New Delhi :The Central government is preparing to water down the regulatory requirements for medical device testing laboratories by providing exemption from mandatory National Accreditation Body for Testing and Calibration Laboratories (NABL) accreditation. The move, which could hamper efforts to ensure quality and reliability in the medical devices sector, was recommended by the Drug Technical Advisory Board (DTAB) at its meeting on November 29, it is learnt.
As per 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.
The proposed measure, cleared by the apex drug technical body, will provide an exemption to the mandatory NABL accreditation clause in the case of state and central laboratories which have already been testing medical devices including catheters, surgical dressings and absorbent cotton for at least two years.
According to industry sources, testing at accredited and reliable facilities is imperative to ensure patient safety as decision on performance evaluation of these products is made by the manufacturer and the regulator on the basis of these reports. Stringent measures to ensure rule compliance is crucial to the medical industry, which is facing a credibility crisis in the wake of media reports revealing regulatory inadequacies, they say.
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.
The government move to dilute norms for state labs has come as a surprise for many. A few months back, the Central Drugs Standard Control Organisation (CDSCO) had asked NABL-accredited laboratories across the country with capacity to test medical devices to get themselves registered with the authority. The labs were also urged to communicate details about the devices and in vitro diagnostics that can be tested at their facilities. As per the notification, the information has been sought “in light of MD Rules and those labs which are found suitable may officially be designated as central medical device testing lab for the purpose of testing”.
Industry experts also question the DTAB’s ability and expertise to arrive at decisions pertaining to medical devices that have a different engineering technology and bat for a Medical Devices Experts Advisory Group. In many developed nations, for instance the UK, a Devices Expert Advisory Committee is in place and is responsible for providing independent, external expert input on medical devices to the Medicines and Healthcare products Regulatory Agency, the apex healthcare regulator.
