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Stent Effect: Government Plans To Create Standards For Medical Devices Based On Pricing

The government has made a separate committee to create guidelines under G.N Singh, DCGI

Photo Credit : Shutterstock


Country's two largest bodies in drug regulation have come together to solve your worries related to medical devices. Drug pricing regulator, National Pharmaceutical Pricing Authority (NPPA) and drug quality controller, Drug Controller General of India (DCGI) are planning to bring further clarity on sales of proficient medical devices in the market.

The move comes after bringing stents, a tiny tube-shaped device placed in narrowed or blocked coronary arteries to maintain blood supply to the heart, under price control, last month. On 13 February, NPPA fixed ceiling prices of bare metal stents at Rs7,260 per unit and those of drug-eluting stents and biodegradable stents at Rs 29,600 per unit in a bid to provide affordable treatment to patients.

While the move has been widely appreciated, health activists raised several concerns related to the price and quality correlation. To address those concerns, NPPA has requested Ministry of Health and Family Welfare to look at strategies that how the government would instil confidence in patients and ensure that medical devices, which are now cheaper, are supported by rigorous testing and regulatory approvals. "We may conduct a study which could track the scientific record of a medical device to establish a relationship between price and quality of products. Or a new certification authority may come into place," said a senior official at heath ministry requesting anonymity.

On the other hand, the government has made a separate committee to create guidelines under G.N Singh, DCGI. "After NPPA's brave decision, we need to put a system in place so that manufacturers don't play with the quality of products to adjust reduced prices," Singh told Businessworld.

Singh pointed that country lacks global benchmarks and standards to measure the efficacy of medical devices. " We have formed a subject expert committee which is heading the plan and forming guidelines for medical devices. We are re-working on medical device pharmacovigilance program, to track the success and failure rate of medical devices under different categories and brands," Singh said.

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stents stents business medical devices drug regulation nppa