New Delhi: Being aware of the fact that India is dependent on imports of medical devices to the tune of 80 percent, a Parliamentary standing committee has suggested to the Central government, a fresh regulation for medical devices to encourage the 'Make in India' concept.
A senior government official told ETV Bharat that India's imports of medical devices crossed Rs 63,000 crore in 2021-22 and the estimated market is Rs 1,60,000 crore. It is worth mentioning that the Parliamentary committee made the suggestions following its field visit to different States.
The committee further recommends to the Ministry of Pharmaceutical expedite the process of formulating the new separate legislation having adequate provisions to give the medical device industry in the country a kick-start for pacing up with the global market.
"Since the Ministry of Health and Family Welfare is the key stakeholder and the medical devices are very diverse in range with respect to technology and material science, inter-ministry coordination is required between various departments, which should be done by the Ministry of Health and Family Welfare only," the official said while quoting the recommendation of the Parliamentary committee.
In fact, the Covid19 pandemic has highlighted the need to support indigenous manufacturers of medical devices. "The pandemic highlighted the need for infrastructure, funds for research and development, the requirement of skilled manpower, a strong synergy between central and state regulatory authorities, etc plaguing the medical device industry in India," the official said.
To know the status and prospects of the medical device industry in India, the Parliamentary committee delegation visited a number of States during the last year.
Jammu & K Kashmir: At present, 11 medical device industries exist in the UT of J&K and there are no testing laboratories in the UT. Setting up medical device parks with common utilities and incentivizing domestic manufacturers are two key steps to strengthen the medical device industry in the UT of J&K. Non-availability of raw materials, high input and transportation costs and lack of skilled labor resources are major challenges identified in J&K.
Haryana: High cost of land and electricity in the State are major challenges in the medical device industry.
Assam: Presently, Assam has only one licensed manufacturing facility for class-B medical devices. The medical device segment has good market potential in the State.
Gujarat: Due to the current dual licensing procedure in Medical Devices Rules, 2017, MSME manufacturers from the State are having difficulties in getting licenses from the central licensing authority. As per MDR 2017, manufacturing license premises for class A & B medical devices is audited by the notified body. Due to the limited number of notified bodies coupled with a lesser staff, new manufacturers are facing delays in audits.
Jharkhand: Very few medical device industries are situated in Jharkhand which manufacture limited categories of medical devices.
Meghalaya: The manufacturing status of the medical devices industry in the state is nil. However, the market potential in the State is huge.
Odisha: There are a few medical device manufacturing industries or units in the State. Presently, there are around 25 manufacturers in the state. One of the main reasons for the very low number of medical device manufacturing units is the non-availability of any electronics components manufacturing units.
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India is the 4th largest Asian medical devices market after Japan, China, and South Korea and is among the top 20 medical device markets globally.
The Government of India has recommended various initiatives to strengthen the medical device sector, with emphasis on research and development (R&D) and 100 percent FDI for medical devices to boost the market.
Significantly, to boost domestic manufacturing of medical devices and attract huge investment in India, the department of pharmaceutical launched a PLI scheme for domestic manufacturing of medical devices, with a total outlay of funds worth Rs 3,420 crore for the period 2021-28.
