Jogo de India para regular a indústria médica do dispositivo

por Brendon Nafziger, DOTmed News Associate Editor | June 23, 2010
India would have
control over some
medical devices.
India is set to reverse its hands-off policy on medical devices, the Indian press is reporting, bringing closer scrutiny to a device industry that has up till now been largely left to its own devices.

On June 11, India's health ministry said it had proposed a law that would regulate the country's nearly $2 billion medical device industry, according to press accounts.

The law, the Central Devices Act, would require all device makers and importers to register with the Drugs Controller General of India. Makers of low-risk external devices such as X-rays would be allowed to self-regulate, while implantable products would fall directly under the DCGI's control, Dinesh Trivedi, minister of state for health and family welfare, told reporters, according to the Indian paper The Economic Times.

Currently, only 14 devices are classified as drugs and regulated by the Central Drugs Standard Control Organization. These include syringes, stents, catheters, heart valves, orthopedic implants and bone cements, according to the CDSCO's website.

The bill must be approved by the state governments, which are required to consent to health legislation in India, before it can be introduced into parliament during the upcoming summer assembly, called the monsoon session.