No more unregulated medical devices

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Preparations are underway to implement regulations that will control all medical devices across the country. The Drug Controller General of India (DCGI) plans to enforce new regulations from 1st October. Under the new system, all four categories of medical devices will fall within the purview of regulations, ensuring quality control of the devices. Currently, only category A and B medical devices are being regulated, while category C and D medical devices remain outside the purview of regulations. Medical devices falling under category A and B have low to medium risk, while those falling under category C and D have high to very high risk.

What’s the situation? According to Rajeev Singh Raghuvanshi, the Drug Controller General of India, the medical device manufacturing sector is an emerging sector. During the pandemic, the demand for various medical products increased, and due to the government’s emphasis on Make in India, this sector is growing rapidly. Bringing all types of medical devices under regulation will ensure quality in their production. The current goal is to increase the country’s pharmaceutical industry from the existing $50 billion to over $100 billion by 2028 and more than $120 billion by 2030. To take advantage of the opportunities in this sector, it is necessary to ensure the quality of products.

It should be noted that the Central Cabinet approved the National Medical Devices Policy 2023 on 26th April to ensure the quality of medical devices. In 2020, India’s medical device market was approximately $11 billion, and it is estimated to have a 1.5% share in the global market.