Even as the essentiality of medical device like stents will be determined by the Government on the basis of the critical nature of their use in the human body, its performance and regulatory compliance, only 0.02 per cent population of India undergoes angioplasty every year. This is way too low when compared to several other healthcare emergencies in the country.
There is a wrong perception that one per cent of population (12 million people) undergoes angioplasty every year in India. Around 33 per cent of coronary stents are already being provided to beneficiaries of Central and State Government schemes at subsidized prices to ensure access and affordability.
Recently released government data also reveals that total coronary interventions in 2014 were 2.48 lakh and total of 3.10 lakh stents were implanted at an average of 1.2 stents per procedure. According to this data, 56.1 per cent of the total procedures were funded by government and private insurance.
According to a manufacturer, three lakh drug eluting stents (DES) were sold in India in the year 2014 of which one lakh DES were sold as a part of government healthcare schemes. DES was launched in India in 2006 and has evolved as a technology to give better patient health outcomes in terms of clearing heart blockages as compared to bare metal stents. The MRP of a DES ranges anywhere between Rs.75,000 to Rs.2 lakh+ while bare metal stent costs two to three times less or more if delivered through government healthcare schemes.
Industry experts pinpoint that treating all the drug eluting stents as same is like treating all antibiotics as same. DES is a category, it is not a product. Drugs and devices are inherently different in their composition as well as the market that they cater. Identical policy measures for drugs and devices would be detrimental to the device industry.
Subsequent to Government's plan to fix prices of medical devices based on its study in the past two years considering its essentiality and affordability, Industry bodies have also asserted that Government should ensure that best quality stents and medical devices are provided and sub-standard devices should not be marketed.