Even as the product quality of indigenously manufactured drug eluting stents (DES) is better than those produced globally, to enhance the prospects of the Indian industry in the global market, there is an urgent need to incentivise and create an eco -system for global players to set up R&D and manufacturing base in the country emulating the models in Ireland and the US. This will also help the domestic industry to realize its full potential, according to Ganesh Sabat, CEO, Sahajanand Medical Technologies (SMT).
The company recently concluded randomised clinical study of fourth generation DES against Abbott, the market leader in Europe across seven countries including UK, Netherlands, Italy, Poland in 27 centres, the report of which will be out next year.
“There is a need to analyse how global manufacturing and R& D base can be developed in India so that domestic players can be encouraged. We have to emulate the model of Ireland which is a medical device hub, has a sound ecosystem for investments, patent protection, flat tax rate for medical devices companies at 12.5 per cent, rebate on R & D, universities to support and offer dual specialization degree to produce medical device professionals,” he adds.
Specialisation in academics like biology, pharmacology and engineering which universities in Ireland are offering can help the professionals to hone engineering skills to implant the device and also to determine the clinical implications after the implantation to help create life saving medical devices.
Ireland has developed the ecosystem and requisite infrastructure for medical devices. Even California and Minnesota in the US are at the forefront of advancing technologies. Therefore, it is high time India to compete with Ireland and the US to lure global players to India, he emphasizes.
For this, there is a need to provide an ecosystem and also economic incentives to the global players. Last but not the least is the gap to fill in terms of specialised courses on regulatory approvals where we need to equip companies on documentation, approach in streamlining processes and skilled operators to possibly know how to work on a product having components as small a size that of a micron to be implanted inside the human body.
This also requires training of operators which is again of paramount importance, he pinpoints.
Though the future of healthcare is medical device and the market potential is multifold, yet nothing is in place, hence he adds that there is a need to analyse the market potential.
“Around 10 per cent of the revenue of SMT goes into R & D. It also becomes imperative for us to adopt best practices from global players having revenues ranging from US$10 billion to US$ 40 billion to bring in innovation and create a market in the country for medical devices,” he says.
Talking about the product quality and efficacy of DES produced in India, Sabat said that SMT and indigenous players have been able to bridge the demand -supply gap post the price capping exercise of the government covering coronary stents and implants.
He informed that good quality cardiac stents are widely available at government notified prices to accomplish 1500 angioplasties done per day in India, highlighting the potential of Indian stent manufacturers over MNCs.