There have been two major policy decisions on the medical technology by the Indian government in last few months . One is the finalization of the new policy draft and another is the price cap on coronary medical stents . Both have created happiness as well as flutter in respective sections of the society . The happy ones are millions of patients and of course the regulators who feel that they have done the justice . On the other hand , the industry is miffed with the decision as they feel that it is arbitrary and doesn ’ t include their suggestions , not to talk about unbearable revenue loss . Both the indigenous and foreign multinationals are unanimous in their criticism of the government ’ s order . Yet the good part is that the industry also has appreciated its recognition and separate identity from pharma .
The Indian medical device industry has for a very long time been urging that this inconsistency has been one of the chief bottlenecks for the growth of the industry and hampered its development as a globally competitive on the lines of Indian pharma sector . Currently India imports over 70 percent of its medical device requirements and the total annual market size is estimated at over USD 10 billion .
Mr Simranjit Singh , General Manager , Medical Devices & Diagnostics , Asia , QuintilesIMS calls the move a potential one to bring about breakthrough changes . “ The decision to delink medical devices from pharmaceuticals is a much needed and welcome step ,” he said adding “ The rules provide for a higher level of scrutiny and rigor that will have a long term positive impact on the safety and use of medical devices , in addition to creating a transparent , predictable and safer regulatory regime that will catalyze the entire sector . It is important to note that regulators have taken cognizance of stakeholder feedback to the draft rules in developing the Medical Devices Rules 2017 , while not compromising patient safety . Such a collaborative approach by the regulators is appreciated and is a much needed step in a relatively greenfield area .”
Price cap on stents emerges as the new battleground
The Government of India issued the notification for
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