Lok Sabha Question No. 4626 (UNSTARRED), answered on 2026-03-20
Subject: MedTech Mitra Initiative
Ministry: HEALTH AND FAMILY WELFARE
Asked by: Shri Bastipati Nagaraju, Shri B K Parthasarathi

## GOVERNMENTOFINDIA MINISTRY OFHEALTH AND FAMILY WELFARE DEPARTMENTOFHEALTH RESEARCH

## LOK SABHA UNSTARRED QUESTION NO. 4626 TO BE ANSWERED ON 20 TH MARCH, 2026

## MEDTECH MITRAINITIATIVE

## 4626. SHRI BASTIPATI NAGARAJU: SHRI B K PARTHASARATHI:

Will the Minister of HEALTHANDFAMILYWELFARE be pleased to state:

- (a) the details of the total number of project proposals received and approved under the MedTech Mitra initiative, State wise;
- (b) the details of the funds allocated for this initiative since its inception, year-wise and projectwise;
- (c) the details of the average time taken to grant regulatory clearance and approvals to MedTech innovators;
- (d) whether any issues have been reported in the implementation of the scheme; and
- (e) if so, the details thereof along with the measures taken by the Government to address the same?

## ANSWER THE MINISTER OF STATE IN THE MINISTRY OF HEALTH AND FAMILY WELFARE

## (SHRI PRATAPRAO JADHAV)

(a) and (b): Indian Council of Medical Research (ICMR) has informed that the MedTech Mitra provides end-to-end guidance for the development and commercialization of medical technologies, including medical devices, diagnostics, therapeutics, and vaccines to innovators from academia, start -ups and industry.

- i. Total number of applications received from innovators on MedTech MITRA: 826
- ii. Total queries addressed so far through personal interaction including Technical Advisory Committee (TAC) meetings: 748
- iii. The state-wise distribution of applications is given in Annexure.

MedTech Mitra is an inter-ministerial and inter-departmental initiative and the applicants get support from several knowledge partners such as ICMR for pre-clinical and clinical evaluation, Department of Health Research (DHR) for Health Technology Assessment (HTA) and inclusion in Treatment Guidelines, Central Drugs Standard Control Organization (CDSCO) for guidance on regulatory pathway, National Institution for Transforming India (NITI) Aayog for mediating investor support, Atal Innovation Mission and ICMR-CoEs in 6 Indian Institute of Technology (IITs) for incubation support, Bureau of Indian Standards for quality standards related support, Atomic Energy Regulatory Board for support to devices related to radiation based diagnosis and therapy, Andhra MedTech Zone for pre-compliance gap analysis and bench top testing of medical devices, Department of Pharmaceuticals for industrial support for test batches, Ministry of Micro, Small and Medium Enterprises (MSME) for up-scaling the innovative products, National Health Systems Resource Centre (NHSRC) and Government e- Marketplace (GeM) for procurement. The following are the details of funds allocated for the initiative from DHR-ICMR:

1. ICMR has established 8 Centres for Advanced Research (CAR) at prestigious medical colleges & hospitals institutes for undertaking clinical evaluation of medical devices & diagnostic technologies. Total funding sanctioned from 2024-2026 is approximately Rs. 42 crore.
2. The funding of Rs. 6.8 crore for a period of one year (2024-25) has been sanctioned to ICMRCAR at AMTZ for undertaking pre-compliance gap analysis & testing of MedTech Mitra technologies.
3. The funding of Rs. 2.96 crore has been approved for undertaking clinical investigation of 2 medical device technologies through ICMR- Indian Clinical Trial and Education Network (INTENT).
4. The funding of Rs. 3.05 crore has been approved for undertaking clinical studies of therapeutics & vaccines through ICMR-INTENT.
5. The pre-clinical studies of medical devices are being undertaken at ICMR-National Animal Resource Centre for Biomedical Research (NARFBR), Hyderabad. Total budget for undertaking these studies is Rs. 1.25 crore.
6. (c) to (e): MedTech Mitra initiative provides support for regulatory facilitation including regulatory dossier submission, query resolution and formulation of regulatory strategy. Since its launch, many innovators have benefitted from the regulatory guidance and support. Till now, 70 innovators have received Test Licences. In view of the timely and appropriate regulatory guidance and pre-clinical and clinical support, the average time taken for the regulation compliant development is reduced and varies for different products. The implementation of this initiative has been effective as per the outcome of support extended in the form of incubation, regulatory approvals, pre-clinical and clinical evaluation, feedback from the innovators and stakeholders. The initiative was launched with 7 knowledge partners. To further enable the different strategic support for innovators, particularly in the areas of: a) radiation-based technologies, b) access to the Government e- Marketplace (GeM) for innovators at advanced stages, and c) assessment of technology suitability across different levels of healthcare (primary, secondary/community, and tertiary), additional experts have been on-boarded as knowledge partners from the Atomic Energy Regulatory Board (AERB), GeM, and National Health Systems Resource Centre (NHSRC), respectively. To further strengthen the MedTech ecosystem, Ministry of Micro, Small and Medium Enterprises (MSME) was also onboarded as key knowledge partner. In order to provide holistic support to MedTech Innovators, 'Medical Innovations Patent Mitra' initiative has been launched by ICMR, under the guidance of NITI Aayog, in partnership with Department of Pharmaceuticals (DoP) and supported by Department for Promotion of Industry and Internal Trade (DPIIT). This initiative provides expert guidance and comprehensive support to innovators in biomedical domain, facilitating patent filings and technology transfer of medical innovations, thereby strengthening the innovation ecosystem of India.

## ANNEXURE

## ANNEXURE REFERRED TO IN REPLY TO PARTS (a) and (b) OF THE LOK SABHA UNSTARRED QUESTION NO. 4626 FOR 20.03.2026 REGARDING MEDTECH MITRA INITIATIVE

| State            |   No. of applications |
|------------------|-----------------------|
| Andhra Pradesh   |                    22 |
| Assam            |                     3 |
| Bihar            |                     5 |
| Delhi            |                   109 |
| Goa              |                     6 |
| Gujarat          |                    45 |
| Haryana          |                    51 |
| Himachal Pradesh |                     2 |
| Jammu &Kashmir   |                     1 |
| Jharkhand        |                     6 |
| Karnataka        |                   112 |
| Kerala           |                    12 |
| Madhya Pradesh   |                    17 |
| Maharashtra      |                   162 |
| Meghalya         |                     1 |
| Nagaland         |                     1 |
| Odisha           |                     9 |
| Puducherry       |                     1 |
| Punjab           |                    26 |
| Rajasthan        |                    13 |
| Tamil Nadu       |                    66 |
| Telangana        |                    35 |
| Uttar Pradesh    |                    82 |
| Uttarakhand      |                    16 |
| West Bengal      |                    23 |

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