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Medical devices sector needs compendium on similar lines of Pharmacopeia to bring in uniformity in standards: Veena Kohli

Nandita Vijay, Bengaluru
Saturday, February 17, 2018, 08:00 Hrs  [IST]

Indian medical device sector requires a compendium on similar lines that of Pharmacopeia that will have monographs for all medical devices with standard test procedures and specifications that would bring in uniform benchmark for quality and performance, said Veena Kohli, secretary, Association of Diagnostics Manufacturers of India and CEO, Vanguard Diagnostics.

This is the best way to give a fillip to the Union government’s Make in India initiative, she added.

Now the Make in India initiative can become a reality in the medical devices sector including in-vitro diagnostics only if efforts to upscale manufacturing standards  to global benchmarks are made. The factors which are prerequisite for the in-vitro diagnostics or any medical devices to be sold in the country is the access to technology. There is a need to adhere to uniform quality standards in manufacture. With this we will grow to the global standards only then the Make in India initiative will be a quality initiative, said Kohli on the sidelines of the 3rd edition of the India Pharma 2018 and India Medical Devices 2018 in Bengaluru.

With regard to access to technology, Kohli stated that the country has a treasure trove of the same which is locked in the research labs of institutions. These have to be available to the industry for commercialization. For the technologies which are not well built in India, it is critical to ensure that they must accessed from abroad through a collaboration or technology transfer pact from global players.  After we have overcome the hurdle of technology access in India, we need to make raw materials, components and spare parts easily available and locally manufactured at reasonable prices to be able to take the manufacturing forward in the country, she said.

The requirements of a uniform quality standards with a specific compendium  will enable the medical devices industry to be on par with global standards . Only then will the Make in India programme be a quality initiative. Therefore the  Indian medical devices sector needs a compendium on similar lines that of Pharmacopeia to bring in uniformity in standards she said.


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