While the new Drugs and Cosmetics Bill 2015 was introduced to the Indian Parliament late last year, lawmakers in India’s lower house have yet to approve the legislation. The Drugs and Cosmetics Bill 2015 would overhaul many existing medical device regulations and, most importantly, clearly define the guidelines regulating medical devices and pharmaceuticals. Under the current laws, some medical devices are regulated as pharmaceutical products rather than devices.
According to AdvaMed, the current impasse is slowing imports into India. Medical device companies looking to export devices to India are unsure if their products are regulated as a medical device or pharmaceutical, and the legislative holdup is making it more difficult for foreign medical device companies.