New Delhi, May 22 (KNN) The Central Drugs and Standards Control Organisation (CDSCO) and the Bureau of Indian Standards (BIS) are in the process of revising and enhancing the benchmarks for the safety and performance of life-saving medical devices available in India.

This move comes as the Indian government recognises the need to keep pace with evolving technologies in the medical sciences sector, reported Mint.

Currently, there are approximately 1,500 standards governing different pharmaceutical products in the country.

However, the medical device landscape is more expansive, with around 6,000 different devices in use. The CDSCO has classified approximately 3,000 of these medical devices into various categories based on their intended use.

The forthcoming regulations aim to establish harmonised governance within the medical device industry. Discussions are ongoing between the Department of Pharmaceuticals, NITI Aayog, and the Union Health Ministry to finalise the updated norms.

The medical device market in India is a rapidly growing segment, valued at an estimated USD 11 billion in 2020 and accounting for approximately 1.5 per cent of the global market share.

These products encompass a wide range of items, including electronic equipment, implants, consumables, disposables, surgical instruments, and in-vitro diagnostic reagents, among others.

India currently relies on imports for nearly 80 per cent of its medical device needs. However, the government is actively working to establish medical device clusters and parks to reduce this import dependency.

A senior official from the regulatory authorities stated, "We are in the process of formulating standards for all types of medical devices available in the country.”

He also highlighted, “The Bureau of Indian Standards has limited existing standards, so we are revising the standards for all products.”

“The devices should meet essential safety and performance criteria, allowing manufacturers the flexibility to choose applicable standards. It is mandatory for manufacturers to comply with the standards for their products," the official added.

The official further emphasised, "Since technology is rapidly evolving, it is crucial to periodically review and update the standards to ensure that products meet the required quality and safety benchmarks."

Rajiv Nath, Forum Coordinator, Association of Indian Manufacturers of Medical Devices (AiMeD), expressed gratitude towards the government's efforts, stating, "We are very thankful to the government that in the last 5 years, there has been exemplary progress in publishing new standards for medical devices by adopting ISO standards.”

He mentioned, “This helps manufacturers and procurement professionals align with the right quality and performance specifications."

(KNN Bureau)