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Current Status of Medical Device Regulations and Patentability of Medical Devices in India

Current Status of Medical Device Regulations and Patentability of Medical Devices in India
Photo by Abby Anaday / Unsplash

A study by Deloitte and the Indian Health Care Federation predicts that the medical device sector in India will grow rapidly and achieve a market size of $50 billion by 2025. Currently, India is Asia's fourth-largest medical device market and one of the top 20 markets globally.

Despite this growth, India remains heavily reliant on imported medical devices, with 80% of its devices being imported. In the fiscal year 2021-22, medical device imports in India increased by 41%, reaching a value of Rs. 63,200 crores, up from Rs. 44,708 crores in the previous year, according to data from the Union Ministry of Commerce and Industry.

China remains India's top source of medical device imports, with imports from China increasing by 48% from Rs. 9,112 crores in 2020-21 to Rs. 13,538 crores in 2021-22. Medical device imports from the United States also saw a steep rise of 48%, reaching Rs. 10,245 crores in 2021-22 from Rs. 6,919 crores in the previous fiscal year. Notably, the value of medical devices imported from China was almost equal to the combined value of imports from Germany, Singapore, and the Netherlands in 2021-22.

The global market for medical devices has grown significantly, reaching $456.8 billion in 2020 from $228 billion in 2015. The United States holds a major share of 45% of the global medical device market, followed by the European market (30%) and Japan with a 10% market share. Although India's medical device manufacturing sector is one of the top 20 markets globally, it remains a minor player in the industry.

Medical Devices Import in India (Source: Business Standard Sohini Das, July 2022)

The issue of patenting methods for medical treatment is complex, as it involves not only patent law but also medical law. The fundamental principle of medical legislation is to preserve human life, as embodied by the Hippocratic Oath. In contrast, patent law aims to promote innovation by rewarding inventors. This creates a tension between the need for doctors to have freedom in their treatment choices and the desire to incentivize innovation through patents. Exclusions from patentability, such as for medical, surgical, and therapeutic treatments, have wide-ranging implications on socioeconomic, medical, and ethical levels. While the TRIPS Agreement provides for exceptions and exclusions, their implementation has been inconsistent.

The issue of patenting methods for medical treatment is complex, as it involves not only patent law but also medical law. The fundamental principle of medical legislation is to preserve human life, as embodied by the Hippocratic Oath. In contrast, patent law aims to promote innovation by rewarding inventors. This creates a tension between the need for doctors to have freedom in their treatment choices and the desire to incentivize innovation through patents. Exclusions from patentability, such as for medical, surgical, and therapeutic treatments, have wide-ranging implications on socioeconomic, medical, and ethical levels. While the TRIPS Agreement provides for exceptions and exclusions, their implementation has been inconsistent.

Under Article 27 of the Trade-Related Aspects of Intellectual Property Rights (TRIPS) agreement of the World Trade Organisation, member states have the discretion to grant patents for "diagnostic, therapeutic, and surgical methods for the treatment of humans or animals." However, only the USA, Australia, and New Zealand have chosen to allow patenting of these methods. In contrast, India has classified such methods as non-patentable inventions under Section 3(i) of the Patents Act, 1970.

In India, certain inventions have been deemed non-patentable under Section 3(i) of the Patents Act, 1970, which excludes "any process for the medicinal, surgical, curative, prophylactic [diagnostic, therapeutic] or other treatment of human beings or any process for a similar treatment of animals […] to render them free of disease or to increase their economic value or that of their products.” This includes surgical methods, therapeutic methods utilizing specific compounds, and diagnostic methods for certain medical conditions.

The Indian Patent Office has cited examples such as the isolation of bone marrow, adipose tissue, and skin from humans through surgery and the use of biomarkers for COPD diagnosis as non-patentable inventions. However, detection tests such as screening tests that detect risk factors for disease in healthy individuals and prediction methods for disease progression in already diagnosed individuals are not excluded under Section 3(i) as they do not impact the development of treatment methods.

India's exclusion of surgical, therapeutic, and diagnostic methods of treatment for humans and animals from the purview of patentable subject matter is a result of the TRIPS agreement. Plants were also previously excluded but were later included after the passage of The Patents (Amendment) Act of 2002.

