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Sree Chitra aims big in medical devices sector

Vinson Kurian

Thiruvananthapuram , Dec. 8

THE Sree Chitra Tirunal Institute for Medical Sciences and Technology here visualises a major role for itself in the evolving medical devices sector in the country.

The objective has been delineated in a Vision 2020 document prepared by the biomedical technology wing of the Institute. According to Dr G.S. Bhuvaneshwar, Head of the biomedical technology wing, it would play the role of a strategic investor, facilitator and catalyst in the development of the Indian medical devices industry under a Tenth Plan action programme.

The institute's facility has just been certified by international assessors COFRAC of France as complying with ISO/IEC 17025 standards with respect to testing services for medical devices. This is perhaps the first laboratory in South Asia to be assessed in this manner.

The wing plans to invest in manpower development and high-quality research. It proposes to start an MS course in biomedical technology in partnership with a leading academic institution, even as it would focus on business-driven development in implantables.

Tissue engineering is another sector that is being pursued with interest. In its role as a facilitator, the division sees itself emerging as a national test centre for biomaterials and medical devices.

Testing services accredited to international standards would be ensured in this manner. A modular flexible manufacturing facility and incubation centre would also be set up as part of the programme.

The biomedical wing would seek to catalyse ideas and concepts through the proposed information services and industrial consultancy, Dr Bhuvaneshwar said. The goal is to ensure a knowledge-based industrial growth.

Among a series of initiatives planned in association with prospective partners is a survey on the medical devices sector, spearheaded by consultancy major McKinsey.

Support programmes for the industry have been envisaged with an aim to enable members to deal with the nitty-gritty of global regulatory requirements, particularly CE (Consultants Europe) certification of medical devices.

Consultants Europe is a technical and legal organisation specialised in the CE mark and CE marking certification of products. It is active worldwide and offers a complete range of technical legal services ensuring that products comply with the CE mark and CE marking regulations.

Among other initiatives are the setting up and management of a technology business incubator for medical devices at the biomedical wing. Dwelling on factors affecting the growth of medical devices industry in India, Dr Bhuvaneshwar said non-availability of technology, which is expensive in the first place, was a major limiting aspect.

Lack of trained manpower familiar with Good Manufacturing Practices, research and development and regulatory requirements had also hampered the prospects. Non-availability of, and in some cases lack of access to, information sources also limited the scope of growth in the sector.

Among other barriers the industry had run into were insufficient technology development and entrepreneurship, very little testing and qualification facilities and the absence of an Indian regulatory authority, Dr Bhuvaneshwar summarised.

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