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CDSCO Directs Stakeholders: IVF Media, Reagents & ART Consumables Must Be Supplied Only to Registered Centres
Background
India's growing assisted reproductive technology (ART) sector operates under a dual regulatory framework — medical devices regulation for the products used, and sector-specific legislation for the facilities that use them. On 23 June 2026, the Drugs Controller General of India (DCGI), Dr. Rajeev Singh Raghuvanshi, issued a circular reminding all stakeholders of the obligations that arise from this intersection.
The circular, issued by the Central Drugs Standard Control Organisation (CDSCO) under its Medical Devices Division, addresses a specific and growing concern: ART media and related consumables are reportedly being supplied to facilities that are not registered under the governing Acts — creating risks for patients and enabling misuse of sensitive reproductive healthcare services.
What Does the Circular Say?
| Circular Date | 23 June 2026 |
| File Reference | MED/71/2026-eoffice |
| Issuing Authority | CDSCO, Medical Devices Division, Government of India |
| Signatory | Dr. Rajeev Singh Raghuvanshi, Drugs Controller General (India) |
| Addressed To | All Stakeholders |
| Copied To | All State/UT Licensing Authorities; All Zonal/Sub-zonal CDSCO offices; CDSCO website |
The circular makes the following key regulatory points:
- All medical devices — including ART media, In-Vitro Fertilization (IVF) solutions, cryopreservation reagents, and related consumables — are regulated under the Medical Devices Rules, 2017, and a licence is required to import or manufacture such products.
- These products are currently used by ART clinics and banks registered under the ART (Regulation) Act, 2021 and the Surrogacy (Regulation) Act, 2021.
- CDSCO has found that these products are being supplied to facilities not registered under those Acts — a practice that poses risk to patient health and welfare.
- All stakeholders are directed to ensure supply of such products only to registered ART and Surrogacy centres.
Which Products Are Covered?
The circular specifically covers media, reagents, and consumables used in Assisted Reproductive Technology procedures, including:
- In-Vitro Fertilization (IVF) media — culture media, sperm preparation media, and embryo transfer media used at various stages of IVF cycles.
- Cryopreservation materials — solutions and reagents used for freezing and storing gametes and embryos.
- Related ART consumables — ancillary reagents and supplies integral to ART procedures.
All such products fall under the purview of the Medical Devices Rules, 2017, and the circular applies to their manufacturers, importers, distributors, and traders alike.
Why Has CDSCO Acted Now?
The ART (Regulation) Act, 2021 and the Surrogacy (Regulation) Act, 2021 were enacted to ensure safe, ethical, and regulated practice of assisted reproductive services in India. Registration under these Acts is a prerequisite for operating ART clinics and banks, precisely because these procedures carry significant medical, ethical, and social implications.
CDSCO's circular flags that ART media and consumables — which are licensed medical devices — are finding their way to unregistered facilities. This creates a double compliance gap: unregistered facilities are already operating outside the ART regulatory framework, and the supply of licensed medical devices to them further undermines the integrity of the oversight system.
The risk, as stated in the circular, is two-fold: patient safety (use of such products outside regulated clinical settings) and potential misuse of ART services where ethical safeguards are absent.
Compliance Obligations for Stakeholders
Action Checklist — For Manufacturers, Importers & Distributors
- Verify the registration status of all ART/Surrogacy clinic customers before supply or renewal of supply agreements.
- Obtain and retain copies of valid registration certificates issued under the ART (Regulation) Act, 2021 or the Surrogacy (Regulation) Act, 2021.
- Halt supply to any facility that cannot produce proof of valid registration under the applicable Acts.
- Review existing distributor and sub-distributor chains to ensure downstream supply is similarly compliant.
- Ensure all such products continue to be manufactured or imported under a valid Medical Devices Rules, 2017 licence.
- Document customer verification as part of internal quality and compliance records.
Regulatory Framework at a Glance
- Medical Devices Rules, 2017 — Governs the import, manufacture, sale, and distribution of all medical devices in India, including ART media and reagents. A valid Central Licence (Form MD-9/MD-15) is required.
- ART (Regulation) Act, 2021 — Mandates registration of all ART clinics and banks with the National Registry and respective State Boards before they can provide ART services.
- Surrogacy (Regulation) Act, 2021 — Requires registration of surrogacy clinics and lays down conditions for ethical surrogacy practice in India.
What This Means for the ART Industry
This circular signals that CDSCO is actively tracking the supply chain for sensitive ART medical devices and is prepared to issue directions to the entire stakeholder ecosystem — not just device manufacturers — to enforce compliance. It also reflects a growing convergence between the medical devices regulatory framework and the newer ART sector legislation.
For device companies, importers, and traders, this is a clear signal to formalise customer eligibility verification as a standard step in their sales and distribution process. For ART clinics and banks, ensuring that registration under the 2021 Acts is current and in order is more important than ever — as suppliers will be checking.
Need Help Navigating ART or Medical Device Compliance?
Vaayath Consulting Services Private Limited provides end-to-end regulatory advisory for medical device licensing, ART sector compliance, and CDSCO interactions. Reach out to our team for guidance tailored to your product and business.
✉ Contact Us: info@vaayath.comDisclaimer: This blog post is prepared by Vaayath Consulting Services Private Limited for informational purposes only and is based on the CDSCO circular dated 23 June 2026 (File No. MED/71/2026-eoffice). It does not constitute legal or regulatory advice. Stakeholders are advised to refer to the official circular and consult a qualified regulatory professional for specific compliance requirements.
