The Association of Indian Medical Device Industry (AiMeD) urged the Centre in a letter to change the name of the Department of Pharmaceuticals (DoP) to include medical devices as well or to have a separate department, emphasizing the need for a dedicated department that distinguishes between the pharmaceutical and medical devices segments of the industry. “The current name reflects the focus on the mature sector of pharmaceuticals and the ignored import dependent sector of medical devices,” the letter stated. As per the records found in this sector, the country is still dependent on imports for medical gadgets to the tune of roughly 80%. In this pretext, we shall discuss about the need to establish a separate department for medical devices industry in India.
According to the letter given by the AiMeD, “India remains 70 to 80 percent import dependent, with imports crossing $63,000 billion in 2021-2022, and an estimated market of $1,60,000 billion at the retail and institutional level, but with a huge investment opportunity of over $80,000 billion.” The letter also stated that the governing authorities needed support from experts in the fields of medicine, biomedical engineering, product development, and marketing from across departments.
The Association of Indian Medical Device Industry (AIMED) has urged the Indian government to create a separate department for medical devices because of several reasons:
- Unique challenges: The medical device industry faces unique challenges that require a specific focus on this sector. The regulatory requirements, research and development, and marketing strategies for medical devices are different from those of pharmaceuticals.
- Growth potential: The medical device industry in India has tremendous potential for growth, and a separate department can help to drive this growth. The sector can benefit from targeted policies, streamlined regulations, and more funding opportunities.
- International standards: A separate department can help to align Indian regulations with international standards, making it easier for Indian companies to export their products and compete globally.
- Patient safety: A dedicated department can help to ensure that medical devices meet the highest safety standards, protecting patients from harm.
Overall, a separate department for medical devices can help to support the growth of the industry while ensuring patient safety and aligning regulations with international standards.
Purpose behind the Need for a Separate Department for Medical Devices
The purpose behind the need for a separate department for medical devices are discussed below:
- Regulation: Medical devices are regulated differently than drugs, and there are specific regulatory requirements that need to be met before a medical device can be sold on the market. A separate department is needed to oversee compliance with these regulations and ensure that medical devices are safe and effective.
- Expertise: Medical devices require a unique set of skills and knowledge to design, develop, and manufacture. A dedicated department can ensure that there are experts available who have the knowledge and experience to create high-quality medical devices.
- Quality control: Medical devices must meet strict quality control standards to ensure that they are reliable and safe for use by patients. A dedicated department can oversee quality control processes and ensure that devices are manufactured to the highest standards.
- Innovation: Medical devices are constantly evolving, and new technologies are emerging all the time. A dedicated department can help drive innovation in the field of medical devices and ensure that new technologies are developed and brought to market in a safe and effective manner.
Overall, a separate department for medical devices is necessary to ensure that patients have access to safe and effective medical devices that can improve their health and quality of life.
Benefits of Setting up Of a Separate Department for Medical Device
Despite the growth and potential of the industry, the Indian medical device industry faces several challenges, including regulatory issues, limited funding, and inadequate infrastructure. In this context, establishing a separate department for medical devices industry in India could provide numerous benefits, which are discussed below:
- Streamlined regulation: A separate department dedicated to medical devices could establish clear and specific regulatory guidelines and procedures, enabling medical device manufacturers to comply with regulatory requirements efficiently. This would not only facilitate the entry of new players into the market but would also ensure the safety and efficacy of medical devices for patients.
- Increased innovation and R&D: A dedicated department could foster innovation and encourage research and development in the medical devices industry. This would enable the development of new and advanced medical devices that could improve patient outcomes, reduce healthcare costs, and increase India’s global competitiveness in the medical devices market.
- Increased investment: A dedicated department could attract more investment into the medical devices industry by creating an enabling environment for investors. This would include a favorable regulatory environment, access to funding and resources, and infrastructure development.
- Increased exports: A separate department could help develop and implement policies to promote exports of medical devices from India, further increasing India’s competitiveness in the global market.
- Improved healthcare outcomes: A separate department for medical devices could focus on the development and implementation of medical devices that meet the unique needs of the Indian population. This could lead to improved healthcare outcomes and better access to medical care for patients across India.
To sum up, a separate department for the medical devices industry in India could have numerous benefits, including streamlined regulation, increased innovation and R&D, increased investment, increased exports, and improved healthcare outcomes. Establishing such a department would require significant investment and political will, but the long-term benefits could be significant for both the industry and patients in India.