As medical device companies increasingly turn to India for business, manufacturing and R&D, the country's Ministry of Health and Family Welfare is trying to advance a bill that would modernize the country's regulations for the industry.
Right now, as a recent Pharmabiz story explains, medical devices are regulated in India as drugs under the country's Drugs and Cosmetics Act. Only 14 devices are covered under those provisions but thousands more remain unregulated. India's device industry wants separate provisions for medical devices, according to the article, and a bill to make this happen has been in the works now for four-plus years, the story notes. Such a measure would define what a medical device actually is. Additionally, a bill will establish risk classes and corresponding regulatory governance, clinical trial guidelines and other provisions, according to the story.
India's government wants the regulations to be finalized sooner rather than later, according to the piece, so the country's surging device industry has some guidelines to help it grow and properly compete. Separately, international medical device companies increasingly doing business in India undoubtedly want a more modern regulatory framework as they increase their R&D, manufacturing and import/export sales efforts to reach some of the country's billion-plus people.
Ministry officials have subsequently focused on building support with the bill, meeting with industry groups such as the Association of Indian Manufacturers of Medical Devices. They're also trying to build up support from some states in the country that oppose separate regulatory provisions for devices. All states must approve the measure, according to the story. The final goal here is to send a final bill to Parliament of India during the monsoon session.
- here's the Pharmabiz story