Rajiv Nath, Forum Coordinator, Association of Indian Medical Assosication
Quality – For the first time in the history of medical devices, the industry came forward and told that we will make voluntary standards for good manufacturing practices, which resulted in Indian Certification for Medical Devices (ICMED) (including internationally benchmarked standards, such as ISO 13485, ISO 9001 and over and above good selection criteria for machines). Such a forward-looking step was taken even before the government or any other agencies took such a measure.
Selection process of the requirement – The Government in consultation with the industry has frozen the technical specifications and an advisory has gone to all the state governments to ensure no particular standard of a particular nation is used as exclusionary criteria during procurement to give a level-playing field to all players.
Cost – Medical device manufacturing is costly because it requires certain high investment in scientific facilities that are capital intensive in nature. A great step was undertaken by the Andhra Pradesh Government by establishing Andhra Pradesh MedTech Zone (APMTZ) where the Government is setting up all capital-intensive scientific facilities, laboratories, etc. that will be leased out to the manufacturers in Vishakhapatnam. APMTZ will enable to decrease the cost of good quality products.
Other Key Takeaways:
Affordable quality healthcare is only possible with the access to home-grown affordable quality medical devices. Affordability and accessibility are definitely the key, but along with that we also need to see viability.
Isolation will not deliver benefits, interdependency required in healthcare sector.
When we started the journey, India had 70% import dependency, which was not accurately estimated.
As of now medical device industry has more positives than negatives
Healthcare providers need to tap into the effectiveness of this growing strength of the medical device segment without diluting it with mechanisms that are not completely industrial in nature, but are based out of the conflict of interest mechanisms between different healthcare stakeholders
Our perception that IT has not penetrated in northeastern states needs to be changed.
