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Medical devices to face tougher safety norms; CDSCO revisiting standards

Life-saving medical devices will soon have to face tougher safety norms. The Central Drugs and Standards Control Organization (CDSCO) and the Bureau of Indian Standards (BIS) are revisiting the benchmarks set for life-saving medical devices available in the country, said an official.

Given evolving technology in medical sciences, the Union government is now evaluating standards of medical devices for safety and performance.

Currently, there are around 1,500 standards for different pharmaceutical items available in the country.

There are approx 6,000 medical devices in the country. However, CDSCO has classified around 3,000 medical devices in different categories based on usage.

Towards harmonized regulation
The new norms will ensure harmonized regulation in the medical device sector. Discussions are going on with the Department of pharmaceuticals, NITI Aayog and the union health ministry.

The medical devices sector in India is a sunrise sector with the market size estimated to be $11 billion in 2020. Its share in the global medical device market is estimated to be 1.5%. These expensive pharma products comprise electronic equipment; implants; consumables and disposables; surgical instruments and in-vitro diagnostic reagents among others.

India is 80% dependent on imported medical devices. However, the government is working on medical device clusters and parks to reduce import dependency.

“We are in the process of framing the standards for all kinds of medical devices available in the country. Already, BIS has limited standards, so we are sort of revising the standards for all products. The device should have the essential principal checklist for safety and performance, so that manufacturers are given the liberty to choose the applicable standards for their devices. Therefore, it is compulsory for manufacturers to meet the standards for their product,” said the official.

Keeping standards with time
“Since technology is drastically evolving, it is very important to revise the standards from time-to-time to ensure that the product meets the quality and standards, added the official.

Standards help in many ways. They can facilitate trade and commerce, improve processes and make them more efficient, guide in consistent functioning and quality, simplify comparison of products & services, ensure health and safety, conserve resources and reduce impact on our environment and promote technological developments.

“Review of medical devices standards published by BIS is an ongoing dynamic process to align with latest ISO standards that have undergone or undergoing revisions as well as requests from stakeholders. We are very thankful to the government that in the last 5 years there’s been exemplary progress in publishing new standards for medical devices by adopting ISO standards. This helps manufacturers and procurement professionals get aligned to seeking the right quality of performance specifications,” said Rajiv Nath, Forum Coordinator, Association of Indian Manufacturers of Medical Devices (AiMeD).

Queries sent to the health ministry and BIS spokesperson remained unanswered till press time. LiveMint

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