More than 70- 75 per cent of medical equipment are imported from abroad. The industry stakeholders thus recommended the matter of their inclusion in MDTAB to come under the Drugs and Cosmetics (Amendment) Bill 2013. They also recommended development of clinical research capabilities in accordance with global norms and deliberation on the penal provisions in the bill.
"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.
Prabal Chakraborty, vice president, Boston Scientific told IANS, “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.”
Talking about the penal provision in the bill, Sanjay Banerjee, regional managing director, Zimmer India said that, India needs to revise the penalties mentioned in the bill to come as per global standards. The current version penalizes with three years jail and Rs 3 lakh fine. “It should be in line with global practices such as warning letter or a fine, not both,” he said. He also felt the need of proper classification of 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.