Medical device domestic manufacturing has grown 43% in the last four years but innovation in the sector remains weak with only 117 investigational devices among up to 30,000 total product approvals, Drugs Controller General of India (DCGI) Rajeev Raghuvanshi said at the CII Global MedTech Summit on Friday. An investigational device is a first-of-its-kind product that has no existing equivalent device in the market.
PLI Incentives to Shift Focus
Though the government is looking at deepening the domestic value addition through incentives. Department of Pharmaceuticals (DoP) secretary Manoj Joshi stated that the future production linked incentive (PLI) scheme for medical devices could favour component manufacturers over simple assembly operations. For companies entering second-round benefits with low initial local value addition, the government wants to push them toward 40-45% domestic value addition. “We would like to incentivise component makers in large way,” Joshi said.
Joshi added that the government is examining whether companies that invested under the first application round of the PLI in FY21 but are not currently claiming incentives could be given an extended timeframe to qualify.
“We would like the products which are not made in India at all to start with assembly with no requirement of value addition, and those who have started in the first round with low domestic value addition, we would like them to go to 40-45% value addition now.” secretary said.
This is particularly significant given the scale of the domestic MedTech ecosystem. According to government data, India currently has 4,108 licensed medical-device manufacturers, with several companies holding licences across multiple categories of medical devices.
Raghuvanshi noted that domestic manufacturing growth has been heavily concentrated in lower-risk (Class A and B devices), while higher-risk (Class C and D) devices have grown at a much slower pace. He stressed that the industry needs to reverse this trend to shift the market focus from volume to value.
“If we have to shift from volume to value, these numbers are actually worrying,” Raghuvanshi said.
Regulatory Reframing
Joshi also argued that MedTech cannot be regulated in the same manner as pharma. He said devices are fundamentally different engineering products and require a different regulatory approach. India, he added, needs a regulatory framework suited to its own industrial and regulatory capabilities rather than simply adopting US or European models. “Our regulatory system architecture needs to be different,” he said.
Meanwhile, the regulatory focus is set to expand into active enforcement. Raghuvanshi noted that CDSCO has issued around 30,000 product licences over the past two years. With 20 new medical-device officers set to join, doubling the vertical’s strength, audits and inspections are expected to rise significantly. “So we have to be prepared for the audits and inspections going forward,” he said.