Sunday, Dec 14, 2003
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By N. Gopal Raj
For the moment, only some encouraging glimmerings suggest such a possibility exists. About 80 per cent of the Indian drugs market of Rs. 18,000 crores is met by the domestic industry. Just the opposite is true of the Rs. 7,000 crore market in India for medical devices, 80 per cent of which is met through imports.
But one Surat based company is already demonstrating that critical high-quality medical devices can be precision manufactured in India with indigenous technology to stringent European quality standards. The Sahajanand group began by providing laser solutions for the diamond processing industry and then expanded to developing surgical lasers. Sahajanand Medical Technologies used this expertise to design and manufacture coronary stents required in certain heart operations. Not only was the stent designed in-house, but the company also made the computer-aided laser micro-machining equipment to cut intricate struts in fine stainless steel tubes, says Rajesh Vaishnav, a director of the company.
This stent received Europe's CE (Conformitee Europeenne) quality certification in 2001 and is now being exported to a number of countries, according to Mr. Vaishnav. The company at present exports twice as many stents as it sells domestically. Sahajanand introduced a drug-eluting stent last year and is now working to get CE certification for it.
Only biomedical devices which are CE certified can be exported to the European Union and, likewise, the U.S. Food and Drug Administration (FDA) approval is needed for selling in the U.S. Moreover, devices which have such clearances are more easily accepted in other countries as well. TTK Healthcare has started the process for getting CE certification for the heart valve it manufactures, says A. V. Ramani, the company's Senior Vice-President for R&D. As a number of government regulated bodies in Europe can issue the CE certification, the process is less bureaucratic than the centralised procedure for getting the U.S. Food and Drug Administration (FDA) approval, according to him.
Certain laboratories of the Biomedical Technology wing of the Sree Chitra Tirunal Institute for Medical Sciences & Technology, Thiruvananthapuram, have now received appropriate ISO certification. "This means that a number of tests needed to get European and U.S. regulatory approval for biomedical devices can be carried out here," says G. S. Bhuvaneshwar, who heads the Biomedical wing. "Indian companies making biomedical devices should be aiming at a global market and, with our lower costs of testing, we can help them get the required approvals," he adds. Many foreign companies were also showing interest in getting their testing done at the institute, the first in the country to get such certification for biomedical device testing.
India is well placed for manufacturing biomedical devices for the domestic market and for export, believes Mr. Ramani. "Over the next five years or so, you'll probably see joint-venture and Indian companies entering this field," he told The Hindu. Such companies would be able to produce high-quality products at much lower cost. The price of heart-valves, including of imported valves, dropped sharply after TTK began making the heart valve developed at the Sree Chitra Tirunal. Similar cost-reductions occurred when other biomedical devices began to be produced in the country, he points out.When the country establishes a national regulatory authority to control biomedical devices, the testing services at the Sree Chitra's biomedical wing would play an important part in preventing unsafe and untested products from being used, points K. Mohan Das, the Institute director.
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