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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