Made-in-India heart valves

Patients forced to pay lakhs for imported valves as country’s first medical SEZ has been stuck since 2012 for lack of clearances
There’s many a slip be tween PM Narendra Modi’s pet slogan ­ Make in India ­ and harsh reality. A glaring example of this is an ambitious project for the manufacture of lifesaving heart valves. Held up since 2012, the project is mired in a mesh of pending approvals, delayed clearances and lack of financing options.

Every year, Indians suffering from heart valve disease spend crores (see box) on importing expensive replacements from abroad. Many die because they cannot afford the cost. An indigenously made bioprosthetic valve would make treatment accessible to thousands. It would also make India only the third country to manufacture these valves after the US and Brazil.

But that’s not happening yet. Frontier Mediville, India’s first SEZ for research in basic medical sciences, is the brainchild of renowned cardiac surgeon Dr K M Cherian. He bought the land and the foundation stone was laid in March 2008, 40 km from Chennai in Tiruvallur district. Developed as a joint venture with Tamil Nadu Industrial Developmental Corporation (TIDCO) under public-private partnership, the Mediville project was accorded SEZ status for the biotechnology sector by the commerce ministry in March 2009.heart valves

In this state-of-the-art facility, bioprosthetic valves are to be manufactured in collaboration with the Georgia Institute of Technology in the US and prototypes are to be developed at the Global Centre for Medical Innovation in the US, with these institutions signing agreements to ensure technology transfers and training of Mediville staff, including girls from villages nearby . Mediville has also entered into MoUs to collaborate with several other international centres.

The process to get approval from the Committee for the Purpose of Control and Supervision of Experiments on Animals (CPCSEA) to house large and small animals for R&D purposes started in 2013 and is still on. Similarly, the process for getting approval to conduct phase-II clinical trials from the Drug Controller General of India started in September 2010 and was finally completed in 2014. This also involved clearances by Indian Council for Medical Research. Now, the approval for phase-III trials is pending with the DCGI.

“In China, approvals take seven days; in Singapore it takes 12 days and it takes a month in Japan. In comparison, in India it takes years, with no clear reasons given. This is why biotech companies and R&D facilities are locating elsewhere,“ said Dr Cherian.

Time overruns have also led to massive cost overruns. Despite restructuring of loans by the financing banks, the long gestation required for healthcare R&D has created a crisis for the project. Dr Cherian who met the PM is hopeful: “He said policy changes are needed to address these problems and would take time. But I wonder if he realises how out of sync the bureaucracy and regulatory bodies are with his vision. Plus, there has to be a radical change in the way R&D is viewed by the financial system.“

The 360-acre Mediville campus includes facilities to carry out Phase-I clinical trials and bioequivalence and bioavailability studies. It includes classrooms, training facilities and libraries to help train people in medical R&D in keeping with the Skill India vision.

Source: Times of India 24 Jan’2016