Indian device makers want regulation and get it

Strange story came across the Internet this morning. It was from a site called Thaindian News saying India's medical device industry was seeking, and getting, new regulations from the government.

This seemed positively unAmerican (which by definition it was) so I checked it out with the story's reference -- the Confederation of Indian Industry -- a sort of Business Roundtable for Indian companies.

Sure enough. It's true. The $2.12 billion industry is on a hockey stick growth curve and will have sales of nearly $5 billion by 2012. So they want world-standard regulation to go with that.

Turns out Americans have been pushing this for some time. U.S. manufacturers were concerned that their devices were being regulated like drugs, and want "an FDA-like Central Drug Authority of India with regulatory and surveillance powers" along with a separate department for medical devices.

What's in it for India? A regulatory regime based on western standards makes it easier not only to defend the home market but to grow exports.

As Himanshu Baid, managing director of Poly Medicure, an Indian device maker, told the Business Standard last year, "There has to be some clarity on this before Indian players can sell their cost-effective devices in the domestic market."

Cost-effective is the key phrase there.

You might see this as a case of law following the money. India only adopted a uniform patent system in 2005, and already some 64 medical device patents have been granted. Now, with a Western-style device regulatory regime, we're facing a level playing field.