From the March 19, 2007, issue of "The Gray Sheet"
U.S. device industry stakeholders are planning formal talks with India's government about the creation of a regulatory body dedicated to medical devices.
Imports constitute 75% of India's $1.5 billion medical device market, projected to grow at a 12%-16% rate up to 2010, according to Pacific Bridge Medical, a consulting firm focusing on Asian markets for medical products. Many U.S. companies already operate in India, and all of them have to deal with the difficult reality that the majority of medical devices are defined and regulated as drugs.
Although legislation in the parliament is still pending, the Indian government cabinet approved a proposal in January to set up a more centralized regulatory body that would formally recognize and regulate medical devices.
"It is imperative that these regulations be developed in consultation with all stakeholders," Greg Kalbaugh, U.S.-India Business Council (USIBC) director of intellectual property, trade and labor, told "The Gray Sheet" March 13. USIBC, which is comprised of more than 300 U.S. companies with investment interests in India and about 25 global Indian companies, promotes U.S.-India free trade and commercial enterprises.
The group hosted a U.S.-India High Technology Cooperation Group (HTCG) meeting Feb. 22 at which discussions on medical devices were included for the first time. At the meeting, which both U.S. and Indian government representatives attended, USIBC decided to spearhead a joint private-sector working group dedicated to issues facing the medical device industry in India, foremost the development of a regulatory regime for medical devices.
Also, U.S. government representatives agreed during the meeting to travel to India this year - as early as this summer - to discuss business development issues. Part of the talks will be dedicated specifically to addressing medical device industry interests.
"We would obviously support that by bringing the private sector delegates along," Kalbaugh said. "So there would be government-to-government meetings, there would be public-private meetings, and there would be private sector meetings."
Kalbaugh says the mission and accompanying group will focus on both the creation of a regulatory regime for medical devices and promoting the industry in general.
"Everybody was on the same page and everybody agreed that as India develops its regulatory regime, it needs to develop in the right way," Kalbaugh said of U.S. and Indian parties at the Feb. 22 meeting. "And that's going to be important for setting the stage for growth for domestic industry as well as for the entrance of our companies and their technology and their health care."
On the U.S. side of the planned meetings, USIBC will work along with AdvaMed. The Indian cohort will include the Confederation of Indian Industry and the Federation of Indian Chambers of Commerce and Industry. Both sides will also include other interested private sector stakeholders.
India's Device Regs Still Evolving
The pending proposal would create an FDA-like Central Drug Authority of India with regulatory and surveillance powers. The new agency would define medical devices separately from drugs and include a department dedicated to the regulation of all imported and domestic devices. The prospective body would also centralize many of the duties currently shared between the federal and state bodies.
In the current system, most medical devices are defined and regulated as drugs under India's Drug & Cosmetics Act, enacted in 1945. The Central Drug Standards Control Organization shares regulatory duties with state authorities.
Last year, the Indian government began requiring manufacturers to register many implantable devices. Registered devices are subject to device-specific regulations in addition to the broader drug regulations, as long as the two do not directly conflict. But, according to Sunil Patel, a consultant with Pacific Bridge Medical, no clear definition of devices or consistent device regulation procedures yet exists.
- Adosh Unni
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