Govt to bring in amendment to regulate medical devices soon

Written By Unknown on Jumat, 23 Agustus 2013 | 22.23

MUMBAI: The government has decided to regulate medical devices, even as it plans to roll out free diagnostic services at public health centres soon.

At present, there are no specific guidelines specifying standards for medical devices.""An amendment in the Drugs and Cosmetics Act will be made soon to define and regulate medical devices", a senior health ministry official said here on Friday.

Till now medical devices are grouped as drugs. There are 14 medical devices like stents, catheters, heart valves and orthopaedic implants, intended for internal or external use in the diagnosis, treatment, mitigation or prevention of disease or disorder"".

Medical device inspectors will be appointed to monitor the quality and standards of these devices, Shailendra Kumar director drugs, Union ministry of health , said here at an OPPI seminar.

Regarding rolling out free diagnostic services at public health centres, he said that the proposal is at initial stages right now. It will offer basic pathological tests, X-ray and MRI (magnetic resonance imaging) at these centres.

Earlier the government had announced an ambitious free drug scheme under the universal health coverage, for which Rs 16,000 crore has been allocated as part of the 12th Five Year Plan. The scheme has not taken off as yet due to implementation issues. The government will ask states to procure medicines as part of the scheme, he added.


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