Govt Proposes Mandatory BIS Quality Approval For Selected Medical Devices

New Delhi, 18 Feb 2019: The Department of Pharmaceuticals (DoP) has issued six draft quality control orders (QCOs), setting norms in accordance with the Bureau of Indian Standards(BIS) for some medical devices including clinical electrical thermometers and blood glucose monitoring system or Self Testing in Managing Diabetes Mellitus, to ensure safety and effectiveness. 

The orders, once come into force, will make BIS the certifying and enforcing authority in the case of these devices. 

The medical electrical devices to be brought under BIS quality control are cardiac defibrillators, infant radiant warmers, multi-function patient monitoring equipment and pulse oximeter equipment. 

Other products on the list include different types of sphygmomanometers, Rubber gloves and lades, Surgical, Detachable and Handles. The QCOs have been prepared in consultation with BIS and the government will accept comments and suggestions from various stakeholders until April 15.

As per the QCO, the devices should confirm to the corresponding standard specified and should bear the mark under a licence from the BIS. It won’t be applicable to products meant for exports. 

According to industry experts, regulating medical devices one by one as per D&C Act provisions has proved largely ineffective in ensuring patient safety and often resulted in harassment of manufacturers, arbitrary decisions and corruption in the past, as it creates confusion whether similar or connected devices and accessories have to be regulated or not. One way to resolve this issue is to invoke Bureau of Indian Standards Act to regulate medical devices as a group to eliminate sub-standard products of dubious origin.

However, many in the industry are disappointed with the government’s continuing pick-and-choose approach to medical devices. Making voluntary ISI marking mandatory for some devices won’t resolve the problem, they say.

“Strange are the ways of the government, for the last one year we have been requesting for creation of an inter-ministry working group to define minimum standards of quality under a QCO based on BIS standards. We sought application of initially horizontal standards common to all devices – for eg IS/ISO 13485 QMS standard. Neither DoP nor the health ministry, whom we subsequently requested, responded to our request as yet for creating this working group of experts. Now out of the blue, the DoP released this notification of QCO for some of these listed products for which BIS standards exist. Most frustrating experience of departments of government working to protect their turf,” Rajiv Nath, forum coordinator, Association of Indian Medical Device Industry, told Pharmabiz.

According to industry experts, the government is seeking compulsory BIS certification instead of an overarching quality and regulatory strategy that is imperative for the medical devices sector. They also criticise the unwillingness of a section of bureaucracy to engage and involve stakeholders like manufacturers at an earlier stage instead of seeking their inputs after issuing a draft notification. Pharmabiz