Updated 23 October 2026
In-vitro diagnostics distributors in India: 53 licensed establishments
India has 53 licensed establishments in the Index and no independent distributor yet.
The Bastion Hale Distributor Index lists 53 establishments in India whose registry records include in-vitro diagnostics: 0 independent distributors (a channel role such as importer, distributor, wholesaler or authorised representative, and no manufacturing of their own), 2 manufacturers' own import or sales entities, 0 regulatory representatives, and 51 manufacturers or exporters, out of 441 medical device establishments in India overall. The records come from US FDA (openFDA), MHRA UK and Health Canada, last seen on 23 October 2026.
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Include manufacturers, their own sales entities and regulatory representatives (53)
Manufacturers, companies that are a manufacturer's own import or sales arm, and regulatory representatives (authorised representatives, sponsors or registration holders with no import or distribution role). They are registered here but are not independent distributors.
- 1Heuer International (A division of GST Corporation Limited)NOIDA Uttar Pradesh0 lines1 registrationsize 42.7
- 2Harsoria Healthcare Pvt. Ltd. (Unit-2)Baddi Himachal Pradesh0 lines1 registrationsize 33.5
- 3HIMEDIA LABORATORIES PRIVATE LIMITEDDOMBIVLI, THANE Maharashtra, Maharashtra0 lines27 registrationssize 47.5
- 4Harsoria Healthcare Pvt. Ltd.Gurgoon Haryana0 lines10 registrationssize 44.2
- 5Hindustan Syringes & Medical Devices Ltd.Faridabad Haryana, Faridabad0 lines8 registrationssize 41.8
- 6Beckman Coulter India Private LimitedBengaluru (Bangalore) Urban Karnataka, KA0 lines3 registrationssize 32.4
- 7Microtrol Sterilisation Services Pvt. Ltd.Rewari Haryana0 lines2 registrationssize 33.7
- 8GREENS SURGICALS PRIVATE LIMITEDVadodara Gujarat0 lines1 registrationsize 39.6
- 9Auxein medical Private limitedSonipat Haryana0 lines1 registrationsize 39.2
- 10NARANG MEDICAL, LTD.New Delhi0 lines1 registrationsize 38.1
- 11Lord's Mark Industries Pvt LimitedDaman and Diu Dadra and Nagar Haveli0 lines1 registrationsize 38.0
- 12APOTHECARIES SUNDRIES MFG PVT LTDGURUGRAM Haryana0 lines1 registrationsize 35.6
- 13M/S TARUN ENTERPRISESPrayagraj, Uttar Pradesh0 lines1 registrationsize 35.6
- 14HOSPITAL EQUIPMENT MFG. CO.NOIDA Uttar Pradesh0 lines1 registrationsize 35.3
- 15MARK ENTERPRISESNashik Maharashtra0 lines1 registrationsize 34.8
- 16ENDONEST MEDICAL SYSTEMS LLPPALGHAR Maharashtra0 lines1 registrationsize 34.7
- 17MARKEN HEALTHTECH LIMITEDNASHIK Maharashtra0 lines1 registrationsize 33.1
- 18LAPAROMED PRIVATE LIMITEDMumbai Maharashtra0 lines1 registrationsize 33.0
- 19KDANS SURGICAL PRIVATE LIMITEDGANDHINAGAR Gujarat0 lines1 registrationsize 32.9
- 20AUROLABMADURAI Tamil Nadu0 lines1 registrationsize 32.4
In-vitro diagnostics covers analysers, reagents, rapid tests and laboratory consumables across chemistry, haematology, microbiology, immunology and genetics. IVD has its own regulation in most markets, and the EU regulates it under IVDR rather than MDR. Laboratory distributors usually differ from device distributors, even inside the same company.
By role
| Role | Establishments | Share | What it means |
|---|---|---|---|
| Distributor | 2 | 4% | Holds a distribution licence or is listed as distributor (Health Canada MDEL, SFDA, Oman MOH). |
| Registration holder | 3 | 6% | Holds device licences or registrations in its own name (Health Canada MDALL licence holder). |
| Manufacturer | 53 | 100% | Registered as a manufacturer with an address in this market, including foreign registrations. |
| Exporter | 8 | 15% | Registered with the US FDA as an exporter of devices made for export. |
An establishment can hold several roles, so the shares add to more than 100%.
Who holds the registration in India
In India the CDSCO import licence is held by an Indian authorised agent appointed by the manufacturer. The agent can be a distributor or an independent regulatory firm; the licence follows the agent.
This is the general rule, not legal advice. The registration clause in the first distributor contract decides who controls the market later. The Next 10 Markets report covers who holds the registration in each of your ten markets.
Questions about in-vitro diagnostics distributors in India
How many in-vitro diagnostics distributors are there in India?
The Index counts 53 establishments in India with in-vitro diagnostics in their registry record, of which 0 are independent distributors (a channel role and no manufacturing of their own). The number comes from US FDA (openFDA), MHRA UK and Health Canada and was last refreshed on 23 October 2026.
Who can hold an in-vitro diagnostics device registration in India?
In India the CDSCO import licence is held by an Indian authorised agent appointed by the manufacturer. The agent can be a distributor or an independent regulatory firm; the licence follows the agent.
How do I find an in-vitro diagnostics distributor in India?
Open the top establishments on this page and check their roles, principals and registration counts. Then search the Index for your device and India to see the top three names. For a ranked shortlist for your device, see the Next 10 Markets report.
What does the Distributor Index count as an in-vitro diagnostics distributor in India?
A company that appears in a public regulatory registry with an address in India and whose linked device listings fall in the in-vitro diagnostics segment, in any of the roles importer, distributor, wholesaler, authorised representative, registration holder, manufacturer or exporter. Each company is counted once.
Other segments in India
In-vitro diagnostics in other Asia Pacific markets
Sources
- US FDA Establishment Registration and Device Listing, openFDA bulk download: 53 establishments, last seen 23 October 2026. US government work, public domain.
- UK MHRA Public Access Registration Database (PARD): 7 establishments, last seen 23 October 2026. Public register.
- Health Canada MDALL active licence listing and MDEL establishment licence listing: 3 establishments, last seen 23 October 2026. Contains information licensed under the Open Government Licence, Canada.
Index build 23 October 2026. Each establishment is counted once per country after resolving names across sources. Company records only, as the registries publish them.
Registry data. Bastion Hale does not vouch for any establishment.