With 70 to 75 percent of the medical devices in India imported, the industry stakeholders Thursday said they had urged the government to include their representatives in the Medical Devices Technical Advisory Board (MDTAB).
This was one of the recommendations to be incuded in the Drugs and Cosmetics (Amendment) Bill 2013 sent by the stakeholders to the government early this month.
"We import 70 to 75 percent of the medical devices in our country, so given the important role of manufacturers of imported medical devices in providing life-saving medical technologies, their representation is a must," said Gautam Khanna, executive director, Health Care Business.
"The innovation cycle of the medical devices is 18 to 24 months. As India lacks the support ecosystem for innovation and our market is small, the devices have to be imported," said Prabal Chakraborty, vice president, Boston Scientific.
The other recommendations include -- development of clinical research capabilities in accordance with global norms and deliberation on the penal provisions in the bill.
"The penal provision in the bill is defined as three years jail and Rs.3 lakh fine. So there is a need to rethink on the penalties. It should be in line with global practices such as warning letter or a fine, not both," said Sanjay Banerjee, regional managing director, Zimmer India.
"Along with the penalties, there is a need to even classify the devices as low risk, low moderate risk, moderate high risk and high risk. The adoption of a risk based approach to regulation ensures efficiency and safe access to medical technology," added Banerjee.
The industry stakeholders have also demanded a transition time of five years so that they can build adequate resource and expertise from the time of implementation.
