Through Medical Device Rules, the Centre will be able to keep a quality check on all medical devices available in the market.
Industry has hailed registration of medical devices as mandated and notified by the Drugs Controller General of India (DCGI) towards quality assurance of products in India.
State Drug Controllers (SDCs) recently issued notices to all the medical device manufacturers based on the instructions from the Central Drugs Standard Control Organisation (CDSCO), urging medical device manufacturers to register themselves under the Medical Devices Rules (MDR), 2017 by September 30, 2022 towards transitioning to the new medical device licensing regime.
It has been stated in the notice that legal action will be taken if manufacturers do not register their products by the stipulated deadline of September 2022.
Previously, notified medical devices were registered under the Drugs and Cosmetics (D&C) Rules, 1945. Among the medical devices categorised as low risk (group A), low moderate risk (group B), moderate high risk (group C) and high risk (group D) are those used for preventive care, diagnosis, or therapy.
Groups A and B will be controlled by SDCs, while Groups C and D will fall under the CDSCO’s jurisdiction.
Through Medical Device Rules, the Centre will be able to keep a quality check on all medical devices available in the market. Last two years have seen an influx of such products and are widely being used due to ease and convenience they provides.
Morepen Laboratories Ltd which has products whose sales spiked up during the COVID-19 pandemic such as Glucometer and BP monitor in this segment that sells under its Dr Morepen brand has welcomed this development.
Sushil Suri, Chairman and Managing Director of Morepen Laboratories said, “The amendment has been made with the aim to enable quality check of the products thus, protecting the interest of consumers using it. Therapeutic, preventive care and diagnostic devices are largely a part of this category, which can pose high risk on patients’ health in case a false or wrong diagnosis is made.”
“Registration of medical device will restrict the inflow of fake products. As the pandemic wanes off, these products will be used not only for aiding the treatment of acute and chronic medical disorders, but also work as a tool for disease prevention and lifestyle checks,” he added.
With COVID-19 in the past two years, many kinds of medical devices have become a necessity in every home. People have realised the importance of keeping a regular check on their health independently. This has resulted in the purchase of blood glucose monitors, blood pressure monitors and oximeters among other devices that can be utilised from the comfort of one’s home.
Suri further revealed, “There has been a huge influx of local, unorganised, non-licenced, and application-based products in this category that are being widely used without an understanding of its working or its implications. This is an alarming situation where a proper guideline and education for these devices are imperative. Therefore, introducing a regulation in this space had become necessary to further organise the sector. Such an initiative from the Government is a means of bringing transparency, and protecting consumer interest.”
The Medical Device rules comply with worldwide regulatory standards and offer comprehensive laws for the regulation of medical devices, further promoting initiatives of the Government such as Make in India.
“This intervention will help organisations to have a stringent mechanism in place. We realise that there are enough and more companies willing to get into this space and benefit out of from the amendment. The players in the industry are receptive of the registration process and look forward to meet the necessary compliances to further empower our consumers,” industry experts conclude.
