Govt plans to relax medical device-testing labs vetting

| | New Delhi
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Govt plans to relax medical device-testing labs vetting

Friday, 07 December 2018 | Pioneer News Service | New Delhi

At a time when stringent measures are being called for to ensure rule compliance and quality products by the medical industry, the Union Health Ministry is mulling relaxing the regulatory requirements for certain medical device-testing laboratories by providing exemption from mandatory National Accreditation Body for Testing and Calibration Laboratories (NABL) accreditation for two years. 

Sources in the Union Health Ministry said that the Ministry may do away with the NABL requirement for two years as recommended by the Drug Technical Advisory Board (DTAB) in its meeting on November 29.

According to the provisions under Rule 19 of the Medical Devices (MD) Rules 2017, the Government would name laboratories to test medical devices sold across the country and to function as an appellate laboratory. Any state laboratory having the required facilities could also be designated as central testing lab provided that it is duly accredited by the NABL.

 However, the apex drug technical body has proposed to  provide an exemption from mandatory NABL accreditation clause in the case of state and central laboratories which have already been testing medical devices like surgical dressing, catheters and absorbent cotton prior to the Medical Devices Rules 2017 for at least two years.

 In June, the health ministry had designated five laboratories in the public sector to test and evaluate medical devices, almost six months after notifying the new MD Rules. The labs designated are the National Institute of Biologicals at Noida, the Central Drugs Testing Laboratory in Chennai, the Central Drugs Laboratory in Kolkata, the Regional Drugs Testing Laboratory in Guwahati and the Central Drugs Testing Laboratory in Mumbai.

Forum Coordinator of Association of Indian Medical Device Industry Rajiv Nath said that the resolution will allow State Government laboratories to function without accreditation. “These non-accredited labs will be empowered to test Indian manufacturers medical devices and initiate prosecution against them for failing to comply with the stated BIS Standards. Is it a fair prosecution on basis of test report of a non accredited lab?” he questioned.

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