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Here’s Is Why Medical Devices Need A Separate Regulator

According to a survey by Anna University, only one in five ventilators used in hospitals across Tamil Nadu has been certified safe for use by biomedical engineers.While there is no concrete data on complications and deaths caused by malfunctioning equipment it can certainly lead to catastrophic consequences. A lack of a regulatory framework for medical devices is the main reason behind this laxity. At present, only 23 categories of medical devices are regulated by the CDSCO, we need regulation for the rest.

NITI Aayog’s proposal of a separate regulatory body for medical devices is long overdue.

The National Health Protection Scheme has led to an increase in patient pool as well as bed capacity, and the medical devices industry is set to be one of the biggest beneficiaries. If the scheme is implemented effectively, we can expect a compound annual growth rate of at least 30% over three years.

At present, India imports over 80% of its medical devices and the government has stated its intention to make India a global hub for medical device manufacturing and distribution. Lack of predictability has been one of the biggest factors holding back investment.

It will be beneficial for everybody in the healthcare ecosystem to have clarity on future regulation. Manufacturers will be able to obtain licences under a streamlined framework and patients will be able to benefit from better diagnoses and treatments, helping us move closer to achieving universal health coverage in line with the UN SDGs.

It is important that the regulatory body has competent bio-medical engineers, technocrats, scientists, lab technicians, clinicians and surgeons. The range of medical devices is vast and these must not be seen through the lens of drugs & cosmetics, as medical devices do not have any systemic effect. Lack of regulation allows unscrupulous manufacturers to take advantage. To play safe, the government can start with experimenting with a handful of new devices. Meanwhile, it can go about seeking the expertise of players in the industry to draft the Bill. Once the Bill is drafted and approved by the stakeholders in the ecosystem, it can be passed in Parliament.-Financial Express


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