The Indian government is creating a dedicated authority to oversee the regulation and production of medical devices, taking the first steps to separate the sector from the nation’s pharmaceutical regulatory regime.
The plan is the latest attempt by the government to improve device quality in the absence of statutory regulations. Efforts to pass regulations in Parliament have failed repeatedly and registration of devices is limited to certain product categories under the country’s drug laws.
India would also like to get a bigger slice of the global medtech pie. The government estimates its local industry contributes about $4.8 billion of the $220 billion worldwide market and most of its business is in disposables and medical supplies. About 65 percent of the country’s medical devices, including nearly all implantable devices, are imported.
The government is considering offering incentives to the device industry, such as preferred purchasing of locally made devices, seed capital and viability gap funding, tariffs and revised tax and duty structures to attract new companies and have existing companies expand.
The National Medical Device Authority is to be headed by a cabinet-level secretary or joint secretary and housed within the Department of Pharmaceuticals.
Its responsibilities include setting up and managing medical device mega parks throughout the country, creating manufacturing benchmarks based on international best practices and partnering with industry to develop knowledge networks.
The government is seeking comment from industry groups through July 15.