CHENNAI: IT was billed as India’s first Medical Special Economic Zone (SEZ) and launched with great fanfare seven years ago. Unfortunately it has landed in the financial ICU. In 2009, when Mediville project of Frontier Lifeline at Elavur village near Gummidipoondi was accorded the SEZ status, hopes were high among the healthcare fraternity that it would usher in indigenous development of new technologies and pre-clinical animal trials.
However, that seems to have been just a mirage. Despite having the potential to become a major player medical R&D with its world-class facilities, the project has been burdened by cost overruns and project delays.
The creditors are exploring options to auction the assets to recover outstanding loans. State Bank of India, one of main lenders, has classified it as a non-performing asset (NPA).
Acknowledging the problem, Dr KM Cherian, Founder Chairman, Frontier Mediville, told Express that he was helpless.
“I chose to return to India, leaving a lucrative career in Australia and the US, to do something for the country. Today, I stand disappointed. I want to put India on the map as a global player of high end medical products, thereby greatly reducing the cost of healthcare in India. But the complex bureaucratic system has derailed my dream. It took us six years to build the facility, now we are facing the uphill challenge of getting permissions for the research projects,” he rued.
Though several domestic and international research institutes are queuing-up to collaborate with Mediville, he said research projects are not materialising due to delay in getting approvals from multiple departments.
According to him Mediville has lost a revenue of $3.5 million last year alone. Five Indian companies showed interest in conducting pre-clinical trials at Mediville and later approached facilities in China and Singapore. Documents available show the world’s leading medical device company, Medtronic, headquartered in Dublin, Ireland, had envisaged interest to collaborate and so had Argentina.
Clients can’t wait for 1-2 years to start work. In China, approvals can be obtained in 10 days and in Singapore, it takes maximum three weeks. Here, government agencies like committee for the purpose of control and supervision of experiments on animals (CPCSEA), central drugs standard control organisation and Indian council for medical research take ages to give approval.
For instance, Mediville had applied for approval to conduct phase III clinical trial to determine the efficacy, safety and tolerability of tissue engineered xenograft valves in patients with structural heart disease and pulmonary stenosis. The six-member panel headed by Dr Soumya Swaminathan, secretary, Department of Health Research and Director General, ICMR, has been sitting on the project for the past two months.
The Union health Ministry and Central Drugs Standard Control Organisation have forwarded the proposal. The well documented phase II trials were recognised by the international community. “Now, my question is why the unnecessary delay. Our phase III trials involved biological and bioprosthetic valves, which are more desirable than current mechanical valves. Once commercial manufacturing gets started, costs will get cut down by 50 per cent. Ultimately, people of our country are benefited, but the government does not understand this,” Dr Cherian said, adding that he had even met PM Narendra Modi, taking 30 minutes to explain the issues.
On current projects, Dr Cherian said CPCSEA has approved pre-clinical animal trials to be conducted on 16 male pigs and 8 beagles, for an instrument called Hemostat.
Mediville signed a MoU with a Russian manufacturer to make artificial hearts, and may land in trouble if the State doesn’t extend financial assistance.
Dr Cherian said considering the huge cost in the manufacture of HeartMate, Mediville had proposed to carry out the project under public private partnership with the TN government. CM Jayalalithaa was instrumental in identifying the land for Mediville during its inception stage, he said, pinning all hopes on her.
I chose to return to India, leaving a lucrative career in Australia and the United States, to do something for the country. Today, I stand disappointed. I want to put India on the map as a global player of high end medical products, thereby greatly reducing the cost of healthcare in India. But the complex bureaucratic system has derailed my dream. It took us six years to build the facility, now we are facing the uphill challenge of getting permissions for the research projects Dr KM Cherian, Founder Chairman of Frontier Mediville