Health ministry to amend MD Rules to do away with mandatory submission of TSE, BSE certificates by medical device makers

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The Central government may soon do away with the mandatory submission of transmissible spongiform encephalopathies (TSEs) or bovine spongiform encephalopathy (BSE) certificates by manufacturers of medical devices using materials of biological origin.

The guidelines for biological safety in the fourth schedule of the Medical Devices (MD) Rules of 2017 will be amended and rephrased to make them compliant with the safety conditions of the World Organisation of Animal Health, an inter-governmental organisation responsible for animal health, and US Food and Drug Administration.

The plan to change the safety regulations, proposed by the Sree Chitra Tirunal Institute for Medical Sciences and Technology (SCTIMST), was cleared by the Drug Technical Advisory Board, the minutes of the meeting show.

Animal tissues and their derivatives are used globally in various medical devices. Such products can be a major part of devices such as bovine or porcine heart valves and bone substitutes for use in dental or orthopaedic applications. They are also widely utilised as product coating or impregnation during the manufacturing process.

BSE, commonly known as ‘mad cow disease’ and TSEs are a family of illnesses of humans and animals. They are characterised by spongy degeneration of the brain with severe and fatal neurological signs and symptoms.

As per the fourth schedule of the MD Rules, which specifies the requirements for biological safety, the manufacturer has to provide a list of all materials of animal or human origin used in the device. For these materials, data on the selection of sources or donors, harvesting, processing, preservation, testing and handling of tissues, cells and substances should be made available. Process validation results should be included to substantiate manufacturing procedures and TSEs or BSE certificates should also be submitted.

In its representation to the Central Drugs Standard Control Organisation, SCTIMST has stated that India is among countries of negligible BSE risk category and is compliant with safety conditions according to the WOAH. “Regulators such as US FDA have provision for allowing devices made of materials of cattle origin from countries which have no incidence of TSEs or BSE. Considering the fact that India is not included in the list of countries codified under the FDA and has no reported incidence of these diseases, it can be surmised that medical devices made of cattle materials of Indian origin can be used in medical devices,” SCTIMST further pointed out.

Earlier this year, the health ministry came up with the safety and performance guidelines on medical devices that are applicable to all products, including in vitro diagnostics. The guidelines provide an overview of essential principles but do not dictate how manufacturers should prove the effectiveness and safety of their products, thereby giving room for innovation and technological advancement.

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