The Parliamentary Standing Committee on Health and Family Welfare has recommended setting up a new set of regulators at different levels for regulating the Medical Devices industry.
In its one-hundred thirty-eighth report on the medical devices: Regulation and Control, the standing committee said this step would greatly help the manufacturers and will reduce the time required to start a manufacturing unit thereby facilitating ease of doing business. Business Standard has seen the September 2022 report.
Unlike the present structure, the proposed regulator should license the manufacturing of all classes of medical devices i.e. Class A, B, C, and D, the report said. “This would help harmonise the regulation process throughout the country as it would do away with different regulating procedures employed by different States,” it added.
The current market size of the medical devices sector in India is estimated to be 11 billion and its share in the global medical device market is estimated to be 1.5 percent.
India is the fourth largest market for medical devices in Asia after Japan, China, and South Korea and is amongst the top 20 markets in the world. The sector is growing at a CAGR of 15 percent over the last 3 years.
Almost 80 per cent (by value) of the domestic requirements are met by imports. In India disposables and consumables make up the major portion of products manufactured, therefore, to meet the medical devices’ needs of the population, expensive medical devices are imported.
The Committee also recommends that to undertake the regulation for all Classes of medical devices throughout the country, the proposed regulator should be adequately staffed with a workforce which is technically skilled and is well-versed with the functioning of the medical devices industry.
In its report, the standing committee said that a “National Commission on Medical Devices” should be set up to examine all aspects of the industry in detail and also bring a comprehensive law.
“The Committee further recommends that this Commission should study the aspect of centralizing the Medical Device licensing with the Central regulator so as to make the approval process easy. The Ministry should also focus on guaranteeing transparency by designing this legislation so that the citizens/ experts get a right to participate in decision making,” it said in its report.
The blueprint for the new legislation must also include a 10-15 year roadmap with a clear policy plan and targets, it added.
With the industry growing, the government should not afford regulation of medical devices by pharma experts and its time that at ground level the medical device regulations are dispensed with by qualified and well-trained Medical Device Officers to give a fillip to the Medical Device industry in the country, the standing committee felt.
The Committee recommended the Ministry of Health and Family Welfare to allow the new regulator to involve institutions like IISC, CSIR, DRDO and network of IITs to test medical devices for safety and efficacy.
The committee noted in its report that the BIS should focus on harmonising the Indian standards with world-class and globally accepted quality standards. “Adapting Indian standards as per global standards would also help Indian medical device manufacturers in the global market as it would make them more competitive and acceptable, which in turn would transform India into a net exporter of medical devices, spare parts and services,” it said.