Recognising the need to effectively regulate medical devices, India’s Ministry of Health and Family Welfare has proposed a new bill that would differentiate medical devices and drugs and make way for the standardisation, monitoring and regulation of medical devices.
“Regulation of the medical device industry has been a major challenge for the government. At present, thousands of such [devices] are used in an unregulated manner,” Joint Secretary (Health) Arun Kumar Panda recently told attendees of a global congress on Investment Opportunities in Medical Electronics & Devices, organised by the Federation of Indian Chambers of Commerce and Industry (FICCI) in Delhi. The event was organised in association with the Ministry of Health and Family Welfare under the theme, Harnessing Medical Technology for Inclusive Healthcare in India.
The Drug & Cosmetics (D&C) Act of 1940 does not include a definition of what constitutes a medical device. Hence, medical devices are currently notified as drugs. All the rules and regulations of the D&C Act, which were designed for drugs, are applicable to medical devices, said Panda.
The new bill, which will include a separate chapter on medical devices, will soon be put forth before the cabinet, Panda added. The new bill will replace the Drugs and Cosmetics (Amendment) Bill 2007, which is pending in Parliament.
The bill will monitor and set standards for medical devices. When passed, it will help unify the quality of medical devices made in India. This will strengthen the domestic manufacturing industry and could make medical devices more accessible and affordable to India’s population. It also will help the domestic industry gain a foothold in the global medical device market. “We still need to create a place of our own in the medical devices sector,” Panda said.
He explained that the government is keen on strengthening its regulatory body—the Central Drugs Standard Control Organisation—by providing more skilled manpower and improving infrastructure at its offices across the country. For the first time in the 12th Plan, the government of India has allocated Rs.1800 crore in financial support to states and union territories to strengthen the regulatory system dedicated to medical electronics and devices. Much of this grant will be spent on hiring technically qualified employees and establishing more laboratories, training academies and diagnostic labs, and expanding capacity, Panda said.
He also proposed institutionalising a mechanism whereby relevant stakeholders from the sector could come together and discuss new developments and challenges in the medical device arena.
India’s medical device market is valued at almost US$3 billion and is growing at a rate of 15% annually.