Medical devices & Pharmaceuticals in India

Medical devices & Pharmaceuticals in India

• The Indian government is concentrating on producing high-end medical devices and pharmaceuticals as part of its effort to reduce its reliance on imports.

About medical device:

• Engineering and medicine come together in an unusual way in the medical device sector. It entails the construction of devices that sustain life inside the human body.
• Medical devices include surgical instruments, diagnostic tools like X-rays, CT scans, MRIs, and handheld ultrasound imaging devices; tools for life support like ventilators and other similar devices; and implants and disposables.
• Unlike pharmaceuticals, medical devices rely on a variety of technologies, including engineering, electronics, material sciences, and information technology.

Data of medical sector:

• With nearly 80% of sales by value coming from imported medical devices, global corporations are heavily represented in the Indian medical device sector.
• With a market size of USD 5.2 billion, the medical devices sector in India makes up roughly 4-5% of the country's USD 96.7 billion healthcare sector.
• Despite being one of the top twenty markets for medical devices in the world and the fourth largest market in Asia after Japan, China, and South Korea, the medical devices sector in India is quite modest in comparison to the rest of the manufacturing industry.
• 80–90% of the $15 billion market for medical gadgets in India are now imported.
• The top five countries exporting high-tech medical equipment are Singapore, the US, Germany, China, and Japan to india
• The Made in India initiative has designated the medical device industry as a major sector and given it the designation of "Sunshine Sector." By 2030, the Indian medical equipment market might be worth $50 billion.

Medical device history in India:

• MNCs with a 90% market share dominated the Indian medical equipment market in the 1960s.
• With the government's takeover in 1970 with the passage of the Indian Patent Act and the Drug Price Control Order, Indian businesses began to emerge.
• After the "Made in India" programme, a government initiative, was introduced in 2014, the medical device industry in India gained independence. Until recently, there were no rules governing medical equipment.

Medical device clusters in India:

• In Karnataka, manufacturers like Biocon, GE Medical, Skanray, Bigtec Labs, and others mostly concentrate on producing insulin pens, cardiac stents and implants, medical IT, and PCR machines.
• Haryana: The firms involved are BD, Hollister, and Poly Medicure, and they concentrate on producing consumables and dental equipment.
• Medtech innovators in Delhi, including the Stanford-India Bio Design programme.
• Gujarat: Envision Scientific and Invent Bio-Med are supporting the production of stents.
• Tamil Nadu is a significant centre for the manufacture of diagnostics, vital life support equipment, and ophthalmology products. They are produced by Trivitron Healthcare and Opto Circuits.

Problems with India's Underdeveloped Medical Devices Sector:

• Medical device penetration and usage are still below-optimal levels in the industry, which is still in its infancy. In order to promote indigenization, the medical device sector must innovate and do research and development.
• Regulation Deficits/Loopholes: The medical device business is suffering from a lack of regulatory frameworks, unified standards, accreditation, legal requirements, appropriate guidance on quality and best practises, etc.
• Industry representatives are pushing for comprehensive regulation that views medical devices separately throughout the entirety of the product's life cycle, from design to patient tests, incorporating doctor feedback, and monitoring patients who receive implants, etc. Medical devices are still governed by the Drugs and Cosmetics Act of 1940.

Draft National Medical Devices Policy 2022:

• Improving competitiveness by providing financial and tax incentives to encourage private sector investments in the local manufacturing ecosystem.
• In order to increase cost competitiveness and increase the appeal of domestic manufacturers, infrastructure development is being done to provide best-in-class physical basis, including medical device parks with shared amenities like testing centres.
• Supporting R&D and Innovation with an emphasis on improved collaboration in R&D and innovation projects, international collaborations, and joint ventures among key stakeholders to close the knowledge gap between academic curricula and market demands.
• Development of human resources to ensure applicable curricula at the higher education level, the skilling of various stakeholders, and the formation of future-ready HR with necessary skill sets throughout the innovative value chain.
• As part of the "Make in India, Make for the World" campaign, awareness generation and brand positioning are used to promote India as a centre for the production of medical devices.

Initiatives being taken:

• With a focus on 100% FDI for medical devices to expand the market, the Government of India has started a number of efforts to enhance the medical devices sector.
• The National Medical Devices Promotion Council (NMDPC) was reconstituted by the Department of Pharmaceuticals in August 2022, with the Secretary of the Department of Pharmaceuticals serving as its chairman.
• The government introduced a draft of the new Medicines, Medical Devices, and Cosmetics Bill 2022 in July 2022 in an effort to guarantee and provide comprehensive legal protections to guarantee that the medical products marketed in India are trustworthy, effective, and up to required standards.
• A budget of Rs. 86,200 crore (US$ 11.3 billion) was allotted for the pharmaceutical and healthcare sector in the Union Budget 2022–23.
• To boost the acceptance of Indian medical products in the international market, the government announced plans to create a new medicines, cosmetics, and medical devices bill in October 2021.
• The government stated in October 2021 that 13 companies had been given the go-ahead under the PLI plan for medical equipment, which is anticipated to increase domestic production in the nation.
• In September 2021, the government approved a plan to erect a medical devices park in Himachal Pradesh's industrial township of Nalagarh in the Solan district for a cost of Rs. 5,000 crore (US$ 674.36 million).
• A medical devices park in Oragadam, Tamil Nadu, which the government approved in September 2021, is anticipated to provide direct and indirect employment for 10,000 people.

Way Forward

• The sector's diversity, ongoing innovation, and variation necessitate specific coordination and communication between Industry and Stakeholders.
• Medical device companies should establish India as a manufacturing hub for both domestic and foreign markets, engage in indigenous manufacturing combined with India-based innovation, work together on the Make in India and Innovate in India programmes, and create Low to Medium technology products to target the underserved domestic markets.