The Ministry of Chemicals and Fertilizers recently initiated the Scheme for “Promotion of Medical Device Parks” to bolster the medical devices industry in coherence with Atmanirbhar Bharat. This move has brought attention to the unique blend of engineering and medicine that the medical device industry represents.
Understanding the Medical Device Industry
The medical device industry is an interdisciplinary domain intertwining engineering and medical sciences. This sector fabricates machines designed to sustain human life. These devices range from Surgical Equipment, Diagnostic equipment such as Cardiac imaging, CT scans, X-ray, Molecular Imaging, MRI, and Ultrasound-imaging, including handheld devices. Life Support equipment like ventilators, along with Implants and Disposables are also part of this sector.
Aims of the Initiative
The scheme’s primary objectives include easy access to standardized testing and infrastructure through world-class common facilities created via these medical device parks. Additionally, it aims to reduce the production cost of medical devices and enhance their availability and affordability in the domestic market.
Financial Backing for the Scheme
The scheme boasts a financial outlay of Rs 400 crore and will operate from FY 2020-2021 to FY 2024-2025. A selected Medical Device Park will receive financial assistance equivalent to 70% of the common infrastructure facilities’ project cost. In the North-Eastern and Hilly states, the support would be 90% of the project expense. Nonetheless, the maximum assistance per park is capped at Rs. 100 crores. The Centre has already given in-principal approval to parks in Himachal Pradesh, Tamil Nadu, Madhya Pradesh, and Uttar Pradesh.
India’s Position in the Global Medical Devices Sector
While India’s Medical Devices industry contributes around 4-5% to the USD 96.7 billion Indian healthcare sector and stands as the 4th largest market in Asia, it imports 80-90% of medical devices from abroad. The US, Germany, China, Japan, and Singapore are the leading exporters of high-tech medical equipment to India.
Additional Policy Measures
Recently, in June 2021, the Quality Council of India (QCI) and the Association of Indian Manufacturers of Medical Devices (AiMeD) launched the Indian Certification of Medical Devices (ICMED) 13485 Plus scheme. The scheme aims to verify the quality, safety, and effectiveness of medical devices. To promote domestic manufacturing and potentially attract massive investments, the department of pharmaceuticals initiated a PLI scheme with an investment of Rs.3,420 crore for FY21-FY28.
Legislation and Infrastructure Development
As of 1st April 2020, the Ministry of Health and Family Welfare has categorized medical equipment as ‘drugs’ under Section 3 of the Drugs and Cosmetics Act (D & CA), 1940. Medical Devices Parks have been established in Andhra Pradesh, Telangana, Tamil Nadu, and Kerala. In 2020, Kerala inaugurated MedSpark, one of the country’s first medical device parks, in Thiruvananthapuram. The Indian government identified the medical devices sector as a sunrise sector under the ‘Make in India’ campaign launched in 2014.
Last Modified: February 13, 2024