Is India lacking in Medical Device Manufacturing?

Recent years India is showing growth in healthcare industry. As per the data from various sources Indian medical device industry is Fourth largest in Asia and among top 20 globally.Despite of all these and efforts taken by government of India, Medical device manufacturers are facing challenges in this sector. 

Few statistics shows that despite of growth in healthcare sector medical device manufacturing is lacking behind in India. As medical device consultants We have analyzed the data and discussed this issue with  few of the manufacturers. The reasons and the possible solution from their view are briefed here. 

According to them medical device manufacturing is lacking behind and the responsible factors for this can be as follows:  

• Absence of Supportive infrastructure and disrupted supply chain  

Although the government of India has taken steps and launched new scheme to boost the production, medical device manufacturing industry facing obstacles in growth . For the production of qualitative devices, manufacturers need supportive supply chain network & relevant infrastructure especially for the high-end devices and particularly those that entail expensive technology and components. So, the Indian manufacturers mostly focusing on low end products. According to one of approach papers, high technology end devices are served in market by multinational companies. whereas domestic players mainly focus on low end consumables segment. 

• Import duties on finished goods. 

The import duty on raw material and components is higher, so players of the medical device sector bring complete standalone products in the market instead of using raw materials and components that they could use for innovative device manufacturing. 

• Nature of domestic market. 

India is highly populated country and facing high disease burden also, manufacturers from the medical device manufacturing industry having thoughts that high end technologically sophisticated medical devices are not in much demand in non-metro cities, hence there is less scope of investment, the demand of high end technologically driven devices are limited to bigger hospitals, healthcare professionals from the big cities and metro cities of India. The hospitals and healthcare professionals from non-metro cities are opting for less expensive products and devices compared to high end products. Therefore, the thought of the sustainability of the business within the country played on the minds of the manufacturers within the country. 

•  Relevant education and required skill base  

India is among those country who has largest number of STEM graduates which includes Engineers, but there is lack of alignment between biomedical education and engineering disciplines, as per the data gathered from various sources, we have only 217 biomedical   engineering colleges offering full-fledged courses. According to survey of AMTZ, there are less than 20 courses related to biotechnology engineering across India.  

• Limitations of device design as per different temperature and international market  

 Due to the absence of a supportive eco system it is very difficult to make devices and customize them for the international market with the different climatic conditions.  

• Regulatory compliance  

Government is designing new rules and regulations for the betterment of the industry, often government updates their policies and issue guidance to benefit the medical device manufacturing industry and medical device service provider. But many times, updated regulations or notification crates ambiguity among manufacturers. As a medical device regulatory consultant, we are always guiding medical device manufacturers and simplifying things for them. For example, if a manufacturer wants to set up a manufacturing unit, we help them in obtaining the CDSCO manufacturing license . 

When manufacturers have been asked about their thoughts on their expectations  and possible solutions for the same they opened up for the following measures which can be taken by respective authorities.  

Steps can be taken to overcome the issues of medical device manufacturing: 

• Government should identify and encourage the supportive eco system for the highly import dependent devices and technologies. 
•  The Indian companies who want to invest in high end quality devices should get financial support.  
• The existing PLI scheme should include more device categories. Government needs to focus on core technology-based products and innovation. 
• Local value chains should get developed. 
• The negotiation on skilled professionals and low labor cost with foreign companies for technology transfer and investments needs to be addressed for the good practices of domestic companies.  
• According to one survey half of the workforce in the medical device sector is unskilled, to fill this gap addition of Structured biomedical engineering courses and relevant changes in the stream needs to be done. 
• For product development, validation and testing, designing of device needs a good R& D environment, government should aggressively focus on Research and Developments field.  

Medical device manufacturing is not a simple task to do, this is a sensitive and important part of the healthcare industry. The government is proactively taking steps to improve the sector, still few of the device makers share their thoughts on this. As a medical device regulatory consultant, we always work for the betterment of society and our clients. We provide guidance to medical device manufacturers and help them in the regulatory compliance process. Feel free to contact us for our services.