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CDSCO will remain holistic with separate divisions for pharma and medical devices, says Dr Mansukh Mandaviya

Our Bureau, New Delhi
Thursday, August 10, 2023, 15:45 Hrs  [IST]

The Union minister for health and family welfare and chemicals and fertilisers Dr Mansukh Mandaviya has said that the Central Drugs Standard Control Organisation (CDSCO), while remaining as a holistic regulatory agency, will have two divisions - one for drugs and the other for medical devices - under the new proposed Drugs, Medical Devices and Cosmetics Bill.
He was responding to a question from reporters in a press meet held as a Curtain Raiser of India’s first medical technology expo, ‘India MedTech Expo 2023’, scheduled to be held in Gandhinagar, Gujarat from August 17 to 19, 2023 on the sidelines of the G20 Health Ministers’ Meeting.
When the Drugs and Cosmetics Act, 1948 was formulated, the medical devices sector was hardly present in the country and there was no separate Chapter for the sector in the Act. However, in the new Act, there would be a separate chapter for medical devices.
"Under the new Act, we are going to have provisions through which under the joint CDSCO we will have two divisions, one each for pharma and medical devices, which will work separately. We have started working on this," said the minister while asked about the medical devices industry's request for a separate regulatory authority for the sector.
He added that the expertise required for medical devices is different from the expertise needed for the pharma sector. However, in a holistic approach, they are under the umbrella of healthcare.
It may be noted that the medical devices industry has been seeking a separate regulation, and department for the sector, as it cannot be treated as drug industry.
The Department Related Parliamentary Standing Committee on Health and Family Welfare in its 146th report presented in Lok Sabha on August 4, 2023 also emphasized on its recommendations to the central government to set up a separate legislation, create a new department under the Ministry and a separate regulatory infrastructure for the medical devices.
Commenting on another major demand from the industry related to the import of some medical devices which are imported with zero or low import duty while they can also be manufactured in India, the minister said that considering the health requirement is critical and there needs to be a balance between the imports and domestic manufacturing.
Till the required capacity is built, imports need to be allowed. Works are going on in India to build the manufacturing capacity for medical devices, and they need to be supported and provided with a level playing field to bring down the import dependency slowly. The government is monitoring the imports and domestic production continuously and making sure that there is no shortage of devices which may lead to price increase and lack of availability of these products. The government needs to keep it in balance, he added.
Commenting on the Ministry of Environment, Forest & Climate Change’s (MoEFCC) recent move to allow Import of pre-owned medical equipment which has lead to a tussle between the industry organisations, he said that he has the list of devices which has been allowed for imports and there is no decision taken on it so far. The move is from the MoEFCC and the decision has to be from that ministry, he said.
Mandaviya stated that the upcoming MedTech Expo 2023 will showcase India’s innovations and achievements in medical and surgical procedures, drugs, equipment and facilities. He highlighted that the event will enhance visibility of the medical devices ecosystem in India and create a brand identity for the Indian MedTech sector.
“From a market share of 1.5 per cent, we hope to increase India’s market share to 10-12 per cent share over the next 25 years,” he added. He further stated that, “with effective implementation of the recently unveiled National Medical Devices Policy 2023, we are confident of fostering the Medical Devices Sector growth from present $11 Bn to $50 Bn by 2030.”
Union minister of state for chemicals and fertilizers Bhagwant Khuba urged all stakeholders including industries to visit the expo and witness the transformative work being done in this segment.
In the press meet, S Aparna, Secretary, Department of Pharmaceuticals said, “the medical devices sector is one of the fastest growing segments today. Several interventions have been taken by the govt to provide impetus to the industry for domestic manufacturing of medical devices. These interventions have led to 37 unique products which were earlier imported, now being domestically manufactured.”
“Policy interventions are being made to cater to both the manufacturing and demand side of medical devices,” she added.
Four new industrial parks are being constructed across the country for medical devices manufacturing.
“The National Medical Devices Export Promotion Council has also been set up recently to boost exports of medical devices”, she further stated. She also informed that the expo will have a future pavilion and an R&D pavilion and will see participation of states, industries, MSMEs, academia and Innovators etc.
The Expo will have various pavilions, including Future Pavilion, R&D Pavilion, Start-up Pavilion, State Pavilion, Regulators Pavilion and Make in India Showcase. More than 400 exhibitors including 150 plus MSMEs, 150+ domestic and international manufacturers, start-ups, regulatory agencies, state governments and Central Departments will participate in it.
As many as 7 states - Madhya Pradesh, Tamil Nadu, Uttar Pradesh, Himachal Pradesh, Rajasthan, Andhra Pradesh and Gujarat are setting up pavilions during the expo. The expo will also have pavilions for Innovations and R&D, wherein more than more than 30 companies will showcase new research and innovations. A separate pavilion for Start-ups will also be there and as many as 75 start-ups are participating in it. Further, 7 regulatory agencies for medical devices sector including Department of Pharmaceuticals, GeM, ICMR, IPC, CDSCO, NPPA and BIS are participating in it.
Thematic Conference Sessions will be organized during the 3-day event, with the aim to explore boundless frontiers of knowledge, inspire innovations, and forge connections that transcend boundaries. These sessions are created keeping in mind the aim of achieving Vision 2047, a vision that embodies India’s aspirations for the MedTech sector, not just within India but also as a significant contributor to the global healthcare landscape.
A total of 231 foreign buyers from 50 countries primarily from 5 major regions Africa, ASEAN, CIS, Middle East and Oceania will participate in the international buyer-seller meet. This include 55 government officials from Ministry of Health, 111 major buyers & importers of medical devices and equipment, and 60 procurement agencies, said the Department of Pharmaceuticals.


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