The Government of India has taken steps to ensure the growth of a vibrant ecosystem of medical device manufacturing. The 2017 Medical Devices Rules came into effect on January 1 2018, making it the most significant year in terms of regulatory changes for medical device companies. At the time the MDR came into effect, 15 medical devices were regulated under the MDR, while 8 others were regulated as drugs. Since then, the government has notified 14 additional medical devices. There are over 1700 types of medical devices in the global market, out of which only 28 were specifically notified under the MDR. To remedy this, the Ministry of Health and Family Welfare issued a notification on February 11, 2020, effectively bringing all medical devices in India under the MDR.

The Government of India has taken steps to ensure the growth of a vibrant ecosystem of medical device manufacturing. The 2017 Medical Devices Rules came into effect on January 1 2018, making it the most significant year in terms of regulatory changes for medical device companies. At the time the MDR came into effect, 15 medical devices were regulated under the MDR, while 8 others were regulated as drugs. Since then, the government has notified 14 additional medical devices. There are over 1700 types of medical devices in the global market, out of which only 28 were specifically notified under the MDR. To remedy this, the Ministry of Health and Family Welfare issued a notification on February 11, 2020, effectively bringing all medical devices in India under the MDR.

The Medical Devices Rules of 2017 classify medical devices into four categories based on their level of risk, with Class A having the lowest and Class D having the highest level of risk. Class A devices are considered low-risk and do not require regulatory approval. On the other hand, Class D devices are high-risk and require the most stringent regulatory scrutiny.

Class A devices include low-risk items such as stethoscopes, thermometers, and blood pressure monitors, which are exempt from CDSCO registration but must adhere to prescribed standards. Class B devices include moderate-risk items such as syringes, surgical drapes, and nebulisers. Manufacturers of Class B devices must register their products with the CDSCO and obtain a registration certificate while complying with prescribed standards.

Class C devices include high-risk items such as blood glucose monitors, implantable devices, and pacemakers. Manufacturers of Class C devices must obtain a license from the CDSCO, conduct clinical trials, and secure a no-objection certificate (NOC) from the CDSCO. Finally, Class D devices include very high-risk items such as artificial hearts, critical care ventilators, and heart-lung machines. Manufacturers of Class D devices must obtain a license from the CDSCO, conduct clinical trials, and secure a NOC from the CDSCO.

In 2022, the Government of India implemented several strategic initiatives aimed at creating a thriving ecosystem for medical device manufacturing. One such initiative was the extension of the Production Linked Incentive (PLI) Scheme, which offers financial assistance to four med tech parks in different states of India. Additionally, the government revamped the Medical Devices Promotion Council and created the Medical Devices Exports Promotion Council to boost the export and manufacturing growth of the medical devices sector.

To reduce the country's import dependence on medical devices, the government has also taken several steps, such as initiating a PLI scheme for the domestic production of medical devices, establishing a National Medical Equipment Promotion Council, and issuing a revised notice on the Public Procurement Order (PPO) that promotes indigenous medical device manufacture.

The government has also eased the standards for the clearance of medical devices and sanctioned the establishment of four medical device parks to provide essential infrastructure and standard testing facilities.

To make medical device manufacturing in India a viable proposition, the government needs to review and consult stakeholders on a predictable tariff protection policy and implement measures to protect ethical marketing with a cap on MRP or trade margins. The Parliamentary Committee on Health has recommended creating a separate law and regulatory framework for medical devices and taking other steps to address the country's import dependence.

In June 2021, the Quality Council of India and the Association of Indian Manufacturers of Medical Devices introduced the Indian Certification of Medical Devices (ICMED) 13485 Plus system to verify the quality, safety, and efficacy of medical devices. These initiatives demonstrate the government's commitment to promoting local manufacturing of medical devices and enhancing investment in the sector as part of the "Make in India" campaign.

Despite having a regulatory framework in place, The medical device industry in India is facing various challenges. One significant hurdle is the lack of clarity around the regulatory requirements for medical devices. The classification of devices based on their risk profile is considered too broad and fails to consider the unique characteristics of each device.

Another challenge faced by the industry is the absence of a clear timeline for the approval process. Medical devices can take up to two years to obtain approval, which can delay their launch and impact the company's profitability. Additionally, the quality of medical devices manufactured in India is a concern, as substandard and counterfeit products enter the market, raising concerns about their safety and efficacy.

The emergence of AI/ML-based medical devices is another challenge for policymakers. As technology evolves rapidly, regulations are slow to catch up, leaving policymakers unprepared for new and disruptive technologies.

As the medical device industry continues to expand at a rapid rate, it is imperative that the regulatory framework keeps pace with the changes.


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