2015 will be remembered as the year that took the medical device revolution in the country to the next level. Here are the most significant ‘medical device’ highlights that ensured that it remained at the top of the agenda from policy to parks.
Medical Devices Park
States like Andhra Pradesh, Maharashtra and Gujarat are set for a fierce battle to establish a medical device park. However Andhra Pradesh has already taken a lead by finalizing its site in Vishakhapatnam in consultation with the industry partners. The allotted land is about 226 acres and is said to be in an ideal position to have an industrial park dedicated for medical devices. Focus will be on creating an Eco System for High End Medical Device Manufacturing and Import Substitution with an eye for Export Market.
Delinking of medical devices from schedule M III of pharmaceuticals
This year the Government took a vow to delink the medical device industry from the pharmaceutical sector, giving a major push for ‘Make in India’ in the medical device sector, according to people privy to the development. The health ministry has agreed to delink schedule M III of the Drug Rules, which deals with medical devices, from schedule M, which deals with drugs and pharmaceuticals.
Issue of Draft Medical Device Policy
The Department of Pharmaceuticals (DoP) this year issued the draft National Medical Device Policy-2015, for strengthening the ‘Make in India’ drive in medical device sector. As per the draft policy, an autonomous body ‘National Medical Device Authority’ (NMDA) will be created which will provide a single window mechanism to the industry with an objective of promotion of the medical device industry to make the country not only self-reliant but also a global hub of production and innovation in medical devices.
Removal of duty anomalies in medical devices sector
This year the Government agreed in principle to rectify the inverted duty structure for the growing medical devices sector. An inverted duty structure impacts domestic industry adversely as manufacturers have to pay a higher price for raw material in terms of duty, while imported finished products land at lower duty and cost lesser.
Materovigilance Program of India
After several horrific cases of malfunctioning medical devices, like babies being burnt to death due to short circuits in incubators or hip implants causing blood poisoning, the health ministry has approved a materio vigilance programme in an effort to ensure safety of medical devices. The plan is to be coordinated by the Indian Pharmacopoeia Commission, the biotechnology wing of the Sree Chitra Thirunal Institute of Medical Sciences and Technology, Central Drug Standard Control Organization (CDSCO) and National Health Systems Resources Centre.
Designation of WHO Collaborating center
The union health ministry’s apex body for technical assistance, the National Health System Resource Centre’s health Technology Division this year has been designated as the first World Health Organization (WHO) Collaborating Centre for priority medical device and health technology policy in South Asia. This is the fourth such center established globally.
Biomedical Equipment Maintenance Model
This year India joined the club with those few countries who have a budget line for maintenance of medical devices. The program is based on outsourcing of medical equipment maintenance to a single third party service provider which would be monitored on the basis of uptime.
Govt approves 100% FDI in medical devices sector
The Central government this year allowed 100 per cent FDI under automatic route in medical devices sector to encourage manufacturing of equipments, including diagnostic kits and other devices. The 100 per cent FDI, will be permitted under the automatic route, meaning a foreign investor will not have to seek the permission of Foreign Investment Promotion Board (FIPB) to acquire an existing company or set up a new manufacturing unit in the medical devices sector.