“Made in India”: How’s that for an indigenous medical device?

Abstract

With increasing costs of imported equipment, there is a need for Indigenization of medical devices in India. The resources including skilled manpower to develop equipment of a good standard are available in the country. What plagues the developmental process is the lack of adequate interaction between the medical profession and the technologists and reluctance of the industry to venture into the medical device manufacturing. A much bigger and more serious road-block is the lack of formal certification and regulatory processes for these devices. Medical practitioners should be open to evaluating and accepting indigenous equipment that pass the requisite standards. Formal mechanisms should be developed to orient both physicians and engineers to the technical and commercial issues of device development.

Key words

Equipment - health-care economics - indigenization - medical devices - regulation

• References

• 1 India in transition: Regulation of medical devices in India. Available from: http://www.casi.sas.upenn.edu/iit/kamal .[Last accessed on 2013 May 20].
• 2 Torsekar M. India’s medical device sector: Increasing U.S. export opportunities. USITC Executive Briefings on Trade June 2010. Available from: http://www.usitc.gov/publications/332/executive_briefings/FINAL_EBOT_torsekar_0630.pdf .[Last accessed on 2013 Jun 3].
• 3 Available from: http://www.medicaldevices.org/sites/default/files/India%20Medical%20Device%20Regulations.pdf .[Last accessed on 2013 Jun 3]
• 4 Sri Chitra Thirunal Institute for Medical Sciences and Technology Wing. Available from: http://www.sctimst.ac.in/About%20SCTIMST/Organisation/Biomedical%20Technology%20Wing/on .[Last accessed on 2013 Jun 3].