Indian Device Industry Pushes for Certification Requirement Options

India’s medical device industry is urging the country’s government to do away with the insistence on U.S. FDA approval in the tendering process for the public healthcare system and to replace it with more democratic options.

Insistence on an exclusionary FDA certification requirement is a discriminatory clause, as it favors large U.S. companies in the domestic public healthcare procurement process, says Rajiv Nath, forum coordinator of the Association of Indian Medical Device Industry.

“This insistence is a pure absurdity and has resulted in exclusion of domestic manufacturers and manufacturers from other countries from bidding and hiking up the healthcare costs,” Nath says.

Nath points out that India has very competent manufacturers with European Certification or the CE Mark. An additional option could be ISO 13485 certification from a reputable, competent and accredited certification body, while the FDA could be an alternate option, he adds.

Amending the technical specifications would make the bidding process more competitive and democratic, and manufacturers from all over the world could participate in the public healthcare procurement process, Nath says.

“In no country of the world do medical institutions demand that manufacturers meet foreign standards and specification, and invariably have technical certifications to encourage local job creation and local manufacturing industry,” says Mala Vazirani, director of Transasia, a large diagnostic company in India.

“Every government’s mission is to lower healthcare cost and to do away with discrimination against domestic manufacturers. This protectionist policy is particularly the trend for decades in Europe, the USA and Japan, so why not India?” she adds. — Jonathon Shacat