Medical equipment giant — Medtronic had to cancel plans for demonstration of a non-surgical valve replacement procedure at the eleventh hour after the Medical Council of India denied it permission.
"We are evaluating MCI's reason for rejection and will accordingly make a representation to them," said Pawandeep Kaur, Medtronic India spokesperson.The MCI said that the company did not have the required clearances.
“Any surgeon from abroad, wanting to perform a surgery for a product launch or for academic purpose, needs to obtain a temporary registration from MCI. They did not have the permission,” said a member, MCI, on condition of anonymity.
Medtronic is promoting Transcatheter Aortic Valve Implantation (TAVI), which is a minimally-invasive procedure in which a damaged valve can be replaced using non-invasive techniques.
Heart valves replacement is conventionally done using open heart surgery.
MCI also raised issues about charging the patient R12.26 lakh for the product, which they were using for the demonstration, which was scheduled to be held in five hospitals in three cities — Delhi, Mumbai and Bangalore.
Dr Purushottam Lal, director, intervention cardiology at Metro Hospitals, claims he has been doing the same surgery at his hospital for R2.5 lakh.
Dr Lal has also written to Union Health Minister Ghulam Nabi Azad for intervention in the issue (HT has a copy of the letter). “It has been seen that foreign companies have been charging huge amounts from Indian patients for a device which was first introduced in our own country,” read the letter. “The cost to the patient for the replacement of the valve with Medtronic Core Valve will be R12.26 lakh without surgery..., where open heart surgery using the valve in India costs only between R2- 2.5 lakh,” he said.
Medtronic denied the charge. “There is no other such TAVI therapy available at same/lower cost currently in India. We are talking of a breakthrough technology," said a statement from Medtronic India.