, apparatus, appliance, implant, material or other article, whether used alone or in combination, including the software intended by its manufacturer to be used specially for human beings or animals for one or more of the specific purposes.

India has achieved an eminent global position in the pharmaceutical sector. However, the same has not been replicated in the medical devices industry.

Currently, 100 per cent FDI is allowed under the automatic route in the medical devices sector to encourage manufacturing of equipment.

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Source: PTI

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  1. user
    Dr B S Murthy(SURYANARAYANA MURTHY BHAGAVATHULA) March 8, 2017, 7:54 am

    Clinical trials for new medical devises and new applications for existing medical devises is not properly regulated DCGI has only a list of approved medical devises Under that garb many devises are being clinically tested for new application and new devise designers produce letters from DCGI saying that the devise is not included in the list and proceed with plans for clinical use A new control body is supposed to be formed and announced Nothing happened after Prof Valiatha\’n\’s report to form such committee It is time to regulate and give boost to authentic original new Indian Medical devises