India needs regulatory body for medical devices: Kiran Mazumdar-Shaw

Biotech entrepreneur Kiran Mazumdar-Shaw has called for establishing a standard-setting regulatory body for medical devices, as non-certified ones put patients at serious risk. The Chairperson and Managing Director of biotechnlogy firm Biocon told PTI,

"I certainly think we need to have a standard setting regulatory body for medical devices. Precision of any medical intervention is critical as we cannot afford to have non-certified medical devices in the market as we will put patients at serious risk."

On the National Pharmaceutical Pricing Authority's recent decision fixing price caps on coronary stents, Mazumdar-Shaw said price control on stents need to factor in the design and material of their construction.

"Stents are not generic. NPPA needs to understand," she said.

"NPPA is an important pharma pricing regulator. However, they need to negotiate prices upfront and not in an adhoc manner after launch," Mazumdar-Shaw commented when asked about its functioning and scope for improvement.

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According to her, a credible regulatory and quality compliance system that benchmarks to internationally acceptable standards is needed to promote medical devices sector, including exports.

Earlier this month, NPPA cut prices of life-saving coronary stents by up to 85 per cent by capping them at Rs 7,260 for bare metal ones and Rs 29,600 for drug eluting variety.

The maximum retail prices of bare metal stents and drug eluting stents would be Rs 7,623 and Rs 31,080, respectively, inclusive of VAT and other local taxes.

A coronary stent is a tube-shaped device placed in the arteries that supply blood to the heart. It keeps the arteries open in the treatment of coronary heart diseases.

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